chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy, third trimester; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 (Lot number: Ff2588) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy: penicillin" (unspecified if ongoing). The patient was 36 weeks pregnant at the event onset. The patient is expected to deliver one baby. The patient took concomitant medications. Past drug history included: Aspirin, reaction: "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: El 3247, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El1284), administration date: 10Jan2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 23Oct2021, described as "Maternal exposure during pregnancy, third trimester"; IMMUNISATION (non-serious) with onset 23Oct2021, described as "Booster".  The patient delivered a child with Congenital anomaly or birth defect  Follow up information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101724262 Mother/baby case
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Bronchitis, COVID-19, Drug ineffective, Hypersensitivity, Immunisation
Clinical narrative: Sinus pressure; Bronchitis; Sinus infection; Allergies; COVID-19; COVID-19; Booster dose: Aug2021; soreness; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Aug2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2nd, Route: Intramuscular), administration date: 23Apr2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Bronchitis", "Soreness"; Bnt162b2 (Dose: 1st, Route: Intramuscular), administration date: 31Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Bronchitis", "Soreness". The following information was reported: COVID-19 (medically significant) with onset 16Aug2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant) with onset 16Aug2021, outcome "unknown" and all described as "COVID-19"; IMMUNISATION (non-serious) with onset Aug2021, outcome "unknown", described as "Booster dose: Aug2021"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "recovered", described as "Sinus pressure"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "soreness"; BRONCHITIS (non-serious), outcome "not recovered", described as "Bronchitis"; SINUSITIS (non-serious), outcome "recovered", described as "Sinus infection"; HYPERSENSITIVITY (non-serious), outcome "recovered", described as "Allergies". The action taken for adalimumab was dosage not changed.  Additional Information: The reporter's causality for BNT162B2 was reported as For the event(s) Sinus pressure :Not Reported; Pain (Pain) Probable; Bronchitis (Bronchitis)Not Reported; COVID-19 (COVID-19) ): Not Reported; Sinus infection (Sinusitis): ): Not Reported; Allergy (Hypersensitivity) ): Not Reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Drug Ineffective, COVID 19, Booster,Paranasal sinus discomfort, pain, Bronchitis, Sinusitis,Hypersensitivity and suspect drug BNT162B2 cannot be 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : 21K-163-4141765-00
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Paranasal sinus discomfort, Sinusitis
Clinical narrative: Sinus pressure; Bronchitis; Sinus infection; Allergies; COVID-19; COVID-19; Booster dose: Aug2021; soreness; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Aug2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2nd, Route: Intramuscular), administration date: 23Apr2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Bronchitis", "Soreness"; Bnt162b2 (Dose: 1st, Route: Intramuscular), administration date: 31Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Bronchitis", "Soreness". The following information was reported: COVID-19 (medically significant) with onset 16Aug2021, outcome "recovered" (2021), DRUG INEFFECTIVE (medically significant) with onset 16Aug2021, outcome "unknown" and all described as "COVID-19"; IMMUNISATION (non-serious) with onset Aug2021, outcome "unknown", described as "Booster dose: Aug2021"; PARANASAL SINUS DISCOMFORT (non-serious), outcome "recovered", described as "Sinus pressure"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "soreness"; BRONCHITIS (non-serious), outcome "not recovered", described as "Bronchitis"; SINUSITIS (non-serious), outcome "recovered", described as "Sinus infection"; HYPERSENSITIVITY (non-serious), outcome "recovered", described as "Allergies". The action taken for adalimumab was dosage not changed.  Additional Information: The reporter's causality for BNT162B2 was reported as For the event(s) Sinus pressure :Not Reported; Pain (Pain) Probable; Bronchitis (Bronchitis)Not Reported; COVID-19 (COVID-19) ): Not Reported; Sinus infection (Sinusitis): ): Not Reported; Allergy (Hypersensitivity) ): Not Reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the Limited information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Drug Ineffective, COVID 19, Booster,Paranasal sinus discomfort, pain, Bronchitis, Sinusitis,Hypersensitivity and suspect drug BNT162B2 cannot be 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : 21K-163-4141765-00
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chills, Fatigue, Immunisation
Clinical narrative: mild heart pain; Body fatigue; chills; Dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via a regulatory authority. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 12:30 (Batch/Lot number: unknown) at the age of 27 years(not pregnant) as dose 3 (booster), single for covid-19 immunisation in Pharmacy/drug store. Relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Drug name was not reported. There were no concomitant medications. The patient didn't receive other vaccines in 4 weeks and no other medications in 2 weeks. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 07May2021, when the patient was 27 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 12Apr2021, when the patient was 27 years old, for Covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 05Dec2021 12:30, outcome "unknown", described as "Dose 3"; ANGINA PECTORIS (medically significant) with onset 06Dec2021 04:00, outcome "not recovered", described as "mild heart pain"; FATIGUE (non-serious) with onset 06Dec2021 04:00, outcome "not recovered", described as "Body fatigue"; CHILLS (non-serious) with onset 06Dec2021 04:00, outcome "not recovered", described as "chills". Therapeutic measures were not taken as a result of angina pectoris, fatigue, chills. The events were not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Headache, Immunisation, SARS-CoV-2 test
Clinical narrative: seizure; headache; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 10:30 (Lot number: FH8028) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing),  "hypertension" (unspecified if ongoing).  Concomitant medication(s) included: METOPROLOL; AMBIEN; LIALDA. Past drug history included: Known allergies: Amoxicillin, Lisinopril, Contrast Dye, Zithromycin. Vaccination history included: Bnt162b2 (Previous dose number: 2, Previous dose lot number: EW0151,, ), administration date: 12Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (dose number: 1, ), administration date: 15Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; SEIZURE (medically significant) with onset Dec2021, outcome "unknown", described as "seizure"; HEADACHE (non-serious) with onset 27Nov2021 21:00, outcome "unknown", described as "headache". The events "seizure" and "headache" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) showed as clear, notes: The CT scan and EKG that were done at the ER didn't show presence of mass, clot, aneurysm or stroke. The CT scan showed as clear; electrocardiogram: (2021) normal, notes: The CT scan and EKG that were done at the ER didn't show presence of mass, clot, aneurysm or stroke; sars-cov-2 test: (01Dec2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of seizure, headache.  The patient stated that she had not suffered from headache and seizure before receiving the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; headache; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Nov2021 10:30 (Lot number: FH8028) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis" (unspecified if ongoing),  "hypertension" (unspecified if ongoing).  Concomitant medication(s) included: METOPROLOL; AMBIEN; LIALDA. Past drug history included: Known allergies: Amoxicillin, Lisinopril, Contrast Dye, Zithromycin. Vaccination history included: Bnt162b2 (Previous dose number: 2, Previous dose lot number: EW0151,, ), administration date: 12Apr2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (dose number: 1, ), administration date: 15Mar2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; SEIZURE (medically significant) with onset Dec2021, outcome "unknown", described as "seizure"; HEADACHE (non-serious) with onset 27Nov2021 21:00, outcome "unknown", described as "headache". The events "seizure" and "headache" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (2021) showed as clear, notes: The CT scan and EKG that were done at the ER didn't show presence of mass, clot, aneurysm or stroke. The CT scan showed as clear; electrocardiogram: (2021) normal, notes: The CT scan and EKG that were done at the ER didn't show presence of mass, clot, aneurysm or stroke; sars-cov-2 test: (01Dec2021) negative, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of seizure, headache.  The patient stated that she had not suffered from headache and seizure before receiving the vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid positive", which was also reported as "Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101782726 same reporter/drug/event with different patient.;-PFIZER INC-202101782724 same reporter/drug/event with different patient.;-PFIZER INC-202101782729 same reporter/drug/event with different patient.;-PFIZER INC-202101782723 same reporter/drug/event with different patient.;-PFIZER INC-202101782725 same reporter/drug/event with different patient.;-PFIZER INC-202101782727 same reporter/drug/event with different patient.;-PFIZER INC-202101782728 same reporter/drug/event with different patient.;-PFIZER INC-202101782732 same reporter/drug/event with different patient.;-PFIZER INC-202101782731 same reporter/drug/event with different patient.;-PFIZER INC-202101782160 same reporter/drug/AE with different patient.-PFIZER INC-202101782730 same reporter/drug/event with different patient.;-PFIZER INC-202101733108 same reporter/drug/AE with different patient
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Incorrect dose administered, Off label use
Clinical narrative: received an adult dose of the Pfizer-BioNTech Covid19 Vaccine instead of the pediatric formulation for his 2nd dose; received an adult dose of the Pfizer-BioNTech Covid19 Vaccine instead of the pediatric formulation for his 2nd dose; received an adult dose of the Pfizer-BioNTech Covid19 Vaccine instead of the pediatric formulation for his 2nd dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 19:00 (Lot number: FK5127) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot No: FK5127), administration date: 08Nov2021, when the patient was 11 years old, for COVID-19 Immunization. No additional vaccines administered on same date of the Pfizer suspect to the patient.  The following information was reported: OFF LABEL USE (medically significant), ACCIDENTAL OVERDOSE (medically significant), INCORRECT DOSE ADMINISTERED (medically significant) all with onset 29Nov2021 19:00 and all described as "received an adult dose of the Pfizer-BioNTech Covid19 Vaccine instead of the pediatric formulation for his 2nd dose". There was no emergency room visit or physician's office visit due to the adverse events. There was no prior vaccinations (within 4 weeks) to the suspect vaccines.
Age: 41.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4109906-00. A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single and intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (1 in 2 wk) (citrate free)) for psoriasis. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Sep2021, outcome "unknown", COVID-19 (medically significant) with onset 16Sep2021, outcome "recovered" (2021) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Sep2021) positive. The action taken for adalimumab was dosage permanently withdrawn.  The reporter's causality for the event(s) of Covid with BNT162B2 (Drug/Vaccine): was possible. The reporter's causality for the event(s) of Covid with Humira (Adalimumab) was no reasonable possibility.  The lot number for vaccine (BNT162B2) was not provided and will be requested during follow up.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency. Consideration should also be given to the contribution from the co-suspect medication adalimumab
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vitreous detachment
Clinical narrative: with the second dose the chills and aches were very brief; with the second dose the chills and aches were very brief; vitreous detachment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6205) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Smallpox shot for immunisation, reaction(s): "high fever", notes: states that she thinks it was the Smallpox shot that she got when she was very young, but is uncertain if it was the Smallpox shot. States that it caused her to have a very high fever. ; Smallpox shot for immunisation, reaction(s): "One of her adult teeth then grew in half thickness with a brown stain on it", notes: One of her adult teeth then grew in half thickness with a brown stain on it and she was told that was probably because of the high fever she had as a child. . Vaccination history included: Bnt162b2 (Dose:1, lot# EM9809, Anatomical location: left arm), administration date: 11Feb2021, for COVID-19 Immunization. The following information was reported: VITREOUS DETACHMENT (medically significant) with onset Apr2021, outcome "recovering", described as "vitreous detachment"; CHILLS (non-serious), PAIN (non-serious) all with onset May2021, outcome "recovered" (May2021) and all described as "with the second dose the chills and aches were very brief". The event "vitreous detachment" was evaluated at the physician office visit and emergency room visit. Clinical course: States that she had the first dose in Feb, the second in Mar. Then in early Apr she was travelling and got diagnosed with Vitreous Detachment. States she does not know if she had it before, and she had been on a plane, but it was about 6 weeks after her second shot. She said that it was starting to resolved by itself. Patient states that it had seemed to be subsiding. Patient states that with the second dose the chills and aches were very brief; may be like an hour. Denies any other medications, medical conditions, labs, testing, or treatments relevant to these events. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) no other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Patient states that she went to the Emergency Room in (name) and was diagnosed with the vitreous detachment. States that the doctor wanted to make sure it was not a detached retina. When she returned to the states her doctor agreed with the diagnosis that she received in (name).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101741009 same patient/drug, different AE, different dose of vaccine
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA; This is a spontaneous report received from non-contactable reporter (Consumer) from a sales representative. An adult female patient received NT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. It was reported that the patient received a dose of Pfizer BioNTech Covid 19 vaccine and within a short timeframe (minutes) had a TIA (Transient ischaemic attack). It was reported that the patient had numbness in her face. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Migratory paresthesias, mostly in the legs, beginning 15 minutes after receiving her injection; This is a spontaneous report received from contactable physician.  A 11 year-old female patient (not pregnant) received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN, administration date 02Dec2021 (Lot number: unknown) at the age of 11 years as a single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: COVID-19 vaccine (DOSE 1; Lot number: unknown; (manufacturer unknown)), for COVID-19 immunisation.  The following information was reported: PARAESTHESIA (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Migratory paresthesias, mostly in the legs, beginning 15 minutes after receiving her injection". The event "Migratory paresthesias, mostly in the legs, beginning 15 minutes after receiving her injection" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: The patient had no known drug allergies. It was unknown whether, the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "severe allergic reaction". Therapeutic measures were taken as a result of hypersensitivity. Mother mentioned that she spoke with his son's HCP who was unable to determine if the reaction was due to the vaccine. He was given Benadryl and advised to take Tylenol if needed.  This follow-up is being submitted to notify that the lot/batch number is not available despite the fol-low-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: already taken the doses of the covid-19 vaccine and contracted the disease; already taken the doses of the covid-19 vaccine and contracted the disease; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "already taken the doses of the covid-19 vaccine and contracted the disease". Verbatim and Event Description: The patient mentioned that he had already taken the doses of the covid-19 vaccine and contracted the disease. He also shared that he uses Pfizer products.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Migraine, Nausea
Clinical narrative: blood clot; Migraine; Hot & cold; ringing in ears; shooting pain in arm; Nausea; rashe; swollen face; fatigue; brain fog last 2 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 12:00 (Lot number: 8182) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (disability, medically significant, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "blood clot"; MIGRAINE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Migraine"; FEELING OF BODY TEMPERATURE CHANGE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Hot & cold"; TINNITUS (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "ringing in ears"; PAIN IN EXTREMITY (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "shooting pain in arm"; NAUSEA (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Nausea"; RASH (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "rashe"; SWELLING FACE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "swollen face"; FATIGUE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "fatigue"; FEELING ABNORMAL (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "brain fog last 2 months". The events "blood clot", "migraine", "hot & cold", "ringing in ears", "shooting pain in arm", "nausea", "rashe", "swollen face", "fatigue" and "brain fog last 2 months" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Oct2021) negative. Therapeutic measures were taken as a result of thrombosis, migraine, feeling of body temperature change, tinnitus, pain in extremity, nausea, rash, swelling face, fatigue, feeling abnormal. Treatment received for the adverse event included Blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, SARS-CoV-2 test, Swelling face, Thrombosis
Clinical narrative: blood clot; Migraine; Hot & cold; ringing in ears; shooting pain in arm; Nausea; rashe; swollen face; fatigue; brain fog last 2 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 12:00 (Lot number: 8182) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (disability, medically significant, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "blood clot"; MIGRAINE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Migraine"; FEELING OF BODY TEMPERATURE CHANGE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Hot & cold"; TINNITUS (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "ringing in ears"; PAIN IN EXTREMITY (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "shooting pain in arm"; NAUSEA (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Nausea"; RASH (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "rashe"; SWELLING FACE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "swollen face"; FATIGUE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "fatigue"; FEELING ABNORMAL (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "brain fog last 2 months". The events "blood clot", "migraine", "hot & cold", "ringing in ears", "shooting pain in arm", "nausea", "rashe", "swollen face", "fatigue" and "brain fog last 2 months" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Oct2021) negative. Therapeutic measures were taken as a result of thrombosis, migraine, feeling of body temperature change, tinnitus, pain in extremity, nausea, rash, swelling face, fatigue, feeling abnormal. Treatment received for the adverse event included Blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: blood clot; Migraine; Hot & cold; ringing in ears; shooting pain in arm; Nausea; rashe; swollen face; fatigue; brain fog last 2 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 12:00 (Lot number: 8182) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (disability, medically significant, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "blood clot"; MIGRAINE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Migraine"; FEELING OF BODY TEMPERATURE CHANGE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Hot & cold"; TINNITUS (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "ringing in ears"; PAIN IN EXTREMITY (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "shooting pain in arm"; NAUSEA (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "Nausea"; RASH (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "rashe"; SWELLING FACE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "swollen face"; FATIGUE (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "fatigue"; FEELING ABNORMAL (disability, life threatening) with onset 15May2021 12:00, outcome "not recovered", described as "brain fog last 2 months". The events "blood clot", "migraine", "hot & cold", "ringing in ears", "shooting pain in arm", "nausea", "rashe", "swollen face", "fatigue" and "brain fog last 2 months" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Oct2021) negative. Therapeutic measures were taken as a result of thrombosis, migraine, feeling of body temperature change, tinnitus, pain in extremity, nausea, rash, swelling face, fatigue, feeling abnormal. Treatment received for the adverse event included Blood thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Knee operation
Clinical narrative: Knee operation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4103863-00.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and intramuscular, administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: KNEE OPERATION (medically significant) with onset Sep2021, outcome "recovering", described as "Knee operation". The action taken for adalimumab was unknown.  Clinical Course: In Sep2021, the patient experienced LEFT KNEE SURGERY. PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was also considered suspect. In Sep2021, the patient had left knee surgery and reason was unknown why she had the surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. In May2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.  Causality for HUMIRA(ADALIMUMAB) -The reporter's causality for the event(s) of LEFT KNEE SURGERY was not provided. A regulatory authority opinion is that there is no reasonable possibility that the event of LEFT KNEE SURGERY is related to HUMIRA(ADALIMUMAB).   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on underlying elderly age and Underlying history of Rheumatoid Arthritis a possible causal association between the event Knee operation was considered unrelated to the suspect BNT162B2 .
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: She had the first 2 vaccines, she got covid--got sick on Friday and died in the hospital on Sunday; She had the first 2 vaccines, she got covid--got sick on Friday and died in the hospital on Sunday; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, hospitalization, medically significant), SUSPECTED COVID-19 (death, hospitalization, medically significant) all with onset 03Dec2021, outcome "fatal" and all described as "She had the first 2 vaccines, she got COVID--got sick on Friday and died in the hospital on Sunday". The patient date of death was 05Dec2021. The reported cause of death was COVID. It was unknown if an autopsy was performed.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101760616 same reporter/drug/ AE, different patients;US-PFIZER INC-202101760615 same reporter/drug/ AE, different patients; Reported Cause(s) of Death: COVID
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: died from Covid; died from Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), SUSPECTED COVID-19 (death), outcome "fatal" and all described as "died from Covid". The patient date of death was unknown. The reported cause of death was suspected covid-19, drug ineffective. The consumer reported that she knew 3 people that have died from Covid, 1 wasn't vaccinated but 2 were.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101758340 same reporter/drug/ AE, different patients;US-PFIZER INC-202101760616 same reporter/drug/ AE, different patients; Reported Cause(s) of Death: died from Covid; died from Covid
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: died from Covid; died from Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), SUSPECTED COVID-19 (death), outcome "fatal" and all described as "died from Covid". The patient date of death was unknown. The reported cause of death was suspected covid-19, drug ineffective. It was not reported if an autopsy was performed. The consumer reported that she knew 3 people that have died from Covid, 1 wasn't vaccinated but 2 were.   The lot number for bnt162b2 was not provided and will be requested during follow up.  ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101760615 same reporter/drug/ AE, different patients;US-PFIZER INC-202101758340 same reporter/drug/ AE, different patients; Reported Cause(s) of Death: died from Covid; died from Covid
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This case has been considered invalid as the event cannot be assessed with the information provided (unspecified AE). Is the Reporter a Healthcare Professional (HCP)? Yes Occupation/Specialty: Unknown is the reporter's contact information available to you or a sub-contracted party? Unknown is the reporter the prescribing HCP? Unknown Suspect product(s): Pfizer Covid-19 Vaccine Start date: Unknown Stop date: Unknown Verbatim and event description: Caller is a HC Provider. They have the adult and pediatric vaccines stored in the refrigerator. He said that it's supposed to be good for 31 days and the other one is 10 weeks but one of his colleagues opened the fridge and did not close all the way and the temperature went up to 60 degrees Fahrenheit for almost 3 hours. Caller is asking if the vaccines are still viable. Medical Information: Were any unaddressed medical questions referred or forwarded to medical information? Yes : Customer and/or medical inquiry forwarded or referred.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Multiple blood clots in my leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: ER8734) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCN allergy" (unspecified if ongoing). No covid prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, dose brand: Pfizer, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 48 years old, for covid 19 immunization. No other vaccine received in four weeks. The following information was reported: THROMBOSIS (life threatening), outcome "not recovered", described as "Multiple blood clots in my leg". The event "multiple blood clots in my leg" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: post vaccination. Therapeutic measures were taken as a result of thrombosis: Blood thinners administered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: The patient was diagnosed on 30Nov2021 with Covid-19; The patient was diagnosed on 30Nov2021 with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 44-year-old female patient received bnt162b2 (COMIRNATY; Formulation: Solution for Injection), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 30Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 30Nov2021, outcome "recovered" (2021) and all described as "The patient was diagnosed on 30Nov2021 with Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) negative; (30Nov2021) positive, notes: The patient was diagnosed on 30NOV2021 with Covid-19. Action taken for bnt162b2 (COMIRNATY) was not applicable.   The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (13Dec2021): This is a follow-up spontaneous report from a contactable reporter(s) (Pharmacist) from medical information team. Updated information: Outcome of event "Covid-19" was updated to recovered.; Sender's Comments: Based on the information currently available, The casual association between the reported event "Covid-19" and suspected vaccine BNT162B2 cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2021SA394468 (Sanofi).  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC ARREST (death, medically significant), outcome "fatal", described as "cardiac arrest". The patient date of death was unknown. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed. The clinical course was reported as follows: To prevent one covid-19 related death, Pfizer admits their vaccine kills at least three people by causing cardiac arrest.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767784 same reporter/drug/event, different patients;US-PFIZER INC-202101767783 same reporter/drug/event, different patients; Reported Cause(s) of Death: cardiac arrest