chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing). 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2023) Negative; (18Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Feb2023 to 07Feb2023. The patient had sore throat and positive rapid antigen test on 18Feb2023, after testing negative after COVID infection that ended on 03Feb2023 (tested negative that date, and was then symptom-free).  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.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient. A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Dec2020 at 12:00 as dose 1, single (Lot number: EK5739), in left arm, on 07Jan2021 at 12:00 as dose 2, single (Lot number: EL3249), in left arm, on 05Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 29Apr2022 at 00:45 as dose 4 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication included: LISINOPRIL. Past drug history included: Dilantin, reaction: "known allergies Dilantin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (07Feb2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 02Feb2023 to 03Feb2023.
Age: 43.0
Sex: M
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 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 19:00 as dose 5 (booster), single at the age of 43 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 at 09:45 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17Apr2021 at 09:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 03Mar2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Known allergies: Blueberries" (unspecified if ongoing); "Known allergies: Eggs" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Tetracycline, reaction(s): "Known allergies: Tetracycline"; Lisinopril, reaction(s): "Known allergies: Lisinopril"; Dicyclomine, reaction(s): "Known allergies: Dicyclomine". 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 12:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2022 at 14:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Aug2005. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective; patient was treated with PAXLOVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer Dose 3 30Nov2021, Moderna Dose 4 21Jul2022; 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 male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 19Apr2021 as dose 2, single (Lot number: FL3302), in left arm and on 30Nov2021 as dose 3 (booster), single (Lot number: 33026BD) at the age of 56 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jul2022 as dose 4 (booster), single (Lot number: 060A22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jul2022, outcome "unknown", described as "Pfizer Dose 3 30Nov2021, Moderna Dose 4 21Jul2022"; DRUG INEFFECTIVE (medically significant), outcome "unknown", 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart attack in 2017", start date: 2017 (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Home antigen test is positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6202), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8735), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Environmental" (unspecified if ongoing), notes: Known allergies: Environmental; "Known allergies: dust" (unspecified if ongoing), notes: Known allergies: dust; "Known allergies: pollen" (unspecified if ongoing), notes: Known allergies: pollen. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Feb2023, outcome "unknown" and all described as "COVID 19 ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Positive; (17Feb2023) Negative; (18Feb2023) Negative; (19Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; patient took Paxlovid (09Feb2023 to 14Feb2023)  Clinical course: Tested positive for COVID 19 08Feb2023. Started Paxlovid course 09Feb2023 evening, finished 14Feb2023. Tested negative with home test 17Feb2023 and 18Feb2023, only slight congestion remained. On 19Feb2023 woke up with sore throat and worse nasal congestion, tested positive with home test.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Moderna dose number: 1, Date: 16Apr2021; Pfizer-Biontech dose number: 2, Date: 08Oct2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Oct2021 at 17:00 as dose 2, single (Batch/Lot number: unknown) and on 15Apr2022 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Apr2021 at 17:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type II" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Drug allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Oct2021 at 17:00, outcome "unknown", described as "Moderna dose number: 1, Date: 16Apr2021; Pfizer-Biontech dose number: 2, Date: 08Oct2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID (Covid-19 treatment) from 09Feb2023 to 14Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
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 69-year-old male patient received BNT162b2 (BNT162B2 NOS), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Negative, notes: Tested negative for 2 days before the rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna, vaccine dose number=3; vaccine brand=Pfizer / BioNTech, vaccine dose number=2; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9264), in left arm and on 25Feb2021 as dose 2, single (Lot number: EM9809), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2022 as dose 3 (booster), single (Lot number: 054A22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The patient was taking various vitamins until 11Feb2023. The patient has no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2022, outcome "unknown", described as "vaccine brand other=Moderna, vaccine dose number=3; vaccine brand=Pfizer / BioNTech, vaccine dose number=2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Negative, notes: positive test after two negatives 48 hours apart; (Feb2023) Negative, notes: positive test after two negatives 48 hours apart; (Feb2023) Positive, notes: positive test after two negatives 48 hours apart. Therapeutic measures, Paxlovid from 11Feb2023 to 15Feb2023, were taken as a result of drug ineffective, covid-19.
Age: 71.0
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 (Physician).  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 71 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: "Hypertension" (unspecified if ongoing); "Stage 1 breast cancer" (unspecified if ongoing). Concomitant medications included: CELEBREX oral, start date: Jan2020; CRESTOR oral, start date: Jan2020, stop date: 03Feb2023; DIOVAN oral, start date: Jan2020. Past drug history included: Clindamycin, reaction: "Drug allergy". 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: (07Feb2023) Negative, notes: tested negative after day 5 Paxlovid; (10Feb2023) Positive, notes: symptoms began 3 days after last Paxlovid. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included Paxlovid from 03Feb2023 to 07Feb2023. Clinical course: The patient experienced rebound COVID with symptoms worse than the initial episode. Loss of taste was with rebound only. Low grade fever with no breathing issues but significant URI symptoms. Symptoms began 3 days after the last Paxlovid with positive home test. Had tested negative after day 5 of Paxlovid. Symptoms were persisting at the time of day 8.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) to the drug ineffective (LOE) and COVID-19 cannot be ruled out.
Sex: F
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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Lymphocytic colitis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Demerol, reaction(s): "Known allergies: demerol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from17Feb2023 to19Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Somnolence
Clinical narrative: body ache; chills; milder headache; fell asleep; This is a spontaneous report received from contactable reporter (Consumer). Other Case identifier: 2023NVX-US-000000150. A 63-year-old female patient received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1; lot number: unknown), administration date: 19Mar2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "did not eat for 2 days", "she had a severe headache", "chills", "body aches", "nausea", "feverish"; BNT162b2 (Dose 2; lot number: unknown), administration date: 08Apr2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "a low grade fever", "fatigue", "chills", "body aches", "was falling asleep". The following information was reported: PAIN (non-serious), outcome "unknown", described as "body ache"; CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown", described as "milder headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "fell asleep".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 31.0
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 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 6 (booster), single (Lot number: GJ2524) at the age of 31 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27May2022 as dose 5 (booster), single (Lot number: FM9992), 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: "Asthma" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Sciatica" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Chronic Sinusitis" (unspecified if ongoing); "Hidradenitis suppurativa" (unspecified if ongoing); "known allergies: Nickel" (unspecified if ongoing); "known allergies: Cobalt" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: KYLEENA; TRIAMCINOLONE; XYZAL. 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test; positive COVID-19 test; administered with Moderna vaccine as booster dose; 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 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 39 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 03Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 08Nov2021 as dose 3 (booster), single (Lot number: FG3521), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Jun2022 as dose 4 (booster), single (Lot number: 058A22-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative Colitis" (unspecified if ongoing). Concomitant medication(s) included: REMICADE, start date: 24Jan2022. Past drug history included: Minocycline, reaction(s): "Known allergies: Minocycline". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 08Jun2022, outcome "unknown", described as "administered with Moderna vaccine as booster dose"; VACCINATION FAILURE (medically significant) with onset 05Feb2023, outcome "unknown", COVID-19 (medically significant) with onset 05Feb2023, outcome "unknown" and all described as "positive COVID-19 test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19; patient was treated with PAXLOVID.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 06Oct2022 as dose number unknown, single (Lot number: FPH35), in left arm for covid-19 immunisation. The patient's relevant medical history included: "cancer survivor" (unspecified if ongoing), notes: cancer survivor. 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; Dose 1: Moderna/Dose: 2: Moderna/Dose 3: Pfizer/Dose 4: Pfizer; This is a spontaneous report received from contactable reporter(s) (Other HCP). 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 13Jan2023 as dose 4 (booster), single (Lot number: GJ3276) at the age of 61 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Aug2022 as dose 3 (booster), single (Lot number: FP7139) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Dec2020 as dose 1, single (Lot number: o39K20A) and on 22Jan2021 as dose 2, single (Lot number: o28L20A) for covid-19 immunisation. The patient's relevant medical history included: "obesity (BMI 32)" (unspecified if ongoing); "obesity (BMI 32)" (unspecified if ongoing); "A1C 5.8" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; MONTELUKAST. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Aug2022, outcome "unknown", described as "Dose 1: Moderna/Dose: 2: Moderna/Dose 3: Pfizer/Dose 4: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Feb2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2023) Positive, notes: confirmed by PCR next day. Therapeutic measures were taken as a result of drug ineffective, covid-19 included PAXLOVID (COVID 19 Treatment) from 09Feb2023 to 13Feb2023.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: vaccine brand other=Moderna as dose 3; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). The patient has no known allergies. 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 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna as dose 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: day 6; Negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 10Feb2023 to 14Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event CIVID-19 treatment cannot be excluded based on temporal association and available information.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer-Dose Number: 3; Moderna- Dose Number: 4; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: 301553A) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13May2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing); "Known allergies: raw almonds" (unspecified if ongoing); "Known allergies: avocados" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12May2022, outcome "unknown", described as "Pfizer-Dose Number: 3; Moderna- Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment start date: 10Feb2023, treatment stop date: 15Feb2023.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Culture, Gene sequencing, Interchange of vaccine products, Investigation
Clinical narrative: boosted adult traveler acquired COVID-19 after returning home from traveling; boosted adult traveler acquired COVID-19 after returning home from traveling; Dose 1/Dose 2 bnt162b2, Dose 3 mRNA-1273; This is a literature report for the following literature source(s):  An adult patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; mrna 1273 (MRNA 1273), on 20Dec2021 as dose 3, 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 (medically significant) with onset 20Dec2021, outcome "unknown", described as "Dose 1/Dose 2 bnt162b2, Dose 3 mRNA-1273"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as " boosted adult traveler acquired COVID-19 after  returning home from traveling". Clinical courses: Boosted adult traveler acquired COVID-19 after returning home from traveling and were treated with NM/r 300/100 mg taken orally twice daily for 5 days. The patient experienced initial improvement with NM/r followed by rebounding symptoms.  Progressively worsening fatigue, sore throat, nasal congestion, and diarrhea were associated with high viral shedding (cycle threshold = 21.7) and culturable virus 5 days after the NM/r course. The patient underwent the following laboratory tests and procedures: viral shedding: high, notes: cycle threshold = 21.7; Gene sequencing: SARS-CoV2 BA.2 lineage strain PRSD01, notes: Sequence comparison to the BA.2 reference showed no amino acid differences in any coding region, including ORF1a and spike protein; Nasopharyngeal swab: isolated SARS-CoV-2; SARS-CoV-2 antibody test: evaluated the susceptibility of the viral panel to, notes: to the neutralizing antibody response in the plasma from the patient. The average half-maximal authentic virus-neutralizing antibody concentrations against BA.2 PRSD01, BA.1, and parental were 1668, 1170, and 5239, respectively; The half-maximal inhibitory concentrations (IC50), notes: of NM against BA.2 PRSD01 were 2.0-, 1.8-, 1.7-, and 2.0-fold lower than the parental, Delta, BA.1, and BA.2.3 strains, respectively. The remdesivir IC50 for BA.2 PRSD01 was 2.0, 1.8, 1.1, and 1.3 times higher than the parental, Delta, BA.1, and BA.2.3 strains, respectively; Culture: culturable virus 5 days after the NM/r course. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngeal swab, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: boosted adult traveler acquired COVID-19 after returning home from traveling; boosted adult traveler acquired COVID-19 after returning home from traveling; Dose 1/Dose 2 bnt162b2, Dose 3 mRNA-1273; This is a literature report for the following literature source(s):  An adult patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; mrna 1273 (MRNA 1273), on 20Dec2021 as dose 3, 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 (medically significant) with onset 20Dec2021, outcome "unknown", described as "Dose 1/Dose 2 bnt162b2, Dose 3 mRNA-1273"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as " boosted adult traveler acquired COVID-19 after  returning home from traveling". Clinical courses: Boosted adult traveler acquired COVID-19 after returning home from traveling and were treated with NM/r 300/100 mg taken orally twice daily for 5 days. The patient experienced initial improvement with NM/r followed by rebounding symptoms.  Progressively worsening fatigue, sore throat, nasal congestion, and diarrhea were associated with high viral shedding (cycle threshold = 21.7) and culturable virus 5 days after the NM/r course. The patient underwent the following laboratory tests and procedures: viral shedding: high, notes: cycle threshold = 21.7; Gene sequencing: SARS-CoV2 BA.2 lineage strain PRSD01, notes: Sequence comparison to the BA.2 reference showed no amino acid differences in any coding region, including ORF1a and spike protein; Nasopharyngeal swab: isolated SARS-CoV-2; SARS-CoV-2 antibody test: evaluated the susceptibility of the viral panel to, notes: to the neutralizing antibody response in the plasma from the patient. The average half-maximal authentic virus-neutralizing antibody concentrations against BA.2 PRSD01, BA.1, and parental were 1668, 1170, and 5239, respectively; The half-maximal inhibitory concentrations (IC50), notes: of NM against BA.2 PRSD01 were 2.0-, 1.8-, 1.7-, and 2.0-fold lower than the parental, Delta, BA.1, and BA.2.3 strains, respectively. The remdesivir IC50 for BA.2 PRSD01 was 2.0, 1.8, 1.1, and 1.3 times higher than the parental, Delta, BA.1, and BA.2.3 strains, respectively; Culture: culturable virus 5 days after the NM/r course. Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: having headaches every day for the past 10 months; 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 male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 2022, outcome "unknown", described as "having headaches every day for the past 10 months".  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-202300076188 same reporter, product and event; different patients;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: boosted adult traveler acquired COVID-19 after returning to the; boosted adult traveler acquired COVID-19 after returning to the; This is a literature report for the following literature source(s):  An adult patient received BNT162b2 (BNT162B2), on 10May2021 as dose 2, single (Batch/Lot number: unknown), on 02Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 09Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "boosted adult traveler acquired COVID-19 after returning". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courses: Boosted adult traveler acquired COVID-19 after returning and was treated with NM/r 300/100 mg taken orally twice daily for 5 days. Case resolved quickly.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: boosted adult traveler acquired COVID-19 after returning; boosted adult traveler acquired COVID-19 after returning; This is a literature report.  An adult patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown), on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "boosted adult traveler acquired COVID-19 after returning". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical courses: Boosted adult traveler acquired COVID-19 after returning and was treated with NM/r 300/100 mg taken orally twice daily for 5 days. Casee resolved quickly.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: one had been infected with and recovered from a SARS-CoV-2 infection with symptom; one had been infected with and recovered from a SARS-CoV-2 infection with symptom; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), on 14Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "one had been infected with and recovered from a SARS-CoV-2 infection with symptom". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: The average half-maximal authentic, notes: virus-neutralizing antibody concentrations against BA.2 PRSD01, BA.1, and parental of the in the NM/r-treated patient (1668, 1170, and 5239, respectively) is 2.0, 1.7, and 2.6 times lower than the boosted and infected control. No treatment with NM/r (oral protease inhibitor nirmatrelvir combined with ritonavir (Paxlovid)). Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she had headaches for 6 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "she had headaches for 6 months".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021; his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 2, single (Lot number: EK9231) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose Pfizer Covid vaccine was, administered on 28Dec2020 with lot if he can read it and the lot is EH9Y99 and is handwritten on the card), administration date: 28Dec2020, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "unknown", described as "his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021"; ARTHRALGIA (non-serious) with onset Jan2021, outcome "unknown", described as "his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021.". Additional information: A medical doctor on the line calling and stated his wife called yesterday several times and she filed an adverse event on his behalf that soon after his 2nd Pfizer booster dose (as reported), he experienced pain in his fingers and finger joints of both hands. He was calling to provide the lot number from the vaccine he had. He was a 74 year old male. His 1st dose Pfizer Covid vaccine was administered on 28Dec2020 with lot if he can read it and the lot was EH9Y99 and was handwritten on the card; 2nd dose was on 19Jan2021 for the Pfizer Covid vaccine with lot EK9231; 3rd dose Pfizer Covid vaccine on 16Sept2021 with lot FC3183; 4th dose is Moderna vaccine administered on 14May2022 with the lot 048L21A but can't tell due to handwriting and the first digit may be the letter O; 5th dose Moderna on 12Sep2022 with lot AS7144B. It was clarified that his finger pain and finger joint pain started off the 2nd dose of his Pfizer covid vaccine that was administered on 19Jan2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200475581 Same reporter and patient, different dose/events;
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 42-year-old male patient received BNT162b2 (Purple cap), on 13Jan2022 at 18:15 as dose 3 (booster), single (Lot number: FL3197) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Kidney stone" (unspecified if ongoing); "Surgery on left knee (ACL reconstruction)" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, the patient was diagnosed with COVID-19; "meniscus repair" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19".
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: his brother died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  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: DEATH (death), outcome "fatal", described as "his brother died". The date and cause of death for the patient were unknown. Reporter was a medical assistant calling regarding the Pfizer Covid-19 Vaccine that has been administered to his family and now his brother died and he also mentioned (Name withheld) died as well after the vaccination; Also his Uncle and other family members are sick as well. Reporter was the only one who didn't receive the vaccination.  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-PV202300031636 same reporter/drug, different patient/AE;; Reported Cause(s) of Death: his brother died
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: Reporter mentioned (name withheld) died as well after the vaccination.   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-PV202300031962 same reporter/drug, different patient/event.;; Reported Cause(s) of Death: died