chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was stored in fridge for more than 30 days; No adverse event; Patient was administered bivalent vaccine that had been in the fridge past 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days), PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     It was reported that patient had no known conditions and also did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (1st dose) in May 2021; for COVID-19 prophylaxis: Moderna COVID-19 vaccine (2nd dose) in November 2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and Moderna COVID-19 vaccine.    On 27-Mar-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-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 (Patient was administered bivalent vaccine that had been in the fridge past 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days), PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered bivalent vaccine that had been in the fridge past 30 days) and PRODUCT STORAGE ERROR (Vial was stored in fridge for more than 30 days).    Dosage text for suspect product was reported as initial booster.  Concomitant drugs were not reported.  It was unknown if patient number 1 experienced any AEs.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720479, US-MODERNATX, INC.-MOD-2023-720524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720479:same reporter US-MODERNATX, INC.-MOD-2023-720524:same reporter
Age: 55.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; No adverse event; Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Mar-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 19-Mar-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 (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) 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 (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry).    Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator on 11-JAN-2023. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Rhinorrhoea
Clinical narrative: covid 19; had a runny nose in both nostrils.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) and RHINORRHOEA (had a runny nose in both nostrils.) in an adult male 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.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    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 COVID-19 (covid 19) and RHINORRHOEA (had a runny nose in both nostrils.). At the time of the report, COVID-19 (covid 19) and RHINORRHOEA (had a runny nose in both nostrils.) 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.   Patient took multivitamin, when was a kid, high schooler, and as an adult too. Patient was very athletic as a teenager. Patient lived by the Moderna vaccine for COVID-19. Patient had majority of all adult vaccines as well. A couple days ago, for the first time patient had a runny nose in both nostrils. Patient have never had this before. Patient had a runny nostril out of one nostril, left mainly, and usually after breakfast. Patient either have COVID and everyone else in the community was very happy. No treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: have a cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (have a cold) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (have a cold). At the time of the report, NASOPHARYNGITIS (have a cold) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that patient was scheduled to get a booster of Moderna Bivalent the day after in afternoon but had a cold.  Treatment medications were not provided.   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023; No adverse event; Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 16-Mar-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 16-Mar-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 (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023) 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 (Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 11Jan2023 and administered on 16Mar2023).    No concomitant medication details was reported. Vial size was reported as 2.5ml. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-720507 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720507:
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office experienced several temperature excursions with vaccine vials that were used to administer vaccination), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion vials that were used to administer vaccination advised that over 30-40 vaccinations were performed with vials involved in T.E) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B022H2A) 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 TEMPERATURE EXCURSION ISSUE (HCP advised that her office experienced several temperature excursions with vaccine vials that were used to administer vaccination), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion vials that were used to administer vaccination advised that over 30-40 vaccinations were performed with vials involved in T.E) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office experienced several temperature excursions with vaccine vials that were used to administer vaccination), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion vials that were used to administer vaccination advised that over 30-40 vaccinations were performed with vials involved in T.E) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office experienced several temperature excursions with vaccine vials that were used to administer vaccination) and POOR-QUALITY PRODUCT ADMINISTERED (Temperature excursion vials that were used to administer vaccination advised that over 30-40 vaccinations were performed with vials involved in T.E). No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Someone had given a patient of ours an expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Someone had given a patient of ours an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Someone had given a patient of ours an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Someone had given a patient of ours an expired Moderna vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Someone had given a patient of ours an expired Moderna vaccine).    The concomitant medication was not reported by reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No reported symptoms. The treatment medication was not reported by reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine kept on refrigertaor; no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor) and NO ADVERSE EVENT (no adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 06-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine kept on refrigertaor) 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 (Expired vaccine kept on refrigertaor) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (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 (Expired vaccine kept on refrigertaor).    No concomitant medications were reported.  HCP stated that when they had received the Moderna monovalent vaccine, the expiration date stated 31-Dec-2069 and they did not realize that they had to check for the manufacturer expiration date.   The patient did not report any adverse reactions to this invalid dose administration.  The vial was initially stored in the refrigerator on 5-Apr-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 81.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023; No adverse event; Patient received Moderna Bivalent vaccine 2 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine 2 days after beyond use date), PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an 81-year-old 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. 065H22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 17-Mar-2021 and MODERNA COVID-19 VACCINE in April 2021; for Product used for unknown indication: COVID-19 VACCINE on 20-Dec-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, MODERNA COVID-19 VACCINE and Moderna COVID-19 Vaccine.    On 19-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Apr-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 (Patient received Moderna Bivalent vaccine 2 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine 2 days after beyond use date), PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023) 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 (Patient received Moderna Bivalent vaccine 2 days after beyond use date) and PRODUCT STORAGE ERROR (The vial was iniially stored in refrigerator on 18-Mar-2023 and was administered to patient on 19-Apr-2023).    Concomitant drugs were not reported.  It was reported that 1 dose from 1 vial was not exposed to temperature excursion. Patient was not contacted by reported for any side effect.  Treatment medications were not provided.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1415B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer monovalent (lot number SK5127, dose 1) on 10-Nov-2021, Pfizer monovalent (lot number SL0007, dose 2) on 02-Dec-2021, Pfizer monovalent (lot number SK5618 and dose 3) on 21-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer monovalent, Pfizer monovalent and Pfizer monovalent.    On 20-Apr-2023, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administered a dose of the 5-11yo monovalent moderna vaccine as Additional Booster).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.  No reported symptoms. No treatment information was provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test, Somnolence, Vaccination site pain
Clinical narrative: covid 19/ she has lung Covid and fatigue; got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose; slept almost the whole day; there was slight pain on the arm of the injection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ she has lung Covid and fatigue), SOMNOLENCE (slept almost the whole day), VACCINATION SITE PAIN (there was slight pain on the arm of the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was reported that patient was very healthy and is not taking any medications.    In February 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose). In 2021, the patient experienced SOMNOLENCE (slept almost the whole day) and VACCINATION SITE PAIN (there was slight pain on the arm of the injection). In August 2021, the patient experienced COVID-19 (covid 19/ she has lung Covid and fatigue). At the time of the report, COVID-19 (covid 19/ she has lung Covid and fatigue) and SOMNOLENCE (slept almost the whole day) had resolved and VACCINATION SITE PAIN (there was slight pain on the arm of the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: Positive. On 08-Dec-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient did not remember if she got more shots between the Mar-2021 and Oct-2022. Patient was in good shape but has lung Covid fatigues which got when patient had Covid in Aug-2021 (delta strain) and 08-Dec-2021 (patient cannot remember what strain she had but that was before the Omicron). Patient reported that she had these 2 Covid episodes for one day each because she used Colloidal silver which she inhaled. Patient used it in until the symptoms gone away. Patient added that after she got the 1st dose there was zero pain, but she slept almost the whole day. After getting the 2nd dose there was slight pain on the arm of the injection but no pronounced fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Abdominal pain, Chest pain, Headache, Injection site pain, Pain
Clinical narrative: covid 19/ she has lung Covid and fatigue; got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose; slept almost the whole day; there was slight pain on the arm of the injection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ she has lung Covid and fatigue), SOMNOLENCE (slept almost the whole day), VACCINATION SITE PAIN (there was slight pain on the arm of the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was reported that patient was very healthy and is not taking any medications.    In February 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose). In 2021, the patient experienced SOMNOLENCE (slept almost the whole day) and VACCINATION SITE PAIN (there was slight pain on the arm of the injection). In August 2021, the patient experienced COVID-19 (covid 19/ she has lung Covid and fatigue). At the time of the report, COVID-19 (covid 19/ she has lung Covid and fatigue) and SOMNOLENCE (slept almost the whole day) had resolved and VACCINATION SITE PAIN (there was slight pain on the arm of the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: Positive. On 08-Dec-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient did not remember if she got more shots between the Mar-2021 and Oct-2022. Patient was in good shape but has lung Covid fatigues which got when patient had Covid in Aug-2021 (delta strain) and 08-Dec-2021 (patient cannot remember what strain she had but that was before the Omicron). Patient reported that she had these 2 Covid episodes for one day each because she used Colloidal silver which she inhaled. Patient used it in until the symptoms gone away. Patient added that after she got the 1st dose there was zero pain, but she slept almost the whole day. After getting the 2nd dose there was slight pain on the arm of the injection but no pronounced fatigue.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pain in extremity
Clinical narrative: covid 19/ she has lung Covid and fatigue; got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose; slept almost the whole day; there was slight pain on the arm of the injection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19/ she has lung Covid and fatigue), SOMNOLENCE (slept almost the whole day), VACCINATION SITE PAIN (there was slight pain on the arm of the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was reported that patient was very healthy and is not taking any medications.    In February 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose). In 2021, the patient experienced SOMNOLENCE (slept almost the whole day) and VACCINATION SITE PAIN (there was slight pain on the arm of the injection). In August 2021, the patient experienced COVID-19 (covid 19/ she has lung Covid and fatigue). At the time of the report, COVID-19 (covid 19/ she has lung Covid and fatigue) and SOMNOLENCE (slept almost the whole day) had resolved and VACCINATION SITE PAIN (there was slight pain on the arm of the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06Mar or 10Mar, she got the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: Positive. On 08-Dec-2021, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that patient did not remember if she got more shots between the Mar-2021 and Oct-2022. Patient was in good shape but has lung Covid fatigues which got when patient had Covid in Aug-2021 (delta strain) and 08-Dec-2021 (patient cannot remember what strain she had but that was before the Omicron). Patient reported that she had these 2 Covid episodes for one day each because she used Colloidal silver which she inhaled. Patient used it in until the symptoms gone away. Patient added that after she got the 1st dose there was zero pain, but she slept almost the whole day. After getting the 2nd dose there was slight pain on the arm of the injection but no pronounced fatigue.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pain in extremity
Clinical narrative: painful/minor pain on her arms and legs but she felt that these were just radiating pain/pain she said was very strong and intense and this was coming from her core body - from her head, chest down to her abdomen; There were some minor pain in legs but she felt that these were just radiating pain.; pain on her right arm where the injection was/slight pain on the arm of the injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN (painful/minor pain on her arms and legs but she felt that these were just radiating pain/pain she said was very strong and intense and this was coming from her core body - from her head, chest down to her abdomen), PAIN IN EXTREMITY (There were some minor pain in legs but she felt that these were just radiating pain.) and VACCINATION SITE PAIN (pain on her right arm where the injection was/slight pain on the arm of the injection) in a 70-year-old 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-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (There were some minor pain in legs but she felt that these were just radiating pain.) and VACCINATION SITE PAIN (pain on her right arm where the injection was/slight pain on the arm of the injection). On 31-Oct-2022, the patient experienced PAIN (painful/minor pain on her arms and legs but she felt that these were just radiating pain/pain she said was very strong and intense and this was coming from her core body - from her head, chest down to her abdomen). At the time of the report, PAIN (painful/minor pain on her arms and legs but she felt that these were just radiating pain/pain she said was very strong and intense and this was coming from her core body - from her head, chest down to her abdomen) had resolved, PAIN IN EXTREMITY (There were some minor pain in legs but she felt that these were just radiating pain.) outcome was unknown and VACCINATION SITE PAIN (pain on her right arm where the injection was/slight pain on the arm of the injection) was resolving.        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 reported.  Patient got the 1st dose of the Moderna Covid-19 in Feb-2021 and 2 weeks later (definitely she said), either 06-Mar or 10-Mar, she got the 2nd dose. Patient reported that, that she got the vaccine at around 5:00pm and 1-2 hours after that she had the most "painful physical experience outside of childbirth". That lasted for about 4 hours. Patient did not take any medication for the pain and she fell asleep around 9:00pm. When she woke up the next day, she felt much better.  Dosage text reported as unknown.   This case was linked to MOD-2023-720519 (Patient Link).
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023; No adverse event; 5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023) 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-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 20-Apr-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 (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023) 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 (5 boosters were administered on 20-Apr-2023 that had BUD 15-Apr-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 16-Mar-2023 and dose was administered on 20-Apr-2023).    No concomitant medications were reported.  It was unknown if patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 2.5 mL.The vial was initially stored in the refrigerator on 16-Mar-2023. Vial did not undergo any temperature excursions. No treatment information was provided.  This case was reported for the patient 1 of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-720518, US-MODERNATX, INC.-MOD-2023-720544, US-MODERNATX, INC.-MOD-2023-720545, US-MODERNATX, INC.-MOD-2023-720546 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720545:4th patient case US-MODERNATX, INC.-MOD-2023-720544:3rd patient case US-MODERNATX, INC.-MOD-2023-720546:5th patient case US-MODERNATX, INC.-MOD-2023-720518:2nd patient case
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: limited AE is being submitted; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (limited AE is being submitted) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 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 IMMUNISATION REACTION (limited AE is being submitted). At the time of the report, IMMUNISATION REACTION (limited AE is being submitted) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vials were stored in the fridge for more than 30 days; No adverse event; HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge), PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 18-Apr-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 18-Apr-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 they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge), PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days) 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 (HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge) and PRODUCT STORAGE ERROR (Vials were stored in the fridge for more than 30 days).    No concomitant information was reported.  Suspect product dosage text was reported as initial booster.  It was unknown if patient number 3 experienced any adverse events.  No treatment information was provided.   HCP stated they accidentally administered 3 doses of Moderna COVID-19 Vaccine after more than 30 days that vials were stored in the fridge.   This case was linked to US-MODERNATX, INC.-MOD-2023-720530, US-MODERNATX, INC.-MOD-2023-720479 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720530:same reporter US-MODERNATX, INC.-MOD-2023-720479:same reporter
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eyelid irritation
Clinical narrative: that she is experiencing issues with the muscle activity with her eye lids to both of her eyes since receiving her last Moderna vaccination in October 2022; This spontaneous case was reported by a patient and describes the occurrence of EYELID IRRITATION (that she is experiencing issues with the muscle activity with her eye lids to both of her eyes since receiving her last Moderna vaccination in October 2022) in a 58-year-old female 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.     Patient relevant medical history/conditions, allergy, concomitant diseases and risk factor was reported as unknown.     In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced EYELID IRRITATION (that she is experiencing issues with the muscle activity with her eye lids to both of her eyes since receiving her last Moderna vaccination in October 2022). At the time of the report, EYELID IRRITATION (that she is experiencing issues with the muscle activity with her eye lids to both of her eyes since receiving her last Moderna vaccination in October 2022) 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 was provided. No treatment medications was provided. Patient was having trouble with her muscle in the eye lids and already visited 8 doctors but nobody knows what was happening, but she knew it was because of the Moderna COVID-19 Vaccine.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Product administration interrupted; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted).    No concomitant medications was provided. No treatment medications was provided. The patient was due for his second dose of the Primary Series Moderna vaccine and the Monovalent vaccine is not available. More than 36 days in between doses of the Moderna Primary Series.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2022, the patient experienced TINNITUS (ringing in ears). At the time of the report, TINNITUS (ringing in ears) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient did not experience any additional symptoms/events. There were no lab data/results available. No treatment information was reported.