chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine dose administered after more than 12 hours past vial first puncture and the vial was stored in fridge post puncture; Moderna vaccine dose administered after more than 12 hours past vial first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine dose administered after more than 12 hours past vial first puncture) and PRODUCT STORAGE ERROR (Moderna vaccine dose administered after more than 12 hours past vial first puncture and the vial was stored in fridge post puncture) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine dose administered after more than 12 hours past vial first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine dose administered after more than 12 hours past vial first puncture and the vial was stored in fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine dose administered after more than 12 hours past vial first puncture) and PRODUCT STORAGE ERROR (Moderna vaccine dose administered after more than 12 hours past vial first puncture and the vial was stored in fridge post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The facility received the vial on 22-Apr-2022 and it was thawed when the facility received it.  The vial was first punctured on 10-May-2022 at 2:20 P.M.  The patient received Moderna vaccine on 11-May-2022 at timing of either 8:30 A.M or 12:20 P.M.  The vial was not exposed to room temperature for more than 24 hours.  The vial did not undergo any temperature excursions. The patient did not report any adverse reactions to the expired dose.  The healthcare provider wanted to know if the vaccine was viable or should the patients be re-vaccinated or not.  Treatment information was not provided.   This case was linked to MOD-2022-567443.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (tree pollen, of which there is plenty right now), Penicillin allergy and Asthma. Concomitant products included ESOMEPRAZOLE from 30-Apr-2022 to 12-May-2022 and MESTRANOL, NORETYNODREL (ENOVID) from 28-Apr-2022 to 04-May-2022 for an unknown indication.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive.). At the time of the report, COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) After testing almost negative on a rapid test at day 5, positive (Positive) I got a strong positive on day 10 and positive (Positive) day 12, still strong positive.         The patient Conmed included Covid-19 treatment on 30Apr2022 and stopped on 04May2022 . The patient received other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient got a strong positive on day 10 with runny nose and slight body aches and also experienced one or two temporary bouts of unexpected fatigue. Treatment for the event was not reported.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected nonserious AESI event of COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive) which occurred 5 months 22 days after the third dose of mRNA-1273 vaccine. Ongoing pandemic of COVID -19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected nonserious AESI event of COVID-19 (After testing almost negative on a rapid test at day 5, I got a strong positive on day 10. Today is day 12, still strong positive) which occurred 5 months 22 days after the third dose of mRNA-1273 vaccine. Ongoing pandemic of COVID -19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: positive for COVID again; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and COVID-19 (positive for COVID again) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032f21a) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN from 01-Jan-2021 to an unknown date for an unknown indication.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2022, the patient experienced COVID-19 (COVID-19). On 10-May-2022, the patient experienced COVID-19 (positive for COVID again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-May-2022 to 05-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (COVID-19) had resolved. At the time of the report, COVID-19 (positive for COVID again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 10-May-2022, Body temperature: 99.7 99.7. On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: negative (Negative) Negative (By day 7).         It was reported that patient started Paxlovid on day of COVID positive diagnosis and completed 5 day regimen. By day 3 of regimen started feeling better. By day 7, tested negative for COVID. On day 9, had a symptoms bad runny nose, muscle aches, chills, and low grade fever (99.7); tested positive for COVID again. The patient was isolated at the time of reporting.  Company comment: This is a spontaneous case reported by a consumer. A 39-year-old male patient experienced 2 non serious episodes of COVID-19 (AESI) after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Approximately 5 months after vaccination he had a positive diagnosis and completed 5 day regimen of Paxlovid; by day 7 he tested negative. On day 9, patient tested positive for COVID again. Relevant concurrent medical conditions included diabetes mellitus which represents a risk factor for infections, including COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 39-year-old male patient experienced 2 non serious episodes of COVID-19 (AESI) after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Approximately 5 months after vaccination he had a positive diagnosis and completed 5 day regimen of Paxlovid; by day 7 he tested negative. On day 9, patient tested positive for COVID again. Relevant concurrent medical conditions included diabetes mellitus which represents a risk factor for infections, including COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID-19 virus) and DRUG INEFFECTIVE (received first Moderna booster in Aug-2021 and had Covid-19 in Jan-2022) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first 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. In January 2022, the patient experienced COVID-19 (got COVID-19 virus) and DRUG INEFFECTIVE (received first Moderna booster in Aug-2021 and had Covid-19 in Jan-2022). At the time of the report, COVID-19 (got COVID-19 virus) and DRUG INEFFECTIVE (received first Moderna booster in Aug-2021 and had Covid-19 in Jan-2022) outcome was unknown. No concomitant medication was reported. No treatment information was provided. Company comment: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. Additionally, Drug ineffective was also reported. The exact date of onset of the event and administration of third dose of mRNA-1273 was not provided, hence latency could not be assessed. The initial two doses of mRNA-1273 were administered on unspecified dates. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. Additionally, Drug ineffective was also reported. The exact date of onset of the event and administration of third dose of mRNA-1273 was not provided, hence latency could not be assessed. The initial two doses of mRNA-1273 were administered on unspecified dates. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Cannot move left arm; Hurting from shoulder to elbow in left arm; Swelling of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot move left arm), VACCINATION SITE PAIN (Hurting from shoulder to elbow in left arm) and VACCINATION SITE SWELLING (Swelling of the left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 30A21A and 013M20A) for COVID-19 vaccination.     The patient did not receive any other vaccine beside the Moderna COVID-19 vaccine in the last months.  The patient was never tested positive for COVID-19.  Concurrent medical conditions included Drug allergy (Allergic to codeine) and Blood cholesterol abnormal.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot move left arm), VACCINATION SITE PAIN (Hurting from shoulder to elbow in left arm) and VACCINATION SITE SWELLING (Swelling of the left arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot move left arm), VACCINATION SITE PAIN (Hurting from shoulder to elbow in left arm) and VACCINATION SITE SWELLING (Swelling of the left arm) had not resolved.            The patient took unspecified cholesterol medicine as concomitant medication.  The patient reported that her symptoms started the day she received the second booster dose and had gotten worse since then.  The patient did not take medications for these symptoms except to apply ice.
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Eye pruritus, Ocular discomfort, Ocular hyperaemia, Skin wrinkling
Clinical narrative: eye irritation; extreme itchiness, itchiness around the eyes; redness around the eyes; wrinkles around the eyes; extreme discomfort; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eye irritation), EYE PRURITUS (extreme itchiness, itchiness around the eyes), OCULAR HYPERAEMIA (redness around the eyes), SKIN WRINKLING (wrinkles around the eyes) and OCULAR DISCOMFORT (extreme discomfort) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE IRRITATION (eye irritation), EYE PRURITUS (extreme itchiness, itchiness around the eyes), OCULAR HYPERAEMIA (redness around the eyes), SKIN WRINKLING (wrinkles around the eyes) and OCULAR DISCOMFORT (extreme discomfort). At the time of the report, EYE IRRITATION (eye irritation) and EYE PRURITUS (extreme itchiness, itchiness around the eyes) had not resolved and OCULAR HYPERAEMIA (redness around the eyes), SKIN WRINKLING (wrinkles around the eyes) and OCULAR DISCOMFORT (extreme discomfort) outcome was unknown.            No concomitant medications were provided by the reporter. It was reported that patient experienced extreme itchiness after the booster dose, It is still ongoing, patient have seen pcp and a dermatologist. eye reactions and they do not exactly fit description, itchiness and redness and wrinkles around the eyes causing extreme discomfort. Patient took  steroids and other prescribed meds with no help.      This case was linked to MOD-2022-567946 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Feeling achy; exhausted; Headache; fever/fever of 101.3 degrees Farenheight; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Feeling achy), FATIGUE (exhausted), HEADACHE (Headache) and PYREXIA (fever/fever of 101.3 degrees Farenheight) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (Feeling achy), FATIGUE (exhausted), HEADACHE (Headache) and PYREXIA (fever/fever of 101.3 degrees Farenheight). At the time of the report, MYALGIA (Feeling achy), FATIGUE (exhausted), HEADACHE (Headache) and PYREXIA (fever/fever of 101.3 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) 101.3 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment  medications were reported. Patient received her booster dose of the Moderna COVID-19 vaccine on 14-Dec-2021, theexpiration date was 02-Jan-2022. The patient received the booster dose in the right arm. The patient had no side effects or adverse events to the booster dose Patient with the family was at a wedding on 26-Dec-2021 and exposed to COVID-19 infected individuals. None of them caught COVID-19.   This case was linked to MOD-2022-567683 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine administration; Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) and PRODUCT STORAGE ERROR (Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Allergies to medication, food and other products were unknown. It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. Chronic and acute illness at the time of vaccination and one month prior was unknown.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:50 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:50 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration). In May 2022, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) and PRODUCT STORAGE ERROR (Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine administration) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vial expired on 02-May-2022, pulled from freezer at 10AM on 03-May-2022, put in refrigerator until approximately 1:45 PM).    The reporter's occupation was given as COVID operation chief. Prescription, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and or at the time of the adverse event was unknown. The vial was pulled from freezer at 10 AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM. The vial did not undergo any temperature excursions. The event did not cause the patient to seek medical care. It was unknown if the patient had experienced a similar event in the past. Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: patient had flu like symptoms; no energy; itching at the injection site; The caller had soreness/ soreness at the injection site; redness/ redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (patient had flu like symptoms), ASTHENIA (no energy), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (The caller had soreness/ soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness/ redness at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (patient had flu like symptoms), ASTHENIA (no energy), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (The caller had soreness/ soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness/ redness at the injection site). At the time of the report, INFLUENZA LIKE ILLNESS (patient had flu like symptoms) and ASTHENIA (no energy) had resolved and VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (The caller had soreness/ soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness/ redness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Flu-like symptoms lasted for 6 to 8 hours. Reporter stated that her busy life might have contributed to the no energy. No treatment details were reported.   This case was linked to MOD-2022-567475, MOD-2022-568117, MOD-2022-568134, MOD-2022-568154, MOD-2022-568158 (Patient Link).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM; 12 doses administered past manufactures expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 doses administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:10 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 doses administered past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 doses administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (12 doses administered past manufactures expiration date) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM).    No concomitant medications were reported by the reporter.  All 12 doses were administered between 2-3 PM on 03-May-2022  The vial was initially stored in the refrigerator was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM.  No the vial did not undergo any temperature excursions.  No treatment medications were reported by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM; dose administered past manufactures expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     It was unknown if the patient was diagnosed or tested for COVID-19. It was reported that whether patient had acute illness at the time of vaccination and up to one month before, chronic or long-standing health conditions and allergies were unknown.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:40 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:40 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) and PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022 and pulled from freezer at 10AM on 03May2022 and put in refrigerator until approximately 1:45 PM).    No concomitant medications was reported.  Patient received the second booster dose on 03-May-2022 post the expiry date. Vial was pulled from freezer at 10 AM and was again put in refrigerator until approximately till 1:45 PM on 03-May-2022. The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. It is unknown whether patient had any allergies. It was unknown if patient had acute illness at the time of vaccination as well as unknown for chronic health conditions. The patient's past medical history included COVID-19. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:30 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:30 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/ Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered past manufactures expiration date/ Expired vaccine administered) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02-May-2022, was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM). No concomitant product reported by reporter. It was unknown if patient experienced similar adverse event in the past. Vaccine did not undergone any temperature excursion issue. Vaccine was pulled from freezer at 10AM on 03-May-2022 and was put in refrigerator until approximately 1:45 PM. No treatment medication reported by reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired 2nd Booster; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065K21A, 030B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired 2nd Booster) outcome was unknown. Concomitant product use was not provided by the reporter.  Patient received an expired second booster of Moderna COVID-19 vaccine on 06-May-2022. No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM; dose administered past manufactures expiration date/ Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient had no known allergy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 03-May-2022 at 3:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM).    No concomitant product reported by reporter.  It was unknown if patient had the ever been diagnosed with Covid-19. It was unknown if patient had acute illness or chronic health conditions at the time of vaccination . It was unknown if patient experienced similar adverse event in the past. Vaccine did not undergone any temperature excursion issue. Vaccine was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM. Dose administered after 30 day Use By Date or after manufacturer date of expiry.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 22March2022 and administration of vaccine on 10May2022; patient  got a dose after the use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient  got a dose after the use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22March2022 and administration of vaccine on 10May2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient  got a dose after the use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22March2022 and administration of vaccine on 10May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient  got a dose after the use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22March2022 and administration of vaccine on 10May2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment medications was not provided by the reporter. The hcp wanted to know if the dose was considered as viable or do they need to re-dose. One doses vials administered after 30-day use By date. On 22-Mar-2022, the vial was initially stored in the refrigerator.  On 10-May-2022, the vaccine was administered. The vial does not undergone any temperature excursions.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received 0.5 ml for booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 ml for booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 ml for booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.5 ml for booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that an immunocompromised patient had received a total of four doses and each one of the doses had been 0.5 ml.  No treatment information was provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Coccydynia, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: pre-existing pain in sacro-iliac joint worsened/spread to the left sacro-iliac joint; pain in the coccyx area; walks awkward and limited to 15 minutes of walking; pain spread to the hamstrings and legs; severe joint pains; severe muscle pains; This spontaneous case was reported by a patient and describes the occurrence of SACRAL PAIN (pre-existing pain in sacro-iliac joint worsened/spread to the left sacro-iliac joint), COCCYDYNIA (pain in the coccyx area), GAIT DISTURBANCE (walks awkward and limited to 15 minutes of walking), PAIN IN EXTREMITY (pain spread to the hamstrings and legs) and ARTHRALGIA (severe joint pains) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 071C21A, 026A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID or COVID positive test.  The patient's past medical history included Joint pain. Previously administered products included for Flu: flu vaccine (Given 2 years ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Systolic hypertension, Idiopathic thrombocytopenic purpura, Sacro-iliac pain, Coccyx pain, Arthritis, Allergy to nuts and Drug allergy. Concomitant products included ROMIPLOSTIM (NPLATE) for Idiopathic thrombocytopenic purpura.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, the patient experienced ARTHRALGIA (severe joint pains) and MYALGIA (severe muscle pains). On an unknown date, the patient experienced SACRAL PAIN (pre-existing pain in sacro-iliac joint worsened/spread to the left sacro-iliac joint), COCCYDYNIA (pain in the coccyx area), GAIT DISTURBANCE (walks awkward and limited to 15 minutes of walking) and PAIN IN EXTREMITY (pain spread to the hamstrings and legs). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form once a day. At the time of the report, SACRAL PAIN (pre-existing pain in sacro-iliac joint worsened/spread to the left sacro-iliac joint), COCCYDYNIA (pain in the coccyx area), GAIT DISTURBANCE (walks awkward and limited to 15 minutes of walking), PAIN IN EXTREMITY (pain spread to the hamstrings and legs), ARTHRALGIA (severe joint pains) and MYALGIA (severe muscle pains) had not resolved.            Other concomitant included Alpha blocker and vasodilator for systolic hypertension.  Symptoms were reported as worsened.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Sacral pain
Clinical narrative: pre-existing pain in sacro-iliac joint worsened/spread to the left sacro-iliac joint; pain in the coccyx area; walks awkward and limited to 15 minutes of walking; pain spread to the hamstrings and legs; severe joint pains; severe muscle pains; This spontaneous case was reported by a patient and describes the occurrence of SACRAL PAIN (pre-existing pain in sacro-iliac joint worsened/spread to the left sacro-iliac joint), COCCYDYNIA (pain in the coccyx area), GAIT DISTURBANCE (walks awkward and limited to 15 minutes of walking), PAIN IN EXTREMITY (pain spread to the hamstrings and legs) and ARTHRALGIA (severe joint pains) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 071C21A, 026A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient never had COVID or COVID positive test.  The patient's past medical history included Joint pain. Previously administered products included for Flu: flu vaccine (Given 2 years ago). Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Systolic hypertension, Idiopathic thrombocytopenic purpura, Sacro-iliac pain, Coccyx pain, Arthritis, Allergy to nuts and Drug allergy. Concomitant products included ROMIPLOSTIM (NPLATE) for Idiopathic thrombocytopenic purpura.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, the patient experienced ARTHRALGIA (severe joint pains) and MYALGIA (severe muscle pains). On an unknown date, the patient experienced SACRAL PAIN (pre-existing pain in sacro-iliac joint worsened/spread to the left sacro-iliac joint), COCCYDYNIA (pain in the coccyx area), GAIT DISTURBANCE (walks awkward and limited to 15 minutes of walking) and PAIN IN EXTREMITY (pain spread to the hamstrings and legs). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 dosage form once a day. At the time of the report, SACRAL PAIN (pre-existing pain in sacro-iliac joint worsened/spread to the left sacro-iliac joint), COCCYDYNIA (pain in the coccyx area), GAIT DISTURBANCE (walks awkward and limited to 15 minutes of walking), PAIN IN EXTREMITY (pain spread to the hamstrings and legs), ARTHRALGIA (severe joint pains) and MYALGIA (severe muscle pains) had not resolved.            Other concomitant included Alpha blocker and vasodilator for systolic hypertension.  Symptoms were reported as worsened.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator and administered on 29-Apr-2022; dose of expired Moderna Covid-19 vaccine was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of expired Moderna Covid-19 vaccine was administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator and administered on 29-Apr-2022) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of expired Moderna Covid-19 vaccine was administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator and administered on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of expired Moderna Covid-19 vaccine was administered to patient) and PRODUCT STORAGE ERROR (Vaccine expired on 17-Apr-2022 but was initially stored in the refrigerator and administered on 29-Apr-2022) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   The vial was initially stored in refrigerator on 29-Apr-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red arm allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red arm allergic reaction). At the time of the report, VACCINATION SITE ERYTHEMA (red arm allergic reaction) outcome was unknown.  No concomitant and treatment medications was provided by the reporter.  This case was linked to MOD-2022-567470 (Patient Link).