chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Vaccination complication
Clinical narrative: Little reaction to the first 2 shots of Moderna vaccine; Lethargy; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Little reaction to the first 2 shots of Moderna vaccine), LETHARGY (Lethargy) and FATIGUE (Tiredness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Little reaction to the first 2 shots of Moderna vaccine), LETHARGY (Lethargy) and FATIGUE (Tiredness). At the time of the report, VACCINATION COMPLICATION (Little reaction to the first 2 shots of Moderna vaccine), LETHARGY (Lethargy) and FATIGUE (Tiredness) outcome was unknown.            No Concomitant medication reported. No Treatment medication reported.   This case was linked to MOD-2021-320916.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Pyrexia
Clinical narrative: 100.8°F fever; Back pain; Having no strength/ couldn't lift off the chair; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), ASTHENIA (Having no strength/ couldn't lift off the chair) and PYREXIA (100.8°F fever) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028l20a and 027c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced BACK PAIN (Back pain) and ASTHENIA (Having no strength/ couldn't lift off the chair). On 16-Sep-2021, the patient experienced PYREXIA (100.8°F fever). On 15-Sep-2021, BACK PAIN (Back pain) and ASTHENIA (Having no strength/ couldn't lift off the chair) had resolved. At the time of the report, PYREXIA (100.8°F fever) outcome was unknown.            He used to take number of medications as concomitant for unknown indication. Treatment information was not reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered way beyond 12 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered way beyond 12 hours after first puncture) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered way beyond 12 hours after first puncture). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered way beyond 12 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.  On 15-Sep-2021, the patient received a dose of Moderna COVID-19 vaccine from an expired vial that was sitting in the refrigerator way beyond 12 hours after it was first punctured. The vial was first punctured on 24-Aug-2021 then placed in the refrigerator and injected to one patient on 15-Sep-2021. The vial did not undergone any previous temperature excursions.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Not receiving 2nd dose on time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not receiving 2nd dose on time) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not receiving 2nd dose on time). On 08-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Not receiving 2nd dose on time) had resolved.            No concomitant medication reported. No treatment information was provided. The patient missed to attend the second dose appointment on 08-Sep-2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Headache, Influenza like illness, Myalgia
Clinical narrative: everything was heightened with the 3rd one; headache; body ache; flu like symptoms; cough; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (one thing that has lingered is the cough/non-productive cough/it's a chest cough), CONDITION AGGRAVATED (everything was heightened with the 3rd one), HEADACHE (headache) and MYALGIA (body ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062921A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included ETANERCEPT (ENBREL) and PROPRANOLOL for an unknown indication.   On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (one thing that has lingered is the cough/non-productive cough/it's a chest cough), HEADACHE (headache) and MYALGIA (body ache). On an unknown date, the patient experienced CONDITION AGGRAVATED (everything was heightened with the 3rd one). On 05-Sep-2021, HEADACHE (headache) and MYALGIA (body ache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and CONDITION AGGRAVATED (everything was heightened with the 3rd one) outcome was unknown and COUGH (one thing that has lingered is the cough/non-productive cough/it's a chest cough) had not resolved.            No treatment details were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Food allergy, Influenza like illness
Clinical narrative: flu-like symptoms; some of the alpha-gal allergy symptoms/It was a similar reaction to when she has allergic reactions to mammal ingredients/ It affected the digestive system.; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FOOD ALLERGY (some of the alpha-gal allergy symptoms/It was a similar reaction to when she has allergic reactions to mammal ingredients/ It affected the digestive system.) and FATIGUE (fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), FOOD ALLERGY (some of the alpha-gal allergy symptoms/It was a similar reaction to when she has allergic reactions to mammal ingredients/ It affected the digestive system.) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), FOOD ALLERGY (some of the alpha-gal allergy symptoms/It was a similar reaction to when she has allergic reactions to mammal ingredients/ It affected the digestive system.) and FATIGUE (fatigue) had resolved.            No treatment medications were reported. It was reported that patient experienced fatigue, flu-like symptoms, some of the alpha-gal allergy symptoms. It was a similar reaction to when she has allergic reactions to mammal ingredients. It affected the digestive system. These symptoms lasted 4-5 days.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site reaction
Clinical narrative: larger rash; it was not quite as itchy; covid arm came earlier; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (covid arm came earlier), VACCINATION SITE RASH (larger rash) and VACCINATION SITE PRURITUS (it was not quite as itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE REACTION (covid arm came earlier). On an unknown date, the patient experienced VACCINATION SITE RASH (larger rash) and VACCINATION SITE PRURITUS (it was not quite as itchy). On 04-Mar-2021, VACCINATION SITE REACTION (covid arm came earlier), VACCINATION SITE RASH (larger rash) and VACCINATION SITE PRURITUS (it was not quite as itchy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not reported.    This case was linked to MOD-2021-012002 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Heart rate, Nasopharyngitis, Pain
Clinical narrative: chills; did not feel to good/wore them out/bad day; wanted to sleep; got a cold/felt cold; body was aching very bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel to good/wore them out/bad day), SOMNOLENCE (wanted to sleep), NASOPHARYNGITIS (got a cold/felt cold), PAIN (body was aching very bad) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced FEELING ABNORMAL (did not feel to good/wore them out/bad day), SOMNOLENCE (wanted to sleep), NASOPHARYNGITIS (got a cold/felt cold) and PAIN (body was aching very bad). On 15-Sep-2021, the patient experienced CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (did not feel to good/wore them out/bad day), SOMNOLENCE (wanted to sleep), NASOPHARYNGITIS (got a cold/felt cold), PAIN (body was aching very bad) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Heart rate: 100 (High) heart beating very rapidly for 3 hours  over 100 per minute.         Patient state did not take any medication regularly nor diagnosed with peri/myocarditis. Patient was ok the first day after the second dose, but he next day the did not feel to good around the afternoon, and at 10pm they started to feel their heart beating very rapidly for 3 hours, over 100  per minute, very constantly till around to 2:30am. no concomitant medications were provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: chills; did not feel to good/wore them out/bad day; wanted to sleep; got a cold/felt cold; body was aching very bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel to good/wore them out/bad day), SOMNOLENCE (wanted to sleep), NASOPHARYNGITIS (got a cold/felt cold), PAIN (body was aching very bad) and CHILLS (chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced FEELING ABNORMAL (did not feel to good/wore them out/bad day), SOMNOLENCE (wanted to sleep), NASOPHARYNGITIS (got a cold/felt cold) and PAIN (body was aching very bad). On 15-Sep-2021, the patient experienced CHILLS (chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (did not feel to good/wore them out/bad day), SOMNOLENCE (wanted to sleep), NASOPHARYNGITIS (got a cold/felt cold), PAIN (body was aching very bad) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, Heart rate: 100 (High) heart beating very rapidly for 3 hours  over 100 per minute.         Patient state did not take any medication regularly nor diagnosed with peri/myocarditis. Patient was ok the first day after the second dose, but he next day the did not feel to good around the afternoon, and at 10pm they started to feel their heart beating very rapidly for 3 hours, over 100  per minute, very constantly till around to 2:30am. no concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Had a very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had a very sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Viral meningitis in 1986. Concurrent medical conditions included Allergy to antibiotic (Levaquin), Allergy to antibiotic (Biaxin), Penicillin allergy, Lyme disease, Mycoplasma infection, Migraine, ADD and Costochondritis (costochondritis comes and goes, after each vaccine it actually improves and then comes back - very odd.) since 2020.    On 08-Jan-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 VACCINATION SITE PAIN (Had a very sore arm). At the time of the report, VACCINATION SITE PAIN (Had a very sore arm) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medication was reported. Treatment information were not provided.  Patient had been tested Negative for COVID-19 many times.   Patient reported that each time I had Moderna vaccine, this strange chest wall pain would completely go away for a few weeks and then return 4-6 weeks later.  Very odd but figured it was worth reporting.  Patient was currently being evaluated for CIRS (chronic inflammatory response syndrome).   This case was linked to MOD-2021-308000, MOD-2021-308016 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Musculoskeletal stiffness, Myalgia
Clinical narrative: Stiffness on motion; joint pain; Flu like fatigue; Muscular pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness on motion), ARTHRALGIA (joint pain), FATIGUE (Flu like fatigue) and MYALGIA (Muscular pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Psoriatic arthritis and Allergy to antibiotic (Geocillin Hives only transitory, not chronic) since 1999. Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis, GLUCOSAMINE SULFATE (GLUCOSAMINE SULPHATE), ACETYLSALICYLIC ACID (ASPIRIN 81), ASCORBIC ACID, RETINOL, TOCOPHEROL (OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 05-Apr-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness on motion), ARTHRALGIA (joint pain), FATIGUE (Flu like fatigue) and MYALGIA (Muscular pain). In 2021, MUSCULOSKELETAL STIFFNESS (Stiffness on motion), ARTHRALGIA (joint pain), FATIGUE (Flu like fatigue) and MYALGIA (Muscular pain) had resolved.            No treatment medication was reported   This case was linked to MOD-2021-296799 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: Fatigue; injection site arm pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VACCINATION SITE PAIN (injection site arm pain) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (seasonal allergy flare up : fatigue, H/A, stuffy nose, malaise.) since 14-Aug-2021, Sinus disorder NOS (sinus flare up : fatigue, H/A, stuffy nose, malaise.) since 14-Aug-2021 and Potassium low. Concomitant products included IPRATROPIUM BROMIDE (ATROVENT) from 14-Aug-2021 to 23-Aug-2021 for Allergy aggravated and Sinus disorder NOS, LOSARTAN and HCTZ for Blood pressure abnormal, POTASSIUM for Potassium decreased, COLECALCIFEROL (VIT D3) for Supplementation therapy.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021 at 3:00 PM, the patient experienced FATIGUE (Fatigue), VACCINATION SITE PAIN (injection site arm pain) and CHILLS (chills). On 18-Aug-2021, FATIGUE (Fatigue), VACCINATION SITE PAIN (injection site arm pain) and CHILLS (chills) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-255766 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Very itchy; Soreness came back; Red circle is way bigger; Considering not to have the second dose; Very sore arm; Headache; Achy/Sore like if I had worked out on the gym; Severe tiredness; Swollen lymph node; Big red circle on the injection site; Vision is kind of blurry; Swollen thing in my neck, like a big marble; Feel terrible in general; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Vision is kind of blurry), NASAL DISCOMFORT (Swollen thing in my neck, like a big marble), FEELING ABNORMAL (Feel terrible in general), VACCINATION SITE PRURITUS (Very itchy) and LYMPHADENOPATHY (Swollen lymph node) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALINE A) for an unknown indication.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VISION BLURRED (Vision is kind of blurry), NASAL DISCOMFORT (Swollen thing in my neck, like a big marble), FEELING ABNORMAL (Feel terrible in general), LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE ERYTHEMA (Big red circle on the injection site), HEADACHE (Headache), MYALGIA (Achy/Sore like if I had worked out on the gym) and FATIGUE (Severe tiredness). On 10-Sep-2021, the patient experienced MYALGIA (Very sore arm). On 17-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy), MYALGIA (Soreness came back), VACCINATION SITE ERYTHEMA (Red circle is way bigger) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Considering not to have the second dose). At the time of the report, VISION BLURRED (Vision is kind of blurry), NASAL DISCOMFORT (Swollen thing in my neck, like a big marble), FEELING ABNORMAL (Feel terrible in general), VACCINATION SITE PRURITUS (Very itchy), LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE ERYTHEMA (Big red circle on the injection site), MYALGIA (Very sore arm), MYALGIA (Soreness came back), VACCINATION SITE ERYTHEMA (Red circle is way bigger), HEADACHE (Headache), MYALGIA (Achy/Sore like if I had worked out on the gym), FATIGUE (Severe tiredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Considering not to have the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal discomfort, Vaccination site erythema, Vaccination site pruritus, Vision blurred
Clinical narrative: Very itchy; Soreness came back; Red circle is way bigger; Considering not to have the second dose; Very sore arm; Headache; Achy/Sore like if I had worked out on the gym; Severe tiredness; Swollen lymph node; Big red circle on the injection site; Vision is kind of blurry; Swollen thing in my neck, like a big marble; Feel terrible in general; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Vision is kind of blurry), NASAL DISCOMFORT (Swollen thing in my neck, like a big marble), FEELING ABNORMAL (Feel terrible in general), VACCINATION SITE PRURITUS (Very itchy) and LYMPHADENOPATHY (Swollen lymph node) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided.  Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALINE A) for an unknown indication.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced VISION BLURRED (Vision is kind of blurry), NASAL DISCOMFORT (Swollen thing in my neck, like a big marble), FEELING ABNORMAL (Feel terrible in general), LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE ERYTHEMA (Big red circle on the injection site), HEADACHE (Headache), MYALGIA (Achy/Sore like if I had worked out on the gym) and FATIGUE (Severe tiredness). On 10-Sep-2021, the patient experienced MYALGIA (Very sore arm). On 17-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Very itchy), MYALGIA (Soreness came back), VACCINATION SITE ERYTHEMA (Red circle is way bigger) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Considering not to have the second dose). At the time of the report, VISION BLURRED (Vision is kind of blurry), NASAL DISCOMFORT (Swollen thing in my neck, like a big marble), FEELING ABNORMAL (Feel terrible in general), VACCINATION SITE PRURITUS (Very itchy), LYMPHADENOPATHY (Swollen lymph node), VACCINATION SITE ERYTHEMA (Big red circle on the injection site), MYALGIA (Very sore arm), MYALGIA (Soreness came back), VACCINATION SITE ERYTHEMA (Red circle is way bigger), HEADACHE (Headache), MYALGIA (Achy/Sore like if I had worked out on the gym), FATIGUE (Severe tiredness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Considering not to have the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Im just feeling heavy fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Im just feeling heavy fatigue) 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 FATIGUE (Im just feeling heavy fatigue). At the time of the report, FATIGUE (Im just feeling heavy fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose of the Moderna COVID 19 vaccine that was beyond 12 hours post punctured.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose of the Moderna COVID 19 vaccine that was beyond 12 hours post punctured.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose of the Moderna COVID 19 vaccine that was beyond 12 hours post punctured.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose of the Moderna COVID 19 vaccine that was beyond 12 hours post punctured.) 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. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Flatulence
Clinical narrative: flatulence; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (flatulence) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 FLATULENCE (flatulence). At the time of the report, FLATULENCE (flatulence) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Touch of soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Touch of soreness in my 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Touch of soreness in my arm). At the time of the report, MYALGIA (Touch of soreness in my arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2021-322925 (Patient Link).   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I had a racing heart beat, I had a pounding heart beat; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (I had a racing heart beat, I had a pounding heart beat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Arrhythmia.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PALPITATIONS (I had a racing heart beat, I had a pounding heart beat). At the time of the report, PALPITATIONS (I had a racing heart beat, I had a pounding heart beat) 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.  No treatment medication was reported.  Patient took second dose on 26-JAN-2021 in right arm (lot no.-012M20A)   This case was linked to MOD-2021-322985 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Tenderness
Clinical narrative: arm tender; generally being run down; slight fever (lasted for a day); This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm tender), FATIGUE (generally being run down) and PYREXIA (slight fever (lasted for a day)) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) 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 TENDERNESS (arm tender), FATIGUE (generally being run down) and PYREXIA (slight fever (lasted for a day)). At the time of the report, TENDERNESS (arm tender) and PYREXIA (slight fever (lasted for a day)) had resolved and FATIGUE (generally being run down) 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 treatment medications were reported for dose 1. No concomitant medications were reported.   This case was linked to MOD-2021-322691 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Severe itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Severe itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PRURITUS (Severe itching). At the time of the report, PRURITUS (Severe itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information was provided. No concomitant medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown [Expire: Unknown]) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 CHILLS (Chills) and HEADACHE (headache). At the time of the report, CHILLS (Chills) and HEADACHE (headache) 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 was not provided by the reporter Treatment information was not provided     This case was linked to MOD-2021-322952 (Patient Link).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No other information avaialable.; VARlVAX administered after temperature excursion; This spontaneous report was received from a consumer, referring to a patient of unknown age and gender. The patient 's pertinent medical history, drug reactions/ allergies and concomitant medication were not provided.      On 09-SEP-2021, the varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T032316, expiration date 22-SEP-2022; strength, dose and route were unknown) administered for prophylaxis after temperature excursion (product storage error).         Temperature excursion of this vaccine was 21 Fahrenheit degrees for 2 hours and 5 minutes. The previous temperature excursion was reported as 7.5 Fahrenheit degrees for 1 hour and 55 minutes and 7.5 Fahrenheit degrees for 30 minutes, respectively. No other information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: First shot kicked my fricken butt!; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient got Shingles vaccine and stated that shot kicked fricken butt, still worth it. The follow up would not possible, as contact information was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received dose in 2004).   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The reporter stated that, had the Shingles shot in 2018, now have shingles at the time or reporting. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: red welt; This case was reported by a consumer via interactive digital media and described the occurrence of erythema urticarial in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced erythema urticarial. On an unknown date, the outcome of the erythema urticarial was recovered/resolved.   It was unknown if the reporter considered the erythema urticarial to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self reported the case. The age at vaccination was not reported. The patient received Shingles shot like two weeks ago and had the biggest red welt that just kept getting bigger for like 4 days. The patient stated that hopefully his/her next one would be easier. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: urticaria rash; This case was reported by a physician and described the occurrence of urticarial rash in a 78-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, between 2 and 3 weeks after receiving Shingrix, the patient experienced urticarial rash. On an unknown date, the outcome of the urticarial rash was recovered/resolved.   It was unknown if the reporter considered the urticarial rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter stated that 2 to 2 and half week's post vaccination, developed an urticaria rash over the entire body lasting about 2 weeks. The patient's physician was unsure if it was due to the vaccine or not but some other cause. The reporter asked if 2nd dose could be taken. The reporter did not consent to follow up.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose was given to adult; Adult use of a child product; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 54-year-old male patient who received HBV (Engerix B pediatric) (batch number 9KG7R, expiry date 9th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 2021, the patient received the 1st dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 7th September 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse was reporting that, a pediatric dose of Engerix-B was given to an adult patient, which led to underdose and adult use of a child product The reporter consented to follow up.
Sex: U
Vaccine: DTAP, DTAPIPV, HEP, HEPA, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: administered vaccines that were 27°F; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Menveo, Kinrix, Kinrix Pre-Filled Syringe Device, Boostrix, Havrix, Engerix B, Engerix B Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Menveo, Kinrix, Kinrix Pre-Filled Syringe Device, Boostrix, Havrix, Engerix B, Engerix B Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter reported that patients had been administered some vaccines that were exposed to to a minimum temperature of 27 degree F for 44 min, which led to incorrect storage of drug. The vaccines in the temperature excursion were Menveo, Kinrix, Boostrix, Havrix, Engerix-B and Infanrix. The HCP did not have any information on how many patients had received the vaccines, nor did he have any information on which patient received which vaccine at the time of the reporting. No further details were provided. The vaccine administration facility was the same as primary reporter. The health care professional consented to follow-up by phone so as to complete the patient and vaccine information missing at the time of the call.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Administered intramuscularly; This case was reported by a nurse and described the occurrence of wrong route of administration in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3A333, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 22nd September 2021, the patient received the 1st dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 22nd September 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong route of administration. On an unknown date, the outcome of the wrong route of administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Nurse reported that the patient received a dose of Rotarix advertently by intramuscular route which led to wrong route of administration. Reporter consented to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal
Clinical narrative: LOW ANTIBODIES AGAINST COVID VIRUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcohol user, and cancer survivor, and other pre-existing medical conditions included: The patient did not have drug abuse or illicit drug usage. The patient experienced drug allergy when treated with inosine, lisinopril, and sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021, the patient experienced low antibodies against covid virus. Laboratory data included: Antibody test (NR: not provided) Showed less than 50% antibodies (Negative). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low antibodies against covid virus was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: SIGNIFICANT IRREGULARITY IN MENSURAL CYCLES; ALTERED MENSTRUAL CYCLE; This spontaneous report received from a consumer concerned multiple female patients of unspecified age. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch numbers were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients experienced significant irregularity in mensural cycles, and altered menstrual cycle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the significant irregularity in mensural cycles and altered menstrual cycle was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944982.