chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diffuse large B-cell lymphoma, Pain
Clinical narrative: Diffuse B cell lymphoma; he was having pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 82-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Caller states her uncle has anxiety.; "undergoing chemotherapy" (unspecified if ongoing), notes: She states her uncle is in chemotherapy now and is improving a little.; "her uncle has been taking this cholesterol medication for a while" (unspecified if ongoing), notes: Caller states her uncle has been taking this cholesterol medication for a while.; "uncle has been taking this prostate medication for a while." (unspecified if ongoing), notes: Caller states her uncle has been taking this prostate medication for a while. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE: 1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 3, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: DIFFUSE LARGE B-CELL LYMPHOMA (medically significant), outcome "recovering", described as "Diffuse B cell lymphoma"; PAIN (non-serious), outcome "unknown", described as "he was having pain". The event "diffuse b cell lymphoma" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of diffuse large b-cell lymphoma.  Clinical information: Caller states her uncle was got lymphoma around the same time as her mother in law as he was having pain at the same time as her mother in law. Caller states her uncle has Diffuse B cell lymphoma. Caller states her uncle didn't go to the doctor until Feb2022. Caller states her uncle is in chemotherapy now and is improving a little. Caller her uncle has received 4 doses of the COVID-19 Vaccine and states she is not sure if all of the COVID-19 Vaccines were Pfizer but she thinks so. Caller has no NDC, Lot number, or expiration dates for any of the COVID-19 Vaccines. She also does not have the date of vaccination for any of the COVID-19 Vaccines. Prior Vaccinations (within 4 weeks) patient did not had any other vaccinations within four weeks prior to the first administration date of the suspect 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: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19 Clinical course included Paxlovid, 4 days later it has come back full force. 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: Blood immunoglobulin A, COVID-19, Creatinine renal clearance, Drug ineffective, Immunisation
Clinical narrative: Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later/tested positive; Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to Covid five hours later/tested positive; Off Label Use; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing), notes: no reaction to antibodies; "single kidney" (unspecified if ongoing), notes: single kidney; "hypertension - labile BP" (unspecified if ongoing), notes: hypertension - labile BP; "autoimmune thyroiditis" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing), notes: 18-19 years. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 06May2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 06May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 08May2022, outcome "not recovered", described as "Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later/tested positive"; COVID-19 (medically significant) with onset 08May2022, outcome "not recovered", described as "Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to Covid five hours later/tested positive". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin A: (unspecified date) low, notes: naturally; Creatinine renal clearance: (unspecified date) 45; SARS-CoV-2 test: (2022) Positive; (08May2022) Positive; (13May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included the reporter received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later. The reporter tested positive 08May2022 and tested positive 13May2022 and thereafter, with test becoming "more positive" (stronger appearance of positive line) with succeeding days.   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 in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test
Clinical narrative: Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later/tested positive; Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to Covid five hours later/tested positive; Off Label Use; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), on 24Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunosuppressed" (unspecified if ongoing), notes: no reaction to antibodies; "single kidney" (unspecified if ongoing), notes: single kidney; "hypertension - labile BP" (unspecified if ongoing), notes: hypertension - labile BP; "autoimmune thyroiditis" (unspecified if ongoing); "Raynaud's" (unspecified if ongoing); "Celiac disease" (unspecified if ongoing), notes: 18-19 years. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 06May2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 06May2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 08May2022, outcome "not recovered", described as "Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later/tested positive"; COVID-19 (medically significant) with onset 08May2022, outcome "not recovered", described as "Caller received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to Covid five hours later/tested positive". The patient underwent the following laboratory tests and procedures: Blood immunoglobulin A: (unspecified date) low, notes: naturally; Creatinine renal clearance: (unspecified date) 45; SARS-CoV-2 test: (2022) Positive; (08May2022) Positive; (13May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included the reporter received Pfizer vaccine primary series, Pfizer booster 24Aug2021. On 06May2022 caller received second booster and was exposed to COVID five hours later. The reporter tested positive 08May2022 and tested positive 13May2022 and thereafter, with test becoming "more positive" (stronger appearance of positive line) with succeeding days.   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 in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Apr2021 as dose  2, single (Batch/Lot number: unknown), in left arm and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Sulfur" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) COVID-19. Therapeutic measures were taken as a result of covid-19. Clinical course included: The patient received Paxlovid from 11May2022 to 15May2022 for the treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, 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: Penicillins" (unspecified if ongoing). There were no concomitant medications. There were no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: Product: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 19May2022, lot number: Ga2279, indication: Treatment of COVID-19  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 in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Reports his covid sxs were mild but progressing/States he had pfizer covid vaccine(primary) and the booster which is probably why his sxs were only mild; Reports his covid sxs were mild but progressing/States he had pfizer covid vaccine(primary) and the booster which is probably why his sxs were only mild; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Reports his covid sxs were mild but progressing/States he had pfizer covid vaccine(primary) and the booster which is probably why his sxs were only mild". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective. Clinical course: Caller stated he was prescribed paxlovid for mild COVID 19 infection (omicron variant) and took the first dose yesterday at about 4:15 pm. He developed a 'bad reaction' such as sweating and nausea yesterday. He was unsure whether it was a reaction to the paxlovid or because he took it in close proximity with his other medications. This morning, he took his other medications at around 6:30 am and took the paxlovid at about 9:30 am and has not had any issues since. Asking if there was a recommended time interval between the 2 doses and also the general timing if he was taking other medications. Also suggested that if we were going to update the package insert that it should include the recommended interval between doses. Reported his COVID sxs were mild but progressing (prior to starting product). Stated he had pfizer COVID vaccine (primary) and the booster which was probably why his sxs were only mild.   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
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EL 8982), on 10Mar2021 as dose 2, single (Lot number: EN 6208) and on 29Sep2021 as dose 3 (booster), single (Lot number: 30125BA) at the age of 70 years for Covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "Sarcoidosis of the lung and heart" (unspecified if ongoing), notes: other medical history: Sarcoidosis of the lung and heart; "Sarcoidosis of the lung and heart" (unspecified if ongoing), notes: other medical history: Sarcoidosis of the lung and heart; "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; METOPROLOL SUCCINATE; OMEPRAZOLE; FOLIC ACID; PREDNISONE; METHOTREXATE; PREMARIN; RESTASIS; ASPIRIN 81; VITAMIN D3; FISH OIL; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; BIOTIN, CITRICAL SLOW RELEASE CALCIUM and MULTIVITAMIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Tested positive for Covid using home test kit on 12May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive; (19May2022) Negative; (21May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical information: It was reported that the patient took other medications in 2 weeks.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and on 31May2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received proprietary medicinal product name Paxlovid for the treatment of covid-19, date of start of drug 09may2022, date of last administration 14may2022. congestion symptoms returned after 6 days of feeling better after finishing Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: M
Vaccine: COVID19, 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.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative citis" (unspecified if ongoing), notes: Other medical History:Ulcerative citis. Concomitant medication(s) included: IMURAN [AZATHIOPRINE SODIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2022) Positive, notes: Positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
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).  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 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). The patient's relevant medical history included: "lupus" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing); "Scleroderma" (unspecified if ongoing); "Raynauds" (unspecified if ongoing); "Known allergy: Amoxicillin" (unspecified if ongoing); "Colitis" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE; RITUXAN; NIFEDIPINE. Past drug history included: Known allergy: sulfa, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: very minimal Clinical course: symptoms on 5/6/2022 when tested, positive; (05Jun2022) Positive, notes: Complete return of symptoms on day 14, positive rapid test. 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. Adverse event: delay of covid 19 illness- very minimal symptoms on 06May2022 when tested positive, completed course of Paxlovid d/t immunocompromised status. Complete return of symptoms on day 14, positive rapid test, loss of taste/smell day 15  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 in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 45.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 at 12:45 as dose 1, single (Lot number: FR8730), in left arm, on 15Apr2021 at 10:30 as dose 2, single (Lot number: EN5318), in left arm and on 18Nov2021 at 18:30 as dose 3 (booster), single (Lot number: FH8030) at the age of 45 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The patient did not receive any other medication in 2weeks.  The following information was reported: 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: positive; negative; positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Adverse event: On day 11 of after symptoms started, 4 days after I ended the Paxlovid treatment, and 3 days after testing negative, I have tested positive again. Adverse event country: reported; Adverse event start date: 21May2022; Adverse event start time: 07:45 AM; Anti-viral details: Product: COVID 19 Treatment; Brand: Pfizer paxlovid; Treatment start date: 12May2022; Treatment stop date: 17May2022; Lot number: GC0466; Indication: Treatment of COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: had a reaction and wasn't feeling well post booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US093492 (Agency).  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER: UNKNOWN, DOSE NUMBER: UNKNOWN), for Covid-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "had a reaction and wasn't feeling well post booster.".  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: 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) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), first regimen from 29Oct2021 (Batch/Lot number: unknown) to 29Oct2021 at single (dose 3 (booster), single), second regimen from 15Mar2021 (Batch/Lot number: unknown) to 15Mar2021 at single (dose 2, single) and third regimen from 15Feb2021 (Batch/Lot number: unknown) to 15Feb2021 at single (dose 1, single) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive; (2022) Negative; (2022) Positive; (2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received anti-viral product of Pfizer brand for covid -19 treatment start date 11May2022 and stop date 15May2022. After full course of Paxlovid, the patient tested negative 3 days in a row for covid. On the 4th day, she tested positive again. Other medication in 2 weeks included levothyroxine. No known allergies were reported.  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, Drug ineffective, SARS-CoV-2 test
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Lot number: Ew0154), in right arm and on 19May2021 as dose 2, single (Lot number: Ew0163) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pulmonary fibrosis" (unspecified if ongoing); "known allergies: Sulfur contrast dye" (unspecified if ongoing), notes: nown allergies: Sulfur contrast dye. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" 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 covid-19. Clinical course: The patient did not taken other medication in 2 weeks of vaccination. She took treatment of Covid-19 Paxlovid, which started from 18May2022. The lot number of Paxlovid Ga3595. She had experienced flu like symptoms.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19;This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 14:00 as dose 1, single (Lot number: EL8982), in left arm and on 09Feb2021 at 14:00 as dose 2, single (Lot number: EM9810) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Nov2021 at 22:00 as dose 3 (booster), single (Lot number: 033F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRENATAL MULTIVITAMIN + DHA, start date: 01Mar2022, stop date: 20May2022. 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: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 17Feb2021 as dose 2, single (Lot number: EM9809), in right arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure controlled well with medication. Concomitant medication(s) included: ESTRING, start date: 17Mar2022; LOSARTAN POTASSIUM ACCORD, start date: 01Feb2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had no known allergies. Losartan Potassium and Estring were product of Lupin Limited and Pfizer respectively. Patient was treated with Paxlovid (Lot number: FX4465) for Covid-19 from 10May2022 to 14May2022. After finishing Paxlovid on 14May2022, patient had a rebound of Covid symptoms beginning 16May2022. Her nose began to run and then got severe head congestion. Patient had a low grade fever for 2 days as well and was very fatigued.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 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: "blood pressure" (unspecified if ongoing), notes: I have blood pressure meds, cholesterol and asthma; "Cholesterol" (unspecified if ongoing), notes: I have blood pressure meds, cholesterol and asthma; "Asthma" (unspecified if ongoing), notes: I have blood pressure meds, cholesterol and asthma. Concomitant medication(s) included: SINGULAIR; XOPENEX; CLARITINE; LINZESS and Steroid pills 20,20,20,10,10,10 mg within 2 weeks of vaccination. Past drug history included: Decongestants, reaction(s): "Known allergies: Decongestants". 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: (May2022) Positive. 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.
Age: 46.0
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) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Known allergy: Zpack" (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". 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
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) (Consumer or other non-HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 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. Concomitant medication(s) included: ZYRTEC R.  The following information was reported: COVID-19 (medically significant) with onset 16May2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant) with onset 16May2022 at 12:00, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Have rebound COVID since 16May2022. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient had other medication in 2 weeks.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
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.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 82 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Super ventricular tachycardia" (unspecified if ongoing); "arthritis" (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 "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. Other medication in 2weeks and known allergies were reported as 'No'. Paxlovid was taken by patient for COVID-19 treatment on 30Apr2022 and was stopped on 05May2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 78-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9264), in right arm, on 16Feb2021 as dose 2, single (Lot number: EL9266), in right arm and on 28Sep2021 as dose 3 (booster) single (Lot number: FF2389) at the age of 77 years, in right arm for Covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Known allergies; penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; ROSUVASTATIN; EZETIMIBE; TAMSULOSIN; ASPIRIN; VITAMIN D3; FISH OIL; GLUCOSAMINE. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "Indication Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) positive. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: From 05May2022 to 10May2022 the patient received Paxlovid for Covid-19 treatment. On 19May2022, 9 days after finishing the Paxlovid, patient had new Covid symptoms and tested positive again for Covid on a rapid at-home test. Patient was previously symptom-free for 11 days.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 63-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 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: "ADHD" (unspecified if ongoing), notes: ADHD; "Cantelope" (unspecified if ongoing), notes: known allergies: Cantelope; "Tremor" (unspecified if ongoing), notes: Tremor. Concomitant medication(s) included: RAPAMYCIN; VALACYCLOVIR [VALACICLOVIR]; INNOPRAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, 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: "Anxiety" (unspecified if ongoing); "Sulfa meds" (unspecified if ongoing). Concomitant medication(s) included: CELEXA [CITALOPRAM HYDROBROMIDE]. 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: Tested negative multiple days in a row; (12May2022) Negative, notes: negative for Covid on a rapid test; (21May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Started testing negative for Covid on a rapid test on 12May2022. Tested negative multiple days in a row. Tested positive on a rapid again today (21May).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
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 71-year-old male patient received BNT162b2 (BNT162B2), in Jan2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Additional information: Treatment drug included Paxlovid (Lot number: 00069-1085-30) from 20May2022. Vaccine administration time 10:00AM.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: indication=Treatment of COVID-19; indication=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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL9267), on 16Mar2021 as dose 2, single (Lot number: EN6206) and on 06Oct2021 as dose 3 (booster), single (Lot number: EW016) at the age of 44 years for covid-19 immunization. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: ASPRIN, start date: 03May2022; DOXYCYCLINE MONOHYDRATE, start date: 17May2022; DEXAMETHASONE, start date: 13May2022, stop date: 22May2022; SAXENDA, start date: Jul2020; IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION, start date: 13May2022; ALBUTEROL SULFATE, start date: 05May2022, stop date: 13May2022; BUDESONIDE, start date: 13May2022; BUDESONIDE, start date: Apr2020; ALPRAZOLAM, start date: May2018; MELOXICAM, start date: 09Mar2022, stop date: 03May2022; METRONIDAZOLE, start date: 22Feb2022; AZELASTINE, start date: 25Mar2022; EXHANCE, start date: 05Jan2022; TURMERIC +, start date: Mar2021; ELDERBERRY [SAMBUCUS NIGRA], start date: Mar2020; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE], start date: Mar2020; MONTELUKAST, start date: May2018; MULTIVITAMIN [VITAMINS NOS], start date: May2017; also reported as other medication in 2weeks. Past drug history included: Known allergies: sulphur drugs, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid (Lot number: FX4468) from 04May2022 to 09May2022. Clinical course was reported as, Several days completing the Paxlovid series, On 13May2022 at 05:00, covid symptoms shortness of breath, difficulty breathing, wheezing, congestion returned and were worse then before starting treatment. Treatment received for symptoms included breathing treatments and oral steroids. Patient was recovering from symptoms.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; manufacturer unknown), for covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "not recovered" and all described as "tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive. It was unknown if 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: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from contactable reporter(s) (Nurse and Consumer or other non HCP).  An 87-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Amloidosis" (unspecified if ongoing), notes: Past Medical History: Amloidosis; "asthma" (unspecified if ongoing); "atrial fibrillation" (unspecified if ongoing); "disorder of lipoid metabolism" (unspecified if ongoing), notes: disorder of lipoid metabolism; "hypertension" (unspecified if ongoing); "mixed hyperlipidemia" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing), notes: Allergies: Penicillin. Concomitant medication(s) included: FERROUS GLUCONATE; KLOR-CON; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN D3; FUROSEMIDE; ELIQUIS; SINVASTATINA; VALSARTAN. Past drug history included: Spironolactone, reaction(s): "Allergies: Spironolactone", notes: Allergies: Penicillin, Spironolactone. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset May2022, outcome "not recovered".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.