chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.); heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.); my PLT count Keep dropping, from 200 to 156.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administered in arm left, administration date 18Nov2021 (Lot number: FH8028) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing). No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 01:15 AM), administration date: 31Mar2021, when the patient was 64 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0164, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 64 years old, for COVID-19 Immunization; Influenza vaccine, administration date: 23Sep2021, for immunisation. The following information was reported: HEART RATE INCREASED (medically significant), BLOOD PRESSURE INCREASED (medically significant) all with onset 19Nov2021 07:00, outcome "not recovered" and all described as "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)"; PLATELET COUNT DECREASED (non-serious) with onset 19Nov2021 07:00, outcome "not recovered", described as "my PLT count Keep dropping, from 200 to 156.". The events "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)", "heart rate and blood pressure increased. (140 heartbeats, 150 blood pressure.)" and "my plt count keep dropping, from 200 to 156." were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (19Nov2021) 150; heart rate: (19Nov2021) 140; platelet count: (18Apr2018) 210; (23Jan2019) 226; (20Feb2020) 206; (24May2021) 195; (19Nov2021) 200 to 156; (22Nov2021) 175; (16Dec2021) 156. Therapeutic measures were not taken as a result of heart rate increased, blood pressure increased, platelet count decreased. Clinical course: On 19Nov2021 at 07:00, second day from third dose, heart rate and blood pressure increased (140 heartbeats, 150 blood pressure). Patient checked blood test record by accident and found out that PLT count kept dropping from 200 to 156. Since the vaccination, the patient has not been tested for COVID-19. Case was reported as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: After 3 doses, they tested positive for covid with in 2 weeks post vaccination; After 3 doses, they tested positive for covid with in 2 weeks post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 18 year-old 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: VACCINATION FAILURE (medically significant) with onset 01Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" (Jan2022) and all described as "After 3 doses, they tested positive for covid with in 2 weeks post vaccination". The event "after 3 doses, they tested positive for covid with in 2 weeks post vaccination" and "after 3 doses, they tested positive for covid with in 2 weeks post vaccination" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The patient had no other vaccine in four weeks. It was reported that after 3 doses, patient tested positive for covid within 2 weeks post vaccination. It was unknown if patient had covid prior vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral thrombosis
Clinical narrative: Brain clot; This is a spontaneous report received from a non-contactable reporter (Consumer).  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBRAL THROMBOSIS (death, medically significant), outcome "fatal", described as "Brain clot". The patient date of death was unknown. The reported cause of death was cerebral thrombosis. It was not reported if an autopsy was performed. It was reported that 2 men was died from a brain clot after receiving Pfizer Covid Vaccine. One of the patients died on the way to the emergency department before they got to the hospital, but reporter was unable to clarify which of those 2 patients that was. Reporter did not know if patient died last night, several days ago or when.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200106634 same reporter/product/event, different patient; Reported Cause(s) of Death: Brain clot
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: Alopecia Areata flare up/Patches of bald spots; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 39 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2021 16:15 (Lot number: EL 9266) at the age of 38 years as dose 2, single and administered in arm left, administration date 22Oct2020 17:00 (Lot number: FH8020) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Gastric Sleeve" (unspecified if ongoing); "Ana markers" (unspecified if ongoing); "lupus" (unspecified if ongoing); "RA marker" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergies" (unspecified if ongoing); "pulmonary embolism" (unspecified if ongoing); "c-sections" (unspecified if ongoing), notes: twice; "gallbladder removal" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SERTRALINE; MONTELUKAST; BUPROPION; LISINO [LISINOPRIL DIHYDRATE]. Past drug history included: Cipro, reaction(s): "Allergy: Cipro". Vaccination history included: Bnt162b2 (Dose 1, lot number: EL 9262, in the left arm at 02:00 PM), administration date: 22Jan2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: ALOPECIA AREATA (medically significant) with onset 01Jun2021, outcome "recovering", described as "Alopecia Areata flare up/Patches of bald spots". The event "alopecia areata flare up/patches of bald spots" was evaluated at the physician office visit. Therapeutic measures were taken as a result of alopecia areata, possible steroid injections. Clinical information: The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had alopecia areata flare up with 3-6 months of dose. Had coming out in handfuls, patches of bald spots.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient had 3 vaccines and still tested positive for covid; patient had 3 vaccines and still tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 15 year-old male patient received bnt162b2 (COMIRNATY) (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 had no relevant medical history. The patient did not have COVID prior to vaccination. There were no concomitant medications. The patient did not have other vaccines in four weeks and no other medications in two weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "recovered" (Jan2022) and all described as "patient had 3 vaccines and still tested positive for covid". The event "patient had 3 vaccines and still tested positive for covid" and "patient had 3 vaccines and still tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive. It was unknown if therapeutic measures were 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: 11.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Headache, SARS-CoV-2 test
Clinical narrative: Headache; Coughing; got the first dose; tested positive with Covid; got the first dose; tested positive with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FK5618) at the age of 11 years 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "got the first dose; tested positive with Covid"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; COUGH (non-serious), outcome "unknown", described as "Coughing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: They got their Covid shot on 02Dec2021 and then they were due for their second dose but then they got Covid, tested positive for Covid on 03Jan2021. When they got Covid they did had headache and coughing.  Product investigation received from product quality group on 20Jan2022 for COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 PEDIATRIC with lot number: FK5618. The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported F-Lot: FK5618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111153 same product and event, different patients;US-PFIZER INC-202200111144 same product and event, different patients;US-PFIZER INC-202200111162 same product and event, different patients.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the first dose; tested positive with Covid; got the first dose; tested positive with Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the parent.  A child female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Dec2021 (Lot number: FK5618) as dose 1 (tris), single for COVID-19 immunization. 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 03Jan2022, outcome "unknown" and all described as "got the first dose; tested positive with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: They got their Covid shot on 02Dec2021 and then they were due for their second dose but then they got Covid, tested positive for Covid on 03Jan2022. When they got Covid they did had headache and coughing (for clarification).  Investigation results were received for PFIZER-BIONTECH COVID-19 VACCINE. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported F-Lot: FK5618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111074 same product and event, different patients
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got the first dose; tested positive with Covid; got the first dose; tested positive with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program (159558). The reporter is the parent.  A 9 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 02Dec2021 (Lot number: FK5618) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. There was no prior vaccination (4 weeks prior). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "got the first dose; tested positive with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient got the Covid shot on 02Dec2021 and then was due for his second dose but then got Covid, tested positive for Covid on 03Jan2022. The parent stated that, "When they got Covid they did had headache and coughing" (for clarification). Product investigation received from product quality group on 20Jan2022 for COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 PEDIATRIC with lot number: FK5618. The Investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported F-Lot: FK5618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111074 same product and event, different patients
Sex: U
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: he's about to die, his severity is big; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. A 12 year-old patient received bnt162b2 (BNT162B2) (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: NEAR DEATH EXPERIENCE (medically significant, life threatening), outcome "unknown", described as "he's about to die, his severity is big".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient vaccinated with 3 doses of pfizer covid19 vaccine and patient still came down with covid.; patient vaccinated with 3 doses of pfizer covid19 vaccine and patient still came down with covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 49 year-old male 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 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 20Jan2022, outcome "recovering" and all described as "patient vaccinated with 3 doses of pfizer covid19 vaccine and patient still came down with covid.". The event "patient vaccinated with 3 doses of pfizer covid19 vaccine and patient still came down with covid." and "patient vaccinated with 3 doses of pfizer covid19 vaccine and patient still came down with covid." was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. No other vaccines received in for weeks. No other medication received in two weeks. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient had covid prior vaccination. Patient also had covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Psoriasis, SARS-CoV-2 test, Scar, Skin discolouration
Clinical narrative: hands had a severe reaction that looked like psoriasis; skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white; skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white; The backs of my daughter's hands had a severe reaction that looked like psoriasis.  Her skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white.; Although the texture has returned to normal, the color has scarred/remained; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 15:00 (Lot number: FE3594) at the age of 12 years 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: COVID-19 (non-serious) with onset 18Dec2021, outcome "unknown", described as "covid test result=Positive"; PSORIASIS (non-serious) with onset 19Dec2021 09:00, outcome "recovered with sequelae", described as "hands had a severe reaction that looked like psoriasis"; SKIN HYPERTROPHY (non-serious), SKIN EXFOLIATION (non-serious) all with onset 19Dec2021 09:00, outcome "recovered with sequelae" and all described as "skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white"; SKIN DISCOLOURATION (non-serious) with onset 19Dec2021 09:00, outcome "not recovered", described as "The backs of my daughter's hands had a severe reaction that looked like psoriasis.  Her skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white."; SCAR (non-serious) with onset 19Dec2021 09:00, outcome "not recovered", described as "Although the texture has returned to normal, the color has scarred/remained". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of psoriasis, skin hypertrophy, skin exfoliation, skin discolouration, scar.  Additional information: Patient had no Covid prior to vaccination. She had no known allergies. Patient had no other vaccine in four weeks and no other medications in two weeks. Treatment included constant application of Vaseline and beeswax.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Skin hypertrophy
Clinical narrative: hands had a severe reaction that looked like psoriasis; skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white; skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white; The backs of my daughter's hands had a severe reaction that looked like psoriasis.  Her skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white.; Although the texture has returned to normal, the color has scarred/remained; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 15:00 (Lot number: FE3594) at the age of 12 years 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: COVID-19 (non-serious) with onset 18Dec2021, outcome "unknown", described as "covid test result=Positive"; PSORIASIS (non-serious) with onset 19Dec2021 09:00, outcome "recovered with sequelae", described as "hands had a severe reaction that looked like psoriasis"; SKIN HYPERTROPHY (non-serious), SKIN EXFOLIATION (non-serious) all with onset 19Dec2021 09:00, outcome "recovered with sequelae" and all described as "skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white"; SKIN DISCOLOURATION (non-serious) with onset 19Dec2021 09:00, outcome "not recovered", described as "The backs of my daughter's hands had a severe reaction that looked like psoriasis.  Her skin there turned from soft (with never a problem) to very thick, hard, scaley red/purple/white."; SCAR (non-serious) with onset 19Dec2021 09:00, outcome "not recovered", described as "Although the texture has returned to normal, the color has scarred/remained". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of psoriasis, skin hypertrophy, skin exfoliation, skin discolouration, scar.  Additional information: Patient had no Covid prior to vaccination. She had no known allergies. Patient had no other vaccine in four weeks and no other medications in two weeks. Treatment included constant application of Vaseline and beeswax.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Systemic lupus erythematosus
Clinical narrative: New onset of LUPUS; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 (Lot number: EL9269) at the age of 51 years as dose 1, single and administered in arm right, administration date 03Mar2021 (Lot number: EN9581) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing); "barbiturates" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; PROGESTERONE. Past drug history included: Percocet, reaction(s): "allergies"; Clindamycin, reaction(s): "allergies". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 22Feb2021, outcome "not recovered", described as "New onset of LUPUS". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of systemic lupus erythematosus.  Clinical course: Patient did not received any other vaccine in four weeks. Plaquenil was considered as treatment drug for the event. Patient did not had covid prior and post vaccination; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Paraesthesia, Transient ischaemic attack
Clinical narrative: TIA; right side of the face and head she had a tingling feeling; complex migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 30Jan2021 (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: TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "TIA"; PARAESTHESIA (non-serious), outcome "unknown", described as "right side of the face and head she had a tingling feeling"; MIGRAINE (non-serious), outcome "unknown", described as "complex migraine". It was reported that She received her first vaccine 30Jan2021 and few weeks later on the right side of the face and head she had a tingling feeling that travelled down, and the doctor mentioned it might be a possible TIA (ministroke) or a complex migraine after the second dose she felt sheer exhaustion. she felt all those side effects again after receiving the booster dose on 29Dec2021. within 3-4 days after booster, she had sheer exhaustion that is unbelievable, and it is 20Jan2022 now and she still feel the Throbbing on her face and back of her head. she is scheduled for EEG of her Head to see what's wrong. with all the side affects her job is suffering, she couldn't concentrate for months, and these side effects never went away, there is always a discomfort on the side and back of the head. she takes tylenol for it, but she wants to stop that as she doesn't want to affect her Liver. So, what can you do for me? : E-transmitting potential duplicate AE, additional information was not gathered as she mentioned she filed a report and pfizer has contacted her multiple times to follow up with her symptoms, but no one is doing anything to help her. Caller states that she made a report regarding her AE a year ago and wants to know what Pfizer's recommendation is as her doctor has no advice for her. She has had enough. she has been through hell with this vaccine and booster and the neurologist doesn't know what to do as the doctor said, " we do not have any information to know if this is caused by the vaccine". at first, she refused to provide more information about her AE as she already filed a report and insisted that i would pull out the report from last time. she asked me to read from the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 11-year-old vaccinated with both on time vaccines tested positive for covid; 11-year-old vaccinated with both on time vaccines tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), 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 31Dec2021, outcome "recovered" and all described as "11-year-old vaccinated with both on time vaccines tested positive for covid". The event "11-year-old vaccinated with both on time vaccines tested positive for covid" and "11-year-old vaccinated with both on time vaccines tested positive for covid" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: post vaccination. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had no known allergies. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive for the Virus; 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.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 27Dec2021 (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 (non-serious) with onset Jan2022, outcome "unknown", described as "positive for the Virus". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Context: Reporter stated that her 7 year old son received his first dose of Pfizer BioNtech vaccine on 27Dec2021 and on first week of January he tested positive for the Virus. Reporter stated that her seven year old son missed his second dose of vaccine because he tested positive after getting the first dose. Is for the Pfizer Covid 19 vaccine. she wants to know when he can have the second dose of the vaccine. The case was reported as non serious.  Description of Product Complaint: Description of complaint: Pfizer Covid 19 vaccine: Clarified that her son had his first shot on 27Dec2021 and the first week January tested positive for the virus. Product strength and count size dispensed: Is a sample of the product available to be returned, if requested (Y/N): Packaging sealed and intact?   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid 19 virus and tested positive; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY), administration date 08Jan2022 (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: COVID-19 (non-serious) with onset 15Jan2022, outcome "unknown", described as "Covid 19 virus and tested positive". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had first dose of the Pfizer COVID 19 vaccine on 08Jan2022. Last Saturday they contracted Covid 19 virus and tested positive. He described it as horrible, terrible, very ill, chills, headache, and more symptoms of the Covid 19 virus.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200112254 same reporter/product/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (parent). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Jan 8, 2022, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had COVID-19 (tested positive for COVID-19 virus), onset Jan 15, 2022, with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. Additional information: The patient had the first dose of the Pfizer COVID-19 vaccine on Jan 8, 2022. Last Saturday the patient contracted the COVID 19 virus and tested positive. He described it as horrible, terrible, very ill, chills and headache. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-202200111998 same reporter/product/event, different patient.
Sex: U
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 a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "tested positive for Covid". It was reported that the patient tested positive for Covid on 12Jan2022 (reported as last Wednesday). The patient had no symptoms till 18Jan2022 when she/he tested negative in a home test in Jan2022. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Wednesday; (Jan2022) negative.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Intraocular pressure increased, Intraocular pressure test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; Intraocular pressure high; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4237795-00, US-PFIZER INC-202200112374.  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Apr2021 (Batch/Lot number: unknown) at the age of 62 years as dose 2, single and intramuscular, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. 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), outcome "not recovered" and all described as "COVID-19"; INTRAOCULAR PRESSURE INCREASED (non-serious), outcome "not recovered", described as "Intraocular pressure high". The patient underwent the following laboratory tests and procedures: intraocular pressure test: high. The action taken for adalimumab was unknown.  The reporter considered "covid-19" related to bnt162b2.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Covid-19 and eye pressure is high was not provided. Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): For Covid-19, Causality as per reporter (Drug/Vaccine) was possible and for Intraocular pressure high (Intraocular pressure increased): Causality as per reporter (Drug/Vaccine) was Not Reported.  The reporter's assessment of the causal relationship of the event Intraocular pressure high with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have Covid and have majority of the symptoms; have Covid and have majority of the symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have Covid and have majority of the symptoms". The patient provided feedback after getting Pfizer Covid vaccine and booster. She has had both vaccines and the booster, and was told if she does get Covid it would not be that bad dimly a headache and sore throat but she definitely wouldn't. It get all the symptoms like someone who is unvaccinated. Well she got Covid and had majority of the symptoms, fever, chills, body aches, headache, sore throat, cough, congestion, extreme tiredness and difficulty breathing with any movement.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid 19 even though patient has had 3 pfizer vaccines; tested positive for covid 19 even though patient has had 3 pfizer vaccines; This is a spontaneous report received from a contactable reporter (Physician) for a Pfizer sponsored program. The reporter is the patient, a family practice physician.  A 71 year-old patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster dose), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "B cell lymphoma" (ongoing), notes: in remission; "Weakened immune system" (ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "tested positive for covid 19 even though patient has had 3 pfizer vaccines". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.Clinical course: Patient's oncologist was concerned about patient weakened immune system and arranged for patient to get paxlovid thru an infectious disease specialist and patient had stated it today.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event tested positive for covid 19 even though patient has had 3 pfizer vaccines cannot be excluded based on temporal association and available information.
Sex: M
Vaccine: COVID19
Symptoms: Transfusion
Clinical narrative: blood transfusion; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program.  A 71 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TRANSFUSION (medically significant) with onset Sep2021, outcome "unknown", described as "blood transfusion". Clinical Course: The patient had a blood transfusion in Sep2021. The patient, has already had the 1st and 2nd doses of the COVID vaccine before he had the blood transfusion, he had this blood transfusion about 3 months ago, and now he wants to take this booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out.  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: U
Vaccine: COVID19
Symptoms: Abdominal distension
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Jul 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed abdominal distension (severe bloating/stomach distention), onset 2021, with outcome of not recovered. Additional information: The patient received Pfizer COVID-19 booster and within an hour their stomach ballooned by 5 inches. In August, the second dose was oh so much worse. 3 pant sizes up in a week. Still up 3 due to the bloat. The lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dysphonia, Pyrexia, Shoulder operation
Clinical narrative: Surgery on Shoulder; Hoarseness / hoarse voice; Coughing Spells; Fever; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FJ5682) at the age of 67 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (ongoing), notes: Well Controlled; "Asthma" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: EL3249), administration date: 15Jan2021, for COVID-19 IMMUNIZATION; Bnt162b2 (Second dose, Lot: EL9264), administration date: 05Feb2021, for COVID-19 IMMUNIZATION. The following information was reported: SHOULDER OPERATION (medically significant), outcome "unknown", described as "Surgery on Shoulder"; DYSPHONIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Hoarseness / hoarse voice"; COUGH (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Coughing Spells"; PYREXIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Fever". Therapeutic measures were taken as a result of dysphonia included Tylenol and Robitussin, drinks warm water and lemon and ginger tea. Clinical course: The patient stated that she received her Booster dose last Wednesday and the following day she had a hoarse voice, some fever and coughing spells. She wants to know if losing your voice is a side effect of the booster dose because she never had this problem with the first two. It has been over a week now and she still feels the side effects. She is on Medical leave because she had surgery on her shoulder and so she hasn't been out, so why should she feel like this?    Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Shoulder operation and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.