chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach hurt; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurt) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032b21a and 031b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-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 ABDOMINAL PAIN UPPER (Stomach hurt). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurt) outcome was unknown.            No concomitant medication was provided. Ibuprofen had not helped.   This case was linked to MOD-2021-424354 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Follow contains no new information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on his arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021, the patient experienced VACCINATION SITE PAIN (soreness on his arm). At the time of the report, VACCINATION SITE PAIN (soreness on his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Heart and diabetic medications. No Treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Non-Significant Follow Up
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-May-2021. Concurrent medical conditions included Headache, Obesity, Hyperlipidemia, Prediabetes and Hypertension. Concomitant products included LISINOPRIL for an unknown indication.    On 07-Sep-2021 at 2:37 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The booster dose has not been very good to me.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The booster dose has not been very good to me.) 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 (The booster dose has not been very good to me.). At the time of the report, VACCINATION COMPLICATION (The booster dose has not been very good to me.) outcome was unknown.            No concomitant medication was reported.  No treatment medication use was reported.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: My son has concerns about the side effects relating to heart issues; This spontaneous case was reported by another health care professional and describes the occurrence of CARDIAC DISORDER (My son has concerns about the side effects relating to heart issues) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (My son has concerns about the side effects relating to heart issues). At the time of the report, CARDIAC DISORDER (My son has concerns about the side effects relating to heart issues) 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 medication was reported. The treatment information was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: stomach hurt; wanting to threw up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (stomach hurt) and NAUSEA (wanting to threw up) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069h21a, 032b21a and 031b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced ABDOMINAL PAIN (stomach hurt) and NAUSEA (wanting to threw up). At the time of the report, ABDOMINAL PAIN (stomach hurt) and NAUSEA (wanting to threw up) outcome was unknown.            No concomitant medications was provided. No treatment medications was provided.   This case was linked to MOD-2021-424319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Non significant follow-up appended.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was administered past the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered past the 30 day beyond use date) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Seizure, Obesity, Hyperlipidemia, Depression and Hypertension (HTN). Concomitant products included AMLODIPINE, LISINOPRIL, PRAVASTATIN, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) and METOPROLOL TARTRATE for an unknown indication.    On 07-Sep-2021 at 2:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021 at 2:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered past the 30 day beyond use date). On 07-Sep-2021 at 2:30 PM, EXPIRED PRODUCT ADMINISTERED (vaccine was administered past the 30 day beyond use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  It was reported that  the patient was not diagnosed or tested positive for COVID-19. It was also reported that the patient had no acute illnesses at the time of vaccination and up to one month before.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: some pain at left upper arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (some pain at left upper arm) 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 PAIN IN EXTREMITY (some pain at left upper arm). At the time of the report, PAIN IN EXTREMITY (some pain at left upper arm) 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 medication was reported by the reporter. No treatment was reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: muscle ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 045121A) for COVID-19 vaccination.     No Medical history reported.  Concomitant products included VERAPAMIL and LEVOTHYROXINE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle ache) and HEADACHE (headache). At the time of the report, MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.            Other concomitant medication includes losartan/HCTZ 12.5 mg.  No treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain and swelling seven day after the 1st Dose; swelling seven day after the 1st Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (injection site pain and swelling seven day after the 1st Dose) and VACCINATION SITE SWELLING (swelling seven day after the 1st 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site pain and swelling seven day after the 1st Dose) and VACCINATION SITE SWELLING (swelling seven day after the 1st Dose). At the time of the report, VACCINATION SITE PAIN (injection site pain and swelling seven day after the 1st Dose) and VACCINATION SITE SWELLING (swelling seven day after the 1st Dose) 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 medication was reported by the reporter.  No treatment medication was reported by the reporter.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Given Moderna COVID-19 vaccine to 16-year-old boy; 2 doses of Pfizer vaccine previously and this was the 1st dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Given Moderna COVID-19 vaccine to 16-year-old boy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Pfizer vaccine previously and this was the 1st dose of Moderna) in a 16-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: Pfizer vaccine (Got 2 doses of Pfizer vaccine previously). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Given Moderna COVID-19 vaccine to 16-year-old boy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Pfizer vaccine previously and this was the 1st dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Given Moderna COVID-19 vaccine to 16-year-old boy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 doses of Pfizer vaccine previously and this was the 1st dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  On an unknown date, a 16 year-old boy was inadvertently given Moderna dose. The patient and his parents requested for Moderna vaccine. The patient did not experience AE.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: blood pressure  was too low; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (blood pressure  was too low) 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 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 HYPOTENSION (blood pressure  was too low). At the time of the report, HYPOTENSION (blood pressure  was too low) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported that she took the incorrect pill and her blood pressure was already low.  No concomitant medication was reported. No treatment medication was reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema of eyelid, Eye irritation, Eye pain, Lacrimation increased, Ocular discomfort
Clinical narrative: Both eyes began to water and had lots of tears; Both eyes began to burn; Hard to see; Shooting pain from eyes; Eyelids became very red almost purple; Through the night eyes seemed to shut with crusty substance and had trouble opening them back up; The white part of eyes were red; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Both eyes began to water and had lots of tears), EYE IRRITATION (Both eyes began to burn), VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes) and ERYTHEMA OF EYELID (Eyelids became very red almost purple) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes), ERYTHEMA OF EYELID (Eyelids became very red almost purple), OCULAR DISCOMFORT (Through the night eyes seemed to shut with crusty substance and had trouble opening them back up) and OCULAR HYPERAEMIA (The white part of eyes were red). On 21-Dec-2021 at 6:00 PM, the patient experienced LACRIMATION INCREASED (Both eyes began to water and had lots of tears) and EYE IRRITATION (Both eyes began to burn). At the time of the report, LACRIMATION INCREASED (Both eyes began to water and had lots of tears), EYE IRRITATION (Both eyes began to burn), VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes), ERYTHEMA OF EYELID (Eyelids became very red almost purple), OCULAR DISCOMFORT (Through the night eyes seemed to shut with crusty substance and had trouble opening them back up) and OCULAR HYPERAEMIA (The white part of eyes were red) outcome was unknown.            Concomitant information was not provided.  Patient went to doctor on 22 Dec 2021 and the treatment medication included antibiotic eyedrops.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Visual impairment
Clinical narrative: Both eyes began to water and had lots of tears; Both eyes began to burn; Hard to see; Shooting pain from eyes; Eyelids became very red almost purple; Through the night eyes seemed to shut with crusty substance and had trouble opening them back up; The white part of eyes were red; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Both eyes began to water and had lots of tears), EYE IRRITATION (Both eyes began to burn), VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes) and ERYTHEMA OF EYELID (Eyelids became very red almost purple) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2021, the patient experienced VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes), ERYTHEMA OF EYELID (Eyelids became very red almost purple), OCULAR DISCOMFORT (Through the night eyes seemed to shut with crusty substance and had trouble opening them back up) and OCULAR HYPERAEMIA (The white part of eyes were red). On 21-Dec-2021 at 6:00 PM, the patient experienced LACRIMATION INCREASED (Both eyes began to water and had lots of tears) and EYE IRRITATION (Both eyes began to burn). At the time of the report, LACRIMATION INCREASED (Both eyes began to water and had lots of tears), EYE IRRITATION (Both eyes began to burn), VISUAL IMPAIRMENT (Hard to see), EYE PAIN (Shooting pain from eyes), ERYTHEMA OF EYELID (Eyelids became very red almost purple), OCULAR DISCOMFORT (Through the night eyes seemed to shut with crusty substance and had trouble opening them back up) and OCULAR HYPERAEMIA (The white part of eyes were red) outcome was unknown.            Concomitant information was not provided.  Patient went to doctor on 22 Dec 2021 and the treatment medication included antibiotic eyedrops.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Obesity, Hyperlipidemia and Hypertensive heart disease. Concomitant products included GABAPENTIN (NEURONTIN), ALBUTEROL SULFATE, ROSUVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 07-Sep-2021 at 4:02 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Oral pain, Tooth disorder
Clinical narrative: dental work done after first dose; mouth is still bothering him after first dose; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (dental work done after first dose) and ORAL PAIN (mouth is still bothering him after first dose) 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 TOOTH DISORDER (dental work done after first dose) and ORAL PAIN (mouth is still bothering him after first dose). The patient was treated with CORTISONE for Dental disorder NOS, at an unspecified dose and frequency and IBUPROFEN for Dental disorder NOS, at an unspecified dose and frequency. At the time of the report, TOOTH DISORDER (dental work done after first dose) outcome was unknown and ORAL PAIN (mouth is still bothering him after first dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. Patient had some dental work done and took pain killer. He had scheduled to received the second dose of Moderna COVID-19 Vaccine on 06Apr2021. Patient stopped taking the Ibuprofen last Tuesday.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in the muscle) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-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 MYALGIA (Soreness in the muscle). At the time of the report, MYALGIA (Soreness in the muscle) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient stated that soreness in the muscle went away in a day or two.  It was reported that the patient was not on any concomitant medication and had not taken any treatment.   This case was linked to MOD-2021-424520, MOD-2021-424521 (Patient Link).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease, CKD-MBD and Glaucoma. Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) to be not related.    No Concomitant Medications were Reported. No Treatments were Reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchiness; Hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and URTICARIA (Hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced PRURITUS (Itchiness) and URTICARIA (Hives). At the time of the report, PRURITUS (Itchiness) and URTICARIA (Hives) outcome was unknown.            Patient was not on any concomitant medication. Treatment included Antihistamines. Patient had no events with the second dose.   This case was linked to MOD-2021-424536 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Emotional poverty, Lethargy, Pyrexia
Clinical narrative: felt really lethargic and unresponsive; no energy; no emotion; body temperature 1.2° higher than usual/fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt really lethargic and unresponsive), ASTHENIA (no energy), EMOTIONAL POVERTY (no emotion) and PYREXIA (body temperature 1.2° higher than usual/fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022BZ1A and 016CZ1A) for COVID-19 vaccination.     The patient's past medical history included Shoulder operation (reconstructive surgery he had on the left shoulder). Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM for Hypothyroidism, FEXOFENADINE, LOSARTAN POTASSIUM, ESCITALOPRAM OXALATE, APIXABAN (ELIQUIS) and FLUVASTATIN SODIUM for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced LETHARGY (felt really lethargic and unresponsive), ASTHENIA (no energy), EMOTIONAL POVERTY (no emotion) and PYREXIA (body temperature 1.2° higher than usual/fever). On 03-Jun-2021, LETHARGY (felt really lethargic and unresponsive), ASTHENIA (no energy), EMOTIONAL POVERTY (no emotion) and PYREXIA (body temperature 1.2° higher than usual/fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Body temperature: 98.2° (High) 98.2° (body temperature was 1.2° higher than usual). On an unknown date, Body temperature: 96.9°f - 97°f (normal) His normal body temperature was 96.9°F - 97°F.         Concomitant medication of the patient also included Sunlife silver which the patient was taking as multivitamin.  The patient received the vaccines on left arm, which was the non-dominant arm.  The patient didn't experience any symptoms after receiving the first dose and stated it was like a walk in the park.  After the second dose, the patient had no problem at all on the day he received the shot, but the next day, he had some mild symptoms. The patient didn't experience pain and didn't consider this situation real negative. The patient went to therapy because of a reconstructive surgery which he had on the left shoulder and this therapy was prescheduled.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-424377 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: really really sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VACCINATION COMPLICATION (really really sick). At the time of the report, VACCINATION COMPLICATION (really really sick) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Non Significant Follow-up appended no new information
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included Headache. Concurrent medical conditions included Obesity, Depression, Anxiety and Penicillin allergy (allergy to PCN). Concomitant products included HYDROXYZINE and FLUOXETINE for an unknown indication.   On 10-Sep-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 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine expired) to be not related.    No treatment medications were provided.  The vaccines expired on 31-Aug-2021, there were two dates that the vaccine clinic was open, 03-Sep-2021 and 17-Sep-2021. The vials did not undergone a temperature excursion. The vials were removed from the freezer on the day of vaccination. This lot number expiration date was not extended.   This case was linked to MOD-2021-328706 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: his arm is sore, every time he raises his hand he feels his arm is sore; Muscles sore/Soreness near injection site muscles; he makes a quick motion, he feels the soreness too. It is in the muscle area of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (his arm is sore, every time he raises his hand he feels his arm is sore), MYALGIA (Muscles sore/Soreness near injection site muscles) and VACCINATION SITE PAIN (he makes a quick motion, he feels the soreness too. It is in the muscle area of the injection site) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 024M20A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (his arm is sore, every time he raises his hand he feels his arm is sore), MYALGIA (Muscles sore/Soreness near injection site muscles) and VACCINATION SITE PAIN (he makes a quick motion, he feels the soreness too. It is in the muscle area of the injection site). At the time of the report, PAIN IN EXTREMITY (his arm is sore, every time he raises his hand he feels his arm is sore), MYALGIA (Muscles sore/Soreness near injection site muscles) and VACCINATION SITE PAIN (he makes a quick motion, he feels the soreness too. It is in the muscle area of the injection site) had not resolved.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-424465, MOD-2021-424521 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness in muscles; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness in muscles) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-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 MYALGIA (Soreness in muscles). At the time of the report, MYALGIA (Soreness in muscles) had resolved.            Patient was  not on any concomitant medication. Patient had  not taken any treatment.  The  soreness in the muscle went away In a day or two.   This case was linked to MOD-2021-424520, MOD-2021-424465 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Something of a cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Something of a cough) in a 75-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Something of a cough). At the time of the report, COUGH (Something of a cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.   She reported that she was one of the first ones to get the 1st dose after the front liners. It was reported that patient read at  Moderna website that if one has an upper respiratory infection it could be COVID rather than something else.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Body temperature, Chills, Feeling abnormal, Gait disturbance
Clinical narrative: Worst than Swine Flu  body response after booster/Worst than COVID disease body response after booster; whole body felt horrible after booster; Blister on hand after booster; Could not walk after booster; Could not work after booster; Extreme chills after booster; Fever 102 F after booster; Extreme body ache after booster; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Worst than Swine Flu  body response after booster/Worst than COVID disease body response after booster), FEELING ABNORMAL (whole body felt horrible after booster), BLISTER (Blister on hand after booster), GAIT DISTURBANCE (Could not walk after booster) and IMPAIRED WORK ABILITY (Could not work after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Swine influenza (Swine Flu a few years ago). Previously administered products included for COVID-19 vaccination: J & J Vaccine (first dose and did not have any side effects) in April 2021. Past adverse reactions to the above products included No adverse event with J & J Vaccine.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced VACCINATION COMPLICATION (Worst than Swine Flu  body response after booster/Worst than COVID disease body response after booster), FEELING ABNORMAL (whole body felt horrible after booster), BLISTER (Blister on hand after booster), GAIT DISTURBANCE (Could not walk after booster), IMPAIRED WORK ABILITY (Could not work after booster), CHILLS (Extreme chills after booster), PYREXIA (Fever 102 F after booster) and MYALGIA (Extreme body ache after booster). On 22-Dec-2021, VACCINATION COMPLICATION (Worst than Swine Flu  body response after booster/Worst than COVID disease body response after booster), FEELING ABNORMAL (whole body felt horrible after booster), BLISTER (Blister on hand after booster), GAIT DISTURBANCE (Could not walk after booster), IMPAIRED WORK ABILITY (Could not work after booster), CHILLS (Extreme chills after booster), PYREXIA (Fever 102 F after booster) and MYALGIA (Extreme body ache after booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, Body temperature: 102 (High) Fever 102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Worst than Swine Flu  body response after booster/Worst than COVID disease body response after booster; whole body felt horrible after booster; Blister on hand after booster; Could not walk after booster; Could not work after booster; Extreme chills after booster; Fever 102 F after booster; Extreme body ache after booster; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Worst than Swine Flu  body response after booster/Worst than COVID disease body response after booster), FEELING ABNORMAL (whole body felt horrible after booster), BLISTER (Blister on hand after booster), GAIT DISTURBANCE (Could not walk after booster) and IMPAIRED WORK ABILITY (Could not work after booster) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020 and Swine influenza (Swine Flu a few years ago). Previously administered products included for COVID-19 vaccination: J & J Vaccine (first dose and did not have any side effects) in April 2021. Past adverse reactions to the above products included No adverse event with J & J Vaccine.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2021, the patient experienced VACCINATION COMPLICATION (Worst than Swine Flu  body response after booster/Worst than COVID disease body response after booster), FEELING ABNORMAL (whole body felt horrible after booster), BLISTER (Blister on hand after booster), GAIT DISTURBANCE (Could not walk after booster), IMPAIRED WORK ABILITY (Could not work after booster), CHILLS (Extreme chills after booster), PYREXIA (Fever 102 F after booster) and MYALGIA (Extreme body ache after booster). On 22-Dec-2021, VACCINATION COMPLICATION (Worst than Swine Flu  body response after booster/Worst than COVID disease body response after booster), FEELING ABNORMAL (whole body felt horrible after booster), BLISTER (Blister on hand after booster), GAIT DISTURBANCE (Could not walk after booster), IMPAIRED WORK ABILITY (Could not work after booster), CHILLS (Extreme chills after booster), PYREXIA (Fever 102 F after booster) and MYALGIA (Extreme body ache after booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, Body temperature: 102 (High) Fever 102 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Polymerase chain reaction
Clinical narrative: Vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Obesity, Triglyceride increased and Depression. Concomitant products included HYDROXYZINE for an unknown indication.   On 07-Sep-2021 at 2:31 PM, 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 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Polymerase chain reaction: positive (Positive) Positive for COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no known drug allergies. The patient had no acute illnesses at the time of vaccination and up to one month before. Treatment medications were not reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered more than 12 hours post puncture) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered more than 12 hours post puncture). On 22-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered more than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site rash
Clinical narrative: Rash on arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on arm) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on arm) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE RASH (Rash on arm) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication details was reported.  No treatment medication details was reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) to be not related.    Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Aches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and FATIGUE (Tiredness) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Aches) and FATIGUE (Tiredness). At the time of the report, PAIN (Aches) and FATIGUE (Tiredness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-424596, MOD-2021-424597 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Asthma, Hyperlipidemia, Chronic kidney disease, Prediabetes and Allergy to antibiotic (Allergy to Bactrim). Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), OMEPRAZOLE, NIFEDIPINE and SIMVASTATIN for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.