chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and in Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 84 years, in right arm 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 Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information:  COVID 19 Treatment start date: 27Jun2022 and stop date: 01Jul2022  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: Anxiety, Myocardial infarction
Clinical narrative: Heart attack; anxiety; This is a spontaneous report received from a contactable reporter(s) (Lawyer).  A male patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 01Apr2021, for Covid-19 Immunization; BNT162b2 (Dose 2), administration date: 22Apr2021, for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant), outcome "unknown", described as "Heart attack"; ANXIETY (non-serious), outcome "unknown". The patient was hospitalized for myocardial infarction (hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of myocardial infarction.  Additional information: On 04Aug2021 (Second patient name withheld) went to receive the covid vaccine. He received his first dose on 01Apr2021 and his second dose on 22Apr2021. After 7 months began to experience the side effects of the Pfizer vaccine. Additionally, based on insureds actions, reporter client received a heart attack, was in the ICU for 5 days and developed anxiety during this time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Malaise, Pruritus
Clinical narrative: Itchy scalp/more itchy scalp; DID NOT FEEL GOOD; losing hair; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 48-year-old female patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Intramuscular), administration date: 31Jan2021, when the patient was 48-year-old, for COVID-19 immunization, reaction(s): "Psoriasis flare-up"; BNT162b2 (DOSE 2, SINGLE, Intramuscular), administration date: 21Feb2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "recovered", described as "losing hair"; MALAISE (non-serious) with onset Jul2022, outcome "unknown", described as "DID NOT FEEL GOOD"; PRURITUS (non-serious), outcome "recovered", described as "Itchy scalp/more itchy scalp".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Therapeutic response shortened
Clinical narrative: bad flare of plaque psoriasis; Wearing off effect; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4365197-00 (AbbVie).  A 49-year-old female patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (ongoing) (Lot number: 1161377), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious) with onset Jan2021, outcome "recovered", described as "bad flare of plaque psoriasis"; THERAPEUTIC RESPONSE SHORTENED (non-serious) with onset 2021, outcome "unknown", described as "Wearing off effect". The action taken for risankizumab was dosage not changed. Additional information: On an unspecified date in Jan2021, the patient had a bad flare of plaque psoriasis after first injection of Covid-19. After taking second covid-19 vaccine, she brought out with psoriasis. She started losing hair after taking booster dose of covid-19 vaccine. She was feeling good. She had Covid-19 in Jul2022. She felt it was like a sinus infection and did not felt good. She reported that when she was close to or month before next Skyrizi injection she had to have itchier scalp, but as soon as she got the Skyrizi injection, it went away. She had no flakes but had a little more itching. Pfizer BioNTech COVID-19 vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Adverse event information provided by patient was related to covid vaccine. Causality for SKYRIZI (RISANKIZUMAB): The reporter's causality for the event(s) of BAD FLARE OF PLAQUE PSORIASIS AFTER FIRST INJECTION OF COVID-19 VACCINE was not provided. Drug: SKYRIZI(Injection)(RISANKIZUMAB): Causality: Wearing off effect (Therapeutic response shortened): Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not Reported. Psoriasis flare-up (Psoriasis): Action(s) taken with drug: Dose Not Changed. Causality as per reporter (Drug/Vaccine): Not Reported. Drug: Pfizer biotech COVID-19 Vaccine (Tozinameran): Causality: Wearing off effect (Therapeutic response shortened): Causality as per reporter (Drug/Vaccine): Not Reported. Psoriasis flare-up (Psoriasis): Causality as per reporter (Drug/Vaccine): Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9264), in right arm, on 18Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 25Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 27May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hep C" (unspecified if ongoing), notes: Other medical history: had Hep C until 2017, cured; "Known allergies: Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: sulphur drugs, reaction(s): "Known allergies: sulphur drugs".  The following information was reported: VACCINATION FAILURE (medically significant) with onset Sep2022, outcome "unknown", COVID-19 (medically significant) with onset Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I tested negative at home; (unspecified date) Positive, notes: then positive at a clinic; (unspecified date) Positive, notes: indication: Treatment of COVID-19; (unspecified date) Negative, notes: (rapid & PCR) the negative at home; (unspecified date) Negative, notes: (rapid & PCR) the negative at home; (11Sep2022) Negative, notes: negative on a rapid yesterday at a different clinic (11Sep22); (12Sep2022) Positive, notes: then positive again today at a different clinic (rapid 12Sep22). Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown".   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 information provided, a causal relationship between BNT162B2 and the reported event Pulmonary embolism 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: dose 4 Moderna; Treatment of COVID-19; Treatment of COVID-19; 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 23Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 12Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing), notes: Hashimoto's, Asthma; "Asthma" (unspecified if ongoing), notes: Hashimoto's, Asthma. There were no concomitant medications. Past drug history included: Imiquimod, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20May2022, outcome "unknown", described as "dose 4 Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid-19 treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 includes Paxlovid from 03Sep2022 to 07Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Indication=Treatment of COVID-19; Indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  AA 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTIN; CRESTOR; OMEPRAZOLE; METFORMIN. Past drug history included: Phenobarbital, reaction(s): "Known allergies: phenobarbital", notes: Known allergies: phenobarbital; Fluconazole, reaction(s): "Known allergies: fluconazole", notes: Known allergies: fluconazole. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (10Sep2022) Negative, notes: after ending Paxlovid and testing negative for two days; (11Sep2022) Negative, notes: after ending Paxlovid and testing negative for two days; (12Sep2022) Positive, notes: I started testing positive after two days; (13Sep2022) Positive, notes: I'm still testing positive 5 days after ending Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Other medication in 2 weeks was Yes. Paxlovid treatment start date was 04Sep2022, treatment stop date was 09Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 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), 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 included: "Prostatectomy 7 years ago" (unspecified if ongoing), notes: Other medical history: Prostatectomy 7 years ago. There were no concomitant medications. The patient had not taken other medication within 2 weeks. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after 2 negative tests; Negative, notes: Tested positive after 2 negative tests; Positive, notes: Rebound 5 days after completing treatment. Tested positive after 2 negative tests; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took anti-viral (Paxlovid) for COVID 19 Treatment on 31Aug2022 and stopped on 04Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient 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 Aug2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8733), in left arm, on 16Apr2021 as dose 2, single (Lot number: EW0151), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; ZYRTEC [CETIRIZINE HYDROCHLORIDE].  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: (unspecified date) Positive; (09Sep2022) Positive, notes: Rebound COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with Paxlovid from 31Aug2022 to 05Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 09:00 as dose 1, single (Lot number: EN6201), on 05Mar2021 at 12:30 as dose 2, single (Lot number: EN6198), in left arm, on 23Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "interstitial lung disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "familial hyperlipidemia" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "gout" (unspecified if ongoing); "preDM" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) included: TENORMIN oral; NORVASC oral; CLONIDINE oral; SYNTHROID oral; LOSARTAN oral; POTASSIUM CITRATE oral; VITAMIN D3 oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Pyrexia: 100 Fahrenheit; SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks product: Tenormin Norvasc clonidine synthroid Losartan potassium citrate Vitamin D3. Other medication in 2 weeks administrator route: oral, chronic meds. Adverse event: extreme prostration, loss of appetite, new onset clay-colored stools, and fever to 100F. Other medical history: Interstitial lung disease, hypertension, familial hyperlipidemia, kidney stones, gout, prediabetic (preDM).; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Vaccination failure and Covid-19 cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Faeces pale
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 at 09:00 as dose 1, single (Lot number: EN6201), on 05Mar2021 at 12:30 as dose 2, single (Lot number: EN6198), in left arm, on 23Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 25Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "interstitial lung disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "familial hyperlipidemia" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "gout" (unspecified if ongoing); "preDM" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) included: TENORMIN oral; NORVASC oral; CLONIDINE oral; SYNTHROID oral; LOSARTAN oral; POTASSIUM CITRATE oral; VITAMIN D3 oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Pyrexia: 100 Fahrenheit; SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2 weeks product: Tenormin Norvasc clonidine synthroid Losartan potassium citrate Vitamin D3. Other medication in 2 weeks administrator route: oral, chronic meds. Adverse event: extreme prostration, loss of appetite, new onset clay-colored stools, and fever to 100F. Other medical history: Interstitial lung disease, hypertension, familial hyperlipidemia, kidney stones, gout, prediabetic (preDM).; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Vaccination failure and Covid-19 cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I have an aunt and she had the Covid Shot and in less that a a week she was dead; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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 and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "I have an aunt and she had the Covid Shot and in less that a a week she was dead". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: The patient who was reporter's aunt had the Covid shot and in less than a week she was dead. Reporter did not have any shots.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: I have an aunt and she had the Covid Shot and in less that a a week she was dead
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on 04Sep; tested positive on 9/4; 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 53-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), on 18Apr2021 as dose 2, single (Lot number: EN6204) and on 27Aug2021 as dose 3 (booster), single (Lot number: EW0179) at the age of 52 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 003K21-2!) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "overweight" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 04Sep2022, outcome "not recovered", described as "tested positive on 04Sep"; COVID-19 (medically significant) with onset 04Sep2022, outcome "not recovered", described as "tested positive on 9/4". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: at home Covid tests barely registered positive; (unspecified date) Positive, notes: Monday night the test came back with a definite positive; (04Sep2022) Positive, notes: I tested positive on 04Sep. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received any other medication in 2weeks. The patient had no known allergies. He tested positive on 04Sep and began 5 day treatment same day, he finished on thursday- at home covid tests barely registered positive over the weekend, felt pretty good- monday night the test came back with a definite positive and by tuesday morning- he felt like he did last week tuesday morning- he felt like he did last week fatigue- and lots of congestion in the sinuses. Treatment start date: 04Sep2022. Treatment stop date: 08Sep2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201160311 same product, patient, different AEs, different dose;
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from 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 27Nov2021 as dose 3 (booster), single (Lot number: FH8027) and on 21May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 61 years 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: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL HCTZ; CETIRIZINE HYDROCHLORIDE; IBUPROFEN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Sep2022) Positive, notes: antigen test; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid from 30Aug2022 to 04Sep2022 for COVID 19 Treatment. Experienced COVID rebound with symptoms and positive antigen test. Adverse event start date: 10Sep2022, 03: 30, recovering. No treatment received. The patient had no allergy.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Chills; Headache; Body aches; Shaking; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in right arm 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; Covid-19 vaccine (DOSE 3; (BOOSTER) MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Body aches"; CHILLS (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022); PYREXIA (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Fever"; HEADACHE (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022); NAUSEA (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (12Sep2022 at 13:00); TREMOR (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Shaking". Therapeutic measures were not taken as a result of pyrexia, chills, headache, pain, tremor, nausea.  Adverse event: All symptoms began 7 hours after the shot. Nausea subsided by 1 pm the following day, all other symptoms lasted until two days later. Patient did not receive any treatment. Patient  did not get covid prior vaccination and was not tested post vaccination. Patient did not receive any vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Fever; Chills; Headache; Body aches; Shaking; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Sep2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 25 years, in right arm 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; Covid-19 vaccine (DOSE 3; (BOOSTER) MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Body aches"; CHILLS (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022); PYREXIA (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Fever"; HEADACHE (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022); NAUSEA (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (12Sep2022 at 13:00); TREMOR (non-serious) with onset 11Sep2022 at 22:00, outcome "recovered" (13Sep2022), described as "Shaking". Therapeutic measures were not taken as a result of pyrexia, chills, headache, pain, tremor, nausea.  Adverse event: All symptoms began 7 hours after the shot. Nausea subsided by 1 pm the following day, all other symptoms lasted until two days later. Patient did not receive any treatment. Patient  did not get covid prior vaccination and was not tested post vaccination. Patient did not receive any vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: heartburn; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 09:00 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: DYSPEPSIA (non-serious) with onset 12Sep2022 at 20:30, outcome "unknown", described as "heartburn".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Pyrexia
Clinical narrative: Joint pain; Fever; can't walk for two days after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "Joint pain", "Can't walk for two days after"; Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Can't walk for two days after", "Fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: Jul2022, for Covid-19 immunization, reaction(s): "Joint pain", "Can't walk for two days after", "Fever". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can't walk for two days after".  Additional Information:Narrative case summary and further information Submitted. Reporter was related to study or programme. Confirmed that Patient was the reporter. Reason for no lot number of Pfizer COVID-19 vaccine was Complainant hung up abruptly/transfer incomplete. Confirmed that bivalent Pfizer COVID-19 vaccine was Pfizer product.Attempted transfer from (Name withheld) with Pfizer Program Support Call Center of consumer who mentioned she got her first shot of booster last July, and also her last shot will be in the month of September. She experienced some weird reactions: joint pain, fever, and can't walk for two days after, and for each of three consecutive doses she had the same reaction. Caller also had an inquiry, and asked if vaccines are FDA approved. Agent gave answer to that, caller wanted more clarification for regards to that. He provided her the number for Pfizer Medical Information. Agent clarified caller already got bivalent COVID-19 vaccine and experienced the same reaction like she experienced with her last two or three doses. Agent said caller got her first booster in July.   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-202201160812 Same reporter/events/patient, different products; Report 3 of 4;US-PFIZER INC-202201160811 Same reporter/events/patient, different products; Report 2 of 4;US-PFIZER INC-202201160813 Same reporter/events/patient, different products; Report 4 of 4;
Age: 73.0
Sex: M
Vaccine: 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 73-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) and on 05Jun2022 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostate cancer" (unspecified if ongoing). There were no concomitant medications. No known allergies. The following information was reported: DRUG INEFFECTIVE (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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral treatment started on 31Aug2022 and stopped on 05Sep2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: body/muscle aches; muscle aches; headache; chills; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 49 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Factor V Leiden blood clots" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. Vaccination history included: BNT162b2 (DOSE 1), administration date: 27Jan2021, when the patient was 48-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, Lot number : EL3247), administration date: 17Feb2021, when the patient was 48-year-old, for Covid-19 immunization, reaction(s): "Flu-like symptoms", "muscle aches", "fatigue", "injection site soreness", "fairly severe chills", "body aches", "headache"; BNT162b2 (DOSE 3, Lot number : EW0217), administration date: 29Sep2021, when the patient was 48-year-old, for Covid-19 immunization, reaction(s): "mild injection site pain began approx 4-6hrs post dose and lasted 1-2days", "chills", "shaking began approx 14hrs post dose and lasted 3-4hours", "flu-like body aches", "general ill-feeling began 14hrs post does and lasted 1.5days", "headache began 14hrs post dose and lasted 2.5days". The following information was reported: PAIN (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering", described as "body/muscle aches"; CHILLS (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering"; HEADACHE (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering"; MYALGIA (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering", described as "muscle aches"; FATIGUE (non-serious) with onset 13Sep2022 at 05:00, outcome "recovering", described as "tiredness". Therapeutic measures were not taken as a result of pain, myalgia, headache, chills, fatigue.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021177906 same reporter/patient, different product/dose/AE;US-PFIZER INC-202101311721 same reporter/patient, different product/dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Alopecia, Cardiac flutter, Fatigue, Feeling abnormal
Clinical narrative: pregnancy loss; iron/ferritin deficiency; arm/leg tingles; heart flutters; GI slowness/issues; extreme fatigue; brain fog; excessive hair loss; 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 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 Number: 1 , manufacturer unknown. Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "pregnancy loss"; IRON DEFICIENCY (non-serious), outcome "unknown", described as "iron/ferritin deficiency"; PARAESTHESIA (non-serious), outcome "unknown", described as "arm/leg tingles"; CARDIAC FLUTTER (non-serious), outcome "unknown", described as "heart flutters"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "GI slowness/issues"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; ALOPECIA (non-serious), outcome "unknown", described as "excessive hair loss". It was unknown if therapeutic measures were taken as a result of abortion spontaneous, iron deficiency, paraesthesia, cardiac flutter, gastric disorder, fatigue, feeling abnormal, alopecia.  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: Gastric disorder, Iron deficiency, Paraesthesia
Clinical narrative: pregnancy loss; iron/ferritin deficiency; arm/leg tingles; heart flutters; GI slowness/issues; extreme fatigue; brain fog; excessive hair loss; 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 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 Number: 1 , manufacturer unknown. Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "pregnancy loss"; IRON DEFICIENCY (non-serious), outcome "unknown", described as "iron/ferritin deficiency"; PARAESTHESIA (non-serious), outcome "unknown", described as "arm/leg tingles"; CARDIAC FLUTTER (non-serious), outcome "unknown", described as "heart flutters"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "GI slowness/issues"; FATIGUE (non-serious), outcome "unknown", described as "extreme fatigue"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; ALOPECIA (non-serious), outcome "unknown", described as "excessive hair loss". It was unknown if therapeutic measures were taken as a result of abortion spontaneous, iron deficiency, paraesthesia, cardiac flutter, gastric disorder, fatigue, feeling abnormal, alopecia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pyrexia
Clinical narrative: Joint pain; Fever; can't walk for two days after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jul2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "joint pain", "cant walk for two days after", "fever"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "joint pain"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "cant walk for two days after", "fever". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can't walk for two days after". Additional information: She got her first shot of booster last Jul, and also her last shot will be this month in Sep. She experienced some weird reactions: joint pain, fever, and cant walk for two days after, and for each of three consecutive doses she had the same reaction. Report related to a study or programme: Yes. Other Conditions: Not Provided. Other Products: Not Provided. Investigations: Not Provided. The reporter had an inquiry and was asking if vaccines were FDA approved. The patient already got bivalent COVID-19 vaccine and experienced the same reaction like she experienced with her last two or three doses.   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-202201160522 Same reporter/events/patient, different products; Report 2 of 4;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Gait disturbance, Pyrexia
Clinical narrative: Joint pain; Fever; can't walk for two days after; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jul2021 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 (Primary immunization series completed; unknown manufacturer(Dose 1 and 2)), for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can't walk for two days after".  Additional Information: Attempted transfer from (name withheld) with Pfizer. Patient experienced some weird reactions: joint pain, fever, and can't walk for two days after, and for each of three consecutive doses Patient had the same reaction. Patient also had an inquiry, and is asking if vaccines are  approved. Agent gave answer to that, Patient wants more clarification for regards to that. Experienced with her last two or three doses. Agent says Patient got her first booster in July.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Gait disturbance, Pyrexia
Clinical narrative: Joint pain; Fever; can't walk for two days after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can't walk for two days after". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: She experienced some weird reactions: joint pain, fever, and can't walk for two days after, and for each of three consecutive doses she had the same reaction. The reporter had also an inquiry, and is asked if vaccines are FDA approved.   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-202201160522 Same reporter/events/patient, different products; Report 4 of 4;