chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1&2: COVID-19 vaccine; Dose 3: Moderna COVID-19 vaccine; Dose 4&5: BNT162b2; This is a spontaneous report received from a contactable reporter (Nurse) from. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: ER8735) at the age of 62 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 26Jul2022 as dose 4 (booster), single (Lot number: 058A22-2A) and on 25Oct2022 as dose 5 (booster), single (Lot number: 053D22A) 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: "colon cancer" (unspecified if ongoing), notes: History of colon cancer, chemo done Apr2018.; "chemo", start date: Apr2018 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Jul2022, outcome "unknown", described as "Dose 1&2: COVID-19 vaccine; Dose 3: Moderna COVID-19 vaccine; Dose 4&5: BNT162b2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". 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. Additional information: COVID 19 treatment included Paxlovid from 30Mar2023 to 04Apr2023. The patient has no known allergies.; 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: 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 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Sep2022 as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2023) Negative; (10Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid from 04Apr2023 to 09Apr2023 for COVID-19 treatment. The patient had no known allergies.  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: Gait inability, Laboratory test, Muscular weakness, Pain in extremity
Clinical narrative: Weakness and pain in legs/legs would give out at any time; Weakness and pain in legs; can't walk now without a walker or assistance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), 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. Vaccination history included: Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: MUSCULAR WEAKNESS (medically significant), outcome "not recovered", described as "Weakness and pain in legs/legs would give out at any time"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Weakness and pain in legs"; GAIT INABILITY (medically significant), outcome "not recovered", described as "can't walk now without a walker or assistance". The events "weakness and pain in legs/legs would give out at any time", "weakness and pain in legs" and "can't walk now without a walker or assistance" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: tests: can't find anything wrong. Therapeutic measures were taken as a result of muscular weakness, pain in extremity, gait inability. Clinical course: The patient experienced weakness and pain in legs, can't walk now without a walker or assistance. Her legs would give out at any time, so she has undergone many tests and can't find anything wrong, so they were wondering if it's from the vaccine. Treatment of events included physical therapy, many tests, and walker. It was unknown if patient had Covid prior vaccination or if patient was Covid tested post vaccination. The 3rd dose received was reported as not bivalent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Irregular breathing, Palpitations
Clinical narrative: Heart palpitations; irregular breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 36-year-old female patient (not pregnant) 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: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PALPITATIONS (non-serious), outcome "not recovered", described as "Heart palpitations"; IRREGULAR BREATHING (non-serious), outcome "not recovered". The events "heart palpitations" and "irregular breathing" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of palpitations, irregular breathing.  Additional information: Reportedly, the patient had many tests and wore a monitor for a week. It was unknown if patient had other vaccine in four weeks. It was also unknown if patient had covid prior to vaccination or covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: Unable to walk; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 11Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious) with onset 13Jun2022, outcome "not recovered", described as "Unable to walk". The event "unable to walk" required emergency room visit. It was unknown if therapeutic measures were taken as a result of gait inability. Additional information: It was unknown if the patient had COVID prior to vaccination and if the patient was tested for COVID post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Inflammation, Pain, Wrong product administered
Clinical narrative: Left knee inflamed and swollen; Entire left side of body, to bottom of foot arch, was achy and inflamed; Entire left side of body, to bottom of foot arch, was achy and inflamed; Wrong vaccine administered; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Mar2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 28Mar2023 at 12:00, outcome "unknown", described as "Wrong vaccine administered"; PAIN (medically significant), INFLAMMATION (medically significant) all with onset 29Mar2023, outcome "recovered" (2023) and all described as "Entire left side of body, to bottom of foot arch, was achy and inflamed"; ARTHRITIS (medically significant) with onset 29Mar2023, outcome "recovering", described as "Left knee inflamed and swollen". The events "left knee inflamed and swollen" and "entire left side of body, to bottom of foot arch, was achy and inflamed" required physician office visit. Therapeutic measures were taken as a result of arthritis, pain, inflammation. Clinical course: Entire left side of body, to bottom of foot arch, was achy and inflamed. After a few days it dissipated but left knee continued to be inflamed and swollen. Had to go to orthopedist to get cortisone shot. Patient had no other vaccine in four weeks. Vaccine was obtained at Pharmacy or Drug Store. Event resulted in Doctor or other healthcare professional office/clinic visit.  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.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Indication: Treatment of COVID-19; Indication: Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FF2293), in left arm and on 26Feb2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 56 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Nov2022 at 18:30 as dose 5 (booster), single (Lot number: 05D22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "ckd stage 2B" (unspecified if ongoing), notes: ckd stage 2B; "obesity" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing). Concomitant medication(s) included: PROGESTERONE, start date: Mar2021; VITAMIN B12 [CYANOCOBALAMIN], start date: Sep2021; SPIRONOLACTONE, start date: Sep2021; EVENING PRIMROSE, start date: Feb2022; HYDROXYCHLOROQUINE, start date: Nov1998; GABAPENTIN, start date: Nov1998; DULOXETINE, start date: Mar2014; ZOLPIDEM, start date: Nov1998; VITAMIN D3, start date: Jan2020. Past drug history included: Keflex [cefalexin], reaction(s): "Allergy"; Tetracycline, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Nov2022 at 18:30, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 29Mar2023 to 03Apr2023 for COVID-19 treatment.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: EP7534), on 13Apr2021 as dose 2, single (Lot number: EW0162) and on 12Jan2022 as dose 3 (booster), single (Lot number: 33030BD) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Clozapine, reaction(s): "Known allergies: clozapine"; Ibuprofen, reaction(s): "Known allergies: ibuprofen"; Cipro, reaction(s): "Known allergies: cipro"; Loxapine, reaction(s): "Known allergies: loxapine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Oral Paxlovid from 05Apr2023 to 08Apr2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, there is a reasonable possibility of a causal  association between the reported adverse events vaccination failure, Covid-19 and the suspect  product BNT162b2.
Age: 75.0
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 contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 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 was not reported. The patient took 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: (09Apr2023) very faint T line; (10Apr2023) very faint T line. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Additional information: The patient was treated with Paxlovid from 24Mar2023 to 29Mar2023. Positive rapid test 11 days after finishing Paxlovid. The patient has no known allergies.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 1, single (Lot number: FW0172), in left arm and on 15Nov2021 as dose 2, single (Lot number: 320308D) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Multiple Sclerosis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "pre-diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ceftriaxone, reaction(s): "Known allergies: Ceftriaxone". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 38 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2021 at 13:30 as dose 1, single (Lot number: ER8737), on 22Apr2021 at 10:15 as dose 2, single (Lot number: ER8736) and on 03Dec2021 as dose 3 (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: OMEPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 1, 2, 4: Pfizer/BioNTech; Dose 3, 5: Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, single (Lot number: EW0150), in left arm, on 25Apr2021 as dose 2, single (Lot number: EW0165), in left arm and on 10May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in right arm and on 26Sep2022 at 19:00 as dose 5 (booster), single (Lot number: ASH63B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: ALENDRONATE, start date: 01Jul2021, stop date: 21Mar2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Dose 1, 2, 4: Pfizer/BioNTech; Dose 3, 5: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: Tested negative; (unspecified date) positive, notes: tested positive; (05Apr2023) positive, notes: Tested positive for 2 more days; (unspecified date) positive, notes: Tested positive for 2 more days. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 72 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: "radiation", stop date: 10Mar2023, notes: 6 weeks of radiation ended 10Mar2023; "Known allergies: milk" (unspecified if ongoing); "Known allergies: banana" (unspecified if ongoing); "Known allergies: adhesive tape" (unspecified if ongoing); "Known allergies: trout fish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: dose 1 and 2: Moderna, Dose 3 and 4: Pfizer; COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and on 11May2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation; elasomeran (MODERNA 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Feb2023, outcome "recovered" (2023) and all described as "COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "dose 1 and 2: Moderna, Dose 3 and 4: Pfizer". Clinical course: COVID on 06Feb2023 and quarantined for 5 days. No further medical issues.  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-202200922255 same patient/drug; different dose/events;
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was vaccinated and got COVID for the 2nd time in two years. Patient also prescribed Paxlovid.  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-202300150494 same reporter/patient, different drug and event;
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: TENIVAC had an excursion at temperature -1.07C for 2 days and 13 hours with no adverse event; TENIVAC administered after an excursion with no adverse event.; Initial information received on 07-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA111249.  This case involves a 40 years old male patient to whom diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered after an excursion at temperature -1.07c for 2 days and 13 hours with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that on an unknown date the tenivac had an excursion at temperature -1.07c for 2 days and 13 hours with no adverse event (product storage error) (unknown latency). The refrigerator door was left open and excursion occurred due to a human error.  On 09-Feb-2023, the patient was administered unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection, (lot LU7189AA; strength and expiry date not reported) via unknown route in unknown administration site for Immunization after an excursion with no adverse event (poor quality product administered) (latency; on same day).  Action taken: not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: TENIVAC had an excursion at temperature -1.07C for 2 days and 13 hours with no adverse event; TENIVAC administered after an excursion with no adverse event; Initial information received on 07-Apr-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA111504.  This case involves a 23 years old female patient to whom diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] was administered after an excursion at temperature -1.07c for 2 days and 13 hours with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was reported that on an unknown date the tenivac had an excursion at temperature -1.07c for 2 days and 13 hours with no adverse event (product storage error) (unknown latency). The refrigerator door was left open and excursion occurred due to a human error.  On 22-Feb-2023, the patient was administered unknown dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, suspension for injection, (lot LU7189AA; strength and expiry date not reported) via unknown route in unknown administration site for Immunization after an excursion with no adverse event (poor quality product administered) (latency; on same day).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Extra dose administered, Medication error, Syncope
Clinical narrative: syncope; extra dose of MENQUADFI was administered to a patient; Initial information received on 07-Apr-2023 regarding an unsolicited valid  serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 17 years old female patient who was administered an extra dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] and experienced syncope.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Mar-2023, the patient received 0.5 ml (Dose 3) of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot number: U7449AA, Expiry date: 23-SEP-2024) (Frequency-once; Strength- standard)  via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation).  On 20-Mar-2023, the patient was administered an extra dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine (extra dose administered) (Latency: same day) and experienced syncope (syncope) (Latency: same day).  Supervisor reported an extra dose of MENQUADFI was administered to a patient who had a syncope episode after the administration. Caller is inquiring about safety information. This situation is reported as a medication error due to an extra dose of MENQUADFI being administered.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (syncope)  Outcome: Unknown for the reported event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Seriousness Criteria: Medically significant for syncope.; Sender's Comments: Sanofi company comment dated 11-Apr-2023: This case involves a 17 years old female patient who was administered an extra dose of Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] and experienced syncope. Furthermore, information regarding condition at the time of vaccination excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: patient was administered pentacel, but it was not reconstituted with the HIB component with no adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis /IPV(VERO)/HIB(PRP/T) vaccine [Pentacel], but it was not reconstituted with the hib component with no adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis /IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ788AAA, strength - standard, frequency - once, expiry dat - 18-Sep2023) via unknown route in unknown administration site for immunization but it was not reconstituted with the hib component with no adverse event (single component of a two-component product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired DAPTACEL with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old male patient who was administered with expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (Mmr) and Varicella Zoster Vaccine (VARICELLA VACC.) for Prophylactic Vaccination (Immunisation).  On 06-Apr-2023, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5828AA, Expiry date: 30-MAR-2023) (Strength: Standard, Frequency: once) via intramuscular route in the right thigh for Prophylactic Vaccination (Immunisation).  On 06-Apr-2023, the patient was administered with expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event (expired product administered) (latency: same day).  It was reported, This is reported as a medication error due to the inappropriate administration of an expired product to a patient.   Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event, Poor quality product administered
Clinical narrative: caller confirmed that a dose of act-hib was administered in which the diluent has expired with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves 1 years old male patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] in which the diluent has expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) for Prophylactic vaccination; and Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 10-Apr-2023, the patient received 0.5 ml of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (DILUENT-Lot Number:U7261AA, Expiration Date :2023-04-07) (ACT-HIB-Lot Number:UJ679AA, Expiration Date :2023-05-28) (Frequency-ONCE) (Strength- Standard) via intramuscular route in the right thigh for prophylactic vaccination (Immunisation).  On 10-Apr-2023, the patient was administered HIB (PRP/T) Vaccine in which the diluent has expired with no reported adverse event (poor quality product administered) (Latency: same day).  Action taken: not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Hypoxia, Metastases to abdominal cavity, Metastases to lymph nodes, Neoplasm malignant
Clinical narrative: Pfizer vaccine was administered outside of Facility- reported by patient  R09.02 HYPOXEMIA 12/14/2021 CANCER METASTATIC TO INTRAABDOMINAL LN R09.02 HYPOXEMIA 12/14/2021 ASTHMA, UNSPECIFIED
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aphasia, Cough, SARS-CoV-2 test negative, Throat irritation
Clinical narrative: I was having a tickling cough on the 4th by the 8th I could not even talk. I had no voice and the cough has not stopped. I had a fever from the 7th to the 8th. I have taken COVID-19 home tests and went in for a PCR test and that was negative. My healthcare provider gave me a cough medicine and an inhaler and have me doing a gargle. At this point I still have the cough but I am not fully recovered at this point.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Four months after 4th Pfizer dose, broke out in a rash on my arms and legs in a rash of red dots. There were no physical bumps and it wasn't itchy. Lasted for 1 day then it was gone.
Age: 1.33
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Irritability, Pyrexia, Rash
Clinical narrative: High fever, rash all over, no appetite, irritable
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arterial occlusive disease, Arteriogram coronary abnormal, Asthenia, Chest X-ray abnormal, Chest pain
Clinical narrative: I woke up with a fever, a bad cough, and chest pain. I thought I was just sick. I kind of hoped it would just get better. The symptoms continued; the chest pain diminished, but the coughing and fever continued for the next three days. I went to urgent care on 3/11/2023. I underwent tests for COVID-19, streptococcus, pneumonia, and the flu. I underwent a chest X-ray. I was diagnosed with an upper respiratory infection after I tested negative on all of those. I was prescribed an antibiotic whose name I don't remember. The symptoms did not improve. On 3/15/2023, I called the nurse line and told them that my symptoms hadn't improved, and I was instructed to go to the ER. At the ER, I was tested for COVID-19 and various other illnesses, and the results were all negative. I underwent a chest CT scan, which showed fluid around my heart and lungs. The ER doctor told me that this was concerning and that I should see with my PCP soon. On 3/17/2023, I saw my PCP, who did an EKG that showed I was having a heart attack. She called an ambulance, and I was sent to the ER. At the ER, an angiogram was done, which showed that I had a main artery that was 100% blocked. Two stents were put into the artery, and a balloon was also placed somewhere. I was admitted to the hospital and stayed two days. On 4/3/2023 and 4/4/2023, I was in the hospital again, this time for diabetic ketoacidosis. I am currently on insulin, and I was given IV fluids to treat the ketoacidosis. At the time of this writing, I am still weak and tired. I am now going cardiac rehab twice a week; I will be doing this for 18 weeks.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram thorax abnormal, Condition aggravated, Coronary angioplasty, Coronary arterial stent insertion, Cough
Clinical narrative: I woke up with a fever, a bad cough, and chest pain. I thought I was just sick. I kind of hoped it would just get better. The symptoms continued; the chest pain diminished, but the coughing and fever continued for the next three days. I went to urgent care on 3/11/2023. I underwent tests for COVID-19, streptococcus, pneumonia, and the flu. I underwent a chest X-ray. I was diagnosed with an upper respiratory infection after I tested negative on all of those. I was prescribed an antibiotic whose name I don't remember. The symptoms did not improve. On 3/15/2023, I called the nurse line and told them that my symptoms hadn't improved, and I was instructed to go to the ER. At the ER, I was tested for COVID-19 and various other illnesses, and the results were all negative. I underwent a chest CT scan, which showed fluid around my heart and lungs. The ER doctor told me that this was concerning and that I should see with my PCP soon. On 3/17/2023, I saw my PCP, who did an EKG that showed I was having a heart attack. She called an ambulance, and I was sent to the ER. At the ER, an angiogram was done, which showed that I had a main artery that was 100% blocked. Two stents were put into the artery, and a balloon was also placed somewhere. I was admitted to the hospital and stayed two days. On 4/3/2023 and 4/4/2023, I was in the hospital again, this time for diabetic ketoacidosis. I am currently on insulin, and I was given IV fluids to treat the ketoacidosis. At the time of this writing, I am still weak and tired. I am now going cardiac rehab twice a week; I will be doing this for 18 weeks.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diabetic ketoacidosis, Electrocardiogram abnormal, Fatigue, Influenza virus test negative, Laboratory test normal
Clinical narrative: I woke up with a fever, a bad cough, and chest pain. I thought I was just sick. I kind of hoped it would just get better. The symptoms continued; the chest pain diminished, but the coughing and fever continued for the next three days. I went to urgent care on 3/11/2023. I underwent tests for COVID-19, streptococcus, pneumonia, and the flu. I underwent a chest X-ray. I was diagnosed with an upper respiratory infection after I tested negative on all of those. I was prescribed an antibiotic whose name I don't remember. The symptoms did not improve. On 3/15/2023, I called the nurse line and told them that my symptoms hadn't improved, and I was instructed to go to the ER. At the ER, I was tested for COVID-19 and various other illnesses, and the results were all negative. I underwent a chest CT scan, which showed fluid around my heart and lungs. The ER doctor told me that this was concerning and that I should see with my PCP soon. On 3/17/2023, I saw my PCP, who did an EKG that showed I was having a heart attack. She called an ambulance, and I was sent to the ER. At the ER, an angiogram was done, which showed that I had a main artery that was 100% blocked. Two stents were put into the artery, and a balloon was also placed somewhere. I was admitted to the hospital and stayed two days. On 4/3/2023 and 4/4/2023, I was in the hospital again, this time for diabetic ketoacidosis. I am currently on insulin, and I was given IV fluids to treat the ketoacidosis. At the time of this writing, I am still weak and tired. I am now going cardiac rehab twice a week; I will be doing this for 18 weeks.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Myocardial infarction, Pericardial effusion, Pleural effusion, Pyrexia
Clinical narrative: I woke up with a fever, a bad cough, and chest pain. I thought I was just sick. I kind of hoped it would just get better. The symptoms continued; the chest pain diminished, but the coughing and fever continued for the next three days. I went to urgent care on 3/11/2023. I underwent tests for COVID-19, streptococcus, pneumonia, and the flu. I underwent a chest X-ray. I was diagnosed with an upper respiratory infection after I tested negative on all of those. I was prescribed an antibiotic whose name I don't remember. The symptoms did not improve. On 3/15/2023, I called the nurse line and told them that my symptoms hadn't improved, and I was instructed to go to the ER. At the ER, I was tested for COVID-19 and various other illnesses, and the results were all negative. I underwent a chest CT scan, which showed fluid around my heart and lungs. The ER doctor told me that this was concerning and that I should see with my PCP soon. On 3/17/2023, I saw my PCP, who did an EKG that showed I was having a heart attack. She called an ambulance, and I was sent to the ER. At the ER, an angiogram was done, which showed that I had a main artery that was 100% blocked. Two stents were put into the artery, and a balloon was also placed somewhere. I was admitted to the hospital and stayed two days. On 4/3/2023 and 4/4/2023, I was in the hospital again, this time for diabetic ketoacidosis. I am currently on insulin, and I was given IV fluids to treat the ketoacidosis. At the time of this writing, I am still weak and tired. I am now going cardiac rehab twice a week; I will be doing this for 18 weeks.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Streptococcus test negative, Upper respiratory tract infection
Clinical narrative: I woke up with a fever, a bad cough, and chest pain. I thought I was just sick. I kind of hoped it would just get better. The symptoms continued; the chest pain diminished, but the coughing and fever continued for the next three days. I went to urgent care on 3/11/2023. I underwent tests for COVID-19, streptococcus, pneumonia, and the flu. I underwent a chest X-ray. I was diagnosed with an upper respiratory infection after I tested negative on all of those. I was prescribed an antibiotic whose name I don't remember. The symptoms did not improve. On 3/15/2023, I called the nurse line and told them that my symptoms hadn't improved, and I was instructed to go to the ER. At the ER, I was tested for COVID-19 and various other illnesses, and the results were all negative. I underwent a chest CT scan, which showed fluid around my heart and lungs. The ER doctor told me that this was concerning and that I should see with my PCP soon. On 3/17/2023, I saw my PCP, who did an EKG that showed I was having a heart attack. She called an ambulance, and I was sent to the ER. At the ER, an angiogram was done, which showed that I had a main artery that was 100% blocked. Two stents were put into the artery, and a balloon was also placed somewhere. I was admitted to the hospital and stayed two days. On 4/3/2023 and 4/4/2023, I was in the hospital again, this time for diabetic ketoacidosis. I am currently on insulin, and I was given IV fluids to treat the ketoacidosis. At the time of this writing, I am still weak and tired. I am now going cardiac rehab twice a week; I will be doing this for 18 weeks.