chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
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). An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 60-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 60, in right arm, on Dec 31, 2021, single dose, for COVID-19 immunization. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot# unknown); both single dose, for immunisation. Medical history not reported. No concomitant medications. The patient experienced ineffective drug/vaccination failure (medically significant), and COVID-19/treatment for COVID-19 (medically significant), with outcome of unknown. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of vaccination failure and COVID-19. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). Program ID:. A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had fatigue/ongoing fatigue and dizziness, with outcome of unknown. Additional information: Since the  first dose of the COVID-19 vaccine, a year ago, patient experienced ongoing fatigue and dizziness. Only since the shot, the patient had problems. The patient needed to know what is going on. Why these side effects for so long after the shot. The information on the batch/lot number for BNT162B2 requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL/HCTZ, start date: 03Jun2019; AMLODIPINE BESYLATE, start date: 03Jun2019, stop date: 03Jun2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02May2022 at 19:00, outcome "not recovered" and all described as "I tested negative on 27Apr2022 and began to feel symptoms again late on 02May2022. I tested positive for the second time on 03May2021 with a home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2021) positive, notes: I tested positive with a home test; (27Apr2022) Negative. Therapeutic measures were not taken as a result of vaccination failure, Covid-19.
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain
Clinical narrative: pain all over his body.; Caller states her husband is not able to do things he used to be able to do, like he can't run or play outside with his grandkids.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain all over his body."; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Caller states her husband is not able to do things he used to be able to do, like he can't run or play outside with his grandkids.". Therapeutic measures were taken as a result of pain, loss of personal independence in daily activities. The reporter stated that after his husband got the second dose of the Pfizer-BioNTech COVID-19 Vaccine, he started experiencing pain all over his body. He's in a lot of pain everyday, not able to do things he used to do before taking the vaccine. It doesn't matter what medication he takes, it doesn't help.  He has visited different doctors and no one is really able to help him. Caller states her husband is having a lot of pain and he has been in a lot of pain. Caller states he has been in and out of the doctor and he has been on all kinds of medicine and nothing is helping him. Caller states her husband is not able to go to work, because he is in pain every single day. Caller states her husband is not able to do things he used to be able to do, like he can't run or play outside with his grandkids. Caller states it hurts her seeing him in pain and not able to play with the grandkids, it is horrible. Caller states it started after his 2nd dosage and he has been in pain ever since. Caller states if, they give him a different pain med, it will kind of ease up for a while but it will never go away. Caller clarifies his pain is all over.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown), in arm for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed but manufacture name unknown), for COVID-19 immunization; Covid-19 vaccine (First booster dose, manufacture name unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "patient had an odd, hardened area on the arm where patient received 2nd booster". Additional information: Forwarded as an Adverse Event on 03May2022. Reporter provided verification of contact address on 02May2022. Customer Verbatim: patient had an odd, hardened area on the arm where patient received 2nd booster if Covid vaccine. Was this normal. Will it ever go away and it's been months. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Body temperature, Cough, Depressed level of consciousness, Fatigue
Clinical narrative: increased difficulty with alertness; For five days: Fever 102; aches; tired; 2 days sleeping; cough; sneezing; memory recall; word retrieval; Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "HTN" (ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTAN; HCTZ; JANUVIA; GLIPIZIDE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unkown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unkown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Apr2022 at 16:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 19Apr2022 at 16:00, outcome "unknown"; HYPERSOMNIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "2 days sleeping"; PYREXIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "For five days: Fever 102"; PAIN (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "aches"; COUGH (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering"; DEPRESSED LEVEL OF CONSCIOUSNESS (medically significant) with onset 20Apr2022 at 04:00, outcome "recovering", described as "increased difficulty with alertness"; MEMORY IMPAIRMENT (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "memory recall"; SNEEZING (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering"; FATIGUE (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "tired"; APHASIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "word retrieval". The patient underwent the following laboratory tests and procedures: Body temperature: 102, notes: fever 102. Therapeutic measures were not taken as a result of depressed level of consciousness, pyrexia, pain, fatigue, hypersomnia, cough, sneezing, memory impairment, aphasia.  Clinical information: No other vaccine in four weeks. No covid prior vaccination: Covid was not tested post vaccination.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Immunisation, Memory impairment, Off label use, Pain
Clinical narrative: increased difficulty with alertness; For five days: Fever 102; aches; tired; 2 days sleeping; cough; sneezing; memory recall; word retrieval; Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "HTN" (ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTAN; HCTZ; JANUVIA; GLIPIZIDE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unkown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unkown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Apr2022 at 16:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 19Apr2022 at 16:00, outcome "unknown"; HYPERSOMNIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "2 days sleeping"; PYREXIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "For five days: Fever 102"; PAIN (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "aches"; COUGH (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering"; DEPRESSED LEVEL OF CONSCIOUSNESS (medically significant) with onset 20Apr2022 at 04:00, outcome "recovering", described as "increased difficulty with alertness"; MEMORY IMPAIRMENT (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "memory recall"; SNEEZING (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering"; FATIGUE (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "tired"; APHASIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "word retrieval". The patient underwent the following laboratory tests and procedures: Body temperature: 102, notes: fever 102. Therapeutic measures were not taken as a result of depressed level of consciousness, pyrexia, pain, fatigue, hypersomnia, cough, sneezing, memory impairment, aphasia.  Clinical information: No other vaccine in four weeks. No covid prior vaccination: Covid was not tested post vaccination.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sneezing
Clinical narrative: increased difficulty with alertness; For five days: Fever 102; aches; tired; 2 days sleeping; cough; sneezing; memory recall; word retrieval; Off label use; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "HTN" (ongoing); "Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LOSARTAN; HCTZ; JANUVIA; GLIPIZIDE; FLOMAX [TAMSULOSIN HYDROCHLORIDE]. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unkown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unkown), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Apr2022 at 16:00, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 19Apr2022 at 16:00, outcome "unknown"; HYPERSOMNIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "2 days sleeping"; PYREXIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "For five days: Fever 102"; PAIN (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "aches"; COUGH (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering"; DEPRESSED LEVEL OF CONSCIOUSNESS (medically significant) with onset 20Apr2022 at 04:00, outcome "recovering", described as "increased difficulty with alertness"; MEMORY IMPAIRMENT (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "memory recall"; SNEEZING (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering"; FATIGUE (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "tired"; APHASIA (non-serious) with onset 20Apr2022 at 04:00, outcome "recovering", described as "word retrieval". The patient underwent the following laboratory tests and procedures: Body temperature: 102, notes: fever 102. Therapeutic measures were not taken as a result of depressed level of consciousness, pyrexia, pain, fatigue, hypersomnia, cough, sneezing, memory impairment, aphasia.  Clinical information: No other vaccine in four weeks. No covid prior vaccination: Covid was not tested post vaccination.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 28Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 39 years for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Apr2022, outcome "not recovered" and all described as "I tested positive for Covid-19 on 21Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: After taking the full course of Paxlovid I tested negative for 1 day; (unspecified date) Positive, notes: tested positive again and remain positive; (21Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Patient received vaccine. He did not receive any other medication in 2 weeks. Paxlovid (lot number=FX8140) was given as a treatment for Covid-19 on 21Apr2022 and stopped on 27Apr2022. He tested positive for Covid-19 on 21Apr. After taking the full course of Paxlovid he tested negative for 1 day and then tested positive again and remain positive. On day ten patient started having symptoms, mainly in the evening, and now lethargy, runny nose, and a slight cough are back again. Adverse event started on 01May2022. No treatment was given for this. Patient had no known allergies. No follow up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Dermatomyositis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: was all better and now 10 days after my first Paxlovid dose, and 1 day after testing negative for Covid on 2 rapid tests, I developed a new nasal pressure and congestion; Positive, notes: 3 days after those negative tests, I just tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient had received other medication in 2 weeks. Patient had received Paxlovid on 22Apr2022 for treatment of COVID-19 and stop on 27Apr2022. She was all better and now 10 days after her first Paxlovid dose, and 1 day after testing negative for Covid on 2 rapid tests, she developed a new nasal pressure and congestion. 3 days after those negative tests, she just tested positive for Covid again. Seems to be a recurrence since I haven't been out of my house much at all in the last 2 days since leaving isolation. Other medication in 2 weeks product was Xeljanz. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: severe hearing loss in my right ear; roaring in my head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Lot number: ff2590) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug allergy". Vaccination history included: Covid-19 vaccine (DOSE NUMBER: UNKNOWN, MANUFACTURER: UNKNOWN), for COVID-19 immunisation. Other medication in 2weeks: Unknown. The following information was reported: TINNITUS (non-serious) with onset 21Oct2021 at 22:00, outcome "not recovered", described as "roaring in my head"; DEAFNESS (medically significant) with onset 21Oct2021 at 22:00, outcome "not recovered", described as "severe hearing loss in my right ear". It was unknown if therapeutic measures were taken as a result of deafness, tinnitus. Adverse event: After receiving the pfizer booster in Oct2021 I developed roaring in my head and severe hearing loss in my right ear. This was confirmed by 2 ENT specialists. Treatment for adverse event reported as unknown.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Ascites, Computerised tomogram, Hepatic cirrhosis, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: Developed leg swelling; Had ascites; CT scan in Feb2022 showed liver cirrhosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 93-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 93 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, brand=Pfizer, brand unknown=False, lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion, dose number=2), for COVID-19 immunization; Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion, dose number=1), administration date: 2020, for COVID-19 Immunization.  The following information was reported: HEPATIC CIRRHOSIS (death) with onset Feb2022, outcome "fatal", described as "CT scan in Feb2022 showed liver cirrhosis"; PERIPHERAL SWELLING (death), outcome "fatal", described as "Developed leg swelling"; ASCITES (death), outcome "fatal", described as "Had ascites". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Feb2022) liver cirrhosis, notes: CT scan in Feb2022 showed liver cirrhosis; SARS-CoV-2 test: (09Feb2022) Positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of hepatic cirrhosis, peripheral swelling, ascites. The patient date of death was 13Apr2022. Reported cause of death: "Liver cirrhosis". No autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug 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 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. ,Linked Report(s) : US-PFIZER INC-202200655288 similar report from same reporter; Reported Cause(s) of Death: Liver cirrhosis
Age: 93.0
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(s) (Other HCP). A 93-year-old male patient received BNT162b2 (BNT162B2), in Feb2020 as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 93 years for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Feb2022, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2022) Positive, notes: Nasal Swab. Clinical information: The patient did not received any other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid19, Drug ineffective and the administration of the vaccine cannot be excluded. Linked Report(s): US-PFIZER INC-202200655282 similar report from same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: after receiving the third dose booster of the covid 19 vaccine from Pfizer noticed hair loss/ alopecia; His skin md diagnosed him "alopecia aerate; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID: (141003).  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "after receiving the third dose booster of the covid 19 vaccine from Pfizer noticed hair loss/ alopecia"; ALOPECIA AREATA (non-serious), outcome "unknown", described as "His skin md diagnosed him "alopecia aerate". Therapeutic measures were taken as a result of alopecia, alopecia areata.  Additional info: Patient started of therapy on 28Apr2022 for alopecia aerate (XELJANZ, 10 mg, twice a day, oral, from 28Apr2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
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(s) (Consumer or other non HCP). A 28-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: EP6955), in 2021 as dose 2, single (Lot number: EP6955) and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 28 years for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 03May2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "received a positive COVID-19 at home test on 03May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: COVID-test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, Covid-19. It was reported that patient received a positive COVID-19 at home test on 03May2022. Symptoms include headache, chills and nausea. No Prolonged Hospitalization required for event. No Known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient was tested for COVID-19 Since the vaccination. Awareness Date: 03May2022. Follow-Up (05May2022): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Her brother was also boosted with his 4th booster and recently was diagnosed with Covid/ She stated they all have had the Pfizer Covid vaccine for their vaccinations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Additional information: In addition, caller mentioned that she had her 4th Pfizer Covid vaccine booster and recently was diagnosed with Covid. Her brother was also boosted with his 4th booster and recently was diagnosed with Covid. And her son also has Covid but has not yet had a booster. She stated they all have had the Pfizer Covid vaccine for their vaccinations. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 59-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "bronchitis" (unspecified if ongoing); "asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 03May2022, outcome "unknown" and all described as "experienced some symptoms of Covid and tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) positive. Clinical information: Caller states she was done with the Paxlovid on Wednesday and felt much better and as of Sunday she started feeling the same symptoms of a little breathlessness, coughing, and some congestion overall, and took a test again, and was back to being completely positive, and was extremely careful, and there was no way that she got it a 2nd time. Caller states she began having symptoms of a little breathlessness, coughing and some congestion and that began on Sunday 01May2022 and those symptoms are ongoing and she had started taking Paxlovid almost immediately after the symptoms began and started the Paxlovid on 22Apr2022 and finished the Paxlovid on 27Apr2022 and she would say she did not get very far before she took the Paxlovid and her symptoms that began on Sunday are ongoing and about the same. States her symptoms may be a little bit less and she has not taken her fever or temperature today and does not think she is feverish. Description of Product Complaint: Description of complaint: Caller states she tested positive for Covid and took that test today 03May2022; as of Sunday she started feeling the same symptoms of a little breathlessness, coughing, and some congestion overall and took a test again and was back to being completely positive; Caller states for the lot number for Paxlovid, she has to go get her glasses which are her reading glasses. Caller states she has one question that nobody asked and for what it is worth she was totally vaccinated and boosted and this was a breakthrough of that and confirmed she had received the Pfizer Covid vaccine; caller states she has no dates of vaccine administration, lot numbers, expiry dates or NDC numbers to provide at this time as she would have to go find her card and it is not with her at this time. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he tested positive with Covid-19 and he is fully vaccinated". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: he tested positive with Covid-19 and he is fully vaccinated. Clinical information: Patient just started taking Paxlovid and mentioned that he tested positive with Covid-19 and he was fully vaccinated. He mentioned that he knows that Paxlovid can cause liver damage and he was asking when he can start drinking alcohol after taking Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 62-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Apr2021 at 14:00 as dose 2, single (Lot number: EW0153Q), in left arm, on 09Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 18Mar2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 62 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: FENOFIBRATE, start date: 16Apr2022, stop date: 03May2022; HYDROCHLOROTHIAZIDE, start date: 16Apr2022, stop date: 03May2022; LOSARTIN, start date: 16Apr2022, stop date: 03May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative 4 consecutive days; (unspecified date) Positive, notes: COVID-19 Treatment; (02May2022) Positive, notes: then tested positive again two days in a row. Therapeutic measures were taken as a result of Covid-19. Clinical course: Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "slow transit constipation" (unspecified if ongoing); "Lyme" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "asthma" (unspecified if ongoing); "EBV" (unspecified if ongoing); "gastroparesis" (unspecified if ongoing); "slow bowel dysmotility" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: I tested negative on days 3 & 4; (2022) Negative, notes: I tested negative on days 3 & 4; (2022) Positive, notes: 6 days later I tested positive again. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Patient had Paxlovid rebound. Patient had a 5 day course of Paxlovid and asked her Dr. if she could do another course, because she could still feel that the virus was active in her body. Patient tested negative on days 3 & 4 after taking Paxlovid. She still felt terrible and 6 days later she tested positive again for Covid. Patient tested because her congestion came back. Patient had not received any other medication in 2weeks. Patient had received treatment with anti-viral therapy Paxlovid from 18Apr2022 to 22Apr2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: F
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). The reporter is the patient. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Oct2021 at 16:00 as dose number unknown, single (Lot number: 301458A) at the age of 50 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Known allergies: Sulfa/sulfides" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; ZEGERID; YAZ; LEVOTHYROXINE; PAXLOVID taken for Covid-19, start date: 19Apr2022, stop date: 23Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022 at 12:00, outcome "unknown", COVID-19 (medically significant) with onset 28Apr2022 at 12:00, outcome "recovering" and all described as "A week later testing Covid positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; positive. Therapeutic measures were not taken as a result of Covid-19. Clinical information: Relapsed after taking Paxlovid and testing negative. A week later testing Covid positive. No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Investigation, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 41-year-old male patient received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6206), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 41 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: shellfish. Concomitant medication(s) included: NYQUIL, start date: 22Apr2022, stop date: 24Apr2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: tested: (02May2022) Positive, notes: tested positive for COVID again. Therapeutic measures were taken as a result of Covid-19, vaccination failure. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 01May2021 as dose 2, single (Lot number: ER8736), in left arm and on 18Nov2021 as dose 3 (booster), single (Lot number: 320308d) at the age of 57 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "Parkinson's disease" (unspecified if ongoing); "known allergies: Penicillin tetanus" (unspecified if ongoing), notes: known allergies: Penicillin tetanus. Concomitant medication(s) included: CARBIDOPA AND LEVODOPA. Vaccination history included: Tetanus (known allergies: Penicillin tetanus), for Immunization, reaction(s): "known allergies: Penicillin tetanus". The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Herpes, allergies" (unspecified if ongoing), notes: Herpes, allergies; "allergies" (unspecified if ongoing), notes: allergies. Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR SODIUM]; LORATADINE. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Paxlovid: Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
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), Program ID: Unknown. A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: my wife has lupus. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "My wife is fully vaccinated; She had the Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive; (27Apr2022) Negative; (28Apr2022) Negative; (29Apr2022) Negative; (30Apr2022) Negative; (01May2022) Negative. Therapeutic measures were taken as a result of Covid-19. Clinical course: It was reported that, first of all reporter want to say that It really was a miracle drug, reporter wife has lupus, Tuesday night last week she got sick, Wednesday morning she tested positive for Covid-19. Wednesday morning she was immediately given Paxlovid and discontinued her lupus Medication (further clarification unknown). By Sunday morning she had tested negative, she tested negative that she went to the urgent care tested negative at the urgent care, so from Wednesday onward she was positive so Sunday now was sudden she was negative. So the question was and reporter know there no where on the website. Patient wife was fully vaccinated (Pfizer Covid-19 vaccine), reporter also fully vaccinated. She had the Covid and she had the Paxlovid and she's now negative, was she still contagious that was she still have enough viral load to give Covid to anybody now that she negative 3 days in a row. 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: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 73-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after getting the booster shots". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she's 73 y/o and she has Covid after getting the booster shots. Clinical course: Caller wants to know where she can get the medication Paxlovid. Was not able to transfer to PRIVATE, caller disconnected the call. Created a manual AE form. Medical Information (Live Operators Only): Were any unaddressed medical questions referred or forwarded to Medical Information: YES: Customer and/or medical inquiry forwarded or referred to MI. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.