chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Food allergy, Pruritus, Throat irritation, Tongue discomfort
Clinical narrative: He was once able to eat some of his favorite fruits but now he is allergic to them; itching; burning in tongue and throat; burning in tongue and throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: Mar2021, for COVID-19 immunization. The following information was reported: FOOD ALLERGY (non-serious), outcome "unknown", described as "He was once able to eat some of his favorite fruits but now he is allergic to them"; PRURITUS (non-serious), outcome "unknown", described as "itching"; TONGUE DISCOMFORT (non-serious), THROAT IRRITATION (non-serious), outcome "unknown" and all described as "burning in tongue and throat".  Additional information: It was reported that patient explained that he had an adverse event to the vaccine. He was once able to eat some of his favorite fruits but now he was allergic to them. Patient had reaction to Apple, Cherry, Jackfruit, birch pollen group fruits.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Neck pain
Clinical narrative: upper back, neck and should pain; upper back, neck and should pain; upper back, neck and should pain; This is a spontaneous report received from non-contactable reporter(s) (Physician). The reporter is the patient.  A 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: BACK PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "upper back, neck and should pain".  Additional information: Physician reported that she as well as others she knew (patients, friends, family members) had experienced continued upper back, neck and shoulder pain since receiving the COVID vaccine, irrespective of manufacturer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administered expired ACTHIB with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 15-month-old female patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past vaccination(s) included diphtheria vaccine toxoid,HIB vaccine CONJ (TET TOX), pertussis vaccine acellular 5-component,polio vaccine INACT 3V (MRC 5),tetanus vaccine toxoid (Pentacel) and was given 3 doses of same. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) and influenza vaccine INACT SPLIT 4V (Fluzone Quadrivalent) both for Immunisation.  On 02-Nov-2022, the patient received suspect HIB (PRP/T) vaccine at a dose of 0.5 ml (lot UJ585AAA, expiry date: 16-Oct-2022) via intramuscular route in the left thigh for immunization.  On 02-Nov-2022 the patient was administered expired acthib with no reported adverse event (expired product administered, same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Device malfunction, Exposure via skin contact, Medication error, No adverse event
Clinical narrative: when they were administering ADACEL to a patient, it did not go through needle and medication got onto patient's skin with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 31 years old female patient and reporter reported that Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] administering to her, it did not go through needle and medication got onto patient's skin with no reported adverse event.  It was unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jun-2023, the patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 18-Mar-2025, lot U7671AA) via intramuscular route in the right deltoid for immunization and on the same day they were administering adacel to a patient, it did not go through needle and medication got onto patient's skin with no reported adverse event (accidental exposure to product).  It was unknown if there were lab data/results available.  Reportedly: when they attempted to inject the medication, all of the medication shot out above the needle; states it came from where they attach the needle to the syringe; the serum shot through the side and did not go through the needle. The medication got onto the patient's skin on their arm. The caller states that they had the patient immediately rinse off the affected area and made her wait while they monitored her for any potential reactions; states that the patient was fine and did not experience any reactions afterwards. There was no Broke or cracked during preparation or use and received broken or cracked in the carton. There were not any signs of damage to any other vial in the carton.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: U
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: Menactra vaccine administration was at 9 y of age for a patient with no reported adverse event; Initial information received on 18-Jun-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 9 years old and unknown gender patient who had meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] administration was at 9 y of age for a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength and expiration date: not provided) for immunization and menactra vaccine administration was at 9 y of age for a patient with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of meningococcal a-c-y-w135 (d conj) vaccine. Information on the batch number was requested.  It was reported Menactra vaccine administration was at 9 y of age for a patient. What should be done done next with this patient vaccine schedule  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Tenivac given to a patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and gender patient and it was reported expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-JUN-2023, an expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] Suspension for injection (batch/lot number, expiry date, strength, route: not reported) given to a patient in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: same day). Information on the batch number was requested.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of adacel was given to the patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administered an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] 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 HPV vaccine and meningococcal vaccine for Prophylactic vaccination (immunization).  On 19-Jun-2023, the patient received a dose of 0.5 ml (dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: U70938A; expiry date: 18-Jun-2023; strength: standard; frequency: once) via intramuscular route in left deltoid for immunization.  On 19-Jun-2023 the patient was administered an expired dose of diphtheria-2/tetanus/5 AC pertussis vaccine 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 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: M
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of pentacel was administered to a patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient and it was reported expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] was administered to a patient 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 rotavirus vaccine live oral 1V (Rotarix); and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) both for Prophylactic vaccination.  On 10-MAY-2023, an expired dose of 0.5 mL of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (batch/lot number: UJ663AAA; expiry date: 04-May-2023; Frequency = once; strength: unknown) was administered to a patient via intramuscular route in unknown administration site with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  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: HEP, HEPA, MEN, MMR, VARCEL
Symptoms: Expired product administered, Pruritus, Swelling face
Clinical narrative: The patient received an expired dose of VARIVAX on 4/26/2023.; Itching; Facial Swelling; This spontaneous report was received from a licensed vocational nurse concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-APR-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U012222, expiration date: 16-APR-2023, administered as prophylaxis (strength, and route of administration were not provided) (Expired product administered). In addition, on the same day (26-APR-2023), she also received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection as prophylaxis (dose, route of administration, lot#, and expired date were not provided), meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), hepatitis b vaccine rhbsag (yeast) (ENGERIX-B), hepatitis a vaccine inact (HAVRIX) (doses, formulation, routes of administration, lot#, expired date, and indication were not provided). The reporter informed that all of the vaccines administered were the second dose in their respective series except hepatitis a vaccine inact (HAVRIX).  On an unspecified day in April 2023, the patient experienced itching (pruritus) and facial swelling (swelling face). Therefore, her patients parent took her to the emergency department on 27-APR-2023 (approximately 24 hours after vaccination with multiple vaccines to include varicella virus vaccine live (oka/merck) [VARIVAX]) and it was suggested having the patient allergy tested. It was reported that the patient was administered a dose of an antihistamine and was subsequently sent home from the emergency department and was not admitted to the hospital. It was also stated that a Varicella Zoster Virus (VZVIP) packet being sent via email since the HCP was not available at that moment and would  be back until 26-MAY-2023. No additional information was reported. The outcome of the events was not provided.  The action taken and causal relationship between the events and the suspect vaccines were not reported.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No further AE details; Date of excursion: 3/2/2023; This spontaneous report has been received from a pharmacist, regarding an 18-months-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 02-MAR-2023, doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: W0252273, which was changed to the valid lot number W025273 by the validation lot team, with an expiration date on 10-AUG-2024) underwent a temperature excursion of 70 degrees Fahrenheit (F), for 9 minutes. No previous temperature excursions were reported.   On 13-JUN-2023, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters (ml) once as prophylaxis (lot number: W0252273) (strength, route and anatomical location of administration were not reported) (Product storage error).  No symptoms or further adverse events were reported.   This case is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2306USA007844:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported. No further AE details; Date of excursion: 3/2/2023; This spontaneous report has been received from a pharmacist, regarding a 1-years-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 02-MAR-2023, doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: W0252273, which was changed to the valid lot number W025273, with an expiration date on 10-AUG-2024) underwent a temperature excursion of 70 degrees Fahrenheit (F), for 9 minutes. No previous temperature excursions were reported.   On 12-JUN-2023, the patient was vaccinated with the improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, at a dose of 0.5 milliliters (ml) once as prophylaxis (lot number: W0252273) (strength, route and anatomical location of administration were not reported) (Product storage error). No symptoms or further adverse events were reported.   This case is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2306USA007844:
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: fever throughout the night with intense body aches & fatigue for present for about 24 hours following the injection; fever throughout the night with intense body aches & fatigue for present for about 24 hours following the injection; fever throughout the night with intense body aches & fatigue for present for about 24 hours following the injection; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 55-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Apr2023 at 05:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "anemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLIMEPIRIDE; BENAZEPRIL; LEVOTHYROXINE; PRAVASTATIN; TRULICITY. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 01Apr2023 at 21:00, outcome "recovered" (03Apr2023) and all described as "fever throughout the night with intense body aches & fatigue for present for about 24 hours following the injection". It was unknown if therapeutic measures were taken as a result of pyrexia, pain, fatigue. Additional information: The patient have no known allergies. Patient have no vaccine on the same date and other vaccine in four weeks.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Tinnitus
Clinical narrative: Blood Pressure was Sky High; Ringing in ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for covid-19 Immunization. The following information was reported: HYPERTENSION (non-serious), outcome "unknown", described as "Blood Pressure was Sky High"; TINNITUS (non-serious), outcome "unknown", described as "Ringing in ears". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient took the booster. He didn't have any problems with the first two but with the Booster, his blood pressure was sky high and he had ringing in his ears and the vaccine didn't work too good with the 3rd one. He states with the first 2 he felt okay, but the booster messed him up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GT2524) at the age of 75 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL8982), in left arm, on 17Mar2021 as dose 2, single (Lot number: EN6201), in left arm and on 09Sep2021 as dose 3 (booster), single (Lot number: FC8184), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm and on 21May2023 as dose 6 (booster), single (Lot number: AS7185B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "moderate hyperlipidemia" (unspecified if ongoing); "Known allergies: some shellfish" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown", described as "Vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: Patient received Paxlovid (Lot number GF7870 & G02988, Pfizer) for Significant symptomatic Covid rebound on 18Jun2023 with from 10Jun2023 for COVID 19 anti viral treatment.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, and the events covid-19, vaccination failure, Interchange of vaccine products  cannot be excluded.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Dose 4:Moderna; Dose 1, 2 and 3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 11May2021 as dose 2, single (Lot number: EW0176), in left arm and on 10Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 26Oct2022 as dose 4 (booster), single (Lot number: 061F22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Bactrim/sulfas" (unspecified if ongoing), notes: Known allergies: Bactrim/sulfas. The patient took concomitant medications (Multivitamins). Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: Bactrim/sulfas. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Oct2022, outcome "unknown", described as "Dose 4:Moderna; Dose 1, 2 and 3: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2023) Negative, notes: Positive test day 12 after previously testing negative in days 8 and 10; (18Jun2023) Negative, notes: Positive test day 12 after previously testing negative in days 8 and 10; (20Jun2023) Positive, notes: Positive test day 12 after previously testing negative in days 8 and 10. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: Ew0170), in left arm and on 07May2021 as dose 2, single (Lot number: Ew0176) at the age of 32 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Dec2021 as dose 3 (booster), single (Lot number: 028k21a), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: patient was treated with nirmatrelvir, ritonavir. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir from 08Jun2023 to 13Jun2023.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This case has been considered as invalid as Unspecified Product. Upon follow-up information on [20Jun2023], this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), on 22Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR taken for blood cholesterol increased, start date: 2013, stop date: 02Oct2021; HYDROCHLOROTHIAZIDE taken for blood pressure measurement, start date: 2013, stop date: 02Oct2021. Vaccination history included: Covid-19 vaccine (Dose 1, single Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant) with onset 02Oct2021, outcome "fatal", described as "heart attack". Therapeutic measures were not taken as a result of myocardial infarction. The patient date of death was 02Oct2021. Reported cause of death: "heart attack". It was not reported if an autopsy was performed.   Clinical information: our product killed the reporter dad. The reporter does not know what it was worth, but the reporter father was a great man and killed him. The reporter knows you really do not give a crap, but the reporter thought you needed to know. Any compensation would be helpful for the reporters family and the reporter. After 2nd shot on 22Mar2021 died of heart attack on 02Oct2021. Admission to hospital due to the event was no. Any treatment received was no. The surgery planned prior to taking the product was no. The reporter feels each patient receiving the Pfizer shot should have had their health history looked at. There was no warning label.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: heart attack
Age: 8.0
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: received two doses in 2017 and never received the third booster dose. They are a category risk 3 and require a booster dose due to travel with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case is linked to case 2023SA188357.  This case involves a 8 years old and unknown gender patient who, received two doses Of Rabies (Hdc) Vaccine [Imovax Rabies] in 2017 and never received the third booster dose. they are a category risk 3 and require a booster dose due to travel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient received two doses of suspect Rabies (Hdc) Vaccine (lot number: not reported, Expiry date: not reported) via unknown route in unknown administration site, indication: prophylactic vaccination) in 2017 and never received the third booster dose. they are a category risk 3 and require a booster dose due to travel with no reported adverse event (inappropriate schedule of product administration).  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 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: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Swollen glands (5 days and still continuing ) Full body rash (2 days and still continuing)
Age: 17.0
Sex: M
Vaccine: COVID19, MENB, MNQ
Symptoms: Discontinued product administered
Clinical narrative: Pfizer-BioN Tech MONOVALENT given instead of Pfizer-BioN Tech BIVALENT vaccine, for 12yrs+
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Vomiting
Clinical narrative: Patient received Menveo and Bexsero vaccine at 16:40. This author asked patient to wait for 30 minutes to monitor for reaction. Pt and pt mother verbalized understanding and waited in exam room. After 15 minutes, pt approached this author and asked to wait in waiting area. 5 minutes later, patient mother informed staff that patient was having difficulty breathing.  Rapid response was activated at 1700.  MD and ED personal showed up at 1700. Pt threw up continuously. Vital signs were captured from patient with 98 pulse and 96 O2 Sat on room air. Epinephrine was administered to patient to right thigh at 1702. 22 gauge IV started in right AC at 1700. Pt alert and oriented throughout the rapid response. Pt stayed conscious throughout rapid response. Pt transferred to ED with ED personal.
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient given pediatric Hep B vaccine instead of adult Hep B vaccine.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Approximately 4 days after getting booster shot started having slight dizziness. Still having a little now. Have not seen my Doctor. Unless it gets worse, not going to the Doctor.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that theDepartment of Health recommends being revaccinated at their earliest convenience.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the  Department of Health recommends being revaccinated at their earliest convenience.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: The patient received a vaccine that had not been stored properly.  Rather than storing under refrigeration upon receipt from the manufacturer, the vaccine was placed into a freezer that maintained temperatures between -4- and 5-degrees Fahrenheit.  Guidance from the manufacturer states that while administration of a vaccine having undergone this temperature excursion would not cause harm to the patient, the effectiveness of the vaccine cannot be verified.  No harm has been reported by this patient and they have been notified that the Department of Health recommends being revaccinated at their earliest convenience.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Fatigue, Oropharyngeal pain
Clinical narrative: Cough, sore throat, runny nose, congestion, sneezing, no smell or taste, tired.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: Cough, sore throat, runny nose, congestion, sneezing, no smell or taste, tired.
Age: 32.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was three days pass the stated expiration date. The Moderna team did an analyse on the lot number and determined that the vaccine was still valid and effective at the time of the adminestration.  No advers reaction from the client.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: The vaccine was adminestered three days after the stated expiration date. There was no adverse reaction  from the client. No need for any action or treatment. 06/21/2023 03:50pm
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Local reaction, Skin warm
Clinical narrative: Large localized reaction of the left leg with redness and warmth spreading rapidly requiring a visit to ER for steroid administration.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness
Clinical narrative: Tdap and MenQuadfi given in R arm IM. HPV9 given IM in L arm. Patient sitting on table then moved to chair to sit but sister. Patient then stated within 2 minutes of last vaccine (HPV9) that she felt like she would pass out. Patient passed out on her sisters shoulder mom then picked her head up and childs eyes tolled back. The Dr. came in and laid child down on seat and monitored her for at least the next hour. Once patient felt ok, water given and family helped child to restroom and then left office. Nurse from our office called mom next day was doing better.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: Pt developed shingles L4 dermatome right leg, VZV PCR (+)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine) 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 EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine).    This case was created for patient 14 out of 20.  Concomitant medication was not provided. Pharmacist called to report that several nursing home patients received expired Bivalent booster dose of Moderna COVID-19 vaccine, located in the freezer thawed.  They were all in intact carton. Vial size was 2.5 ml and had not underwent any temperature excursions. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-727268 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727268:Patient 3 out of 20