chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Contacted covid; Contacted covid; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01Jan2022 14:00 (Batch/Lot number: unknown) at the age of 50 years as dose 2, single and intramuscular, administered in arm left, administration date 12Jan2021 14:00 (Batch/Lot number: unknown) as dose 1, single at the age of 49 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01Jan2022 14:00, outcome "unknown", COVID-19 (medically significant) with onset 01Jan2022 14:00, outcome "recovering" and all described as "Contacted covid"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Jan2022 14:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: COVID test post vaccination: COVID test type post vaccination: Nasal Swab, COVID test name post vaccination: Quickbue at home OTC COVID test. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Tested positive for covid; Tested positive for covid; congestion; fever; sore throat; occasional cough; running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jun2021 (Lot number: EN6203) at the age of 46 years as DOSE 2, SINGLE and administered in arm left, administration date 21May2021 (Lot number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing). The patient had no allergies. The patient had no other vaccines within 4 weeks. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "recovering" and all described as "Tested positive for covid"; NASAL CONGESTION (non-serious) with onset 31Dec2021, outcome "recovering", described as "congestion"; PYREXIA (non-serious) with onset 31Dec2021, outcome "recovering", described as "fever"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 31Dec2021, outcome "recovering", described as "occasional cough"; RHINORRHOEA (non-serious) with onset 31Dec2021, outcome "recovering", described as "running nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Covid test after post vaccination: Home kit. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasal congestion, pyrexia, oropharyngeal pain, cough, rhinorrhoea.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for covid; Tested positive for covid; congestion; fever; sore throat; occasional cough; running nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jun2021 (Lot number: EN6203) at the age of 46 years as DOSE 2, SINGLE and administered in arm left, administration date 21May2021 (Lot number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing). The patient had no allergies. The patient had no other vaccines within 4 weeks. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "recovering" and all described as "Tested positive for covid"; NASAL CONGESTION (non-serious) with onset 31Dec2021, outcome "recovering", described as "congestion"; PYREXIA (non-serious) with onset 31Dec2021, outcome "recovering", described as "fever"; OROPHARYNGEAL PAIN (non-serious) with onset 31Dec2021, outcome "recovering", described as "sore throat"; COUGH (non-serious) with onset 31Dec2021, outcome "recovering", described as "occasional cough"; RHINORRHOEA (non-serious) with onset 31Dec2021, outcome "recovering", described as "running nose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Covid test after post vaccination: Home kit. Therapeutic measures were not taken as a result of vaccination failure, covid-19, nasal congestion, pyrexia, oropharyngeal pain, cough, rhinorrhoea.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Dec2021 (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: LOSS OF CONSCIOUSNESS (death) with onset Dec2021, outcome "fatal", described as "passed out". The patient date of death was unknown. The reported cause of death was loss of consciousness. The patient passed out shortly after receiving the COVID-19 vaccine from Pfizer-BioNTech. It was in Dec2021, never heard from her again. This was the 1st warning to the world about and was equally ignored by the media.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: passed out
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 10Dec2021 (Lot number: FL0007) at the age of 7 years as dose 2, single and administration date 26Nov2021 (Lot number: FK5618) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "tested positive for COVID". He received the 2nd dose 14 days from the 1st dose and due to this the vaccination status is not valid. He also tested positive for COVID on a rapid PCR test on 04Jan2022. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: RAPID Ag test at home on 27Dec positive; RAPID Ag test at home on 27Dec positive; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 27 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via unspecified route of administration, administration date 07Dec2021 (Lot number: FF2589) at the age of 27 years as dose 3 (booster), single, then administration date 18Mar2021 (Lot number: EL3247) as dose 2, single and then administration date 25Feb2021 (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: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "RAPID Ag test at home on 27Dec positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. It was further reported that patient had symptoms of head cold and sore throat (ST) on 26Dec2021-27Dec2021 and rapid test Ag test at home on 27Dec2021 was positive. It was unknown if patient was diagnosed with covid-19 prior to vaccination and it was unknown if patient received any other vaccines within 4 weeks prior to the covid vaccine. The patient received the most recent covid-19 vaccine in workplace clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure  and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available. Given the nature of the event of immunisation role of suspect product BNT162B2 cannot be assessed for it.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for Covid using rapid test.; Tested positive for Covid using rapid test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 26Jul2021 (Lot number: EE0171) at the age of 12 years as dose 2, single and administration date 02Jul2021 (Lot number: Ew0196) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "recovered" (Jan2022) and all described as "Tested positive for Covid using rapid test.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has been tested for COVID-19 post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Male patient had 2 doses (initial doses) and tested positive January 4th and presented with mild Covid symptoms; Male patient had 2 doses (initial doses) and tested positive January 4th and presented with mild Covid symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Male patient had 2 doses (initial doses) and tested positive January 4th and presented with mild Covid symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: I had COVID; The first Pfizer vaccine we got it on Monday and I came down with COVID on Sunday; We were tested and we had COVID; I had COVID; The first Pfizer vaccine we got it on Monday and I came down with COVID on Sunday; We were tested and we had COVID; We were pretty sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Aug2021 (Lot number: FC3183, Expiration Date: Oct2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "I had COVID; The first Pfizer vaccine we got it on Monday and I came down with COVID on Sunday; We were tested and we had COVID"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "We were pretty sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive. Therapeutic measures were not taken as a result of covid-19, illness. Clinical course: This is the first case out of two cases in which reporter is calling for herself (Consumer). She does not know what they put in the vaccines, but the first one she had was okay. When confirmed that the consumer got COVID after receiving Pfizer COVID 19 Vaccine, Consumer stated, "Yes, the first Pfizer vaccine we got it on Monday and on Saturday her husband came down with COVID and she did on Sunday and they were pretty sick. They were tested and they had COVID. Then they did monoclonal antibody, so they had to wait for 3 months and then they decided okay they will have the second Pfizer. Her husband reacted better, but she had all of this, she was feeling better now but out of the 21 side effects she had 10 and one that she just told us, she almost fell on the ground, 11. So half of the side effects she had. The patient inquired about booster and said that what are they putting in this vaccine (General statement)." Consumer was informed about the role of Pfizer Drug Safety and requested to probe. The consumer did not had any vaccination 4 weeks prior to COVID 19 Vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Home AG-Positive (cough, congestion stuffy nose, SOB); Home AG-Positive (cough, congestion stuffy nose, SOB); Dose 3; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 26-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administration date 15Oct2021 (Lot number: FF2589) at the age of 26 years as dose 3 (booster), single, via an unspecified route of administration, administration date 23Mar2021 (Lot number: EL3247) at the age of 25 years as dose 2, single and via an unspecified route of administration, administration date 04Mar2021 (Lot number: EL3247) at the age of 25 years as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 15Oct2021, outcome "unknown", described as "Dose 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022 17:00, outcome "recovering" and all described as "Home AG-Positive (cough, congestion stuffy nose, SOB)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test (Home AG): (04Jan2022) negative; (05Jan2022) positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: The patient received the booster dose in a workplace clinic. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if patient was diagnosed with COVID-19 infection prior to vaccination. In the week of 25Dec2021, the patient had a travel, then on 05Jan2022, the patient tested positive in Ag test with symptoms cough, congestion stuffy nose, and SOB (shortness of breath) that started on 04Jan2022 17:00.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between the reported events immunisation, vaccination failure, Covid-19 and the suspect BNT162B2 is possible.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, VIth nerve paralysis
Clinical narrative: sixth nerve palsy right eye; Horizontal double vision/diagnosed with diplopia; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 30Dec2021 09:30 (Lot number: 33130BA) at the age of 59 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Hypertension" (unspecified if ongoing). Patient had no allergies. Concomitant medication included: LISINOPRIL. Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (DOSE 1, SINGLE, Lot number: FJ8762, Administration time: 01:00 PM, Vaccine location: Left arm), administration date: 09Dec2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: VITH NERVE PARALYSIS (medically significant) with onset 03Jan2022, outcome "not recovered", described as "sixth nerve palsy right eye"; DIPLOPIA (non-serious) with onset 03Jan2022, outcome "not recovered", described as "Horizontal double vision/diagnosed with diplopia". The events "sixth nerve palsy right eye" and "horizontal double vision/diagnosed with diplopia" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of vith nerve paralysis, diplopia. Clinical course: After 72 hours patient began experiencing horizontal double vision. It has become more pronounced since injection. Patient went to emergency room and was seen by urgent care physician and an ophthalmologist. Patient was diagnosed with diplopia and sixth nerve palsy right eye. Later notified by ophthalmologist that vaccination could be the cause of diplopia. The patient  again went to emergency room and was seen by the ophthalmologist for further medical help for the events. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got dose 1 on 13Dec2021. On 06Jan2022 she tested positive for covid; got dose 1 on 13Dec2021. On 06Jan2022 she tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200047512.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 06Jan2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got dose 1 on 13Dec2021. On 06Jan2022 she tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. Description of complaint:  Patient was tested positive for covid and has NO symptoms. She was scheduled to take her 2nd dose on 16Jan2022 (10 days after testing positive), assuming she had no symptoms, reporter enquires if it safe for her to take it on this date or should she wait?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4014738-00 (AbbVie).  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 15Jul2021 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single and intramuscular, administration date 01May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1151650) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2021, outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug Ineffective and suspected covid-19 with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse drug reaction, Immunisation, Rheumatoid arthritis
Clinical narrative: booster; rheumatoid arthritis flare up; Drug side effect; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4014738-00.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1151650) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1st, Route of Admin : Intramuscular), administration date: 01May2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19"; Bnt162b2 (Dose:2nd, Route of Admin : Intramuscular), administration date: 15Jun2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "COVID-19", "COVID-19". The following information was reported: IMMUNISATION (medically significant) with onset 20Dec2021, outcome "unknown", described as "booster"; RHEUMATOID ARTHRITIS (medically significant) with onset Dec2021, outcome "unknown", described as "rheumatoid arthritis flare up"; ADVERSE DRUG REACTION (medically significant) with onset Dec2021, outcome "unknown", described as "Drug side effect". The action taken for adalimumab was unknown. Clinical course: Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID-19 with Humira (Adalimumab) was no reasonable possibility. For the events Rheumatoid arthritis flare up & Drug side effect Causality for Humira as per reporter (Drug/Vaccine) was Reasonable possibility. The reporter's causality for the of events Rheumatoid arthritis flare up & Drug side effect with PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was possible.  Follow-up activities closed as this is an Other company report and routine follow-ups are not conducted as responsibility of f/up lies with the other company.; Sender's Comments: Based on the information provided, a causal association between reported events immunisation, rheumatoid arthritis, adverse drug reaction and the suspect BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Currently, on 01112022, area has a rash, small bumps; Currently, on 01112022, area has a rash, small bumps; Itching and burning at injection site during second vaccination; Itching and burning at injection site during second vaccination; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 23Dec2021 (Lot number: unknown) at the age of 41 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex and "Fruit allergy" (unspecified if ongoing), notes: Known allergies: avocado, kiwi. Concomitant medications were not reported. Past drug history included: Ceftin, reaction: "Drug allergy", notes: Known allergies: Ceftin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Anatomical location: Left arm), administration date: 02Dec2021, when the patient was 41 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 23Dec2021, outcome "not recovered", and all described as "Itching and burning at injection site during second vaccination"; VACCINATION SITE RASH (non-serious), VACCINATION SITE MASS (non-serious) all with onset 11Jan2022, outcome "not recovered", and all described as "Currently, on 01112022, area has a rash, small bumps". Therapeutic measures were not taken as a result of vaccination site pruritus, vaccination site pain, vaccination site rash and vaccination site mass.  Additional Information: 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. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstrual disorder
Clinical narrative: I have noticed a change in my menstral cycle; BNT162b2 was administered after 42 days of primary dose.; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 04Sep2021 at 14:00 (Lot number: unknown) at the age of 21 years 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, Anatomical Location: Right arm, Administration Time: 14:00), administration date: 05Mar2021, when the patient was 21 years old, for COVID-19 immunisation.  The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 04Dec2021, outcome "unknown", described as "I have noticed a change in my menstral cycle"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Sep2021 at 14:00, outcome "unknown", described as "BNT162b2 was administered after 42 days of primary dose". Therapeutic measures were not taken as a result of menstrual disorder.  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 not 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Pain, Pyrexia
Clinical narrative: Body aches/ full body sourness; Soar joints; Swollen stomach; Pain in the stomach; Fatigue; Chills; Fever; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.   A 55-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Dec2021 at 14:00 (Lot number: unknown) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Clot blood" start date: an unknown date in 2018 (unspecified if ongoing), notes: 4 years prior the patient had a blood clot in small intestine and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Concomitant medications included: AMLODIPINE; BENAZEP; ALLOPURINOL and 81 MG ASPIRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical location: right arm; Administration time: 12:00), administration date: 01Apr2021, when the patient was 54 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical location: left arm; Administration time: 12:00), administration date: 23Apr2021, when the patient was 54 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021 at 14:00, outcome "unknown", described as "Dose received: 3"; CHILLS (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Chills"; PYREXIA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Body aches/ full body sourness"; ARTHRALGIA (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Soar joints"; ABDOMINAL DISTENSION (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Swollen stomach"; ABDOMINAL PAIN UPPER (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Pain in the stomach"; FATIGUE (non-serious) with onset an unknown date in Jan2022, outcome "not recovered", described as "Fatigue". The events "Chills", "Fever", "Body aches/ full body sourness", "Soar joints", "Swollen stomach", "Pain in the stomach" and "Fatigue" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chills, pyrexia, pain, arthralgia, abdominal distension, abdominal pain upper and fatigue.  Additional information: The patient had no known allergies. The patient did not receive other vaccines within four weeks prior to COVID vaccine. First 2 days the patient had chills, fever. It was reported that 1 "through" 2 weeks later and present the patient had body aches, sour joints, swollen stomach, pain in the stomach, fatigue, full body soreness. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Swelling
Clinical narrative: Swelling and pain in left armpit; Swelling and pain in left armpit; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 10Jan2022 (Lot number: 33025BD) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. The patient had received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0158, Anatomical Location: Left arm), administration date: 15Apr2021, when the patient was 33 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW0172, Anatomical Location: Left arm), administration date: 06May2021, when the patient was 33 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Jan2022, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 11Jan2022, outcome "unknown", and all described as "Swelling and pain in left armpit". Therapeutic measures were not taken as a result of swelling and axillary pain.  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 not 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Dysgeusia, Immunisation, Muscle twitching
Clinical narrative: Nonstop twitching in left arm; I also experienced a awful taste of medicine; Loss smell; Dose received: 3; This is a spontaneous report from a contactable consumer (other healthcare professional). The reporter is the patient.  A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 at 16:00 (Lot number: PD7218) at the age of 35 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: EL3246; Administration time: 12:00; Anatomical location: right arm; Route of administration: unspecified), administration date: 14Jan2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL9261; Administration time: 07:00; Anatomical location: right arm; Route of administration: unspecified), administration date: 05Feb2021, when the patient was 34 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 16:00, outcome "unknown", described as "Dose received: 3"; DYSGEUSIA (non-serious) with onset 07Jan2022 at 16:15, outcome "recovered" (10Jan2022 at 16:15), described as "I also experienced a awful taste of medicine"; ANOSMIA (non-serious) with onset 07Jan2022 at 16:15, outcome "recovering", described as "Loss smell"; MUSCLE TWITCHING (non-serious) with onset 08Jan2022 at 03:00, outcome "recovering", described as "Nonstop twitching in left arm". Therapeutic measures were not taken as a result of dysgeusia, anosmia and muscle twitching.  Additional Information: The patient had no known allergies. Prior to the 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. Twitching began at 03:00 after the vaccine. She also experienced an awful taste of medicine and loss smell. The twitching was slowly getting better. No more taste of medicine, it lasted 3 days and she was slowly getting her smell back. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Booster; Oxygen levels were too low. Patient had to be hospitalized; This is a spontaneous report received from a contactable reporter (other health care professional (HCP)).  A 55-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient had not known allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, lot number unknown), for COVID-19 Immunization; Bnt162b2 (Dose 1, lot number unknown), for COVID-19 Immunization. The patient had not received any other vaccines within four weeks. The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "Booster"; OXYGEN SATURATION DECREASED (hospitalization) with onset 23Dec2021, outcome "unknown", described as "Oxygen levels were too low. Patient had to be hospitalized". The patient was hospitalized for oxygen saturation decreased (hospitalization duration: 5 days). The event "oxygen levels were too low. patient had to be hospitalized" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: oxygen saturation: (23Dec2021) too low. It was unknown if therapeutic measures were taken as a result of oxygen saturation decreased and if patient was tested for COVID-19 post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Immunisation, SARS-CoV-2 test
Clinical narrative: Intense headache every day after shot. Headache gets worse when lying down. Throbbing and thumping.; Extreme pressure in the head.; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 32-year-old female patient received bnt162b2 (BNT162B2), administered in left arm, administration date 08Jan2022 at 09:00 (Lot number: FL3197) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: NUVARING. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6207, Anatomical location: Left arm, Administration time: 16:00), administration date: 31Mar2021, when the patient was 31 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN0161, Anatomical location: Left arm, Administration time: 15:00), administration date: 29Apr2021, when the patient was 32 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Jan2022 at 09:00, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 09Jan2022 at 22:00, outcome "not recovered", described as "Intense headache every day after shot. Headache gets worse when lying down. Throbbing and thumping"; HEAD DISCOMFORT (non-serious) with onset 09Jan2022 at 22:00, outcome "not recovered", described as "Extreme pressure in the head". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache and head discomfort.  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. Therapeutic measures taken as a result of headache and head discomfort included treatment with tylenol and ibuprofen.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Vision blurred
Clinical narrative: Intense headache every day after shot. Headache gets worse when lying down. Throbbing and thumping.; Extreme pressure in the head.; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 32-year-old female patient received bnt162b2 (BNT162B2), administered in left arm, administration date 08Jan2022 at 09:00 (Lot number: FL3197) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: NUVARING. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6207, Anatomical location: Left arm, Administration time: 16:00), administration date: 31Mar2021, when the patient was 31 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN0161, Anatomical location: Left arm, Administration time: 15:00), administration date: 29Apr2021, when the patient was 32 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 08Jan2022 at 09:00, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset 09Jan2022 at 22:00, outcome "not recovered", described as "Intense headache every day after shot. Headache gets worse when lying down. Throbbing and thumping"; HEAD DISCOMFORT (non-serious) with onset 09Jan2022 at 22:00, outcome "not recovered", described as "Extreme pressure in the head". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache and head discomfort.  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. Therapeutic measures taken as a result of headache and head discomfort included treatment with tylenol and ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Pregnancy test
Clinical narrative: Menstrual cycle ended after one day. Typical menstrual cycle last 5-7 days. The menstrual cycle has not resumed.; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 28Dec2021 at 09:30 (Lot number: FL3197) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AMENORRHOEA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Menstrual cycle ended after one day. Typical menstrual cycle last 5-7 days. The menstrual cycle has not resumed". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea.  Additional Information: The patient reported that there was no possibility of pregnancy. There were several negative pregnancy tests. Known allergies was reported as not available (N/a). 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Congenital anomaly, Immunisation, Maternal exposure during pregnancy
Clinical narrative: Sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'Congenital anomaly/birth defect'; Sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'Congenital anomaly/birth defect'; dose received: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A fetus patient was exposed to bnt162b2 (Pfizer-BioNTech COVID-19), transplacental, administration date 22Dec2021 00:15 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The mother of the patient was 37 years old at the time of vaccination. Date of last menstrual period of the mother: 04Nov2021. The mother was 6 weeks pregnant at the time of exposure to bnt162b2. The mother was 7 weeks pregnant at the event onset. The mother is expected to deliver a baby(s) on 11Aug2022. The mother's relevant medical history and concomitant medications were not reported. The mother's vaccination history included: Bnt162b2 (Dose Number: 02, Vaccine Administration date: 02Jun2021, Lot no.: EW0178, Anatomical Site: Arm left), administration date: 02Jun2021, for Covid-19 immunization, reaction(s): "gestational period:7, 1st dose:12May2021,2nd dose:02Jun2021"; Bnt162b2 (Dose Number: 01, Vaccine Administration date: 12May2021, Lot no.: EW0183), administration date: 12May2021, for Covid-19 immunization, reaction(s): "gestational period:7, 1st dose:12May2021,2nd dose:02Jun2021". The following information was reported: IMMUNISATION (death, congenital anomaly) with onset 22Dec2021 00:15, outcome "fatal", described as "dose received: 3"; MATERNAL EXPOSURE DURING PREGNANCY (death, congenital anomaly), CONGENITAL ANOMALY (death, congenital anomaly) all with onset 25Dec2021, outcome "fatal" and all described as "Sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'Congenital anomaly/birth defect'". The events "dose received: 3", "sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'congenital anomaly/birth defect'" and "sever reaction including fever followed by miscarriage 3 days after vaccination/seriousness criterion was reported as 'congenital anomaly/birth defect'" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of congenital anomaly. The patient date of death was 25Dec2021. The reported cause of death was abortion spontaneous. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200029132 mother case; Reported Cause(s) of Death: Miscarriage