chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Patient  received a Booster dose of 0.5ml at a pharmacy; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patient  received a Booster dose of 0.5ml at a pharmacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient  received a Booster dose of 0.5ml at a pharmacy). At the time of the report, ACCIDENTAL OVERDOSE (Patient  received a Booster dose of 0.5ml at a pharmacy) outcome was unknown.            Concomitant medications details were not reported by the reporter. Patient received the primary series of the Moderna Covid-19 Vaccine. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-513834 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement, Breast pain, Swelling, Weight
Clinical narrative: Swelling got worse; left breast started hurting/pain in the breast/it was getting bigger; left breast started hurting/pain in the breast/it was getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling got worse), BREAST ENLARGEMENT (left breast started hurting/pain in the breast/it was getting bigger) and BREAST PAIN (left breast started hurting/pain in the breast/it was getting bigger) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Fibrocystic breast. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for Flu.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING (Swelling got worse), BREAST ENLARGEMENT (left breast started hurting/pain in the breast/it was getting bigger) and BREAST PAIN (left breast started hurting/pain in the breast/it was getting bigger). At the time of the report, SWELLING (Swelling got worse) had not resolved and BREAST ENLARGEMENT (left breast started hurting/pain in the breast/it was getting bigger) and BREAST PAIN (left breast started hurting/pain in the breast/it was getting bigger) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: gained weight (High) gained weight and lost weight (Low) lost weight.         Treatment information was not reported.  The patient would be undergoing a mammogram test soon (in about a month). Usually the patient felt the pain when the patient gained weight, and felt better when the patient lost weight.  The patient had skipped mammogram test in 2021 last because of the pain. The patient had not been exposed to COVID at all, and was being overly cautious.   This case was linked to MOD-2022-513823, MOD-2022-513833 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow-up received contains no new information
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Swelling
Clinical narrative: Swelling, still there a little bit; Really strong reaction/long lasting reaction; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling, still there a little bit) and VACCINATION COMPLICATION (Really strong reaction/long lasting reaction) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 045B21A and 046B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (in late September - left arm) in September 2021. Past adverse reactions to the above products included No adverse event with Flu shot.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-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 experienced SWELLING (Swelling, still there a little bit) and VACCINATION COMPLICATION (Really strong reaction/long lasting reaction). At the time of the report, SWELLING (Swelling, still there a little bit) had not resolved and VACCINATION COMPLICATION (Really strong reaction/long lasting reaction) outcome was unknown.            No medical history information was reported. No concomitant medication was provided.  There was nothing to worry about. The blood work was fine. Swelling never went away. Skipped mammogram in 2021 last because of the pain. The patient had not been exposed to COVID at all, be overly cautious.  No treatment medication was provided.   This case was linked to MOD-2022-513832, MOD-2022-513823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Non Significant follow-Up - No new pertinent information was added.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: 3rd dose given at 0.25ml to an immunocompromised patient; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (3rd dose given at 0.25ml to an immunocompromised patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Cancer (been on chemotherapy for cancer prior to getting the 1st dose of   the Moderna Covid-19 vaccine).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (3rd dose given at 0.25ml to an immunocompromised patient). At the time of the report, ACCIDENTAL UNDERDOSE (3rd dose given at 0.25ml to an immunocompromised patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Two children were given too much but it's not clear what the dosage was; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Two children were given too much but it's not clear what the dosage was) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Two children were given too much but it's not clear what the dosage was). At the time of the report, ACCIDENTAL OVERDOSE (Two children were given too much but it's not clear what the dosage was) outcome was unknown.            No concomitant product reported by reporter. No treatment medication reported by reporter. Reporter was unclear whether it was Spikevax or another manufacturer's vaccine.   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received a Moderna booster dose from a vial that had been refrigerated more than 30 days; refrigerated more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster dose from a vial that had been refrigerated more than 30 days) and PRODUCT STORAGE ERROR (refrigerated more than 30 days) in a 41-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster dose from a vial that had been refrigerated more than 30 days) and PRODUCT STORAGE ERROR (refrigerated more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a Moderna booster dose from a vial that had been refrigerated more than 30 days) and PRODUCT STORAGE ERROR (refrigerated more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2022: Follow up received contains non significant information.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient; Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 066821A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson Vaccine (lot number was 066H21A, expiration date was 02-Apr-2022 and first dose) on 25-Jun-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson Vaccine.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions was administered to patient ) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment details was provided.  The date on which the vial was moved from freezer to refrigerator was 3-Mar-2022. Maximum or minimum temperatures reached at the storage condition, as applicable were 49 degrees Fahrenheit and 37.7 degrees Fahrenheit respectively. The vial was stored in refrigerator and was in refrigerated storage condition at the time of the excursion. Vials were not visualized and the proposed desired use by date of the vial was given as 16-Mar-2022. The nurse reported no adverse reactions or side effects to the vaccine.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) 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. Concomitant medication was not reported. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit. Vial moved from freezer to refrigerator on 3-MAR-2022. The Nurse reports no adverse reactions or side effects to the Moderna COVID-19 vaccine. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions; Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursion) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. The Nurse reported that patient had no adverse reactions or side effects to the Moderna Covid-19 vaccine. Nurse does not have any information on the first dose of the vaccine Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer doses (The patient received first two doses of Pfizer vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer doses.    On 09-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. The vial was stored in refrigerator and the date vial(s) moved from freezer to refrigerator on 03-Mar-2022. Maximum or minimum temperatures reached, as applicable (specify temp is in C or F) was Maximum Temperature was 49 degrees Fahrenheit and Minimum Temperature is 37.7 degrees Fahrenheit. The temperature excursions occurred on 04-Mar-2022, 05-Mar-2022, 07-Mar-2022, 08-Mar-2022, 08-Mar-2022, 09-Mar-2022, and 10-Mar-2022. Vials were not visualized and proposed desired Use by Date is given as 16-Mar-2022 No treatment details were provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received the Moderna COVID-19 vaccine that had undergone multiple temperature excursions; Patient received the Moderna COVID-19 vaccine that had undergone multiple temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 vaccine that had undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that had undergone multiple temperature excursions) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that had undergone multiple temperature excursions). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 vaccine that had undergone multiple temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna COVID-19 vaccine that had undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna COVID-19 vaccine that had undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Reporter stated that storage condition at the time of the excursion was refrigerated storage, Maximum or minimum temperatures reached where Maximum Temperature was 49 degrees Fahrenheit and Minimum Temperature was 37.7 degrees Fahrenheit and Several Temperature Excursions were occurred. On 03-Mar-2022 the vial was moved from freezer to refrigerator and 10 Vials were impacted. Reporter also stated that patient had no adverse reactions or side effects to the Moderna COVID-19 vaccine.  Treatment information was not provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.). On 07-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. Nurse reported that Patient received vaccine in question as a booster dose. Nurse reported that information was not available on patients first two doses and it was not known that in which arm the patient received the vaccine. The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine. It was reported that patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions. Maximum Temperature is 49 degrees Fahrenheit, Minimum Temperature is 37.7 degrees Fahrenheit. The temperature excursions occurred on 4 MAR 2022, 5 MAR 2022, 7 MAR 2022, 8 MAR 2022, 9 MAR 2022, and 10 MAR 2022. Date vial moved from freezer to refrigerator was 3 MAR 2022, stored in refrigerator and Vials were not visualized. No treatment information was reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six  patients received the vaccine in question) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit. Vial moved from freezer to refrigerator on 3-MAR-2022. The nurse does not have information on the first two vaccinations. The nurse reports no adverse reactions or side effects to the Moderna COVID-19 vaccine. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions; Moderna Covid-19 vaccine which has undergone multiple temperature excursions, Twenty six patients received the vaccine in question; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions, Twenty six patients received the vaccine in question) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions, Twenty six patients received the vaccine in question). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions, Twenty six patients received the vaccine in question) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  The temperature excursions occurred on 4MAR2022, 5MAR2022, 7MAR2022, 8MAR2022, 8MAR2022, 9MAR2022, and 10MAR2022. The nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine.  No treatment medications were reported.   This case was linked to MOD-2022-513717 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Vial moved from freezer to refrigerator on 3-MAR-2022. The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness due COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness due COVID-19 vaccine) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness due COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (Arm soreness due COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.  It was reported that no adverse reactions or side effects to the Moderna Covid-19 vaccine. It was reported that the vial was moved to refrigerator on 03-Mar-2022.Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. The temperature excursions occurred on 4-mar-2022, 5-mar-2022, 7-mar-2022, 8-mar-2022,9-mar-2022, and 10-mar-2022.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Nurse reports no adverse reactions or side effects to the Moderna COVID-19 vaccine.  No concomitant medication was reported. No treatment medications was reported.  It was reported that the vial was moved to refrigerator on 03-Mar-2022.Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022.Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. The vial was stored in refrigerator and the date vial(s) moved from freezer to refrigerator on 3-MAR-2022. Maximum or minimum temperatures reached, as applicable was Maximum Temperature was 49 degrees Farenheit and Minimum Temperature was 37.7 degrees Farenheit. The temperature excursions occurred on 4-MAR-2022, 5-MAR-2022, 7-MAR-2022, 8-MAR-2022, 8-MAR-2022, 9-MAR2-022, and 10-MAR-2022. Vials were not visualized and  Proposed desired Use by Date is given as 16-MAR-2022 No treatment details were provided. It was reported that there were no adverse reactions or side effects to the Moderna Covid-19 vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Injection site discomfort
Clinical narrative: mild chest pressure; injection site discomfort; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (mild chest pressure) and INJECTION SITE DISCOMFORT (injection site discomfort) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (mild chest pressure) and INJECTION SITE DISCOMFORT (injection site discomfort). At the time of the report, CHEST DISCOMFORT (mild chest pressure) and INJECTION SITE DISCOMFORT (injection site discomfort) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications information was reported.    It was reported that the patient was experiencing injection site discomfort and mild chest pressure for 2-3 days.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions; Moderna Covid-19 vaccine which has undergone multiple temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant drug details were reported.  The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit. The temperature excursions occurred on 4-Mar-2022, 05 Mar 2022, 07 Mar 2022, 08 Mar 2022, 09 Mar 2022 and 10 Mar 2022. Proposed desired use by date was reported to be on 16 Mar 2022. Date vial(s) moved from freezer to refrigerator is 03 Mar 2022.  No Treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions and patient received the vaccine; Moderna Covid-19 vaccine which has undergone multiple temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions and patient received the vaccine) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions and patient received the vaccine). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions and patient received the vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Storage condition at the time of the excursion was refrigerated storage. Maximum temperature reached was 49 degrees Fahrenheit and minimum temperature reached was 37.7 degrees Fahrenheit. Vial moved from freezer to refrigerator on 3 MAR 2022. Proposed desired use by date was reported to be on 16 Mar 2022. The temperature excursions occurred on 4 Mar 2022, 5 Mar 2022, 7 Mar 2022, 8 Mar 2022, 9 Mar 2022 and 10 Mar 2022. It was not known which arm the patient received the vaccine in. Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions. The nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. No treatment medications were reported.