chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: U
Vaccine: FLU3
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: medication error due to temperature excursion product administered to patient with no reported AE; medication error due to temperature excursion product administered to patient with no reported AE; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 42 years old of an unknown gender patient who was administered vaccines post medication error due to temperature excursion with no reporter adverse event , after receiving vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED( lot UJ899AA and expiration date:30-Jun-2023) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On 06-Oct-2022 ,the patient developed a non-serious  event of medication error due to temperature excursion product administered to patient with no reported ae (poor quality product administered) (latency: same day)(Product storage error )(Latency: Unknown).   Action taken :not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: received a FLUZONE HD QIV in error, due to patients age with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 59 years old female patient who received an influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] in error, due to patient 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 a  dose of suspect influenza quadrival A-B high dose HV vaccine (Lot Number:UT7743CA,Expiration Date :30-06-2023) reported via unknown route in unknown administration site for prophylactic vaccination in error, due to patient age with no reported adverse event (product administered to patient of inappropriate age) (unknown 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 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.; Sender's Comments:  01320915:
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL administered post excursion with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA422364.  This case involves a 14 years old male patient to whom punctured IPV (VERO) [IPOL].administered post excursion 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 MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation; MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 03-Oct-2022, the patient received  0.5 ml (once) dose of suspect punctured IPV (VERO), Suspension for injection (lot V1A024M; expiry date 17-Feb-2024) via intramuscular route in the right deltoid for Immunization  post excursion with no reported adverse event (poor quality product administered) (latency: on same day).  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 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: F
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: punctured IPOL administered post excursion with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health care professional.  This case is linked to cases 2022SA422378 and 2022SA424157.  This case involves a 17 years old female patient and reporter reported punctured ipol administered post excursion with no reported adverse event (IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; varicella zoster vaccine (varicella vaccine) for prophylactic vaccination; and hepatitis B vaccine (hepatitis B vaccine) for Prophylactic vaccination.  On 03-Oct-2022, the patient received a dose of suspect IPV (VERO) standard at a dose of 0.5 ml (milliliter) Once (lot V1A024M, expiry date 17-Feb-2024)(form : unknown) via intramuscular route in right deltoid for Immunization.  On 03-Oct-2022 the patient was administered punctured ipol post excursion with no reported adverse event (poor quality 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.
Age: 15.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: stated a dose of IPOL vaccine, that expired on 10OCT2022, was administered yesterday 12OCT2022 with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who experienced was administered a expired dose of IPV (VERO) [IPOL] vaccine, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  IPOL vaccine (strength: standard) (lot T1E872M, exp: 10-oct-2022) , that expired on 10-Oct-2022, was administered yesterday at dose of 0.5 ml total dose on 12-Oct-2022 via intramuscular route in the right deltoid for immunization with no reported adverse events (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.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Off label use
Clinical narrative: 52-year-old female receiving Fluzone Quadrivalent High-Dose, with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 52-year-old female patient who was receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Oct-2022, the patient received 0.7ml dose total of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation: unknown) (lot number: UJ895AC and expiry date: 30-Jun-2023) via intramuscular route in the left arm for Immunization and 52-year-old female was receiving fluzone quadrivalent high-dose, with no reported adverse event (off label use; latency: same day).  It was reported, the Nurse reported that the error was due to the order was given verbally; that the provider misspoke thinking the consumer was over 65-years; and the age of the patient was not checked prior to administration.   Action taken was not applicable.  At time of reporting, the outcome was Unknown.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: child received an expired dose of daptacel with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 5 years old male patient who received an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine (Daptacel) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact (IPV).  On 13-Oct-2022, the patient had received a dose of 0.5 ml total (dose 4) of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection standard (lot C5774CA, expiry date- 18-Sep-2022) via intramuscular route in the left deltoid for Immunization.  On 13-Oct-2022, the patient had received an expired dose of daptacel with no reported adverse event (expired product administered) latency same day following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  No lab data was reported  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.
Sex: F
Vaccine: FLU3
Symptoms: Suspected product contamination, Urticaria
Clinical narrative: entire arm "blew up" instantly with a giant welt; suspect that test was contaminated with something; Initial information received from on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced entire arm "blew up" instantly with a giant welt while receiving vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] and while treated with TUBERCULIN TEST [TUBERSOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection 0.1 mL once (with an unknown batch number) for PPD skin test and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (strength, dose, formulation, route,lot number not reported) in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event entire arm "blew up" instantly with a giant welt (urticaria) and "suspect that test was contaminated with something"(Suspected product contamination) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and TUBERCULIN TEST.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.
Age: 7.0
Sex: M
Vaccine: FLUR3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 7-year-old child received the flubok (with no reported adverse event); Initial information regarding an unsolicited valid non-serious case received via health professional on 14-Oct-2022. GMI number: 01322654  This case involves a 7-year-old male child received Influenza Quadrivalent Recombinant Vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Oct-2022, the 7-year-old male child received suspect Flublok vaccine at dose 0.5ml once (lot: UJ893AB, expiry date: 09-Jun-2023) via intramuscular route in the right deltoid for Immunization with no reported adverse event) (product use issue) at same day latency.  It was reported that "Physician office staff is calling to report that a 7-year-old child received the FLUBLOK. Caller is wanting to know what to do and what side effects the child may have. This situation is reported as a medication error due to giving the medication to not approved age."   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.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired fluzone quadrivalent with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who reported expired fluzone quadrivalent with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 11-OCT-2022, the patient received a  0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (strength, formulation, route, lot number, route: not reported) in unknown administration site for Influenza.  On 11-OCT-2022 the patient reported a non-serious event expired fluzone quadrivalent with no reported adverse event (expired product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Elderly female over 65 years age Fluzone Quadrivalent rather than the indicated fluzone high-dose quadrivalent, with no reported adverse event; Initial information received on 17-Oct-2022 along with live follow-up of same RA regarding an unsolicited valid non-serious case received via consumer/non-hcp. RA number: 01324598 and 01324661.  This case involves Elderly female over 65 years age to whom vaccine INFLUENZA QUADRIVAL A-B VACCINE [Fluzone Quadrivalent] rather than the indicated Fluzone high-dose quadrivalent, 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 over 65 years was administered suspect Fluzone Quadrivalent rather than the indicated Fluzone high dose quadrivalent at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination with no reported adverse event (wrong product administered) at unknown latency.  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: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: patients skin the medication ran out onto the patients' arm, with no reported adverse event; Initial information received on 17-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA430802(CLUSTER).  This case involves a 22 years old female patient to whom skin the medication ran out onto the patients' arm, with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On 12-Oct-2022, the patient received a 0.5ml 1X(once) dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength: unknown, lot UT7716JA and expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On 12-Oct-2022 the patient developed a non-serious event of patients skin the medication ran out onto the patients' arm, with no reported adverse event (accidental exposure to product) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. The reporter stated that when she placed the needle on the end of the syringe, she heard a click sound prior to administration.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUC3
Symptoms: Diarrhoea, Nausea
Clinical narrative: Nausea; Diarrhea; This spontaneous case from the United States was received on 06-Oct-2022 from other healthcare professional (nurse) via Communications (reference number: SEQW22-04040) with additional information received on 12-Oct-2022 (being processed together) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced nausea and diarrhea.  The outcome of the events was not reported.  The reporter assessed the events of nausea and diarrhea to be related to Flucelvax Quadrivalent. As reported, diarrhea and nausea, both were related to the vaccine as not one else had these symptoms prior to vaccine administration and these only occurred in the patients that received the vaccine.  This case is linked with the cases 202204733, 202204734, 202204735, 202204736, 202204737, 202204738, 202204739, 202204740 and 202205485 (the same reporter).  Company comment: The events of diarrhea and nausea are assessed as unassessable to Flucelvax Quadrivalent due to unclear temporal relationship.; Reporter's Comments: As reported, diarrhea and nausea, both were related to the vaccine as not one else had these symptoms prior to vaccine administration and these only occurred in the patients that received the vaccine.; Sender's Comments: The events of diarrhea and nausea are assessed as unassessable to Flucelvax Quadrivalent due to unclear temporal relationship.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: Patient was given Benadryl and prednisone in the emergency department and watched
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Vaccination site discharge
Clinical narrative: No Adverse event; a lot of the vaccine ran down my arm to my elbow; It was a partial dose that I got./I'm concerned that I didn't get the full dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCHARGE (a lot of the vaccine ran down my arm to my elbow), ACCIDENTAL UNDERDOSE (It was a partial dose that I got./I'm concerned that I didn't get the full dose) and NO ADVERSE EVENT (No Adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 19-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced VACCINATION SITE DISCHARGE (a lot of the vaccine ran down my arm to my elbow) and ACCIDENTAL UNDERDOSE (It was a partial dose that I got./I'm concerned that I didn't get the full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, VACCINATION SITE DISCHARGE (a lot of the vaccine ran down my arm to my elbow), ACCIDENTAL UNDERDOSE (It was a partial dose that I got./I'm concerned that I didn't get the full dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for VACCINATION SITE DISCHARGE (a lot of the vaccine ran down my arm to my elbow) and ACCIDENTAL UNDERDOSE (It was a partial dose that I got./I'm concerned that I didn't get the full dose).    Patient received the 5th dose of Moderna Covid-19 Vaccine, Bivalent about 40 min ago.  It was reported that When the student nurse pulled the needle out, a lot of the vaccine ran down patient arm to her elbow. It was a partial dose that patient got. patient was concerned & asked her about it. She then went to ask someone else, & that person said 'it'll be ok. You'll still get the full effect.  Patient taken 5 different immunosuppressants. patient was concerned that  patient didn't get the full dose. And immunocompromised people don't ever get the full effect of vaccines anyway.   Patient received First dose on 24-Jan-2021 with Lot number 027L20A. Patient received second dose on 24-Feb-2021 with Lot number 032L20A. Patient received First  booster dose on 21-Aug-2021 with Lot number 52C21A. Patient received second booster dose on 18-Feb-2022 with Lot number 025L21B.  No treatment drug were reported.   This case was linked to MOD-2022-661309 (Patient Link).
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022; No adverse event; patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.), PRODUCT STORAGE ERROR (Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064A22A and 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.), PRODUCT STORAGE ERROR (Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received  monovalent Moderna Covid-19 vaccine that was past the 30 day use by date in the refrigerator.) and PRODUCT STORAGE ERROR (Vaccine had been in the refrigerator for more than 30 days, initially stored in refrigerator on 06 Sep 2022, date administered on 18 Oct 2022).    Vial size was 2.5ml. The vial was initially stored in the refrigerator on 6-SEP-2022. The vial does not undergone any temperature excursions.  No concomitant and treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient had Moderna bivalent booster vaccine for their first primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient had Moderna bivalent booster vaccine for their first primary dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient had Moderna bivalent booster vaccine for their first primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient had Moderna bivalent booster vaccine for their first primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 INCORRECT DOSE ADMINISTERED (Patient had Moderna bivalent booster vaccine for their first primary dose).    No concomitant information provided Two patients walked into the Pharmacy the previous day and received the moderna bivalent booster vaccine for their first primary dose. The patients had never received a primary series of the Moderna Covid-19 vaccine. No treatment information provided   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Lethargy, Musculoskeletal stiffness, Pain
Clinical narrative: Body aches, stiff neck, lethargy, depression
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Headache, Myalgia, Fever,  SORE ARM; CHILLS Narrative:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood creatinine normal, Blood glucose normal, Brain natriuretic peptide increased
Clinical narrative: 5/13/22: Received vaccine and became exhausted and had arm pain almost immediately. Went to be early.  5/14/22: Did not get out of bed, was lethargic, had arm pain, a headache, and later in the day developed a fever (101.3) 5/15/22: Did not want to get out of bed, was hard to rise. Forced him up to take a shower and visit his grandmother. He had a fever (101 and higher) and was very tired all day. He fell asleep around 3pm at his grandmother's house so we came home.  When we arrived home at around 3:30 pm, he complained of chest pain. We decided to take him to the ER. Just before leaving, he told us he needed to throw up and he did. He then said he felt much better. Thinking his chest pain was caused by indigestion due to his diet at his grandmother's house (soda and chips), we let him go to bed early and sleep instead of taking him to the ER.  5/16/22: He woke up at 1:30 am and threw up again. He said he felt ok and went back to sleep. Continued fevers of 102. He woke up again at 4:30 am and told us his chest hurt and it hurt to breathe.  We took him to the doctor that morning. He sent us to the Emergency Room. After running tests and noticing high Troponin and (spikes and lows) on heart rate monitor,  they decided to transport him via chopper to another Hospital, with thunderstorms in the area, he was sent via ambulance at 9pm. He was admitted at 11pm through the ER and we got into a room by 4am on 5/17/22.  Admission diagnosis: acute myocarditis, unspecified myocarditis type Treated with Ibuprofen and Famotidine Released after troponin levels reached 4.  Ibuprofen and famotidine taken until June 2 when levels were somewhat normalized on follow up EKG.  Follow ups in June, September, and April.  Because his inflammation has not gone down, Dr, the cardiologist will follow the patient for the next few years and has recommended he see the cardiac athletic specialist to help him re-introduce some sports; however he cannot swim or participate in contact sports. (As of 10/21/22)
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Carbon dioxide normal, Cardiac monitoring abnormal, Cardiac stress test, Chest X-ray, Chest pain
Clinical narrative: 5/13/22: Received vaccine and became exhausted and had arm pain almost immediately. Went to be early.  5/14/22: Did not get out of bed, was lethargic, had arm pain, a headache, and later in the day developed a fever (101.3) 5/15/22: Did not want to get out of bed, was hard to rise. Forced him up to take a shower and visit his grandmother. He had a fever (101 and higher) and was very tired all day. He fell asleep around 3pm at his grandmother's house so we came home.  When we arrived home at around 3:30 pm, he complained of chest pain. We decided to take him to the ER. Just before leaving, he told us he needed to throw up and he did. He then said he felt much better. Thinking his chest pain was caused by indigestion due to his diet at his grandmother's house (soda and chips), we let him go to bed early and sleep instead of taking him to the ER.  5/16/22: He woke up at 1:30 am and threw up again. He said he felt ok and went back to sleep. Continued fevers of 102. He woke up again at 4:30 am and told us his chest hurt and it hurt to breathe.  We took him to the doctor that morning. He sent us to the Emergency Room. After running tests and noticing high Troponin and (spikes and lows) on heart rate monitor,  they decided to transport him via chopper to another Hospital, with thunderstorms in the area, he was sent via ambulance at 9pm. He was admitted at 11pm through the ER and we got into a room by 4am on 5/17/22.  Admission diagnosis: acute myocarditis, unspecified myocarditis type Treated with Ibuprofen and Famotidine Released after troponin levels reached 4.  Ibuprofen and famotidine taken until June 2 when levels were somewhat normalized on follow up EKG.  Follow ups in June, September, and April.  Because his inflammation has not gone down, Dr, the cardiologist will follow the patient for the next few years and has recommended he see the cardiac athletic specialist to help him re-introduce some sports; however he cannot swim or participate in contact sports. (As of 10/21/22)
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspepsia, Echocardiogram abnormal, Electrocardiogram ST segment depression, Electrocardiogram ST segment elevation
Clinical narrative: 5/13/22: Received vaccine and became exhausted and had arm pain almost immediately. Went to be early.  5/14/22: Did not get out of bed, was lethargic, had arm pain, a headache, and later in the day developed a fever (101.3) 5/15/22: Did not want to get out of bed, was hard to rise. Forced him up to take a shower and visit his grandmother. He had a fever (101 and higher) and was very tired all day. He fell asleep around 3pm at his grandmother's house so we came home.  When we arrived home at around 3:30 pm, he complained of chest pain. We decided to take him to the ER. Just before leaving, he told us he needed to throw up and he did. He then said he felt much better. Thinking his chest pain was caused by indigestion due to his diet at his grandmother's house (soda and chips), we let him go to bed early and sleep instead of taking him to the ER.  5/16/22: He woke up at 1:30 am and threw up again. He said he felt ok and went back to sleep. Continued fevers of 102. He woke up again at 4:30 am and told us his chest hurt and it hurt to breathe.  We took him to the doctor that morning. He sent us to the Emergency Room. After running tests and noticing high Troponin and (spikes and lows) on heart rate monitor,  they decided to transport him via chopper to another Hospital, with thunderstorms in the area, he was sent via ambulance at 9pm. He was admitted at 11pm through the ER and we got into a room by 4am on 5/17/22.  Admission diagnosis: acute myocarditis, unspecified myocarditis type Treated with Ibuprofen and Famotidine Released after troponin levels reached 4.  Ibuprofen and famotidine taken until June 2 when levels were somewhat normalized on follow up EKG.  Follow ups in June, September, and April.  Because his inflammation has not gone down, Dr, the cardiologist will follow the patient for the next few years and has recommended he see the cardiac athletic specialist to help him re-introduce some sports; however he cannot swim or participate in contact sports. (As of 10/21/22)
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ambulatory, Fatigue, Haematocrit normal, Haemoglobin decreased, Headache
Clinical narrative: 5/13/22: Received vaccine and became exhausted and had arm pain almost immediately. Went to be early.  5/14/22: Did not get out of bed, was lethargic, had arm pain, a headache, and later in the day developed a fever (101.3) 5/15/22: Did not want to get out of bed, was hard to rise. Forced him up to take a shower and visit his grandmother. He had a fever (101 and higher) and was very tired all day. He fell asleep around 3pm at his grandmother's house so we came home.  When we arrived home at around 3:30 pm, he complained of chest pain. We decided to take him to the ER. Just before leaving, he told us he needed to throw up and he did. He then said he felt much better. Thinking his chest pain was caused by indigestion due to his diet at his grandmother's house (soda and chips), we let him go to bed early and sleep instead of taking him to the ER.  5/16/22: He woke up at 1:30 am and threw up again. He said he felt ok and went back to sleep. Continued fevers of 102. He woke up again at 4:30 am and told us his chest hurt and it hurt to breathe.  We took him to the doctor that morning. He sent us to the Emergency Room. After running tests and noticing high Troponin and (spikes and lows) on heart rate monitor,  they decided to transport him via chopper to another Hospital, with thunderstorms in the area, he was sent via ambulance at 9pm. He was admitted at 11pm through the ER and we got into a room by 4am on 5/17/22.  Admission diagnosis: acute myocarditis, unspecified myocarditis type Treated with Ibuprofen and Famotidine Released after troponin levels reached 4.  Ibuprofen and famotidine taken until June 2 when levels were somewhat normalized on follow up EKG.  Follow ups in June, September, and April.  Because his inflammation has not gone down, Dr, the cardiologist will follow the patient for the next few years and has recommended he see the cardiac athletic specialist to help him re-introduce some sports; however he cannot swim or participate in contact sports. (As of 10/21/22)
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Infectious mononucleosis, Intensive care, Lethargy, Metabolic function test, Myocarditis
Clinical narrative: 5/13/22: Received vaccine and became exhausted and had arm pain almost immediately. Went to be early.  5/14/22: Did not get out of bed, was lethargic, had arm pain, a headache, and later in the day developed a fever (101.3) 5/15/22: Did not want to get out of bed, was hard to rise. Forced him up to take a shower and visit his grandmother. He had a fever (101 and higher) and was very tired all day. He fell asleep around 3pm at his grandmother's house so we came home.  When we arrived home at around 3:30 pm, he complained of chest pain. We decided to take him to the ER. Just before leaving, he told us he needed to throw up and he did. He then said he felt much better. Thinking his chest pain was caused by indigestion due to his diet at his grandmother's house (soda and chips), we let him go to bed early and sleep instead of taking him to the ER.  5/16/22: He woke up at 1:30 am and threw up again. He said he felt ok and went back to sleep. Continued fevers of 102. He woke up again at 4:30 am and told us his chest hurt and it hurt to breathe.  We took him to the doctor that morning. He sent us to the Emergency Room. After running tests and noticing high Troponin and (spikes and lows) on heart rate monitor,  they decided to transport him via chopper to another Hospital, with thunderstorms in the area, he was sent via ambulance at 9pm. He was admitted at 11pm through the ER and we got into a room by 4am on 5/17/22.  Admission diagnosis: acute myocarditis, unspecified myocarditis type Treated with Ibuprofen and Famotidine Released after troponin levels reached 4.  Ibuprofen and famotidine taken until June 2 when levels were somewhat normalized on follow up EKG.  Follow ups in June, September, and April.  Because his inflammation has not gone down, Dr, the cardiologist will follow the patient for the next few years and has recommended he see the cardiac athletic specialist to help him re-introduce some sports; however he cannot swim or participate in contact sports. (As of 10/21/22)
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Painful respiration, Pyrexia, SARS-CoV-2 test negative, Troponin I increased
Clinical narrative: 5/13/22: Received vaccine and became exhausted and had arm pain almost immediately. Went to be early.  5/14/22: Did not get out of bed, was lethargic, had arm pain, a headache, and later in the day developed a fever (101.3) 5/15/22: Did not want to get out of bed, was hard to rise. Forced him up to take a shower and visit his grandmother. He had a fever (101 and higher) and was very tired all day. He fell asleep around 3pm at his grandmother's house so we came home.  When we arrived home at around 3:30 pm, he complained of chest pain. We decided to take him to the ER. Just before leaving, he told us he needed to throw up and he did. He then said he felt much better. Thinking his chest pain was caused by indigestion due to his diet at his grandmother's house (soda and chips), we let him go to bed early and sleep instead of taking him to the ER.  5/16/22: He woke up at 1:30 am and threw up again. He said he felt ok and went back to sleep. Continued fevers of 102. He woke up again at 4:30 am and told us his chest hurt and it hurt to breathe.  We took him to the doctor that morning. He sent us to the Emergency Room. After running tests and noticing high Troponin and (spikes and lows) on heart rate monitor,  they decided to transport him via chopper to another Hospital, with thunderstorms in the area, he was sent via ambulance at 9pm. He was admitted at 11pm through the ER and we got into a room by 4am on 5/17/22.  Admission diagnosis: acute myocarditis, unspecified myocarditis type Treated with Ibuprofen and Famotidine Released after troponin levels reached 4.  Ibuprofen and famotidine taken until June 2 when levels were somewhat normalized on follow up EKG.  Follow ups in June, September, and April.  Because his inflammation has not gone down, Dr, the cardiologist will follow the patient for the next few years and has recommended he see the cardiac athletic specialist to help him re-introduce some sports; however he cannot swim or participate in contact sports. (As of 10/21/22)
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased, Vomiting
Clinical narrative: 5/13/22: Received vaccine and became exhausted and had arm pain almost immediately. Went to be early.  5/14/22: Did not get out of bed, was lethargic, had arm pain, a headache, and later in the day developed a fever (101.3) 5/15/22: Did not want to get out of bed, was hard to rise. Forced him up to take a shower and visit his grandmother. He had a fever (101 and higher) and was very tired all day. He fell asleep around 3pm at his grandmother's house so we came home.  When we arrived home at around 3:30 pm, he complained of chest pain. We decided to take him to the ER. Just before leaving, he told us he needed to throw up and he did. He then said he felt much better. Thinking his chest pain was caused by indigestion due to his diet at his grandmother's house (soda and chips), we let him go to bed early and sleep instead of taking him to the ER.  5/16/22: He woke up at 1:30 am and threw up again. He said he felt ok and went back to sleep. Continued fevers of 102. He woke up again at 4:30 am and told us his chest hurt and it hurt to breathe.  We took him to the doctor that morning. He sent us to the Emergency Room. After running tests and noticing high Troponin and (spikes and lows) on heart rate monitor,  they decided to transport him via chopper to another Hospital, with thunderstorms in the area, he was sent via ambulance at 9pm. He was admitted at 11pm through the ER and we got into a room by 4am on 5/17/22.  Admission diagnosis: acute myocarditis, unspecified myocarditis type Treated with Ibuprofen and Famotidine Released after troponin levels reached 4.  Ibuprofen and famotidine taken until June 2 when levels were somewhat normalized on follow up EKG.  Follow ups in June, September, and April.  Because his inflammation has not gone down, Dr, the cardiologist will follow the patient for the next few years and has recommended he see the cardiac athletic specialist to help him re-introduce some sports; however he cannot swim or participate in contact sports. (As of 10/21/22)
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, muscle aches, chills, headache
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Joint injury, Pain, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli, Vision blurred
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient was given her first pediatric Pfizer dose and a couple of minutes later upon standing up, she fainted into her mother's arms. She was then asked to remain seated and a few minutes later the mother started walking her to the bathroom where she was having blurred vision and mild sweating. We then called EMS and the fire department showed up who took her vitals which were all normal and at that time (25 mins later) she felt well enough to walk to the car accompanied by the fire department.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient was given her first pediatric Pfizer dose and a couple of minutes later upon standing up, she fainted into her mother's arms. She was then asked to remain seated and a few minutes later the mother started walking her to the bathroom where she was having blurred vision and mild sweating. We then called EMS and the fire department showed up who took her vitals which were all normal and at that time (25 mins later) she felt well enough to walk to the car accompanied by the fire department.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Injection site pain, Tachycardia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Medium
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: Systemic: open sore at injection site-Mild, Additional Details: patient denied any allergic symptoms