chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule, Vaccination site pain
Clinical narrative: Injection arm became sore; Knot at injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Injection arm became sore) and VACCINATION SITE NODULE (Knot at injection site) 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) UNK dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection arm became sore) and VACCINATION SITE NODULE (Knot at injection site). At the time of the report, VACCINATION SITE PAIN (Injection arm became sore) and VACCINATION SITE NODULE (Knot at injection site) 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 medications were provided.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: not feeling t; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling t) 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) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling t). At the time of the report, VACCINATION COMPLICATION (not feeling t) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications and treatment medications was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: injection site was red and had a lump; injection site was red and had a lump; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE MASS (injection site was red and had a lump) and INJECTION SITE ERYTHEMA (injection site was red and had a lump) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced INJECTION SITE MASS (injection site was red and had a lump) and INJECTION SITE ERYTHEMA (injection site was red and had a lump). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Injection site lump and Injection site redness, at a dose of 1 dosage form. At the time of the report, INJECTION SITE MASS (injection site was red and had a lump) and INJECTION SITE ERYTHEMA (injection site was red and had a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: did not receive full second dose; did not receive full second dose; This spontaneous case was reported by a health care professional and describes the occurrence of UNDERDOSE (did not receive full second dose) and DEVICE CONNECTION ISSUE (did not receive full second dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 049C21A) for COVID-19 vaccination.     No medication history was provided.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 26-May-2021, the patient experienced UNDERDOSE (did not receive full second dose) and DEVICE CONNECTION ISSUE (did not receive full second dose). At the time of the report, UNDERDOSE (did not receive full second dose) and DEVICE CONNECTION ISSUE (did not receive full second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash (on the waistline), rash (down the whole back) and rash (from the neck down the chest) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# unknown) for COVID-19 immunization. No medical history reported. On May 19, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced rash (on the waistline), rash (down the whole back) and rash (from the neck down the chest). At the time of the report, rash (on the waistline), rash (down the whole back) and rash (from the neck down the chest) outcome: unknown. The action taken with either mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 103 temp; 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 PYREXIA (103 temp) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PYREXIA (103 temp). At the time of the report, PYREXIA (103 temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Body temperature: 103 (High) The patient had 103 temperature since the second vaccination.         No Concomitant medication information provided. No treatment medication information provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; 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 HYPERSENSITIVITY (severe allergic reaction) 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 HYPERSENSITIVITY (severe allergic reaction). At the time of the report, HYPERSENSITIVITY (severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Treatment medication was not provided
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Inappropriate schedule of product administration, Paraesthesia, Photopsia, Stress
Clinical narrative: I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing; I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing; pins and needles and swelling throughout my body; pins and needles; I have burning sensation throughout my body; two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make; it feels like a really bad sunburn that travels all around the body; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles) and BURNING SENSATION (I have burning sensation throughout my body) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included Levothyroxine 137mcg for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles), BURNING SENSATION (I have burning sensation throughout my body), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make) and SUNBURN (it feels like a really bad sunburn that travels all around the body). At the time of the report, STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles), BURNING SENSATION (I have burning sensation throughout my body), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make) and SUNBURN (it feels like a really bad sunburn that travels all around the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Sunburn, Swelling
Clinical narrative: I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing; I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing; pins and needles and swelling throughout my body; pins and needles; I have burning sensation throughout my body; two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make; it feels like a really bad sunburn that travels all around the body; This spontaneous case was reported by a consumer and describes the occurrence of STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles) and BURNING SENSATION (I have burning sensation throughout my body) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included Levothyroxine 137mcg for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles), BURNING SENSATION (I have burning sensation throughout my body), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make) and SUNBURN (it feels like a really bad sunburn that travels all around the body). At the time of the report, STRESS (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), PHOTOPSIA (I'm stressed out because i got the Moderna shot on 13Apr2021 and immediately I had flashing), SWELLING (pins and needles and swelling throughout my body), PARAESTHESIA (pins and needles), BURNING SENSATION (I have burning sensation throughout my body), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two weeks after I took the vaccine the chiropractor gave me an alignment and it seemed to make) and SUNBURN (it feels like a really bad sunburn that travels all around the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; pain In The back of my thigh; 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 HEADACHE (headache) and PAIN IN EXTREMITY (pain In The back of my thigh) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PAIN IN EXTREMITY (pain In The back of my thigh). At the time of the report, HEADACHE (headache) and PAIN IN EXTREMITY (pain In The back of my thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in my fingers; 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 HYPOAESTHESIA (numbness in my fingers) 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 HYPOAESTHESIA (numbness in my fingers). At the time of the report, HYPOAESTHESIA (numbness in my fingers) 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tiredness after the second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (tiredness after the second dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 015M20A) for COVID-19 vaccination.     Concomitant products included PYRIDOXINE HYDROCHLORIDE (VIT B6) and COLECALCIFEROL (D3) for General physical condition normal, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes NOS, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (tiredness after the second dose). On 18-Feb-2021, FATIGUE (tiredness after the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     No treatment was reported.         Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Non Significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: 3 small ball an my collarbone and one on neck; 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 LYMPHADENOPATHY (3 small ball an my collarbone and one on neck) 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 LYMPHADENOPATHY (3 small ball an my collarbone and one on neck). At the time of the report, LYMPHADENOPATHY (3 small ball an my collarbone and one on neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood test abnormal, Cholelithiasis, Feeding disorder, Gallbladder disorder
Clinical narrative: gallstones; Blood tests had significant problems in liver, kidney and pancreas; Without any food and sleeping / He could not fall asleep due to the illness; Without any food; Vomiting; Nausea; Gallbladder issue; consistently had hiccups; This spontaneous case was reported by a consumer and describes the occurrence of GALLBLADDER DISORDER (Gallbladder issue), HICCUPS (consistently had hiccups), CHOLELITHIASIS (gallstones), BLOOD TEST ABNORMAL (Blood tests had significant problems in liver, kidney and pancreas) and INSOMNIA (Without any food and sleeping / He could not fall asleep due to the illness) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gallstones.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced GALLBLADDER DISORDER (Gallbladder issue), HICCUPS (consistently had hiccups), INSOMNIA (Without any food and sleeping / He could not fall asleep due to the illness), FEEDING DISORDER (Without any food), VOMITING (Vomiting) and NAUSEA (Nausea). On 25-May-2021, the patient experienced CHOLELITHIASIS (gallstones) and BLOOD TEST ABNORMAL (Blood tests had significant problems in liver, kidney and pancreas). The patient was treated with ONDANSETRON on 13-May-2021 at a dose of 1 dosage form four times per day. At the time of the report, GALLBLADDER DISORDER (Gallbladder issue), INSOMNIA (Without any food and sleeping / He could not fall asleep due to the illness), FEEDING DISORDER (Without any food) and NAUSEA (Nausea) outcome was unknown and HICCUPS (consistently had hiccups), CHOLELITHIASIS (gallstones), BLOOD TEST ABNORMAL (Blood tests had significant problems in liver, kidney and pancreas) and VOMITING (Vomiting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Blood test: abnormal Liver, kidney and pancreas.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional information received on 14-JUN-2021 contains significant information-Patient demographics and events were updated.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hiccups, Insomnia, Nausea, Vomiting
Clinical narrative: gallstones; Blood tests had significant problems in liver, kidney and pancreas; Without any food and sleeping / He could not fall asleep due to the illness; Without any food; Vomiting; Nausea; Gallbladder issue; consistently had hiccups; This spontaneous case was reported by a consumer and describes the occurrence of GALLBLADDER DISORDER (Gallbladder issue), HICCUPS (consistently had hiccups), CHOLELITHIASIS (gallstones), BLOOD TEST ABNORMAL (Blood tests had significant problems in liver, kidney and pancreas) and INSOMNIA (Without any food and sleeping / He could not fall asleep due to the illness) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gallstones.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced GALLBLADDER DISORDER (Gallbladder issue), HICCUPS (consistently had hiccups), INSOMNIA (Without any food and sleeping / He could not fall asleep due to the illness), FEEDING DISORDER (Without any food), VOMITING (Vomiting) and NAUSEA (Nausea). On 25-May-2021, the patient experienced CHOLELITHIASIS (gallstones) and BLOOD TEST ABNORMAL (Blood tests had significant problems in liver, kidney and pancreas). The patient was treated with ONDANSETRON on 13-May-2021 at a dose of 1 dosage form four times per day. At the time of the report, GALLBLADDER DISORDER (Gallbladder issue), INSOMNIA (Without any food and sleeping / He could not fall asleep due to the illness), FEEDING DISORDER (Without any food) and NAUSEA (Nausea) outcome was unknown and HICCUPS (consistently had hiccups), CHOLELITHIASIS (gallstones), BLOOD TEST ABNORMAL (Blood tests had significant problems in liver, kidney and pancreas) and VOMITING (Vomiting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2021, Blood test: abnormal Liver, kidney and pancreas.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Additional information received on 14-JUN-2021 contains significant information-Patient demographics and events were updated.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive the second dose of Moderna COVID-19 vaccine more than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of Moderna COVID-19 vaccine more than 35 days after the first dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of Moderna COVID-19 vaccine more than 35 days after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of Moderna COVID-19 vaccine more than 35 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Feeling sick; Running a low grade fever; 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 MALAISE (Feeling sick) and PYREXIA (Running a low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick) and PYREXIA (Running a low grade fever). At the time of the report, MALAISE (Feeling sick) and PYREXIA (Running a low grade fever) outcome was unknown.            No concomitant medication information was provided No treatment medication information was provided
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Mental disorder, Myalgia
Clinical narrative: mental sharpness "is not the same as it was before I got the shot"; Left arm soreness; Left arm soreness; brain fog; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (brain fog), MENTAL DISORDER (mental sharpness "is not the same as it was before I got the shot"), INJECTION SITE PAIN (Left arm soreness) and MYALGIA (Left arm soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced FEELING ABNORMAL (brain fog) and MYALGIA (Left arm soreness). On an unknown date, the patient experienced MENTAL DISORDER (mental sharpness "is not the same as it was before I got the shot") and INJECTION SITE PAIN (Left arm soreness). On 26-Apr-2021, MYALGIA (Left arm soreness) outcome was unknown. At the time of the report, FEELING ABNORMAL (brain fog), MENTAL DISORDER (mental sharpness "is not the same as it was before I got the shot") and INJECTION SITE PAIN (Left arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported concomitant medications like Gummy vitamins and Vitafusion. Treatment medication is not reported.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: pain in my arm like shooting pain; nausea; 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 PAIN IN EXTREMITY (pain in my arm like shooting pain) and NAUSEA (nausea) 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 PAIN IN EXTREMITY (pain in my arm like shooting pain) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (pain in my arm like shooting pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: A patient is here today to get  2nd dose, 60 days after getting  his 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (A patient is here today to get  2nd dose, 60 days after getting  his 1st dose) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (A patient is here today to get  2nd dose, 60 days after getting  his 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (A patient is here today to get  2nd dose, 60 days after getting  his 1st dose) had resolved.        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.   Reporter did not allow further contact
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: occasional cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (occasional cough) in a 93-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (occasional cough). At the time of the report, COUGH (occasional cough) outcome was unknown.            NO CONCOMITANT AND TREATMENT MEDICATION WERE USED
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It's been 70 days since my first shot; 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 PRODUCT DOSE OMISSION ISSUE (It's been 70 days since my first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been 70 days since my first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It's been 70 days since my first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Nausus; Headaches; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausus), HEADACHE (Headaches) and VOMITING (Vomiting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausus), HEADACHE (Headaches) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausus), HEADACHE (Headaches) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Surgery, Therapeutic response unexpected
Clinical narrative: Surgery for gangrene (Bacteria infection); have experienced a Good side effect,great RA relief; 83 days since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (83 days since 1st dose), SURGERY (Surgery for gangrene (Bacteria infection)) and THERAPEUTIC RESPONSE UNEXPECTED (have experienced a Good side effect,great RA relief) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (83 days since 1st dose). On an unknown date, the patient experienced SURGERY (Surgery for gangrene (Bacteria infection)) and THERAPEUTIC RESPONSE UNEXPECTED (have experienced a Good side effect,great RA relief). On 26-May-2021, PRODUCT DOSE OMISSION ISSUE (83 days since 1st dose) had resolved. At the time of the report, SURGERY (Surgery for gangrene (Bacteria infection)) and THERAPEUTIC RESPONSE UNEXPECTED (have experienced a Good side effect,great RA relief) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant products included medications for blood pressure, diabetes and cholesterol. It was reported that second dose was scheduled on 01 Apr 2021 but missed as patient undergone surgery.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant Follow Up received- New event added
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness, Somnolence, Vomiting
Clinical narrative: Sick; Sleepy; Weak; Throwing up; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), SOMNOLENCE (Sleepy), ASTHENIA (Weak), VOMITING (Throwing up) and FATIGUE (Very tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-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 ILLNESS (Sick), SOMNOLENCE (Sleepy), ASTHENIA (Weak), VOMITING (Throwing up) and FATIGUE (Very tired). At the time of the report, ILLNESS (Sick), SOMNOLENCE (Sleepy), ASTHENIA (Weak), VOMITING (Throwing up) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Very sore arm after 2nd dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Very sore arm after 2nd dose of vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Very sore arm after 2nd dose of vaccine). At the time of the report, VACCINATION SITE PAIN (Very sore arm after 2nd dose of vaccine) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site induration, Vaccination site mass
Clinical narrative: knot in the injection site / lump at injection site; sore the first day; yesterday the site became painful; small red circle in the injection site; 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 VACCINATION SITE MASS (knot in the injection site / lump at injection site), PAIN (sore the first day), VACCINATION SITE INDURATION (yesterday the site became painful) and VACCINATION SITE ERYTHEMA (small red circle in the injection site) 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 VACCINATION SITE MASS (knot in the injection site / lump at injection site), PAIN (sore the first day), VACCINATION SITE INDURATION (yesterday the site became painful) and VACCINATION SITE ERYTHEMA (small red circle in the injection site). At the time of the report, VACCINATION SITE MASS (knot in the injection site / lump at injection site), VACCINATION SITE INDURATION (yesterday the site became painful) and VACCINATION SITE ERYTHEMA (small red circle in the injection site) outcome was unknown and PAIN (sore the first day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain, Pruritus, Rash macular
Clinical narrative: pinpoint needle pain; excessive itching (back, torso, chest)/inside of his elbows and knee itch; excessive scratching (back, torso, chest); two red spots, on elbow and on knee; felt like there was an elephant on his chest (chest pain); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (pinpoint needle pain), PRURITUS (excessive itching (back, torso, chest)/inside of his elbows and knee itch), PRURITUS (excessive scratching (back, torso, chest)), RASH MACULAR (two red spots, on elbow and on knee) and CHEST PAIN (felt like there was an elephant on his chest (chest pain)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney stone, Blood pressure abnormal, Acid reflux (oesophageal), Cancer, Type 2 diabetes mellitus and Cholesterol high. Concomitant products included FAMOTIDINE for Acid reflux (oesophageal), FLUTICASONE and LORATADINE for Allergy, BACLOFEN for Back pain, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Bladder disorder NOS, AMLODIPINE for Blood pressure management, FINASTERIDE for Cancer, ROSUVASTATIN for Cholesterol high, LATANOPROST (LATANOPROST 1A PHARMA) for Glaucoma, ASPIRIN [ACETYLSALICYLIC ACID], ISOSORBIDE, LOSARTAN and METOPROLOL for Heart disease, unspecified, ALLOPURINOL SODIUM (ALLOPURINOL [ALLOPURINOL SODIUM]) for Kidney stone prevention, ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (VISION SHIELD EYE HEALTH) for Macular degeneration, TOPIRAMATE for Tremor, METFORMIN for Type 2 diabetes mellitus, VITAMIN D3 for Vitamin D deficiency, THIOCTIC ACID (ALPHA LIPOIC ACID 400), POLYCARBOPHIL CALCIUM (FIBER), MULTIVITAMIN [VITAMINS NOS], CLOPIDOGREL BISULFATE (PLAVIX) and VITAMIN B12 NOS for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pinpoint needle pain), PRURITUS (excessive itching (back, torso, chest)/inside of his elbows and knee itch), PRURITUS (excessive scratching (back, torso, chest)), RASH MACULAR (two red spots, on elbow and on knee) and CHEST PAIN (felt like there was an elephant on his chest (chest pain)). The patient was treated with NITROGLYCERIN (sublingual) for Chest pain, at a dose of 0.4 milligram. At the time of the report, PAIN (pinpoint needle pain), PRURITUS (excessive itching (back, torso, chest)/inside of his elbows and knee itch), PRURITUS (excessive scratching (back, torso, chest)), RASH MACULAR (two red spots, on elbow and on knee) and CHEST PAIN (felt like there was an elephant on his chest (chest pain)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: CAN I TAKE MY 2ND VACCINE SINCE IT IS PASS DUE; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (CAN I TAKE MY 2ND VACCINE SINCE IT IS PASS DUE) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (LOSARTIN).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (CAN I TAKE MY 2ND VACCINE SINCE IT IS PASS DUE). At the time of the report, PRODUCT DOSE OMISSION ISSUE (CAN I TAKE MY 2ND VACCINE SINCE IT IS PASS DUE) had resolved.        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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Vaccination site pain
Clinical narrative: Soreness of the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness of the left arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21H and 001C21A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included LOSARTAN, METFORMIN, OXYBUTYNIN, PRAVASTATIN and TAMSULOSIN for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-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 VACCINATION SITE PAIN (Soreness of the left arm). At the time of the report, VACCINATION SITE PAIN (Soreness of the left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, C-reactive protein: 10.78 (High) C- reactive protein levels, 10.78 when went for a routine blood work on 24th May 2021.         Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 46 individuals were given a dose of the Moderna vaccine, 9 days post the recommended storage of 30 days in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (46 individuals were given a dose of the Moderna vaccine, 9 days post the recommended storage of 30 days in the refrigerator) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (46 individuals were given a dose of the Moderna vaccine, 9 days post the recommended storage of 30 days in the refrigerator). At the time of the report, PRODUCT STORAGE ERROR (46 individuals were given a dose of the Moderna vaccine, 9 days post the recommended storage of 30 days in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of increased heart rate (heart rate was 180 for 3 days after Moderna shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced increased heart rate (heart rate was 180 for 3 days after Moderna shot). At the time of the report, increased heart rate (heart rate was 180 for 3 days after Moderna shot) outcome: unknown. Diagnostic results: On an unknown date, heart rate: 180 (inconclusive). The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: At day 46 past my first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (At day 46 past my first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (At day 46 past my first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (At day 46 past my first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Pink bruising on index finger; Sore arm; Headache; Aches and pains; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Pink bruising on index finger), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Aches and pains) and FATIGUE (Tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concomitant products included FISH OIL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Aches and pains) and FATIGUE (Tiredness). On 26-May-2021, the patient experienced CONTUSION (Pink bruising on index finger). On 24-May-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Aches and pains) and FATIGUE (Tiredness) had resolved. At the time of the report, CONTUSION (Pink bruising on index finger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received on 27 May 2021 included: Lot no and contact information updated.