chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after the published expiry date), PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after the published expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after the published expiry date), PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was provided vaccine after the published expiry date) and PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator). No concomitant medications were reported. It was reported that, the medical assistant thought that the expiration date was 20-Jun-2022 when looked this up before however there was nothing in writing or printed to confirm the expiration date of 20-Jun-2022. Vial was initially stored in refrigerator on 07-Jun-2022. The vial did not undergo temperature excursion. The patient had not experienced any adverse events. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Significant live follow up received contains updated reporter details, suspect details and expiry date. On 02-Sep-2022: Follow up received contains nonsignificant information.
Age: 88.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022; No adverse event; patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers), PRODUCT STORAGE ERROR (Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022) and NO ADVERSE EVENT (No adverse event) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers), PRODUCT STORAGE ERROR (Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that was expired and past the Manufacturers) and PRODUCT STORAGE ERROR (Vaccine expired on 20May2022 ,stored in refrigerator on 7Jun2022 and administered on 8Jun2022).    No concomitant drug information was provided. Vial was initially stored in refrigerator on 7Jun2022. Vial had not undergone any temperature excursion issue.  It was unknown if the patient had allergies to any food, medication, or other products. It was also unknown if the patient had received any other vaccine 1 month prior to Moderna vaccine and had any COVID-19 positive test or diagnosis previously. It was also unknown if the adverse event caused the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  No adverse event was reported.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2022: Follow-up received, updated suspect drug information and I narrative. On 02-Sep-2022: Follow-up received contains no new information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Paraesthesia, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PAIN (On the 2nd day after the 2nd booster dose he began having severe & sudden effects including whole body pain), INFLUENZA LIKE ILLNESS (had flu-like symptoms) and PARAESTHESIA (Tingling similar to foot neuropathy which has lessened and continued) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 055M21A, 058F21A, 032L20A and 039K20-2A) for COVID-19 vaccination. Concurrent medical conditions included Peripheral neuropathy. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced PAIN (On the 2nd day after the 2nd booster dose he began having severe & sudden effects including whole body pain), INFLUENZA LIKE ILLNESS (had flu-like symptoms) and PARAESTHESIA (Tingling similar to foot neuropathy which has lessened and continued). At the time of the report, PAIN (On the 2nd day after the 2nd booster dose he began having severe & sudden effects including whole body pain) and INFLUENZA LIKE ILLNESS (had flu-like symptoms) outcome was unknown and PARAESTHESIA (Tingling similar to foot neuropathy which has lessened and continued) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Tested negative for COVID. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID) in a male patient of an unknown age 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 COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) outcome was unknown.            No concomitant medication information was provided. It was reported that patient received 2nd booster in Jan. Patient got covid-19 infection in July and received antibody treatment.  Company Comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine (reported as second booster dose). The patient received unspecified antibody treatment. Exact date of vaccinations, onset date of the event, clinical course and relevant diagnostic tests were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.    Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine (reported as second booster dose). The patient received unspecified antibody treatment. Exact date of vaccinations, onset date of the event, clinical course and relevant diagnostic tests were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (The patient was given two 0.25 ml doses of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7143C and AS7143C) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1), Pfizer (Dose 3 (first booster dose)) and Pfizer (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. On 02-Sep-2022 at 1:20 PM, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 02-Sep-2022 at 2:42 PM, received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 02-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (The patient was given two 0.25 ml doses of the Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (The patient was given two 0.25 ml doses of the Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. No past illness information for the patient was not provided. The patient had not experienced symptoms with any previous doses of any vaccines. No concomitant medications were reported. The patient had not experienced any symptoms since having the two doses of 0.25 ml. Treatment information was provided as none.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Controlled hypertension and High cholesterol (controlled). Concomitant products included PREDNISONE and HYDROCORTISONE for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product included Blood Pressure Medication, Cholesterol Medicine and Medication for prostrate. Patient received first booster dose sometime in the fall of 2021. Patient experienced sore injection site arm for first, second and first booster dose. No treatment information was provided by the reporter. This case was linked to MODERNATX, INC.-MOD-2022-639221 (E2B Linked Report). This case was linked to MOD-2022-638954 (Patient Link).; Sender's Comments: MODERNATX, INC.-MOD-2022-639221: Same reporter
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (Received dose which was previously affected by a temperature excursion for less than 1 hour), PRODUCT STORAGE ERROR (Vaccine previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose after its beyond use date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received dose which was previously affected by a temperature excursion for less than 1 hour), PRODUCT STORAGE ERROR (Vaccine previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (Received dose which was previously affected by a temperature excursion for less than 1 hour), PRODUCT STORAGE ERROR (Vaccine previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (Received dose which was previously affected by a temperature excursion for less than 1 hour) and PRODUCT STORAGE ERROR (Vaccine previously affected by a temperature excursion). No concomitant medication was reported by reporter. Vial was initially refrigerated and thawed on 26-Jun-2022. No treatment medication was reported by reporter. This case was linked to US-MODERNATX, INC.-MOD-2022-638955, US-MODERNATX, INC.-MOD-2022-638952 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-638955: US-MODERNATX, INC.-MOD-2022-638952.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: receiving doses after its beyond use date and previously affected by a temperature excursion; No adverse event; received dose after its beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses after its beyond use date and previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses after its beyond use date and previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses after its beyond use date and previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date) and PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses after its beyond use date and previously affected by a temperature excursion).    No concomitant medications information was reported. Date the vial was initially stored in the refrigerator and initially thawed was reported as July 26 2022. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-638955, US-MODERNATX, INC.-MOD-2022-638948.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-638955:Same Reporter US-MODERNATX, INC.-MOD-2022-638948:Same Reporter
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Several months after receiving the Moderna Covid-19 vaccine 2nd booster the patient developed Urticaria), RASH (Caller says as soon as she put the Benadryl cream on her husbands rash the rash would disappear and then pop up somewhere else/caller said that her husband's Dermatologist called this a "running rash") and RASH PRURITIC (Rash was extremely itchy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Controlled hypertension and Hypercholesterolaemia (controlled). Concomitant products included PREDNISONE and HYDROCORTISONE for an unknown indication. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced URTICARIA (Several months after receiving the Moderna Covid-19 vaccine 2nd booster the patient developed Urticaria). On an unknown date, the patient experienced RASH (Caller says as soon as she put the Benadryl cream on her husbands rash the rash would disappear and then pop up somewhere else/caller said that her husband's Dermatologist called this a "running rash.") and RASH PRURITIC (Rash was extremely itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash and Itchy rash, at an unspecified dose and frequency. At the time of the report, URTICARIA (Several months after receiving the Moderna Covid-19 vaccine 2nd booster the patient developed Urticaria), RASH (Caller says as soon as she put the Benadryl cream on her husbands rash the rash would disappear and then pop up somewhere else/caller said that her husband's Dermatologist called this a "running rash.") and RASH PRURITIC (Rash was extremely itchy) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications also included blood pressure medication, cholesterol medication and medication for prostate. This case was linked to MOD-2022-638947 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received doses of the Moderna COVID-19 vaccine after its beyond use date from different vials), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses after its beyond use date and previously affected by a temperature excursion), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 26-Jul-2022 and vaccine was administered on 01-Sep-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011b22a) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received doses of the Moderna COVID-19 vaccine after its beyond use date from different vials). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses after its beyond use date and previously affected by a temperature excursion), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 26-Jul-2022 and vaccine was administered on 01-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received doses of the Moderna COVID-19 vaccine after its beyond use date from different vials), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses after its beyond use date and previously affected by a temperature excursion), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 26-Jul-2022 and vaccine was administered on 01-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received doses of the Moderna COVID-19 vaccine after its beyond use date from different vials), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses after its beyond use date and previously affected by a temperature excursion) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 26-Jul-2022 and vaccine was administered on 01-Sep-2022). Patient received the second booster dose. No concomitant medications information was reported. Number of doses/vials 2 doses from 2 different vials. Date the vial was initially stored in the refrigerator and initially thawed was reported as July 26 2022. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-638952, US-MODERNATX, INC.-MOD-2022-638948 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-638952: US-MODERNATX, INC.-MOD-2022-638948.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had a recent COVID-19 infection / Tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 034F21A, 0071321A and 002M20A) for COVID-19 vaccination. The patient had no any allergies. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2022, the patient experienced COVID-19 (Had a recent COVID-19 infection / Tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine). At the time of the report, COVID-19 (Had a recent COVID-19 infection / Tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant product reported by reporter. Agent asked if they had previously received a Moderna Covid 19 vaccine and caller stated they both did. Patient received 2 primary series and 2 booster doses. No treatment medication reported by reporter. Company comment: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID 19. The event occurred approximately 4 months after the fourth dose of mRNA-1273. As reported, the patient tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-638959 (Patient Link). Sender's Comments: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID 19. The event occurred approximately 4 months after the fourth dose of mRNA-1273. As reported, the patient tested positive for COVID-19 after receiving 4 doses of the Moderna COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 year old patient who received a first dose of the Moderna Covid-19 vaccine as a primary series dose of the Moderna Covid-19 vaccine 24 hours after the Moderna Covid-19 vaccine was first punctured.) and NO ADVERSE EVENT (no adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2022 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022 at 5:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 year old patient who received a first dose of the Moderna Covid-19 vaccine as a primary series dose of the Moderna Covid-19 vaccine 24 hours after the Moderna Covid-19 vaccine was first punctured.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 year old patient who received a first dose of the Moderna Covid-19 vaccine as a primary series dose of the Moderna Covid-19 vaccine 24 hours after the Moderna Covid-19 vaccine was first punctured.) and NO ADVERSE EVENT (no adverse event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (4 year old patient who received a first dose of the Moderna Covid-19 vaccine as a primary series dose of the Moderna Covid-19 vaccine 24 hours after the Moderna Covid-19 vaccine was first punctured). No concomitant medication were provided. The vial was initially stored in the refrigerator on 19-AUG-2022 and was first punctured on 30-Aug-2022 at 5:00PM. It was reported that neither, the punctured vial was stored in a cooler with Ice Packs in the cooler. Cooler was cold but there was no temperature monitor in the cooler so the exact temperature for the time that the vial was in the cooler was not known. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8 degree to 25 degree C equal to 46 degree to 77 degree F) was for 45 minutes. No treatment details were provided
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -09-feb-2021/ 2nd dose- 02-Mar-2021).    Concomitant medications details were not reported.  It was unknown if the patient had ever tested positive for COVID-19, or had any allergy and had any acute illness at the time of vaccination and up to 1 month before and received any vaccine one month prior to moderna covid-19 vaccine. It was unknown if the patient had taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination and other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was unknown if the adverse event caused patient to seek medical care (office visit, Urgent care, ER, hospitalized), or the patient experienced a similar event in the past and the symptoms improved or worsened.  No adverse events reported.  No treatment medication were provided.   This case was linked to MOD-2022-637963 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Live follow-up appended.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Mother died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Mother died) in a female patient of an unknown age 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not provided. No Treatment information was reported.   Reporter wanted information on how many people had to die before they stop giving these injections, reporter's mother had died.  Company comment: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the fatal unexpected serious event of death that occurred unknown days after receiving a dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed as vaccination dates and event onset dates were not provided. No further details on risk factors, clinical course, patient's medical history and additional vaccination details were reported. Date of death and cause of death was unknown. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events' seriousness was assessed as per medical judgement and available information.   The reporter stated that vaccine was full of toxins and stated there was no data on effectiveness.   This case was linked to US-MODERNATX, INC.-MOD-2022-639298, US-MODERNATX, INC.-MOD-2022-639300, US-MODERNATX, INC.-MOD-2022-639297 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no medical history reported, who experienced the fatal unexpected serious event of death that occurred unknown days after receiving a dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed as vaccination dates and event onset dates were not provided. No further details on risk factors, clinical course, patient's medical history and additional vaccination details were reported. Date of death and cause of death was unknown. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events' seriousness was assessed as per medical judgement and available information. US-MODERNATX, INC.-MOD-2022-639300:16 of her Friend's case/ people all over the world US-MODERNATX, INC.-MOD-2022-639298:Brother in law case US-MODERNATX, INC.-MOD-2022-639297:Father in law case; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: father in law died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (father in law died) in a male patient of an unknown age 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant drug was reported.  Reporter stated that the vaccine was full of toxins. There was no data on the effectiveness. Reporter stated that kid's death was up 700%. She stated that people all over the world have died from this injection. She stated that health departments were promoting toxic ingredients. She stated that the injection was murdering kids and adults and everyone in the world.  No Treatment medications were reported.  Company Comment: This spontaneous case concerns a male patient (age not specified) with no medical history reported, who experienced the unexpected Fatal serious (medically significant) event of Death that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further details on clinical course, other lab test results and treatment received were reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-639298, US-MODERNATX, INC.-MOD-2022-639300, US-MODERNATX, INC.-MOD-2022-639230 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a male patient (age not specified) with no medical history reported, who experienced the unexpected Fatal serious (medically significant) event of Death that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. No further details on clinical course, other lab test results and treatment received were reported. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-639298:brother-in law case US-MODERNATX, INC.-MOD-2022-639300:multiple patients invalid case US-MODERNATX, INC.-MOD-2022-639230:mother  in law case; Reported Cause(s) of Death: unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Brother in law is dying; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (Brother in law is dying) in a male patient of an unknown age 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 IMMUNISATION REACTION (Brother in law is dying) (seriousness criterion medically significant). At the time of the report, IMMUNISATION REACTION (Brother in law is dying) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.  Company comment. This spontaneous case concerns a male patient (unknown age) with no medical history reported, who received a dose of mRNA  1273 vaccine and experienced the unexpected, serious medically significant event of immunisation reaction. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The report mentioned the patient "is dying". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-639230, US-MODERNATX, INC.-MOD-2022-639297 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a male patient (unknown age) with no medical history reported, who received a dose of mRNA  1273 vaccine and experienced the unexpected, serious medically significant event of immunisation reaction. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The report mentioned the patient "is dying". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-639230:Mother case US-MODERNATX, INC.-MOD-2022-639297:Father-in law case
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Feeling abnormal, Headache, Immunisation reaction, Insomnia
Clinical narrative: had some aches with previous shots; maybe a low grade fever, like a mild flu; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07622A, 030L20A, 001A21A and 012F21A) for COVID-19 vaccination.     Patient was never been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Essential tremor, Penicillin allergy, Allergy (Dermatological stabs) and Dust allergy. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu). At the time of the report, PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu) outcome was unknown.            The patient received first booster on 22-Oct-2021 and second booster on 30-Mar-2022.  It was reported that the patient had all Moderna COVID-19 vaccine shots prior to receiving the bivalent Moderna COVID-19 vaccine on 03-Sep-2022 and only had some aches and might be a low grade fever, like a mild flu.  No treatment information was reported.   This case was linked to MOD-2022-639416 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pain, Tremor
Clinical narrative: had some aches with previous shots; maybe a low grade fever, like a mild flu; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07622A, 030L20A, 001A21A and 012F21A) for COVID-19 vaccination.     Patient was never been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Essential tremor, Penicillin allergy, Allergy (Dermatological stabs) and Dust allergy. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu). At the time of the report, PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu) outcome was unknown.            The patient received first booster on 22-Oct-2021 and second booster on 30-Mar-2022.  It was reported that the patient had all Moderna COVID-19 vaccine shots prior to receiving the bivalent Moderna COVID-19 vaccine on 03-Sep-2022 and only had some aches and might be a low grade fever, like a mild flu.  No treatment information was reported.   This case was linked to MOD-2022-639416 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: had some aches with previous shots; maybe a low grade fever, like a mild flu; This spontaneous case was reported by a patient and describes the occurrence of PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07622A, 030L20A, 001A21A and 012F21A) for COVID-19 vaccination.     Patient was never been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Essential tremor, Penicillin allergy, Allergy (Dermatological stabs) and Dust allergy. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu). At the time of the report, PAIN (had some aches with previous shots) and PYREXIA (maybe a low grade fever, like a mild flu) outcome was unknown.            The patient received first booster on 22-Oct-2021 and second booster on 30-Mar-2022.  It was reported that the patient had all Moderna COVID-19 vaccine shots prior to receiving the bivalent Moderna COVID-19 vaccine on 03-Sep-2022 and only had some aches and might be a low grade fever, like a mild flu.  No treatment information was reported.   This case was linked to MOD-2022-639416 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 prophylaxis. The patient's past medical history included Artery dissection. Concurrent medical conditions included Fibromuscular dysplasia since January 2013 and Migraine (Visits neurologist about once a year of migraines). Concomitant products included WARFARIN for Fibromuscular dysplasia, UBROGEPANT (UBRELVY) for Migraine. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). In March 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. It was reported that patient had recovered after a day and so and proceeded with living life with no after effects of the vaccine. No treatment medication were reported. This case was linked to MOD-2022-639577 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast cancer, Influenza like illness, Lymphadenopathy
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 prophylaxis. The patient's past medical history included Artery dissection. Concurrent medical conditions included Fibromuscular dysplasia since January 2013 and Migraine (Visits neurologist about once a year of migraines). Concomitant products included WARFARIN for Fibromuscular dysplasia, UBROGEPANT (UBRELVY) for Migraine. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). In March 2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. It was reported that patient had recovered after a day and so and proceeded with living life with no after effects of the vaccine. No treatment medication were reported. This case was linked to MOD-2022-639577 (Patient Link).