chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021 at 9:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:32 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Mar-2021 at 9:04 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 32.62 The age of patient was provided as 32.54   Concomitant products were not provided.  On 02-Mar-2021, Excursion time was 9A, 10A, 11A, 12P, 2P, 3P temperature was 27, 29,32, 33,35, 36 total doses given for the day was 177, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  On 30-Mar-2021, Excursion time was 9A temperature was 33 total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 10:03 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 10:03 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.24. Concomitant products were not provided. On 29-Apr-2021, Excursion time was 10 AM, with temperature as 33. Total doses given for the day was 201 vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 19-Apr-2021 and. Vial was moved to clinic on 29-Apr-2021. 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021. On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 AM: 45, 1PM: 45, 2 PM: 44, 3 PM: 45, 4 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 3:09 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 3:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 43.53.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 2 PM and 3 PM, temperature was 32, 32,32, 35 and 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 43.68 Concomitant medication was not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.     On 13-Feb-2021 at 9:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 9:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 46.68  On 02-Mar-2021, Excursion time was 9A temperature was 32 total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 16 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:40 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.47.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer or refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence, Vaccination site pain
Clinical narrative: WITH THE SECOND COVID VACCINE PATIENT HAD ACHINESS IN ARM; FATIGUED; SLEEPY; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (WITH THE SECOND COVID VACCINE PATIENT HAD ACHINESS IN ARM), FATIGUE (FATIGUED) and SOMNOLENCE (SLEEPY) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for RA.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (WITH THE SECOND COVID VACCINE PATIENT HAD ACHINESS IN ARM), FATIGUE (FATIGUED) and SOMNOLENCE (SLEEPY). In April 2021, VACCINATION SITE PAIN (WITH THE SECOND COVID VACCINE PATIENT HAD ACHINESS IN ARM), FATIGUE (FATIGUED) and SOMNOLENCE (SLEEPY) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information were provided.  Onset 09 Apr 2021 with HUMIRA(ADALIMUMAB) was no reasonable  possibility.   This case was linked to MOD-2022-577123 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 12:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 12:41 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 55.35.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 9 AM, temp was 32; total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were moved to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 12:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 55.39 years.  Concomitant products were not provided.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10 AM. Total 150 doses were given for the day. Vials were not frozen. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. 15 vials were sent to clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.; Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 026D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-577165, MOD-2022-577166, MOD-2022-577168 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: still hurts/arm and shoulder always hurts; problem in my arm/came back/then stopped/pain lasted for the first two weeks/pain never went away/worse/never goes away/From shoulder down to my finger; From shoulder down to my finger; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (still hurts/arm and shoulder always hurts), PAIN IN EXTREMITY (problem in my arm/came back/then stopped/pain lasted for the first two weeks/pain never went away/worse/never goes away/From shoulder down to my finger) and ARTHRALGIA (From shoulder down to my finger) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021921A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (still hurts/arm and shoulder always hurts), PAIN IN EXTREMITY (problem in my arm/came back/then stopped/pain lasted for the first two weeks/pain never went away/worse/never goes away/From shoulder down to my finger) and ARTHRALGIA (From shoulder down to my finger). At the time of the report, VACCINATION SITE PAIN (still hurts/arm and shoulder always hurts), PAIN IN EXTREMITY (problem in my arm/came back/then stopped/pain lasted for the first two weeks/pain never went away/worse/never goes away/From shoulder down to my finger) and ARTHRALGIA (From shoulder down to my finger) had not resolved.            No concomitant medication reported.  The patient reported the third vaccine was hurt in Dec-2021 and continued.  The patient stated had a problem in arm and the pain never went away.  The pain lasted for the first two weeks, then stopped. But it came back and it was worse. It was from shoulder down to finger.  No treatment medication reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on her side; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (itchy rash on her side) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash on her side). At the time of the report, RASH PRURITIC (itchy rash on her side) had not resolved.            No concomitant medication information was provided. Patient was in a hurry and did not wish to provide a full adverse event report at the time of the call. Patient  asked for a treatment recommendation to treat an itchy rash on her side. She stated she recently received the Moderna booster dose (date not provided) and then the rash occurred. Patient  had not spoken to her healthcare provider about the rash. No additional information provided.  No treatment medication were provided.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Blood test abnormal, Chills, Fatigue, Inflammation, Influenza like illness
Clinical narrative: Blood test abnormal; Fatigue; Inflammation; ache; Flu like symptoms; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue), INFLAMMATION (Inflammation), PAIN (ache) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Plaque psoriasis and PREDNISONE for an unknown indication.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 10 D and PREDNISONE (unknown route) at an unspecified dose. On an unknown date, the patient experienced BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue), INFLAMMATION (Inflammation), PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills). At the time of the report, BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue) and INFLAMMATION (Inflammation) outcome was unknown and PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FATIGUE (Fatigue), PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) to be probably related. No further causality assessments were provided for BLOOD TEST ABNORMAL (Blood test abnormal) and INFLAMMATION (Inflammation).    No concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information were provided.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain
Clinical narrative: Blood test abnormal; Fatigue; Inflammation; ache; Flu like symptoms; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue), INFLAMMATION (Inflammation), PAIN (ache) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Plaque psoriasis and PREDNISONE for an unknown indication.    No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 in 10 D and PREDNISONE (unknown route) at an unspecified dose. On an unknown date, the patient experienced BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue), INFLAMMATION (Inflammation), PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills). At the time of the report, BLOOD TEST ABNORMAL (Blood test abnormal), FATIGUE (Fatigue) and INFLAMMATION (Inflammation) outcome was unknown and PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FATIGUE (Fatigue), PAIN (ache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) to be probably related. No further causality assessments were provided for BLOOD TEST ABNORMAL (Blood test abnormal) and INFLAMMATION (Inflammation).    No concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information were provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Burning sensation, Ear discomfort, Hypoaesthesia
Clinical narrative: After the shot, I felt okay.  in the evening after dinner, I did a routing excise using 5lb weights using both arms.  in the later evening my left side of ear felt uncomfortable.  The second morning, my left side back was painful, but not so bad.  but in the night, it waked me up with burning pain on my back, and burning pain in my  esophagus all the way to my throat.  I never had this in my life before.  I feel my whole up body(left) was on fire.  I took some tums, and Prilosec again, did message on my back.  it?s getting better next day.  and I went to see my acupuncture doctor, GI doctor.  the symptom is still there.  today, I feel my left side arm, hand and foot numbness.  I was very worried now.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oesophageal pain, Oropharyngeal pain, Pain, Sleep disorder, Throat irritation
Clinical narrative: After the shot, I felt okay.  in the evening after dinner, I did a routing excise using 5lb weights using both arms.  in the later evening my left side of ear felt uncomfortable.  The second morning, my left side back was painful, but not so bad.  but in the night, it waked me up with burning pain on my back, and burning pain in my  esophagus all the way to my throat.  I never had this in my life before.  I feel my whole up body(left) was on fire.  I took some tums, and Prilosec again, did message on my back.  it?s getting better next day.  and I went to see my acupuncture doctor, GI doctor.  the symptom is still there.  today, I feel my left side arm, hand and foot numbness.  I was very worried now.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Systemic: Generalized redness at site of injection. Not itchy or painful-Mild
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Weakness-Medium
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: numbness in left pinky-Severe, Systemic: Stroke-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Medium, Additional Details: Pt came is the 02/25/22 in the morning with complaint of diziness and numbness throughout left side of body the day of the shot but now at the time of speaking to pt the next day his main complaint was tingling/numbness on the left pinky (slightly in left arm) and slight dizziness. He came to the pharmacy able to walk, speak clearly, no odd movements/gait. Pt went to hospital 2/25/22 later in the day and was diagnoised with a stroke and is being treated at the hospital. Pt speaks mandarin only.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Needle issue
Clinical narrative: Error: Patient Accidentally Stuck by Needle-
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypotension, Pain
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Headache-Medium, Systemic: Hypotension-Medium
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Asthenia, Back pain, Breath odour, Decreased appetite, Dysuria
Clinical narrative: Day 1- extreme tiredness and complaints of being very sore - we thought was normal Day 2- excessive tiredness  continued Day 3- excessive tiredness  continued Day 4-  excessive tiredness continued and decreased appetite with some weakness  Day 5- all of the above plus less urination and strange breath smell (light scent) Day 6- all of the above plus becoming more severe  Day 7- all of the above and urine output decreased to half of normal - 3x daily and she struggled to urinate  Day 8- all of the above plus inability to urinate back pain excessive sweating  Day 9- ER & admitted to hospital- was told any vaccine not just this vaccine can cause reactions  Day 10- hospital tests continued
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Fatigue, Hyperhidrosis, Laboratory test, Pain, Urinary retention
Clinical narrative: Day 1- extreme tiredness and complaints of being very sore - we thought was normal Day 2- excessive tiredness  continued Day 3- excessive tiredness  continued Day 4-  excessive tiredness continued and decreased appetite with some weakness  Day 5- all of the above plus less urination and strange breath smell (light scent) Day 6- all of the above plus becoming more severe  Day 7- all of the above and urine output decreased to half of normal - 3x daily and she struggled to urinate  Day 8- all of the above plus inability to urinate back pain excessive sweating  Day 9- ER & admitted to hospital- was told any vaccine not just this vaccine can cause reactions  Day 10- hospital tests continued
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Urine output decreased
Clinical narrative: Day 1- extreme tiredness and complaints of being very sore - we thought was normal Day 2- excessive tiredness  continued Day 3- excessive tiredness  continued Day 4-  excessive tiredness continued and decreased appetite with some weakness  Day 5- all of the above plus less urination and strange breath smell (light scent) Day 6- all of the above plus becoming more severe  Day 7- all of the above and urine output decreased to half of normal - 3x daily and she struggled to urinate  Day 8- all of the above plus inability to urinate back pain excessive sweating  Day 9- ER & admitted to hospital- was told any vaccine not just this vaccine can cause reactions  Day 10- hospital tests continued
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram abnormal, Pulmonary embolism, Scan
Clinical narrative: Pulmonary Embolus noted on cat scan
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy muscle, Inflammation, Magnetic resonance imaging abdominal, Muscular weakness, Myopathy
Clinical narrative: gradually development of severe muscle weakeness and inflammatory myopathy consistent with polymyositis
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyositis
Clinical narrative: gradually development of severe muscle weakeness and inflammatory myopathy consistent with polymyositis
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Change of bowel habit, Constipation, Cytokine increased, Decreased appetite
Clinical narrative: -April 2021 - bouts of extreme fatigue lasting 2-3 days, occurring once every 2 weeks.  -June 12, 2021 - Severe insomnia - 0-2 hours of sleep per night (continues for next two months) -June 12, 2021 - Extreme neurological symptoms - electric shock sensations/pains throughout entire body, adrenaline dumps, tachycardia, palpitations, brain zaps, strange pounding sensations in the back of my head, hypnic jerks -June 12, 2021 and on - Inability to go to the bathroom (#2) for days. When I did go, consistently was completely changed. Stool was small/hard/rocky. There also was no signal to go. I was going on schedule and almost forcing it out.  -June 12,2021 and on - severe weight loss, complete loss of appetite  -June 12, 2021 and on - extreme visual distortions - everything is wavy and moving in front of my eyes. I wasn't able to focus on anything. Strange sensation of being 'drunk' (was not on anything intoxicating) -June 12, 2021 and on - severe sensory loss. Retraction of emotions, feelings of hunger, feelings of 'tiredness' while doing cardio exercise, loss of the ability to sweat, loss of the ability to look into digital screens
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Emotional disorder, Exercise tolerance decreased, Faecal volume decreased, Faeces hard
Clinical narrative: -April 2021 - bouts of extreme fatigue lasting 2-3 days, occurring once every 2 weeks.  -June 12, 2021 - Severe insomnia - 0-2 hours of sleep per night (continues for next two months) -June 12, 2021 - Extreme neurological symptoms - electric shock sensations/pains throughout entire body, adrenaline dumps, tachycardia, palpitations, brain zaps, strange pounding sensations in the back of my head, hypnic jerks -June 12, 2021 and on - Inability to go to the bathroom (#2) for days. When I did go, consistently was completely changed. Stool was small/hard/rocky. There also was no signal to go. I was going on schedule and almost forcing it out.  -June 12,2021 and on - severe weight loss, complete loss of appetite  -June 12, 2021 and on - extreme visual distortions - everything is wavy and moving in front of my eyes. I wasn't able to focus on anything. Strange sensation of being 'drunk' (was not on anything intoxicating) -June 12, 2021 and on - severe sensory loss. Retraction of emotions, feelings of hunger, feelings of 'tiredness' while doing cardio exercise, loss of the ability to sweat, loss of the ability to look into digital screens
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling drunk, Headache, Hunger, Hypohidrosis
Clinical narrative: -April 2021 - bouts of extreme fatigue lasting 2-3 days, occurring once every 2 weeks.  -June 12, 2021 - Severe insomnia - 0-2 hours of sleep per night (continues for next two months) -June 12, 2021 - Extreme neurological symptoms - electric shock sensations/pains throughout entire body, adrenaline dumps, tachycardia, palpitations, brain zaps, strange pounding sensations in the back of my head, hypnic jerks -June 12, 2021 and on - Inability to go to the bathroom (#2) for days. When I did go, consistently was completely changed. Stool was small/hard/rocky. There also was no signal to go. I was going on schedule and almost forcing it out.  -June 12,2021 and on - severe weight loss, complete loss of appetite  -June 12, 2021 and on - extreme visual distortions - everything is wavy and moving in front of my eyes. I wasn't able to focus on anything. Strange sensation of being 'drunk' (was not on anything intoxicating) -June 12, 2021 and on - severe sensory loss. Retraction of emotions, feelings of hunger, feelings of 'tiredness' while doing cardio exercise, loss of the ability to sweat, loss of the ability to look into digital screens
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammatory marker increased, Insomnia, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Myoclonus
Clinical narrative: -April 2021 - bouts of extreme fatigue lasting 2-3 days, occurring once every 2 weeks.  -June 12, 2021 - Severe insomnia - 0-2 hours of sleep per night (continues for next two months) -June 12, 2021 - Extreme neurological symptoms - electric shock sensations/pains throughout entire body, adrenaline dumps, tachycardia, palpitations, brain zaps, strange pounding sensations in the back of my head, hypnic jerks -June 12, 2021 and on - Inability to go to the bathroom (#2) for days. When I did go, consistently was completely changed. Stool was small/hard/rocky. There also was no signal to go. I was going on schedule and almost forcing it out.  -June 12,2021 and on - severe weight loss, complete loss of appetite  -June 12, 2021 and on - extreme visual distortions - everything is wavy and moving in front of my eyes. I wasn't able to focus on anything. Strange sensation of being 'drunk' (was not on anything intoxicating) -June 12, 2021 and on - severe sensory loss. Retraction of emotions, feelings of hunger, feelings of 'tiredness' while doing cardio exercise, loss of the ability to sweat, loss of the ability to look into digital screens
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Neurogenic bowel, Neurological symptom, Pain, Palpitations, Scan with contrast normal
Clinical narrative: -April 2021 - bouts of extreme fatigue lasting 2-3 days, occurring once every 2 weeks.  -June 12, 2021 - Severe insomnia - 0-2 hours of sleep per night (continues for next two months) -June 12, 2021 - Extreme neurological symptoms - electric shock sensations/pains throughout entire body, adrenaline dumps, tachycardia, palpitations, brain zaps, strange pounding sensations in the back of my head, hypnic jerks -June 12, 2021 and on - Inability to go to the bathroom (#2) for days. When I did go, consistently was completely changed. Stool was small/hard/rocky. There also was no signal to go. I was going on schedule and almost forcing it out.  -June 12,2021 and on - severe weight loss, complete loss of appetite  -June 12, 2021 and on - extreme visual distortions - everything is wavy and moving in front of my eyes. I wasn't able to focus on anything. Strange sensation of being 'drunk' (was not on anything intoxicating) -June 12, 2021 and on - severe sensory loss. Retraction of emotions, feelings of hunger, feelings of 'tiredness' while doing cardio exercise, loss of the ability to sweat, loss of the ability to look into digital screens