chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 26.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given Beyond use date Pt had no adverse events
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given beyond use date Pt had no adverse events
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given beyond use date Pt had no adverse events
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given beyond use date Pt had no adverse events
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given beyond use date Pt had no adverse events
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given beyond use date Pt had no adverse events
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine give beyond use date pt had no adverse events
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date  pt had no adverse events
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiomyopathy, Catheterisation cardiac abnormal, Chronic left ventricular failure, Ejection fraction decreased
Clinical narrative: Left heart catheterization, non-ischemic cardiomyopathy, Ef estimated at 35% to 40% 5/01/2023 7:17 am Chronic systolic Heart failure
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given beyond use date Pt had no adverse events
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product use issue
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 87.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None - Vaccine given beyond use date. Pt had no adverse events.
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: None- Vaccine given beyond use date. Patient had no adverse events.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product use issue
Clinical narrative: NONE - vaccine given beyond use date pt had no adverse events
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: NONE - Vaccine given beyond use date pt had no adverse events
Age: 59.0
Sex: F
Vaccine: COVID19-2, FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for an unknown indication.    Concurrent medical conditions included Type 2 diabetes mellitus, Chronic back pain (Pain) and Drug allergy (Gabapentin). Concomitant products included TRAMADOL from 20-Nov-2022 to an unknown date for Pain, ATORVASTATIN from 15-Sep-2022 to an unknown date, SITAGLIPTIN PHOSPHATE (JANUVIA) from 15-Sep-2022 to an unknown date, METFORMIN from 19-Sep-2022 to an unknown date and HYDROCHLOROTHIAZID from 19-Sep-2022 to an unknown date for an unknown indication.   On 13-Dec-2022 at 3:46 AM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient received first dose of INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) (Intramuscular) 1 dosage form. On 13-Dec-2022, the patient experienced UNDERDOSE (Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) 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 UNDERDOSE (Patients have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    No information about previous COVID-19 vaccination doses.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had received Moderna first dose on 05Nov2021 at 01:32pm, lot number: 066F21A on left deltoid with a dose of 0.5ml and second dose on 03Dec2021 at 02:22 pm, lot number: 018F21A, on left deltoid with a dose of 0.5ml.  Treatment medication not reported by the reporter.  This case contains information about patient 9th out of 17 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow up received and included Patient details were added, Medical history was added, Dose details were added, Co suspect was added and Concomitants were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Sex: M
Vaccine: HPV4
Symptoms: Autopsy, Death
Clinical narrative: died while playing hockey; Information has been received from a physician concerning a 15 year old male with asthma and "cardiac history" (unspecified) who on 30-AUG-2010 was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot number 665607/1333Y). Concomitant therapy included atorvastatin calcium (LIPITOR). On 27-SEP-2010 the patient died while playing hockey. The physician reported "awaiting autopsy results". At the time of the report no further information was available.  The reporter considered death to be life-threatening.  A lot check has been initiated.  Follow-up information from the physician who indicated that the concurrent condition of "cardiac history" was further described as subaortic stenosis. Cause of death had not been definitively determined, but the physician believed it was cardiac related, and not associated with the HPV rL1 6 11 16 18 VLP vaccine (yeast). The physician said he would call back when the autopsy report results were in.   A standard lot check investigation has  been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements Evaluation and Research and was released.  Follow up information has been received on 04-JUL-2023. Asthma was identified as a potential risk factor for sudden death.; Sender's Comments: , MERCK1010USA02704:Mfr number; Reported Cause(s) of Death: died while playing hockey
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid twice now, since I got the shots and the boosters; Covid twice now, since I got the shots and the boosters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid twice now, since I got the shots and the boosters".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Post-acute COVID-19 syndrome, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; My thoughts were my child got vaccinated and still got long covid so I question the accuracy of this ad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "My thoughts were my child got vaccinated and still got long covid so I question the accuracy of this ad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Brain injury
Clinical narrative: Brain lesions; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN INJURY (medically significant), outcome "unknown", described as "Brain lesions". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I realized vaccinations dont work because I caught covid even though i was fully vaccinated with boosters; I realized vaccinations dont work because I caught covid even though i was fully vaccinated with boosters; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dosr number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I realized vaccinations dont work because I caught covid even though i was fully vaccinated with boosters". Clinical Course:Reporter considered that the event caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Near death experience
Clinical narrative: I almost died; Allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "I almost died"; HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Allergic reaction". Clinical Course: Patient dont trust the vaccine. She almost died from an allergic reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got COVID even with vaccine but it was not as bad; got COVID even with vaccine but it was not as bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID even with vaccine but it was not as bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 1.25
Sex: F
Vaccine: IPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: administered IPOL instead of Prevnar to the patient, with no reported adverse event; Initial information received on 06-Jul-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 15-month-old female patient who was administered IPV (VERO) [IPOL] instead of prevnar to the patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 16-Jun-2023, the patient received a Primary 0.5 mg dose of suspect IPV (VERO) Suspension for injection (strength, expiry date: unknown) (lot: U10571M) via intramuscular route in the left thigh for Prophylactic vaccination (immunization).  On 16-Jun-2023 the patient had an event of administered ipol instead of prevnar to the patient, with no reported adverse event (wrong product administered) (latency: same day) following the administration of IPV (VERO).  It was unknown if nay lab data/tests results available.  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  Outcome: unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired pentacel was given with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 1-year-old male patient to whom expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was given 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 for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 05-Jul-2023, the patient received 0.5 ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength: unknown) (lot: UJ672AAA, expiry date: 27-Apr-2023) via unknown route in unknown administration site for immunization.  On 05-Jul-2023 the patient had an event of expired pentacel was given with no reported adverse event (expired product administered) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  It was unknown if any lab data/test results available.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  Outcome: Unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: nurse accidentally forgot to mix the HIB portion, so the 4-month-old child only got the DTAP/IPOL mix but did not receive the HIB with no reported adverse event; Initial information received on 07-Jul-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old of unknown gender patient whose nurse accidentally forgot to mix the hib portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], so the 4-month-old child only got the dtap/ipol mix but did not receive the hib with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Jul-2023, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for immunization.  On 06-Jul-2023, the nurse accidentally forgot to mix the hib portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], so the 4-month-old child only got the dtap/ipol mix but did not receive the hib with no reported adverse event (product preparation error) (Latency:same day).  It was reported, Clinic supervisor called to get information on incident that occurred yesterday 06Jul2023 with a PENTACEL vaccine. Caller reports that a nurse accidentally forgot to mix the HIB portion, so only got the DTAP/IPOL mix but did not receive the HIB. Does the child need to be re-vaccinated with PENTACEL or can the remaining vial of HIB be mixed with a diluent and given? This situation is reported as a medication error due to--not giving the medication together as intended.  Action taken: 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 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: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: quadracel is given to a 4 yo a day after expiration date with no reported adverse event; Initial information received on 08-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 years old patient of unknown gender who was given diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] a day after expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Jul-2023, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine (Suspension for injection) (lot: c5916aa; expiry date: 06-Jul-2023) via unknown route in unknown administration site for Immunization.  On 07-Jul-2023 the patient was given diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] a day after expiration date with no reported adverse event (expired product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: reports that they administered 2 expired daptacel to patients with no reported adverse event; Initial information received on 10-Jul-2023 from an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age female patient for whom it was reported that they administered 2 expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to patients with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 28-Jun-2023, the patient received an expired dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: C5893AA; expiry date: 21-Jun-2023) via unknown route in unknown administration site 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 reports that they administered 2 expired daptacel to patients 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: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No symptoms reported.; Improper storage of product in use (as per label); This spontaneous report was received from pharmacist and refers to a 17-year-old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, drug reactions, or allergies, and concomitant medications was not provided.  On 13-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella virus vaccine live (oka/merck) (VARIVAX) at a dose of 0.5 milliliter (mL) /once, lot number W0252273 with (expiration date of 02-JUN-2023), but upon internal validation established as W025273 with an (expiry date of 10-AUG-2024) (conflicting information as it was reported that the product was expired)) administered for prophylaxis (route of administration and anatomical location were not provided)( product storage error). The administered dose of the vaccine had experienced a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023. It was not reported if the information was obtained from the data logger or not. There was no adverse effect reported. On 29-JUN-2023, it was confirmed from a nurse that the lot number for varicella virus vaccine live (oka/merck) (VARIVAX) was as W025273, upon internal validation, expiration date was established as 10-AUG-2024.  This is one of several reports received from the same reporter.
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Two days of diarrhea and stomach pain
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Incoherent, Vomiting
Clinical narrative: 5 Minutes after giving patient Vaccines the patient started to vomit, dizzy, and was a little coherent for like 10 minutes
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/22/2023,  2/7/2023,  2/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE MI
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE 2/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: GIVEN TO PATIENT OUTSIDE AGE RANGE, DID NOT REPORT ANY ADVERSE EFFECTS, PER MFR MAY NOT BE AS EFFECTIVE AS BOOSTRIX FOR  OVER 64
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 73.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse event occurred.
Age: 23.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: global headache, myalgia, and fatigue ongoing for weeks following vaccinations.  continuing to experience headaches, which were never an issue before. no tx other than OTC pain management
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Discomfort, Injection site swelling, Pruritus
Clinical narrative: There's little swelling around site on one arm.  But,  she suddenly became itchy,  uncomfortable all over with no visible skin rash
Age: 1.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Dose 0.2ml/10mcg administered. Based on vaccination status, 0.25ml/25mcg is recommended.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Paraesthesia, Periarthritis
Clinical narrative: pt reports tingling in arm once needle placed and frozen shoulder following administration of vaccine
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose normal, Dizziness, Feeling of body temperature change, Nausea, Pallor
Clinical narrative: 1020 Mother reported the patient feeling dizzy. Went to go get juice for the patient. Patient was then reported to be lightheaded. Mother requested Benadryl and an EPI-pen.  Pt stated she was hot and cold and nauseous. Patient was pale in color.  Patient was laid down with feet elevated.  Cooling measures applied. Vitals checked.  1024 Blood sugar: 105 BP 110/67 HR 80 R 24 O2 Sat 99 %.   Patient was encouraged to take slow deep breathes,   1030 BP 115/75 HR 70 R 20 O2 Sat 99%.  Patient was provided water, juice and a protein bar.  Patient was able to be sat up in the sitting position and was feeling better. Encouraged fluids for patient.  Patient stated she had not eaten or drank much prior to appointment.  1052 patient left with mother and brother. Color had came back, patient stated she felt better. Mom advised they were headed to get lunch.
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Dose 0.2ml/10mcg administered. Based on vaccination status, 0.25ml/25mcg is recommended.
Age: 81.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Chills, Diarrhoea, Injection site erythema, Nausea
Clinical narrative: Nausea, Shivering, Diarrhea Redness around injection site
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Dose 0.2ml/10mcg administered. Based on vaccination status, 0.25ml/25mcg is recommended. No adverse effect.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 13 Jul 2021  @ 0930 seen by provider - Area of erythema present to R upper thigh 11.5 cm x 6.2 cm. Area of induration present to center of erythema measuring 3.5 x 2.8 cm. Mild warmth present. Mild tenderness present to area of induration only. Diagnosis noted as: Cellulitis noted to RLE, anterolateral aspect of right thigh. Sulfamethoxazole-trimethoprim ordered.  Follow up instructions per provider: Mother to take picture today, inner circle was documented 7/12 AM and outer circle documented today while in clinic 0900.  - Mother will send picture of this AM as well as tomorrow AM via Portal tomorrow morning for an update  - NP to call Mother after reviewed pictures in order to evaluate need to RTC or make changes  - FU sooner PRN fever, not wanting to ambulate, increased pain or fussiness, decreased appetite, not playful  - Otherwise, will FU via telephone in 24 hrs Mother states patient was also seen by health care provider on 12 Jul 2023 for same complaint. Mother states one dose antibiotics were administered at this visit.
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Dose 0.2ml/10mcg administered. Based on vaccination status, 0.25ml/25mcg is recommended. No adverse effect.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site swelling, Muscle swelling, Swelling
Clinical narrative: Patient reports left sided arm swelling at the injection site. Patient reports left sided swelling of her neck and back muscles, and swelling of her left chest muscles.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Dose 0.2ml/10mcg administered. Based on vaccination status, 0.25ml/25mcg is recommended. No adverse effect.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Tornado hit in the county resulting in a temperature excursion.  Verification via manufacturer performed; however, wording not understood that vial was considered activated since vial had been punctured and a dose removed.  Office was contacted by consultant that medication was considered activated since the vial was opened prior to the excursion and should not be used. Re-verification with the manufacturer performed. At that time, it was noted dose was considered invalid and patient would need revaccinated. Parent contacted and aware.
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 57.0
Sex: F
Vaccine: YF
Symptoms: Unevaluable event
Clinical narrative: Administered using a 5/8" needle at the deltoid.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: PASSED OUT
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE ST ELEVATION MI, ANTERIOR WALL
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Lymph node pain
Clinical narrative: Lymph node tenderness of left side of the neck and left armpit, redness with warmth at the vaccine injection site of left deltoid
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiac arrest, Death, Loss of consciousness
Clinical narrative: Patient received COVID vaccine at pharmacy on 7/10/2023. He presented to the ER later that day after passing out at home. On 7/12/23 he was brought to the ER  by EMS in asystole. Pt expired 7/12/2023 in the ED.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram abnormal, Lymphoedema, Peripheral swelling
Clinical narrative: Left arm became very swollen. After doctor visit and chest ct scan, I was sent to a vascular doctor. H e diagnosed me with lymphedema. In treatment now.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Syncope
Clinical narrative: The patient felt dizzy and fainted on her way out of the store.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness, pain and swelling at site x 3 days.  fever chills on day x1 .
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Recumbivax-Adult was administered.  At time of next dose, noted that this client was 18 y/o not the required 20y/o
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT
Age: 0.25
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Diet refusal, Erythema, Infant irritability, Injection site urticaria, Poor feeding infant
Clinical narrative: Patient refused to nurse following vaccine administration. Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back. Patient was very warm to the touch and red. Very irritable. 9mg of Benadryl were given when this occurred. Patient began to improve around 15 min later.
Age: 0.25
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Skin warm, Urticaria
Clinical narrative: Patient refused to nurse following vaccine administration. Hives began to appear a few minutes after vaccines were given to bilateral legs as well as the patient's back. Patient was very warm to the touch and red. Very irritable. 9mg of Benadryl were given when this occurred. Patient began to improve around 15 min later.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autoscopy, Dizziness, Fatigue, Feeding disorder
Clinical narrative: Next morning woke up extreme fatigue, Neurological  weakness couldn?t feel legs feet hands.  Extreme Dizziness , unable to eat or drink. Completely felt  out of body experience.  This continued for 2-3 days and long term after dizziness weakness took several months to go away. Today the dizziness and fatigue returns frequently.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fluid intake reduced, Laboratory test, Sensory loss
Clinical narrative: Next morning woke up extreme fatigue, Neurological  weakness couldn?t feel legs feet hands.  Extreme Dizziness , unable to eat or drink. Completely felt  out of body experience.  This continued for 2-3 days and long term after dizziness weakness took several months to go away. Today the dizziness and fatigue returns frequently.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia, Hypoxia, Type 2 diabetes mellitus
Clinical narrative: HYPOXIA 3/28/2023 DM 2 W HYPERGLYCEMIA
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Metabolic encephalopathy
Clinical narrative: R09.02 HYPOXIA 4/19/2023 METABOLIC ENCEPHALOPATHY
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Presyncope
Clinical narrative: Patient experience vasovagal response following vaccine administration
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Dyspnoea, Respiratory failure
Clinical narrative: J96.12 CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 4/2/2023 SHORTNESS OF BREATH
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Embolic stroke
Clinical narrative: I63.9 ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 4/13/2023 ABNL ECHOCARDIOGRAM
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inflammation, Injection site pain, Musculoskeletal disorder, Pain
Clinical narrative: Pain at the injection site in my left shoulder is still present. The entire left side of my body hurt for almost two weeks, but just the left side.  Joint pain and inflamation started about one month after the first injection.  The severity diminished after approximately 8 months but I still suffer from severe inflamation specifically hands and spine, occasionally my hands do not work well enough to operate tools or a computer keyboard.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypertensive urgency
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 5/1/2023 SYNCOPE ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 5/1/2023 HYPERTENSIVE URGENCY
Age: 8.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The vaccine was inadvertently administered before the minimum age of 9 years old. The patient nearly 2 months away from her 9th birthday, when she would be eligible for the vaccine.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Patient received the Moderna Pink cap when they should have received the Moderna blue cap.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Acute respiratory failure, Atelectasis, Atrial fibrillation, Atrioventricular block first degree
Clinical narrative: 73-year-old male past medical history of CAD, A-fib, hypertension, short-term memory loss, nursing home resident presents to the ER due to shortness of breath.  Patient states that has been more short of breath today.  He has also been less alert than baseline.  He was difficult to arouse this morning at the nursing facility.  He was unable to take his medications.  He was sent to the ER for evaluation.  Patient tested positive for COVID 2 days ago was started on molnupiravir.  No reported chest pain, focal weakness, headache.  No reported abdominal pain   Clinical Summary Patient was admitted to hospital for management of acute hypoxic respiratory failure in the setting of COVID-19 infection.  He was placed on Decadron and remdesivir.  Initially he was kept on empiric antibiotics in the case of superimposed bacterial infection as CT scan did show atelectasis versus infiltrate in the lower lobes.  His oxygenation was continually monitored.  4/5 he was continued on 3 L nasal cannula.  Procalcitonin was checked and was negative so antibiotics were de-escalated.  On 4/6 the patient's oxygenation had significantly improved and he was doing well on room air.  He did develop acute onset nausea and vomiting that was not relieved with Compazine.  KUB was obtained and showed severe gaseous distention of the stomach.  CT abdomen and pelvis was done to rule out small bowel obstruction and no obstruction was seen.  4/7 his nausea and vomiting had resolved and he was tolerating a regular diet.  His mentation had improved to baseline.  Patient was stable for discharge back to skilled nursing facility and was transferred back to facility on 4/7.   Discharge diagnosis COVID 19 infection Acute hypoxic respiratory failure -resolved  Nausea and vomiting - resolved  Metabolic encephalopathy - resolved  Hyponatremia -r esolved  Paroxysmal atrial fibrillation 1st degree AVB Chronic HFpEF Essential hypertension Hypothyroidism Morbid obesity BMI 49.3
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure, Cardiac failure chronic, Computerised tomogram abdomen normal, Computerised tomogram thorax abnormal
Clinical narrative: 73-year-old male past medical history of CAD, A-fib, hypertension, short-term memory loss, nursing home resident presents to the ER due to shortness of breath.  Patient states that has been more short of breath today.  He has also been less alert than baseline.  He was difficult to arouse this morning at the nursing facility.  He was unable to take his medications.  He was sent to the ER for evaluation.  Patient tested positive for COVID 2 days ago was started on molnupiravir.  No reported chest pain, focal weakness, headache.  No reported abdominal pain   Clinical Summary Patient was admitted to hospital for management of acute hypoxic respiratory failure in the setting of COVID-19 infection.  He was placed on Decadron and remdesivir.  Initially he was kept on empiric antibiotics in the case of superimposed bacterial infection as CT scan did show atelectasis versus infiltrate in the lower lobes.  His oxygenation was continually monitored.  4/5 he was continued on 3 L nasal cannula.  Procalcitonin was checked and was negative so antibiotics were de-escalated.  On 4/6 the patient's oxygenation had significantly improved and he was doing well on room air.  He did develop acute onset nausea and vomiting that was not relieved with Compazine.  KUB was obtained and showed severe gaseous distention of the stomach.  CT abdomen and pelvis was done to rule out small bowel obstruction and no obstruction was seen.  4/7 his nausea and vomiting had resolved and he was tolerating a regular diet.  His mentation had improved to baseline.  Patient was stable for discharge back to skilled nursing facility and was transferred back to facility on 4/7.   Discharge diagnosis COVID 19 infection Acute hypoxic respiratory failure -resolved  Nausea and vomiting - resolved  Metabolic encephalopathy - resolved  Hyponatremia -r esolved  Paroxysmal atrial fibrillation 1st degree AVB Chronic HFpEF Essential hypertension Hypothyroidism Morbid obesity BMI 49.3