chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Immunisation, Loss of consciousness, Pruritus
Clinical narrative: Passed out next AM; Itching all over about 30 minutes post injection; Booster; Very dizzy; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 12:00 (Lot number: 331308A) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seizure disorder" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing). The patient took concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not have covid before vaccination. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Vaccine Administration Time: 12:00 AM), administration date: 06Apr2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Vaccine Administration Time: 12:00 AM), administration date: 16Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant); LOSS OF CONSCIOUSNESS (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Passed out next AM"; PRURITUS (non-serious) with onset 22Dec2021 at 12:30, outcome "not recovered", described as "Itching all over about 30 minutes post injection"; DIZZINESS (non-serious) with onset 22Dec2021, outcome "not recovered", described as "Very dizzy". The patient described the events as itching all over about 30 minutes post injection. Passed out next AM. Very dizzy. Almost passed out again second day post injection. Therapeutic measures were not taken as a result of loss of consciousness, pruritus, dizziness. Patient did not had covid test post vaccination.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone contusion, Immunisation, Pain of skin, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare ups in hips; Bruise on both sided of the hip bone; Sore spot on left arm below the elbow; booster; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4193509-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer biontech covid-19 vaccine (Dose 1, Route: Intramuscular), administration date: 05Feb2021, for COVID-19 immunisation; Pfizer biontech covid-19 vaccine (Dose 2, Intramuscular), administration date: 06Mar2021, for COVID-19 immunisation. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Rheumatoid arthritis flare ups in hips"; BONE CONTUSION (non-serious) with onset 2021, outcome "unknown", described as "Bruise on both sided of the hip bone"; PAIN OF SKIN (non-serious) with onset 2021, outcome "not recovered", described as "Sore spot on left arm below the elbow"; IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster". The action taken for adalimumab was unknown. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of 'Bruise on both sides of the hip bone, Rheumatoid Arthritis Flare ups in Hips and sore on left arm below the elbow' was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, a possible causal association between the reported events rheumatoid arthritis, bone contusion, pain of skin, immunisation, and the suspect BNT162B2 cannot be totally 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
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: has tested positive for covid via home test (no rapid test); has tested positive for covid via home test (no rapid test); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient in his early 20's 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) with onset Dec2021, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Dec2021, outcome "recovered" (Dec2021) and all described as "has tested positive for covid via home test (no rapid test)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive; (Dec2021) positive; (Dec2021) negative. The patient believed he contracted virus on 19Dec2021. He took 3 home tests (no rapid test). The first two tests had come back positive, and the most recent one had come back negative. The reporter did not think they were all taken on the same day. As of 25Dec2021 the patient was doing fine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Brain injury
Clinical narrative: Irreparable Damage/brain injury; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (medically significant), outcome "not recovered", described as "Irreparable Damage/brain injury".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: all of them and the booster; Came positive from Covid/ Positive from Covid; Came positive from Covid/ Positive from Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (004756).  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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:IMMUNISATION (medically significant),outcome "unknown", described as "all of them and the booster  COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Came positive from Covid/ Positive from Covid"; The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  Additional information: The reporter stated that "his grandma (grandmother), 86 years old, came positive from Covid, and wants to know or find out about the Paxlovid, if it was being distributed or not, so his grandmother was positive from Covid. The reporter stated that they just enquired for Paxlovid of the Pfizer, but since there was already an adverse event so, and need to report it. No, this was for the Paxlovid." The reporter stated, "I want to know how the Paxlovid was available, if it was available, said, if it was available through has to be prescribe or over the counter or not", and the reporter was informed about this information. When asked if the patient received any of the Covid19 Vaccine, then the reporter stated, "Yes, all of them and the booster but was not provided with any answer to his question, already waited 20 minutes just to get to talk and all that happening was to collect more information from reporter and not provided to any of the asked information." When asked for permission for further probing, the reporter stated, "Absolutely not, No."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid test positive"; EXPOSURE TO SARS-COV-2 (medically significant), outcome "unknown", described as "often near people who test positive for Covid". The patient was often near people who test positive for COVID and were likely vaccinated. It was a frequent occurrence. Two roommates have at one point or another tested positive. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive..  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858695 same reporter/vaccine, different patients, similar events
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Diarrhoea, Drug ineffective
Clinical narrative: Cough became productive; splitting headache; fever; diarrhea; dry cough; chills; Contracted Covid-19 after being fully vaccinated; Contracted Covid-19 after being fully vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative and regulatory authority. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, administration date 23Sep2021 (Lot number: 301308A) as dose 2, single and administration date 01Sep2021 (Lot number: FC3188) 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: COVID-19, vaccination failure all with onset 2021, outcome unknown; headache, pyrexia, diarrhea, cough and chills onset 23Dec2021; productive cough onset 24Dec2021, outcome unknown. Symptoms begin on 22Dec2021.  No follow-up attempts are possible. No further information is expected.  Additional information: description of event: contracted Covid-19 after being fully vaccinated. Symptoms began on 22Dec2021. On 23Dec2021 had splitting headache, fever, diarrhea, dry cough and chills. Cough became productive on 24Dec2021. Event took place after use of product.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Productive cough, Pyrexia
Clinical narrative: Cough became productive; splitting headache; fever; diarrhea; dry cough; chills; Contracted Covid-19 after being fully vaccinated; Contracted Covid-19 after being fully vaccinated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative and regulatory authority. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, administration date 23Sep2021 (Lot number: 301308A) as dose 2, single and administration date 01Sep2021 (Lot number: FC3188) 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: COVID-19, vaccination failure all with onset 2021, outcome unknown; headache, pyrexia, diarrhea, cough and chills onset 23Dec2021; productive cough onset 24Dec2021, outcome unknown. Symptoms begin on 22Dec2021.  No follow-up attempts are possible. No further information is expected.  Additional information: description of event: contracted Covid-19 after being fully vaccinated. Symptoms began on 22Dec2021. On 23Dec2021 had splitting headache, fever, diarrhea, dry cough and chills. Cough became productive on 24Dec2021. Event took place after use of product.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Impaired gastric emptying
Clinical narrative: gastroparesis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 34 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The patient developed gastroparesis 10 days later his second vaccination. The gastroparesis has become more manageable over the past few months. The following information was reported: IMPAIRED GASTRIC EMPTYING (medically significant) with onset 2021, outcome "unknown", described as "gastroparesis". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter (consumer).  A male patient in his 20's received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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) and SUSPECTED COVID-19 (medically significant) all with onset 19Dec2021, outcome "unknown" and all described as "Contracted COVID". Clinical course: The patient could have contracted COVID last Sunday (19Dec2021) where there has been traces back to COVID spread. The reporter believed it was confirmed by test, but he/she was not 100% sure.   The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Maternal exposure timing unspecified, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: who is pregnant has covid; Believe they tested positive; Believe they tested positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. Other Case identifier(s): -PFIZER INC-202101858753 (Pfizer).  A female patient (pregnant) 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) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovering" and all described as "Believe they tested positive"; MATERNAL EXPOSURE TIMING UNSPECIFIED (medically significant), outcome "unknown", described as "who is pregnant has covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. It was reported that the patient is pregnant and has COVID. The baby is due in Mar. The reporter cannot confirm vaccine status but the patient may be vaccinated (likely). Unsure when or what vaccine. The reporter believe the patient tested positive on an unspecified date in Dec2021. The reporter assessed the case as serious.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : -PFIZER INC-202101858682 same reporter/drug, different patients, similar events
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Believe they tested positive; Believe they tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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), outcome "unknown" and all described as "Believe they tested positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Reporter cannot confirm vaccine status of patient, but may be vaccinated (likely). Unsure when or what vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart palpitations 4days after second and third mrna vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 58-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 12:00 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hbp" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: PALPITATIONS (medically significant) with onset 05May2021 12:00, outcome "not recovered", described as "Heart palpitations 4days after second and third mrna vaccination". The event "heart palpitations 4days after second and third mrna vaccination" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of palpitations with Beta blockers. Mag.  Additional information: Patient received third dose on 01Dec2021 at 12:00 PM administered in right arm for COVID-19 immunization. other vaccine on same date Pfizer mrna first dose on 01Dec2021 administered in left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19. This case assessed as non-serious by the reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Palpitations
Clinical narrative: Dose Number:3; Heart palpitations 4days after second and third mrna vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 12:00 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hbp" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01May2021, when the patient was 58 years old, for COVID-19 immunization, reaction(s): "Heart palpitations 4days after second and third mrna vaccination"; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 01Dec2021 12:00, outcome "unknown", described as "Dose Number:3"; PALPITATIONS (medically significant) with onset Dec2021, outcome "not recovered", described as "Heart palpitations 4days after second and third mrna vaccination". The event "heart palpitations 4days after second and third mrna vaccination" was evaluated at the emergency room visit. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of palpitations. Treatment included: Beta blocker's. Mag. Device Date: 24Dec2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Two roommates have at one point or another tested positive; Two roommates have at one point or another tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE, COVID-19, outcome unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858522 same reporter/vaccine, different patients, similar events; US-PFIZER INC-202101858696 same reporter/vaccine/event, different patients
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: two roommates that have previously tested positive; two roommates that have previously tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Contracted COViD 12 days after Pfizer vaccine booster; Contracted COVID 12 days after Pfizer vaccine booster; booster; This is a spontaneous report received from non-contactable reporter from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Batch/Lot number: unknown) as dose number unknown (booster), single 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 but unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown; IMMUNISATION (medically significant), outcome unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: diagnosed with covid; diagnosed with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202101886107 (pfizer), US-PFIZER INC-202200000007 (pfizer).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "shoulder surgery" (unspecified if ongoing), notes: had shoulder surgery last year or early this year to treat a longstanding injury. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with covid". Patient diagnosed with covid. Males all mid -late 20s. They reside in withheld. This is a recent event. Not sure what vaccines are provided in withheld, but they are likely all vaccinated.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101872620 same reporter/vaccine/event, different patient;US-PFIZER INC-202101872619 same reporter/vaccine/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Drug ineffective, Influenza like illness
Clinical narrative: Contracted Covid-19 after being fully vaccinated/tested positive for Covid-19; Contracted Covid-19 after being fully vaccinated/tested positive for Covid-19; Flu like symptoms; Fever; Chills; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 62-year-old male patient received bnt162b2, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 11Mar2021 (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, COVID-19, influenza like illness, pyrexia and asthenia, all with onset 2021, all with outcome unknown.  Additional information: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Contracted Covid-19 after being fully vaccinated/tested positive for Covid-19; Contracted Covid-19 after being fully vaccinated/tested positive for Covid-19; Flu like symptoms; Fever; Chills; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a sales representative. The reporter is the patient.  A 62-year-old male patient received bnt162b2, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 11Mar2021 (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, COVID-19, influenza like illness, pyrexia and asthenia, all with onset 2021, all with outcome unknown.  Additional information: Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: prior to being eligible for vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for covid-19 immunization; Bnt162b2 (Dose 1), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Nov2021, outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive. The patient was fully vaccinated (all three doses) and she had covid prior to being eligible for vaccine. Today she tested positive for covid again. She has no known underlying conditions. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: an extreme bout of vertigo.; On my second dose of the Pfizer vaccine, I experienced dizziness all day. It improved and after several days seemed to have resolved. But, about a month later, I ended up in the ER (my first visit eve; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Jul2021 (Lot number: EW0191) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "OA" (unspecified if ongoing); "Hbp" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0127, Location of injection: Arm Right), administration date: 12Jun2021, when the patient was 56 years old, for Covid-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as yes. The patient had known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: VERTIGO (hospitalization) with onset 08Aug2021, outcome "not recovered", described as "an extreme bout of vertigo."; DIZZINESS (hospitalization) with onset 08Aug2021, outcome "not recovered", described as "On my second dose of the Pfizer vaccine, I experienced dizziness all day. It improved and after several days seemed to have resolved. But, about a month later, I ended up in the ER (my first visit eve". The patient was hospitalized for vertigo, dizziness (hospitalization duration: 1 day(s)). The events "an extreme bout of vertigo." and "on my second dose of the pfizer vaccine, i experienced dizziness all day. it improved and after several days seemed to have resolved. but, about a month later, i ended up in the er (my first visit eve" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of vertigo, dizziness. Clinical course was reported as on my second dose of the Pfizer vaccine, I experienced dizziness all day. It improved and after several days seemed to have resolved. But, about a month later, I ended up in the ER (my first visit ever) with an extreme bout of vertigo. I ended up in the hospital. Still dealing with vertigo after treatment. I was diagnosed with vertigo caused by a virus or similar type that had affected my inner ear. I had not been ill with anything for at least 2 years prior to this, the only thing would be the covid vaccine that affected my inner ear causing this continual bout of vertigo. Treatment received for the adverse event was medication, therapy. Device Date was reported as, 24Dec2021.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Mental impairment, Syncope
Clinical narrative: I got very dizzy and almost blacked out; I was sweating and could barely think of what to do because I was almost fainting; I was sweating and could barely think of what to do because I was almost fainting; I got very dizzy and almost blacked out; I was sweating and could barely think of what to do because I was almost fainting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 (Lot number: EW0173) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulpha" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Right), administration date: 11Apr2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), DIZZINESS (non-serious) all with onset 07May2021, outcome "recovered" (2021) and all described as "I got very dizzy and almost blacked out"; SYNCOPE (medically significant), MENTAL IMPAIRMENT (medically significant), HYPERHIDROSIS (non-serious) all with onset 07May2021, outcome "recovered" and all described as "I was sweating and could barely think of what to do because I was almost fainting". Therapeutic measures were not taken as a result of loss of consciousness, syncope, mental impairment, dizziness, hyperhidrosis. The patient receive the third dose on  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pericarditis, SARS-CoV-2 test
Clinical narrative: Dose number:03; pericarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 (Lot number: 320308D) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing); "Insulin resistance" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TOPAMAX; LEVOTHYROXINE; TRINTELLIX. Past drug history included: Known_allergies:clindamycin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, rev_dose_lot_number=ek5730, prev_dose_vaccine_location= Left arm), administration date: 07Jan2021, when the patient was 48 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, prev_dose_lot_number=el1283, prev_dose_vaccine_location= Left arm), administration date: 28Jan2021, when the patient was 48 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 11Nov2021, outcome "unknown", described as "Dose number:03"; PERICARDITIS (hospitalization, medically significant) with onset 22Dec2021 08:00, outcome "recovering", described as "pericarditis". The patient was hospitalized for immunisation (start date: Dec2021); for pericarditis (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 2 day(s)). The event "pericarditis" was evaluated at the emergency room visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) negative. Therapeutic measures were not taken as a result of pericarditis. Device Date: 25Dec2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and pericarditis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pain, Rash, Urticaria
Clinical narrative: blistering hives/rash; Left side severe back, flank and rib pain; blistering hives/rash; blistering hives/rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 11:00 (Lot number: 331308A) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Drug allergy", notes: known allergies:  Keflex. The following information was reported: RASH (non-serious), BLISTER (non-serious), URTICARIA (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "blistering hives/rash"; PAIN (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Left side severe back, flank and rib pain". Therapeutic measures were not taken as a result of rash, pain, blister, urticaria.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no information on other medications that the patient received within 2 weeks of vaccination, Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19 Reported Events are Left side severe back, flank and rib pain followed by blistering hives/rash.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter. A 45-year-old male patient received bnt162b2 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) 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, COVID-19, outcome unknown and all described as He got the second dose he develop COVID as well after the vaccine/he develop the COVID 3 days after the vaccine. Clinical course: The patient had no prior vaccination. The nurse's husband received the third dose of the vaccine the day prior, and he had COVID/was diagnosed that day. He started developing symptoms after the vaccine the day prior and that day he was very sick, so he was tested positive. But this is not the first time, when he got the second dose, he developed COVID as well after the vaccine. But last time, he developed COVID 3 days after the vaccine. So, the nurse was calling to check if there were any reports of people getting actual COVID after the vaccine. The nurse stated, it's just confusing because he got COVID after the second shot as well and now, and that time, he was tested positive and now today, he was tested positive again. So, it's every time he gets the shot the second and the booster, he got the COVID. No lab test done, and for treatment, the patient took Vitamin C, Zinc and Tylenol, Motrin but not treatment like medicine. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Immunisation, Loss of consciousness, Mental impairment
Clinical narrative: blacked out; was almost fainting; could barely think of what to do; very dizzy; I also thought I was going to vomit; sweating; Dose received: 3; 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 received BNT162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 (Lot number: FF2590) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulpha" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not have covid before vaccination. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Right), administration date: 06May2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "I got very dizzy and almost blacked out.", "almost blacked out.", "I was sweating and could barely think of what to do because I was almost fainting.", "almost fainting."; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Right), administration date: 11Apr2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant); LOSS OF CONSCIOUSNESS (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "blacked out"; SYNCOPE (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "was almost fainting"; MENTAL IMPAIRMENT (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "could barely think of what to do"; DIZZINESS (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "very dizzy"; NAUSEA (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "I also thought I was going to vomit"; HYPERHIDROSIS (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "sweating". The patient reported that after the 2nd and 3rd vaccines, upon waking up the following day, she got very dizzy and almost blacked out. She was sweating and could barely think of what to do because she was almost fainting. She also thought she was going to vomit when it happened after the 3rd vaccine (next day) but she didn't. She sat with her head down between her legs and the symptoms faded. Therapeutic measures were not taken as a result of loss of consciousness, syncope, mental impairment, dizziness, nausea, hyperhidrosis. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Syncope
Clinical narrative: blacked out; was almost fainting; could barely think of what to do; very dizzy; I also thought I was going to vomit; sweating; Dose received: 3; 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 received BNT162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 (Lot number: FF2590) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulpha" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other vaccine within four weeks. The patient did not have covid before vaccination. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0173, Location of injection: Arm Right), administration date: 06May2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "I got very dizzy and almost blacked out.", "almost blacked out.", "I was sweating and could barely think of what to do because I was almost fainting.", "almost fainting."; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Right), administration date: 11Apr2021, when the patient was 54 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant); LOSS OF CONSCIOUSNESS (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "blacked out"; SYNCOPE (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "was almost fainting"; MENTAL IMPAIRMENT (medically significant) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "could barely think of what to do"; DIZZINESS (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "very dizzy"; NAUSEA (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "I also thought I was going to vomit"; HYPERHIDROSIS (non-serious) with onset 02Dec2021 06:30, outcome "recovered" (Dec2021), described as "sweating". The patient reported that after the 2nd and 3rd vaccines, upon waking up the following day, she got very dizzy and almost blacked out. She was sweating and could barely think of what to do because she was almost fainting. She also thought she was going to vomit when it happened after the 3rd vaccine (next day) but she didn't. She sat with her head down between her legs and the symptoms faded. Therapeutic measures were not taken as a result of loss of consciousness, syncope, mental impairment, dizziness, nausea, hyperhidrosis. No follow-up attempts are possible. No further information is expected.