chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia
Clinical narrative: cough; low grade fever; feeling tired; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (cough), PYREXIA (low grade fever) and FATIGUE (feeling tired) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced COUGH (cough), PYREXIA (low grade fever) and FATIGUE (feeling tired). At the time of the report, COUGH (cough), PYREXIA (low grade fever) and FATIGUE (feeling tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She wanted to know if the vaccine will cause false positive for Covid-19 test.She's referring to the home antigen test, and wants to get her granddaughter tested.  Caller denied providing further details for Safety reporting, stating it's her privacy'. Denied consent for follow up, caller said she will follow up herself as she's a nurse.  23 Dec 2021
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. There were two vials that were punctured and used some time between June and November 5, but  can't back track those dates, they were written on the vials themselves, which were disposed of. It just came to their attention that the vials were being used past the recommended 12 hour post puncture time. It was reported that vial was punctured on 11-NOV-2021 and dose given then kept in refrigerator after puncture.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) 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 information was reported.   This case was linked to MOD-2021-418964 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Drug details were reported.  No Treatment information was provided
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was not provided by the reported.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) 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: Chest pain, Paraesthesia
Clinical narrative: Light chest pain /chest pain; Pins and needles in my hands; This spontaneous case was reported by a pharmacist and describes the occurrence of CHEST PAIN (Light chest pain /chest pain) and PARAESTHESIA (Pins and needles in my hands) 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 21-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced CHEST PAIN (Light chest pain /chest pain) and PARAESTHESIA (Pins and needles in my hands). At the time of the report, CHEST PAIN (Light chest pain /chest pain) and PARAESTHESIA (Pins and needles in my hands) 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.   Concomitant medications were not provided. Treatment information was not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea
Clinical narrative: I felt anxieties; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (I felt anxieties) and DYSPNOEA (Shortness of breath) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Asthma.    On 22-Dec-2021 at 5:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced ANXIETY (I felt anxieties) and DYSPNOEA (Shortness of breath). At the time of the report, ANXIETY (I felt anxieties) and DYSPNOEA (Shortness of breath) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients were given shots during excursions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (patients were given shots during excursions). On 28-Oct-2021, PRODUCT STORAGE ERROR (patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment drugs were reported.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 09-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions). On 09-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS. Concomitant products included METOPROLOL SUCCINATE for Heart disorder, CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    In February 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 (soreness in the arms). At the time of the report, PAIN IN EXTREMITY (soreness in the arms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-423761, MOD-2021-423994 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arms). At the time of the report, PAIN IN EXTREMITY (soreness in the arms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication use was reported.   This case was linked to MOD-2021-423760, MOD-2021-423679 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt very little after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt very little after first shot) in an adult 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt very little after first shot). At the time of the report, VACCINATION SITE PAIN (Arm hurt very little after first shot) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided. It was reported that Moderna shots were a breeze unlike patient rabies shot.
Sex: F
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: had a surgery on 30 March 2021; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (had a surgery on 30 March 2021) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced SURGERY (had a surgery on 30 March 2021). The patient was treated with OXYCODONE at an unspecified dose and frequency. At the time of the report, SURGERY (had a surgery on 30 March 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment was provided. Patient called on 5-April-2021 to ask if there was an interaction between the Moderna COVID-19 vaccine and surgical procedure.  She had a surgery on 30-March-2021 and She was put on stool softener, Oxycodone, and antibiotics after the surgery.  She received her first vaccine on 12-March-2021, and she was schedule for her second vaccine on  9-April-2021.  She wanted to know if the surgery and the medicine she was taking will have an effect on the vaccine scheduled on 9April.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye swelling, Lip swelling, Nausea, Oropharyngeal pain
Clinical narrative: Swelling between toes; Sore throat; Face, nose swollen; Developed an ear ache; Eyes swollen; Lips swollen; Hives and welts forming on my face, arm, scalp, legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache) and EYE SWELLING (Eyes swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose Lot number EW0161 administered on left non dominant arm) on 14-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Second dose Lot number EW0167 administered on left non dominant arm) on 05-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for an unknown indication.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 21-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache), EYE SWELLING (Eyes swollen), LIP SWELLING (Lips swollen), URTICARIA (Hives and welts forming on my face, arm, scalp, legs) and NAUSEA (Nausea). The patient was treated with LORATADINE at an unspecified dose and frequency; PREDNISONE at a dose of 50mg per day for 7 days and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache), EYE SWELLING (Eyes swollen), LIP SWELLING (Lips swollen), URTICARIA (Hives and welts forming on my face, arm, scalp, legs) and NAUSEA (Nausea) had not resolved.            Patient stated that she experienced Swollen nose on 21-Dec-2021 which was not resolved.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling face, Urticaria
Clinical narrative: Swelling between toes; Sore throat; Face, nose swollen; Developed an ear ache; Eyes swollen; Lips swollen; Hives and welts forming on my face, arm, scalp, legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache) and EYE SWELLING (Eyes swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose Lot number EW0161 administered on left non dominant arm) on 14-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Second dose Lot number EW0167 administered on left non dominant arm) on 05-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for an unknown indication.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 21-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache), EYE SWELLING (Eyes swollen), LIP SWELLING (Lips swollen), URTICARIA (Hives and welts forming on my face, arm, scalp, legs) and NAUSEA (Nausea). The patient was treated with LORATADINE at an unspecified dose and frequency; PREDNISONE at a dose of 50mg per day for 7 days and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache), EYE SWELLING (Eyes swollen), LIP SWELLING (Lips swollen), URTICARIA (Hives and welts forming on my face, arm, scalp, legs) and NAUSEA (Nausea) had not resolved.            Patient stated that she experienced Swollen nose on 21-Dec-2021 which was not resolved.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 29-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose given 23 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 23 days after first dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 23 days after first dose). On 22-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose given 23 days after first dose) had resolved.            Concomitant medication information not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A Moderna Covid-19 vaccine booster was dose given to a patient 20 hrs after 1st puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 vaccine booster was dose given to a patient 20 hrs after 1st puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 vaccine booster was dose given to a patient 20 hrs after 1st puncture). On 23-Dec-2021, EXPIRED PRODUCT ADMINISTERED (A Moderna Covid-19 vaccine booster was dose given to a patient 20 hrs after 1st puncture) 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects lasting 4 weeks; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Side effects lasting 4 weeks) 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 (Side effects lasting 4 weeks). At the time of the report, VACCINATION COMPLICATION (Side effects lasting 4 weeks) 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 Drug details were reported.  No Treatment information was provided  Past medical issues were amplified.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) 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 information was reported.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; Vial stored in refrigerator once punctured, in freezer prior to puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture). On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Vial stored in refrigerator once punctured, in freezer prior to puncture) 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 provided.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-418964 (Patient Link).
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial puncture 11/11/21dose given kept in refrigerator after puncture; Patient received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial puncture 11/11/21dose given kept in refrigerator after puncture) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial puncture 11/11/21dose given kept in refrigerator after puncture). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial puncture 11/11/21dose given kept in refrigerator after puncture) 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 information was provided  The vial punctured on 11 Nov 2021 dose given kept in refrigerator after puncture.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: pain in leg went back; she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in leg went back) and THERAPEUTIC RESPONSE UNEXPECTED (she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     The patient's past medical history included Osteopenia ((arthritis in her bones)). Previously administered products included for COVID-19 vaccination: Pfizer (First Pfizer shot on 25May2021, given in left non-dominant arm. Lot number: EW00170. Expiration date: 31Aug2021.) on 25-May-2021, Pfizer (Second Pfizer shot on 15Jun2021 and given in left non-dominant arm. Lot number: EW0217. Expiration date: 30Sep2021.) on 15-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]), ACETYLSALICYLIC ACID (BABY ASPIRIN), HYDROCHLOROTHIAZIDE, ATORVASTATIN, VITAMIN D3, PANTOPRAZOLE, CARVEDILOL, RIVAROXABAN (XARELTO) and POLYVINYL ALCOHOL (LIQUID TEARS) for an unknown indication.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in leg went back) and THERAPEUTIC RESPONSE UNEXPECTED (she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg). At the time of the report, PAIN IN EXTREMITY (pain in leg went back) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details were reported.  The patient said that that she has osteopenia (arthritis in her bones). She sleeps on her right side and takes 2 Tylenol before going to sleep. Around 1:30 to 2:30 am she wakes up because of pain in her right leg, which is very painful. Sometimes, she needs to get up and sleep in the recliner because she doesn't deal well with pain.  However, after getting the Moderna booster shot on Monday afternoon, she didn't have pain in her right leg for 63 hours. On Monday night and Tuesday night, there was no pain in her leg. She slept all night with no pain whatsoever in her leg. It felt like she could do a cartwheel and felt so good. Last night, around 3:30 am the pain went back in her leg. She said that maybe the Moderna vaccine made her pain go away and after 63 hours the pain was back.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with the vaccine from a vial which was punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which was punctured for more than 12 hours) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021 at 3:53 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 09-Nov-2021 at 3:53 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which was punctured for more than 12 hours). On 09-Nov-2021 at 3:53 PM, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from a vial which was punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.  Vial was initially punctured on 05 Nov 2021 at 10:00AM.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient given 2nd dose 1 week before the due date; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given 2nd dose 1 week before the due date) 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 04-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given 2nd dose 1 week before the due date). On 04-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient given 2nd dose 1 week before the due date) 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (feels a bit bad), feeling hot (at night he was hot) and headache (bit of a headache/little headaches) in an adult male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 027H21B, 027C21A and 016B21A) for COVID-19 immunization. No medical history reported. On Jan 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 14, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 21, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (feels a bit bad), feeling hot (at night he was hot) and headache (bit of a headache/little headaches). At the time of the report, feeling abnormal (feels a bit bad), feeling hot (at night he was hot) and headache (bit of a headache/little headaches) outcome: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-424356 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) 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 NAUSEA (nausea). At the time of the report, NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose more than 36 days after the first; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after the first) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after the first). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after the first) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-424298 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout after dose 1) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout after dose 1). The patient was treated with PREDNISONE ongoing since an unknown date for Gout, at an unspecified dose and frequency. At the time of the report, GOUT (Gout after dose 1) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. Patient was taking Prednisone for treating Gout at the time of report.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Vaccination site pain
Clinical narrative: pain only at the time of administration where he felt like the healhcare provider hit a nerve; pain only at the time of administration where he felt like the healhcare provider hit a nerve; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (pain only at the time of administration where he felt like the healhcare provider hit a nerve) and VACCINATION SITE PAIN (pain only at the time of administration where he felt like the healhcare provider hit a nerve) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced NEURALGIA (pain only at the time of administration where he felt like the healhcare provider hit a nerve) and VACCINATION SITE PAIN (pain only at the time of administration where he felt like the healhcare provider hit a nerve). At the time of the report, NEURALGIA (pain only at the time of administration where he felt like the healhcare provider hit a nerve) and VACCINATION SITE PAIN (pain only at the time of administration where he felt like the healhcare provider hit a nerve) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient received 2nd dose on 15 May 2021.  No medical history was provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Herpes virus infection
Clinical narrative: herpes outbreak after receiving second dose; This spontaneous case was reported by a physician and describes the occurrence of HERPES VIRUS INFECTION (herpes outbreak after receiving second 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES VIRUS INFECTION (herpes outbreak after receiving second dose). At the time of the report, HERPES VIRUS INFECTION (herpes outbreak after receiving second dose) outcome 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 called to ask if patient can take antiviral medication due to herpes outbreak after receiving second dose of Moderna vaccine 5 days ago.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Neck pain, Pain, Vaccination site reaction
Clinical narrative: Moderna arm; lot of pain; can't rest the arm/"affecting her daily living; pain from the neck; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Moderna arm), PAIN (lot of pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't rest the arm/"affecting her daily living), NECK PAIN (pain from the neck) and ARTHRALGIA (joint pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a and 039b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-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 VACCINATION SITE REACTION (Moderna arm), PAIN (lot of pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't rest the arm/"affecting her daily living), NECK PAIN (pain from the neck) and ARTHRALGIA (joint pain). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Moderna arm), PAIN (lot of pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't rest the arm/"affecting her daily living), NECK PAIN (pain from the neck) and ARTHRALGIA (joint pain) outcome was unknown.            Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Endodontic procedure
Clinical narrative: Root canal; This spontaneous case was reported by a consumer and describes the occurrence of ENDODONTIC PROCEDURE (Root canal) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ENDODONTIC PROCEDURE (Root canal). At the time of the report, ENDODONTIC PROCEDURE (Root canal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter. No treatment medication was reported by reporter.