chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: The patient had COVID after the 2 doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient had COVID after the 2 doses of the Moderna COVID-19 vaccine) in a 7-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Heart disorder. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (The patient had COVID after the 2 doses of the Moderna COVID-19 vaccine). At the time of the report, COVID-19 (The patient had COVID after the 2 doses of the Moderna COVID-19 vaccine) outcome was unknown.    Concomitant medication included an unknown heart medication. The patient is fully  vaccinated with the 2 shots of Moderna COVID-19 vaccines and had been 6 month. The patient is in mid 70s and the reporter think patient received shots on February or March. No treatment medication was provided. This case concerns a patient in mid 70s with reported medical history of Heart disorder who experienced non-serious unexpected event of special interest COVID-19. It was reported that the patient experienced COVID-19 approximately 6 months after the 2 shots of mRNA-1273. The rechallenge was not applicable as the event occurred following the second dose. It was reported that the patient experienced mild case of COVID-19, however, no further information regarding clinical course of the event was provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient in mid 70s with reported medical history of Heart disorder who experienced non-serious unexpected event of special interest COVID-19. It was reported that the patient experienced COVID-19 approximately 6 months after the 2 shots of mRNA-1273. The rechallenge was not applicable as the event occurred following the second dose. It was reported that the patient experienced mild case of COVID-19, however, no further information regarding clinical course of the event was provided. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit risk relationship of mRNA-1273 is not affected by this report.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Diarrhoea, Headache, Myalgia
Clinical narrative: Knot at the injection site; Diarrhea; High fever (104); Vomiting; Headache; Nausea; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A, 030L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis and Gout.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). The patient was treated with INDOMETHACIN [INDOMETACIN] for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Body temperature: 104 (High) high fever 104.No concomitant medications were reported.   This case was linked to MOD-2021-386081 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site mass, Vomiting
Clinical narrative: Knot at the injection site; Diarrhea; High fever (104); Vomiting; Headache; Nausea; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting) and HEADACHE (Headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006021A, 030L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis and Gout.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). The patient was treated with INDOMETHACIN [INDOMETACIN] for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Knot at the injection site), DIARRHOEA (Diarrhea), PYREXIA (High fever (104)), VOMITING (Vomiting), HEADACHE (Headache), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Body temperature: 104 (High) high fever 104.No concomitant medications were reported.   This case was linked to MOD-2021-386081 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm after first vaccine) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore left arm after first vaccine). At the time of the report, PAIN IN EXTREMITY (sore left arm after first vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.No treatment information was provided. This case was linked to MOD-2021-386110 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: hardness; pain/tenderness; swelling in the arm of the injection site; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (pain/tenderness), VACCINATION SITE SWELLING (swelling in the arm of the injection site) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (pain/tenderness), VACCINATION SITE SWELLING (swelling in the arm of the injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE INDURATION (hardness), VACCINATION SITE PAIN (pain/tenderness), VACCINATION SITE SWELLING (swelling in the arm of the injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.            No concomitant drug and treatment drug details were reported.  Patient enquired if ice pack could be used. Company comment includes This case concerns a female patient, unknown age, with no disclosed medical history, who experienced the non-serious, expected events of vaccination site pain, vaccination site swelling, vaccination site induration, and vaccination site erythema. The events occurred  one day after the booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient, unknown age, with no disclosed medical history, who experienced the non-serious, expected events of vaccination site pain, vaccination site swelling, vaccination site induration, and vaccination site erythema. The events occurred  one day after the booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat
Clinical narrative: dry throat; cough; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat) and COUGH (cough) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011O21A) for COVID-19 vaccination.  Concomitant products included VALSARTAN for Blood pressure, APIXABAN (ELIQUIS) for an unknown indication.On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY THROAT (dry throat) and COUGH (cough). At the time of the report, DRY THROAT (dry throat) and COUGH (cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.The patient said that she takes Eliquis and Valsartan for blood pressure as regular medication. This case was linked to MOD-2021-386475 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Non significant follow up appended.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: very bad rash develop a week or so after my 2nd dose of the vaccine in mid February; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (very bad rash develop a week or so after my 2nd dose of the vaccine in mid February) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced RASH (very bad rash develop a week or so after my 2nd dose of the vaccine in mid February). At the time of the report, RASH (very bad rash develop a week or so after my 2nd dose of the vaccine in mid February) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Treatment medication was not provided. Concomitant medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gave a booster dose from a vile that had been started the previous day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a booster dose from a vile that had been started the previous day) in a  patient of an unknown age and gender 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 (gave a booster dose from a vile that had been started the previous day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave a booster dose from a vile that had been started the previous day) had resolved. Concomitant medications was not provided by the reporter.The previous day, vial had been refrigerated the whole time. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe pain in my forearm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe pain in my forearm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (severe pain in my forearm). At the time of the report, PAIN IN EXTREMITY (severe pain in my forearm) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Yes length of time for side effects; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (Yes length of time for side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Yes length of time for side effects). At the time of the report, VACCINATION COMPLICATION (Yes length of time for side effects) 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 did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis.The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients.The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Fahrenheit and maximum 5.7 degree Fahrenheit. The excursion duration was 6 minutes.On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.No concomitant medications were reported.No treatment drugs were reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. There was an excursion from the freezer on 01-Oct-2021 and the vaccine was administered to the patient on 01-Nov-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contains Patient demographics, Vaccine start date and Dose number of the vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was temperature excursion from their freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from their freezer) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No Concomitant medications were provided. On 01-Oct-2021, There was temperature excursion from  freezer. It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes. No treatment medications were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medications were reported. No treatment medications were provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from their freezer; There was an excursion from their freezer/they were administered to 118 patients.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not know how to do the analysis. She stated that her team already knows the recommended temperatures and wanted to know if the vials were still okay to be used because they were administered to 118 patients. Concomitant medications were not reported. Treatment information was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided No treatment medication provided  There was an excursion from that freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gave options for excursions above one hour and not less than, so she does not know how to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021 contains Patient demographics, Vaccine start date and Dose number of the vaccine.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: there was an excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) had resolved. Not Provided.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant drugs were not reported.Treatment medications were not provided.Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received on 15-Nov-2021, reporter contact details updated.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from freezer on 01 Oct 2021.  Used the excursion tool but there was no option for the excursion. The tool only gave options for excursions above one hour and not less than, so  does not know how to do the analysis.   No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received include reporter's, patient's and product's details.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Presyncope, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypotension-Mild, Systemic: Vomiting-Mild, Additional Details: pt vomited and had low bp rate as measured by pulse oximeter. paramedics were called, administer fluids, detrmined pt has vasovagal response. after cleared by EMS patient was able to walk out.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Electrocardiogram, Flushing, Headache
Clinical narrative: Flushed face,  Rt chest pain, Rt neck pain transient headache, transient itching at ankles but no rash, no fever, transient sudden Lt knee pain that  resolved in under 15 minutes. Observed and given tylenol.  All symptoms resolved in 2 hours. Temperature, BP, Hr all normal during observation
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pruritus, Sinus arrhythmia
Clinical narrative: Flushed face,  Rt chest pain, Rt neck pain transient headache, transient itching at ankles but no rash, no fever, transient sudden Lt knee pain that  resolved in under 15 minutes. Observed and given tylenol.  All symptoms resolved in 2 hours. Temperature, BP, Hr all normal during observation
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient did not have reaction immediately post-vaccination during observation period. Experienced later on same day and following day. Pt has generalized itching/rash/hives causing mild discomfort.. Counseled on use of OTC pain medications, ice and antihistamines. No report of symptoms related to anaphylaxis such as swelling of airways/lips/throat/tongue. Advised to reach out to doctor for further attention.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Menstruation delayed, Myalgia, Pain
Clinical narrative: Severe headache lasting 2 days, fever, ringing of ears, aches and pains in bones and muscles, missed period
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Severe headache lasting 2 days, fever, ringing of ears, aches and pains in bones and muscles, missed period
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Bradycardia, Dizziness, Flushing
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Medium, Additional Details: 5 MINUTES AFTER ADMINISTRATION, PATIENT EXPERIENCES SEIZURE FOR ABOUT 5 SECONDS, PUPIL FIXED, PALE SKIN, SWEATING, LOSS OF BALANCE. HYPOTENSION (BP 104/61) . BRADYCARDIA (HR 49). PT RECOVERED FROM BRADYCARDIA IN ABOUT 15 MINS, AND HIS LIPS COLOR RETURNED BACK TO RED/PINK. PT WAS ABLE TO COMMUNICATE HE'S FEELING BETTER. AFTER 30 MINS HIS BP 115/87 THEN 123/88. HR 70 THEN 76. OXYGEN LEVEL 99.  FOLLOWED UP WITH PATIENT. HE IS HOME AND FEELING FINE.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Pallor, Pupil fixed, Seizure
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Medium, Additional Details: 5 MINUTES AFTER ADMINISTRATION, PATIENT EXPERIENCES SEIZURE FOR ABOUT 5 SECONDS, PUPIL FIXED, PALE SKIN, SWEATING, LOSS OF BALANCE. HYPOTENSION (BP 104/61) . BRADYCARDIA (HR 49). PT RECOVERED FROM BRADYCARDIA IN ABOUT 15 MINS, AND HIS LIPS COLOR RETURNED BACK TO RED/PINK. PT WAS ABLE TO COMMUNICATE HE'S FEELING BETTER. AFTER 30 MINS HIS BP 115/87 THEN 123/88. HR 70 THEN 76. OXYGEN LEVEL 99.  FOLLOWED UP WITH PATIENT. HE IS HOME AND FEELING FINE.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Seizure-Medium, Systemic: Weakness-Medium, Additional Details: 5 MINUTES AFTER ADMINISTRATION, PATIENT EXPERIENCES SEIZURE FOR ABOUT 5 SECONDS, PUPIL FIXED, PALE SKIN, SWEATING, LOSS OF BALANCE. HYPOTENSION (BP 104/61) . BRADYCARDIA (HR 49). PT RECOVERED FROM BRADYCARDIA IN ABOUT 15 MINS, AND HIS LIPS COLOR RETURNED BACK TO RED/PINK. PT WAS ABLE TO COMMUNICATE HE'S FEELING BETTER. AFTER 30 MINS HIS BP 115/87 THEN 123/88. HR 70 THEN 76. OXYGEN LEVEL 99.  FOLLOWED UP WITH PATIENT. HE IS HOME AND FEELING FINE.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Flushing, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Immediately after injection, pt reported severe pain at injection site, nausea, dizziness and felt like he was going to pass out.  Gave pt water and he felt like he was going to vomit.  Patient very weak and almost passed out while sitting in chair. Patient asked to lay on floor and was moved to floor. Pharmacist called 911 to report symptoms/ask for EMS to come check vitals.  While waiting for EMS patient improved and father did not allow EMS to check patient.  Patient left on own.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: Immediately after injection, pt reported severe pain at injection site, nausea, dizziness and felt like he was going to pass out.  Gave pt water and he felt like he was going to vomit.  Patient very weak and almost passed out while sitting in chair. Patient asked to lay on floor and was moved to floor. Pharmacist called 911 to report symptoms/ask for EMS to come check vitals.  While waiting for EMS patient improved and father did not allow EMS to check patient.  Patient left on own.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Condition aggravated, Confusional state, Coordination abnormal
Clinical narrative: Pain at site, severe fatigue, chills, sweats, nausea, fever, headache, confusion, extreme lethargy, extreme lack of coordination, heart racing, joint pain, muscle pain full body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site pain, Lethargy
Clinical narrative: Pain at site, severe fatigue, chills, sweats, nausea, fever, headache, confusion, extreme lethargy, extreme lack of coordination, heart racing, joint pain, muscle pain full body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Palpitations, Pyrexia
Clinical narrative: Pain at site, severe fatigue, chills, sweats, nausea, fever, headache, confusion, extreme lethargy, extreme lack of coordination, heart racing, joint pain, muscle pain full body.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Mild, Systemic: Vomiting-Mild, Additional Details: Mother reported that patient has some abdominal pain on and off 3 weeks getting the 2nd Pfizer vaccine. Patient loses appetite and has severe stomach cramps.  I advised mother to take patient to an urgent care or emergency room if symptoms have not subsided.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pruritus, Rash, Swelling face
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: patient walked into pharmacy and presented with a swollen face, very swollen lips, body rash and itching. it was recomended she take benadryl asap and gor to er. she said she had benadryl at home and would take it there. she was counsled that this reaction could continue to get worse and her best course would be to go to ER. she seemed annoyed and unlikely to follow this recommendation.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Lip swelling, Swelling, Swelling face, Urticaria
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: patient walked into pharmacy and presented with a swollen face, very swollen lips, body rash and itching. it was recomended she take benadryl asap and gor to er. she said she had benadryl at home and would take it there. she was counsled that this reaction could continue to get worse and her best course would be to go to ER. she seemed annoyed and unlikely to follow this recommendation.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pruritus, Rash, Swelling face
Clinical narrative: Approx. (8) hours after shot whole face, lips, eyes, cheeks, neck swelled. Eyes swollen shut, lips 3 times the size and body was covered with hives.  I took some over the counter Zyrtec. The next morning Thursday referenced paperwork given "What Should I do About Side Effects?  Call the vaccination provider . So went back to vaccination site - they instructed me to go to the ER.  I opted to wait it out given I cannot afford an ER bill.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Lip swelling, Swelling, Swelling face, Urticaria
Clinical narrative: Approx. (8) hours after shot whole face, lips, eyes, cheeks, neck swelled. Eyes swollen shut, lips 3 times the size and body was covered with hives.  I took some over the counter Zyrtec. The next morning Thursday referenced paperwork given "What Should I do About Side Effects?  Call the vaccination provider . So went back to vaccination site - they instructed me to go to the ER.  I opted to wait it out given I cannot afford an ER bill.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine administered expired  on 11/7/2021 10 days past the expiration date. .Vaccine administration error.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Bleeding at time of injection.  Later pain and bruising at injection site with goose egg size swelling and extreme soreness.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Cognitive disorder, Condition aggravated, Dysuria
Clinical narrative: Urinary symptoms that began within 72 hrs of second dose, increased frequency, pain during urination, lower back and flank pain, pain in lower abdomen, no signs of infection or bacteria were found in several urinalysis. Cognitive issues and a cloudiness, fatigue and tinnitus. Severe flare up of RA symptoms, especially in hands.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Flank pain, Pollakiuria, Rheumatoid arthritis
Clinical narrative: Urinary symptoms that began within 72 hrs of second dose, increased frequency, pain during urination, lower back and flank pain, pain in lower abdomen, no signs of infection or bacteria were found in several urinalysis. Cognitive issues and a cloudiness, fatigue and tinnitus. Severe flare up of RA symptoms, especially in hands.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Urine analysis
Clinical narrative: Urinary symptoms that began within 72 hrs of second dose, increased frequency, pain during urination, lower back and flank pain, pain in lower abdomen, no signs of infection or bacteria were found in several urinalysis. Cognitive issues and a cloudiness, fatigue and tinnitus. Severe flare up of RA symptoms, especially in hands.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain, Skin warm, Sleep disorder
Clinical narrative: Started feeling achy all over 10:30 PM last night after vaccine. Awake several times during the night. Wife was awakened by my shivering with chills about 3:00 AM this morning. Chilling badly with a sheet and 2 quilts on me.  Awake 6:00 AM, too warm, no fever. Very sore across upper back.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This was my booster and I developed a fever of 104 the evening of the day I had the booster. I took 1300 MG of Arthritis strength Tylenol but still had the fever after an hour so then I took 600 MG of Ibuprofen and the fever finally broke late evening. The next day 17Nov21 I had a massive headache and was achy but my fever was gone.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Breast pain, Breast swelling, Fatigue
Clinical narrative: Very tired and weak, bone pain, and very cold. lasting 36 hours   On 11/13/21 am Right arm felt very weak and "funny", her lymph nodes in right axilla area very swollen and sore- swelling and soreness travelled to side of right breast.  Came to the employee health clinic on site  on Monday, 11/15/21.  She saw Dr. - he examined employee. There was still some soreness and lymph node swelling- he told employee to take tylenol or motrin as needed.  On 11/19/21 time of report- symptoms are better, minimal lymph node swelling now and little soreness, other symptoms gone.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Lymph node pain, Lymphadenopathy, Muscular weakness
Clinical narrative: Very tired and weak, bone pain, and very cold. lasting 36 hours   On 11/13/21 am Right arm felt very weak and "funny", her lymph nodes in right axilla area very swollen and sore- swelling and soreness travelled to side of right breast.  Came to the employee health clinic on site  on Monday, 11/15/21.  She saw Dr. - he examined employee. There was still some soreness and lymph node swelling- he told employee to take tylenol or motrin as needed.  On 11/19/21 time of report- symptoms are better, minimal lymph node swelling now and little soreness, other symptoms gone.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Injection site pain, Non-cardiac chest pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: pain under breast-Medium, Additional Details: Patient complained about having pain under breast after third dose of moderna. Patients reports that the pain goes to the back area but more in the front. patient is currently consulting with doctor. Patient will be getting a X-ray and PET to investigate further.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: The nurse sated that she reconstituted the 5-11 year old  Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT CAME TO  THE PHARMACY ON 11/16/2021-COMPLAINING ABOUT THE REDNESS OF THE ARM, MILD SWELLING AND PAIN-RECOMMENDED PT TO TAKE BENADRYL AND PATIENT TOOK BENADRYL,, FOLLOWED UP WITH PT ON 11/17 AND 11/18-PT RECOVERED COMPLETELY ON 11/18/2021
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough event
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Dizziness, Feeling abnormal, Headache
Clinical narrative: I woke at 1:30am, 12 hours after my shot, with a severe headache and nausea. I felt dizzy and weak. I did not take my temperature because I felt too sick to look for the thermometer. I took 2 ibuprofin but it didn't help. Symptoms lessened over the next 12 hours but did not go away for 2 days. After that, I  felt foggy and unfocused. For weeks I noticed a  marked increase of incidents where I could not rem- ember famillar words.    (see next page) For example, I tried to say to my husband while out  on a walk " Look at that birdhouse," but I could not remember the word " birdhouse" I tried to call it " birdbox" and " birdhome." This was 3 weeks after my shot. I also had several occasions while driving, of suddenly not knowing where I was for several moments, before finally realizing I was actually on a familiar route- in broad daylight. This happened rarely in the past and only at night. It is over 7 months later and I am still having these incidents of forgetting familiar information. This rarely happened to me before I got COVID vaccine. I do not want to get any more COVID 19 shots. I fear they may cause me to become unable to work because I may forget all the many details I need to remember to do my job as a personal care aide for 2 clients-
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Memory impairment, Nausea, Sleep disorder
Clinical narrative: I woke at 1:30am, 12 hours after my shot, with a severe headache and nausea. I felt dizzy and weak. I did not take my temperature because I felt too sick to look for the thermometer. I took 2 ibuprofin but it didn't help. Symptoms lessened over the next 12 hours but did not go away for 2 days. After that, I  felt foggy and unfocused. For weeks I noticed a  marked increase of incidents where I could not rem- ember famillar words.    (see next page) For example, I tried to say to my husband while out  on a walk " Look at that birdhouse," but I could not remember the word " birdhouse" I tried to call it " birdbox" and " birdhome." This was 3 weeks after my shot. I also had several occasions while driving, of suddenly not knowing where I was for several moments, before finally realizing I was actually on a familiar route- in broad daylight. This happened rarely in the past and only at night. It is over 7 months later and I am still having these incidents of forgetting familiar information. This rarely happened to me before I got COVID vaccine. I do not want to get any more COVID 19 shots. I fear they may cause me to become unable to work because I may forget all the many details I need to remember to do my job as a personal care aide for 2 clients-
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear pruritus, Erythema, Pruritus, Rash
Clinical narrative: 12/12/21-approximately 6:00am noticedmy left ear was red/itchy. 1:30pm noticed my right side had a rash type itchy/ache. 12/15/21 woke up @ 6:30 am left side of face burning/itchy.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: 12/12/21-approximately 6:00am noticedmy left ear was red/itchy. 1:30pm noticed my right side had a rash type itchy/ache. 12/15/21 woke up @ 6:30 am left side of face burning/itchy.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash at injection site.  Approximately 3 inches in diameter. Warm, swollen, itchy.