chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid: Treatment start date: 03Jan2023, stop date: 08Jan2023 for covid-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 at 14:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "Underactive thyroid" (unspecified if ongoing), notes: Other medical history: Underactive thyroid; "High cholesterol" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: Other medical history: Allergies. Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid (Lot number: 2707499) started on 04Jan2023 and stopped on 10Jan2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller said she had all four Pfizer shots, including the booster/taking Paxlovid; Caller said she had all four Pfizer shots, including the booster/taking Paxlovid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (Not Known). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller said she had all four Pfizer shots, including the booster/taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Other HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), single (Lot number: GJ6739) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0171), in left arm and on 31Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation.  The patient's relevant medical history included: "Prediabetic" (unspecified if ongoing); "IBS" (unspecified if ongoing); "POCS" (unspecified if ongoing).  The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: the patient was treated with Paxlovid. I tested negative for covid two day after finishing Paxlovid but then tested postitive six days after finishing Paxlovid.; Sender's Comments: Based on the available information in the case, the causal association between the events VACCINATION FAILURE, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; 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.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose number unknown (booster), single (Lot number: GJ3275) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Dec2022, outcome "unknown".  Additional information: The patient wanted to know if tinnitus was common after receiving the Pfizer COVID vaccine and if so, how long does it take to go away. Caller stated, "We started with the Pfizer COVID vaccine when it first came out 2021 and since that time, we received all the boosters and last month, I got another booster which was taking care of the new variants. A week later, i have what I call tinnitus, which is ringing in the ears. Have you had any other people complaining about of tinnitus after one or more doses of the vaccine."  Caller stated he received the shot on 13Dec2022 and the Lot was GJ3275. And was not able to confirm which vaccine he received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026676 Same patient/vaccine, different dose/event.;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: tinnitus; 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.  An 84-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Dec2022 as dose number unknown (booster), single (Lot number: GJ3275) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization; Bnt162b2 (Dose: 2), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Dec2022, outcome "unknown".  Additional information: The patient wanted to know if tinnitus was common after receiving the Pfizer COVID vaccine and if so, how long does it take to go away. Caller stated, "We started with the Pfizer COVID vaccine when it first came out 2021 and since that time, we received all the boosters and last month, I got another booster which was taking care of the new variants. A week later, i have what I call tinnitus, which is ringing in the ears. Have you had any other people complaining about of tinnitus after one or more doses of the vaccine."  Caller stated he received the shot on 13Dec2022 and the Lot was GJ3275. And was not able to confirm which vaccine he received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026676 Same patient/vaccine, different dose/event.;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products, Ischaemic stroke
Clinical narrative: On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain; Interchange of vaccine products; 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), in Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Janssen covid vaccine (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2022, outcome "unknown"; ISCHAEMIC STROKE (medically significant) with onset 10Dec2022, outcome "unknown", described as "On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain".  Clinical course: Female consumer stated that she had previously had 2 doses of Janssen Covid vaccine and then on Aug2022 had a booster of the Pfizer Covid vaccine. She states at the time of the dose she did not have any side effects. On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain. She reports that it came out of no where and she did not have many risk factors. She described being an overall healthy individual. She stated that she saw on the news that there have been some reports of strokes linked to the vaccine. She would like to know if there is any information on this happening. She would like to know if she should have further vaccine doses since she had this stroke that may have been related.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Ischaemic stroke
Clinical narrative: On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain; Interchange of vaccine products; 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), in Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Janssen covid vaccine (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Aug2022, outcome "unknown"; ISCHAEMIC STROKE (medically significant) with onset 10Dec2022, outcome "unknown", described as "On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain".  Clinical course: Female consumer stated that she had previously had 2 doses of Janssen Covid vaccine and then on Aug2022 had a booster of the Pfizer Covid vaccine. She states at the time of the dose she did not have any side effects. On 10Dec2022 she had an ischemic stroke that she described as mild and deep in the brain. She reports that it came out of no where and she did not have many risk factors. She described being an overall healthy individual. She stated that she saw on the news that there have been some reports of strokes linked to the vaccine. She would like to know if there is any information on this happening. She would like to know if she should have further vaccine doses since she had this stroke that may have been related.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ2524) for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6205), on 28Mar2021 as dose 2, single (Lot number: ER8733), on 01Oct2021 as dose 3 (booster), single (Lot number: EW8733) and on 22Apr2022 as dose 4 (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LEVOTHYROXINE, start date: Oct1990; NADOLOL, start date: Mar2022; ALENDRONATE, start date: Oct2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2023) Positive, notes: still testing positive with flowflex rapid test on day 12. Therapeutic measures were taken as a result of covid-19, which included Paxlovid from 08Jan2023 to 06Jan2023. Clinical course: The patient had no known allergies. Despite mild symptoms to start, which were gone by day 4, the patient was still testing positive with flowflex rapid test on day 12, on 15Jan2023, which was recovering with no treatment.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid for Indication treatment of COVID-19, treatment start date was 30Dec2022 and treatment stop date was 04Jan2023. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: She hasn't had her period; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AMENORRHOEA (non-serious), outcome "unknown", described as "She hasn't had her period".  Additional information: Caller was a transgender and she mentioned that she got the COVID-19 shot and she hasn't had her period. Caller wants to know if this was the cause of the Pfizer COVID-19 vaccine couple years back I was a man pfizer vaccine my period was gone. Pfizer BioNTech COVID-19 vaccine. Did not get period. Transitioned from being a man.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Dyspnoea, Illness, Tuberculosis
Clinical narrative: infected with tuberculosis; Shortness of breath; she was sick; 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 21-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 20 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DYSPNOEA (caused and prolonged hospitalization) with onset 2021, outcome "unknown", described as "Shortness of breath"; TUBERCULOSIS (caused and prolonged hospitalization, medically significant) with onset 2021, outcome "unknown", described as "infected with tuberculosis"; ILLNESS (non-serious), outcome "unknown", described as "she was sick". The patient was hospitalized and prolonged hospitalization for tuberculosis, dyspnoea (hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: Body height: 5 foot 2. Therapeutic measures were taken as a result of tuberculosis, dyspnoea, illness.  Clinical course: Term highlighted by the reporter: Yes, highlighted by the reporter, serious. There were no information for results in death, life threatening, disabling/incapacitating, congenital anomaly/birth defect, other medically important condition, caused/prolonged hospitalization: true. There were no other conditions, investigations, other products. Infected with tuberculosis: Is done with medication now, done with the treatment. Clarified that caller had treatment for tuberculosis. After first shot, she was sick and when she went for second shot, was sick so, they could not give her the second dose. After one week, went back to hospital and they found out she was infected with TB, tuberculosis and treatment started. Clarified that she did not get second dose Covid-19 vaccine. Clarified that she was admitted to hospital for one month. When she was there they found the tuberculosis. Went to hospital because of shortness of breath. When she went to the hospital, they tested her and found out she had active tuberculosis. Treatment: Just finished treatment this month, 05Jan2023. Name of treatment was unknown. Was taking a medication from the Clinic. NDC, LOT, EXP: Unknown. Not able to read vaccine card, it is messy. Clarified that she only had one dose of Covid-19 vaccine. There was prior vaccinations (within 4 weeks) and family medical history relevant to adverse events (AEs). Seriousness Criteria: hospitalization, if hospitalized, duration of stay: 1 month. AE required visit to: check all that apply: Hospital admission 1 month. Autopsy Information: N/A.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Carotid artery occlusion, Cerebral artery occlusion, Cerebrovascular accident
Clinical narrative: stroke; his artery is totally blocked, blocked artery in his neck to the brain; his artery is totally blocked, blocked artery in his neck to the brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Pfizer COVID-19 Vaccine), for COVID-19 immunisation; Bnt162b2 (Dose 2, single, Pfizer COVID-19 Vaccine), for COVID-19 immunisation. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; CAROTID ARTERY OCCLUSION (medically significant), CEREBRAL ARTERY OCCLUSION (medically significant), outcome "unknown" and all described as "his artery is totally blocked, blocked artery in his neck to the brain".  Clinical course: Reporter mentioned that she and her husband already got the 3 shots of Pfizer COVID-19 Vaccine and she mentioned that her husband experienced a stroke, and they want to know the if the Pfizer shot instigated some of it and they are calling to ask, what was the legal status on this. If the vaccine instigated this situation and must find out what was the legal status. She also mentioned that they have 3 authorities in their family and there was so much to get into the legal history right now. So, they are just reporting this stroke that her husband experienced, and also mentioned that he got block, his artery was totally blocked, blocked artery in his neck to the brain that is why he experienced stroke. Appropriate response could not be provided as the Reporter hung up the call abruptly. Call back was done, however reporter did not responded over the call. Thus, further probing could not be done. Hence, limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 79 years, in right arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Novacane, reaction(s): "known allergies: Novacane", notes: known allergies: Novacane. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as patient received paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, SARS-CoV-2 test, Vitreous floaters
Clinical narrative: vaginal spotting; floaters in the right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 10:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 69 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Sulfur, reaction(s): "Known allergies: sulfur". Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER) SINGLE,, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE,, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE,, Unknown Manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE,, Unknown Manufacturer), for Covid-19 immunization. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 11Nov2022 at 07:00, outcome "recovering", described as "floaters in the right eye"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 11Nov2022 at 07:00, outcome "recovering", described as "vaginal spotting". The events "vaginal spotting" and "floaters in the right eye" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of postmenopausal haemorrhage, vitreous floaters. Clinical course: Patient had not received any other vaccine in four weeks. The patient received other medications in two weeks. Started having floaters in the right eye and vaginal spotting, treatment with Scrapped the uterus under local anesthesia. No covid prior vaccination, Post vaccination covid tested (Negative).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Inappropriate schedule of product administration
Clinical narrative: Hair loss; Alopecia areata; Dose 1 - 01-APR-2021: Dose 2 - 18-MAY-2021 (> di  42days); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18May2021 at 12:00 as dose, 2 single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, lot unknown, administration time: 12:00 PM), administration date: 01Apr2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18May2021, outcome "unknown", described as "Dose 1 - 01-APR-2021: Dose 2 - 18-MAY-2021 (> di  42days)"; ALOPECIA AREATA (non-serious) with onset 08Jun2021, outcome "not recovered"; ALOPECIA (non-serious) with onset 08Jun2021, outcome "not recovered", described as "Hair loss". The events "hair loss" and "alopecia areata" required physician office visit. Therapeutic measures were not taken as a result of alopecia, alopecia areata.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia (HR of 120 - 140 bpm for 12 hours); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for 1 day at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunization, reaction(s): "Tachycardia (HR of 120 - 140 bpm for 12 hours)". The following information was reported: TACHYCARDIA (non-serious), outcome "unknown", described as "Tachycardia (HR of 120 - 140 bpm for 12 hours)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient administered other vaccine in four weeks. The other vaccine in 4 weeks Flu shot on 13Nov2021 and on 01Sep2022 in right arm. Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses of the Pfizer covid-19 vaccine. The patient recovered from the event. There was no treatment given. No covid prior vaccination. No covid tested post vaccination.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Condition aggravated, Heart rate, Off label use, Product use issue, Tachycardia
Clinical narrative: which was worse after doses 3 and 4; Tachycardia (HR of 120 - 140 bpm for 12 hours); Product use for unapproved combination; off label use; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Nov2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses, Dose 1), for Covid-19 immunization, reaction(s): "Tachycardia"; Bnt162b2 (Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses, Dose 2), for Covid-19 immunization, reaction(s): "Tachycardia". The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 13Nov2021, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 13Nov2021, outcome "unknown"; TACHYCARDIA (non-serious) with onset 14Nov2021, outcome "recovered", described as "Tachycardia (HR of 120 - 140 bpm for 12 hours)"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "which was worse after doses 3 and 4". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tachycardia.  Additional information: Tachycardia (HR of 120 - 140 bpm for 12 hours) the day after all 4 doses of the Pfizer covid-19 vaccine, which was worse after doses 3 and 4. I had the flu shot on the same day as dose 3 in Nov2021. I had the flu shot 01Sep2022, 16 days before I had dose 4 of the Pfizer covid vaccine (17Sep2022) and had tachycardia that was worse (more rapid HR and lasted longer) than after dose 3. The patient received Other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: A little tired; Sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:   A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "A little tired"; PAIN (non-serious), outcome "unknown", described as "Sore".  Additional information: His wife just a little tired and sore after the Pfizer booster vaccine.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: high fevers; uncontrollable body shakes; teeth chattering; Intense headaches; chest pain; light headedness; rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0161, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0171, Location of injection: Arm Right), administration date: 06May2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fevers"; TREMOR (non-serious), outcome "unknown", described as "uncontrollable body shakes"; CHILLS (non-serious), outcome "unknown", described as "teeth chattering"; HEADACHE (non-serious), outcome "unknown", described as "Intense headaches"; CHEST PAIN (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "light headedness"; RASH (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, tremor, chills, headache, chest pain, dizziness, rash.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026408 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300026409 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300026410 same reporter/patient/product, different dose/AE;
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Tremor
Clinical narrative: high fevers; uncontrollable body shakes; teeth chattering; Intense headaches; chest pain; light headedness; rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0161, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0171, Location of injection: Arm Right), administration date: 06May2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fevers"; TREMOR (non-serious), outcome "unknown", described as "uncontrollable body shakes"; CHILLS (non-serious), outcome "unknown", described as "teeth chattering"; HEADACHE (non-serious), outcome "unknown", described as "Intense headaches"; CHEST PAIN (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "light headedness"; RASH (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, tremor, chills, headache, chest pain, dizziness, rash.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026408 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300026409 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300026410 same reporter/patient/product, different dose/AE;
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: high fevers; uncontrollable body shakes; teeth chattering; Intense headaches; chest pain; light headedness; rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0161, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0171, Location of injection: Arm Right), administration date: 06May2021, when the patient was 29-year-old, for COVID-19 immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fevers"; TREMOR (non-serious), outcome "unknown", described as "uncontrollable body shakes"; CHILLS (non-serious), outcome "unknown", described as "teeth chattering"; HEADACHE (non-serious), outcome "unknown", described as "Intense headaches"; CHEST PAIN (non-serious), outcome "unknown"; DIZZINESS (non-serious), outcome "unknown", described as "light headedness"; RASH (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, tremor, chills, headache, chest pain, dizziness, rash.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026408 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300026409 same reporter/patient/product, different dose/AE;US-PFIZER INC-202300026410 same reporter/patient/product, different dose/AE;
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0161), in left arm, on 06May2021 as dose 2, single (Lot number: EW0171), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient was covid tested post vaccination; covid test type post vaccination was Nasal Swab; and Covid test result was Positive. The patient had no other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024971 Same reporter/patient/product, different dose/event.;
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Tremor
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0161), in left arm, on 06May2021 as dose 2, single (Lot number: EW0171), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient was covid tested post vaccination; covid test type post vaccination was Nasal Swab; and Covid test result was Positive. The patient had no other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024971 Same reporter/patient/product, different dose/event.;
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0161), in left arm, on 06May2021 as dose 2, single (Lot number: EW0171), in right arm and on 12Jan2022 as dose 3 (booster), single (Lot number: FH8027) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: The patient was covid tested post vaccination; covid test type post vaccination was Nasal Swab; and Covid test result was Positive. The patient had no other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300024971 Same reporter/patient/product, different dose/event.;
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Swelling
Clinical narrative: swelling in axillary and breast; swelling in axillary and breast; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Aug2021 as dose 2, single (Lot number: FC3181) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: T3/T4 SUPPORT; VITAMIN C [ASCORBIC ACID]; ASPIRIN [ACETYLSALICYLIC ACID]. Past drug history included: Demerol, reaction(s): "known allergies: demerol"; Sudafed, reaction(s): "known allergies: sudafed"; Augmenting, reaction(s): "known allergies: augmenting". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FA7484, Location of injection: Arm Right), administration date: 29Jul2021, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious), BREAST SWELLING (non-serious), outcome "unknown" and all described as "swelling in axillary and breast". The events "swelling in axillary and breast" required physician office visit. Therapeutic measures were not taken as a result of swelling, breast swelling. Additional information: Other medical history - factor 5 (as reported). Unknown if patient experienced COVID-19 prior vaccination and was not tested for COVID-19 post vaccination.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Illness, Lymphadenopathy, Pyrexia
Clinical narrative: got sick; fever; chills; swollen lymph nodes under left arm pits; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 at 08:00 as dose 3 (booster), single (Lot number: EW0196) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TRADJENTA; LISINOPRIL; VIT D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 28Dec2020, when the patient was 54-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 15Jan2021, when the patient was 54-year-old, for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "recovering", described as "got sick"; PYREXIA (non-serious), outcome "recovering", described as "fever"; CHILLS (non-serious), outcome "recovering"; LYMPHADENOPATHY (non-serious), outcome "recovering", described as "swollen lymph nodes under left arm pits". The events "got sick", "fever" and "swollen lymph nodes under left arm pits" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After third and fourth doses got sick and had fever and chills and developed swollen lymph nodes under left arm pits. Patient had no other vaccine in four weeks. Patient had no Covid prior vaccination and tested covid post vaccination. Patient had no known allergies.