chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Abdominal pain upper, Body temperature, Headache, Malaise
Clinical narrative: Feel sick; Stomach ache; My stomach's upset. I haven't thrown up, but my stomach is upset; Patient received  first dose as Moderna Bivalent Vaccine; Headache; I have 100 degree temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache), ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine) and HEADACHE (Headache) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Aug-2023, the patient experienced MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache), ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine), HEADACHE (Headache) and PYREXIA (I have 100 degree temperature). At the time of the report, MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) had not resolved and ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine) and PYREXIA (I have 100 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2023, Body temperature: 100 degree Celsius.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient mom was elderly, and she was not well and patient just wanted to make sure that his mother can't contract it. No treatment medication was reported.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Feel sick; Stomach ache; My stomach's upset. I haven't thrown up, but my stomach is upset; Patient received  first dose as Moderna Bivalent Vaccine; Headache; I have 100 degree temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache), ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine) and HEADACHE (Headache) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Aug-2023, the patient experienced MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache), ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine), HEADACHE (Headache) and PYREXIA (I have 100 degree temperature). At the time of the report, MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) had not resolved and ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine) and PYREXIA (I have 100 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2023, Body temperature: 100 degree Celsius.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient mom was elderly, and she was not well and patient just wanted to make sure that his mother can't contract it. No treatment medication was reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Agent spoke per Management of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Administration Errors and Deviations; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Agent spoke per Management of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Administration Errors and Deviations) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Agent spoke per Management of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Administration Errors and Deviations) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Agent spoke per Management of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Administration Errors and Deviations) 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 PRODUCT DOSE OMISSION ISSUE (Agent spoke per Management of Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Administration Errors and Deviations).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1 lot number AS1417B) on 23-Mar-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine.    On 11-Aug-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 11-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL) 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 WRONG PRODUCT ADMINISTERED (Patient never received a second dose of the Moderna COVID-19 vaccine. He then received a dose of the bivalent vaccine with the pink cap 0.2 mL).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  No treatment information was reported.
Age: 12.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: IPOL for a total of 13 hrs, with a maximum warm temperature of 9.9 C with no reported adverse event; IPOL was administered to a patient post excursion with no reported adverse event; Initial information received on 11-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 year old male patient to whom IPV (VERO) [IPOL] was administered post excursion total of 13 hours, with a maximum warm temperature of 9.9 c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Jul-2023, the patient received a dose 0.5 ml of suspect IPV (VERO) Suspension for injection strength, expiry date: not reported lot W1A191M via intramuscular route in unknown administration site for immunization and was exposed to a total of 13 hours, with a maximum warm temperature of 9.9 c with no reported adverse event (product storage error)(same day latency).  On 24-JUL-2023 IPOL was administered to a patient post excursion with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event ipol for a total of 13 hrs, with a maximum warm temperature of 9.9 c with no reported adverse event and ipol was administered to a patient post excursion with no reported adverse 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.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received an expired dose of acthib with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 years old male patient who received an expired dose of HIB (PRP/T) vaccine [ACT-HIB] 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); and pneumococcal vaccine (Pneumococcal 15) for Prophylactic vaccination.  On 14-Aug-2023, the patient received 0.5 mL dose 4 of expired suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ803AA; expiry date: 13-Aug-2023) via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient received an expired dose of acthib with no reported adverse 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.
Age: 1.83
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: patient only received the liquid part of the pentacel vaccine and not the powder part with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 months old female patient who only received the liquid part of the pentacel vaccine and not the powder part with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jul-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ805AA, expiry date: 17-Feb-2024 via intramuscular route at unknown administration site for immunization (strength: unknown), patient only received the liquid part of the pentacel vaccine and not the powder part with no reported 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 single component of a two-component product administered.   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: 4.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of ACT-HIB to a patient, with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who was administered an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Aug-2023, the patient received a dose 4 dose 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength unknown) lot UJ796AA expiry date: 12-Aug-2023 via intramuscular route in the left thigh for Immunization.  On 14-AUG-2023 patient was administered an expired dose of act-hib to a patient, with no reported adverse event (expired product administered) on the same day following the administration of HIB (PRP/T) VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered an expired dose of act-hib to a patient, with no reported adverse 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.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Accidental exposure to product, Medication error, No adverse event, Syringe issue
Clinical narrative: vaccine leaked from the neck of the syringe(tip cap), was shot into the air and dripped onto the patient's arm with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 years old male patient and diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel] leaked from the neck of the syringe(tip cap), was shot into the air and dripped onto the patient's arm with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2023, the patient received a dose 1 at a dose of 0.5 ml of suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 18-Mar-2025 and lot U7671AA) via intramuscular route in the left deltoid for Immunization and on the same day vaccine leaked from the neck of the syringe(tip cap), was shot into the air and dripped onto the patient's arm with no reported adverse event (accidental exposure to product).  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 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: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of acthib was administered with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom expired dose of acthib was administered 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 pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine Toxoid (DTAP) for Prophylactic vaccination.  On 15-Aug-2023, the patient received 0.5 ml (dose 4) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection lot UJ787AA, expiry date-11-Aug-2023 via intramuscular route in left quadricep for immunization (strength: unknown), expired dose of acthib was administered with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.   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: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: reports that one of her staff had administered an expired daptacel with no reported adverse event; Initial information received on 15-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient  and reporter reported that the one of her staff had administered an 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 Hib Vaccine (Hib) And Pneumococcal Vaccine Conj 13v (Crm197) (Prevnar 13) for Prophylactic vaccination.  On 15-Aug-2023, the patient received a dose 4 at a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 30-Mar-2023 and lot C5828AA) via intramuscular route in left vastus lateralis for immunization and on the same day her staff had administered an expired daptacel with no reported adverse event (expired product administered).  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 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: 0.5
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Single component of a two-component product administered
Clinical narrative: nurse reports that when she administered pentacel to a patient, she did not reconstituted the liquid dtap-ipv portion with the powder hib portion; states that she only administered the liquid dtap-ipv portion with no adverse event; Initial information received on 16-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 month old male patient and nurse reports that when administered diphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient, she did not reconstituted the liquid dtap-ipv portion with the powder hib portion; states that only administered the liquid dtap-ipv portion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Rotavirus Vaccine And Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) for Prophylactic vaccination.  On 15-Aug-2023, the patient received a dose 3 at a dose of 0.5 ml of suspect DIPHTHERIAdiphtheria/tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 02-Apr-2024, lot UJ859AA) via intramuscular route in the left thigh for Prophylactic vaccination (immunization) and nurse did not reconstituted the liquid dtap-ipv portion with the powder hib portion; states that only administered the liquid dtap-ipv portion 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 events.   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.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Nurse stated that the patient involved has not reported adverse reaction related to the improperly stored and administered vaccine.; Nurse calling to report adverse event for improperly stored and administered VARIVAX.  Nurse reporting temperature excursion in which VARIVAX was left at room temperature for 24 hours on 8/10/2023 and vaccine was administered on 8/11/2023.  Nurse sta; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 11-AUG-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml) of a two-dose series (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number U025204, expiration date reported and validated as 13-AUG-2023) as prophylaxis (product storage error). The nurse stated that the patient involved had not reported adverse reaction related to the improperly stored and administered vaccine.  The vaccine was left at room temperature for 24 hours on 10-AUG-2023.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report inadvertent administration of VARIVAX after a temperature excursion. Limited patient demographics provided. No additional AE/PQC.      ?    Names of vaccines involved (including lot/exp): VARIVAX W039697 12/13/2024        ?; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 14-AUG-2023, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W039697, expiration date was reported and validated as 13-DEC-2024) as prophylaxis, after a temperature excursion (product storage error). No additional adverse event (AE).  The vaccine experienced a temperature excursion of 7 degrees Fahrenheit (F) for 2 hours and 11 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No Additional AE/PQC reported; HCP reports that the patient received a dose of VARIVAX that has suffered a TE; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 11-AUG-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters as prophylaxis (lot number: w039292, which was determined to be valid, with an expiration date on 11-DEC-2024) (strength, scheme, route and anatomical location of administration were not reported) (Product storage error).   The administered dose underwent a temperature excursion of -14.3 degrees Celsius for 13 minutes, with a previous temperature excursion of -10.6 degrees Celsius for 38 minutes.   No additional adverse event was reported.  This is one of three cases form the same reporter.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid Nasal Test: Positive.; Covid Nasal Test: Positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 at 15:30 as dose 1, single (Lot number: EE3590), in left arm and on 01Nov2021 at 15:30 as dose 2, single (Lot number: FF2583) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not have covid prior to vaccination. No known allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "Covid Nasal Test: Positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276548 Same reporter/patient/drug,  different events and time gap.;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia
Clinical narrative: Covid Nasal Test: Positive.; Covid Nasal Test: Positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 at 15:30 as dose 1, single (Lot number: EE3590), in left arm and on 01Nov2021 at 15:30 as dose 2, single (Lot number: FF2583) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient did not have covid prior to vaccination. No known allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "Covid Nasal Test: Positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300276548 Same reporter/patient/drug,  different events and time gap.;
Age: 51.0
Sex: M
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type2" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Nov2021. Past drug history included: Known allergies: sulphur meds, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. After being diagnosed with covid 19 on 05Aug2023, took 5 days of Paxlovid, finished on 10Aug2023 or 11Aug2023. Patient started feeling ill again 15Aug2023 at 06:30 AM, major sinus drip, cough, sneezing. Did home test on 16Aug2023 tested positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Said his arms was kind of sore; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Aug2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 73 years for COVID-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (primary immunization series complete; lot number: unknown), for COVID-19 immunization; BNT162b2 (dose number unknown, single; lot number: unknown), administration date: 2022, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Aug2023, outcome "unknown", described as "Said his arms was kind of sore". Additional information: The patient reported that he went to the pharmacy at the time of the report and told them he wanted the new Pfizer COVID-19 vaccine. He said on TV they said to get your new COVID shot. So he was given a COVID shot and said his arms was kind of sore. He then learned that he was given the Pfizer COVID vaccine, bivalent for adults and told them that it's not the one he wanted. He was told he was given another dose of the vaccine he got by the end of last year. So patient was wondering if the new vaccine comes out in September or October, the fact that he had that shot, if he can get the new one by then. Of note, he said all his COVID vaccines are Pfizer's. He also shared that his wife died due to COVID, mentioned she was his high school sweetheart and said that he was okay however due to depression, he's on medication he said.  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: 69.0
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 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 21Feb2021 as dose 1, single (Lot number: 002A21A), in right arm, on 25Mar2021 as dose 2, single (Lot number: 037A21B), in right arm and on 22Jan2022 as dose 3 (booster), single (Lot number: 047F21A), in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM VITAMIN D3 [CALCIUM;COLECALCIFEROL], start date: 16Sep2009; SIMVASTATIN, start date: 15Sep2020, stop date: 07Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 07Aug2023 to 12Aug2023 for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300277719 same patient different drug/event;
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Aug2023 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Aug2023, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 as the patient took Paxlovid on 07Aug2023 to 12Aug2023.  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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Full blood count, International normalised ratio, Loss of personal independence in daily activities, Muscular weakness
Clinical narrative: her legs got weak; she almost couldn't get up on the bus; it took her energy away; her arm started hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "Pulmonary hypertension" (ongoing), notes: She was on a high dose steroid for her Pulmonary Hypertension; "Arthritis" (ongoing); "Overweight" (ongoing), notes: A little Overweight; "Hemolytic anemia" (ongoing); "Migraine" (ongoing); "Pacemaker" (ongoing); "Oxygen 24 Hours" (ongoing); "Massive Blood Clots" (ongoing); "Compromised Immune System" (ongoing); "Heart and Lung Disease" (ongoing); "Lung Disease" (ongoing); "Lupus" (ongoing); "Macrocytic cells" (unspecified if ongoing), notes: she has Macrocytic cells because they are so large. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "unknown", described as "her arm started hurting"; MUSCULAR WEAKNESS (non-serious) with onset 04Mar2021, outcome "unknown", described as "her legs got weak"; ASTHENIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "it took her energy away"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 04Mar2021, outcome "unknown", described as "she almost couldn't get up on the bus". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, Patient was trying to lose weight. She was on a high dose steroid for her Pulmonary Hypertension because it was really bad and the high dose steroids caused her to gain weight. She tries to take care of herself. Patient stated she has a pacemaker, she was on 24 hour oxygen, she is on coumadin because she has massive blood clots, her Immune System is Compromised, Heart and Lung Disease, Diabetes, Pulmonary Hypertension, Lupus, Arthritis and she was told she is a little overweight. She also has Migraines. Investigations included, they are always drawing PT/INR tests and running other tests such as CBC because her Red Blood Cells are too big. She had Hemolytic Anemia. States she has Macrocytic cells because they are so large. If her Hemoglobin and Hematocrit drop, she has to go back to the Cancer Doctor again. Patient stated with the First One, her arm started hurting the next day and her legs got weak and she almost couldn't get up on the bus. The social worker said she needed to use a wheelchair for a while because it took her energy away.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Prothrombin time
Clinical narrative: her legs got weak; she almost couldn't get up on the bus; it took her energy away; her arm started hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "Pulmonary hypertension" (ongoing), notes: She was on a high dose steroid for her Pulmonary Hypertension; "Arthritis" (ongoing); "Overweight" (ongoing), notes: A little Overweight; "Hemolytic anemia" (ongoing); "Migraine" (ongoing); "Pacemaker" (ongoing); "Oxygen 24 Hours" (ongoing); "Massive Blood Clots" (ongoing); "Compromised Immune System" (ongoing); "Heart and Lung Disease" (ongoing); "Lung Disease" (ongoing); "Lupus" (ongoing); "Macrocytic cells" (unspecified if ongoing), notes: she has Macrocytic cells because they are so large. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Mar2021, outcome "unknown", described as "her arm started hurting"; MUSCULAR WEAKNESS (non-serious) with onset 04Mar2021, outcome "unknown", described as "her legs got weak"; ASTHENIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "it took her energy away"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 04Mar2021, outcome "unknown", described as "she almost couldn't get up on the bus". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that, Patient was trying to lose weight. She was on a high dose steroid for her Pulmonary Hypertension because it was really bad and the high dose steroids caused her to gain weight. She tries to take care of herself. Patient stated she has a pacemaker, she was on 24 hour oxygen, she is on coumadin because she has massive blood clots, her Immune System is Compromised, Heart and Lung Disease, Diabetes, Pulmonary Hypertension, Lupus, Arthritis and she was told she is a little overweight. She also has Migraines. Investigations included, they are always drawing PT/INR tests and running other tests such as CBC because her Red Blood Cells are too big. She had Hemolytic Anemia. States she has Macrocytic cells because they are so large. If her Hemoglobin and Hematocrit drop, she has to go back to the Cancer Doctor again. Patient stated with the First One, her arm started hurting the next day and her legs got weak and she almost couldn't get up on the bus. The social worker said she needed to use a wheelchair for a while because it took her energy away.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Investigation, Somnolence
Clinical narrative: wanted to sleep a lot; tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Comments: Diabetes; "Pulmonary hypertension" (ongoing), notes: Comments: Pulmonary hypertension,she was on high dose steroid for her Pulmonary Hypertension; "Arthritis" (ongoing), notes: Comments: Arthritis; "Overweight" (ongoing), notes: Comments: Overweight A little Overweight; "Hemolytic anemia" (ongoing), notes: Comments: Hemolytic anemia; "Migraine" (ongoing), notes: Comments: Migraine; "Pacemaker" (ongoing), notes: Comments: Pacemaker; "Oxygen 24 Hours" (ongoing), notes: Comments: Oxygen 24 Hours; "Massive Blood Clots" (ongoing), notes: Comments: Massive Blood Clots; "Compromised Immune System" (ongoing), notes: Comments: Compromised Immune System; "Heart and Lung Disease" (ongoing), notes: Comments: Heart and Lung Disease; "Heart and Lung Disease" (ongoing), notes: Comments: Heart and Lung Disease; "Lupus" (ongoing), notes: Comments: Lupus. Concomitant medication(s) included: COUMADIN taken for thrombosis. Vaccination history included: BNT162b2 (First Dose: 03Mar2021 Given at (name-withheld)), administration date: 03Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "it took her energy away", "her arm started hurting", "her legs got weak", "she almost couldn't get up on the bus". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "wanted to sleep a lot". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated she was trying to lose weight. She was on a high dose steroid for her pulmonary hypertension because it was really bad, and the high dose steroids caused her to gain weight. The reporter stated she tries to take care of herself. She was on coumadin because she has massive blood clots. Regarding investigations, the reporter stated they were always drawing PT/INR tests and running other tests such as CBC because her red blood cells were too big. She had hemolytic anemia. Stated she had macrocytic cells because they were so large. If her Hemoglobin and Hematocrit dropped, she had to go back to the cancer doctor again. Pfizer Covid 19 Shot Second One adverse event: reporter stated with the second one she was really tired, and she wanted to sleep a lot but with this one {sixth one) she feels weak and sick and when she saw her temperature went up, she thought as long as it went down, she didn't worry about it. Given on 25Mar2021. NDC, Lot, Expiration: Unknown.  The information on the batch/lot number for 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: 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 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had Paxlovid Treatment from 06Aug2023 to 11Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300277805 same patient, different event/ drug;