chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome
Clinical narrative: Neurologist has diagnosed post vaccine and CFS; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHRONIC FATIGUE SYNDROME (Neurologist has diagnosed post vaccine and CFS) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 000050A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHRONIC FATIGUE SYNDROME (Neurologist has diagnosed post vaccine and CFS) (seriousness criterion disability). At the time of the report, CHRONIC FATIGUE SYNDROME (Neurologist has diagnosed post vaccine and CFS) outcome was unknown.            Concomitant product use was not provided by the reporter.  Since receiving vaccination the patient took ill on 12-Feb-2022 and has not been able to work.  The patient was a fit and healthy 41-year-old who worked full-time in construction and was a part-time goalkeeping coach, with no under lying issues. He was running 15k the week he received Moderna vaccine.  Neurologist has diagnosed post vaccine and CFS but he had so many other health issues at the time of report and was using a wheelchair.   The patient rolled up his sleeve and supposedly did the right thing and no-one wants to take responsibility for his horrific health problems (at least 26 different symptoms).  Treatment information was not provided. Company comment This is a spontaneous case concerning a 41-year-old healthy and fit male patient, with no medical history reported, who experienced the serious (disability) AESI of Chronic fatigue syndrome, which occurred 1 day after a dose of mRNA-1273. The patient worked full-time in construction and was a part-time goalkeeping coach, with no underlying issues. He was even running 15km the week he received Moderna vaccine. The patient started feeling ill 1 day after the vaccine and later on, the Neurologist has diagnosed chronic fatigue syndrome, but he also had so many other health issues, at least 26 different symptoms, and was using a wheelchair. No further clinical information was available for review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Product dose omission issue
Clinical narrative: Reportedly, the individual experienced "side effects",; Reportedly, the individual experienced "side effects", and therefore did not get her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Reportedly, the individual experienced "side effects",) and PRODUCT DOSE OMISSION ISSUE (Reportedly, the individual experienced "side effects", and therefore did not get her second dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     No Medical History information was reported.    In June 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Reportedly, the individual experienced "side effects",) and PRODUCT DOSE OMISSION ISSUE (Reportedly, the individual experienced "side effects", and therefore did not get her second dose). At the time of the report, IMMUNISATION REACTION (Reportedly, the individual experienced "side effects",) and PRODUCT DOSE OMISSION ISSUE (Reportedly, the individual experienced "side effects", and therefore did not get her second dose) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Food allergy, Hypersensitivity
Clinical narrative: new food allergies; allergic reaction; This spontaneous case was reported by a nurse and describes the occurrence of FOOD ALLERGY (new food allergies) and HYPERSENSITIVITY (allergic reaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    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 FOOD ALLERGY (new food allergies). an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, FOOD ALLERGY (new food allergies) had not resolved and HYPERSENSITIVITY (allergic reaction) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient reported between 45 to 50 years.  Concomitant medication of the patient was not reported.  The patient had allergic reaction, 10 days after receiving the first Moderna booster. Due to allergic reaction, the patient visited to emergency room and received treatment with unspecified steroids for hives and dermatographia presentation (symptoms of allergic reaction). Allergic reaction subsided over time (4 months). At the time of reporting, the patient only had new food allergies.  No treatment information was provided by the reporter for the event food allergies.   This case was linked to US-MODERNATX, INC.-MOD-2023-706659 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706659:Case for a female (30ish)
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: allergic reaction 9 to 10 days after 1st Moderna monovalent booster; This spontaneous case was reported by a nurse and describes the occurrence of ALLERGY TO VACCINE (allergic reaction 9 to 10 days after 1st Moderna monovalent booster) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    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 ALLERGY TO VACCINE (allergic reaction 9 to 10 days after 1st Moderna monovalent booster). At the time of the report, ALLERGY TO VACCINE (allergic reaction 9 to 10 days after 1st Moderna monovalent booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 30ish. No concomitant medications were reported.  The patient reported a allergic reaction 9 to 10 days after 1st Moderna monovalent booster that required a trip to emergency room (ER) for treatment.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706654 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706654:Case for
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Latex allergy.    On 31-Jan-2023, 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 31-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna COVID-19 Vaccine Bivalent for adults was administered approximately 22 hours post puncture).    No concomitant medications were reported.   The patient did not experience any adverse events.  No treatment details were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching; slight rash; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching) and RASH (slight rash) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067521A, 0461321 and 038AZ1A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Shingles (about 2 months ago) in 2022 and Shingles (about 2 months ago) in 2022. Past adverse reactions to the above products included No adverse event with Shingles and Shingles. Concurrent medical conditions included Sinusitis, Acid reflux (esophageal) and Seasonal allergy.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2022, the patient experienced PRURITUS (itching) and RASH (slight rash). At the time of the report, PRURITUS (itching) and RASH (slight rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Patient experienced itching and a slight rash about 2 months ago. No treatment information was reported.   This case was linked to MOD-2023-706655 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: No adverse event; The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023; Accidentally administered 2 doses of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023), EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023) and EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023), EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster) 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 initially stored in the refrigerator on 22Dec2022 and administered on 24Jan2023) and EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster).    No concomitant drug information was provided.  It was reported that by the pharmacist that they accidentally administered 2 doses of the bivalent booster doses (6 months - 5 years old) to 2 patients. Vaccine was initially stored in refrigerator on 22Dec2022.  No treatment drug information was provided.  The case was reported for one of the two child patients who had received the vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706642 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706642:Master case
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose) and NO ADVERSE EVENT (No Adverse Event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second 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 WRONG PRODUCT ADMINISTERED (received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received a Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose).    Concomitant medications were not reported.  Patient received Bivalent Moderna COVID-19 vaccine instead of the 2nd primary dose in another state. Reporter does not have any information as to the date of administration and the lot number of the Moderna COVID-19 Bivalent Shot.   Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-2022; No adverse event; 4 adults patients received doses after its beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-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. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date), PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adults patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (Date vials were initially thawed: shipment received in liquid state on Oct 11 2022, vaccine was administered on 22-Dec-2022).    No concomitant medication was provided.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Vial size included 2.5 mL and vials did not undergone any temperature excursions.  Treatment medication was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706651, US-MODERNATX, INC.-MOD-2023-706894, US-MODERNATX, INC.-MOD-2023-706901 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706651:Master case - 1st adult patient US-MODERNATX, INC.-MOD-2023-706894:Master case - 2nd adult patient US-MODERNATX, INC.-MOD-2023-706901:Master case - 3rd adult patient
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine administered past the 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered past the 30 day beyond use date) 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 (Vaccine administered past the 30 day beyond use date).    No concomitant medication was reported.   It was reported that Vaccine administered past the 30 day beyond use date and conduct a lot assessment for the following Lots with Dates moved to refrigeration: Moderna, 014B22A, 13-JUN-2022 Moderna, 011B22A, 21-JUL-2022 Moderna, 063B22A, 12-SEP-2022 Moderna, 074B22A, 04-NOV-2022 Moderna, 015B22A, 04-DEC-2022 Moderna, 020H22A, 07-NOV-2022 Moderna, 011H22A, 04-DEC-2022 Moderna, AS1414B, 21-JUN-2022 Moderna, AR9236B, 28-AUG-2022 Moderna, AR4504B, 18-JUL-2022 Moderna, AR5186C, 09-SEP-2022  Source email was from MI-00010791.  It was reported that the office was aware of 3 patients that had received mention vaccine vials.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-705204, US-MODERNATX, INC.-MOD-2023-706506 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2023: Significant follow-up appended _Dosage information updated. On 31-Jan-2023: Significant Live follow up appended : Dosage information updated On 31-Jan-2023: Significant live FU received: Narrative updated. On 01-Feb-2023: Non Significant follow up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705204:Master case (Patient 1 of 3) US-MODERNATX, INC.-MOD-2023-706506:Patient 3 of 3
Sex: U
Vaccine: COVID19, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23) and NO ADVERSE EVENT (no adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23).    This case contains information for the 1st infant patient out of 3 patients (2 infants and 1 adult) described by the reporter.  No concomitant medications were reported.  Reporter wants to know if there was any stability information for this invalid dose and reporter states that the patients could had possibly been 2 infants and 1 adult impacted by this invalid dose.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706707, US-MODERNATX, INC.-MOD-2023-706711 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: The recent follow-up contains no new information. On 31-Jan-2023: Live Significant Follow-up contains Product information and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706707:Master Case US-MODERNATX, INC.-MOD-2023-706711:Master Case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: No adverse event; Accidentally administered 2 doses of the bivalent booster; Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster), EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023) and NO ADVERSE EVENT (No adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster) and EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster), EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023) 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 EXTRA DOSE ADMINISTERED (Accidentally administered 2 doses of the bivalent booster) and EXPIRED PRODUCT ADMINISTERED (Vaccine was stored in refrigerator on 22DEC2022 and administered on 24JAN2023).    No concomitant drug information was provided.  It was reported that by the pharmacist that they accidentally administered 2 doses of the bivalent booster doses (6 months - 5 years old) to 2 patients. Vaccine was initially stored in refrigerator on 22Dec2022.  No treatment drug information was provided.  The case was reported for one of the two child patients who had received the vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-706842 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706842:Master case
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Idiopathic intracranial hypertension
Clinical narrative: I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.; I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) 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)) (batch no. ASKU) 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 ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) (seriousness criterion medically significant) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) and IDIOPATHIC INTRACRANIAL HYPERTENSION (I ended up with iih, palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. Palpdemia of the eyes, and arrhythmia of my heart from your booster vaccine. So, what are you going to do about it, diagnosis and documented. No treatment medication was provided by reporter.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Arrhythmia (AESI) and Idiopathic intracranial hypertension, which occurred on an unknown date after mRNA-1273.222 vaccine, administered as a booster dose within COVID-19 vaccination schedule. Papilledema was also reported. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Patient had no known relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.).    No concomitant medications were reported.  The health care professional stated that, the patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture. Patient did not reported any adverse event.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706846 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706846:Same reporter
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Jan-2023,  after starting , the patient experienced WRONG PRODUCT ADMINISTERED (bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (bivalent booster (0.5 ml) instead of the 2nd primary dose of Moderna COVID-19 vaccine).    Patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medications were not reported.  No treatment information was provided
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Patient had no known relevant medical history/conditions, allergy, concomitant diseases and risk factor.     On 01-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated patients was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture.).    Concomitant products were not reported.  The health care professional stated that, the patient was administered with Moderna COVID-19 Vaccine Bivalent for adults more than 12 hours post puncture. Patient did not reported any adverse event.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706683 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706683:Same reporter
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received Moderna Monovalent shot instead of Bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Moderna Monovalent shot instead of Bivalent) and NO ADVERSE EVENT (No adverse event) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074B22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (dose 2), PFIZER BIONTECH COVID-19 VACCINE (dose 1) and PFIZER BIONTECH COVID-19 VACCINE (dose 3). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 30-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (patient received Moderna Monovalent shot instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Moderna Monovalent shot instead of Bivalent) had not resolved 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 (patient received Moderna Monovalent shot instead of Bivalent).    No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) in an adult female patient 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 31-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The caller wanted to ask if developing supraclavicular lymphadenopathy was a expected reaction to the vaccine. No treatment medications were provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Nervousness, Pain in extremity
Clinical narrative: couldn't get up; my whole body was shaky; weakness; Her feet and legs were screaming in pain, both legs; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), PAIN IN EXTREMITY (Her feet and legs were screaming in pain, both legs), DYSSTASIA (couldn't get up) and NERVOUSNESS (my whole body was shaky) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergic to Penicillin, Latex, Sulfa and all Cephalosporins. Patient stated that she has a blood disorder Idiopathic Thrombocytopenic Purpura and has no spleen. Patient is also a diabetic.  The patient's past medical history included Allergy to antibiotic, Idiopathic thrombocytopenic purpura, Diabetic, Latex allergy and Penicillin allergy. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Lot Number EW0202 ) in July 2021 and Moderna COVID-19 Vaccine (Lot Number 055A22A ) on 24-Aug-2022; for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 31-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Jan-2023, the patient experienced ASTHENIA (weakness) and PAIN IN EXTREMITY (Her feet and legs were screaming in pain, both legs). On an unknown date, the patient experienced DYSSTASIA (couldn't get up) and NERVOUSNESS (my whole body was shaky). At the time of the report, ASTHENIA (weakness) and PAIN IN EXTREMITY (Her feet and legs were screaming in pain, both legs) had not resolved and DYSSTASIA (couldn't get up) and NERVOUSNESS (my whole body was shaky) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Ozempic, Paxlovid (Unknown if patient had COVID-19) and Spironolactone. Past adverse reactions to the above products included No adverse event with Ozempic, Paxlovid and Spironolactone. Concurrent medical conditions included Asthma and Obesity.    On 01-Feb-2023, 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 01-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (adult patient was accidentally administered with 1 booster of Moderna COVID-19 Vaccine Bivalent for pediatrics on 1Feb2023).    Concomitant products were not reported.  It was unknown whether patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine. No adverse event was reported and reporter does not have any information about patient previous doses.  Treatment medications were not reported.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (Dose 1) on 03-Jan-2023. Past adverse reactions to the above products included No adverse reaction with COVID-19 VACCINE.    On 01-Feb-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (an 08-year-old patient received 0.5 ml Bivalent Moderna COVID-19 vaccine instead of 2nd primary dose).    No concomitant product reported by the reporter. It was reported that multiple errors may had occurred. The 2nd primary dose was Bivalent vaccine, and they administered 0.5ml instead of 0.25 ml of Bivalent shot. No treatment medication reported by the reporter.