chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight Fever; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Slight Fever) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Pneumonia, Diabetes, Dysphagia, Cognitive impairment (Mild Cognitive Impairment) and BPH. Concomitant products included RIVASTIGMINE (EXELON PATCH 10) for Dementia, INSULIN GLARGINE (LANTUS) for Diabetes, HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE SAR) for Hypertension, OXYCODONE HYDROCHLORIDE (OXYCODONE ACCORD LP) for Pain, CARBIDOPA, LEVODOPA (SINEMET DEPOT) for Parkinson's disease.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight Fever). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PYREXIA (Slight Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-315627 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 Patients received their 2 nd dose from a vial greater than 12 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 Patients received their 2 nd dose from a vial greater than 12 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 Patients received their 2 nd dose from a vial greater than 12 hours post puncture). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 Patients received their 2 nd dose from a vial greater than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Fatigue, Feeling abnormal, Hypotension, Pain in extremity
Clinical narrative: Dizziness; Arm is sore; Some days better than others as far as how she feels; Hypotension; Fatigue; occasionally feels exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore), FEELING ABNORMAL (Some days better than others as far as how she feels), HYPOTENSION (Hypotension) and FATIGUE (Fatigue; occasionally feels exhausted) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension.   On 15-Apr-2021, the patient started TREPROSTINIL SODIUM (TYVASO) (Other) 0.6 milligram per millilitre, 18-54 µg (3-9 breaths) four times a day (QID) via inhalation (IH) route.. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore), FEELING ABNORMAL (Some days better than others as far as how she feels), HYPOTENSION (Hypotension) and FATIGUE (Fatigue; occasionally feels exhausted). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Arm is sore), FEELING ABNORMAL (Some days better than others as far as how she feels), HYPOTENSION (Hypotension) and FATIGUE (Fatigue; occasionally feels exhausted) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.   The patient reported that she just had COVID booster and arm was sore, some days have been better than others as far as how she felt, blood pressure was low at times with some dizziness, and also occasionally felt exhausted. Action taken with Tyvaso was not reported for the events of pain in extremity, feeling abnormal, hypotension, dizziness, and fatigue.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received includes No new information
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment information was provided.  It was reported that Our Moderna vaccine (Lot# 026C21A) was pulled from the freezer on 10/13/2021 with a "use by date" of 11/12/2021 (30 days storage viability in the fridge). The Moderna Vial does not have an expiration date on it. However the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 10/24/2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received-No new information was added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported No treatment medication was provided It was reported that Our Moderna vaccine (Lot# 026C21A) was pulled from the freezer on 10/13/2021 with a "use by date" of 11/12/2021 (30 days storage viability in the fridge). The Moderna Vial does not have an expiration date on it. However the Moderna Vail Expiration Date Checker states that this lot number has an expiration date of 10/24/2021.   This case was linked to MOD-2021-364614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received contain information about the dose and updated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product details and treatment product details were not provided.   This case was linked to MOD-2021-364572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains no new information.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered on 25Oct2021 has an expiration date of 10/24/2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021 has an expiration date of 10/24/2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021 has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered on 25Oct2021 has an expiration date of 10/24/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided.  No treatment medication details was provided.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge). The Moderna Vial did not have an expiration date on it. However,The expired vaccine was administered to patients on 25 Oct 2021 and 26 Oct 2021.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contain no new information.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given. In source document stated that vaccine was pulled from the freezer on 10/13/2021 with a "use by date" of 11/12/2021   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up  contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nausea, Rhinorrhoea
Clinical narrative: Cough; Runny nose; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose) and NAUSEA (Nauseous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced NAUSEA (Nauseous). On 27-Oct-2021, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported. It was reported that the patient received moderna vaccine on 26 Oct 2021 and felt nauseous. On 27 Oct 2021 the patient had a cough and runny nose.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-364572, MOD-2021-364614 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received  contains no new information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-364572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up contains no new information.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow Up received includes no new information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received on 29-OCT-2021 contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a vaccine more than 12 hours after puncture/ vial is not discarded after 12 hours and a dose is inadvertently administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a vaccine more than 12 hours after puncture/ vial is not discarded after 12 hours and a dose is inadvertently administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a vaccine more than 12 hours after puncture/ vial is not discarded after 12 hours and a dose is inadvertently administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a vaccine more than 12 hours after puncture/ vial is not discarded after 12 hours and a dose is inadvertently administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Hand was tingling and numb like I had slept on it and it is still like that; My fingers on my right hand; Hand was tingling and numb like I had slept on it and it is still like that; My fingers on my right hand; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0179), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient was calling because patient took the Pfizer vaccine on the 29th (not clarified) and on the 30th, patient woke up and hand was tingling and numb like, patient had slept on it and it was still like that, today was the 8th. Patient stated that fingers on right hand, was that one of the side effect. Patient wanted to know that how long is it supposed to last. The Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: He got a bad reaction to it. He was sicker from the injection than he was with COVID; This is a spontaneous report from a contactable consumer (patient), based on information received by Pfizer (manufacturer control number US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-053531). This case was split from master case # 2021681255 to capture a 83-year-old male patient received COVID-19 Vaccine and experienced Sickness.  A 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date May2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 from Jan2021 to an unknown date, atrial fibrillation from 20Apr2021 to an unknown date, drug allergy statins, pneumonia, fall, CVA, cardiovascular disease, unspecified. Concomitant medications included apixaban (ELIQUIS) taken for cerebrovascular accident prophylaxis from 20Apr2021 to 01Jun2021, evolocumab (REPATHA), amlodipine, omeprazole, clopidogrel, tamsulosin. The patient previously took steroids. On an unspecified date the patient reported he got a bad reaction to it. he was sicker from the injection than he was with covid. His HCP told him to stretch the second injection out a little longer to five or six weeks. The outcome of the event was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Urticaria
Clinical narrative: Welts all over body / Urticaria; Flucelvax given on 10Oct2021; Flucelvax given on 10Oct2021; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 26Oct2021, this case now contains a serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (the patient) and nurse. A 12-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 10Oct2021 12:00 (Lot Number: FC3182, at the age of 12-years-old) as dose 1, single for COVID-19 immunization; influenza vaccine inact sag 3v (FLUCELVAX), via an unspecified route of administration in the left arm on 10Oct2021 (Lot number was not reported), as dose 1, single for immunization. Medical history included: ongoing egg allergy. The patient did not have COVID prior to vaccination. Family medical history included her dad had hives with first COVID injection/ vaccine. There were no concomitant medications. On 11Oct2021 08:00 (also reported as 11:00), the patient experienced welts all over body, also reported as urticaria. Treatment included dexamethasone acetate (DECADRON) intramuscular (IM) injection 1 mg, diphenhydramine 50 mg oral. Treatment also included diphenhydramine hydrochloride (BENADRYL), prednisone, and famotidine. The clinical course was as follows: hives started 11Oct2021 morning, seen at urgent care 11Oct2021, given DECADRON IM, prednisone, BENADRYL. Seen at primary care physician office on 12Oct2021, still had hives. Added famotidine to the regimen (H2 blocker). A nurse reported the patient provided information regarding the reported adverse event. The nurse considered BNT162B2 to have a casual effect to the adverse event. The outcome of urticaria was recovering. The patient was not tested for COVID post-vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided and known safety profile, a causal association between BNT162B2 and the reported hives cannot be completely excluded. 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Hyperhidrosis, Immunisation
Clinical narrative: Extremely fatigued; pain in sternum that traveled to right arm.; pain in sternum that traveled to right arm.; Chills; sweating after getting booster 2 weeks ago; Booster; This is a spontaneous report from a contactable Nurse. This 55-year-old female Nurse reported that: A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FF2588) intramuscular, administered in arm left on 29Sep2021 15:00 (at the age of 55-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included hypertension and food allergy (known allergies: Kiwi) from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was received other medications in two weeks HTCZ. The patient had covid prior vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL0142) intramuscular, administered in right arm on 06Jan2021 as dose 1, single and received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1284) intramuscular, administered in left arm on 27Jan2021 as dose 2, single both doses for covid-19 immunization (at the age of 54-years-old). On 29Sep2021 15:00, the patient had booster. On 11Oct2021, the patient experienced extremely fatigued, pain in sternum that traveled to right arm, chills and sweating after getting booster 2 weeks ago. Treatment was received in response to the adverse events Tylenol and Alka Seltzer cold and flu tablets. The patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. Covid test type Nasal Swab.  the patient underwent lab tests and procedures which included Nasal swab test: negative result. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Extremely fatigued; pain in sternum that traveled to right arm.; pain in sternum that traveled to right arm.; Chills; sweating after getting booster 2 weeks ago; Booster; This is a spontaneous report from a contactable Nurse. This 55-year-old female Nurse reported that: A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FF2588) intramuscular, administered in arm left on 29Sep2021 15:00 (at the age of 55-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included hypertension and food allergy (known allergies: Kiwi) from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was received other medications in two weeks HTCZ. The patient had covid prior vaccination. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL0142) intramuscular, administered in right arm on 06Jan2021 as dose 1, single and received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1284) intramuscular, administered in left arm on 27Jan2021 as dose 2, single both doses for covid-19 immunization (at the age of 54-years-old). On 29Sep2021 15:00, the patient had booster. On 11Oct2021, the patient experienced extremely fatigued, pain in sternum that traveled to right arm, chills and sweating after getting booster 2 weeks ago. Treatment was received in response to the adverse events Tylenol and Alka Seltzer cold and flu tablets. The patient diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. Covid test type Nasal Swab.  the patient underwent lab tests and procedures which included Nasal swab test: negative result. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: developed a swollen left Infraclavicular lymph node about the size of a gumball and very painful.; developed a swollen left Infraclavicular lymph node about the size of a gumball and very painful.; This is a spontaneous report from a contactable consumer (patient). This 44 year-old female consumer (Patient) reported for herself.  A 44-year-old non-pregnant female (not-pregnant at the time of vaccination) patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2589), via an unspecified route of administration, administered in Left arm on 09Sep2021 11:00 AM (age at vaccination 43-year-old), as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: PF2590), via an unspecified route of administration, administered in Left arm on 11Oct2021 11:30 AM (age at vaccination 44-year-old), as dose 2, single for covid-19 immunisation. The patient's medical history was none. The patient had no known allergies. Concomitant medications included trazodone (TRAZODONE) and escitalopram oxalate (LEXAPRO) taken for an unspecified indication within 2 weeks of vaccination. On 21Sep2021 08:00 AM within 1-2 days after each shot, the patient experienced a swollen left infraclavicular lymph node about the size of a gumball and very painful. The patient did not receive any treatment for the events. The patient had no COVID prior vaccination. The patient did not receive any other vaccine in four weeks. The patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 04Apr2021. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Fluid retention, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: had been slowly gaining water weight and all of a sudden in Aug it began to accelerated to the point where he couldn''t breath very well and his oxygen dropped; all of a sudden he gained 5 pounds that proved to be water gain; all of a sudden he gained 5 pounds that proved to be water gain; inability to take full breaths; getting tired easily; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received bnt162b2 (Lot Number: ER8734; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in arm left on 03Apr2021 10:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. Medical history included asthma (in past and lungs not so great). The patient's concomitant medications were not reported. The patient previously received first dose of BNT162b2 (Lot number: EN6208, Expiry Date: 30Jun2021) in left upper arm on 13Mar2021 for Covid-19 immunization and no adverse effect. The patient wanted to report back about the virus check he had a health situation that arose that may have traced back to the second Pfizer Covid vaccine. He ended up in the emergency room and had extensive follow up visits and nothing was apparently resolved. The received the second vaccine on 03Apr2021. It took a while for things to happen and it wasn't obvious at first. He had inability to take full breaths and was getting tired easily. That started about a month or so after the second vaccine, after May. It got slowly worse over time until it got to Aug2021 and then all of a sudden he gained 5 pounds that proved to be water gain. He had been slowly gaining water weight and all of a sudden in Aug it began to accelerate to the point where he couldn't breathe very well and his oxygen dropped. The extensive follow up visits started also 09Aug2021 and he is currently being treated with diuretics. They started him on one dose and then another one. Clarifies he is being treated with Furosemide (brand Lasix) 20mg 1 tablet by mouth daily, but originally was on 40mg. Unable to provide the NDC, Lot, or expiry for either dose from orange pharmacy bottle. Family medical history relevant to the events was none. No further details provided. No other vaccines received the same day and no problems with vaccines in the past. States his last appointment he had was on 09Sep2021. No further details provided. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight increased
Clinical narrative: had been slowly gaining water weight and all of a sudden in Aug it began to accelerated to the point where he couldn''t breath very well and his oxygen dropped; all of a sudden he gained 5 pounds that proved to be water gain; all of a sudden he gained 5 pounds that proved to be water gain; inability to take full breaths; getting tired easily; This is a spontaneous report from a contactable consumer. A 55-year-old male patient received bnt162b2 (Lot Number: ER8734; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in arm left on 03Apr2021 10:00 (at the age of 55-year-old) as single dose for covid-19 immunisation. Medical history included asthma (in past and lungs not so great). The patient's concomitant medications were not reported. The patient previously received first dose of BNT162b2 (Lot number: EN6208, Expiry Date: 30Jun2021) in left upper arm on 13Mar2021 for Covid-19 immunization and no adverse effect. The patient wanted to report back about the virus check he had a health situation that arose that may have traced back to the second Pfizer Covid vaccine. He ended up in the emergency room and had extensive follow up visits and nothing was apparently resolved. The received the second vaccine on 03Apr2021. It took a while for things to happen and it wasn't obvious at first. He had inability to take full breaths and was getting tired easily. That started about a month or so after the second vaccine, after May. It got slowly worse over time until it got to Aug2021 and then all of a sudden he gained 5 pounds that proved to be water gain. He had been slowly gaining water weight and all of a sudden in Aug it began to accelerate to the point where he couldn't breathe very well and his oxygen dropped. The extensive follow up visits started also 09Aug2021 and he is currently being treated with diuretics. They started him on one dose and then another one. Clarifies he is being treated with Furosemide (brand Lasix) 20mg 1 tablet by mouth daily, but originally was on 40mg. Unable to provide the NDC, Lot, or expiry for either dose from orange pharmacy bottle. Family medical history relevant to the events was none. No further details provided. No other vaccines received the same day and no problems with vaccines in the past. States his last appointment he had was on 09Sep2021. No further details provided. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased interest, Furuncle, Hair growth abnormal, Penis disorder, Taste disorder
Clinical narrative: boil to left ear; small boils to crotch area; stated that chicken cooked a certain way does not taste right; stated that his penis has gotten somewhat bigger; stated that he is getting more hair on his legs than what he has had; has not had smoothies in 3 months because he has not had the desire; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150, Expiry date: unknown), via an unspecified route of administration on 31Mar2021 (at the age of 62 years old) as dose 1, single for covid-19 immunisation. No relevant medical history reported. There were no concomitant medications. On 11Aug2021 patient had boil to left ear, small boils to crotch area. On Jun2021 patient states getting more hair on his legs than what he had/ not really hairy and on Jul2021 patient states that chicken cooked a certain way does not taste right and penis has gotten somewhat bigger (Stated that when he gets hard, he gets hard). While unspecified date in 2021 had smoothies in 3 months because he has not had the desire. He went to get antibody and was told that he had COVID-19 in 2021. Patient went to dermatologist treatment for getting boils. The outcome of the events boil to left ear, penis has gotten somewhat bigger was recovering, of small boils to crotch area, getting more hair on his legs than what he had, chicken cooked a certain way did not taste right was not recovered, of he did not have the desire was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Chest pain, Muscle spasms
Clinical narrative: cramping or pain under his right chest/ little crampy underneath his right chest; muscle cramp under his lower chest/ muscle cramp under the right chest; arthritis has flared really bad; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the right arm on 18Oct2021 (batch/lot number was not reported) at the age of 56 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concurrent conditions included high blood pressure and "sugar" (captured as "diabetes), both from an unknown date; and arthritis in left arm from Jul2021 and ongoing. Concomitant medications included amlodipine (AMLODIPINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), nebivolol hydrochloride (BYSTOLIC), dextropropoxyphene hydrochloride, paracetamol (DI-GESIC), and empagliflozin (JARDIANCE), indications and therapy dates for all were not reported. Patient did not receive other vaccinations (4 weeks prior). The patient received the Pfizer vaccine yesterday (18Oct2021), about 10 o'clock and had some side effects. The side effects were cramping or pain under his right chest, every once in a while, not consistent. It is little crampy underneath his right chest since an unspecified date. Patient further reported that he had muscle cramp under his lower chest and that's all the side effect he has right now. It just started with muscle cramp under the right chest. Patient took Aleve, Aspirin as treatment for the events. It was also reported that patient had arthritis in his left arm, and since vaccine the arthritis has flared really bad on 21Oct2021. No investigation assessments were provided. The patient has not recovered from the event "arthritis has flared really bad." Outcome of the other events was unknown.  The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller states someone she knows got Covid-19, was vaccinated, and then got Covid-19 again. Caller unsure which Covid-19 vaccine this person received.; Caller states someone she knows got Covid-19, was vaccinated, and then got Covid-19 again. Caller unsure which Covid-19 vaccine this person received.; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A patient of unknown gender and age received unknown dose of BNT162B2 (COVID-19 VACCINE MANUFACTURER UNKNOWN, formulation: Solution for injection, lot number and expiry date not reported), via unspecified route on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medication was not reported. The patient was vaccinated and then got Covid-19 again (coded to drug ineffective). It was unsure which Covid-19 vaccine this patient received. The outcome of both the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Cardiac function test, Erythema, Fatigue
Clinical narrative: next day i fell extreme fatigue and sweats; next day i fell extreme fatigue and sweats; 10 minutes after the shot my blood pressure went very high; my face turned beat red; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution.  A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Oct2021 12:00 (Lot Number: 30135BA; expiry date: unknown) at the age of 51-years-old, as dose 1, single, for Covid-19 immunization. Medical history included fruit -anaphylaxis and Covid-19 from Nov2020 to an unknown date. The patient had no other health issues. There were no concomitant medications. The patient previously took certain antibiotics and experienced drug hypersensitivity. The patient was not tested for Covid-19 post vaccination. The vaccine was administered in the hospital. The patient did not receive other vaccines in four weeks. The patient did not receive other medications in two weeks. On 19Oct2021 at 12:10 (10 minutes after the shot), patient's blood pressure went very high, and his face turned beat red. The nurse took his pressure, and it was 167 over 101. It remained at that level only fluctuating 5 points within a time period of 1hr. They kept him onsite for monitoring. They sent him home with the same high blood pressure level. Next day, (20Oct2021) patient felt extreme fatigue and sweats. He called his doctor, and they took him in immediately. That next afternoon pressure was still at 158 over 101. They sent him to the emergency room for further blood work and tests for the heart; both with unknown results. His pressure was still the same today (21Oct2021) at 157 over 93. They told him to call cardiologist and he was waiting for an appointment. He does not have high blood pressure it's always been 120 over 80 at last. Dr physical in Jun2021 - no family history either. Patient stated that the shot caused this new health issue. Patient stated that he had Covid in Nov2020 and to this day, he had very high antibodies as he had been tested in Aug2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and disability or permanent damage. The events were not treated. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.