chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM2" (unspecified if ongoing), notes: DM2; "CKD3 (on lower dose of paxlovid)" (unspecified if ongoing), notes: CKD3 (on lower dose of Paxlovid); "arthritis" (unspecified if ongoing); "Known Allergies: Latex" (unspecified if ongoing), notes: Known Allergies: Latex. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid for treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Hepatic enzyme
Clinical narrative: After 4th dose - ALT 48/Elevated liver enzymes after each Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 as dose 4 (booster), single (Lot number: GH9703), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Exparel, reaction(s): "known_allergies: possibly Exparel", notes: known_allergies: possibly Exparel. Vaccination history included: Bnt162b2 (dose 1; lot EL9262, location : right arm), for COVID-19 immunization, reaction(s): "Elevated liver enzymes"; Bnt162b2 (dose 2; lot EL9269; location: right arm), for COVID-19 immunization, reaction(s): "ALT 1,010", "Bilirubin 5.1H", "Elevated liver enzymes"; Bnt162b2 (dose 2; lot EL9269; location right arm), for COVID-19 immunization, reaction(s): "AST 312"; Bnt162b2 (dose 3; lot FD7218; location: right arm), for COVID-19 immunization, reaction(s): "ALT 42", "Elevated liver enzymes". The following information was reported: ALANINE AMINOTRANSFERASE INCREASED (hospitalization) with onset 2023, outcome "recovered with sequelae", described as "After 4th dose - ALT 48/Elevated liver enzymes after each Covid Vaccine". The patient was hospitalized for alanine aminotransferase increased (hospitalization duration: 4 day(s)). The event "after 4th dose - alt 48/elevated liver enzymes after each covid vaccine" required emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: (2023) 48, notes: levels return to normal levels after 2-3 months; Hepatic enzyme: (2023) Elevated, notes: after each Covid Vaccine. Therapeutic measures were taken as a result of alanine aminotransferase increased.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300090561 same patient/event, different dose;US-PFIZER INC-2021196091 same patient, different dose, different event;US-PFIZER INC-2021154607 same patient, different dose, different event;
Age: 61.0
Sex: F
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 (consumer). The reporter is the patient. A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (lot number GJ6665) at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (lot number unknown), as dose 2, single (lot number unknown), as dose 3 (booster), single (lot number unknown) and as dose 4 (booster), single (lot number unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: PROGESTERONE, start date: 01Jan2022; ESTRADIOL, start date: 01Jan2022. Past drug history included: Clarythomicin, reaction: "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant) and COVID-19 (medically significant) both with onset Feb2023, outcome "unknown" and described as "treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective and covid-19 which included Paxlovid taken from 24Feb2023 to 28Feb2023.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID, start date: 01Apr2005. Past drug history included: Allergic to clindamycin, reaction(s): "Allergy"; Allergic to tetracycline, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid on 20Feb2023 to 24Feb2023. Clinical course: the patient was taking other medication within 2 weeks of starting COVID-19 treatment. After taking Paxlovid, she experienced symptoms of a sore throat and a runny nose, and subsequently tested positive again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Sleep disorder, Vaccination site pain
Clinical narrative: Can't sleep at night; pain from the shot/Pain in her left shoulder; Pain in her left shoulder. Had become very irritating and painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EP7534), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01, Lot number: unknown), for COVID-19 Immunization, reaction(s): "Had rotor cuff surgery...Mentioned that she had two shots prior to the surgery."; Bnt162b2 (Dose: 02, Lot number: unknown), for COVID-19 Immunization, reaction(s): "Had rotor cuff surgery...Mentioned that she had two shots prior to the surgery.". The following information was reported: SLEEP DISORDER (non-serious), outcome "not recovered", described as "Can't sleep at night"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain from the shot/Pain in her left shoulder"; IRRITABILITY (non-serious), outcome "not recovered", described as "Pain in her left shoulder...Had become very irritating and painful". Therapeutic measures were taken as a result of sleep disorder, vaccination site pain, irritability. Additional information: Reporter stated that she called about the Pfizer shot. Unable to clarify which type of Pfizer shot. Mentioned that she had took the Pfizer shot before she had the last booster a year ago. Is experiencing pain from the shot. Is in her left shoulder. Wanted to know if that is a side effect. Wanted to know what she can do about it. Just had the booster. Third shot: Pain in her left shoulder: Started 6 months after she got it. Had become very irritating and painful. Some people say it will go away and it has been a year and has not gone away. Was after the third shot. Treatment: Put on a pain patch and it goes away and when not use it gets worst. Can't sleep at night sometimes from the pain: About a month ago. Only hurts at night when she is laying on it the pain comes through then. Began after the third shot. Treatment: Doctor gave her some medicine to relax her. When she takes the pills for relaxing probably sleeps through the pain then. Had rotor cuff surgery (right side): Had rotor cuff surgery last year. Had it in 2022. Mentioned that she had two shots prior to the surgery. Clarified that these were all for the Pfizer shots. First Pfizer shot had no lot or expiry to provide. Second Pfizer shot had no lot or expiry to provide. Recovered completely in 2022. Treatment: Went to therapy. Sender's Comments: Linked Report(s): US-PFIZER INC-202300091711 same patient and product, different dose number and event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Granuloma annulare, Investigation, SARS-CoV-2 test
Clinical narrative: Nonstop diarrhea; Granuloma annulare generalized all over arms, hands, legs, and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 2, single (Lot number: EW0162) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Hay fever" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer Unknown), for COVID-19 immunization. There was no vaccine in 4 weeks. The patient had no COVID-19 prior to vaccination. According to the patient, within one week on receiving vaccine the patient had two major reactions. From 12Apr2022, the patient experienced granuloma had two major reactions: Granuloma annulare generalized all over arms, hands, legs, and feet which continues to this day 02Mar2023 despite using various treatments to get rid of it and nonstop diarrhea -8 times a day- which continued until Nov2022 making the patient homebound. The events "nonstop diarrhea" and "granuloma annulare generalized all over arms, hands, legs, and feet" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal swabs several times; tests for diarrhea: Unknown results. Therapeutic measures were taken as a result of diarrhoea, granuloma annulare which includes changes of diet. The outcome for Nonstop diarrhea was recovered in Nov2022; outcome for granuloma annulare generalized all over arms, hands, legs, and feet was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Rotator cuff repair
Clinical narrative: Had rotor cuff surgery...Mentioned that she had two shots prior to the surgery.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: ROTATOR CUFF REPAIR (medically significant) with onset 2022, outcome "recovered" (2022), described as "Had rotor cuff surgery...Mentioned that she had two shots prior to the surgery.". Therapeutic measures were taken as a result of rotator cuff repair. Clinical course: Patient had rotor cuff surgery (right side) last year, had it on unspecified date in 2022. Mentioned that she had two shots prior to the surgery. It was reported that these were all for the Pfizer shots. First Pfizer shot had no lot or expiry to provide. Second Pfizer shot had no lot or expiry to provide. Recovered completely in 2022. Treatment: Went to therapy.   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-202300091588 same patient and product, different dose number and event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Magnetic resonance imaging, SARS-CoV-2 test
Clinical narrative: covid after pfizer shot; covid after pfizer shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other Conditions: No. 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 "covid after pfizer shot". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: swelling of optic discs, notes: Did an MRI which confirmed swelling of optic discs; SARS-CoV-2 test: positive, notes: she had COVID. 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: 88.0
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.  An 88-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 88 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: "Tuberculosis" (unspecified if ongoing), notes: at age 19. No other significant history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Feb2023 to 21Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Allergy test, Arthritis, Condition aggravated, Erythema, Eyelids pruritus
Clinical narrative: wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; eyelids started flaking, itching, peeling; eyelids started flaking, itching, peeling; Made worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  An elderly patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, lot unknown), administration date: 23Sep2021, for COVID-19 immunization, reaction(s): "wrists red, inflamed, itching running rash", "eyelids started flaking, itching, peeling"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, lot unknown), administration date: 16May2022, for COVID-19 immunization, reaction(s): "wrists red, inflamed, itching running rash", "eyelids started flaking/peeling", "eyelids started itching", "Made worse"; Bnt162b2 (DOSE 1, SINGLE, lot unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, lot unknown), for COVID-19 immunization. The following information was reported: CONDITION AGGRAVATED (medically significant) with onset 2022, outcome "unknown", described as "Made worse"; SKIN EXFOLIATION (medically significant), EYELIDS PRURITUS (medically significant) all with onset 2022, outcome "unknown" and all described as "eyelids started flaking, itching, peeling"; RASH (medically significant), PRURITUS (medically significant), ERYTHEMA (medically significant), ARTHRITIS (medically significant) all with onset 2022, outcome "unknown" and all described as "wrists red, inflamed, itching running rash". The events "wrists red, inflamed, itching running rash" and "eyelids started flaking, itching, peeling" required physician office visit. The patient underwent the following laboratory tests and procedures: Allergy test: Unknown results. Therapeutic measures were taken as a result of rash, pruritus, erythema, arthritis, skin exfoliation, eyelids pruritus. Clinical courses: About 2 weeks after 3rd (23Sep2021), eyelids started flaking, itching, peeling. A few months later, wrists red, inflamed, itching running rash.16May2022, 4th. 14Nov2022, 5th. Over last 16 months, 3 dermatologists, allergy tests, multiple doctor visits. No help. 3 Steroid shot helped for about a week. Multiple cortisone topicals. Made worse. 24Feb2023 whole face, chest, wrists.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300037618 Same patient/ AE, different drug dose;US-PFIZER INC-202300092268 Same patient/ AE, different drug dose;
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; wrists red, inflamed, itching running rash; eyelids started flaking, itching, peeling; eyelids started flaking, itching, peeling; Made worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  An elderly patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, lot unknown), administration date: 23Sep2021, for COVID-19 immunization, reaction(s): "wrists red, inflamed, itching running rash", "eyelids started flaking, itching, peeling"; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, lot unknown), administration date: 16May2022, for COVID-19 immunization, reaction(s): "wrists red, inflamed, itching running rash", "eyelids started flaking/peeling", "eyelids started itching", "Made worse"; Bnt162b2 (DOSE 1, SINGLE, lot unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, lot unknown), for COVID-19 immunization. The following information was reported: CONDITION AGGRAVATED (medically significant) with onset 2022, outcome "unknown", described as "Made worse"; SKIN EXFOLIATION (medically significant), EYELIDS PRURITUS (medically significant) all with onset 2022, outcome "unknown" and all described as "eyelids started flaking, itching, peeling"; RASH (medically significant), PRURITUS (medically significant), ERYTHEMA (medically significant), ARTHRITIS (medically significant) all with onset 2022, outcome "unknown" and all described as "wrists red, inflamed, itching running rash". The events "wrists red, inflamed, itching running rash" and "eyelids started flaking, itching, peeling" required physician office visit. The patient underwent the following laboratory tests and procedures: Allergy test: Unknown results. Therapeutic measures were taken as a result of rash, pruritus, erythema, arthritis, skin exfoliation, eyelids pruritus. Clinical courses: About 2 weeks after 3rd (23Sep2021), eyelids started flaking, itching, peeling. A few months later, wrists red, inflamed, itching running rash.16May2022, 4th. 14Nov2022, 5th. Over last 16 months, 3 dermatologists, allergy tests, multiple doctor visits. No help. 3 Steroid shot helped for about a week. Multiple cortisone topicals. Made worse. 24Feb2023 whole face, chest, wrists.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300037618 Same patient/ AE, different drug dose;US-PFIZER INC-202300092268 Same patient/ AE, different drug dose;
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Heavy period happened post primary series. (I was Covid positive at that time); This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 46-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 2, single (Lot number: EJ1685) at the age of 44 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for hyperlipidaemia, start date: 2001 (ongoing); CETIRIZINE oral taken for hypersensitivity, start date: 2011 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Time:4:PM, Anatomical Site of injection: L Arm, Route of administration: Intramuscular, Batch / Lot Number: EJ1685), administration date: 31Dec2020, when the patient was 44-year-old, for COVID-19 Immunization, reaction(s): "covid positive and didn't know it. Only symptoms (Sx) were fatigue and back pain", "Heavy period happened post Primary series". The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Heavy period happened post primary series. (I was Covid positive at that time)".  Clinical course: Reporter consider Pfizer product had a causal effect to the adverse event. Dose 3, 30Dec2021, L Arm, Intramascular, Moderna 027H21B. Dose 4 15Nov2022 4 Pm, L Arm, Intramuscular, Pfizer GH9697. No Prior Vaccinations. Of note I am the Patient and I am the pharmacist and the vaccine coordinator of the hospital sights where I received the primary series and Moderna Booster. Heavy period happened post Primary series. (I was Covid Positive at that time). And After 2nd booster Nov2022. I did not have it after moderna booster.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201380361 Same patient, different dose/ AE;
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Chest X-ray, Electrocardiogram, SARS-CoV-2 test
Clinical narrative: tested positive for COVID after having the Pfizer COVID vaccine; tested positive for COVID after having the Pfizer COVID vaccine; 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 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN9581), on 03Mar2021 as dose 2, single (Lot number: EN6203), on 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA) and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: high blood pressure he is medicated for the high blood pressure; diagnosed 5 years ago; "prediabetic" (ongoing), notes: prediabetic diagnosed 5 years ago; "Fever" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation; TYLENOL taken for pyrexia. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "tested positive for COVID after having the Pfizer COVID vaccine". The patient underwent the following laboratory tests and procedures: Blood test: (15Feb2023) normal, notes: everything for the tests was normal and he had no specific results to provide; Chest X-ray: (15Feb2023) normal, notes: everything for the tests was normal and he had no specific results to provide; Electrocardiogram: (15Feb2023) normal, notes: everything for the tests was normal and he had no specific results to provide; SARS-CoV-2 test: (15Feb2023) Positive, notes: He is still testing positive and went to the hospital on 15Feb2023; (26Feb2023) Positive, notes: Result: positive; Unit: Not Provided; (02Mar2023) Positive, notes: Result: positive; Unit: Not Provided. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course details: The patient was still testing positive and went to the hospital on 15Feb2023 and started Paxlovid that day and stopped it on the 19th or 20th of February. At the hospital they did blood tests, an EKG, and took a chest X-ray on 15Feb2023 and those were the only other tests that were done; everything for the tests was normal and he had no specific results to provide. The patient probably got a flu shot around the same time but he was not sure and he might have gotten it at the same time as the COVID vaccine but he does not remember and got the flu shot this year but was unsure if it was at same time as the COVID vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: tested positive for COVID after having the Pfizer COVID vaccine; tested positive for COVID after having the Pfizer COVID vaccine; 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 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9693), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN9581), on 03Mar2021 as dose 2, single (Lot number: EN6203), on 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA) and on 10Apr2022 as dose 4 (booster), single (Lot number: FK9894) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (ongoing), notes: high blood pressure he is medicated for the high blood pressure; diagnosed 5 years ago; "prediabetic" (ongoing), notes: prediabetic diagnosed 5 years ago; "Fever" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA taken for immunisation; TYLENOL taken for pyrexia. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "tested positive for COVID after having the Pfizer COVID vaccine". The patient underwent the following laboratory tests and procedures: Blood test: (15Feb2023) normal, notes: everything for the tests was normal and he had no specific results to provide; Chest X-ray: (15Feb2023) normal, notes: everything for the tests was normal and he had no specific results to provide; Electrocardiogram: (15Feb2023) normal, notes: everything for the tests was normal and he had no specific results to provide; SARS-CoV-2 test: (15Feb2023) Positive, notes: He is still testing positive and went to the hospital on 15Feb2023; (26Feb2023) Positive, notes: Result: positive; Unit: Not Provided; (02Mar2023) Positive, notes: Result: positive; Unit: Not Provided. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course details: The patient was still testing positive and went to the hospital on 15Feb2023 and started Paxlovid that day and stopped it on the 19th or 20th of February. At the hospital they did blood tests, an EKG, and took a chest X-ray on 15Feb2023 and those were the only other tests that were done; everything for the tests was normal and he had no specific results to provide. The patient probably got a flu shot around the same time but he was not sure and he might have gotten it at the same time as the COVID vaccine but he does not remember and got the flu shot this year but was unsure if it was at same time as the COVID vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: we both tested positive for COVID; we both tested positive for COVID; 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 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0161, Expiration Date: 09Jul2021), on 31Jul2021 as dose 2, single (Lot number: EW0161) and on 04Feb2022 as dose 3 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient's relevant medical history included: "Dementia" (ongoing), notes: Dementia; "Hypertension" (ongoing), notes: hypertension at 93-94; "papillary cancer", start date: 1978 (unspecified if ongoing), notes: papillary cancer in 1978; "thyroid", start date: 1978 (unspecified if ongoing), notes: thyroid hit me 1978; "major back surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown", COVID-19 (medically significant) with onset 2023, outcome "not recovered" and all described as "we both tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: test for the COVID and fluid and the fluid was negative but the COVID came back positive; (unspecified date) Positive, notes: whole test making us positive; (01Mar2023) Positive, notes: we both tested positive for COVID last night. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course details: The patient never had COVID until this time, was diagnosed in Wednesday of this week, starting of the symptoms on Monday. The patient and his wife went to an emergency medical shop, there was a physician there and they gave a test for the COVID and fluid and the fluid was negative but the COVID came back positive. The patient still had symptoms of COVID; he has back pain, nasal.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report received from contactable consumer.   A 64-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GL0446) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0161), on 31Jul2021 as dose 2, single (Lot number: EW0161) and on 04Feb2022 as dose 3 (booster), single (Lot number: FJ5682) for covid-19 immunisation. The patient's relevant medical history included: "she got sick with Covid", start date: 2020, stop date: 2020. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "positive for COVID". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: test for the COVID and fluid and the fluid was negative; (unspecified date) positive, notes: the COVID came back positive; (01Mar2023) positive, notes: positive for COVID last night. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID (Lot number: GF7317 and expiration date: Apr2023). Clinical course: The reporter stated his wife (this patient) got all of the Pfizer vaccines primary and boosters (Pfizer COVID-19 Vaccine) and then since diagnosed with COVID; still got COVID. The patient has had COVID much before this was the second time for her. The patient went to an emergency medical shop, there was a physician there and they give a test for the COVID and fluid and the fluid was negative but the COVID came back positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300093945 Same reporter, product and events, different patient.;
Age: 44.0
Sex: M
Vaccine: 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 45-year-old male patient received BNT162b2 (BNT162B2), on 21Jun2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (ongoing). Concomitant medication(s) included: HUMIRA, start date: 08Dec2022, stop date: 09Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The COVID-19 was treated with Paxlovid. Treatment start date: 22Feb2023 and treatment stop date: 26Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300094071 same patient, different drug/different event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: States she took a covid test 2 weeks after had covid infection and it came back positive; States she took a covid test 2 weeks after had covid infection and it came back positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient stated she also had covid infection in January after an ER visit. The patient stated she took a covid test 2 weeks after had covid infection and it came back positive. Stated she was told by someone that it will always come back positive which is why they dont recommend testing. She was asking if this is true and stated someone else told her it wasn't.   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: Chills, Influenza like illness, Malaise, Pyrexia, Vomiting
Clinical narrative: Flu like symptoms; felt unwell; Chills; Fever; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US031704_NS (Novartis).  A 76-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; MALAISE (non-serious), outcome "unknown", described as "felt unwell"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; VOMITING (non-serious), outcome "unknown".  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: Limb discomfort
Clinical narrative: something wrong going on in his leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:   A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "something wrong going on in his leg".  Additional information : It was reported that, some random guy gave the vaccine and he had a doubt that it is not a Pfizer vaccine, though he is sure that it is a Pfizer Vaccine, ever since he received the vaccine there is something wrong going on in his leg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: DNA antibody, Haematology test, Scan, Thrombosis
Clinical narrative: Blood clot in right leg; pain in leg and was swollen; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A female patient (age reported as 48, unit unspecified) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot in right leg; pain in leg and was swollen". The patient had a pain in leg, it went away, then 2 days later in came back and was swollen. The patient had it scanned and there was a blood clot. She then had a hematology work up and a DNA test done that showed no genetic reasoning for the blood clot. It was determined by the hematologist that the cause was very likely the COVID-19 vaccine. The event took place after use of product. events "blood clot in right leg; pain in leg and was swollen" required physician office visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in jaw, Pyrexia
Clinical narrative: Fever of 104; Jaw pain; Chills; This is a spontaneous report received from non-contactable reporter(s) (Consumer) from a Pfizer sales representative.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Fever of 104"; PAIN IN JAW (non-serious), outcome "unknown", described as "Jaw pain"; CHILLS (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had fever of 104 within a week of her COVID vaccine. The high fever led to jaw pain from the chills that accompanied her fever. The fever lasted 2-3 days before resolving. The patient was afraid to receive the bivalent booster because of her previous experience.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FK9896) at the age of 67 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression", start date: 2010 (ongoing). Concomitant medication(s) included: VENLAFAXINE taken for depression, start date: 2010 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: Noon, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Lot no: EN6203), administration date: 10Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Time: Noon, Anatomical Site of injection: Left Arm, Route of administration: Intramuscular, Lot no: ER8730), administration date: 31Mar2021, for COVID-19 immunisation. The following information was reported: CARDIAC DISORDER (medically significant) with onset 23Dec2021, outcome "not recovered", described as "Heart issues". Therapeutic measures were taken as a result of cardiac disorder.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300066826 same patient/reporter, different drug/AE;US-PFIZER INC-202300066655 same patient/reporter, different drug/AE;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Very heavy/sustained menstruation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EL3247, Expiration Date: May2021) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Headaches/Cramps" (ongoing); "Headaches/Cramps" (ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] oral taken for muscle spasms, headache (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical location: Left arm, Batch/Lot number: EL3247, Expiry date: 00May2021), administration date: 12Apr2021, for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 2021, outcome "unknown", described as "Very heavy/sustained menstruation". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: The patient had very heavy/sustained menstruation for a period of approximate 2 months started in Jun-Jul2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201375441 same patient and product, different dose and event;
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: General physical health deterioration, Interchange of vaccine products
Clinical narrative: Had Moderna and Pfizer vaccines; jeopardize his and his wifes health; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-713239 (Moderna).  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Had Moderna and Pfizer vaccines"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "jeopardize his and his wifes health".  Additional information: The caller stated that he had Moderna and Comirnaty vaccines and has learned information since that could jeopardize his and his wife's health. The reaction did not lead to death/ Life threatening/ hospitalization/ Disability/ Congenital anomaly/ Other medically important condition.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary mass
Clinical narrative: Lung nodules; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: ER8729) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "Blood Pressure" (unspecified if ongoing); "neck Pain" (unspecified if ongoing); "Family history of stroke" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE HCL oral taken for anxiety (ongoing); HYDROCHLOROTHIAZIDE oral taken for blood pressure abnormal (ongoing); IBUPROFEN oral taken for neck pain (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] oral taken for cerebrovascular accident (ongoing). Vaccination history included: BNT162b2 (1st dose:, Anatomical site of injection: Left Arm, Batch/Lot number: EN6207), administration date: 18Mar2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Lung nodule". The following information was reported: PULMONARY MASS (medically significant) with onset 04May2021, outcome "unknown", described as "Lung nodules". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (11Mar2020) Lung cancer screen pulmonary nodules: None; (04May2021) Lung cancer screen pulmonary nodules: multiple; (16Sep2022) Lung cancer screen pulmonary multiple new nodules, notes: Lung cancer screen pulmonary multiple new nodules (5.8x3.2). Therapeutic measures were not taken as a result of pulmonary mass.  Clinical course: Test: CT Scan. Date: 17Mar2023 Next appointment. Dose 3, Date: 11Oct2021, Anatomical site of injection: Left Arm, Batch Lot number: 301558A. Dose 4, Date: 20Apr2022, Anatomical site of injection: Left Arm, Batch Lot number: FJ4991.