chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Fatigue, Headache, Staphylococcal infection
Clinical narrative: Cellulitis; Fatigue; Minor headache; Methicillin resistant Staphylococcus aureus infection; 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. Other Case identifier(s): 22K-163-4246636-00 (AbbVie).  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for colitis ulcerative. Relevant medical history included: "DEEP VEIN THROMBOSIS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 17Mar2021, when the patient was 48 years old, for Covid-19 Immunization; Bnt162b2 (Dose:2), administration date: 07Apr2021, when the patient was 48 years old, for Covid-19 Immunization.Concomitant drugs were not reported. Irregular labs were reported.  The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "Cellulitis"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Minor headache"; STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown", described as "Methicillin resistant Staphylococcus aureus infection". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB):The reporter's causality for the event(s) of FATIGUE AFTER COVID VACCINE, CELLULITIS, MINOR HEADACHE AFTER COVID VACCINE and METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS was not reported.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN:The reporter's causality for the event(s) of FATIGUE AFTER COVID VACCINE, CELLULITIS, MINOR HEADACHE AFTER COVID VACCINE and METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash/She stated that her sister in law and also a third person had the same reaction; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (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: RASH (non-serious), outcome "unknown", described as "rash/She stated that her sister in law and also a third person had the same reaction".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200153346 Different patient, same drug/event.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash/She stated that her sister in law and also a third person had the same reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (Pfizer-BioNTech COVID-19) (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: RASH (non-serious), outcome "unknown", described as "rash/She stated that her sister in law and also a third person had the same reaction".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200153268 Different patient, same drug/event.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 100.5; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 10-year-old male patient received bnt162b2 (BNT162B2), administered in left arm (Lot number: 5618) at the age of 10 years as dose 1 (tris), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 27Jan2022 at 06:00, outcome "unknown", described as "Fever 100.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: I was vaccinated and got the booster. 3 months later I got sick with Omicron; I was vaccinated and got the booster. 3 months later I got sick with Omicron; I was vaccinated and got the booster. 3 months later I got sick with Omicron; 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. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "I am 65 with COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), ILLNESS (non-serious), outcome "unknown" and all described as "I was vaccinated and got the booster. 3 months later I got sick with Omicron". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: i got sick with omicron, notes: 3 months later I got sick with Omicron. Clinical Information: Patient was 65 with COPD. she was vaccinated and got the booster. 3 months later she got sick with Omicron.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heavy menstrual bleeding, Menstruation irregular, Pain
Clinical narrative: Painful with episodes of extreme dizzyness.; Menorrhagia and irregular mensturation lasting 8 days or more.; Menorrhagia and irregular mensturation lasting 8 days or more.; Painful with episodes of extreme dizzyness.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: May2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right), administration date: May2021, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious), PAIN (non-serious), outcome "recovered with sequelae" and all described as "Painful with episodes of extreme dizzyness."; HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION IRREGULAR (non-serious), outcome "recovered with sequelae" and all described as "Menorrhagia and irregular mensturation lasting 8 days or more.". The events "painful with episodes of extreme dizzyness.", "menorrhagia and irregular mensturation lasting 8 days or more.", "menorrhagia and irregular mensturation lasting 8 days or more." and "painful with episodes of extreme dizzyness." were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness, heavy menstrual bleeding, menstruation irregular, pain.  Additional information: The patient did not received any other vaccine within four weeks. The patient was recovered with lasting effects and was seeking gynaecological treatment as result. Covid tested post vaccination: unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Urticaria
Clinical narrative: About three weeks after second dose, got hives/ urticaria. It travels around body (arms, legs, back, head, face, neck, lips, etc.; BNT162B2 was administered at left leg; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 64-year-old male patient received bnt162b2 (BNT162B2), administered in left leg, administration date 14Apr2021 at 10:30 (Lot number: ER8729) at the age of 64 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Allergy to antibiotic" (unspecified if ongoing), notes: Known allergies: No, except may be allergic to certain antibiotics. Concomitant medications included: LOSARTIN and LEVOTHYROXINE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EP7534, Route of administration: Unspecified, Anatomical site: Left arm, Administration time: 09:00), administration date: 24Mar2021, when the patient was 64 years old, for COVID-19 immunisation.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 14Apr2021 at 10:30, outcome "unknown", described as "BNT162B2 was administered at left leg"; URTICARIA (non-serious) with onset an unknown date in May2021, outcome "not recovered", described as "About three weeks after second dose, got hives/ urticaria. It travels around body (arms, legs, back, head, face, neck, lips, etc". The event "About three weeks after second dose, got hives/ urticaria. It travels around body (arms, legs, back, head, face, neck, lips, etc." was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the event urticaria had not stopped since occurrence and patient never had it before vaccine. The event was still there as of 27Jan2022 (reported as today). The patient tried to control it with ZYRTEC as per family doctor and dermatologist. Treatment included ZYRTEC and ZYZOL for urticaria.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Persisted extreme swelling of lymph node on left side of neck below the upper jaw; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 29Oct2021 at 14:00 (Lot number: FF8841) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: ER8731; Anatomical Location: Left arm; Administration time: 14:00), administration date: 02Apr2021, when the patient was 49 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: EW0164; Anatomical Location: Left arm; Administration time: 14:00), administration date: 23Apr2021, when the patient was 49 years old, for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Persisted extreme swelling of lymph node on left side of neck below the upper jaw". The event "Persisted extreme swelling of lymph node on left side of neck below the upper jaw " was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for lymphadenopathy included prescribed Augmentin Anti-biotics.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her husband had received the Pfizer COVID-19 vaccine and tested positive for COVID-19 on Tuesday; her husband had received the Pfizer COVID-19 vaccine and tested positive for COVID-19 on Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74 year-old male patient 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) all with onset 25Jan2022, outcome "unknown" and all described as "her husband had received the Pfizer COVID-19 vaccine and tested positive for COVID-19 on Tuesday". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Jan2022) positive.  Additional information: Description of complaint: Agent reported caller had also said that her husband had received the Pfizer COVID-19 vaccine and tested positive for COVID-19 on Tuesday. There was a Product Complaint. DSU: E-submitting duplicate AE report for caller (69 years old) and her husband (74 years old).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 46 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: FF2589) at the age of 46 years as dose 3 (booster), single, administration date 17Feb2021 (Lot number: EL3247) as dose 2, single and administration date 27Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "recovering" and all described as "covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Jan2022) positive, notes: Other. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown Prior to vaccination, if the patient was diagnosed with COVID-19 and Since the vaccination, the patient had been tested for COVID-19. It was reported that daughter sick 20Jan and then dx (diagnosed) with covid 22Jan, she woke up sick 27Jan2022 and tested home Ag positive with mild symptoms. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Illness, Pain
Clinical narrative: tested positive; tested positive; sick; cough; HA body aches; fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 47 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 03Feb2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "tested positive"; ILLNESS (non-serious) with onset 26Jan2022, outcome "unknown", described as "sick"; PYREXIA (non-serious) with onset 26Jan2022, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 26Jan2022, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 26Jan2022, outcome "unknown", described as "HA body aches"; COUGH (non-serious) with onset 26Jan2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Jan2022) positive, notes: Other; (26Jan2022) negative, notes: Other. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, illness, pyrexia, chills, pain, cough.  Clinical course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, has the patient been tested for COVID-19 was Yes. covid test type post vaccination was Other.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive; tested positive; sick; cough; HA body aches; fever; chills; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 47 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF2589) at the age of 47 years as dose 3 (booster), single, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 03Feb2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "tested positive"; ILLNESS (non-serious) with onset 26Jan2022, outcome "unknown", described as "sick"; PYREXIA (non-serious) with onset 26Jan2022, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 26Jan2022, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 26Jan2022, outcome "unknown", described as "HA body aches"; COUGH (non-serious) with onset 26Jan2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Jan2022) positive, notes: Other; (26Jan2022) negative, notes: Other. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, illness, pyrexia, chills, pain, cough.  Clinical course: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. Prior to vaccination, was the patient diagnosed with COVID-19 was Unknown. Since the vaccination, has the patient been tested for COVID-19 was Yes. covid test type post vaccination was Other.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Photosensitivity reaction, Pyrexia
Clinical narrative: Chills; Fever; Nausea; Headache; Severe photosensitivity; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Jan2022 at 16:00 (Lot number: unknown) at the age of 61 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: UNKNOWN, Administration time: 09:00), administration date: 05Mar2021, when the patient was 60 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Anatomical Location: Right arm, Administration time: 09:00), administration date: 01Apr2021, when the patient was 60 years old, for COVID-19 immunisation.  The following information was reported: CHILLS (non-serious) with onset 20Jan2022 at 20:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 20Jan2022 at 20:00, outcome "recovering", described as "Fever"; NAUSEA (non-serious) with onset 20Jan2022 at 20:00, outcome "recovering", described as "Nausea"; HEADACHE (non-serious) with onset 20Jan2022 at 20:00, outcome "recovering", described as "Headache"; PHOTOSENSITIVITY REACTION (non-serious) with onset 20Jan2022 at 20:00, outcome "recovering", described as "Severe photosensitivity". Therapeutic measures were not taken as a result of chills, pyrexia, nausea, headache and photosensitivity reaction.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result 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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Consistent headache lasting to date; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 13Jan2022 (Lot number: 33036130) at the age of 32 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: LEXAPRO.  The following information was reported: HEADACHE (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Consistent headache lasting to date". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The event headache occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate, Hyperhidrosis, Hypotension, SARS-CoV-2 test
Clinical narrative: rapid atrial fibrillation; chest pain and HR 220; diaphoretic; hypotension; This is a spontaneous report received from contactable reporter via COVID-19 Vaccine Adverse Event Self-Reporting Solution portal. The reporter is the patient.  A 60 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 12Jan2022 15:00 (Lot number: FJ5683) at the age of 60 years as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. Relevant medical history included: "former history of atrial fibrillation (fib)," start date: 2019 (unspecified if ongoing), notes: prior to ablation 3 years prior reporting (completely controlled after ablation); "ablation" (unspecified if ongoing); "hypertension (HTN)" (unspecified if ongoing). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took other unspecified concomitant medications within 2 weeks of vaccination. The following information was reported: ATRIAL FIBRILLATION (medically significant, life threatening) with onset 22Jan2022 09:30, outcome "not recovered," described as "rapid atrial fibrillation; chest pain and heart rate (HR) 220"; HYPERHIDROSIS (life threatening) with onset 22Jan2022 09:30, outcome "not recovered," described as "diaphoretic"; HYPOTENSION (life threatening) with onset 22Jan2022 09:30, outcome "not recovered," described as "hypotension." The events "rapid atrial fibrillation; chest pain and HR 220," "diaphoretic," and "hypotension" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: HR: (22Jan2022) 220 and Nasal Swab: (22Jan2022) negative. Therapeutic measures were taken as a result of atrial fibrillation, hyperhidrosis, and hypotension, which included rescue squad, intravenous (IV) fluids, and medication.; Sender's Comments: Based on available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be fully excluded.  However, the history of atrial fibrillation is confounding. 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Laboratory test, Metabolic function test, SARS-CoV-2 test
Clinical narrative: I was COVID positive; COVID positive; I am vaccinated (COVID-19 Vaccine) twice; I was COVID positive; COVID positive; I am vaccinated (COVID-19 Vaccine) twice; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 28Jan2021 (Lot number: EL1283) at the age of 66 years as dose 2, single and administration date 07Jan2021 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Emphysema" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; SYNTHROID; VITAMIN D [ERGOCALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I was COVID positive; COVID positive; I am vaccinated (COVID-19 Vaccine) twice". The patient underwent the following laboratory tests and procedures: laboratory test: (Jan2022) unknown results; metabolic function test: (Jan2022) unknown results; sars-cov-2 test: (unspecified date) positive. Therapeutic measures were taken as a result of covid-19. The patient was in a COVID positive pass held and she went heading calls and she could not locate any of the infusions for the monoclonal antibodies (further clarification unknown). Treatment for adverse event: Consumer stated, "No and steroids, they started steroids in the hospital (daily shot) but that was it." The patient was vaccinated (COVID-19 Vaccine) twice but no booster, so did very well. When clarified if consumer was tested COVID positive after receiving COVID Vaccine, Consumer stated other people might have still be positive including her daughter who worked in a nursing facility. So, they all had it, they were all positive this past weeks including the children (further number of patients and patient details were unknown hence split not made), whatever they did very well. She tested 'blue' positive in the hospital so (further clarification unknown). Confirmed that consumer was tested COVID positive after receiving COVID Vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: The evening after vaccine broke out into hives; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2022 at 13:00 (Lot number: FK9729) at the age of 51 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Iodine allergy" (unspecified if ongoing), notes: Known allergies: Injected iodine. Concomitant medications included: LEXAPRO, SINGULAIR and THYROID MED. Past drug history included: Keflex, reaction: "Drug allergy", notes: Known allergies: Keflex family. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: EL3248; Anatomical site: Right arm; Route of administration: Unspecified), administration date: 21Apr2021, when the patient was 50 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3248; Anatomical site: Left arm; Route of administration: Unspecified), administration date: 30Mar2021, when the patient was 50 years old, for COVID-19 immunisation.  The following information was reported: URTICARIA (non-serious) with onset 27Jan2022 at 16:00, outcome "not recovered", described as "The evening after vaccine broke out into hives". Therapeutic measures were not taken as a result of urticaria.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, administration date Jul2021 (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: THROMBOSIS (death) with onset 19Jan2022, outcome "fatal", described as "blood clots". The event "blood clots" was evaluated at the emergency room visit. The patient date of death was 20Jan2022. The reported cause of death was thrombosis. It was not reported if an autopsy was performed. Clinical course: The caller states she is not sure if the product is the Pfizer Covid vaccine. She stated evidently, they think it was the Covid 19 vaccine that caused his death. She further reported that the patient went to the Emergency Room on 19Jan2022 and had blood clots, that he was eventually put on a breathing machine, that the patient had a horrible reaction to the Covid vaccine last Jul2021 and his health had been declining ever since.   The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.; Reported Cause(s) of Death: Blood clot
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Feeling abnormal, Illness, Pain
Clinical narrative: the next day she started vomiting; feeling bad; aches/ body aches/ little sore; sick; severe stomach pain; fever of a 103; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jan2022 (Batch/Lot number: unknown) at the age of 6 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (medically significant) with onset Jan2022, outcome "recovered", described as "fever of a 103"; FEELING ABNORMAL (non-serious) with onset 25Jan2022, outcome "unknown", described as "feeling bad"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "aches/ body aches/ little sore"; VOMITING (non-serious) with onset 26Jan2022, outcome "unknown", described as "the next day she started vomiting"; ILLNESS (non-serious) with onset Jan2022, outcome "not recovered", described as "sick"; ABDOMINAL PAIN UPPER (non-serious) with onset Jan2022, outcome "unknown", described as "severe stomach pain". The patient underwent the following laboratory tests and procedures: body temperature: (Jan2022) 103. The patient started feeling bad the evening of the vaccine. She run a fever of 103 that was really hard for the mother to put down. They were able to finally bring the fever down and she had some aches and pain but then the next day, she started vomiting which she did not see as a side effect in the list of side effects. On Friday (Jan2022), she is still sick and having a severe stomach pain. The reporter added, as well as body aches. The body aches and the fever had gone away, she's still a little sore she said. The patient is having a side effect not listed in the side effects and the reporter asked for advice on what to do.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: the next day she started vomiting; feeling bad; aches/ body aches/ little sore; sick; severe stomach pain; fever of a 103; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jan2022 (Batch/Lot number: unknown) at the age of 6 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PYREXIA (medically significant) with onset Jan2022, outcome "recovered", described as "fever of a 103"; FEELING ABNORMAL (non-serious) with onset 25Jan2022, outcome "unknown", described as "feeling bad"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "aches/ body aches/ little sore"; VOMITING (non-serious) with onset 26Jan2022, outcome "unknown", described as "the next day she started vomiting"; ILLNESS (non-serious) with onset Jan2022, outcome "not recovered", described as "sick"; ABDOMINAL PAIN UPPER (non-serious) with onset Jan2022, outcome "unknown", described as "severe stomach pain". The patient underwent the following laboratory tests and procedures: body temperature: (Jan2022) 103. The patient started feeling bad the evening of the vaccine. She run a fever of 103 that was really hard for the mother to put down. They were able to finally bring the fever down and she had some aches and pain but then the next day, she started vomiting which she did not see as a side effect in the list of side effects. On Friday (Jan2022), she is still sick and having a severe stomach pain. The reporter added, as well as body aches. The body aches and the fever had gone away, she's still a little sore she said. The patient is having a side effect not listed in the side effects and the reporter asked for advice on what to do.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Cerebrovascular accident, Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: had the glucose come higher; has numbness on right side in her fingers and in the middle of her right hand; stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 at 17:00 (Lot number: EW0171) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 05Nov2020 (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Taking for a long time, more than 20 years; "High blood pressure" (unspecified if ongoing), notes: diagnosed more than 20 years ago ; "Glucose" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); ATENOLOL taken for blood pressure abnormal (ongoing); CETIRIZINE taken for hypersensitivity (ongoing); MONTELUKAST taken for hypersensitivity; GLIFAGE XR taken for blood glucose. Vaccination history included: Bnt162b2 (DOSE: 1, Lot: RS737), administration date: 06Apr2021, when the patient was 59 years old, for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 03Sep2021, outcome "unknown", described as "stroke"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "had the glucose come higher"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "has numbness on right side in her fingers and in the middle of her right hand". The patient underwent the following laboratory tests and procedures: blood glucose: (unspecified date) unknown results, notes: Normally it is 7-100 or 90-110; (10Jan2022) 268, notes: the last glucose was 268; sars-cov-2 test: (unspecified date) positive, notes: Yes I did test last week; (unspecified date) positive, notes: I did test this week it is positive.   No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bipolar disorder
Clinical narrative: bipolar disorder; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult (reported as mid to late 20s) male patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history was reported as "there may have been signs of bipolar issues well before the disease was recognized, just as a note, not 100% sure." It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccine. The patient's concomitant medications were not reported. The following information was reported: BIPOLAR DISORDER (hospitalization), outcome "unknown", described as "bipolar disorder". Therapeutic measures were taken as a result of bipolar disorder. The patient was diagnosed with bipolar disorder. There were several events that led to this, including hospitalization for some days due to episode. The reporter believed hospitalization event may have been early 2021 but was unsure. The reporter believed the patient was potentially diagnosed post-vaccination. The reporter did not  know dates of vaccination for the patient but believed he was definitely at least fully vaccinated now. The reporter was not exactly sure which vaccine was received and what dose. The reporter believed the patient had more recently been trying different medications or had been in the process of finding a good one with least negative effects.  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Hair texture abnormal
Clinical narrative: A few days after receiving her second shot some of her hair fell out and that now her hair has a different texture; A few days after receiving her second shot some of her hair fell out and that now her hair has a different texture; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   An adolescent female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN; Route of Administration: Unspecified), for COVID-19 immunisation.  The following information was reported: ALOPECIA (non-serious), HAIR TEXTURE ABNORMAL (non-serious) all with, outcome "unknown", and all described as "A few days after receiving her second shot some of her hair fell out and that now her hair has a different texture".   Additional Information: The patient is 14-15 years of age. It was unknown whether any therapeutic measures were taken as a result of the events. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: health issues regarding stress-induced seizures (I believe incl upon waking up) and other potential issues.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient in her mid 20's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "severe allergies to mold and potentially other things" (unspecified if ongoing); "severe allergies to mold and potentially other things" (unspecified if ongoing); "I believe they also have ADHD" (unspecified if ongoing). The patient took concomitant medications (reported as unsure but likely yes and Likely is on medication to manage the disorders and allergy issues). Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown, Batch/Lot number unknown), administration date: 2021, for COVID-19 immunization. Reporter stated it may have been Pfizer and patient was likely vaccinated by spring/early summer. The following information was reported: SEIZURE (disability, medically significant) with onset 2021, outcome "unknown", described as "health issues regarding stress-induced seizures (I believe incl upon waking up) and other potential issues." Reporter cannot remember all explicit issues of patient, but was impacting daily life activity. Seems like patient was doing better now as she had resumed what seems like normal activity, but cannot confirm details. Reporter forget if patient sought medical attention.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives on her arm; Rash; 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 female patient received bnt162b2 (BNT162B2), administration date 13Jan2022 (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: URTICARIA (non-serious) with onset Jan2022, outcome "not recovered", described as "hives on her arm"; RASH (non-serious) with onset Jan2022, outcome "not recovered", described as "Rash".  Additional information: Patient had her first dose of the Pfizer COVID on the 13Jan2022. Patient had no reactions at all. Patient had a small patch of hives the following week on her arm. It was all cleared up. Patient hasn't had hives before. A friend of hers had a necklace which made her neck break out. Her friend gave her the necklace. Patient got the necklace last weekend. She put it on, and now she has hives. Patient never had a reaction to Nickle, but she had a rash on her neck that has been there since Monday. That has been five days since it has started. She knows for sure she got it at (Institute Name withheld). She knows that hives were a possibility. Is it okay to get her second vaccine on 03Feb2022. Patient wants to know if she needs to wait until the hives disappear in order to receive the second dose of the vaccine or be vaccinated while having the hives on her arm.  The lot number for bnt162b2 was not provided and will be requested during follow up.