chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Huge swelling, huge lump that?s getting bigger, big purple bruise, redness all around the injection side, major pain can?t do anything with my arm, headache,fever,chills
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) 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 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced URTICARIA (hives). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form; FAMOTIDINE (PEPCID AC) for Antihistamine therapy, at a dose of 1 dosage form and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at a dose of 1 dosage form. At the time of the report, URTICARIA (hives) was resolving.            Concomitant product use was not provided by the reporter. Patient took other treatment medication included a week worth of steroids and lotion also helps temporarily.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: has an infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (has an infection) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced INFECTION (has an infection). At the time of the report, INFECTION (has an infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient wanted to know for the infection, if she was allowed to take antibiotics after getting the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: typical reactions and side effects after the booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (typical reactions and side effects after the booster dose) 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 VACCINATION COMPLICATION (typical reactions and side effects after the booster dose). At the time of the report, VACCINATION COMPLICATION (typical reactions and side effects after the booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: What to do about side effects after 2nd vaccine/received the Moderna COVID-19 Vaccine and experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What to do about side effects after 2nd vaccine/received the Moderna COVID-19 Vaccine and experienced a side effect) 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 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 VACCINATION COMPLICATION (What to do about side effects after 2nd vaccine/received the Moderna COVID-19 Vaccine and experienced a side effect). At the time of the report, VACCINATION COMPLICATION (What to do about side effects after 2nd vaccine/received the Moderna COVID-19 Vaccine and experienced a side effect) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: adverse symptom after a dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse symptom after a dose of Moderna COVID-19 vaccine) 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 (adverse symptom after a dose of Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (adverse symptom after a dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old son had one dose of moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son had one dose of moderna) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son had one dose of moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son had one dose of moderna) had resolved.            Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: administered with vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administered with vaccine which underwent temperature excursion) had resolved.        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 and treatment medication details were reported.  The reporter reports that they had a temperature excursion in their pharmacy involving 2 lot numbers:  Lot number(s) - 045C21A with the temperature excursion occurring on 20Oct2021-04Nov2021; 065F21A (09Nov2021-17Nov2021).  From lot number 045C21A, 3 booster doses were given on 27Oct2021; 3 booster doses and 1 regular dose on 28Oct2021; 3 booster doses and 1 regular dose on 29Oct2021; and 3 booster doses on 02Nov2021 From lot number O65F21A; 1 booster dose and 1 regular dose were given on 09Nov2021; 1 booster dose on 10Nov2021; 4 booster doses on 11Nov2021; 1 booster dose on 16Nov2021 and 1 booster dose on 17Nov2021.
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Low oxygen levels; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (Low oxygen levels) 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 OXYGEN SATURATION DECREASED (Low oxygen levels). At the time of the report, OXYGEN SATURATION DECREASED (Low oxygen levels) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: low (Low) LOW.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Products were reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient that received the second dose of moderna vaccine after 10 days of getting the first shot; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient that received the second dose of moderna vaccine after 10 days of getting the first shot) 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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient that received the second dose of moderna vaccine after 10 days of getting the first shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (a patient that received the second dose of moderna vaccine after 10 days of getting the first shot) had resolved.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information were reported. No treatment medication were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Stiffness throughout body; Pain at injection site; Low grade fever; Chills; Nausea; Fatigue; Headache; General muscle pain; Joint Pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills) and NAUSEA (Nausea) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 049C21CA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza (first dose on left arm) on 09-Sep-2021. Past adverse reactions to the above products included No adverse event with Influenza.   On 16-Jul-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Sep-2021 at 7:00 AM, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (General muscle pain) and ARTHRALGIA (Joint Pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 28-Sep-2021 at 3:00 PM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 01-Oct-2021, MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (General muscle pain) and ARTHRALGIA (Joint Pain) had resolved.            No concomitant medication was reported by reporter.  Patients symptoms were not as severe as from first dose. Symptoms recurred lasting 2 to 3 days.   This case was linked to MOD-2021-262783 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Stiffness throughout body; Pain at injection site; Low grade fever; Chills; Nausea; Fatigue; Headache; General muscle pain; Joint Pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills) and NAUSEA (Nausea) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 049C21CA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Influenza (first dose on left arm) on 09-Sep-2021. Past adverse reactions to the above products included No adverse event with Influenza.   On 16-Jul-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Sep-2021 at 7:00 AM, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (General muscle pain) and ARTHRALGIA (Joint Pain). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. On 28-Sep-2021 at 3:00 PM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 01-Oct-2021, MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), VACCINATION SITE PAIN (Pain at injection site), PYREXIA (Low grade fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (General muscle pain) and ARTHRALGIA (Joint Pain) had resolved.            No concomitant medication was reported by reporter.  Patients symptoms were not as severe as from first dose. Symptoms recurred lasting 2 to 3 days.   This case was linked to MOD-2021-262783 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: After expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (After expiration date). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (After expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients have received doses of the Moderna covid-19 vaccine after the published expiration date between 28OCT2021 and 14DEC2021.  Date the vial(s) were moved from freezer to refrigerated conditions (calendar date is required): 04NOV2021  No concomitant medication information was provided. No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Migraine, Pain in extremity
Clinical narrative: Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this; Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this; Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this; Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 22:30 (Lot number: EW0168) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hashimotos disease" (unspecified if ongoing); "food and skin allergies" (unspecified if ongoing), notes: food and skin allergies; "skin allergies" (unspecified if ongoing), notes: skin allergies. Concomitant medication(s) included: LEVOXYL; IBUPROFEN; TYLENOL; TENSION HEADACHE RELIEVERS. Past drug history included: Morphine, reaction(s): "known allergies:Morphine", notes: Morphine, Z-pack, food and skin allergies. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=EW0217,, lot unknown=False,, administration date=23Jul2021,, administration time=11:00 PM,, dose number=1,, vaccine location=Left arm), administration date: 23Jul2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), MIGRAINE (non-serious), HOT FLUSH (non-serious), FATIGUE (non-serious) all with onset 14Aug2021, outcome "not recovered" and all described as "Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this". Therapeutic measures were not taken as a result of pain in extremity, migraine, hot flush,  fatigue.  Additional information: Starting on 14Aug, my arm was very sore. Migraines kicked in, hot body flashes and severe, extreme fatigue. Arm pain has stopped, migraines, hot body flashes and extreme fatigue continue to this day. No Covid prior vaccination.No Covid tested post vaccination.No other vaccine in four weeks.  Follow-up attempts are completed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Paraesthesia, Skin discolouration
Clinical narrative: "bump or a pimple" on her arm and leg, not at the injection site, that itches/little pimple and I scratch it's kind a little red/red little bumping; red around; one on my leg; l little brown bumping; red little bumping; red around; one on my leg; l little brown bumping; little tingling; little tingling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 (Batch/Lot number: unknown) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were reported. Vaccination history included: Bnt162b2 (DOSE1 ), administration date: 03Aug2021, for Covid-19 immunisation, reaction(s): "HAD NO REACTION OR ANYTHING ".  The following information was reported: PAPULE (non-serious), outcome "unknown", described as ""bump or a pimple" on her arm and leg, not at the injection site, that itches/little pimple and I scratch it's kind a little red/red little bumping; red around; one on my leg; l little brown bumping"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "red little bumping; red around; one on my leg; l little brown bumping; little tingling"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tingling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Consumer stated, "Yes because I have a little itching, and I have like a little not this is little pimple like and I scratch it's kind a little red and I have the another one so I just want to know that some kind of allergies or something after the shot at the certain time. Exactly, not exactly around my shot but it's like I have one on my leg and one on my arm, and then it's just itch a little bit, but I am not ill or anything but I just want to know because sometime it a little tingling sometime, so that what it is."Yes, I take Calciferol (Not clarified hence not captured in tab), I am almost 90 years old so I do take medication, but I feel good. Regarding treatment consumer stated, "No, I am a diabetic, no I didn't take anything because it isn't that bad but it's just a red little bumping, and give a look red around and than I have one on my leg, I guess, I can feel little brown bumping it and then it just itch and every time, sometime little tingling say a little tingling, so all that I feel like so.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall, Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm; Hurt; Shivers; Tired; Fall; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 19May2021 (Batch/Lot number: unknown) at the age of 54 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Wasp allergy" (unspecified if ongoing). Concomitant medication(s) included: AMANTADINE; ADDERALL; ATORVASTATIN; CLOBETASOL; OCREVUS. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Hurt"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Shivers"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tired"; FALL (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fall".  Additional information: Patient's concomitant medication included CALCIU (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: mild nausea; fatigue; This is a spontaneous report received from a non-contactable reporter (Other HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 09:00 (Lot number: EW0217) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Raynaud's syndrome" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication included: IRON; PROBIOTICS; PREBIOTICS NOS. Past drug history included: Amoxicillin, reaction: "Known Allergies: Amoxicillin".  The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "mild nausea"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue".  Additional Information: The first dose of bnt162b2 was received by the patient at exactly 09:00 on May2021 at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination including multivitamins, iron, pre/probiotics. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101260777 Same reporter, patient, and product; Different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for COVID-19 Immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches".  Additional information: Events was experienced day and night. The reporter would like to know if the patient should take the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: a little tired the next day; Pfizer Covid-19 vaccine that was administered at least 12 hours but not greater than 24 hours from time of dilution; Pfizer Covid-19 vaccine that was administered at least 12 hours but not greater than 24 hours from time of dilution; booster dose; This is a spontaneous report from a contactable other hcp. This Other hcp reported for a 55-year-old female patient received booster dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot: EW0170, Expiry date: Unknown) via an unspecified route of administration on 10Nov2021 (age at vaccination: 55years-old) as dose 3 (booster), single for covid-19 immunization. Medical history included hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included epinephrine (EPIPEN) taken for hypersensitivity, start and stop date were not reported and Just vitamins. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Historical vaccine included dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8733, Expiry date: Unknown) via an unspecified route of administration on 01Apr2021 (age at vaccination: 55years-old) as dose 1, single and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0170, Expiry date: Unknown) via an unspecified route of administration on 22Apr2021 (age at vaccination: 55years-old) for Covid-19 Immunization. It was reported that the patient was administered the booster dose of the Pfizer COVID-19 vaccine at least 12 hours but not more than 24 hours from time of dilution. Reporter said that it was stored in the vial and it was stored in the refrigerator before it was administered to the patient, upon follow-up 07Dec2021, onset 11Nov2021 FATIGUE (non-serious) with , outcome "unknown", described as "a little tired the next day".  Follow-up attempts are completed. No further information is expected.  Follow-up (07Dec2021): This is a spontaneous follow-up report from a contactable Other HCP. This Other HCP reported in response to the HCP letter sent and included that, Updated Information included: Event (fatigue) and clinical information was added.  Additional information: Patient age at vaccination, Route of Administration, Vaccination Facility Type was added.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administration date 11Aug2021 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation; propranolol hydrochloride (BETALOL [PROPRANOLOL HYDROCHLORIDE]) (Batch/Lot number: unknown) for blood pressure measurement. Relevant medical history included: "Blood pressure measurement" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BRONCHITIS (non-serious) with onset Aug2021, outcome "unknown", described as "Bronchitis". Therapeutic measures were taken as a result of bronchitis.  Additional information: Patient got bronchitis 2 weeks later of vaccination and given antibiotics (Treatment).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Headache, Immunisation
Clinical narrative: 3 doses; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): AGN278357 (Allergan).  A 63 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 27Aug2021 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; atogepant (ATOGEPANT) (Batch/Lot number: unknown). Relevant medical history included: "skin cancer" (unspecified if ongoing); "Patient had a small surgery for skin cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 21Feb2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "no reaction was experienced"; Bnt162b2 (DOSE: 2), administration date: 10Mar2021, when the patient was 62 years old, for COVID-19 immunization, reaction(s): "no reaction was experienced". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; IMMUNISATION (non-serious) with onset 27Aug2021, outcome "unknown", described as "3 doses". The action taken for atogepant was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Swollen lymph node under arm; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Swollen lymph node under arm"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose Number: 3". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient had no covid prior vaccination and it was unknown if patient was tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.