chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer). 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 10Nov2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 53 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer treatment ended 30Dec2022. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid from 24Feb2023 to 01Mar2023.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 at 10:00 as dose 5 (booster), single (Lot number: Gj3277) at the age of 65 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: En6204), in left arm, on 10Apr2021 as dose 2, single (Lot number: Er8731), in right arm, on 08Nov2021 as dose 3 (booster), single (Lot number: Ff2593), in left leg and on 25Apr2022 as dose 4 (booster), single (Lot number: Fj4989), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism"; "Sulpha allergy". The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 and included treatment with PF-07321332, ritonavir (PAXLOVID) from 24Feb2023 to 01Mar2023.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: None. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had no known allergies.  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, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, start date: 24Apr2014; FISH OIL, start date: 01Dec2019; MULTIVITAMIN [VITAMINS NOS], start date: 03Feb2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Mar2023) Positive, notes: 07Mar2023 and tested positive; (Mar2023) Negative, notes: Tested negative for Covid on Sunday Mar2023. 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: Linked Report(s) : US-PFIZER INC-202300100617 same patient, different drug/event;
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included nirmatrelvir/ ritonavir (PAXLOVID) from 26Feb2023 to 03Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna/ Vaccine dose number=1/2/3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 007M20A), in right arm, on 25Jan2021 as dose 2, single (Lot number: 023M20A), in right arm, on 30Oct2021 as dose 3 (booster), single (Lot number: 939903), in right arm and on 02Sep2022 as dose 5 (booster), single (Lot number: AS7140C), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetanus toxoid for known allergies tetanus toxoid. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2022, outcome "unknown", described as "Vaccine brand other=Moderna/ Vaccine dose number=1/2/3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Feb2023) Negative, notes: Finished paxlovid course (no missed doses) 24Feb. Tested negative the next day; (07Mar2023) Positive, notes: retested positive 07Mar. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I believe some type of clot on my left side of my neck and my right side of my neck; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "I believe some type of clot on my left side of my neck and my right side of my neck". Clinical course: patient stated, "I'm suffering from. Umm, I believe some type of clot on my left side of my neck and my right side of my neck. I forget the name of the. The vein that's going up through to my brain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Moderna, Dose Number: 4 / Pfizer, Dose Number: 1, 2, 3; COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Apr2021 as dose 1, single (Lot number: EW0170), in left arm, on 15May2021 as dose 2, single (Lot number: EW0182), in left arm and on 16Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Sep2022 at 09:00 as dose 4 (booster), single (Lot number: AS714OC), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mood disorders" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jan2023, outcome "recovered" (09Feb2023) and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Moderna, Dose Number: 4 / Pfizer, Dose Number: 1, 2, 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jan2023) positive, notes: COVID 19 Treatment. The patient was treated with Paxlovid from 26Jan202. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disease recurrence, Gastrooesophageal reflux disease, Regurgitation
Clinical narrative: his reflux was aggravated; his reflux was aggravated; had regurgitation in the back of his throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 2-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "reflux" (not ongoing), notes: He is a "reflux infant" so has a history of reflux but has resolved. The patient's concomitant medications were not reported. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), DISEASE RECURRENCE (non-serious), outcome "recovered" and all described as "his reflux was aggravated"; REGURGITATION (non-serious), outcome "unknown", described as "had regurgitation in the back of his throat". Additional information: the mother of patient reported that her son is a "reflux infant" so has a history of reflux but has resolved. She reported that every time he got the vaccine (has received 3 doses), it aggravated his reflux or it started acting up again. On Monday, 06Mar2023, he received his Pfizer Covid 19 vaccine bivalent booster for 6 months to 4 years old, and she noticed that night his reflux was aggravated and had regurgitation in the back of his throat that night and has been occurring intermittently since then. This same thing happened with his first two doses in his primary series.  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-202300102877 Same reporter, same patient, same event, different shot;US-PFIZER INC-202300102439 Same reporter, same patient, different shot/event;
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: after the second shots I have never had a breakout since; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2021 as dose 2, single (Lot number: ER8729) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Herpes", start date: 1983 (unspecified if ongoing), notes: He had Herpes for 40 years; the herpes that he had was gone after he took the vaccine. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: ER8727, The very one of the Shots I had a very light Break out), administration date: 22Mar2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "The very one of the Shots I had a very light Break out". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "recovered", described as "after the second shots I have never had a breakout since". Therapeutic measures were not taken as a result of therapeutic response unexpected.  Additional information: He had Herpes for 40 years, the herpes that he had was gone after he took the vaccine. The very one of the Shots he had a very light Break out, and after the Second Shots he have never had a Break out since. Not reporting any issues (side effects, complaints, etc.) with a Pfizer product. Reported issue occurred after use of a Pfizer product. 20Oct2021, Pfizer Lot: FG3590. Booster 29Sep2022 Pfizer Lot: GH9694. Patient fine now.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300043098 same reporter/patient/AE, different dose;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; 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 62-year-old female patient received BNT162b2 (BNT162B2), on 10Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) 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. Past drug history included: Bactrim, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: COVID 19 Treatment. The patient received Paxlovid from 17Feb2023 to 22Feb2023 and experienced rebound symptoms 7 days after last dose of Paxlovid on 21Feb2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine  brand=Pfizer / BioNTech/vaccine  brand  other=Moderna; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: Gj2524) at the age of 53 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11May2021 as dose 1, single (Lot number: 027c21a), in right arm, on 08Jun2021 as dose 2, single (Lot number: 011d21a), in right arm and on 03Jan2022 as dose 3 (booster), single (Lot number: 059h21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing); "diabetes type 2" (unspecified if ongoing); "pituitary tumor" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine  brand=Pfizer / BioNTech/vaccine  brand  other=Moderna".  The patient received treatment with Paxlovid from 25Feb2023 to 02Mar2023 and experienced Paxlovid rebound on 07Mar2023.
Sex: U
Vaccine: COVID19
Symptoms: Syncope, Vital signs measurement
Clinical narrative: syncope; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 07Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown, Expiration Date: 24Aug2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "recovered". He believes the patient was a gentleman that is no longer with the pharmacy and has not been for a long time. The patient experienced Syncope and came back to his senses. He said that the patient was at their pharmacy for a couple of months and then went to a different state. It has been a while since these adverse events occurred and said that it was close to 1.5 to 2 years ago now. He thinks one was Moderna and the other one was Pfizer. Both Patients had syncope that was momentary and came back, and vitals were ok.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported event Syncope. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 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). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID". The patient ang his wife got the Pfizer COVID bivalent vaccine in Sep2022. The both took a five day course of Paxlovid and had two days of negative test. Commented to please consider recommending 3 month vaccinations for sensitive groups along with a ten day course of Paxlovid. 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: Linked Report(s) : US-PFIZER INC-202300101212 same reporter, product and events; different patients;
Sex: U
Vaccine: COVID19
Symptoms: Multiple sclerosis
Clinical narrative: MS started after one week of the first dose of BNT162b2; This is a literature report.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, 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: MULTIPLE SCLEROSIS (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "MS started after one week of the first dose of BNT162b2". Therapeutic measures were taken as a result of multiple sclerosis.; Sender's Comments: Based on the temporal relationship, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event Multiple sclerosis. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, Medication error
Clinical narrative: patient was given a dose of PENTACEL today and the vaccine expired on 31Jan2023,with no reported adverse event; Initial information received  on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 4 months old female patient who was given a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] today and the vaccine expired on 31jan2023,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) for Prophylactic vaccination.  On 03-Mar-2023, the patient received dose 2 at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength: standard) (lot number: UJ658AAA, expiry date: 31-Jan-2023) via unknown route in unknown administration site for Immunization and on the same day, patient was given a dose of pentacel today and the vaccine expired on 31jan2023,with no reported adverse event (expired product administered).  It was reported, reporter stated that she is the manager in the office. Caller states that she is calling about PENTACEL and the expiration date. Caller asking if the company has any information regarding this.  No further information provided by the reporter.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error
Clinical narrative: an expired ActHIB vaccine was given with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid non-serious case received via consumer/non-hcp (practice manager). number: 01518653.  This case involves patient of unspecified demographics to whom expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Mar-2023, the patient received expired suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection at (unknown: strength, dose, lot number, route, administration site) for immunization with no reported adverse event (expired product administered) at same day latency.  It was reported that "the caller states that she is a practice manager and an expired ActHIB vaccine was given this morning and she would like to know if the patient needs to be revaccinated."   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 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: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: patient of 3 years age inadvertently received a dose of QUADRACEL with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid non-serious case received via health professional. number: 01519769.  This case involves 3 years old female patient who was inadvertently received a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] 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 HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 02-Feb-2023, the patient 3 years age inadvertently received suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection at dose 0.5ml once lot U7526AA via intramuscular route in the right deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.     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.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: staff found the expiration date on the PENTACEL confusing and caused them to administer the PENTACEL after it had expired with no reported adverse event; Initial information received on 07-Mar-2023 regarding an unsolicited valid non-serious case received via consumer/non-hcp. number: 01521982.  This case involves patient of unspecified demographics to whom as staff found the expiration date on the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] confusing and caused them to administer the Pentacel after it had expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2023, the patient received suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection at dose 0.5ml once (lot: UJ648AAA, expiry date: 25-Feb-2023) via unknown route in unknown administration site for immunization, staff found the expiration date on the Pentacel confusing and caused them to administer the Pentacel after it had expired with no reported adverse event (expired product administered) at same day latency.  Action taken: Not applicable.  No corrective treatment was received for the event.  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 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: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysstasia, Muscle spasms, Nodule, Pain, Rash
Clinical narrative: Rash and nodule on the spine. Severe pain and muscle spasm with accompanying reduced ability to stand upright.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Facial pain, Hypoaesthesia, Lymphadenopathy, Neck pain
Clinical narrative: Facial numbness with tingling and pain sensation and enlarged lymph nodes several hours after the 1st dose of Moderna shot  Swollen neck with pain started soon after A rash over the legs and body within a few months Diagnosed with t-cell lymphoma in March 2022  Died August 2022 He visited his doctor for all those symptoms and received treatment at the hospital for cancer. He received both doses of the Moderna vaccine (2/13/2021 & 3/13/2021)
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Swelling, T-cell lymphoma
Clinical narrative: Facial numbness with tingling and pain sensation and enlarged lymph nodes several hours after the 1st dose of Moderna shot  Swollen neck with pain started soon after A rash over the legs and body within a few months Diagnosed with t-cell lymphoma in March 2022  Died August 2022 He visited his doctor for all those symptoms and received treatment at the hospital for cancer. He received both doses of the Moderna vaccine (2/13/2021 & 3/13/2021)
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Dermatomal Rash appeared on 2/27/23, shingles in appearance, erythematous / vesicular cluster at epigastric region anterior / midline, extending under breast, then T1 posterior R arm pain with faint crusts seen on exam on 3/6/2023.  Given valtrex 1Gm TID x 7 days on 3/6/23.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Dermatomal Rash appeared on 2/27/23, shingles in appearance, erythematous / vesicular cluster at epigastric region anterior / midline, extending under breast, then T1 posterior R arm pain with faint crusts seen on exam on 3/6/2023.  Given valtrex 1Gm TID x 7 days on 3/6/23.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Pt. called Friday to say her arm was really red and swelling. she said it was about 2 inches across. I told her to put cold compresses and to take Benadryl if she had itching/rash. She said she had benadryl cream and was going to try. She came back today and it was still swollen, and warm to touch. she ended up putting hydrocortisone cream because she didn't have benadryl and bought benadryl today. The injection site was swollen ,itchy and about 2 inches still. She did not see physician .
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Unable to Sleep-Medium
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: MY LEFT ARM HURT WHEN I GOT THE VACCINE AND MY ARM STILL HURTS FOUR MONTHS LATER. THE PAIN IS EVEN IN THE SHOULDER .
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 1st case of shingles confirmed in May 2022, lasting through July 2022. 2nd case of shingles confirmed by doctor on 3/8/2023.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient came to receive a booster shot which he had already received on 9/12/2023. The vaccine was erroneously verified as acceptable. He received a second updated bi-valent vaccine which is not currently approved. Patient has not relayed any adverse response to this date.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: External ear pain, Vertigo positional
Clinical narrative: Intermittent  vertigo with sudden change of position , mild external ear pain
Age: 12.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Oedema peripheral, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: 3/10/23- edema, swelling, redness, warmth, itching of entire upper arm.  Benadryl and hydrocortisone cream for symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Haemorrhage, Headache, Hypersensitivity
Clinical narrative: Serious allergic reaction, anaphylaxis,, facial swelling, bleeding severe head pain, dizziness blurry vision
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Surgery, Swelling face, Vision blurred
Clinical narrative: Serious allergic reaction, anaphylaxis,, facial swelling, bleeding severe head pain, dizziness blurry vision
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Joint swelling, Peripheral swelling
Clinical narrative: DONOR REPORTS THAT HIS RIGHT AND LEFT HAND/WRISTS BECAME RED AND SWOLLEN 7 DAYS POST VACCINATION. DONOR HAD BILATERAL HAND SUGERY IN 2017. HX OF OSTEOARTHRITIS. DONOR BELIEVES HE MAY HAVE UNDIAGNOSED RA. DONOR WAS SEEN AT CLINIC ON 2/23/23 AND TREATED WITH ORAL STERIODS FOR 5 DAYS; COMPLETED. SYMPTOMS RESOLVED AND NO OTHER COMPLAINTS.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Bell's palsy, Laparoscopic surgery, Mass excision, Menstrual disorder
Clinical narrative: Following vaccination, I stopped menstruation.  Got diagnosed with Bell?s palsy in August 2022 Feb 1 2023, went to ER with abdominal pain and they found a 14cm mass on my right ovary  Feb 18 2023, had surgery to remove the mass, right ovary and right fallopian tube (Laparoscopic Unilateral Salpingo Oomphorectomy)  March 9 2023, Diagnosed with Stage 1A Granulosa Cell Tumor of the Right Ovary
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ovarian granulosa cell tumour, Ovarian mass, Salpingo-oophorectomy unilateral
Clinical narrative: Following vaccination, I stopped menstruation.  Got diagnosed with Bell?s palsy in August 2022 Feb 1 2023, went to ER with abdominal pain and they found a 14cm mass on my right ovary  Feb 18 2023, had surgery to remove the mass, right ovary and right fallopian tube (Laparoscopic Unilateral Salpingo Oomphorectomy)  March 9 2023, Diagnosed with Stage 1A Granulosa Cell Tumor of the Right Ovary
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Urticaria bilateral lower legs two weeks after vaccine.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injected limb mobility decreased, Pain
Clinical narrative: Patient states she is experiencing shooting pain from shoulder joint and is unable to raise or extend her left arm, which began 2 hours after vaccination. Recommended to visit ER if pain continues despite Tylenol use.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Neuralgia
Clinical narrative: Pt reported face pain/nerve pain into the ear.  She did say she had some facial nerve pain yesterday morning prior to the vaccine, but the pain worsened and traveled into her ear by the evening.  Required emergency room visit due to the pain this am.  I explained the vaccine is inactive, does not contain live virus.
Age: 1.17
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: MMRV and Hepatitis A previously given on 2/22/23 when child was brought in by mother of child.  On 3/11/23 Father of child brought in child back to clinic for second dose of flu vaccine and was not aware that patient previously received MMRV and Hepatitis A and these immunizations were repeated.  Child received MMRV and Hep A on 2/22/23 and again on 3/11/23  There was no adverse reaction reported as of yet
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was injected an unknown amount of covid (moderna) vaccine, the patient is concerned if she has protection from covid now.
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Diarrhoea, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, diarrhea, chills, fever, body ache, vomiting
Age: 34.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vomiting
Clinical narrative: Nausea, diarrhea, chills, fever, body ache, vomiting
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Fatigue, Injection site pain
Clinical narrative: patient states no adverse event; patient says she does feel tired and her arm is sore at the injection site; VAERS filled out due to vaccine being given after BUD 03/06/2023 due to being kept in refrigerator since 2/4/23; original vaccine manufacturer expiration of 06/12/2023
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: tinnitus
Age: 6.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong COVID vaccine was administered to the patient due to age.  Contacted the family recently and spoke with the sister who translated to both the parents; patient is okay and experiences no adverse reactions as of 5pm today.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient fainted 10 minutes after receiving vaccine.
Age: 38.0
Sex: F
Vaccine: HPV9
Symptoms: Nervousness, Syncope
Clinical narrative: Pt was very nervous about vaccination, even though this was now her third dose. Hours after receiving, patient fainted outside of store in parking lot. Paramedics arrived; outcome unknown at time of submission.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Magnetic resonance imaging head abnormal
Clinical narrative: Stroke
Age: 9.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Syncope
Clinical narrative: SYNCOPIC EPISODE
Age: 9.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Syncope
Clinical narrative: Syncopic episode post vaccination.
Age: 71.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dyspnoea, Fatigue, Headache, Malaise, Pyrexia
Clinical narrative: Patient called pharmacy (3/10) and said she was not feeling well (headache, fever and tiredness). Explained these symptoms were common with vaccines and should lessen within 24-48 hours. Patient called back tonight (3/11) to say she is still tired and now has shortness of breath. Advise her to seek medical attention at urgent care or hospital.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No adverse events up to date
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Patient came in to office to receive 3rd dose (bivalent) of Pfizer COVID-19 for ages 5-11. In error, the Pfizer 6month-4year COVID-19 bivalent was drawn up and administered to patient. According to CDC guidelines (Appendix D Vaccine administration errors and deviations), since the patient received the wrong product resulting in a lower-than-authorized dose, the patient was called back to the office to repeat the dose immediately.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose administered; This spontaneous report was received from Pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and Concomitant therapies were not reported.  On 14-FEB-2023, the patient was vaccinated with an unknown expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection,  lot #T025374, expiration date: 25-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided).  The pharmacist confirmed that the vaccine did not experience temperature excursion through the date of administration. At the reporting time, no adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called to report late order of VARIVAX that was administered to a patient. HCP could not provide confirmation if the product was improperly stored; No additional AE; HCP called to report late order of VARIVAX that was administered to a patient. HCP could not provide confirmation if the product was improperly stored; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      The healthcare professional reported a late order (product distribution issue) of varicella virus vaccine live (oka/merck) (VARIVAX) that was administered to the patient on 07-MAR-2023, for first time with an expiration date reported as on 05-OCT-2024 (Strength, route of administration, anatomical location and lot # were not reported). Additionally, the healthcare professional could not provide confirmation if the product was improperly stored (product storage error). No additional Adverse Event (AE) was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002607:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Dyspnoea
Clinical narrative: Heart fluttering and shortness of breath with slight dizziness. Started the day after the shot.  Every few hours for the 1st month, then once a day for about 3 months, then about 3 times a week since then.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antinuclear antibody, Aphasia, Behaviour disorder, Blood test normal
Clinical narrative: On Sept 26th, had a sudden onset of neurological symptoms.  She experienced blurred vision, speech difficulty, an overall "out of it" feeling, and muscle tics in her head, arms and legs.  We took her to the ER and tests all came back negative.  Her symptoms began to resolve after 6-8 hrs with the exception of her muscle tics which continued.  Over the next couple month, she experienced 2 more mental episodes where her speech and behavior were affected, and the twitching worsened.  Pediatric neurology referral initially diagnosed her with PANDAS but with no active strep infection, possibly PANS related to some other infection.  Repeat blood work did not show any active infection, however.  It was then hypothesized that hte COVID vaccine, which she had received the month prior might have been a trigger to her immune system, and somehow was mimicking the PANDAS symptoms.  At this time, she is still experienced muscle tics, though not as frequently.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count, Electrocardiogram, Electroencephalogram, Feeling abnormal, Full blood count
Clinical narrative: On Sept 26th, had a sudden onset of neurological symptoms.  She experienced blurred vision, speech difficulty, an overall "out of it" feeling, and muscle tics in her head, arms and legs.  We took her to the ER and tests all came back negative.  Her symptoms began to resolve after 6-8 hrs with the exception of her muscle tics which continued.  Over the next couple month, she experienced 2 more mental episodes where her speech and behavior were affected, and the twitching worsened.  Pediatric neurology referral initially diagnosed her with PANDAS but with no active strep infection, possibly PANS related to some other infection.  Repeat blood work did not show any active infection, however.  It was then hypothesized that hte COVID vaccine, which she had received the month prior might have been a trigger to her immune system, and somehow was mimicking the PANDAS symptoms.  At this time, she is still experienced muscle tics, though not as frequently.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Laboratory test normal, Magnetic resonance imaging, Mental disorder, Muscle spasms
Clinical narrative: On Sept 26th, had a sudden onset of neurological symptoms.  She experienced blurred vision, speech difficulty, an overall "out of it" feeling, and muscle tics in her head, arms and legs.  We took her to the ER and tests all came back negative.  Her symptoms began to resolve after 6-8 hrs with the exception of her muscle tics which continued.  Over the next couple month, she experienced 2 more mental episodes where her speech and behavior were affected, and the twitching worsened.  Pediatric neurology referral initially diagnosed her with PANDAS but with no active strep infection, possibly PANS related to some other infection.  Repeat blood work did not show any active infection, however.  It was then hypothesized that hte COVID vaccine, which she had received the month prior might have been a trigger to her immune system, and somehow was mimicking the PANDAS symptoms.  At this time, she is still experienced muscle tics, though not as frequently.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Neurological symptom, Paediatric acute-onset neuropsychiatric syndrome, Red blood cell sedimentation rate, SARS-CoV-2 test
Clinical narrative: On Sept 26th, had a sudden onset of neurological symptoms.  She experienced blurred vision, speech difficulty, an overall "out of it" feeling, and muscle tics in her head, arms and legs.  We took her to the ER and tests all came back negative.  Her symptoms began to resolve after 6-8 hrs with the exception of her muscle tics which continued.  Over the next couple month, she experienced 2 more mental episodes where her speech and behavior were affected, and the twitching worsened.  Pediatric neurology referral initially diagnosed her with PANDAS but with no active strep infection, possibly PANS related to some other infection.  Repeat blood work did not show any active infection, however.  It was then hypothesized that hte COVID vaccine, which she had received the month prior might have been a trigger to her immune system, and somehow was mimicking the PANDAS symptoms.  At this time, she is still experienced muscle tics, though not as frequently.