|
| VAERS ID: |
910053 (history) |
| Form: |
Version 2.0 |
| Age: |
31.0 |
| Sex: |
Male |
| Location: |
Idaho |
| Vaccinated: | 2020-12-24 |
| Onset: | 2020-12-24 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
- / IM |
Administered by: Private Purchased by: ?
Symptoms: Dyspnoea,
Electrocardiogram,
Nausea,
Pharyngeal swelling,
Respiratory viral panel,
SARS-CoV-2 test negative,
Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amphetamine-dextroamphetamine Zolpidem
Current Illness: Acid Reflux Hiatal Hernia
Preexisting Conditions: Acid Reflux Hiatal Hernia
Allergies: no known
Diagnostic Lab Data: COVID-19 test - negative Respiratory panel - negative CMC EKG
CDC Split Type:
Write-up: 15 minute post vaccination observation patient denied any symptoms. Later in the day patient experienced significant nausea and vomiting followed by mild SOB and throat swelling. |
|
| VAERS ID: |
910059 (history) |
| Form: |
Version 2.0 |
| Age: |
37.0 |
| Sex: |
Female |
| Location: |
Kentucky |
| Vaccinated: | 2020-12-23 |
| Onset: | 0000-00-00 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA |
025J20A / 1 |
LA / IM |
Administered by: Other Purchased by: ?
Symptoms: Acute kidney injury,
Endotracheal intubation,
Gait inability,
Hypoaesthesia,
Pyrexia,
Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), Sexual dysfunction (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cetirezen 10 mg Daily, Lasix 20 Mg daily, Gabapentin 400 bid, Glipizide 5 mg daily, lisnopril 5 mg daily, Levothyroxine25mcg daily, Metoxican 7.5 daily, Sertraline 50 daily
Current Illness: none
Preexisting Conditions: Depression, Diabetes ,Hypertension, Hypothyroidism, Obesity
Allergies: Pencillian
Diagnostic Lab Data:
CDC Split Type:
Write-up: Numbness in sole of feet. Unable to walk, develop high fever, resp failure resulting in intubation, acute kidney injury |
|
| VAERS ID: |
910133 (history) |
| Form: |
Version 2.0 |
| Age: |
64.0 |
| Sex: |
Female |
| Location: |
South Dakota |
| Vaccinated: | 2020-12-23 |
| Onset: | 2020-12-24 |
| Days after vaccination: | 1 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA |
025J20-2A / 1 |
LA / IM |
Administered by: Private Purchased by: ?
Symptoms: C-reactive protein increased,
Full blood count normal,
Speech disorder,
Swollen tongue,
X-ray normal
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Guaifenesin, Albuterol Inh, levothyroxine, amlodipine, coreg, Claritin.
Current Illness: none
Preexisting Conditions: Hypothyroidism, Hypertension, menopause
Allergies: environmental (sneezy/watery eyes), ibuprofen,
Diagnostic Lab Data: Labs completed at 1352. CBC WNL. CRP 7.4. Soft tissue neck xray at 1527 with no acute findings.
CDC Split Type:
Write-up: Noted tongue starting to swell on 12/24 at 1030. Started on left side, then progressed to right side. No SOB, difficulty swallowing or breathing, but staff noted difficulty understanding her speech. Presented to ED at 1300. 50mg Benadryl given IV on 12/24 at 1328 and 125mg solumedrol given IV at 1327. Pt reported improvement in tongue swelling at 1630. |
|
| VAERS ID: |
910202 (history) |
| Form: |
Version 2.0 |
| Age: |
39.0 |
| Sex: |
Male |
| Location: |
New Jersey |
| Vaccinated: | 2020-12-18 |
| Onset: | 2020-12-23 |
| Days after vaccination: | 5 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EH9899 / 1 |
RA / SYR |
Administered by: Private Purchased by: ?
Symptoms: Arthralgia,
COVID-19,
Dizziness,
Loss of consciousness,
Occupational exposure to SARS-CoV-2,
SARS-CoV-2 test positive,
Seizure,
Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: Yes/ medical records.
CDC Split Type:
Write-up: Pediatrician working in the hospital. Was exposed the an office contact wo had covid. Shoulder in soreness. At work on Wednesday. Felt lightheaded had to sit in chair. That''s all he reminders. He workup to a CODE team putting oxygen on him. He has a seizure. Took the COVID test has COVID. Admitted to hospital for 2 days. Likely a syncopal event. |
|
| VAERS ID: |
910251 (history) |
| Form: |
Version 2.0 |
| Age: |
41.0 |
| Sex: |
Male |
| Location: |
Kentucky |
| Vaccinated: | 2020-12-17 |
| Onset: | 2020-12-27 |
| Days after vaccination: | 10 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EK5730 / 1 |
LA / IM |
Administered by: Private Purchased by: ?
Symptoms: Asthenia,
Blood magnesium,
Blood thyroid stimulating hormone,
C-reactive protein,
Chest X-ray,
Computerised tomogram head normal,
Electrocardiogram,
Full blood count,
Influenza virus test,
Lumbar puncture,
Metabolic function test,
Mobility decreased,
Muscular weakness,
SARS-CoV-2 test,
Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine, nicotine patches, Descovy, azelastine, cetirizine, ibuprofen
Current Illness: none
Preexisting Conditions: hypertension, irritable bowel syndrome, kidney stones, HIV exposure 2 months ago
Allergies: none
Diagnostic Lab Data: 12/28/20 Lumbar puncture, urine analysis, COVID test, inflenza tesk, CBC, CT head was negative, CXR, ECG, TSH, Magnesium, CMP, CRP
CDC Split Type:
Write-up: 41-year-old male who presents to the ED today with a complaint of weakness in his bilateral arms and legs. He states he fell slightly weak yesterday but this morning when he woke up around 6 AM he was not able to get out of bed because he was so weak. He states he feels like he has no muscle strength in his arms and legs. He denies any fever. He denies any cough or shortness of breath. He denies any chest pain or abdominal pain. He denies any nausea, vomiting or diarrhea. He denies any numbness in his extremities. He denies any neck or back pain. He did receive the first Covid vaccination on December 17. |
|
| VAERS ID: |
910363 (history) |
| Form: |
Version 2.0 |
| Age: |
84.0 |
| Sex: |
Male |
| Location: |
California |
| Vaccinated: | 2020-12-23 |
| Onset: | 2020-12-26 |
| Days after vaccination: | 3 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA |
LOT 039K20A / 1 |
RA / IM |
Administered by: Senior Living Purchased by: ?
Symptoms: Death,
Hypophagia,
Hypotension,
Somnolence
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2020-12-28
Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: risperidone daily doxazosin
Current Illness: dementia declining oral intake
Preexisting Conditions: history of aspiration pneumonia BPH
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:
Write-up: Patient had mild hypotension, decreased oral intake, somnolence starting 3 days after vaccination and death 5 days after administration. He did have advanced dementia and was hospice eligible based on history of aspiration pneumonia. |
|
| VAERS ID: |
910602 (history) |
| Form: |
Version 2.0 |
| Age: |
46.0 |
| Sex: |
Female |
| Location: |
California |
| Vaccinated: | 2020-12-18 |
| Onset: | 2020-12-18 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EJ1685 / 1 |
- / OT |
Administered by: Unknown Purchased by: ?
Symptoms: Abdominal pain lower,
Pancreatitis
SMQs:, Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETAMINOPHEN; ; SERTRALINE HCL; ZOLOFT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2020506207
Write-up: pancreatitis; acute lower abdominal pain; This is a spontaneous report from a contactable pharmacist. A 46-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly on 18Dec2020 at 08:00 (as reported) at 46-years-old at a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient had no known drug allergy (NKDA). Concomitant medications included acetaminophen (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN), sertraline hcl (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT); all taken for an unspecified indication from an unspecified date to an unspecified date (which were received within two weeks of vaccination). On 18Dec2020 at 17:00, the patient experienced pancreatitis and acute lower abdominal pain; which required hospitalization and were assessed as medically significant. The patient was hospitalized for pancreatitis and acute lower abdominal pain for 3 days on unspecified dates. The clinical course was reported as follows: The patient received the vaccine " at some point in the AM on 18Dec2020 (as reported)." That evening, the patient presented to the emergency department (ED) with acute lower abdominal pain. The patient was diagnosed with pancreatitis and was admitted overnight. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of pancreatitis and acute lower abdominal pain. The clinical outcome of the events was recovering.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association , there is no evidence or argument to suggest a causal relationship between BNT162B2 and the events pancreatitis and acute lower abdominal pain. The events are likely due to an underlying medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. |
|
| VAERS ID: |
910624 (history) |
| Form: |
Version 2.0 |
| Age: |
|
| Sex: |
Male |
| Location: |
Unknown |
| Vaccinated: | 0000-00-00 |
| Onset: | 0000-00-00 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
- / - |
Administered by: Unknown Purchased by: ?
Symptoms: Basal ganglia haemorrhage,
Condition aggravated,
Hypertension
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypertension (narrow)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2020507193
Write-up: Admitted to the hospital with hypertensive basal ganglia bleed, had a head bleed; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in 2020 at single dose for COVID-19 immunization. Medical history included hypertension. The patient''s concomitant medications were not reported. After vaccination, the patient was admitted to the hospital with hypertensive basal ganglia bleed, had a head bleed in 2020. The outcome of event was unknown. Information on the lot/batch number has been requested. |
|
| VAERS ID: |
910626 (history) |
| Form: |
Version 2.0 |
| Age: |
|
| Sex: |
Male |
| Location: |
Unknown |
| Vaccinated: | 2020-12-16 |
| Onset: | 2020-12-19 |
| Days after vaccination: | 3 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
RA / - |
Administered by: Other Purchased by: ?
Symptoms: Respiratory distress,
SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201219; Test Name: covid test/Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2020507536
Write-up: resp distress; This is a spontaneous report from a non-contactable consumer (patient). An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at 16Dec2020 12:00 pm at single dose for covid-19 immunization. Vaccine location was right arm and it was the first dose. The patient medical history and concomitant medications were not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced respiratory distress on 19Dec2020, he was hospitalized for three days. Patient received treatment for the adverse event. Since the vaccination, the patient has been tested for COVID-19 with nasal swab on 19Dec2020, it was negative. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown. The event was serious, the seriousness criteria was Caused/prolonged hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. |
|
| VAERS ID: |
910641 (history) |
| Form: |
Version 2.0 |
| Age: |
54.0 |
| Sex: |
Female |
| Location: |
Maryland |
| Vaccinated: | 2020-12-18 |
| Onset: | 2020-12-18 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-28 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
LA / - |
Administered by: Unknown Purchased by: ?
Symptoms: Cardiac monitoring,
Chest X-ray,
Computerised tomogram,
Dizziness,
Emotional distress,
Fatigue,
Feeling abnormal,
Heart rate decreased,
Hypersomnia,
Injection site pain,
Muscular weakness,
Pain in extremity,
Palpitations,
Paraesthesia,
Pulse abnormal,
Scan with contrast,
Ventricular extrasystoles,
Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Hypokalaemia (broad), Noninfectious myocarditis/pericarditis (broad)
Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20201222; Test Name: Blood pressure; Result Unstructured Data: Test Result:163/76; Comments: Normal base line is 130s/80s maybe lower; Test Date: 20201222; Test Name: cardiac monitor; Result Unstructured Data: Test Result:Results are pending; Test Date: 20201222; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown result; Comments: Result: Pending; Test Date: 20201222; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown result; Comments: Result: Pending; Test Date: 20201222; Test Name: Heart rate; Result Unstructured Data: Test Result:80s-90s; Comments: 90s and then drop to 48; Test Date: 20201219; Test Name: pulse; Result Unstructured Data: Test Result:Thready; Test Date: 20201222; Test Name: Pulse oximetry; Result Unstructured Data: Test Result:97-99 %
CDC Split Type: USPFIZER INC2020508928
Write-up: Weakness and tingling down left arm; Weakness and tingling down left arm; Lightheaded; PVC''s every 3 beats; emotional too and just very tired; Can not read the vaccination card as she does not have her glasses; Palpitations; Fatigue; Slept a lot; Thready pulse and vertigo; Thready pulse and vertigo; Soreness in left arm at the injection site and down the left arm; Soreness in left arm at the injection site and down the left arm; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, reason for no lot number of COVID Vaccine: Can not read the vaccination card as she does not have her glasses, Expiry Date unknown), via an unspecified route of administration in the left arm on 18Dec2020 at single dose for ''Work with COVID patients''. Medical history included none. There were no concomitant medications. The patient experienced weakness and tingling down left arm (hospitalization) on 22Dec2020, lightheaded (hospitalization) on 22Dec2020, PVC''s every 3 beats (hospitalization) on 22Dec2020, soreness in left arm at the injection site and down the left arm on 18Dec2020, thready pulse and vertigo on 19Dec2020, fatigue on 20Dec2020, slept a lot on 19Dec2020, palpitations on 21Dec2020. Details as follows: Caller says she received the vaccine, she is a nurse. She got the vaccine on Friday, 18Dec2020. She had soreness in her arm and at the injection site on Friday but that was it. On Saturday (19Dec2020) she noticed a thready pulse, but went on with her day with only a little arm pain. Sunday (20Dec2020) she was fatigued and the thready pulse continued. She slept a lot on Saturday (19Dec2020) and Sunday (20Dec2020). Yesterday (21Dec2020) she felt a little better, but had palpitations here and there. This morning (22Dec2020) she went into work, was very lightheaded, had tingling down her left arm, and had palpitations. So she hooked herself up to a monitor. Her pulse ox was between 97-99%. Her heart rate would be in the 90s and then drop to 48, so she went down to the ED. She has had a CT, and she is throwing PVC''s every 3 beets. She has not been admitted as they are still waiting for results. She is still in the ED. They did a CT to see if there was a possible clot. On 18Dec2020 she received the vaccine around 2 PM. She had soreness at the injections site and down the left arm, which went away by Sunday (20Dec2020). She now (22Dec2020) has weakness and tingling down the left arm. It was never red or anything at the injection site. Saturday, 19Dec2020, she had thready pulse and Vertigo which lasted until Sunday 20Dec2020. She would be laying in bed and try to flip to the other side and having vertigo. When the fatigue started on Sunday (20Dec2020) she did not feel like herself. She was very emotional too and just very tired. Since she went to the ED she has had a CT scan, one with contrast and one without. She had a chest X-ray, and she is on a cardiac monitor. Results are pending. She has Trigeminy PVCs. She says she never goes to the hospital. But she is not admitted yet (pending clarification). Can not read the vaccination card as she does not have her glasses. Unable to read off the NDC, lot, and expiration date. History: Has been on the same vitamins for two years with nothing new. Blood pressure: Normal base line is 130s/80s maybe lower. Heart rate: Currently within her normal limits of 80s-90s. Depending on what happens, it was asked if she should get the second dose. The patient underwent other lab tests and procedures which included blood pressure measurement: 163/76 on 22Dec2020, chest x-ray: unknown result on 22Dec2020 (Result: Pending), computerised tomogram (CT scan): unknown result on 22Dec2020 (Result: Pending), heart rate: 80s-90s on 22Dec2020, Pulse oximetry: 97-99 % on 22Dec2020, cardiac monitor: results are pending on 22Dec2020. The outcome of events weakness and tingling down left arm, pvc''s every 3 beats, lightheaded, palpitations and fatigue was not recovered. The outcome of the event soreness in left arm at the injection site and down the left arm was recovered on 20Dec2020. The outcome of the events thready pulse and vertigo was recovered on 20Dec2020. The outcome of the event slept a lot was recovered on 20Dec2020. The outcome of other events was unknown. Information on the lot/Batch number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. |
|
