chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure via breast milk, Fatigue, Headache, Myalgia
Clinical narrative: patient was breastfeeding; developed a runny nose; Felt cold; Body aches; had chills; Tired; Headache / headache was pretty bad; This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (developed a runny nose), NASOPHARYNGITIS (Felt cold), EXPOSURE VIA BREAST MILK (patient was breastfeeding), MYALGIA (Body aches) and CHILLS (had chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01320A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced NASOPHARYNGITIS (Felt cold), MYALGIA (Body aches), CHILLS (had chills), FATIGUE (Tired) and HEADACHE (Headache / headache was pretty bad). On 02-Feb-2021, the patient experienced RHINORRHOEA (developed a runny nose). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (patient was breastfeeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 03-Feb-2021, RHINORRHOEA (developed a runny nose), NASOPHARYNGITIS (Felt cold), MYALGIA (Body aches), CHILLS (had chills) and FATIGUE (Tired) had resolved. On 04-Feb-2021, HEADACHE (Headache / headache was pretty bad) had resolved. At the time of the report, EXPOSURE VIA BREAST MILK (patient was breastfeeding) 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.   No concomitant medications were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: patient was breastfeeding; developed a runny nose; Felt cold; Body aches; had chills; Tired; Headache / headache was pretty bad; This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (developed a runny nose), NASOPHARYNGITIS (Felt cold), EXPOSURE VIA BREAST MILK (patient was breastfeeding), MYALGIA (Body aches) and CHILLS (had chills) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01320A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced NASOPHARYNGITIS (Felt cold), MYALGIA (Body aches), CHILLS (had chills), FATIGUE (Tired) and HEADACHE (Headache / headache was pretty bad). On 02-Feb-2021, the patient experienced RHINORRHOEA (developed a runny nose). On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (patient was breastfeeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 03-Feb-2021, RHINORRHOEA (developed a runny nose), NASOPHARYNGITIS (Felt cold), MYALGIA (Body aches), CHILLS (had chills) and FATIGUE (Tired) had resolved. On 04-Feb-2021, HEADACHE (Headache / headache was pretty bad) had resolved. At the time of the report, EXPOSURE VIA BREAST MILK (patient was breastfeeding) 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.   No concomitant medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Muscular weakness
Clinical narrative: Deterioration to the point that he cannot hold a fork or tie his shoelaces; he also cannot go to the bathroom on his own; This spontaneous case was reported by a physician and describes the occurrence of MUSCULAR WEAKNESS (Deterioration to the point that he cannot hold a fork or tie his shoelaces) and HYPOKINESIA (he also cannot go to the bathroom on his own) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A15) for COVID-19 vaccination.     The patient's past medical history included Neuropathy (this decreased her mobility and weakened it (tenderness in the hands) but it had been improving well.) in November 2020.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Deterioration to the point that he cannot hold a fork or tie his shoelaces) and HYPOKINESIA (he also cannot go to the bathroom on his own). At the time of the report, MUSCULAR WEAKNESS (Deterioration to the point that he cannot hold a fork or tie his shoelaces) and HYPOKINESIA (he also cannot go to the bathroom on his own) 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.   concomitantly, in Nov-2020, Patient took only a pill at atb (Livoaquam). No treatment related information has been reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase, Exposure during pregnancy, Prenatal screening test, Ultrasound foetal
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Infertility, Spontaneous abortion on 21-Jul-2020 and Alcohol use (1 to 4 drinks a week).    On 29-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 03-Jun-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 29-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Nov-2020, Prenatal screening test: normal (normal) Normal. On 21-Dec-2020, Aspartate aminotransferase: normal (normal) Normal. On 14-Jan-2021, Ultrasound foetal: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitantly, on 01-Jan-2020, patient started taking Nature Made Prenatal  orally once a day as prenatal vitamin. No treatment related information has been reported.  On 15-Nov-2020, genetic test came with normal results.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysstasia, Nausea
Clinical narrative: dizziness and could not stand up; dizziness and could not stand up; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness and could not stand up), DYSSTASIA (dizziness and could not stand up), CHILLS (Chills) and NAUSEA (Nausea) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 6:00 AM, the patient experienced DIZZINESS (dizziness and could not stand up), DYSSTASIA (dizziness and could not stand up), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizziness and could not stand up), DYSSTASIA (dizziness and could not stand up), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was taken by the patient.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: on her right arm, it became red; on her right arm, it became hot; on her right arm, it became itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (on her right arm, it became red), FEELING HOT (on her right arm, it became hot) and PRURITUS (on her right arm, it became itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ERYTHEMA (on her right arm, it became red), FEELING HOT (on her right arm, it became hot) and PRURITUS (on her right arm, it became itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; Physical therapy (Patient put some cool thing on her arm.) for Erythema; Physical therapy (Patient put some cool thing on her arm.) for Feeling hot and Physical therapy (Patient put some cool thing on her arm.) for Pruritus. At the time of the report, ERYTHEMA (on her right arm, it became red) had not resolved and FEELING HOT (on her right arm, it became hot) and PRURITUS (on her right arm, it became itchy) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on upper left arm , upper left thigh , upper right thigh, upper right arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on upper left arm , upper left thigh , upper right thigh, upper right arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced URTICARIA (hives on upper left arm , upper left thigh , upper right thigh, upper right arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on upper left arm , upper left thigh , upper right thigh, upper right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitantly, patient was taking cholesterol shot, heart medications, and blood thinners.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Fatigue, Malaise
Clinical narrative: Chest pain constantly (due to high heat in room); Malaise; Weakness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain constantly (due to high heat in room)), MALAISE (Malaise), ASTHENIA (Weakness) and FATIGUE (Fatigue) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced CHEST PAIN (Chest pain constantly (due to high heat in room)), MALAISE (Malaise), ASTHENIA (Weakness) and FATIGUE (Fatigue). On 03-Feb-2021, CHEST PAIN (Chest pain constantly (due to high heat in room)) had resolved. At the time of the report, MALAISE (Malaise), ASTHENIA (Weakness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm a rash/ rash, warm/ feeling hot, swollen/ peripheral swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 5 Feb 2021, the patient experienced the events arm a rash, warm, swollen.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events arm a rash, worm, swollen was unknown.  Based on comment, Peripheral swelling (code to LLT/PT vaccination site swelling which is listed across labels) and Feeling hot (code to LLT/PT vaccination site warmth which is listed across labels)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: nonstop fever at 100Degrees; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (nonstop fever at 100Degrees) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 02-Feb-2021, the patient experienced PYREXIA (nonstop fever at 100Degrees). At the time of the report, PYREXIA (nonstop fever at 100Degrees) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 100degree High.         No concomitant and treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination complication
Clinical narrative: Delayed reaction; Somnolence; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed reaction). At the time of the report, VACCINATION COMPLICATION (Delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Follow up received on 22-Apr-2021 included no new information. On 22-Apr-2021: Followup was  received on  22 April 2021. Reporter's last name from Patch to Hatch was added.Follow up received on 22-Apr-2021 included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: large red mark around vaccination area that lasted 9 days; A spontaneous report was received from a Consumer concerning a 2021--years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events large red mark around vaccination area that lasted 9 days.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events large red mark around vaccination area that lasted 9 days.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, large red mark around vaccination area that lasted 9 days was not reported.  Based on comment Injection site erythema coded as Vaccination site erythema
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity, Retching
Clinical narrative: feels like there is a rod in her arm; proceeded to dry-heave; feeling abnormal; Vaccination site reaction; felt really achy in her hips; have not regained her normal level of energy; pretty good headache; felt like she was doing shoulder press for a month nonstop; A spontaneous report was received from a consumer concerning a 53-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave, was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026120A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave, Was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy.Consent for safety to follow-up was received.  Treatment details included none  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy was unknown.  Based on MSA comment, Anxiety, Feeling abnormal, Euphoric, and Malaise is deleted.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feels like there is a rod in her arm; proceeded to dry-heave; feeling abnormal; Vaccination site reaction; felt really achy in her hips; have not regained her normal level of energy; pretty good headache; felt like she was doing shoulder press for a month nonstop; A spontaneous report was received from a consumer concerning a 53-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave, was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026120A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave, Was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy.Consent for safety to follow-up was received.  Treatment details included none  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pretty bad reaction, pretty serious vomiting, immediate reaction, massive rush up her chest into her neck, like an adrenaline sensation, felt high and buzzed up, felt a little funny, felt creaky and foggy, felt really achy in her hips, lethargic, vomited all over, 3 rounds of vomiting, didn`t feel great, arm was really sore, felt like she was doing shoulder press for a month nonstop, felt a little foggy, proceeded to dry-heave was in bed for 2 and half days, pretty good headache, appetite been off, sleep been off, feels like there is a rod in her arm, have not regained her normal level of energy was unknown.  Based on MSA comment, Anxiety, Feeling abnormal, Euphoric, and Malaise is deleted.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Chills, Cold sweat, Decreased appetite
Clinical narrative: Still in bed; had strong reactions; Sore arm; Chills; Foggy brain; Diarrhea; Headache; No appetite; Felt clammy; Weakness; Raspy throat; A spontaneous report was received from a consumer concerning his wife, who is a 60-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had strong reactions, sore arm, chills, foggy brain, diarrhea, headache, no appetite, felt clammy, weakness, raspy throat, still in bed.  The patient's medical history was lupus, Sjogren's syndrome, allergic to sulfa drugs and passion fruit. Concomitant medications reported were prednisone, lubiprostone, aripiprazole, acetylsalicylic acid, carisoprodol, diltiazem hydrochloride, escitalopram oxalate, folic acid, hydroxychloroquine sulfate, lamotrigine, levothyroxine sodium, lorazepam, metoprolol succinate, sumatriptan succinate, tramadol hydrochloride, prazosin, gabapentin for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events strong reactions. About 1 day later she had a sore arm, chills, a foggy brain, diarrhea, headache, no appetite, felt clammy, had weakness, had a raspy throat and is still in bed.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Based on comment Pain in extremity coded as Vaccination site pain and Adverse reaction coded as Vaccination adverse reaction/PT Vaccination complication The outcome of events had strong reactions, sore arm, chills, foggy brain, diarrhea, headache, no appetite, felt clammy, weakness, raspy throat, still in bed was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Headache, Throat irritation, Vaccination complication
Clinical narrative: Still in bed; had strong reactions; Sore arm; Chills; Foggy brain; Diarrhea; Headache; No appetite; Felt clammy; Weakness; Raspy throat; A spontaneous report was received from a consumer concerning his wife, who is a 60-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had strong reactions, sore arm, chills, foggy brain, diarrhea, headache, no appetite, felt clammy, weakness, raspy throat, still in bed.  The patient's medical history was lupus, Sjogren's syndrome, allergic to sulfa drugs and passion fruit. Concomitant medications reported were prednisone, lubiprostone, aripiprazole, acetylsalicylic acid, carisoprodol, diltiazem hydrochloride, escitalopram oxalate, folic acid, hydroxychloroquine sulfate, lamotrigine, levothyroxine sodium, lorazepam, metoprolol succinate, sumatriptan succinate, tramadol hydrochloride, prazosin, gabapentin for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events strong reactions. About 1 day later she had a sore arm, chills, a foggy brain, diarrhea, headache, no appetite, felt clammy, had weakness, had a raspy throat and is still in bed.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Based on comment Pain in extremity coded as Vaccination site pain and Adverse reaction coded as Vaccination adverse reaction/PT Vaccination complication The outcome of events had strong reactions, sore arm, chills, foggy brain, diarrhea, headache, no appetite, felt clammy, weakness, raspy throat, still in bed was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Still in bed; had strong reactions; Sore arm; Chills; Foggy brain; Diarrhea; Headache; No appetite; Felt clammy; Weakness; Raspy throat; A spontaneous report was received from a consumer concerning his wife, who is a 60-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had strong reactions, sore arm, chills, foggy brain, diarrhea, headache, no appetite, felt clammy, weakness, raspy throat, still in bed.  The patient's medical history was lupus, Sjogren's syndrome, allergic to sulfa drugs and passion fruit. Concomitant medications reported were prednisone, lubiprostone, aripiprazole, acetylsalicylic acid, carisoprodol, diltiazem hydrochloride, escitalopram oxalate, folic acid, hydroxychloroquine sulfate, lamotrigine, levothyroxine sodium, lorazepam, metoprolol succinate, sumatriptan succinate, tramadol hydrochloride, prazosin, gabapentin for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 027L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events strong reactions. About 1 day later she had a sore arm, chills, a foggy brain, diarrhea, headache, no appetite, felt clammy, had weakness, had a raspy throat and is still in bed.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   Based on comment Pain in extremity coded as Vaccination site pain and Adverse reaction coded as Vaccination adverse reaction/PT Vaccination complication The outcome of events had strong reactions, sore arm, chills, foggy brain, diarrhea, headache, no appetite, felt clammy, weakness, raspy throat, still in bed was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Arm is hurting/Arm is really sore; Limb discount; A Spontaneous report was received from a consumer, concerning herself, a female patient of unknown age, who received Moderna's COVID-19 vaccine (m-RNA-1273) and experienced the events, arm is hurting, arm really sore, can't even lift it.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273, intramuscularly in the left arm. On 01-FEB-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly, in the left arm, for the prophylaxis of COVID-19 infection.   On 01-FEB-2021, the patient experienced the events, arm is hurting, arm really sore, can't even lift it. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events, arm is hurting, arm really sore, can't even lift it, was unknown at the time of this report.  Based on MSA comment Pain in extremity coded as Vaccination adverse reaction and Limb discomfort coded Vaccination site movement impairment
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Ear pain, Eye pain, Fatigue, Headache
Clinical narrative: pain; pain; bedridden; pain; body aches; Fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden), MYALGIA (body aches) and FATIGUE (Fatigue) in a 35-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.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (body aches), FATIGUE (Fatigue) and PYREXIA (fever). On an unknown date, the patient experienced EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden) and HEADACHE (pain). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden), MYALGIA (body aches), FATIGUE (Fatigue), PYREXIA (fever) and HEADACHE (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: pain; pain; bedridden; pain; body aches; Fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden), MYALGIA (body aches) and FATIGUE (Fatigue) in a 35-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.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (body aches), FATIGUE (Fatigue) and PYREXIA (fever). On an unknown date, the patient experienced EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden) and HEADACHE (pain). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden), MYALGIA (body aches), FATIGUE (Fatigue), PYREXIA (fever) and HEADACHE (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on his neck and lower legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his neck and lower legs) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced RASH (rash on his neck and lower legs). At the time of the report, RASH (rash on his neck and lower legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported. Upon in internal review on 21 May 2021, the age was corrected to unknown age.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.     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 relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-025817 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains no new information. On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Fatigue, Nausea, Pyrexia
Clinical narrative: Super weak; Really nauseous; A really disgusting wet cough; Fever; Generally exhausted; A spontaneous report  was received from a Consumer concerning a 66-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events super weak, really nauseous, a really disgusting wet cough, fever, generally exhausted.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event super weak,Really nauseous, A really disgusting wet cough, Fever, Generally exhausted and the outcome of event is Unknown.  Treatment details included Tylenol, Mucinex  Action taken with mRNA-1273 in response to the events was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness and some pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness and some pain at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness and some pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness and some pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Aching; Chills; High fever, fever was of 100°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever, fever was of 100°F) 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 PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever, fever was of 100°F). At the time of the report, PAIN (Aching), CHILLS (Chills) and PYREXIA (High fever, fever was of 100°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 °F (High) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Digestive stuffs; Shortness of breath 6 to 7 days; Chills; Fever; Nausea; Fatigue; Headache; This spontaneous case was reported by a physician and describes the occurrence of GASTROINTESTINAL DISORDER (Digestive stuffs), DYSPNOEA (Shortness of breath 6 to 7 days), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Digestive stuffs), DYSPNOEA (Shortness of breath 6 to 7 days), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, GASTROINTESTINAL DISORDER (Digestive stuffs) had not resolved and DYSPNOEA (Shortness of breath 6 to 7 days), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Digestive stuffs; Shortness of breath 6 to 7 days; Chills; Fever; Nausea; Fatigue; Headache; This spontaneous case was reported by a physician and describes the occurrence of GASTROINTESTINAL DISORDER (Digestive stuffs), DYSPNOEA (Shortness of breath 6 to 7 days), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Digestive stuffs), DYSPNOEA (Shortness of breath 6 to 7 days), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, GASTROINTESTINAL DISORDER (Digestive stuffs) had not resolved and DYSPNOEA (Shortness of breath 6 to 7 days), CHILLS (Chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Nausea
Clinical narrative: Back ache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and BACK PAIN (Back ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder infection. Concurrent medical conditions included Blood pressure fluctuation (Taking blood pressure pill.).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NAUSEA (Nauseous). On an unknown date, the patient experienced BACK PAIN (Back ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nauseous) had not resolved and BACK PAIN (Back ache) outcome was unknown.            Concomitantly, patient was taking unspecified blood pressure pills.  Action taken with mRNA-1273 in response to the events was not applicable
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 25-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 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmness at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphoedema, Swelling, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Bump on her lymph node. It is 5 inches long and 4 inches wide.; Vaccination site hot to touch; Redness; Bump on her clavicle; Vaccination site swelling; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHOEDEMA (Bump on her lymph node. It is 5 inches long and 4 inches wide.), VACCINATION SITE WARMTH (Vaccination site hot to touch), ERYTHEMA (Redness), SWELLING (Bump on her clavicle) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011Y20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced LYMPHOEDEMA (Bump on her lymph node. It is 5 inches long and 4 inches wide.), VACCINATION SITE WARMTH (Vaccination site hot to touch), ERYTHEMA (Redness), SWELLING (Bump on her clavicle) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with IBUPROFEN (IBUPROFEN EG) at a dose of unknown and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LYMPHOEDEMA (Bump on her lymph node. It is 5 inches long and 4 inches wide.), VACCINATION SITE WARMTH (Vaccination site hot to touch), ERYTHEMA (Redness), SWELLING (Bump on her clavicle) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the event included ibuprofen and acetaminophen.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Tachycardia
Clinical narrative: rapid heart beat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heart beat) and HEADACHE (Headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONIDINE HYDROCHLORIDE (CATAPRES [CLONIDINE HYDROCHLORIDE]).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (rapid heart beat) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (rapid heart beat) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: felt weak; fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) and PYREXIA (fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt weak) and PYREXIA (fever). At the time of the report, ASTHENIA (felt weak) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.