chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: accidentally administered an expired tenivac vaccine to a patient yesterdaywith no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient and reporter stated that expired tenivac vaccine administered accidentally to a patient yesterday with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection total (lot U6831AA, expiry date 08-Oct-2022) (with an unknown strength, dose, route, administration site) for Immunization.  On 13-Oct-2022 the patient accidentally administered with an expired tenivac vaccine yesterday with no reported adverse event (expired product administered) same day following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: half of the dose was administered with no reported adverse event; Initial information  on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient to whom half of the dose was administered with no reported adverse event for vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  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 VACCINE standard strength (dose, formulation: unknown) (lot UT7723KA , exp date: 30-Jun-2023) via unknown route in unknown administration site for immunization. Pharmacist states that approximately half of the dose was administered with no reported adverse event (incorrect dose administered) (latency: same day)) and half of the dose spilled on the patient's arm.  Pharmacist called to get some guidance whether they need to revaccinate a patient that was given FLUZONE QUADRIVALENT.   Upon further question the pharmacist states that the person who administered the vaccine advised her that the spill is due to broken vial but does not have any other information.   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.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: use of fluzone high dose to a 58 year old patient 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 a 58 years old female patient and reported that there was use of fluzone high dose to a 58 year old patient with no reported adverse event, it involved vaccine 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 were reported as none   On 14-Oct-2022, the patient received a  dose of 0.7 ml once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , with an unknown formulation and strength, (lot: UJ924AC ; expiry date: 30-Jun-2023)via intramuscular route in the left deltoid for immunization.  It was reported that on 14-Oct-2022, there was use of Fluzone high dose to a 58 year old patient with no reported adverse event (product administered to patient of inappropriate age) (latency: 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: 87.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: the vaccine "shot from the side" of the syringe; states that the patient received less that half of the dose of FLUZONE HIGH DOSE QIV due to this event with no reported adverse event; Initial information was received from on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 87 years old female patient who received the vaccine "shot from the side" of the syringe; states that the patient received less that half of the dose of influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] due to this event 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 patient received influenza quadrival a-b high dose hv vaccine at a dose of 0.7 ml once (lot UJ926AB, expiry date - 30-Jun-2023) (formulation: unknown) via intramuscular route in the right deltoid for immunization and reported vaccine "shot from the side" of the syringe; states that the patient received less that half of the dose of influenza quadrival A-B high dose hv vaccine due to this event with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event the vaccine "shot from the side" of the syringe; states that the patient received less that half of the dose of fluzone high dose qiv due to this event with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: received 2 doses of FLUZONE-HD QIV 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 a 72 years old female patient who received 2 doses of fluzone-hd qiv with no reported adverse event while receiving vaccine 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.   On 07-Sep-2022, the patient received 0.7 mL of 1 dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE Injection (lot UJ901AA and expiry date: 30-Jun-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  On 14-Oct-2022, she also received 0.7 mL of 2 dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE Injection (with an unknown batch number) via intramuscular route in the left deltoid for prophylactic vaccination.  On 14-Oct-2022, the patient received 2 doses of fluzone-hd qiv with no reported adverse event (inappropriate schedule of product administration) (latency: same day from dose 2) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Epididymitis, Ultrasound scan abnormal
Clinical narrative: Swallow that appeared in his testicle/diagnosed with epididymitis; This spontaneous case was received on 11-Oct-2022 from nurse via Communications (reference number: SEQW22-04326) and concerned a 35-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 05-Oct-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On 06-Oct-2022, one day after receiving Afluria Quadrivalent, the patient complained about a swallow that appeared in his testicle. The patient went to the emergency department (ED), where an ultrasound was performed, and he was diagnosed with epididymitis. The patient was treated with Rocefin (ceftriaxone sodium), intramuscularly and Levaquin (levofloxacin), orally. The ED sent him home after treatment.  At the time of initial report on 11-Oct-2022, the patient had not recovered from the event.  The reporter did not provide a causality assessment.  The event of 'epididymitis' was assessed as serious due to seriousness criterion of medical significance.  Company comment: A 35-year-old patient developed epididymitis one day after receiving the suspect product Afluria Quadrivalent. The patient's medical history and concomitant drugs were not provided.  Based on biological implausibility, causal role of the suspect vaccine is assessed as not related.; Sender's Comments: A 35-year-old patient developed epididymitis one day after receiving the suspect product Afluria Quadrivalent. The patient's medical history and concomitant drugs were not provided.  Based on biological implausibility, causal role of the suspect vaccine is assessed as not related.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Fatigue, Hypotension, Malaise, Nausea
Clinical narrative: Approximately 11 hours after receiving the injection symptoms experienced included nausea, hypotension, loss of appetite, malaise and fatigue. symptoms lasted for 36 hours.
Age: 68.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Feeling abnormal, Vaccination site pain, Wrong product administered
Clinical narrative: Overall bad feeling; Fatigued; Patient right arm was sore at the injection site; Received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Overall bad feeling), FATIGUE (Fatigued), VACCINATION SITE PAIN (Patient right arm was sore at the injection site) and WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent.) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 12-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced VACCINATION SITE PAIN (Patient right arm was sore at the injection site) and WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent.). On 13-Oct-2022, the patient experienced FEELING ABNORMAL (Overall bad feeling) and FATIGUE (Fatigued). On 14-Oct-2022, FEELING ABNORMAL (Overall bad feeling) and FATIGUE (Fatigued) had resolved. At the time of the report, VACCINATION SITE PAIN (Patient right arm was sore at the injection site) and WRONG PRODUCT ADMINISTERED (Received Moderna Covid-19 vaccine monovalent pediatric dose, instead of Moderna Covid-19 Vaccine, Bivalent.) outcome was unknown.            No concomitant medications were reported.  The patient was mistakenly given the patient pediatric dose of the regular Moderna Covid-19 vaccine [Monovalent], instead of the Moderna Covid-19 Vaccine, Bivalent.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659995 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659995:Crosslinked with MOD22-026790 (Husband's case) same reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: very mild headache; mild fatigue; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (very mild headache) and FATIGUE (mild fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. Patient had no medical history relating to mentioned adverse events and both Acute and Chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: flu vaccine (3 weeks ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Allergy to NSAIDs. Concomitant products included CLOPIDOGREL for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL), LOSARTAN, OMEPRAZOLE, ATORVASTATIN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE) and METFORMIN for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (very mild headache) and FATIGUE (mild fatigue). On 11-Nov-2021, HEADACHE (very mild headache) and FATIGUE (mild fatigue) had resolved.            Patient received second dose at the end of Apr-2021.  Patient stated only experienced very mild headache and mild fatigue during 24 hours after first dose, second dose and first booster. After first dose, events of very mild headache and mild fatigue, resolved on an unspecified date in Mar-2021 After second dose on an unspecified date in Apr-2021, patient developed very mild headache and mild fatigue, those resolved on an unspecified date in Apr-2021, after first booster on 10-Nov-2021, patient developed very mild headache and mild fatigue those resolved on 11-Nov-2021. No treatment was given.   This case was linked to MOD-2022-660018 (Patient Link).
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08B22A NDC:80777-273-10) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-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 (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022).    No concomitant medication information was provided.  Caller said that there were informed 14 days later that it expired. Caller said that vaccine expired after the 30 days it was unfrozen on 11-Sep-2022. Patients received vaccine on 21Sep2022 and 22Sep2022.  Vial size was 5.5 mL.  Vial did not undergo any temperature excursion.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660237 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660237:same reporter
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 08B22A NDC:80777-273-10) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    In September 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-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 (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vaccine beyond use by date was 11-Sep-2022 and patient was administered on Sep-2022).    No concomitant medication information was provided.  Caller said that there were informed 14 days later that it expired. Caller said that vaccine expired after the 30 days it was unfrozen on 11-Sep-2022. Vial size was 5.5 mL.  Vial did not undergo any temperature excursion.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-660170; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660170:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product label confusion
Clinical narrative: The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information; The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT LABEL CONFUSION (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and 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 an unknown date, 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 an unknown date, the patient experienced PRODUCT LABEL CONFUSION (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL CONFUSION (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The paper mentioned that I needed to get 2 shots of this/The paper said it was the booster for 12+/They gave me some confusing information) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant product use was not provided by the reporter.  Patient had both the 1st shots, then 2 boosters.  Patient received the new Moderna Covid booster from local Pharmacy. They gave some confusing information. The paper mentioned that patient needed to get 2 shots of this. The paper said it was the booster for 12 plus.  Treatment information was not provided.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance
Clinical narrative: Cannot walk without feeling fatigued.; Extreme Fatigue; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT DISTURBANCE (Cannot walk without feeling fatigued.) and FATIGUE (Extreme Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient never had COVID positive test or diagnosis.  Concurrent medical conditions included Epstein-Barr virus infection (when patient was 16).    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced GAIT DISTURBANCE (Cannot walk without feeling fatigued.) and FATIGUE (Extreme Fatigue). At the time of the report, GAIT DISTURBANCE (Cannot walk without feeling fatigued.) and FATIGUE (Extreme Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Patient was not taking any concomitant medications. It was reported that patient had visited many doctors and taken all kinds of treatments, but nothing seemed to help and did not specify which treatment patient had taken.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Monovalent ages 6-11 vaccine administered instead of receiving Moderna Covid-19 Vaccine, Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of receiving Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of receiving Moderna Covid-19 Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of receiving Moderna Covid-19 Vaccine, Bivalent) 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 WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of receiving Moderna Covid-19 Vaccine, Bivalent).    Concomitant product use was not provided by the reporter.  Patients got Moderna Covid-19 vaccine with Blue Capped Purple-Bordered (Ages 6-11 MONOVALENT) instead of receiving Moderna Covid-19 Vaccine Bivalent.  Treatment information was not provided.
Sex: U
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Three dose rotavirus series; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   Previously administered products included Rotarix (received 1st dose and 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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: 10-OCT-2022 Reporter's Comment: The nurse reported that the she had been giving Rotarix as a three dose rotavirus series for pediatric patients at two, four, six months.  The reporter came into the nursing role at the pediatric practice in December 2021. The reporter said she was instructed to give Rotarix as a three dose series. They use only state funded vaccines at this clinic and she had inputted all Rotarix as a 3 dose series in the state registry for each child vaccinated. The reporter did not consent to follow up. Additional Supportive Information: The nurse reported that the patients received third dose of Rotarix, which led to extra dose administered.
Sex: U
Vaccine: HEPA, HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: one dose of Twinrix in 2012 and one prior dose of adult Hep A vaccine in 2006; This case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hepatitis A vaccine for prophylaxis.   Previously administered products included Twinrix (1st dose received in 2012) and Hepatitis A (1st prior dose of adult Hep A vaccine in 2006).   On an unknown date, the patient did not receive the 2nd dose of Twinrix, Twinrix Pre-Filled Syringe Device and the 2nd dose of Hepatitis A vaccine. On an unknown date, unknown after receiving Twinrix, Twinrix Pre-Filled Syringe Device and Hepatitis A vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 10-Oct-2022 Reporter's comment: Afterhours Customer relationship management submitted on 10th October 2022 and retrieved by medical information at start of business on 11th October 2022.  The customer had a patient who received one dose of Twinrix in 2012 and one prior dose of adult Hepatitis A vaccine in 2006.  The customer asked what was the recommendation for Hepatitis A series completion.  The consent to follow up was granted. The field representative might had already submitted this to safety and this might be a duplicate case.  All details provided via Customer relationship management form were being forwarded to safety and no additional details were provided.  It was noted in the form that the reporter, an unspecified Health-care professional, consents to follow up. Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix and Hepatitis A vaccine, which led to incomplete course of vaccination.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 10-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine) 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 WRONG PRODUCT ADMINISTERED (Monovalent ages 6-11 vaccine administered instead of Bivalent vaccine).    No concomitant product use was reported.  On 14-Oct-2022, a dosing error occurred with a couple of patients. Doses of Blue capped purple-bordered (Ages 6-11 MONOVALENT) given instead of Blue capped gray-bordered (Ages 6 and older BIVALENT) booster doses.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-659880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659880:Master Case
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: wrong vaccine/monovalent received instead of bivalent; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B.) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose 1), COVID-19 VACCINE (Booster dose) and Pfizer COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong vaccine/monovalent received instead of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications was reported. The reporter was trying to find out if her children were given the monovalent or bivalent. She thinks they were given the wrong vaccine at the pharmacy. The pharmacy says they gave the children the monovalent, but they were scheduled for the bivalent vaccine. Her 3 children received two Pfizer doses and a booster.  No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-660584, US-MODERNATX, INC.-MOD-2022-660593 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-660584:Patient 1 US-MODERNATX, INC.-MOD-2022-660593:Patient 2
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, C-reactive protein increased, Chest pain, Dyspnoea
Clinical narrative: Took the COVID booster shot. Was sick with fever, joint pain/muscle aches, and extreme weakness for 2 weeks. Symptoms came and went every 3 days for up to a month. Three months after booster, developed high heart rate for a month straight. Chest pain, short of breath, and heart "skipping a beat". CRP Cardiac was high and still is high. Diagnosed with myocarditis.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Heart rate increased, Illness, Myalgia, Myocarditis
Clinical narrative: Took the COVID booster shot. Was sick with fever, joint pain/muscle aches, and extreme weakness for 2 weeks. Symptoms came and went every 3 days for up to a month. Three months after booster, developed high heart rate for a month straight. Chest pain, short of breath, and heart "skipping a beat". CRP Cardiac was high and still is high. Diagnosed with myocarditis.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Took the COVID booster shot. Was sick with fever, joint pain/muscle aches, and extreme weakness for 2 weeks. Symptoms came and went every 3 days for up to a month. Three months after booster, developed high heart rate for a month straight. Chest pain, short of breath, and heart "skipping a beat". CRP Cardiac was high and still is high. Diagnosed with myocarditis.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given a 3rd dose of Janssen COVID-19 vaccine instead of a COVID bivalent booster.
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: I broke out in hives  all over my body!
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Loss of consciousness, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Medium, Additional Details: Patient passed out after administration of second vaccine. EMS was called and patient passed out and had a mild seizure while EMS was checking his vitals.
Age: 78.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Medium
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Endometriosis, Eye disorder, Inflammation, Pain
Clinical narrative: White Spots like Vitiligo all over body Eye condition worsen y 6 month and new conditions in the eye appeared Endometriosis worsen, pain and inflamation improves
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: White Spots like Vitiligo all over body Eye condition worsen y 6 month and new conditions in the eye appeared Endometriosis worsen, pain and inflamation improves
Age: 48.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: Very swollen lower arm with purple/red discoloration Required antibiotics and Prednisone
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dyskinesia, Hypotonia, Loss of consciousness
Clinical narrative: Patient was administered Flu shot around 9:05am and shortly reported feeling faint afterwards. Shortly, she started sliding off the chair to the floor. Pharmacist rushed to aid her safely to the floor in the consultation room. Patient went unconscious for a few minutes (~3 minutes) but was still moving arms and legs with eyes closed. Opened her eyes and asked, "where am I"? Blood pressure and heart rates were taken and also was observed by a medical provider onsite. Patient regained full consciousness and was monitored for about 30 minutes before leaving Pharmacy. Patient stated she reacts to the sight of blood and has  history of such with a skin tag removal but denies any fainting history with vaccinations or blood draw.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Injection site mass, Injection site swelling, Muscle spasms, Pain
Clinical narrative: -arm very sore -severe tingling like electric current -extreme swelling at injection site -arm very hot to the touch -itching -arm spasms -pain -large lump under skin at injection site
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pruritus, Skin warm
Clinical narrative: -arm very sore -severe tingling like electric current -extreme swelling at injection site -arm very hot to the touch -itching -arm spasms -pain -large lump under skin at injection site
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive pt, vaccinated X4, admitted to hospital
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Ear pain, Eustachian tube dysfunction, Fatigue
Clinical narrative: Aug 20, 2022 developed sore throat, runny nose, fatigue. This progressed to extreme fatigue, upper respiratory congestion, cough, fever. Covid test positive Aug 24. Was unable to do test sooner since was on land tour.  I manages to push through most days, but fatigue and cough were problem. Unable to get paxlovid. Flew home  flew home overnight Aug 26 (don?t remember a lot about flight since I was asleep). Developed severe sinus pain and ear pain august 28. Had video visit with primary care on August 31. Still had bd cough but not SOB. Do with sinus infection. They don?t diagnose ear infections on video visits. Prescribed doxycycline and  Tessalon Perles. Saw dr ept 6 and still had upper respiratory symptoms and sever eustachuan dysfunction. Still severe fatigue.  He prescribed dose pack. Took about 2 more weeks to recover
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory symptom, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Aug 20, 2022 developed sore throat, runny nose, fatigue. This progressed to extreme fatigue, upper respiratory congestion, cough, fever. Covid test positive Aug 24. Was unable to do test sooner since was on land tour.  I manages to push through most days, but fatigue and cough were problem. Unable to get paxlovid. Flew home  flew home overnight Aug 26 (don?t remember a lot about flight since I was asleep). Developed severe sinus pain and ear pain august 28. Had video visit with primary care on August 31. Still had bd cough but not SOB. Do with sinus infection. They don?t diagnose ear infections on video visits. Prescribed doxycycline and  Tessalon Perles. Saw dr ept 6 and still had upper respiratory symptoms and sever eustachuan dysfunction. Still severe fatigue.  He prescribed dose pack. Took about 2 more weeks to recover
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain, Upper respiratory tract congestion
Clinical narrative: Aug 20, 2022 developed sore throat, runny nose, fatigue. This progressed to extreme fatigue, upper respiratory congestion, cough, fever. Covid test positive Aug 24. Was unable to do test sooner since was on land tour.  I manages to push through most days, but fatigue and cough were problem. Unable to get paxlovid. Flew home  flew home overnight Aug 26 (don?t remember a lot about flight since I was asleep). Developed severe sinus pain and ear pain august 28. Had video visit with primary care on August 31. Still had bd cough but not SOB. Do with sinus infection. They don?t diagnose ear infections on video visits. Prescribed doxycycline and  Tessalon Perles. Saw dr ept 6 and still had upper respiratory symptoms and sever eustachuan dysfunction. Still severe fatigue.  He prescribed dose pack. Took about 2 more weeks to recover
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: ear ringing
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: PT complains of not being able to move her arm, pain from her shoulder to her hand, swelling in the hand, and discoloration compared to the other hand
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH CASE
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Arthralgia, Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: patient developed joint pain <24 hours after with itching but no rash. <48 hours awoke with eye lid swelling and itching of hands and feet, spead to hives on elbows.
Age: 7.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood glucose increased, Illness, Vaccination site cellulitis
Clinical narrative: Cellulitis at site of vaccine injection. Improved with antibiotics. Acute illness made blood sugars increase.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient vaccinated against then tested positive for COVID-19
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms ,headache, muscle pain, fever (101.8).
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Nasopharyngitis, Rash, Rash pruritic
Clinical narrative: I developed a painless rash that followed a nerve path on Tuesday, September  27. It remained fairly painless with only mild itching. The next day, I became extremely fatigued and developed mild cold symptoms that lasted 7 days. We have a medically fragile daughter who cannot be vaccinated. She developed chicken pox on October 11,  she is homebound and has not left our house and limited people have entered. Her chicken pox case is lab confirmed. She was and still is very sick from this.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Cardiac telemetry, Computerised tomogram head, Hallucination, Impaired driving ability, Laboratory test
Clinical narrative: From primary care note written by Dr. on 10/7/22, " Here for new medical evaluation of  Hallucinations. She says no complaints till having Flucelvax and Bivalent Covid vaccintaions thurs 9/29/22. Within about 15 in she sqw a disembodied face (male), smiling, no auditory communications and non-threatening. Had another similar vision 15-20 min later while using hwe computer,this time smiling faces, shortly after getting a group picture of her family from her son ('some to me all who are heavy laden' was playng in the background while picture was playing, and son verified he sent the pic.).  Since 9/29 she has daily visions of a 'still picture' hallucination, smiling and non-threatinig, self limited. No headaches, no nightmares. No Hx of mental illness or stress. She lives alone, but has been staying with her daughter for additional safety, her daughter does the driving.       She was seen at ER, at Hospital 9/30, and had normal studies including non-contrast head CT, Lab studies, telemetry. She is scheduled to see NeuroScience Wed 10/12/22. She has been working as scheduled, and has no problems with memory cognition, walking or interacting. She continues to see the images, even during todays visit, she does not have sleep interruptions or nightmares / strange dreams.   Hallucinations, temporally on the day of mixed vaccinations, but NO systemic symptoms to suggest a reaction, and no clinical encephalopathy, nor  Local reactions (rash, induration).  She is concerned about the hallucinations, but NOT afraid of them, and there is no homicidal or suicidal ideation.  NO evidence to clearly correlate this with her vaccination Agree with NeuroScience consultation. May work in meantime, but avoid operating machinery."
Age: 16.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Urticaria
Clinical narrative: About 7:00pm, 4.5 hours was when we notice she was red and had hives, and the top of her legs were covered in hives, and there was small spotches on her lower legs too. Her torso, but after they gave her the steroid at urgent care, it cleared up. But it was mostly on her legs and arms. The doctors were surprised she did not have any breathing issues. This morning, she looks really good, there is nothing on her at all.  She was seen at Urgent Care.
Age: 46.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Hyperhidrosis, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: After I received the vaccine, I had body aches and fever. Twice in the night I woke up with drenched pajamas. I started having symptoms on 10/12/2022 I had a sore throat and it felt like a sinus infection. I tested positive from a home test for COVID-19 on 10/15/2022. I had multiple tests for COVID-19, and it was finally confirmed on 10/19/2022. I got in touch with my doctor and was given a prescription for an inhaler.