chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: pentacel was given subcutaneous this morning in error with no adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3 months old male patient to whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] was given subcutaneous this morning in error with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 13v (crm197) (Prevnar 13), Hepatitis B Vaccine and rotavirus vaccine live reassort oral 5v (Rotateq) for immunisation.  On 14-Jun-2022, the patient received dose:1 of 0.5 ml total 1 day (once) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine Suspension for injection, lot UJ648AAA expiry date: 25-Feb-2023 via subcutaneous route in the left thigh for immunization.  On 14-Jun-2022 the patient was given Pentacel subcutaneous this morning in error with no adverse event (incorrect route of product administration) (Latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Product storage error
Clinical narrative: lowest temperature reached 30.63 Fahrenheit  (F)  and the total excursion lasted 1 hour and 15 minutes with no reported  adverse event; Menactra was administered post excursion with no reported  adverse event on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient and it was reported that temperature reached 30.63 Fahrenheit (F)  and the total excursion lasted 1 hour and 15 minutes with no reported  adverse event and Menactra was administered post excursion with no reported  adverse event , for  vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 13-Jun-2022, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, once ( lot: U7211AA ; expiry date: 14-Mar-2023)  via intramuscular route in the left deltoid for immunization  On 13-Jun-2022 the lowest temperature reached 30.63 Fahrenheit (F)  and the total excursion lasted 1 hour and 15 minutes (product storage error) (latency: same day) for vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE ( Menactra) . And then on the same day , Menactra was administered post excursion (poor quality product administered) . there were no adverse reactions reported  Action taken : not applicable for both the events.  Outcome: unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 21.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event; Received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event; Initial information received on 16-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 21 years old male patient who experienced received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's past vaccination(s) included pertussis vaccine acellular. The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 15-Jun-2022, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot U7453AA, expiry date: 29-Jun-2024, frequency: once, unknown strength via intramuscular route in the left deltoid for immunization.  On an unknown date the patient developed a non-serious event received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event (product storage error) (unknown latency) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  On 15-JUN-2022 the patient developed a non-serious event received adacel after a temperature excursion where the product was not suitable for use with no reported adverse event (poor quality product administered) latency: same day following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (poor quality product administered and product storage error).  At time of reporting, the outcome was Unknown for the event poor quality product administered and product storage error.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood test, Immunology test, Pustular psoriasis, Skin lesion
Clinical narrative: Developed pustular psoriasis within two weeks of receiving my COVID booster shot; I have no history of psoriasis, although my father had psoriasis.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site swelling, Mobility decreased, Muscular weakness
Clinical narrative: Large swelling at injection site,( ice applied)  ongoing headache (tylenol )  inability to use arm due to weakness and pain, chills and slight fever,  jaw pain
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: Large swelling at injection site,( ice applied)  ongoing headache (tylenol )  inability to use arm due to weakness and pain, chills and slight fever,  jaw pain
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (patient's wife) concerned a 40 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-MAY-2022, the patient experienced symptoms similar to his wife but were a bit more intense, at the beginning he went from no cough to fever and his fever lasted a little bit longer. The reporter (patient's wife) stated that her husband had covid (suspected covid-19 infection). On 22-MAY-2022, the patient tested positive on one of the antigen tests. Laboratory data included: COVID-19 antigen test Positive (suspected clinical vaccination failure). The patient did not seek care but stuck it out at home. The patient did not receive a booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint. This case, from the same reporter is linked to 20220610705.; Sender's Comments: V0-20220632754 -COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Postmenopausal haemorrhage
Clinical narrative: Moderna stimulated a menstrual cycle in Menopause with Humira; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Moderna stimulated a menstrual cycle in Menopause with Humira) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, in pre-filled pen. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Moderna stimulated a menstrual cycle in Menopause with Humira) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Moderna stimulated a menstrual cycle in Menopause with Humira) had resolved and ARTHRALGIA (Joint pain) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  Company Comment: This is a spontaneous case concerning  an adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Postmenopausal haemorrhage and expected non-serious event of Arthralgia. The events occurred on an uknown date, after the unspecified dose of mRNA-1273 COVID 19 Vaccine. Patient received Adalimumab on an unknown date. The event Postmenopausal haemorrhage had resolved, while Arthralgia was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.  No treatment medication was reported.; Sender's Comments: This is a spontaneous case concerning  an adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Postmenopausal haemorrhage and expected non-serious event of Arthralgia. The events occurred on an uknown date, after the unspecified dose of mRNA-1273 COVID 19 Vaccine. Patient received Adalimumab on an unknown date. The event Postmenopausal haemorrhage had resolved, while Arthralgia was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive). At the time of the report, COVID-19 (Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive.         No concomitant medications were reported. It was reported that the patient was vaccinated with three doses. He came down with light cold and tested positive. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 (tested positive), which occurred unknown number of days after receiving the third dose of mRNA-1273 Vaccine. According to the patient, on an unspecified date, he came down with light cold and tested positive. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 (tested positive), which occurred unknown number of days after receiving the third dose of mRNA-1273 Vaccine. According to the patient, on an unspecified date, he came down with light cold and tested positive. There is no available information regarding clinical course and treatment medication. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (positive COVID-19 test) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (positive COVID-19 test). At the time of the report, COVID-19 (positive COVID-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant drug information was provided.  Patient had recieved booster dose of Moderna COVID-19 Vaccine on 22-Dec-2021.  No treatment drug information was reported.  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 5 months and 23 days after receiving booster dose of mRNA-1273 vaccine.  SARS-CoV-2 test was positive. Patient received a 2 dose-primary series of mRNA-1273 vaccine given 27 days apart,  the last dose administered approximately 10 months and 17 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 5 months and 23 days after receiving booster dose of mRNA-1273 vaccine.  SARS-CoV-2 test was positive. Patient received a 2 dose-primary series of mRNA-1273 vaccine given 27 days apart,  the last dose administered approximately 10 months and 17 days prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got COVID) in a 31-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced COVID-19 (Got COVID). At the time of the report, COVID-19 (Got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Patient got COVID19.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment medication details reported.  Company Comment:  This spontaneous case concerns a 31-year-old male patient with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency between vaccine and event cannot be established.  SARS-CoV-2 test was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-589941 (Patient Link).; Sender's Comments: This spontaneous case concerns a 31-year-old male patient with no medical history reported, who experienced the unexpected, non-serious adverse event of special interest COVID-19 on an unknown date after receiving the first dose of mRNA-1273 vaccine.  Onset latency between vaccine and event cannot be established.  SARS-CoV-2 test was positive.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Palpitations, Pyrexia
Clinical narrative: Mild heart palpitations for several days after vaccination; Fever for several days after vaccination; Fatigue for several days after vaccination; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Mild heart palpitations for several days after vaccination), PYREXIA (Fever for several days after vaccination) and FATIGUE (Fatigue for several days after vaccination) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Mild heart palpitations for several days after vaccination), PYREXIA (Fever for several days after vaccination) and FATIGUE (Fatigue for several days after vaccination). At the time of the report, PALPITATIONS (Mild heart palpitations for several days after vaccination), PYREXIA (Fever for several days after vaccination) and FATIGUE (Fatigue for several days after vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PALPITATIONS (Mild heart palpitations for several days after vaccination), PYREXIA (Fever for several days after vaccination) and FATIGUE (Fatigue for several days after vaccination) to be related.    Patient will play golf and walks 3 miles (4 times weekly).  No concomitant medications were provided by the reporter. Other treatment medications includes Paxlovid, Shingrix, Escitalopram.  Patient's lab data includes Abnormal EKG'S, had Echocardiogram, Cardiac MRI - Determined to have PAC, PVC arrhythmias.   This case was linked to MOD-2022-590374 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: plaque psoriasis near head/covid vaccine made plaque psoriasis worse; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (plaque psoriasis near head/covid vaccine made plaque psoriasis worse) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced PSORIASIS (plaque psoriasis near head/covid vaccine made plaque psoriasis worse). At the time of the report, PSORIASIS (plaque psoriasis near head/covid vaccine made plaque psoriasis worse) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant medication was not reported. It was unknown if patient was enrolled in a Covid-19 vaccine trial.  Treatment drug details were not reported.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 15-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time vial was first punctured was on 15-Jun-2022 at 9.15 AM, the vial undergo temperature excursions of plus 1.9C to plus 6.4 C for 15 mins.  Storage condition at the time of the excursion was Refrigerator.  Vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial on 15-Jun-2022  Visual inspection noting any vaccine state change was thawed.  Proposed desired use by date was 15-Jun-2022 afternoon.  No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine manufacturer expiration date 20-May-2022 was taken out of the freezer on 20-Apr-2022 and administered on 24-May-2022; Patient was given expired (4 days expired) Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 20-May-2022 was taken out of the freezer on 20-Apr-2022 and administered on 24-May-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER (Dose: 1, Lot/Batch number: EL3302, Dose/volume: 0.3 ml, Route and Body site: Intramuscular, left deltoid.) on 25-Jan-2021, PFIZER (Dose: 2, Lot/Batch number: EL9264, Dose/volume: 0.3 ml, Route and Body site: Intramuscular, left deltoid.) on 18-Feb-2021, PFIZER (Dose: 3, Lot/Batch number: FF8841, Dose/volume: 0.3 ml and Route: Intramuscular.) on 14-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER, PFIZER and PFIZER.    On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 20-May-2022 was taken out of the freezer on 20-Apr-2022 and administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 20-May-2022 was taken out of the freezer on 20-Apr-2022 and administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Moderna vaccine lot 033K21-2A manufacturer expiration date 20-May-2022 was taken out of freezer on 20-Apr-2022. Out of freezer expiration date was 20-May-2022. No treatment information was reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine taken out of freezer on 20-Apr-2022, out of freezer expiration date was 20-May-2022 and administered on 20-May-2022; On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with manufacturer expiry date 10-Jul-2022, beyond 30 days duration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with manufacturer expiry date 10-Jul-2022, beyond 30 days duration) and PRODUCT STORAGE ERROR (Moderna vaccine taken out of freezer on 20-Apr-2022, out of freezer expiration date was 20-May-2022 and administered on 20-May-2022) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 013M20A and 037k20A) for COVID-19 prophylaxis.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-May-2022 at 3:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with manufacturer expiry date 10-Jul-2022, beyond 30 days duration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine taken out of freezer on 20-Apr-2022, out of freezer expiration date was 20-May-2022 and administered on 20-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with manufacturer expiry date 10-Jul-2022, beyond 30 days duration) and PRODUCT STORAGE ERROR (Moderna vaccine taken out of freezer on 20-Apr-2022, out of freezer expiration date was 20-May-2022 and administered on 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Economic problem, Rash
Clinical narrative: It was about a month and a half after the second injection that I started to get s severe skin rash, i went to the doctor and he gave met prednisone tablets and an antibiotic injection, it comes as goes, ever since I have to were long sleeve clothes even if it is warm and need to go for cortizone injections frequintly, it is really an unbearable experiene and when i get same on my hands it hurts. nothing els seems to help not even alergex tablets or ointment.  Please help me
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: Error: Leaking from Injection Site-
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered, Infection, Injection site erythema, Pain in extremity
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Fever-Medium, Additional Details: The day after the injection the patient's hand started to get painful/red/and swollen.  Patient went to the doctor and they thought he had an infection and prescribed antibiotics.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Fever-Medium, Additional Details: The day after the injection the patient's hand started to get painful/red/and swollen.  Patient went to the doctor and they thought he had an infection and prescribed antibiotics.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Clinician gave my son the adult dose.  I had also questioned the dosage prior to her administering  (she was very short and appeared annoyed) and  told me he should receive a full dose which is 100% incorrect.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Clinician gave my son the adult dose.  I had also questioned the dosage prior to her administering  (she was very short and appeared annoyed) and  told me he should receive a full dose which is 100% incorrect.
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: NO ADVERSE EVENTS REPORTED FROM INCORRECT DOSE ADMINISTERED
Age: 9.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: NO ADVERSE EVENTS REPORTED FROM INCORRECT DOSE ADMINISTERED
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lip blister, Lip swelling, Pyrexia
Clinical narrative: my lips broke out in fever blisters and swelling.  I am still dealing with these symtoms
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, fever, dizziness, headache, muscle pain, chills
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue, fever, dizziness, headache, muscle pain, chills
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case. Moderna 3/27/21 018B21A, 4/24/21 043B21A and boosted 11/30/21 012H21B.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: congestion started 6/19
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough event  dose 1 Pfizer 4/3/21  ER2613 dose 2 Pfizer 4/24/21 EW0150
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Thrombocytopenia
Clinical narrative: MOderna vaccine induced  thrombocytopenia  (worsening of  thrombocytopenia)
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Fatigue, Headache, Malaise, Productive cough
Clinical narrative: Started feeling ill on 6/17/22 with slight productive cough, tired and headaches. Treatment includes observation and lovenox. Not a candidate for paxlovid.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Dyspnoea, Rash, Swelling, Urticaria
Clinical narrative: COVID mRNA vaccine- unspecified which one Reaction: cough, hives, rash, shortness of breath, swelling Severity: High
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization with covid; fully vaccinated
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy spreading to chest arms back face
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dyspnoea, Heart rate increased, Hypoaesthesia, Laboratory test
Clinical narrative: Both of my hands numb burning painful and sometimes can't feel heat, same day both my feet same as my hands but hypersensitive on the bottoms of my feet then the numb tingling burning started going up both legs. I had never been so sick. I couldn't get out of bed, couldn't breathe, rapid heart beat, vomiting, and could not stay awake very long. This started the day after the numbness and burning in my hands and feet. Took a week and there was times I thought I was going to die.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mobility decreased, Pain, Paraesthesia, Somnolence
Clinical narrative: Both of my hands numb burning painful and sometimes can't feel heat, same day both my feet same as my hands but hypersensitive on the bottoms of my feet then the numb tingling burning started going up both legs. I had never been so sick. I couldn't get out of bed, couldn't breathe, rapid heart beat, vomiting, and could not stay awake very long. This started the day after the numbness and burning in my hands and feet. Took a week and there was times I thought I was going to die.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Both of my hands numb burning painful and sometimes can't feel heat, same day both my feet same as my hands but hypersensitive on the bottoms of my feet then the numb tingling burning started going up both legs. I had never been so sick. I couldn't get out of bed, couldn't breathe, rapid heart beat, vomiting, and could not stay awake very long. This started the day after the numbness and burning in my hands and feet. Took a week and there was times I thought I was going to die.
Age: 67.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Patient woke up next morning with headache, fever, chills and fatigue. He took aspirin that resolved the headache. He was still experiencing symptoms when reported around 5:00pm. No reaction at either site of administration. Spouse will monitor and give ibuprofen as needed.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Dysstasia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain
Clinical narrative: Approx. 4 days after receiving the 4th Moderna vaccine (booster), patient began experiencing significant left arm pain, swollen left hand,  numbness in his hand, continued pain at the injection site, could not raise left arm above his shoulder. He also started experiencing numbness and tingling in both legs, shooting pains down both legs, and difficulty getting up after sitting.   Prior to this patient was very active (exercising, yard-work, traveling)
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nerve conduction studies, Pain, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Approx. 4 days after receiving the 4th Moderna vaccine (booster), patient began experiencing significant left arm pain, swollen left hand,  numbness in his hand, continued pain at the injection site, could not raise left arm above his shoulder. He also started experiencing numbness and tingling in both legs, shooting pains down both legs, and difficulty getting up after sitting.   Prior to this patient was very active (exercising, yard-work, traveling)
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Our MA accidentally gave patient an adult Pfizer booster dose instead of a pediatric dose. Pt is 5 years old. She notified me promptly of the mistake. I then immediately informed the mother of the patient of the mistake and how it will be handled and what side effects/reactions to watch for. I then informed Dr. of the mistake. Dr. then went out and spoke with mother of patient as well. I then called the local Health Department to report it and find out next steps. RN called Pfizer to report it as well and they both opened a case file. Local Health Department will email me with next steps. The first one was to report it to the mother of patient and let them no their are no adverse reactions/indications. Patient can go back to regular pediatric booster if a second one comes out in the future. I called mother of the patient and let her know what they said and informed her of what our current protocol is and how it will be changed moving forward so this does not happen again.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Carditis, Cerebral haemorrhage, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: Difficulty breathing at rest, seizures stroke symptoms electric schools in brain elevated inflammation markers, 6 months latter brain bleed related to inflammation storm
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea at rest, Electric shock sensation, Hemiparesis, Immunisation reaction, Inflammation
Clinical narrative: Difficulty breathing at rest, seizures stroke symptoms electric schools in brain elevated inflammation markers, 6 months latter brain bleed related to inflammation storm
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Laboratory test, Neurological symptom, Red blood cell sedimentation rate increased, Respiration abnormal
Clinical narrative: Difficulty breathing at rest, seizures stroke symptoms electric schools in brain elevated inflammation markers, 6 months latter brain bleed related to inflammation storm
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Vertigo, Visual impairment
Clinical narrative: Difficulty breathing at rest, seizures stroke symptoms electric schools in brain elevated inflammation markers, 6 months latter brain bleed related to inflammation storm
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: fully vaccinated covid pt admit to hospital
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test negative, Pruritus, Urticaria chronic
Clinical narrative: Chronic Urticaria observed 11 days after vaccine. Never had any types of allergies/hives or urticaria before. Symptoms still present today over 6 months after vaccine. Need to take anti histamines everyday in order to control itching.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose increased, Blood test, Chest X-ray, Decreased appetite, Dehydration
Clinical narrative: approximately 7 hours post, fever (max 102, lasted 48 hours), severe body aches, headache, lethargic, lack of appetite, injection site swelling & soreness,high heart rate & blood sugars
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Electrocardiogram, Headache, Heart rate increased, Influenza virus test, Injection site pain
Clinical narrative: approximately 7 hours post, fever (max 102, lasted 48 hours), severe body aches, headache, lethargic, lack of appetite, injection site swelling & soreness,high heart rate & blood sugars
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lethargy, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: approximately 7 hours post, fever (max 102, lasted 48 hours), severe body aches, headache, lethargic, lack of appetite, injection site swelling & soreness,high heart rate & blood sugars
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Urinary tract infection, Urine analysis abnormal
Clinical narrative: approximately 7 hours post, fever (max 102, lasted 48 hours), severe body aches, headache, lethargic, lack of appetite, injection site swelling & soreness,high heart rate & blood sugars
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Pruritus
Clinical narrative: Patient reports no immediate reaction after vaccination on friday the 10th. Said monday morning afterward her left eye was swollen, and throughout the day the rest of her face including her right eye got more swollen, and her arms/rest of body were red and itchy. Patient said she consulted a nursing friend, took benadryl, and the symptoms were relieved in the next 24-48 hours.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given a booster dose of the Moderna vaccine. Patient was under 18 years old at the time the dose was given. He did not experience any side effects from the vaccine. There is nothing else to report at this time.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Cardio-respiratory arrest, Chest X-ray abnormal, Cough
Clinical narrative: 1/14/22 pt found to be positive for COVID after 1 wk of increasing SOB and cough; Chest x-ray showed bilateral pneumonia; A Fib with RVR; on Vapotherm and steroids; dc'd to rehab facility (Health and Rehab for myopathy/polyneuropathy related to COVID respiratory failure; will need to improve overall functioning to return to home; OT and PT in facility; pt to continue O2 supplementation, albuterol inhaler, Breo Ellipta, Mucinex; found pt unresponsive and with a thready pulse in facility; code blue called; ROSC never achieved; pt expired in the facility
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Myopathy, Pneumonia, Polyneuropathy
Clinical narrative: 1/14/22 pt found to be positive for COVID after 1 wk of increasing SOB and cough; Chest x-ray showed bilateral pneumonia; A Fib with RVR; on Vapotherm and steroids; dc'd to rehab facility (Health and Rehab for myopathy/polyneuropathy related to COVID respiratory failure; will need to improve overall functioning to return to home; OT and PT in facility; pt to continue O2 supplementation, albuterol inhaler, Breo Ellipta, Mucinex; found pt unresponsive and with a thready pulse in facility; code blue called; ROSC never achieved; pt expired in the facility
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse abnormal, Respiratory failure, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: 1/14/22 pt found to be positive for COVID after 1 wk of increasing SOB and cough; Chest x-ray showed bilateral pneumonia; A Fib with RVR; on Vapotherm and steroids; dc'd to rehab facility (Health and Rehab for myopathy/polyneuropathy related to COVID respiratory failure; will need to improve overall functioning to return to home; OT and PT in facility; pt to continue O2 supplementation, albuterol inhaler, Breo Ellipta, Mucinex; found pt unresponsive and with a thready pulse in facility; code blue called; ROSC never achieved; pt expired in the facility
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: pt tested positive for covid.  Had Covid Vaccine
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received a full 0.5ml dose instead of the 0.25ml booster dose.  This was his 4th Moderna dose (2nd booster).   Patient was contacted on Thursday, June 16th and made aware of the error.  No adverse effects noted from the patient.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Colostomy, Large intestinal obstruction, Pneumonia aspiration
Clinical narrative: Pt admitted for acute respiratory failure with hypoxia and currently on high flow nasal cannula, aspiration pneumonia, and sigmoid colon obstruction status post colostomy.  Pt has an initial COVID test that was negative, and then was positive on a respiratory panel.  A PCR was done and the CT value was 32.4.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: Pt admitted for acute respiratory failure with hypoxia and currently on high flow nasal cannula, aspiration pneumonia, and sigmoid colon obstruction status post colostomy.  Pt has an initial COVID test that was negative, and then was positive on a respiratory panel.  A PCR was done and the CT value was 32.4.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Resident received a fifth dose of the Moderna vaccine.  No adverse events/reactions occurred.  Error occurred because Immunization Registry had not been updated with resident's fourth dose when our healthcare facility pulled this information, so she showed as being eligible for a fourth dose.  After it was administered our pharmacy alerted us of the error.