chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Immobile, Mobility decreased
Clinical narrative: immobile; weakness; inability to walk; lack of mobility; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  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: IMMOBILE (medically significant), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "inability to walk"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "lack of mobility". Clinical Course: The caller was calling about the Pfizer-BioNTech Covid-19 vaccine. He was reporting on behalf of his mother. He wanted to know if there were other reports of neurological symptoms happening like weakness, lack of mobility, inability to walk? Are there reports of this happening with other people and if there were any possible treatments for this? He stated they are immobile now. He stated the HCPs do not have any explanation for why this is happening. He stated "that" is the only connection because his mother and brother-in-law are not related and this all happened after getting the vaccines. Explained that Pfizer is unable to make treatment recommendations and that the patient's HCP would be in the best position to provide treatment recommendations.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 76.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, 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), 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment started on 25Aug2022 and stopped on 29Aug2022 for COVID-19.  Clinical information: No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid 02Aug2022 and then again on 30Aug2022; 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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6206), on 31Mar2021 as dose 2, single (Lot number: ER8732), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTIN, stop date: 02Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "recovering" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "recovering", described as "Covid 02Aug2022 and then again on 30Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) Positive; (30Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: Patient had no known allergies. Anti-viral details included PAXLOVID, treatment start date on 02Aug2022 and treatment stop date on 07Aug2022 for COVID-19 treatment. The patient had Covid on 02Aug2022 and then again on 30Aug2022. The patient enquired did the use of Paxlovid reduce the level of antibodies she created the first Covid round. She believed she had two different strains as the symptoms were not alike.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Nausea
Clinical narrative: Fatigue; brain fog; joint pains; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: FATIGUE (non-serious) with onset 29Jan2021, outcome "recovered"; FEELING ABNORMAL (non-serious) with onset 29Jan2021, outcome "recovered", described as "brain fog"; ARTHRALGIA (non-serious) with onset 29Jan2021, outcome "recovered", described as "joint pains"; NAUSEA (non-serious) with onset 29Jan2021, outcome "recovered". Therapeutic measures were not taken as a result of fatigue, feeling abnormal, arthralgia, nausea.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201135285 same reporter/patient/product, different dose/AE;
Age: 21.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 21 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 was not reported. There were no 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: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications was received in 2 weeks. COVID 19 Treatment included Paxlovid. Treatment start date was Aug2022. Treatment stop date was Aug2022. Vaccine dose 3 lot unknown reason: Not available/provided to reporter at the time of report completion. Rebound COVID symptoms one week (7 days) after completing full course of Paxlovid. Symptoms include rhinorrhea, sore throat, and fatigue/general malaise. Had previously tested negative on antigen test on the final day of Paxlovid; tested positive again on antigen test 9 days later (day 3 of rebound symptoms). Symptoms are resolving on day 4 of rebound symptoms. Patient started Recovering.   The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, 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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 69 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Mar2021 as dose 1, single (Lot number: 044A21A), in right arm and on 10Apr2021 at 15:00 as dose 2, single (Lot number: 036B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: (30-39.9). Concomitant medication(s) included: TYLENOL; IBUPROFEN; NAPROXEN SODIUM. Past drug history included: Amoxicillin, reaction(s): "Known allergies : Amoxicillin", notes: Known allergies : Amoxicillin. 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: Body mass index: 30-39.9; SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine, COVID 19 Treatment, from 27Aug2022 to 31Aug2022, Lot number- FY9906, Onset with sore throat followed by headache, sinus congestion, some sneezing/coughing, general fatigue.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Immunosuppression, Lung neoplasm malignant
Clinical narrative: lung cancer; not quite immunosuppressed but I'm close; high cholesterol; 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.  An 81-year-old female patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (Series of primary immunization completed, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 immunization. The following information was reported: LUNG NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "lung cancer"; IMMUNOSUPPRESSION (medically significant), outcome "unknown", described as "not quite immunosuppressed but I'm close"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "high cholesterol". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High.  Clinical information included: Reporter stated that she was a 81-year-old and she have had 5 shots and she was a cancer recovering patient from lung cancer and  also have high cholesterol and she was a chemist and she know what's going on. Caller also said she was not quite immunosuppressed but was close and wanna be careful and wanna make sure she don't get the wrong vaccine. It was confusing to me that they're using 2 different new terms, Comirnaty and also Pfizer-BioNTech covid-19 bivalent. It was not clear in the directions and they are introducing 2 different names. You can tell your boss that the directions are confusing, whoever wrote them. What she was downloading from CDC fact sheet for recipients and caregivers. It was not clear what to do. What was also confusing was whether the bivalent was 1 shot or 2 shots. She will see if it was confusing, then she won't take the shot. She don't want the old mRNA. It was either she took it or not took it. She was on the same page as you. She was not totally immunocompromised but there could be others taking the wrong vaccine.  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, 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) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 20Mar2021 at 19:00 as dose 1, single (Lot number: ER2613), in left arm, on 10Apr2021 at 20:00 as dose 2, single (Lot number: EW0162), in left arm, on 16Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FE3590), in right arm and on 14May2022 at 11:00 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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, notes: Treatment of COVID-19; (31Aug2022) Negative, notes: negative tests; (03Sep2022) Negative, notes: negative tests; (05Sep2022) Positive, notes: Antigen test positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Treatment of COVID-19 included Paxlovid from 26Aug2022 to 30Aug2022 of lot GE0257. no known allergies. other medication in 2weeks product included Lisinopril/HCTZ, other medication in 2weeks brand Lupin Pharm, other medication in 2weeks with start date Aug2022.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; 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.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: En6199), on 01Apr2021 as dose 2, single (Lot number: En6199) and on 03Oct2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 56 years 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), 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: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID given from 25Aug2022 to 29Aug2022.
Sex: F
Vaccine: COVID19
Symptoms: Food allergy
Clinical narrative: patient recently developed an alpha-gal allergy, after receiving her COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  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: FOOD ALLERGY (non-serious), outcome "unknown", described as "patient recently developed an alpha-gal allergy, after receiving her COVID-19 vaccine".  Additional information: The pharmacist asked if there was an easier way to find this information in regards to ingredient content (i.e. presence or absence of animal products) as her patient recently developed an alpha-gal allergy, after receiving her COVID-19 vaccine, and thus the patient was no longer able to consume animal products. It was double-checked with the pharmacist in regards to if it was the Pfizer COVID-19 vaccine for AE Reporting, the pharmacist noted that the patient said it was the Pfizer vaccine, but the pharmacist was not sure and she said she would need to check the patient's file again (and was not able to confirm at this point, as reported).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheadedness; 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 72-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6918) at the age of 71 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VERAPAMIL taken for blood pressure abnormal; LORAZEPAM; AMBIEN. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "lightheadedness". The event "lightheadedness" required physician office visit and emergency room visit.  Additional information: The patient received the Pfizer-BioNTech COVID-19 vaccine two initial shots and two booster doses and was scheduled for the next Pfizer-BioNTech COVID-19 vaccine shot the day after and she remembered that after she had received the first Pfizer-BioNTech COVID-19 vaccine she started experiencing lightheadedness, about a year and a half ago. It's chronic and don't know whether this could had been caused by the Pfizer-BioNTech COVID-19 vaccine. Her lightheadedness was not going away and requested information on whether lightheadedness had been reported as a side effect for the Pfizer-BioNTech COVID-19 vaccine. Additionally stated she would get her scheduled booster dose regardless of the lightheadedness she was experiencing. The lightheadedness was ongoing and chronically the same as when it began. She does not know what it was and was not dizzy and does not have vertigo but was very lightheaded or something. Takes medications and takes Synthroid, Rapamil (as reported) for blood pressure and occasionally takes Lorazepam but not too often and takes Ambien one and one forth and had been taking all these medications for years. Caller stated her son: "Had a severe reaction for a flu shot almost three years ago, he was so severely ill he had a temperature of 104 degrees, almost comatose" and that "he got COVID in Dec". Caller stated she did not know the name of the flu shot he received. Caller stated her son was 41-year-old. The patient had no other conditions and investigations. Prior vaccinations (within 4 weeks) were none. Patient's medical history and family medical history relevant to ae(s) were none. It was also reported that patient had 2nd dose on 18Mar2021 with lot EN6207; 1st booster on 30Sep2021 with lot 20158BA; 2nd booster on 04Apr2022 with lot FK9895.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6199), on 30Mar2021 as dose 2, single (Lot number: EK8733) and on 05Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 62 years 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) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid from 17Aug2022 to 22Aug2022.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted Covid-19; Contracted Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) 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 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 "Contracted Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had 2 primary doses of vaccines and 1 booster dose. Contracted COVID-19 and took Paxlovid then experienced viral rebound after Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200058403 same drug/ event, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Congenital anomaly, Maternal exposure timing unspecified
Clinical narrative: Congenital anomaly or birth defect; Congenital anomaly or birth defect; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A fetus patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (death, congenital anomaly, medically significant), CONGENITAL ANOMALY (death, congenital anomaly, medically significant), outcome "fatal" and all described as "Congenital anomaly or birth defect". The event "congenital anomaly or birth defect" required physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion. The patient date of death was unknown. Reported cause of death: "Congenital anomaly or birth defect". It was not reported if an autopsy was performed. The mother, a 47-year-old female patient, miscarried after her Pfizer vaccine (1st shot). Patient thinks that is the reason why. Prior to vaccination, the mother was not diagnosed with COVID-19. Since the vaccination, it was unknown if the mother had been tested for COVID-19.  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-202201118114 same reporter/drug/event, different patient (baby case);; Reported Cause(s) of Death: Congenital anomaly or birth defect; Congenital anomaly or birth defect
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: sick with COVID; sick with COVID; Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 vaccine (Tozinameran) were also considered suspect; 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-163-4520987-00 (Agency).  A 70-year-old female patient received BNT162b2 (BNT162B2), on 26Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 69 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 027L0A), on 04Mar2021 as dose 2, single (Lot number: 011M20A) and on 10Dec2021 as dose 3 (booster), single (Lot number: 048F21A), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Dizziness" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Tobacco use", stop date: 1998, notes: Tobacco use (stopped 1998); "Abstains from alcohol" (unspecified if ongoing); "Tuberculosis" (unspecified if ongoing); "Statin allergy" (unspecified if ongoing), notes: Statin allergy. Concomitant medication(s) included: PREDNISONE; DILTIAZEM; MECLIZINE [MECLOZINE HYDROCHLORIDE] taken for dizziness; LEFLUNOMIDE taken for rheumatoid arthritis; MELOXICAM taken for arthritis; FOLIC ACID taken for rheumatoid arthritis; CITALOPRAM; LISINOPRIL; TOPIRAMATE; PREGABALIN; ONDANSETRON; BENZONATATE; MONTELUKAST; PRAVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown", described as "Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 vaccine (Tozinameran) were also considered suspect"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "recovered" (28Aug2022) and all described as "sick with COVID". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.8 Fahrenheit; SARS-CoV-2 test: (28Aug2022) Negative; (21Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The reporter considered "covid" not related to BNT162b2.  Clinical information: Solicited report from a consumer of a 70 year old female with events of non-serious slept a lot and sick with COVID with Humira 40mg/0.4ml (Adalimumab). On 21Aug2022, the patient experienced slept a lot and sick with COVID. On 28Aug2022, the slept a lot and sick with COVID resolved. Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 vaccine (Tozinameran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient was treated with Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; 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-163-4525305-00 (Agency).  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset Jul2022, outcome "recovered" (2022) and all described as "COVID-19". Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event COVID with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; 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.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years, 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's relevant medical history included: "Diabetes T2" (unspecified if ongoing), notes: other medical history: Diabetes T2; "Hypothyroid" (unspecified if ongoing), notes: other medical history: Hypothyroid; "obesity" (unspecified if ongoing); "known allergies: Yes. Penicillin" (unspecified if ongoing), notes: known allergies: Yes. Penicillin. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". 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.  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: Rash, Rash macular
Clinical narrative: rash/rash on her arm; three little spots that are still there from her shots; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent.  A 42-year-old 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: RASH (non-serious), outcome "unknown", described as "rash/rash on her arm"; RASH MACULAR (non-serious), outcome "unknown", described as "three little spots that are still there from her shots".  Additional information: the patient received COVID-19 Vaccine and had a rash on her arm with two/three little spots from her shots. She had an allergic reaction which was rash and three little spots that were still there from her shots.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) :PFIZER INC-202201135433 Same reporter/product, different patient/event;
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID positive test; COVID positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 11-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 as dose 1, single (Lot number: FK5618), on 03Dec2021 as dose 2, single (Lot number: FK5618) and on 11Jun2022 as dose 3 (booster), single (Lot number: FL8094) at the age of 10 years, all intramuscular 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) all with onset 05Sep2022, outcome "not recovered" and all described as "COVID positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient did not have covid prior vaccination. Patient covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 4/ Vaccine brand other: Moderna; Vaccine dose number: 3; 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 67-year-old male patient received BNT162b2 (BNT162B2), on 04May2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Feb2021 as dose 2, single (Lot number: 006M20A), in left arm and on 17Sep2021 as dose 3 (booster), single (Lot number: 048F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: EZETIMIBE, start date: Aug2021, stop date: Sep2022; LISINOPRIL, start date: Jan2018, stop date: Sep2022; ROSUVASTATIN, start date: Mar2017, stop date: 19Aug2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04May2022, outcome "unknown", described as "Vaccine brand: Pfizer / BioNTech; Vaccine dose number: 4/ Vaccine brand other: Moderna; Vaccine dose number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Tested positive on antigen test; (unspecified date) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid for Covid -19 treatment from 19Aug2022 to 23Aug2022. The  Covid rebound 13 days after starting paxlovid. Tested positive on antigen test and was symptomatic for 3 days. The patient don't have any known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Influenza, Insomnia
Clinical narrative: 102 temp; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; could not even sleep; neck,shoulder,head ache so bad could not even sleep; flu symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillian" (unspecified if ongoing), notes: known allergies: Penicillian; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: LOSARTAN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Hycodan, reaction(s): "Known allergies: hycodan", notes: Known allergies: hycodan. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "102 temp"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "neck,shoulder,head ache so bad could not even sleep"; INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms"; INSOMNIA (non-serious), outcome "unknown", described as "could not even sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Every shot got worse. First shot 102 temp and neck, shoulder, head ache so bad could not even sleep plus basic flu symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: 102 temp; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; could not even sleep; neck,shoulder,head ache so bad could not even sleep; flu symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillian" (unspecified if ongoing), notes: known allergies: Penicillian; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: LOSARTAN. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine; Hycodan, reaction(s): "Known allergies: hycodan", notes: Known allergies: hycodan. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "102 temp"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "neck,shoulder,head ache so bad could not even sleep"; INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms"; INSOMNIA (non-serious), outcome "unknown", described as "could not even sleep". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Every shot got worse. First shot 102 temp and neck, shoulder, head ache so bad could not even sleep plus basic flu symptoms.   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: Migraine
Clinical narrative: disabling migraines/ it was like someone hit him in the head with a sledge hammer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male 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: MIGRAINE (non-serious), outcome "unknown", described as "disabling migraines/ it was like someone hit him in the head with a sledge hammer".  Additional information: The reporter reported that her brother cannot take the covid vaccines and had the first Pfizer covid vaccine but had disabling migraines and he refused to get another one and it was like someone hit him in the head with a sledge hammer; caller declined to complete a report on her brother. Reporter details: Declined email.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary mass, Body temperature, Condition aggravated, Headache
Clinical narrative: 102 temp; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; flu symtoms; shot 2 was worse and last several days; lump in armpit; neck,shoulder,head ache so bad could not even sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergies" (unspecified if ongoing), notes: Known allergies: sulfa; "Penicillian allergies" (unspecified if ongoing), notes: Known allergies: Penicillian. Concomitant medication(s) included: LOSARTAN. Past drug history included: Hycodan, reaction(s): "allergies", notes: Known allergies: hycodan; Codine, reaction(s): "allergies". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: Unknown; Site of vaccine administration: Left arm), administration date: 09Mar2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "102 temp", "neck,shoulder,head ache so bad", "neck,shoulder,head ache", "neck,shoulder,head ache so bad", "could not even sleep", "flu symptoms". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "102 temp"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), HEADACHE (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "neck,shoulder,head ache so bad could not even sleep"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu symtoms"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "shot 2 was worse and last several days"; AXILLARY MASS (non-serious), outcome "unknown", described as "lump in armpit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, every shot got worse. Patient was very active but, fear that her system was allergic to something in it. Work full time in an office and fear getting Covid as well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Insomnia, Neck pain, Pyrexia
Clinical narrative: 102 temp; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; neck,shoulder,head ache so bad could not even sleep; flu symtoms; shot 2 was worse and last several days; lump in armpit; neck,shoulder,head ache so bad could not even sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sulfa allergies" (unspecified if ongoing), notes: Known allergies: sulfa; "Penicillian allergies" (unspecified if ongoing), notes: Known allergies: Penicillian. Concomitant medication(s) included: LOSARTAN. Past drug history included: Hycodan, reaction(s): "allergies", notes: Known allergies: hycodan; Codine, reaction(s): "allergies". Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: Unknown; Site of vaccine administration: Left arm), administration date: 09Mar2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "102 temp", "neck,shoulder,head ache so bad", "neck,shoulder,head ache", "neck,shoulder,head ache so bad", "could not even sleep", "flu symptoms". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "102 temp"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), HEADACHE (non-serious), INSOMNIA (non-serious), outcome "unknown" and all described as "neck,shoulder,head ache so bad could not even sleep"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu symtoms"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "shot 2 was worse and last several days"; AXILLARY MASS (non-serious), outcome "unknown", described as "lump in armpit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, every shot got worse. Patient was very active but, fear that her system was allergic to something in it. Work full time in an office and fear getting Covid as well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4, (booster), single (Lot number: FJ4991) at the age of 70 years, 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's relevant medical history included: "asthma" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "known allergies: melons" (unspecified if ongoing), notes: known allergies: melons; "known allergies: airborne" (unspecified if ongoing), notes: known allergy: airborne; "Known Allergies: chemical sensitivity" (unspecified if ongoing), notes: Known Allergies: chemical sensitivity. There were no concomitant medications. 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: (unspecified date) Negative, notes: I tested negative for 3 days; (unspecified date) Negative, notes: I tested negative for 3 days; (unspecified date) Negative, notes: I tested negative for 3 days; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (unspecified date) Positive, notes: then have tested positive for 8 consecutive days including today; (06Sep2022) Positive, notes: then have tested positive for 8 consecutive days including today. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received treatment for COVID 19 as Paxlovid on 21Aug2022 and stopped on 26Aug2022.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of Covid-19; 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.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypopituitarism" (unspecified if ongoing); "stroke" (unspecified if ongoing); "blood clots" (unspecified if ongoing); "pituitary macroadenoma" (unspecified if ongoing); "POTS" (unspecified if ongoing); "Ehlers Danlos Syndrome" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, start date: Feb2022; PREDNISONE, start date: Feb2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Aug2022, outcome "unknown" and all described as "Treatment of Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Aug2022) Positive, notes: I first tested positive for Covid; (06Sep2022) Negative, notes: finally tested negative, 4 days after completing a course of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. Patient received Paxlovid for Treatment of COVID-19 on 29Aug2022 and stopped on 02Sep2022. Patient reported that it has been 4 days since my last dose of Paxlovid and she have developed a severe cough. She only had nasal congestion and a sore throat for 24 hours when she first tested positive for covid, and she was able to take Paxlovid within 3 hours of her positive test. Her symptoms went away almost immediately and her considered herself symptom free for the duration of her 10-day isolation. Her cough developed the same day she finally tested negative, 4 days after completing a course of Paxlovid. She would test again in the coming days to see if she has rebound covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.