chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not reported any adverse event.  No treatment medications were provided.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable and patient received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported.  Reportedly, Pharmacist called to discuss a temperature excursion that occurred several days ago in the freezer. the excursion was found out in an audit and all the vaccines were viable. No adverse reactions reported for the patient.  No treatment medications were reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after excursion; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion), POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion).    No Concomitant medications were provided.  Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after excursion; No adverse event; Patient administered doses of the vaccine after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient administered doses of the vaccine after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer.  Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine in question. Patient did not report any adverse event.  No treatment medications were provided.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 at the beginning of 2022) in 2022, Pfizer (0.25 ml of second dose at the beginning of 2022) in 2022 and Pfizer (Dose 3 (monovalent booster)) in July 2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 23-Nov-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient was given the Moderna monovalent for 6m-5y instead of Pfizer bivalent booster).    No concomitant medications were reported.  It was reported that the patient was supposed to get a Pfizer bivalent booster on that day so it would be her fourth shot, instead she was given the Moderna monovalent vaccine that was indicated for use in 6 months - 5 years of age.  No treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient could feel the heat in her arm; Patient has swelling in the injection site; Patient has big red swollen arm patch, the size of an orange in arm of injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Patient could feel the heat in her arm), VACCINATION SITE SWELLING (Patient has swelling in the injection site) and VACCINATION SITE ERYTHEMA (Patient has big red swollen arm patch, the size of an orange in arm of injection) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 20-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Nov-2022, the patient experienced VACCINATION SITE WARMTH (Patient could feel the heat in her arm), VACCINATION SITE SWELLING (Patient has swelling in the injection site) and VACCINATION SITE ERYTHEMA (Patient has big red swollen arm patch, the size of an orange in arm of injection). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Patient could feel the heat in her arm), VACCINATION SITE SWELLING (Patient has swelling in the injection site) and VACCINATION SITE ERYTHEMA (Patient has big red swollen arm patch, the size of an orange in arm of injection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: Positive.         Patient was taking concomitant medications but did not specify on what.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; 0.4 ml administered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (0.4 ml administered) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050022A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Primary vaccination series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .4 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.4 ml administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (0.4 ml administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (0.4 ml administered).    No concomitant medications were reported. The nurse administered about 0.4 ml of a Moderna bivalent booster and wanted to know if that was okay. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; No adverse event; Bivalent dose administered to patient after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered to patient after 30-day use by date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered to patient after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered to patient after 30-day use by date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent dose administered to patient after 30-day use by date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medication was reported. The patient have received first dose and second dose with unknown lot number. HCP stated she did not have any patient demographics or clinical history and she was just calling to know if the was a valid dose. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (High fever) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever). At the time of the report, PYREXIA (High fever) outcome was unknown.            No concomitant medication details was reported.  No treatment medication details was reported.   This case was linked to MOD-2022-677887, MOD-2022-675945 (Patient Link).   Reporter did not allow further contact
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid 19; Contracted Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 11:15 as dose 5 (booster), single (Lot number: GJ6742) at the age of 60 years intramuscular, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 at 09:00 as dose 1, single (Lot number: EL3247), in left arm, on 01Apr2021 at 09:00 as dose 2, single (Lot number: EP6955), in left arm, on 03Dec2021 at 09:45 as dose 3 (booster), single (Lot number: FH8027), in left arm and on 04May2022 at 11:15 as dose 4 (booster), single (Lot number: FL3197), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]; ESOMEPRAZOLE MAGNESIUM; ESCITALOPRAM. Past drug history included: Ceftin, reaction(s): "Known allergies: ceftin". The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Nov2022, outcome "unknown", COVID-19 (medically significant) with onset 21Nov2022, outcome "recovering" and all described as "Contracted Covid 19". The event "contracted covid 19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200672278 Same reporter/patient, same drug/different dose, different AE;US-PFIZER INC-202200672278 Same reporter/patient, same drug/different dose, different AE;
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Herpes simplex virus reactivation with every dose.Reactivation with in hours and up to 3 days following each dose. Upper lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Aug2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FE3592; Anatomical location: Arm Left; Vaccine Administration Time: 15:30), administration date: 30Nov2021, when the patient was 58-year-old, for COVID-19 Immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip"; BNT162b2 (DOSE 2, SINGLE, Lot number: EP6955), administration date: 07Apr2021, when the patient was 57-year-old, for COVID-19 Immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip"; BNT162b2 (DOSE 1, SINGLE, Lot number: EP6955), administration date: 17Mar2021, when the patient was 57-year-old, for COVID-19 immunization, reaction(s): "Herpes simplex virus reactivation with every dose. Reactivation within hours and up to 3 days following each dose. Upper lip". The following information was reported: ORAL HERPES (non-serious) with onset 06Aug2022, outcome "recovered" (08Aug2022), described as "Herpes simplex virus reactivation with every dose.Reactivation with in hours and up to 3 days following each dose. Upper lip". Therapeutic measures were not taken as a result of oral herpes.  Additional information: The patient had no known allergies. The patient did not receive other vaccine in four weeks. The patient did not receive other medication in two weeks. Prior to vaccination the patient was not diagnosed with COVID. Post vaccination, the patient had not tested for COVID.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 12:00 as dose 4 (booster), single (Lot number: gh9694) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 03May2021 at 12:00 as dose 2, single (Lot number: EW0620) and on 18Nov2021 as dose 3 (booster), single (Lot number: FJ1620), in left arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure abnormal" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN taken for blood pressure abnormal; VITAMIN D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) 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. The patient received Paxlovid as treatment for the events. Outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EL9263), in left arm, on 31Mar2021 as dose 2, single (Lot number: EP7533), in left arm, on 03Nov2021 as dose 3 (booster), single (Lot number: FG3527), in left arm and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Thyroiditis" (unspecified if ongoing); "Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ZICAM COLD AND FLU, start date: 11Nov2022, stop date: 12Nov2022; ALKA SELTZER PLUS COLD [ACETYLSALICYLIC ACID;CHLORPHENAMINE MALEATE;PHENYLPROPANOLAMINE HYDROCHLORIDE], start date: 10Nov2022, stop date: 12Nov2022. Past drug history included: Bactrim, reaction(s): "Known allergies"; Erythrimiacin, reaction(s): "Known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient used Paxlovid from 12Nov2022 to 16Nov2022 as treatment of 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: 29.0
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) (Other HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE; BUPROPION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: 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 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Dose Number: 5:Pfizer / Dose Number: 4:Moderna / Dose Number: 3:Pfizer/ Dose Number 2:Pfizer/ Dose Number 1:Pfizer; tested positive/ COVID 19 Treatment; tested positive/ COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6200), in right arm, on 24Mar2021 as dose 2, single (Lot number: ER2613), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF2587), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Apr2022 as dose 4 (booster), single (Lot number: 06SK21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "mild GERD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "dry macular degeneration" (unspecified if ongoing); "food sensitivities" (unspecified if ongoing), notes: a couple of food sensitivities, but no allergies. The patient took concomitant medications included herbs and other supplements. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: codeine (but not derivitives). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Nov2022, outcome "recovering" and all described as "tested positive/ COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering", described as "Dose Number: 5:Pfizer / Dose Number: 4:Moderna / Dose Number: 3:Pfizer/ Dose Number 2:Pfizer/ Dose Number 1:Pfizer". The patient took Paxlovid same day when she first tested positive (09Nov2022). Took the full course as directed. Felt better in a couple of days or so. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Nov2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 40.0
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) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 21Apr2021 as dose 2, single (Lot number: EW0169), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EWV183), in right arm for covid-19 immunisation. The patient's relevant medical history included: "CSF Leak from left nostril (repaired)" (not ongoing); "Known allergies: some foods" (unspecified if ongoing); "headaches" (unspecified if ongoing); "high pressure in head (mostly controlled)" (unspecified if ongoing), notes: mostly controlled; "high blood pressure (controlled)" (unspecified if ongoing), notes: controlled; "high cholesterol (controlled)" (unspecified if ongoing), notes: controlled; "obesity" (unspecified if ongoing), notes: controlled; "depression/anxiety (controlled)" (unspecified if ongoing), notes: controlled; "depression/anxiety (controlled)" (unspecified if ongoing). Concomitant medication(s) included: ALLERGY MEDICINE, start date: 05Jan2019, stop date: 22Nov2022; LAMOTRIGINE, start date: 01Mar2021, stop date: 22Nov2022; AMLODIPINE BESYLATE, start date: 13Jul2020; ROSUVASTATIN CALCIUM, start date: 24Jan2022; ASPIRIN EC, start date: 24Jan2022; ACETAZOLAMIDE, start date: 07Jul2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: He received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap, last Thursday. By Monday he was not feeling well, and he tested positive for COVID; By Monday he was not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 93-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "dialysis" (ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 21Nov2022, outcome "unknown", described as "By Monday he was not feeling well"; COVID-19 (non-serious) with onset 21Nov2022, outcome "unknown", described as "He received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap, last Thursday. By Monday he was not feeling well, and he tested positive for COVID". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller on behalf of her father. He is 93 years old, and he is on dialysis. He received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent gray cap, last Thursday. By Monday he was not feeling well, and he tested positive for COVID. Had a dentist appointment and caller's sister noticed the patient was not feeling well, so tested patient. Caller wanted to know if the vaccine can cause COVID.   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: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Loss of consciousness, Nasopharyngeal swab, Syncope
Clinical narrative: Since then I started feeling irregular heart beats.; I fainted.; I totally lost my consciousness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2021 at 11:30 as dose 3 (booster), single (Lot number: FL3209) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "I also felt dizziness in Jun2021 without any noticeable reasons"; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "I also felt dizziness in Jun2021 without any noticeable reasons". The following information was reported: SYNCOPE (medically significant) with onset 30Dec2021, outcome "unknown", described as "I fainted."; LOSS OF CONSCIOUSNESS (medically significant) with onset 30Dec2021, outcome "unknown", described as "I totally lost my consciousness"; HEART RATE IRREGULAR (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Since then I started feeling irregular heart beats.". The events "i fainted.", "i totally lost my consciousness" and "since then i started feeling irregular heart beats." required emergency room visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Negative.  Clinical course: In the morning of 30Dec2021 at about 11:30 patient took Pfizer Booster on his left arm. Same day at night when he went to bathroom standing in front of the toilet, he fainted. He totally lost my consciousness suddenly. He did not know it lasted for how long, but he did not feel cold. When he came back to bed he saw clock time was 2:30 AM. The following morning he went to Emergency Room. The doctor said that the faint was probably related to the Pfizer Booster. Since then he started feeling irregular heartbeats. First, these irregular heartbeats came upon him once in a while, but now it comes up every day and every hour. Very often! It greatly affects his life. He also felt dizziness in Jun2021 without any noticeable reasons. He believed this was the start-up of Pfizer vaccine side effects. Adverse event resulted in: Emergency room/department or urgent care. Patient had no COVID prior vaccination. Patient tested COVID post vaccination. COVID test type post vaccination: Nasal Swab. COVID test result: Negative.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: also have the same number of vaccines" she was mentioning her partner, who is on Paxlovid; also have the same number of vaccines" she was mentioning her partner, who is on Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) 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; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "also have the same number of vaccines" she was mentioning her partner, who is on Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: reporter was mentioning her partner, who was on Paxlovid, also had the same number of vaccines.  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: 57.0
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 58-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in right leg, in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left leg and in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "overweight" (unspecified if ongoing). Concomitant medication(s) included: TELMISARTAN, start date: 01Jan2022, stop date: 22Nov2022; AMLODIPINE, start date: Jan2022, stop date: Nov2022; ROSUVASTATIN, start date: Jan2022, stop date: Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "recovering" and all described as "Treatment of 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: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Pfizer/BioNTech-Dose Number: 4/Moderna-Dose Number: 1,2,3,5; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 56 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 037K20A), on 09Feb2021 as dose 2, single (Lot number: 012M20A), on 24Oct2021 as dose 3 (booster), single (Lot number: 091D21A) and on 09Sep2022 as dose 5 (booster), single (Lot number: AS7143C) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Indomethacin, reaction(s): "Known allergies: Allergic to Indomethacin", notes: Known allergies: Allergic to Indomethacin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Mar2022, outcome "unknown", described as "Pfizer/BioNTech-Dose Number: 4/Moderna-Dose Number: 1,2,3,5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative; (22Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Paxlovid was taken as an treatment for Covid-19 started from 21-NOV-2022 .; 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 to the drug ineffective, Interchange of vaccine products and COVID-19 cannot be ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Increased ringing in both ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162B2 OMI BA.4-5, on 14Nov2022 at 13:15 as dose 4 (booster), single (Lot number: GH9697) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "Ringing in ears" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; NOVOLOG; IRBESARTAN; ZOLOFT; LAMTRACET. Vaccination history included: Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE: 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 15Nov2022, outcome "not recovered", described as "Increased ringing in both ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient had no known allergies. Prior vaccination, the patient was not diagnosed with COVID. Post vaccination, the patient had not tested COVID. The patient did not receive other vaccine in four weeks.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4487007-00.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 20Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis", start date: 2007 (unspecified if ongoing); "Tobacco User", start date: 1994 (unspecified if ongoing); "abstains from alcohol" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEFLUNOMIDE taken for rheumatoid arthritis; ATENOLOL taken for blood pressure abnormal; BENAZEPRIL taken for blood pressure abnormal; ATORVASTATIN taken for blood cholesterol abnormal; AMLODIPINE taken for blood pressure abnormal. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) Positive, notes: positive covid-19; (11Aug2022) Negative, notes: Covid-19 swab test of nasal and throat negative result for Covid-19; (22Jul2022) Positive, notes: Positive Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The lot number for [BNT162b2], was not provided and will be requested during follow up.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-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) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies Penicillin" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, 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; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: her husband and she had COVID in June; her husband and she had COVID in June; 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 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Feb2022 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "her husband and she had COVID in June". The reporter stated that she and her husband received the first 2 doses and 1 booster dose last February. She wanted to know if they should receive a fourth and fifth dose of this vaccine. The reporter mentioned that her husband and she had COVID in Jun2022. She declined to be transferred. They are 70 years old.  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-202201324645 same reporter/product/AE, different patient;