chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in right 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: "Reynauds" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "MGUS" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: tetracycline". 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 09Aug2022 to 14Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt heat and it radiated down my arm and in my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 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: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Felt heat and it radiated down my arm and in my chest".  Additional information: The patient stated that she took the vaccine Mar2021 and after felt heat and it radiated down my arm and in my chest, but she thought that was normal reaction.   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: Hypersensitivity, Hypoaesthesia, Malaise, Serum sickness
Clinical narrative: felt numbness everywhere/ I was numb for 6-8 months; serum sickness; allergic to something in the medication; don't feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, felt heat and it radiated down my arm and in my chest), administration date: Mar2021, for Covid-19 immunization, reaction(s): "felt heat". The following information was reported: HYPERSENSITIVITY (hospitalization) with onset 2021, outcome "unknown", described as "allergic to something in the medication"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "don't feel good"; HYPOAESTHESIA (hospitalization) with onset 2021, outcome "recovered", described as "felt numbness everywhere/ I was numb for 6-8 months"; SERUM SICKNESS (hospitalization) with onset 2021, outcome "unknown". The patient was hospitalized for hypoaesthesia, serum sickness, hypersensitivity (start date: 2021). The events "felt numbness everywhere/ i was numb for 6-8 months", "serum sickness" and "allergic to something in the medication" required physician office visit. Additional information: Patient stated that with the 2nd vaccine, around 3 weeks after first one (between Mar2021 to Apr2021), patient felt numbness everywhere for a few days it came and went. she ended up going to hospital on the 7th day. They said she was allergic to something in the medication. She went to several Doctors and her Rheumatologist said she had serum sickness, and it would take 6 months or longer to leave her system. She was numb for 6-8 months. She was going to so many doctors trying to figure out what to do. She felt like she was dying. She made a report about the reaction to the vaccine but Pfizer aren't making it easy because you already don't feel good yet are trying to navigate the forms and the email and the websites, She didn't follow up. She had been fine.   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-202201065248 same patient/drug, different doses and events;US-PFIZER INC-202201065250 same patient/drug, different doses and events;
Sex: F
Vaccine: COVID19
Symptoms: Thyroiditis
Clinical narrative: thyroiditis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. .  A 63-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; NUCALA, since 2019 (Batch/Lot number: unknown) for asthma; budesonide, SYMBICORT, (Batch/Lot number: unknown). The patient's relevant medical history included: "Severe asthma" (unspecified if ongoing), notes: Severe asthma. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: THYROIDITIS (non-serious) with onset 2021, outcome "unknown". The action taken for mepolizumab was unknown. The action taken for budesonide, formoterol fumarate was temporarily withdrawn.  Additional information: It was reported that she took Symbicort with Nucala and she did not take Symbicort for a few days because she ran out of it and so on 26Jul2022 to 29Jul2022 she was having some chest tightness. She attributed the chest tightness to maybe not taking Symbicort or due to receiving underdose of Nucala. As reported, the customer did not get the full dose of Nucala Al. She started Nucala AI in 2019 for diagnosis of severe asthma, but she stated in Apr2021 she after receiving the second dose of the COVID-19 (name unknown) she was diagnosed with thyroiditis and was started on medication for it. She attributed the thyroiditis to the COVID-19 vaccine. She stated in Apr2022 she received the booster dose of Pfizer vaccine on 18Apr2022 and 10 days later she started to experience dizziness/ lightheadedness and she was diagnosed with vestibular neuritis and she takes ibuprofen for it. The dizziness had gotten better but still there.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Jan2021 at 15:00 as dose 1, single (Lot number: EL1042), in left arm, on 05Feb2021 at 14:00 as dose 2, single (Lot number: EL3302), in left arm, on 17Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FC3180), in left leg and on 28Jan2022 at 13:00 as dose 4 (booster), single (Lot number: 33130BA) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: (taking immunosuppressant); "Beta Thalassemia Minor" (unspecified if ongoing). Concomitant medication(s) included: GILENYA, start date: 22Nov2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose Number: 1 and Dose Number: 2 were Moderna/Dose Number: 3 was Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 01Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2021 as dose 1, single (Lot number: 030L20A) and on 03Feb2021 as dose 2, single (Lot number: 030L20A) 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 "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Dose Number: 1 and Dose Number: 2 were Moderna/Dose Number: 3 was Pfizer / BioNTech". 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.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: breakthrough Varicella; This spontaneous report was received from a physician assistant via a company representative referring to 7-year-old male patient. The patient's medical history, drug reaction/allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis.  On an unknown date in July 2022, the patient developed breakthrough Varicella. The physician assistant reported that the patient was diagnosed at an urgent care and the case was uncomplicated. It was unknown what symptoms the patient experienced. The patient had sought medical Attention. At the time of reporting, the outcome of breakthrough varicella was not reported. The causal relationship between breakthrough varicella and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.  This is one of two reports from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: second shot was pretty rough, glad it's over; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that second shingles shot was pretty rough, but glad it was over. Additional supportive information: Follow-up would not possible as no contact details were available.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thyroidectomy, and concurrent conditions included: allergy (Unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 4383 and expiry: Unknown) dose was not reported, dose 1, administered in left arm on 25-FEB-2022 for covid-19 prophylaxis. Age at time of vaccination 48 years old. Concomitant medications included levothyroxine sodium. On an unspecified date in 2022, the patient experienced covid-19. The patient received non-company suspect Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, for treatment of covid-19 from 25-JUL-2022 to 29-JUL-2022. On 29-JUL-2022, after the 5 days treatment of Paxlovid, the patient had rebound Covid symptoms. On 30-JUL-2022, day 6th, the patient tested negative for covid-19. Laboratory data included: COVID-19 virus test Negative. On 06-AUG-2022, day 13th, the patient tested positive for covid-19 which was confirmed covid-19 infection and confirmed clinical vaccination failure. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and Paxlovid was not reported. The patient was recovering from confirmed covid-19 infection and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246751.; Sender's Comments: V0-20220832263-covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 74.0
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). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: CL8982), in left arm, on 17Feb2021 as dose 2, single (Lot number: EL8982), in left arm and on 03Dec2021 as dose 3 (booster), single (Lot number: EW0191) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Back Pain" (unspecified if ongoing); "Bronchiectasis" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: RAMIPRIL; ATORVASTATIN; BASAGLAR; VITAMIN D3; TYLENOL; ADVIL [IBUPROFEN]. Past drug history included: Metformin, reaction(s): "drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 including received Paxlovid from 12Aug2022 to 16Aug2022.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "sports asthma" (unspecified if ongoing); "mononucleosis", start date: 2020 (unspecified if ongoing); "known allergies: penicillin (potential)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". Therapeutic measures Paxlovid were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43-year-old female patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LEXIPRON taken for depression, start date: 01Jan2020, stop date: 16Aug2022; BUPROPION taken for depression, start date: 01Jan2020, stop date: 16Aug2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 03Aug2022 to 08Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, 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) (Other HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster ), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: AMLODIPINE, start date: 01Jan2020; LISINOPRIL, start date: 01Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Covid 19 positive. Appears to be Rebound; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2020 at 15:30 as dose 1, single (Lot number: EK9321), in left arm, on 15Jan2021 at 11:00 as dose 2, single (Lot number: EL3246), in left arm, on 26Oct2021 at 11:00 as dose 3 (booster), single (Lot number: EW0217), in left arm and on 14Apr2022 at 11:30 as dose 4 (booster), single (Lot number: FK9729) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). No Known allergies. There were no concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 15Aug2022 at 09:00, outcome "not recovered", described as "Covid 19 positive. Appears to be Rebound"; VACCINATION FAILURE (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: (unspecified date) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid. Therapeutic measures were not taken as a result of disease recurrence.
Age: 40.0
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 a 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 24Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for COVID-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing). Concomitant medication(s) included: EXCEDRIN [CAFFEINE;PARACETAMOL], start date: Aug2022; ONDANSETRON, start date: Aug2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "not recovered" and all described as "Covid -19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Aug2022) positive; (13Aug2022) positive; (16Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, COVID-19 and included Paxlovid. Clinical course: Anti-viral details: COVID-19 Treatment (Paxlovid) was started from 03Aug2022 and stopped on 08Aug2022. The patient reported: "Paxlovid rebound. I developed COVID on 02Aug2022 and began taking Paxlovid the evening of 03Aug2022. My symptoms were overall pretty mild (low fever, headache, throat congestion), and I began feeling better the next morning, and by 06Aug2022 felt entirely recovered. I continued to feel fine for a week, but then on 13Aug2022, I started having COVID symptoms again (congestion, cough, fatigue, headache) and tested a strong positive using a home antigen test. It is now 16Aug2022, and I am still feeling ill and testing positive."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: 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 contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02Jul2022 at 14:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). 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: (unspecified date) Positive, notes: antigen testing became lighter positive daily; (11Aug2022) Negative, notes: negative on 1st day after completing paxlovid; (12Aug2022) Negative, notes: again negative 2 days after completing; (15Aug2022) Positive, notes: I again tested antigen test strongly positive that same day; (unspecified date) Positive, notes: I started paxlovid on day 2 after covid symptoms started and testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound covid infection after completing paxlovid course. I started paxlovid on day 2 after covid symptoms started and testing positive. I felt better 24 hours after starting medication, antigen testing became lighter positive daily and negative on 1st day after completing paxlovid, again negative 2 days after completing. Return of symptoms occurred 5 days after completing paxlovid and i again tested antigen test strongly positive that same day. Now Day 2 after return of symptoms.  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 currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 after BNT162B2 vaccination; Covid-19 after BNT162B2 vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Hypothyroid" (unspecified if ongoing), notes: Other medical history: Hypothyroid. Patient had no known allergies. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 after BNT162B2 vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included Paxlovid from 16Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Age: 58.0
Sex: F
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) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2022 as dose 3 (booster), single (Lot number: 059H21A) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Htn" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "fmd" (unspecified if ongoing); "ACE inhibitors allergies" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; ROSUVASTATIN; VIT D3; VIT B6. Past drug history included: Amlodipine, reaction(s): "Known allergies: Amlodipine"; Keflex, reaction(s): "Known allergies: keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 16Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included Paxlovid. Clinical course: Anti-viral details: COVID 19 Treatment (Paxlovid) was started from 02Aug2022 and stopped on 06Aug2022.  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: Asthenia, Muscle spasms, Pain in extremity
Clinical narrative: Pain in my right leg; Feels like a large leg cramp that never goes away; I wave lost strength on my leg and I am on constant pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in my right leg"; MUSCLE SPASMS (non-serious), outcome "not recovered", described as "Feels like a large leg cramp that never goes away"; ASTHENIA (non-serious), outcome "not recovered", described as "I wave lost strength on my leg and I am on constant pain". Therapeutic measures were not taken as a result of pain in extremity, muscle spasms, asthenia.  Additional information: No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination. The patient was not covid tested post vaccination. No known allergies. Pain in his right leg. Feels like a large leg cramp that never goes away. He had lost strength on his leg and he was on constant pain. Adverse event start date: 15May2021 01:00 AM.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 66-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 66 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: "Hypertension" (unspecified if ongoing); "hyperlipemia" (unspecified if ongoing). 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 "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.  Clinical course: The patient received Paxlovid from 07Aug2022 to 11Aug2022 treatment of COVID-19.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Disease recurrence; Pfizer / BioNTech / Treatment of COVID-19 25Jul2022; Pfizer / BioNTech / Treatment of COVID-19 25Jul2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-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, on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 05May2022 as dose 4 (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 included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: LANTUS; METFORMIN; LOSARTAN; AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "not recovered" and all described as "Pfizer / BioNTech / Treatment of COVID-19 25Jul2022"; DISEASE RECURRENCE (medically significant) with onset 11Aug2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2022) Positive, notes: On 11Aug my symptoms returned and I have tested positive every day since. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course as follows: Took Paxlovid on 25Jul2022 (second day of symptoms). Completed full dose. On 11Aug2022 her symptoms returned, and she have tested positive every day since.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; developed new Covid symptoms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in right 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: "Syringomyelia" (unspecified if ongoing); "thyroid nodules" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing); "adhd" (unspecified if ongoing). Concomitant medication(s) included: ADDERALL, start date: 15Oct2019, stop date: 02Aug2022. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "developed new Covid symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: appearing positive antigen test result than previously; Negative, notes: Tested negative after completing course for 2 consecutive days. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid. Therapeutic measures were not taken as a result of disease recurrence. Clinical course included: patient tested negative after completing course for 2 consecutive days. Six days after completing course developed new Covid symptoms (different from those I had originally). Had sever sore throat then over the next couple days developed cough, congestion and sneezing. Decided to re-test for Covid after3 days and had new stronger/more immediate appearing positive antigen test result than previously.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal association, a causal relationship between all the events and BNT162b2 cannot be excluded.
Age: 79.0
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 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Lot number: EL0140), in left arm, on 03Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: FF2566), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications in 2weeks. Past drug history included: Tetracycline, reaction(s): "Allergy", notes: known allergies: Allergic to tetracycline. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive, notes: Tested positive on July 26 with severe sore throat and fatigue; (04Aug2022) Negative, notes: tested negative on August 4; (07Aug2022) Positive, notes: August 7, I felt very congested and fatigued. Tested positive that evening. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: She felt ill 25July. Tested positive on 26July with severe sore throat and fatigue. Was prescribed Paxlovid which she started on 26July and finished on 31July. Recovered and tested negative on 04August. 07August, she felt very congested and fatigued. Tested positive that evening.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Tested positive today on Day 12 (17Aug2022); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Lot number: ER8734), on 16Apr2021 as dose 2, single (Batch/Lot number: unknown), on 16Oct2021 as dose 3 (booster ), single (Lot number: 3590) and on 09Apr2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 17Aug2022, outcome "not recovered", described as "Tested positive today on Day 12 (17Aug2022)"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (15Aug2022) Negative, notes: on Day 10; (17Aug2022) Positive, notes: on Day 12. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid from 07Aug2022 to 12Aug2022. Therapeutic measures were not taken as a result of disease recurrence. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 73-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 04Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroidectomy" (unspecified if ongoing), notes: other medical history: thyroidectomy; "Type 2 diabetes" (unspecified if ongoing), notes: recent diagnosis. Concomitant medication(s) included: OMEPRAZOLE; LEVOTHYROXINE; CRESTOR; METFORMIN. Past drug history included: Oxycodone, reaction(s): "known allergies: oxycodone", notes: known allergies: oxycodone; Tetracycline, reaction(s): "known allergies: tetracycline", notes: known allergies: tetracycline. 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. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Paxlovid for Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 84.0
Sex: F
Vaccine: 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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 14:00 as dose 1, single (Lot number: EL3249), in left arm, in Feb2021 as dose 2, single (Lot number: EL9269), in left arm, on 30Sep2021 at 12:00 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 04May2022 at 11:00 as dose 4 (booster), single (Lot number: FP1554) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "On blood pressure meds" (unspecified if ongoing); "cpap" (unspecified if ongoing); "have restless leg syndrome" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: GABAPENTIN, start date: 16Jun2014, stop date: 17Aug2022; LEVOTHYROXINE, start date: Jan2000, stop date: Aug2022; AMLODIPINE, start date: Jan2002, stop date: Aug2022; PRAMIPEXOLE, start date: Jan2002, stop date: 17Aug2022; METOPROLOL, start date: Jan2005, stop date: Aug2022. The following information was reported: DRUG INEFFECTIVE (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: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Insulinoma
Clinical narrative: In Mar2022 he had surgery for an insulinoma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 87-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SIMVASTATIN. Vaccination history included: BNT162b2 (Dose: 01, LOT: EN6198), administration date: 26Feb2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (Dose: 02, LOT: EP7534), administration date: 19Mar2021, when the patient was 85-year-old, for COVID-19 immunization. The following information was reported: INSULINOMA (medically significant), outcome "unknown", described as "In Mar2022 he had surgery for an insulinoma". The patient underwent the following laboratory tests and procedures: Biopsy: Everything was clear and the biopsy was good., notes: Everything was clear and the biopsy was good. Therapeutic measures were taken as a result of insulinoma.  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, COVID-19, Nasopharyngitis
Clinical narrative: Cold; COVID-19; Anaphylaxis; MARKETING PROGRAM NAME NOT AVAILABLE.  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499936-00.  A 23-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1162439) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Anaphylaxis"; COVID-19 (medically significant) with onset Dec2021, outcome "recovered"; NASOPHARYNGITIS (non-serious), outcome "recovering", described as "Cold". The action taken for adalimumab was unknown.  Clinical information: After taking the COVID-19 vaccine in Mar2021, the patient had anaphylaxis. In Dec2021, she had COVID-19. The patient had a cold for two to three days. She did not agreed to have physician contacted. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "covid-19" and "cold" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "anaphylaxis" related to BNT162b2.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of anaphylaxis after taking COVID-19 vaccine, cold and COVID-19 with Humira (Adalimumab) was no reasonable possibility. Company's opinion is that there is no reasonable possibility that the events of anaphylaxis after taking COVID-19 vaccine and COVID-19 are related to Humira (Adalimumab). Company's opinion is that the event of cold is not assessable.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.