chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the published expiration date) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  Moderna vaccine was given to 2 patients from the same lot number that was expired. Number of doses/vials-2 doses  Date the vial was initially stored in the refrigerator administered on 10-Jul-2022  The vial was did not undergo any temperature excursions  Patient had not reported any symptoms after receiving Moderna dose.  No additional medications or treatments have been administered in response to this error.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: neck cramps that were severe; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (neck cramps that were severe) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient neither had a COVID positive test nor diagnosis. The patient had no acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (flu vaccine in the fall but not too close to the COVID shots). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Drug allergy (codeine, made her heart race), Drug allergy (SUDAFED, made her heart race) and Seasonal allergy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (neck cramps that were severe). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (neck cramps that were severe) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was not immunocompromised.  Concomitant medication of the patient was not reported.  The patient visited to the doctors for her neck cramps and she was unsure if this was related to the vaccine. The neck cramps had subsided after about a year, it became less and less frequent and rarely occur. The patient did not experience a similar event in the past. Overall status of the patient was improved.  The patient also used CBD cream as corrective treatment.   This case was linked to MOD-2022-609561, MOD-2022-609564 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Sinusitis, Syncope
Clinical narrative: neck cramps that were severe; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (neck cramps that were severe) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient neither had a COVID positive test nor diagnosis. The patient had no acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (flu vaccine in the fall but not too close to the COVID shots). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Drug allergy (codeine, made her heart race), Drug allergy (SUDAFED, made her heart race) and Seasonal allergy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (neck cramps that were severe). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (neck cramps that were severe) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was not immunocompromised.  Concomitant medication of the patient was not reported.  The patient visited to the doctors for her neck cramps and she was unsure if this was related to the vaccine. The neck cramps had subsided after about a year, it became less and less frequent and rarely occur. The patient did not experience a similar event in the past. Overall status of the patient was improved.  The patient also used CBD cream as corrective treatment.   This case was linked to MOD-2022-609561, MOD-2022-609564 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrophy, Gait disturbance, Muscle spasms
Clinical narrative: neck cramps that were severe; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (neck cramps that were severe) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination.     The patient neither had a COVID positive test nor diagnosis. The patient had no acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (flu vaccine in the fall but not too close to the COVID shots). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Drug allergy (codeine, made her heart race), Drug allergy (SUDAFED, made her heart race) and Seasonal allergy.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (neck cramps that were severe). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (neck cramps that were severe) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was not immunocompromised.  Concomitant medication of the patient was not reported.  The patient visited to the doctors for her neck cramps and she was unsure if this was related to the vaccine. The neck cramps had subsided after about a year, it became less and less frequent and rarely occur. The patient did not experience a similar event in the past. Overall status of the patient was improved.  The patient also used CBD cream as corrective treatment.   This case was linked to MOD-2022-609561, MOD-2022-609564 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: Patient is still building the strength; Both of her hips cramped; Difficult to walk; Left side almost atrophied; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Both of her hips cramped), GAIT DISTURBANCE (Difficult to walk), ASTHENIA (Patient is still building the strength) and ATROPHY (Left side almost atrophied) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028l20a and 011j20a) for COVID-19 prophylaxis.     Previously administered products included for Flu vaccination: Flu Vaccine (flu vaccine in the fall but not too close to the COVID shots). Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Drug allergy (codeine or SUDAFED made her heart race) and Seasonal allergy.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced MUSCLE SPASMS (Both of her hips cramped) and GAIT DISTURBANCE (Difficult to walk). In 2021, the patient experienced ATROPHY (Left side almost atrophied). On an unknown date, the patient experienced ASTHENIA (Patient is still building the strength). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DICLOFENAC (VOLTAREN [DICLOFENAC]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Both of her hips cramped) and ATROPHY (Left side almost atrophied) had resolved and GAIT DISTURBANCE (Difficult to walk) and ASTHENIA (Patient is still building the strength) was resolving.            No concomitant product use was provided. The patient had never experienced a similar event in the past and she never had COVID positive test or diagnosis.  Patient was not immunocompromised.  Patient experienced reactions progressively more serious with each vaccination. The right hip cramp only lasted one day. The left hip had only subsided in the last month. After the 2nd shot the patient had contacted her doctor. For the hip it was difficult to get into physical therapy, however the patient worked with a trainer to regain strength on her left side as the left side almost atrophied which lasted almost a year and 4 months. Patient's symptoms had improved and was still building the strength.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Sinusitis, Syncope
Clinical narrative: Patient is still building the strength; Both of her hips cramped; Difficult to walk; Left side almost atrophied; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Both of her hips cramped), GAIT DISTURBANCE (Difficult to walk), ASTHENIA (Patient is still building the strength) and ATROPHY (Left side almost atrophied) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028l20a and 011j20a) for COVID-19 prophylaxis.     Previously administered products included for Flu vaccination: Flu Vaccine (flu vaccine in the fall but not too close to the COVID shots). Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Drug allergy (codeine or SUDAFED made her heart race) and Seasonal allergy.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced MUSCLE SPASMS (Both of her hips cramped) and GAIT DISTURBANCE (Difficult to walk). In 2021, the patient experienced ATROPHY (Left side almost atrophied). On an unknown date, the patient experienced ASTHENIA (Patient is still building the strength). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DICLOFENAC (VOLTAREN [DICLOFENAC]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Both of her hips cramped) and ATROPHY (Left side almost atrophied) had resolved and GAIT DISTURBANCE (Difficult to walk) and ASTHENIA (Patient is still building the strength) was resolving.            No concomitant product use was provided. The patient had never experienced a similar event in the past and she never had COVID positive test or diagnosis.  Patient was not immunocompromised.  Patient experienced reactions progressively more serious with each vaccination. The right hip cramp only lasted one day. The left hip had only subsided in the last month. After the 2nd shot the patient had contacted her doctor. For the hip it was difficult to get into physical therapy, however the patient worked with a trainer to regain strength on her left side as the left side almost atrophied which lasted almost a year and 4 months. Patient's symptoms had improved and was still building the strength.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrophy, Gait disturbance, Muscle spasms
Clinical narrative: Patient is still building the strength; Both of her hips cramped; Difficult to walk; Left side almost atrophied; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Both of her hips cramped), GAIT DISTURBANCE (Difficult to walk), ASTHENIA (Patient is still building the strength) and ATROPHY (Left side almost atrophied) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028l20a and 011j20a) for COVID-19 prophylaxis.     Previously administered products included for Flu vaccination: Flu Vaccine (flu vaccine in the fall but not too close to the COVID shots). Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Drug allergy (codeine or SUDAFED made her heart race) and Seasonal allergy.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced MUSCLE SPASMS (Both of her hips cramped) and GAIT DISTURBANCE (Difficult to walk). In 2021, the patient experienced ATROPHY (Left side almost atrophied). On an unknown date, the patient experienced ASTHENIA (Patient is still building the strength). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DICLOFENAC (VOLTAREN [DICLOFENAC]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Both of her hips cramped) and ATROPHY (Left side almost atrophied) had resolved and GAIT DISTURBANCE (Difficult to walk) and ASTHENIA (Patient is still building the strength) was resolving.            No concomitant product use was provided. The patient had never experienced a similar event in the past and she never had COVID positive test or diagnosis.  Patient was not immunocompromised.  Patient experienced reactions progressively more serious with each vaccination. The right hip cramp only lasted one day. The left hip had only subsided in the last month. After the 2nd shot the patient had contacted her doctor. For the hip it was difficult to get into physical therapy, however the patient worked with a trainer to regain strength on her left side as the left side almost atrophied which lasted almost a year and 4 months. Patient's symptoms had improved and was still building the strength.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 10-Jun-2022 and vaccine was administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-Jun-2022 and vaccine was administered on 12-Jul-2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-Jun-2022 and vaccine was administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 10-Jun-2022 and vaccine was administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications details were reported by the reporter.  Patient weight was reported as 211.6.  On 10-Jun-2022 vial was initially stored in the refrigerator and vaccine was administered on 12-Jul-2022 (30 day beyond use date). No temperature excursions was reported. No Adverse reaction was reported.  No treatment details were reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) 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 October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Patient reported that patient did not need to repeat the dose unless patient experienced any side effects.   No treatment medication information provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The pharmacy sent Moderna COVID-19 vaccines on 10-Jun-2022 but the patient received the vaccine on 12-Jul-2022.; Patient recived vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient recived vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The pharmacy sent Moderna COVID-19 vaccines on 10-Jun-2022 but the patient received the vaccine on 12-Jul-2022.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient recived vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The pharmacy sent Moderna COVID-19 vaccines on 10-Jun-2022 but the patient received the vaccine on 12-Jul-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient recived vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (The pharmacy sent Moderna COVID-19 vaccines on 10-Jun-2022 but the patient received the vaccine on 12-Jul-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.  It was reported that, the pharmacy has sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator, but vaccine was given to the patient on 12-Jul-2022. The patient administered vaccine after the 30 days use date.  The vials did not undergo any temperature excursions. No adverse event reported by the patient.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-607720 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-607720:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-jun-2022 and the doses were administered on 12-jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-jun-2022 and the doses were administered on 12-jul-2022) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-jun-2022 and the doses were administered on 12-jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-jun-2022 and the doses were administered on 12-jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     No concomitant medications was provided by the reporter.  Dose administered past the 30 day storage on the refrigerator Number of doses or vials administered 15 doses. Date the vial was initially stored in the refrigerator 10-Jun-2022. The vial had not undergone any temperature excursion.  No adverse reaction was reported.  No treatment medications were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-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.  It was reported that the patient was vaccinated with vaccine after the 30 days beyond use date. The date the vial was initially stored in the refrigerator was 10-Jun-2022. It was also reported that the vial didn't undergo any temperature excursions. Reportedly, no adverse reactions were reported.  No treatment information was provided by the reporter.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 204. No concomitant medications were reported. It was reported that the vial had not undergone any temperature excursions. No adverse reactions were reported. No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Illness, Nausea
Clinical narrative: Now experiences weakness; 2nd Booster made him sicker; Diarrhea; Nausea; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Now experiences weakness), ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060a21a, 076c21a, 019n21a and 013a21a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine on 13-Nov-2021. Past adverse reactions to the above products included Pneumonia with Flu vaccine.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Now experiences weakness), ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Now experiences weakness) was resolving and ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved.            Patient's height was reported as 6 foot 2. Concomitant medications were taken but not reported. Patient did not remember the exact treatment taken. Patient had not experienced similar events in the past. Patient felt pretty weak but going to recovery. All symptoms were gone except Weakening.   This case was linked to MOD-2022-609577, MOD-2022-609593 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Now experiences weakness; 2nd Booster made him sicker; Diarrhea; Nausea; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Now experiences weakness), ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060a21a, 076c21a, 019n21a and 013a21a) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine on 13-Nov-2021. Past adverse reactions to the above products included Pneumonia with Flu vaccine.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Now experiences weakness), ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Now experiences weakness) was resolving and ILLNESS (2nd Booster made him sicker), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved.            Patient's height was reported as 6 foot 2. Concomitant medications were taken but not reported. Patient did not remember the exact treatment taken. Patient had not experienced similar events in the past. Patient felt pretty weak but going to recovery. All symptoms were gone except Weakening.   This case was linked to MOD-2022-609577, MOD-2022-609593 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Illness, Nausea
Clinical narrative: negligible side effects after the first two doses; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (negligible side effects after the first two doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 19N21A and 013A21A) for COVID-19 vaccination.     Patient do not have any allergies.  The patient had never been diagnosed with/ tested positive for COVID-19.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 IMMUNISATION REACTION (negligible side effects after the first two doses). At the time of the report, IMMUNISATION REACTION (negligible side effects after the first two doses) outcome was unknown.     Unspecified Concomitant has been prescribed regularly.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: negligible side effects after the first two doses; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (negligible side effects after the first two doses) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 19N21A and 013A21A) for COVID-19 vaccination.     Patient do not have any allergies.  The patient had never been diagnosed with/ tested positive for COVID-19.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-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 IMMUNISATION REACTION (negligible side effects after the first two doses). At the time of the report, IMMUNISATION REACTION (negligible side effects after the first two doses) outcome was unknown.     Unspecified Concomitant has been prescribed regularly.  No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Erythema
Clinical narrative: Inconvenience that occurs at bedtime; Red patches on skin/moving from one part of my body to another/armpit to chest/Not hives, looks like red patches of blood/ underneath my groin; This spontaneous case was reported by a pharmacist and describes the occurrence of DISCOMFORT (Inconvenience that occurs at bedtime) and ERYTHEMA (Red patches on skin/moving from one part of my body to another/armpit to chest/Not hives, looks like red patches of blood/ underneath my groin) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 018B21A and 018B21A) for COVID-19 prophylaxis.     The patient never had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE] (6 months prior to booster) in June 2021. Past adverse reactions to the above products included No adverse event with PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE]. Concurrent medical conditions included Seasonal rhinitis, Arthritis and Liver disorder (Elevated SGPT). Concomitant products included MILK THISTLE [SILYBUM MARIANUM] for Liver disorder, ASCORBIC ACID (VIT C) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced DISCOMFORT (Inconvenience that occurs at bedtime) and ERYTHEMA (Red patches on skin/moving from one part of my body to another/armpit to chest/Not hives, looks like red patches of blood/ underneath my groin). At the time of the report, DISCOMFORT (Inconvenience that occurs at bedtime) and ERYTHEMA (Red patches on skin/moving from one part of my body to another/armpit to chest/Not hives, looks like red patches of blood/ underneath my groin) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not experienced a similar event in the past.  Other Concomitant medications also included Glucosamine Chondroitin for arthritis and Centrum, Omega, Tumeric for unknown indication.  Pharmacist(patient) reported that side effects experienced after 8 days following his 1st Moderna booster dose. Patient did not experience any reactions with primary Moderna doses. Patient inquired about possibility of taking the 2nd booster dose, because patient's symptoms lasted 5 months and resolved on it's own without any treatment.   Patient went on to state that perhaps as long as the vaccine lasted. During the call, the patient mentioned that his doctor advised him not to take the 2nd booster.  Adverse event caused patient to seek medical care from primary doctor.  The events were resolved on it's own without any treatment.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administer the vaccine after the beyond use date, it was on the refrigerator for more than 30 days; it was on the refrigerator for more than 30 days then used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine after the beyond use date, it was on the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (it was on the refrigerator for more than 30 days then used) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-May-2022, the patient experienced PRODUCT STORAGE ERROR (it was on the refrigerator for more than 30 days then used). On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine after the beyond use date, it was on the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine after the beyond use date, it was on the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (it was on the refrigerator for more than 30 days then used) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Number of doses was 1 vial 1 dose. The vial was initially stored in the refrigerator was on 27-May-2022. The vial did not undergo any temperature excursions.  No treatment drug detail was reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Patient was administered with vaccine after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Weight of the patient was given as 160.6.  No concomitant medications were reported.  It was reported that the patient was vaccinated with vaccine after the 30 days beyond use date. The date the vial was initially stored in the refrigerator was 10-Jun-2022. It was also reported that the vial did not undergo any temperature excursions. Reportedly, no adverse reactions were reported.  No treatment information was provided by the reporter.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 193.4. No concomitant medications were reported. It was reported that the vial had not undergone any temperature excursions. No adverse reactions were reported. No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received a full dose 2nd booster by mistake/Received 0.5ML from Red cap vial for 2nd booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received a full dose 2nd booster by mistake/Received 0.5ML from Red cap vial for 2nd booster) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 012M20A, 031L20A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-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-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Received a full dose 2nd booster by mistake/Received 0.5ML from Red cap vial for 2nd booster). At the time of the report, ACCIDENTAL OVERDOSE (Received a full dose 2nd booster by mistake/Received 0.5ML from Red cap vial for 2nd booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vials initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vials initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vials initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 145.8  No concomitant medications were reported.  It was reported that, the pharmacy has sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator, but vaccine was given to the patient on 12-Jul-2022. The patient administered vaccine after the 30 days use date.  The vials did not undergo any temperature excursions. No adverse event reported by the patient.  No treatment medications were reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Jun-2022 but vaccine was administered on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 125.4  No concomitant medication information was provided.  The vial did not undergo any temperature excursions.  Patient did not experienced any adverse reaction.  No treatment medication were provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: did not feel great; had a slight fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MALAISE (did not feel great) and PYREXIA (had a slight fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MALAISE (did not feel great) and PYREXIA (had a slight fever). At the time of the report, MALAISE (did not feel great) and PYREXIA (had a slight fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient concomitant medication include anti inflammatories. The caller does not remember which arm that patient received Modern vaccine in. No treatment medications were reported.   This case was linked to MOD-2022-609742, MOD-2022-609744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2022: Follow up contains non significant information.