chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Heart rate, Palpitations, Product dose omission issue
Clinical narrative: has not received her 2nd dose; blur vision; heart was racing; her chest hurt; fluttering heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering heart) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer. Concomitant products included OMEPRAZOLE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), METOPROLOL, VALSARTAN, GABAPENTIN (NEURONTIN), LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM (XANAX) and VITAMINS NOS for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CARDIAC FLUTTER (fluttering heart) (seriousness criterion medically significant), VISION BLURRED (blur vision), PALPITATIONS (heart was racing) and CHEST PAIN (her chest hurt). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose). On 13-May-2021, CARDIAC FLUTTER (fluttering heart), VISION BLURRED (blur vision), PALPITATIONS (heart was racing) and CHEST PAIN (her chest hurt) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of cancer and use of concomitant medication are contributory factors to the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of cancer and use of concomitant medication are contributory factors to the events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: has not received her 2nd dose; blur vision; heart was racing; her chest hurt; fluttering heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering heart) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer. Concomitant products included OMEPRAZOLE, HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), METOPROLOL, VALSARTAN, GABAPENTIN (NEURONTIN), LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM (XANAX) and VITAMINS NOS for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced CARDIAC FLUTTER (fluttering heart) (seriousness criterion medically significant), VISION BLURRED (blur vision), PALPITATIONS (heart was racing) and CHEST PAIN (her chest hurt). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose). On 13-May-2021, CARDIAC FLUTTER (fluttering heart), VISION BLURRED (blur vision), PALPITATIONS (heart was racing) and CHEST PAIN (her chest hurt) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received her 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of cancer and use of concomitant medication are contributory factors to the events.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of cancer and use of concomitant medication are contributory factors to the events.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Headache, Hypoaesthesia
Clinical narrative: It's been 7 months now and his Bell's palsy is not going away and is just as bad as the day after vaccination/Only half of the nerves inside his mouth works; His whole side of the face is numb; got headache like crazy; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (It's been 7 months now and his Bell's palsy is not going away and is just as bad as the day after vaccination/Only half of the nerves inside his mouth works) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Liver transplant and Immunosuppressant drug therapy since an unknown date. Concurrent medical conditions included Bell's palsy (He has Bell's palsy last July. He went on therapy and was getting better) since July 2020. Concomitant products included TACROLIMUS (PROGRAF), LISINOPRIL and GABAPENTIN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-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 FACIAL PARALYSIS (It's been 7 months now and his Bell's palsy is not going away and is just as bad as the day after vaccination/Only half of the nerves inside his mouth works) (seriousness criterion medically significant), HYPOAESTHESIA (His whole side of the face is numb) and HEADACHE (got headache like crazy). At the time of the report, FACIAL PARALYSIS (It's been 7 months now and his Bell's palsy is not going away and is just as bad as the day after vaccination/Only half of the nerves inside his mouth works) had not resolved and HYPOAESTHESIA (His whole side of the face is numb) and HEADACHE (got headache like crazy) outcome was unknown.            Concomitant medication included Etdir. Treatment information included Gabapentin.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested.   This case was linked to MOD-2021-289533 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Vaccination site swelling
Clinical narrative: Possible heart inflammation; injection sight supposed to swell; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDITIS (Possible heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 MYOCARDITIS (Possible heart inflammation) (seriousness criterion medically significant) and VACCINATION SITE SWELLING (injection sight supposed to swell). At the time of the report, MYOCARDITIS (Possible heart inflammation) and VACCINATION SITE SWELLING (injection sight supposed to swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment history was reported.  Very limited information regarding the events has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Laryngitis, Pyrexia
Clinical narrative: Laryngeal swelling with laryngitis; extreme fatigue; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of LARYNGITIS (Laryngeal swelling with laryngitis), FATIGUE (extreme fatigue) and PYREXIA (fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Milk allergy, Fruit allergy (Allergic to pineapple) and Seasonal allergy.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced LARYNGITIS (Laryngeal swelling with laryngitis) (seriousness criterion medically significant), FATIGUE (extreme fatigue) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, LARYNGITIS (Laryngeal swelling with laryngitis), FATIGUE (extreme fatigue) and PYREXIA (fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported by reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded The case was reported as serious but on an event level described as non-serious for each criterion.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded  The case was reported as serious but on an event level described as non-serious for each criterion.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Endocrine ophthalmopathy, Exophthalmos, Eye pain, Vaccination site pain
Clinical narrative: I was diagnosed with Thyroid Eye Disease; I had been having bulging eyes; I had been having dryness; I had been having eye pain; I had a sore arm at injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) and EXOPHTHALMOS (I had been having bulging eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease since 2019. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) for Graves' disease.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm at injection site). On an unknown date, the patient experienced ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) (seriousness criterion medically significant), EXOPHTHALMOS (I had been having bulging eyes) (seriousness criterion medically significant), DRY EYE (I had been having dryness) and EYE PAIN (I had been having eye pain). At the time of the report, ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease), EXOPHTHALMOS (I had been having bulging eyes), DRY EYE (I had been having dryness), EYE PAIN (I had been having eye pain) and VACCINATION SITE PAIN (I had a sore arm at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data was not provided  Treatment product was not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Graves disease could be a confounder of the events. Vaccination site pain is consistent with the Known safety profile of the product.   This case was linked to MOD-2021-290495 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Graves disease could be a confounder of the events. Vaccination site pain is consistent with the Known safety profile of the product.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: I was sick; I summinestred the fist dosis on april, but don`t the second; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second). At the time of the report, ILLNESS (I was sick) and PRODUCT DOSE OMISSION ISSUE (I summinestred the fist dosis on april, but don`t the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.  The patient needed  to start the process of second vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Endocrine ophthalmopathy, Exophthalmos, Eye pain, Vaccination site pain
Clinical narrative: I was diagnosed with Thyroid Eye Disease; I had been having bulging eyes; I had been having dryness; I had been having pain; I had a sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) and EXOPHTHALMOS (I had been having bulging eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Graves' disease since 2019. Concomitant products included LEVOTHYROXINE for Graves' disease.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (I had a sore arm). On 17-May-2021, the patient experienced ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease) (seriousness criterion medically significant), EXOPHTHALMOS (I had been having bulging eyes) (seriousness criterion medically significant), DRY EYE (I had been having dryness) and EYE PAIN (I had been having pain). At the time of the report, ENDOCRINE OPHTHALMOPATHY (I was diagnosed with Thyroid Eye Disease), EXOPHTHALMOS (I had been having bulging eyes), DRY EYE (I had been having dryness), EYE PAIN (I had been having pain) and VACCINATION SITE PAIN (I had a sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she experienced Thyroid Eye Disease.she'd been experiencing eye dryness, pain, & bulging.  She reports that she'd been using over the counter eye drops On 20-May-2021 she saw an ophthalmologist and On 10-Jun-2021 saw an eye surgeon. "My Dr recently told me I need to have a hysterectomy." Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s history of Grave´s disease could be a confounding factor for the event Endocrine ophthalmopathy.   This case was linked to MOD-2021-290469 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient´s history of Grave´s disease could be a confounding factor for the event Endocrine ophthalmopathy.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia, Disturbance in attention
Clinical narrative: memory issues; focus; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus) 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 AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus). At the time of the report, AMNESIA (memory issues) and DISTURBANCE IN ATTENTION (focus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. No treatment details were provided by reporter. Follow thru and losing 30-60 mins of time were reported as adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (mild fever) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (mild fever). At the time of the report, PYREXIA (mild fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were  reported.  Treatment information was not provided by the reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: itching on the right side of the back/Itching at the vaccination site; sensation prevented her for sleeping; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching on the right side of the back/Itching at the vaccination site) and INSOMNIA (sensation prevented her for sleeping) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     The patient's past medical history included Back surgery (An inserted metal in the spine and right shoulder blade).    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced PRURITUS (itching on the right side of the back/Itching at the vaccination site). In August 2021, the patient experienced INSOMNIA (sensation prevented her for sleeping). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of 1 dosage form. At the time of the report, PRURITUS (itching on the right side of the back/Itching at the vaccination site) and INSOMNIA (sensation prevented her for sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The sensation started after vaccination, but it shortly disappeared, then started at the shoulder blade. She also commented that the sensation prevented her for sleeping. Patient also took steroid cream to alleviate the symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness to face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness to face) 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 HYPOAESTHESIA (Numbness to face). At the time of the report, HYPOAESTHESIA (Numbness to face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported.  No Treatment information  was provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic kidney disease, Glomerular filtration rate, Nephritis, Renal impairment
Clinical narrative: nephritis; Very very unusual drop in kidney function; Stage 3 kidney disease; This spontaneous case was reported by a consumer and describes the occurrence of NEPHRITIS (nephritis), RENAL IMPAIRMENT (Very very unusual drop in kidney function) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-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 NEPHRITIS (nephritis) (seriousness criterion medically significant), RENAL IMPAIRMENT (Very very unusual drop in kidney function) (seriousness criterion medically significant) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) (seriousness criterion medically significant). At the time of the report, NEPHRITIS (nephritis), RENAL IMPAIRMENT (Very very unusual drop in kidney function) and CHRONIC KIDNEY DISEASE (Stage 3 kidney disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Glomerular filtration rate: 62 (normal) 62. On 26-Jul-2021, Glomerular filtration rate: 48 (Low) eGFR was down to 48.         No concomitant medical information were reported. No treatment information was reported.  Company Comment: Very limited information regarding these events have been provided at this time. Other factors may have contributed to the low eGFR as 5 months have passed since patient received last dose of vaccine. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Other factors may have contributed to the low eGFR as 5 months have passed since patient received last dose of vaccine. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: worser cough than I had the day before I got the modrna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (worser cough than I had the day before I got the modrna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cough.    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 (worser cough than I had the day before I got the modrna vaccine). At the time of the report, COUGH (worser cough than I had the day before I got the modrna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: had a side effect with my two doses of vaccine other than sore arm/; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore 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, the patient experienced VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore arm). At the time of the report, VACCINATION COMPLICATION (had a side effect with my two doses of vaccine other than sore arm/) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications was provided. No Treatment medications was provided.   This case was linked to MOD-2021-290688 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Extra dose administered, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall; the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall; chills; a low grade fever today of 99.5 F/She had a fever last night with shakes; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), CHILLS (chills), PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) and EXTRA DOSE ADMINISTERED (Extra dose administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced CHILLS (chills), PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) and EXTRA DOSE ADMINISTERED (Extra dose administered). On 18-Aug-2021, the patient experienced VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall) and VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall). At the time of the report, VACCINATION SITE WARMTH (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), VACCINATION SITE ERYTHEMA (the area around the injection site from her 3rd shot on her right arm is fairly red & hot and is 2&1/2 inches wide & 1&1/2 inches tall), CHILLS (chills) and PYREXIA (a low grade fever today of 99.5 F/She had a fever last night with shakes) outcome was unknown and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.            No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2021-290761 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose after day 42; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose after day 42) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter No treatment medication were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up information received on 21-Aug-2021 and Included No new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Seizure, Tooth fracture
Clinical narrative: Seizure; Broke her teeth; 1st dose 15-May-2021 and then the second dose on 30-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 56-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 Root canal procedure (Root canal). Previously administered products included for Product used for unknown indication: Restylane kysse in November 2020. Concurrent medical conditions included Seizure (Seizure disorder) since November 2020.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-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 SEIZURE (Seizure) (seriousness criterion medically significant), TOOTH FRACTURE (Broke her teeth) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-May-2021 and then the second dose on 30-May-2021). The patient was treated with TOPIRAMATE (TOPAMAX) in July 2021 for Seizure, at a dose of 50 milligram. At the time of the report, SEIZURE (Seizure) and TOOTH FRACTURE (Broke her teeth) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 15-May-2021 and then the second dose on 30-May-2021) had resolved.            Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis
Clinical narrative: Bottom lip keeps getting inflamed; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (Bottom lip keeps getting inflamed) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088921A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEILITIS (Bottom lip keeps getting inflamed). At the time of the report, CHEILITIS (Bottom lip keeps getting inflamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Just got 1st shot is my nose suppose to run; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Just got 1st shot is my nose suppose to run) 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 RHINORRHOEA (Just got 1st shot is my nose suppose to run). At the time of the report, RHINORRHOEA (Just got 1st shot is my nose suppose to run) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1 dose of Moderna COVID 19 vaccine given to a patient who is 13 years old.; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 13 years old.) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 13 years old.). On 10-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1 dose of Moderna COVID 19 vaccine given to a patient who is 13 years old.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Jaundice
Clinical narrative: Bell's Palsy; jaundice; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant) and JAUNDICE (jaundice). At the time of the report, BELL'S PALSY (Bell's Palsy) and JAUNDICE (jaundice) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  No concomitant medication was provided by the reporter.  Company Comment: Very limited information regarding these events has been provided at this time.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Additional initial.; Sender's Comments: Very limited information regarding these events has been provided at this time
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Rash pruritic
Clinical narrative: She still has bumps but they are not as raised and itchy; On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy) and PAPULE (She still has bumps but they are not as raised and itchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy). On an unknown date, the patient experienced PAPULE (She still has bumps but they are not as raised and itchy). The patient was treated with LORATADINE at a dose of UNK dosage form and ACRIVASTINE (BENADRYL ALLERGY RELIEF) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (On same day at night, she developed rash on her chest, back, legs, head and face/ rash on top or her feet/It was very itchy / Her stomach got really itchy) and PAPULE (She still has bumps but they are not as raised and itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: I now have covid pneumonia; I was covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (I now have Covid pneumonia) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced COVID-19 (I was covid positive). On an unknown date, the patient experienced COVID-19 PNEUMONIA (I now have covid pneumonia) (seriousness criterion medically significant). At the time of the report, COVID-19 PNEUMONIA (I now have covid pneumonia) and COVID-19 (I was covid positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Company Comment: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.   Reporter did not allow further contact; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a side effect with my two doses of vaccine other than sore arm/; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore 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 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 PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore arm/). At the time of the report, PAIN IN EXTREMITY (had a side effect with my two doses of vaccine other than sore arm/) outcome was unknown.            No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-290599 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, COVID-19, Headache
Clinical narrative: Contracted COVID after taking the vaccine; Couldn't remember things/some short-term memory loss; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches). At the time of the report, COVID-19 (Contracted COVID after taking the vaccine), AMNESIA (Couldn't remember things/some short-term memory loss) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. Treatment information was not provided.  Patient's husband believed that his wife had taken Moderna vaccine if he was not mistaken. His wife worked in the healthcare field and had to take the vaccine through her job. He had to quarantine for 2 weeks after his wife contracted COVID. He confirmed that he had no NDC, lot or expiry date for the Moderna vaccine his wife had taken. He stated that she was doing fine. However; he mentioned that his wife still had headaches but had returned to work. He reported that after contracting COVID, his wife had some kind of memory loss. If she made plans for today, she would not remember.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not gotten his second dose, yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose, yet) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose, yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not gotten his second dose, yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Arm hurt; Slight headache; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included AFib (Tylenol to alleviate the symptoms). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Arm hurt), HEADACHE (Slight headache) and FATIGUE (Felt tired) had resolved.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.  Treatment information was not provided.   This case was linked to MOD-2021-290795 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Ligament sprain, Muscle strain, Myalgia
Clinical narrative: leg sprain; I pulled a muscle in my leg when walking; It dose not bother me all the time  but sometimes it is painful; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (leg sprain), MUSCLE STRAIN (I pulled a muscle in my leg when walking) and MYALGIA (It dose not bother me all the time  but sometimes it is painful) 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 LIGAMENT SPRAIN (leg sprain), MUSCLE STRAIN (I pulled a muscle in my leg when walking) and MYALGIA (It dose not bother me all the time  but sometimes it is painful). At the time of the report, LIGAMENT SPRAIN (leg sprain), MUSCLE STRAIN (I pulled a muscle in my leg when walking) and MYALGIA (It dose not bother me all the time  but sometimes it is painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact