chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Urinary tract infection
Clinical narrative: urinary tract infection; cough; Initial information received on 15-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 79 years old female patient who experienced urinary tract infection and cough while receiving vaccine influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical treatment included STEROIDS with history of needing steroid injections into her hip. The patient's past vaccination(s) included INFLUENZA VACCINE. The patient's past medical history and family history were not provided.   On 24-Oct-2022, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (formulation, strength, dose and lot number not reported) via unknown route in the left arm for prophylactic immunization.  On an unknown date, the patient developed non-serious events of urinary tract infection and cough (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, she took a fluzone quadrivalent high dose vaccine on 24-Oct-2022. On 27-Oct-2022, she received a steroid shot in her hip. After the steroid shot, the patient felt strange, agitated, could not think clearly, could not sleep, and unable to function. The patient also had a Urinary Tract infection that she is unsure if it started before or after getting the fluzone quadrivalent high dose vaccine for which she started antibiotics. The patient also coughed several times during the call.   Action taken was not applicable.  Patient took antibiotics for the treatment of urinary tract infection.  At time of reporting, the outcome was Unknown for both the events.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Accidental exposure to product, Medication error, No adverse event, Product use issue
Clinical narrative: 10-year-old patient was inadvertently administered fluzone high-dose QIV with no reported adverse event; The 10-year-old patient was inadvertently administered Fluzone High-Dose QIV with no reported adverse event; Initial information was received on 16-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 10 years old male patient who had inadvertently administered fluzone high-dose qiv with no reported adverse event after receiving influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 vaccine for COVID-19 immunization.  On 15-Nov-2022, the patient received 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot: UJ895AC) (frequency: total) (expiry date, strength was unknown) via intramuscular route in the left deltoid for Immunisation.  On 15-Nov-2022 the patient had a non-serious event 10-year-old patient was inadvertently administered fluzone high-dose qiv with no reported adverse event (product use issue) and (Accidental exposure to product) (latency: same day) following the administration of influenza quadrival A-B high dose HV vaccine.  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 Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: they administered an act-hib vaccine that was a couple of days out of date,with no reported adverse event; Initial information received on 16-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 months old female patient and it was reported that they administered an act-hib vaccine that was a couple of days out of date, with no reported adverse event after receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination; and hepatitis A vaccine(Hepatitis  A) for Prophylactic vaccination.  On 02-Nov-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE powder and solvent for solution for injection (batch number: UJ603AAA) (strength and expiry date: unknown) via intramuscular route in the right thigh.  On 02-Nov-2022, the patient developed a non-serious event they administered an act-hib vaccine that was a couple of days out of date, with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE.  Lab data not reported.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  At time of reporting, the outcome was unknown for the event they administered an act-hib vaccine that was a couple of days out of date, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received MENQUADFI after it experienced a temperature excursion, with no reported adverse event; patient received MENQUADFI after it experienced a temperature excursion, with no reported adverse event; Initial information received from on 16-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 16 years old female patient who received Meningococcal A-C-Y-W135 (T CONJ) vaccine [MENQUADFI] after it experienced a temperature 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 Hpv Vaccine ; and Influenza Vaccine.  On 21-Oct-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection at dose 0.5 ml(lot U7447AC and expiry date: 20-SEP-2024) (with unknown strength, frequency) via intramuscular route in Left Deltoid for immunization, after it experienced a temperature excursion, with no reported adverse event (product storage error),(Poor quality vaccine administered)  (Latency: same day) following the administration of Meningococcal A-C-Y-W135 (T CONJ) vaccine.  Action taken was not applicable.  The outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: F
Vaccine: FLUC3
Symptoms: Fatigue, Nausea, Pain, Pyrexia, Somnolence
Clinical narrative: Sleepiness; Body aches; Low grade fever / 99.7°F fever; Extreme fatigue; Nausea; This spontaneous case was received on 03-Nov-2022 from other healthcare professional via regulatory authority (reference number: SEQW22-05377) with additional information received on 11-Nov-2022 (reference number: SEQW22-05708) (being processed together) and concerned a 27-year-old, female patient.   The patient's concurrent conditions included mast cell activation syndrome, triggered primarily through gastrointestinal issues. The patient's concomitant medications included famotidine, cetirizine and cromolyn sodium, all used for an unreported indication.   On 02-Nov-2022, at 14:20, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5ml, route of administration, anatomical location: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 942370 and expiry date: 23-May-2023.  On the same date, within an hour, at 15:13, after receiving Flucelvax Quadrivalent, the patient experienced low grade fever, which was followed by fatigue, nausea and mild body aches by 16:00. At that point, the patient left for home. Around 17:00, the patient had a 99.7 degrees Fahrenheit (F) fever, severe body aches, sleepiness, extreme fatigue. The effects remained until the patient went to bed.  On the same date, the patient recovered from the events of sleepiness, fever, and nausea.   On 03-Nov-2022 (as of this date, as reported), the following day, the patient got better and only had fatigue and mild body aches. No medications were taken for treatment.  At the time of initial reporting on 03-Nov-2022, the patient was recovering from the events of 'general body pain' and 'fatigue extreme'. The patient was still feeling symptoms, although less and milder that the day of administration.  The reporter assessed the events to be related to Flucelvax Quadrivalent. The patient reported the events as a reaction to the flu shot.  The case was assessed as non-serious.  Company comment: A 27-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed pyrexia, fatigue, nausea, general body pain and sleepiness. Information regarding the related diagnostic findings has not been provided. Based on plausible time relationship, causality is assessed as possibly related.; Reporter's Comments: The patient reported the events as a reaction to the flu shot.; Sender's Comments: A 27-year-old, female patient was vaccinated with the suspect product Flucelvax Quadrivalent. On the same day after vaccination the patient developed pyrexia, fatigue, nausea, general body pain and sleepiness. Information regarding the related diagnostic findings has not been provided. Based on plausible time relationship, causality is assessed as possibly related.
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Fatigue, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: Vaccination site pain; Neck pain; Jaw pain; Shoulder blade pain; Joint pain; Lower extremities weakness of; Tiredness; Initial information received on 14-Nov-2022 regarding an unsolicited valid serious case from consumer/non-HCP via the regulatory authority under reference GB-MHRA-ADR 27463488.   This case involves a 50-64 years aged female patient who experienced tiredness, vaccination site pain, neck pain, jaw pain, shoulder blade pain, joint pain and lower extremities weakness of after receiving influenza vaccine.  The patient's past medical treatment included influenza virus. The patient's past medical history, vaccination(s) and family history were not provided.   On 09-Nov-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, dose, frequency, route, expiry date, batch number, administration site) for prophylactic vaccination.   On 09-Nov-2022 the patient developed a serious event of tiredness (fatigue) same day following the administration of influenza vaccine.    On an unknown date the patient developed serious events of vaccination site pain, neck pain, jaw pain (pain in jaw), shoulder blade pain (musculoskeletal pain), joint pain (arthralgia), lower extremities weakness of (muscular weakness) (unknown latency) following the administration of influenza vaccine.   No lab data reported.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the events    Outcome was Unknown for all the events  All events were assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 18-Nov-2022: This case involves a 50-64 years aged female patient who experienced tiredness, vaccination site pain, neck pain, jaw pain, shoulder blade pain, joint pain and lower extremities weakness of after receiving influenza vaccine. Based upon the reported information, the role of a vaccine cannot be assessed. However, lack of information regarding past and concomitant medication and medical history precludes comprehensive case assessment.
Sex: F
Vaccine: FLUX
Symptoms: Pain in jaw, Vaccination site pain
Clinical narrative: Vaccination site pain; Neck pain; Jaw pain; Shoulder blade pain; Joint pain; Lower extremities weakness of; Tiredness; Initial information received on 14-Nov-2022 regarding an unsolicited valid serious case from consumer/non-HCP via the regulatory authority under reference GB-MHRA-ADR 27463488.   This case involves a 50-64 years aged female patient who experienced tiredness, vaccination site pain, neck pain, jaw pain, shoulder blade pain, joint pain and lower extremities weakness of after receiving influenza vaccine.  The patient's past medical treatment included influenza virus. The patient's past medical history, vaccination(s) and family history were not provided.   On 09-Nov-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, dose, frequency, route, expiry date, batch number, administration site) for prophylactic vaccination.   On 09-Nov-2022 the patient developed a serious event of tiredness (fatigue) same day following the administration of influenza vaccine.    On an unknown date the patient developed serious events of vaccination site pain, neck pain, jaw pain (pain in jaw), shoulder blade pain (musculoskeletal pain), joint pain (arthralgia), lower extremities weakness of (muscular weakness) (unknown latency) following the administration of influenza vaccine.   No lab data reported.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the events    Outcome was Unknown for all the events  All events were assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 18-Nov-2022: This case involves a 50-64 years aged female patient who experienced tiredness, vaccination site pain, neck pain, jaw pain, shoulder blade pain, joint pain and lower extremities weakness of after receiving influenza vaccine. Based upon the reported information, the role of a vaccine cannot be assessed. However, lack of information regarding past and concomitant medication and medical history precludes comprehensive case assessment.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE reported; the product had a temperature excursion on 9/8/2021; RECOMBIVAX HB expired on 11/3/2022 and a dose was administered to a patient on 11/7/2022; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's medical history was not reported. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 08-SEP-2021, that the product hepatitis b vaccine (recombinant) (RECOMBIVAX HB) had a temperature excursion (product storage error). The details of the temperature excursion were unknown at the time of the call. On 07-NOV-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot # T022566, expiration date: 03-NOV-2022, formulation was not reported, but upon internal validation established as vial, administered for prophylaxis (therapy type: thimerosal free, strength, dose and route were not provided) (expired product administered). No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: two patients received a dose of Havrix that expired 5 weeks earlier; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK receipt date: 14-NOV-2022 Reporters comment: Doctor reported the patient received a dose of Havrix that expired 5 weeks earlier. The health care professional did not provide patient identifiers, lot number, or exact expiration date of product. The reporter consent to follow-up. Additional Supportive information: The patient received a dose of Havrix that expired 5 weeks earlier, which led to expired vaccine used. This case had been linked to the case US2022168145 reported by the same reporter. This case was linked to the cases US2022AMR164695, US2022163626, US2022AMR163547 and US2022AMR163515.; Sender's Comments:  US-GSK-US2022168145:Same reporter. Patient 1 of 2 US-GSK-US2022AMR164695:Same reporter US-GSK-US2022163626:Same reporter US-GSK-US2022AMR163547:Same reporter US-GSK-US2022AMR163515:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Headache, Muscular weakness, Rash vesicular
Clinical narrative: rash with blister; severe acid reflux; muscle weakness; headache; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a day after receiving Shingrix, the patient experienced muscle weakness, headache, blistery rash and esophageal acid reflux. On an unknown date, the outcome of the muscle weakness, headache and blistery rash were recovered/resolved and the outcome of the esophageal acid reflux was not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness, headache, blistery rash and esophageal acid reflux to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's comment: The reporter was calling on behalf of the patient, her aunt. The patient received dose of Shingrix vaccine about 2 months ago from the date of reporting in left arm and experienced side effects within 24 hours like muscle weakness and headache, that lasted about 1 week.  The patient also experienced rash with blister (not sure exact location) that lasted 2-3 weeks and severe acid reflux which had not resolved. The reporter did not consent to follow-up.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received Bexsero subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 21-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th November 2022, the patient received Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On 15th November 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's comment: The reporter stated that a patient received Bexsero subcutaneously. The reporter consented to follow-up via postal. Additional Supportive Information: The patient received dose of Bexsero subcutaneously, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two years ago from the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: A pharmacist called to asked for information about a patient who never received the second dose. The reporter asked if the patient had to start over with Shingrix vaccination (two doses).  The pharmacist did not provide the date of the first dose administration and the lot number of the first dose. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shngrix vaccine, which led to incomplete course of vaccination.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: administered SC; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 49-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2AZ, expiry date 30th June 2023) for prophylaxis.   On 17th November 2022, the patient received Boostrix (subcutaneous). On 17th November 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's comment: A Medical Technician administered a Boostrix vaccine subcutaneously (SC) to a patient. The reporter consented to follow-up via postal. Additional Supportive Information: The patient received dose of Boostrix vaccine subcutaneously, which led to intramuscular formulation administered by other route.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Migraine, Pain
Clinical narrative: Migraine; Pain behind eyes; Pain all over; Horrible Headache/Pounding Headache; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine), EYE PAIN (Pain behind eyes), PAIN (Pain all over) and HEADACHE (Horrible Headache/Pounding Headache) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J COVID-19 Vaccine (Primary series) on 06-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 Vaccine. Concurrent medical conditions included Migraine (and patient usually takes Motrin as needed for Migraine) and Headache (Patient also had been taking Aspirin on & off for headache). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Headache, NAPROXEN (MOTRIN [NAPROXEN]) for Migraine.    On 16-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced MIGRAINE (Migraine), EYE PAIN (Pain behind eyes), PAIN (Pain all over) and HEADACHE (Horrible Headache/Pounding Headache). At the time of the report, MIGRAINE (Migraine), EYE PAIN (Pain behind eyes), PAIN (Pain all over) and HEADACHE (Horrible Headache/Pounding Headache) outcome was unknown.            It was reported that patient had first monovalent Booster of Moderna COVID-19 Vaccine on 22-Oct-2021. Patient had second monovalent Booster of Moderna COVID-19 Vaccine on 02-APR-2022. Patient did not have any side effects with the previous Moderna COVID-19 boosters. No treatment information was provided.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; given vaccine past the manufacturer's expiry date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine past the manufacturer's expiry date) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2022 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine past the manufacturer's expiry date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine past the manufacturer's expiry date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (given vaccine past the manufacturer's expiry date).    No concomitant medications were reported.  The vial of 2.5 ml in a box sealed with the cap on with lot number AR5186C, Expiry date: 17-Nov-2022 was administered past the manufacturer's expiration date. The vial had not undergone any temperature excursions.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; received the first two Moderna vaccines 6 months apart; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first two Moderna vaccines 6 months apart) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first two Moderna vaccines 6 months apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first two Moderna vaccines 6 months apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication were reported.  Patient received the first two Moderna vaccines 6 months apart way back in Jan 2020 or 2021. Patient received first dose of Moderna in January and second dose in July.       No treatment information was provided by the reporter.   This case was linked to MOD-2022-675040 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Given the monovalent vaccine as booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  Reporter stated that both she and her husband got the Moderna bivalent vaccine on 07-Sep-2022. Her husband just got back from his doctor and was told that this was not the bivalent that they got but the old one.  This case is for the husband.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675027 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675027:Wife case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: mild case of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (mild case of COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022, the patient experienced COVID-19 (mild case of COVID-19). At the time of the report, COVID-19 (mild case of COVID-19) outcome was unknown.            No concomitant medication information was provided.  Patient received first dose of Moderna in February and second dose August.  Patient received the first two Moderna vaccines 6 months apart way back in 2021. Six months later patient took a Moderna booster in December2021. Patient not had another shot since then. Someone visited patient and husband, they got a very mild case of COVID-19 on 06Sep2022.   No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-675040, US-MODERNATX, INC.-MOD-2022-675038 (E2B Linked Report). This case was linked to MOD-2022-675042 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675040:MOD-2022-675040 (Patient 1 male booster dose case) US-MODERNATX, INC.-MOD-2022-675038:MOD-2022-675038 (Patient 1 male 2nd dose case)
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received the first two Moderna vaccines 6 months apart; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two Moderna vaccines 6 months apart) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two Moderna vaccines 6 months apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two Moderna vaccines 6 months apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-675038, US-MODERNATX, INC.-MOD-2022-675040 (E2B Linked Report). This case was linked to MOD-2022-675041 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675038:(Patient 1 male 2nd dose case) US-MODERNATX, INC.-MOD-2022-675040:(Patient 1 male booster dose case)
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The patient received a vaccine that was punctured and left at room temperature for greater than 24 hours; No adverse event; The vial was first punctured on 16-Nov-2022 at 9:00 am and administered on 17-Nov-2022 at 9:38 am; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 16-Nov-2022 at 9:00 am and administered on 17-Nov-2022 at 9:38 am), PRODUCT STORAGE ERROR (The patient received a vaccine that was punctured and left at room temperature for greater than 24 hours) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022 at 9:38 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 17-Nov-2022 at 9:28 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 16-Nov-2022 at 9:00 am and administered on 17-Nov-2022 at 9:38 am). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received a vaccine that was punctured and left at room temperature for greater than 24 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 16-Nov-2022 at 9:00 am and administered on 17-Nov-2022 at 9:38 am), PRODUCT STORAGE ERROR (The patient received a vaccine that was punctured and left at room temperature for greater than 24 hours) 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 EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 16-Nov-2022 at 9:00 am and administered on 17-Nov-2022 at 9:38 am) and PRODUCT STORAGE ERROR (The patient received a vaccine that was punctured and left at room temperature for greater than 24 hours).    No concomitant medications were provided. The dose was administered greater than 12 hours post puncture. The vial size was 2.5 ml. The reporter was not sure when it was thawed initially because their facility received it thawed with an expiration Date of 04-Dec-2022. The vial was first punctured on 16-Nov-2022 at 9:00AM. The vial was stored post puncture at room temperature. The vial did not undergo any temperature excursions. The vial was exposed to room temperature for  greater than 24 hours. Reporter says there has been no issues of symptoms No treatment medication was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired dose).    No concomitant medications was reported. Vial size was 5.5ml the vial was initially stored in the refrigerator on 21Oct2022 the vial did not undergo any temperature excursions. It was reported that dose was administered after the published expiration date.  The patient did not reported symptoms. Patient did not taken additional doses, medications, or treatments. No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022; no adverse event; Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-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-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna COVID19 vaccine were given after the beyond use date BUD 17-Nov-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022).    No concomitant medications were provided. The vial size was 2.5ml. The vial was initially stored in the refrigerator on 18-Oct-2022 The vial did not  undergo any temperature excursions. No treatment medication was provided. This case contains information for the 2nd of 14 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:Patient 4 US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675259:Patient 3 US-MODERNATX, INC.-MOD-2022-675268:Patient 11 US-MODERNATX, INC.-MOD-2022-675269:Patient 12 US-MODERNATX, INC.-MOD-2022-675270:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022; No adverse event; bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-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-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022) 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 EXPIRED PRODUCT ADMINISTERED (bivalent Moderna COVID19 vaccine given after the beyond use date BUD 17-Nov-2022) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 18-Oct-2022 and was administered on 18-Nov-2022).    Concomitant drugs were not reported. It was reported that the individual vials of 2.5 ml size did not underwent any temperature excursion. Treatment medications were not provided. This case was reported for Adult patient 5.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260:Patient 5 US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675268:Patient 5 US-MODERNATX, INC.-MOD-2022-675269: US-MODERNATX, INC.-MOD-2022-675270: US-MODERNATX, INC.-MOD-2022-675259:Patient 5
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022; No adverse event; Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022) 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)) (batch no. 051d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Nov-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-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022), PRODUCT STORAGE ERROR (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022) 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 EXPIRED PRODUCT ADMINISTERED (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022) and PRODUCT STORAGE ERROR (Patient received bivalent Moderna COVID19 vaccine after the beyond use date BUD 17Nov2022).    No concomitant medications were reported.  Vial size was reported as 2.5ml The vial was initially stored in the refrigerator on 18-Oct-2022. The via did not undergo any temperature excursions. Beyond use date was reported as 17-Nov-2022.  No treatment medications were reported.  This case contains information for the 10th of 14th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675260, US-MODERNATX, INC.-MOD-2022-675264, US-MODERNATX, INC.-MOD-2022-675268, US-MODERNATX, INC.-MOD-2022-675259, US-MODERNATX, INC.-MOD-2022-675269, US-MODERNATX, INC.-MOD-2022-675270 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675260: US-MODERNATX, INC.-MOD-2022-675268: US-MODERNATX, INC.-MOD-2022-675264:same reporter US-MODERNATX, INC.-MOD-2022-675269: US-MODERNATX, INC.-MOD-2022-675259: US-MODERNATX, INC.-MOD-2022-675270: