chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Drug interaction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 028A21A and 012A21A) for COVID-19 vaccination.  Co-suspect product included non-company product GLATIRAMER ACETATE (COPAXONE) injection for Multiple sclerosis. Concurrent medical conditions included Sulfonamide allergy, Multiple sclerosis, Breast cancer and Ulcerative colitis. Concomitant products included MESALAZINE (MESALAMINE) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. In 2004, the patient started GLATIRAMER ACETATE (COPAXONE) (unknown route) 20 milligram. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, 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 experienced BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster). At the time of the report, BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster) outcome was unknown. It was reported that, the patient did not get the vaccine because in Nov-2021 her healthcare professional advised she had COVID immunity to wait 90 days to get the shot. The patient visited her dentist. The patient started having problem with the multiple sclerosis medication that she had been taking for 18 years. The patient had allergy side effects like bubbling on the skin, and blistering (raw).  The patient was no longer taking Copaxone for multiple sclerosis. The patient was taking Copaxone for 18 years, currently she was having a reaction to it after taking the booster. The expiration dates were not provided. The patient was taking medications. The patient's healthcare professional was aware of side effects. No treatment details were reported.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 028A21A and 012A21A) for COVID-19 vaccination.  Co-suspect product included non-company product GLATIRAMER ACETATE (COPAXONE) injection for Multiple sclerosis. Concurrent medical conditions included Sulfonamide allergy, Multiple sclerosis, Breast cancer and Ulcerative colitis. Concomitant products included MESALAZINE (MESALAMINE) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. In 2004, the patient started GLATIRAMER ACETATE (COPAXONE) (unknown route) 20 milligram. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, 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 experienced BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster). At the time of the report, BLISTER (allergy side effects/Bubbling on the skin/Blistering (Raw)) and DRUG INTERACTION (started having problem with her multiple sclerosis Medication/having a reaction to it after taking the booster) outcome was unknown. It was reported that, the patient did not get the vaccine because in Nov-2021 her healthcare professional advised she had COVID immunity to wait 90 days to get the shot. The patient visited her dentist. The patient started having problem with the multiple sclerosis medication that she had been taking for 18 years. The patient had allergy side effects like bubbling on the skin, and blistering (raw).  The patient was no longer taking Copaxone for multiple sclerosis. The patient was taking Copaxone for 18 years, currently she was having a reaction to it after taking the booster. The expiration dates were not provided. The patient was taking medications. The patient's healthcare professional was aware of side effects. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Cerebrovascular accident (stroke after every shot moderna vaccine); This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident (stroke after every shot moderna vaccine)) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product INSULIN GLARGINE (LANTUS) solution for injection for an unknown indication.    The patient's past medical history and family history were not provided.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and INSULIN GLARGINE (LANTUS) (unknown route) at an unspecified dose once a day. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident (stroke after every shot moderna vaccine)) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident (stroke after every shot moderna vaccine)) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was  provided. The patient said something was wrong with brain. She was told that it needs to be reported she said its because she had a stroke. The patient was on lantus prior to stroke. The patient said stroke had nothing to do with lantus. She stated she got the moderna vaccine and had a stroke after each shot (cerebrovascular accident) (unknown latency). It was not reported if the patient received a corrective treatment for the event (stroke after every shot moderna vaccine). Strength of lantus was reported as 100 iU/mL. No treatment medication information was provided.  Company Comment: This is a spontaneous case concerning an elderly female patient with medical history of Insulin glargine use, who experienced the unexpected, serious (medically significant) adverse event of special interest of Cerebrovascular accident, on unknown date after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical condition for the use of Insulin glargine remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an elderly female patient with medical history of Insulin glargine use, who experienced the unexpected, serious (medically significant) adverse event of special interest of Cerebrovascular accident, on unknown date after receiving a dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical condition for the use of Insulin glargine remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter informed that in the facility where she worked it seems there had been temperature excursions with her freezer. It had been happening for weeks since April 2022. She would like guidance on what to do. She stated that in total there were 49 patients affected, but this number was including the Pfizer vaccines that they had, so she was not sure how many patients were affected and received the Moderna Covid 19 vaccine. The patients received Moderna vaccine in the facility between 21-Apr-2022 to 18-Jun-2022. Storage condition at the time of the excursion was frozen. Expiration dates were unknown and lot numbers included 065K21A and 045L21A. Maximum temperatures reached: 30 Fahrenheit Degrees Minimum temperatures reached -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vials now stored in frozen. Visual inspection did not note any vaccine state change. Number of vials/doses impacted was not sure. No treatment information was reported.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that the facility where she worked, there had been temperature excursions with freezer. It had been happening for weeks since April 2022. The batch numbers were reported as 065K21A and 045L21A. The storage condition at the time of the excursion was reported as frozen storage. The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus 18.9 Fahrenheit degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The vails were stored in frozen state at the time of reporting. The visual inspection noting any vaccine state change was reported as no.  No treatment information was reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). On 28-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen. Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively. The vaccines suffered 2 temperature excursions since April, both lasted less than one minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment information was reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed by visual inspection.  Proposed desired use by date was not provided.  No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 26-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter seems temperature excursions with her freezer in the facility where she works. It was happening for weeks since Apr-2022.  The storage condition at the time of the excursion was reported as frozen storage.  The affected batch lot numbers were reported as 065K21A and 045L21A.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees.  The vaccines suffered 2 temperature excursions since April, both of which lasted less than 1 minute.  The vials were stored frozen.  Visual inspection did not note any vaccine state change.  Treatment information was not provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 19-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Vaccine was frozen at the time of the excursion. The temperatures were reported as Maximum 30 Fahrenheit Degrees and Minimum -18.9 Fahrenheit Degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute Lot numbers were reported as 065K21A and 045L21A.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 3.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure via breast milk, Fatigue, Somnolence
Clinical narrative: slept more; more tired than normal; The caller mentioned she was breastfeeding at the time; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept more), FATIGUE (more tired than normal) and EXPOSURE VIA BREAST MILK (The caller mentioned she was breastfeeding at the time) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 16-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Transmammary) 1 dosage form. On 16-Dec-2021, the patient experienced EXPOSURE VIA BREAST MILK (The caller mentioned she was breastfeeding at the time). On 17-Dec-2021, the patient experienced SOMNOLENCE (slept more) and FATIGUE (more tired than normal). At the time of the report, SOMNOLENCE (slept more), FATIGUE (more tired than normal) and EXPOSURE VIA BREAST MILK (The caller mentioned she was breastfeeding at the time) outcome was unknown.      No concomitant and treatment medications were reported.  Parent stated that the child has not currently received any COVID-19 vaccinations at this point in time.  Parent stated that she received the Pfizer booster dose on 27-May-2022 and her child experienced side effects after the Pfizer dose also.   This case was linked to MOD-2022-592947 (Parent-Child Link).   See case MOD-2022-592947 for details regarding the child case.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna COVID 19 vaccine after temperature excursion; Patient received the Moderna COVID 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID 19 vaccine after temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that, in her facility where she works at there has been temperature excursions with her freezer. It has been happening for weeks since April 2022.   The storage condition at the time of the excursion was frozen. The vial with lot number affected were 065K21A and 045L21A. The maximum or minimum temperatures reached were as follows maximum: 30 Fahrenheit Degrees and minimum -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The reporter does not have the information on date vial(s) moved from freezer to refrigerator. The vials currently stored in frozen state. On visual inspection no changes were observed in any vaccine state. The Proposed desired Use by Date was not reported.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that happened for weeks since April 2022. Storage condition at the time of the excursion were frozen. Lot numbers 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively. Vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, currently stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.    This case was linked to MOD-2022-591989 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: In the Corona period had been vaccinated three times with the Moderna vaccine against COVID 19 and this year had almost no hay fever; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (In the Corona period had been vaccinated three times with the Moderna vaccine against COVID 19 and this year had almost no hay fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Hay fever (Suffered since childhood. Not very severe but for about 2 - 3 weeks a year.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (In the Corona period had been vaccinated three times with the Moderna vaccine against COVID 19 and this year had almost no hay fever). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (In the Corona period had been vaccinated three times with the Moderna vaccine against COVID 19 and this year had almost no hay fever) outcome was unknown.            No concomitant medications were reported  No treatment drugs were reported  Reporter questioned regarding positive side effects of moderna and did have something to do with mRNA vaccine against COVID 19.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.            Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2022-592989, MOD-2022-593014 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Chest discomfort, Chest pain, Electrocardiogram, Fatigue
Clinical narrative: experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.            Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2022-592989, MOD-2022-593014 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Mechanical urticaria, Muscle spasms, Pruritus, Pyrexia
Clinical narrative: experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.            Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2022-592989, MOD-2022-593014 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Urticaria, X-ray
Clinical narrative: experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.            Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2022-592989, MOD-2022-593014 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.            Concomitant medication information was not provided by the reporter.   This case was linked to MOD-2022-592989, MOD-2022-593014 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Severe side effects from the booster shot; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Severe side effects from the booster shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Severe side effects from the booster shot). At the time of the report, IMMUNISATION REACTION (Severe side effects from the booster shot) outcome was unknown.     Patient received booster shot.   No concomitant medication information was provided. No treatment medication were provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter reported that, there was temperature excursions in freezer where the reporter worked. It had been happening for weeks since April 2022. Total 49 patients were affected, but this number was including the Pfizer vaccines that they had, so the reporter was not sure how many patients were affected and received the Moderna Covid 19 vaccine. The storage condition at the time of the excursion was frozen. Lot numbers were 065K21A and 045L21A Maximum or minimum temperatures reached was maximum: 30 Fahrenheit Degrees and minimum -18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The date vial(s) moved from freezer to refrigerator was unknown. The vials were stored now in frozen condition. The state of vaccine was not changed. The number of vials/doses impacted was unknown.  No treatment medications were reported.   This case was linked to MOD-2022-591989 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after 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.  HCP reported about temperature excursions with freezer in the facility. It had been happening for weeks since April 2022.  The batch numbers were reported as 065K21A and 045L21A.  The storage condition at the time of the excursion was reported as frozen storage.  The temperatures excursion range was reported as maximum 30 Fahrenheit degrees and minimum minus18.9 Fahrenheit degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute.   The vails were stored in Frozen state.  Treatment medications were not reported.   This case was linked to MOD-2022-591989.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) had resolved.            No concomitant medication information was provided.  No treatment medication were provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Did not feel well; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Did not feel well) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Vitamin B12 deficiency, Hypothyroidism, Joint pain and Vitamin D deficiency. Concurrent medical conditions included Multiple sclerosis. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Did not feel well). At the time of the report, MALAISE (Did not feel well) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Treatment information was not reported.