chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling - Near Injection Site; Red Dot - Near Injection Site; Itchy Sensation - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Red Dot - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Red Dot - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site). At the time of the report, VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE ERYTHEMA (Red Dot - Near Injection Site) and VACCINATION SITE PRURITUS (Itchy Sensation - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore muscles; This spontaneous case was reported by a health care professional and describes the occurrence of MYALGIA (sore muscles) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bone pain. Concomitant products included HYDRALAZINE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore muscles). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (sore muscles) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-062420 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (potential UTI) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included UTI (the patient had them occasionally in the past.).    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced URINARY TRACT INFECTION (potential UTI). At the time of the report, URINARY TRACT INFECTION (potential UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was going to see the doctor at the time of the report. No concomitant medication details were provided. No treatment medication details were provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR-Non significant info
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Pyrexia
Clinical narrative: diarrhoea; cough; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea), COUGH (cough), CHILLS (chills) and PYREXIA (fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 30-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 DIARRHOEA (diarrhoea), COUGH (cough), CHILLS (chills) and PYREXIA (fever). On 01-Feb-2021, CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, DIARRHOEA (diarrhoea) and COUGH (cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history and relevant concomitant medications weren't reported Treatment information was not provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: right thumb is numb; soreness in the injection stie; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (right thumb is numb) and VACCINATION SITE PAIN (soreness in the injection stie) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN (DIOVAN), AMLODIPINE and EPLERENONE for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HYPOAESTHESIA (right thumb is numb) and VACCINATION SITE PAIN (soreness in the injection stie). At the time of the report, HYPOAESTHESIA (right thumb is numb) and VACCINATION SITE PAIN (soreness in the injection stie) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity, Rash
Clinical narrative: rash in his inner arms; soreness in the arm; dizzy; weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), DIZZINESS (dizzy), ASTHENIA (weak) and RASH (rash in his inner arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Sulfonamide allergy.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), DIZZINESS (dizzy) and ASTHENIA (weak). On 02-Feb-2021, the patient experienced RASH (rash in his inner arms). On 27-Jan-2021, DIZZINESS (dizzy) and ASTHENIA (weak) had resolved. On 31-Jan-2021, PAIN IN EXTREMITY (soreness in the arm) had resolved. At the time of the report, RASH (rash in his inner arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise
Clinical narrative: Generally didn´t feel well; Weak; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MALAISE (Generally didn´t feel well) and ASTHENIA (Weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MALAISE (Generally didn´t feel well) and ASTHENIA (Weak). At the time of the report, MALAISE (Generally didn´t feel well) and ASTHENIA (Weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Pain in extremity, Pyrexia
Clinical narrative: tested positive for COVID-19; temperature of 99°F; slight cough; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PYREXIA (temperature of 99°F), COUGH (slight cough) and COVID-19 (tested positive for COVID-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 04-Feb-2021, the patient experienced PYREXIA (temperature of 99°F) and COUGH (slight cough). On 06-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). On 05-Feb-2021, PYREXIA (temperature of 99°F) and COUGH (slight cough) had resolved. At the time of the report, PAIN IN EXTREMITY (very sore arm) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 99 (High) 99 degree F. On 06-Feb-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included medicine for her blood pressure and 2 antidepressants. Treatment medication was not used.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; temperature of 99°F; slight cough; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PYREXIA (temperature of 99°F), COUGH (slight cough) and COVID-19 (tested positive for COVID-19) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (very sore arm). On 04-Feb-2021, the patient experienced PYREXIA (temperature of 99°F) and COUGH (slight cough). On 06-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19). On 05-Feb-2021, PYREXIA (temperature of 99°F) and COUGH (slight cough) had resolved. At the time of the report, PAIN IN EXTREMITY (very sore arm) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 99 (High) 99 degree F. On 06-Feb-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included medicine for her blood pressure and 2 antidepressants. Treatment medication was not used.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: Can not lift his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift his arm) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift his arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not lift his arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Administration site bruise
Clinical narrative: a blue bruise when they got the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADMINISTRATION SITE BRUISE (a blue bruise when they got the first vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ADMINISTRATION SITE BRUISE (a blue bruise when they got the first vaccine). At the time of the report, ADMINISTRATION SITE BRUISE (a blue bruise when they got the first vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Patient used hot water to treat the site.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Malaise
Clinical narrative: Started not feeling well; really feeling bad; teeth was chattering and getting chills at 6PM; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started not feeling well), FEELING ABNORMAL (really feeling bad) and CHILLS (teeth was chattering and getting chills at 6PM) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, THYROID (ARMOUR THYROID) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced MALAISE (Started not feeling well), FEELING ABNORMAL (really feeling bad) and CHILLS (teeth was chattering and getting chills at 6PM). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Every 6 hours for 3 times and ALBUTEROL [SALBUTAMOL] at a dose of 1 puff. At the time of the report, MALAISE (Started not feeling well), FEELING ABNORMAL (really feeling bad) and CHILLS (teeth was chattering and getting chills at 6PM) outcome was unknown.            No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-178675, MOD-2021-178675 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure measurement, Chills, Decreased appetite, Diarrhoea
Clinical narrative: diarrhea; couldn't eat or drink; blood pressure became elevated; chills; muscle ache; A bad night with his stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (A bad night with his stomach), DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache) and DECREASED APPETITE (couldn't eat or drink) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no known allergies.  The patient's past medical history included Heart attack (2 years prior to report) and Shoulder replacement on 15-Dec-2020. Previously administered products included for an unreported indication: FLU (receives flu short yearly). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (A bad night with his stomach). On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache), DECREASED APPETITE (couldn't eat or drink) and HYPERTENSION (blood pressure became elevated). On 21-Feb-2021, HYPERTENSION (blood pressure became elevated) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (A bad night with his stomach), DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache) and DECREASED APPETITE (couldn't eat or drink) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: elevated (High) elevated; resolved that same day. On 21-Feb-2021, Heart rate: elevated (High) elevated; resolved that same day.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient takes 9 concomitant medications; two are reported. The patient did not take any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hypertension, Myalgia
Clinical narrative: diarrhea; couldn't eat or drink; blood pressure became elevated; chills; muscle ache; A bad night with his stomach; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (A bad night with his stomach), DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache) and DECREASED APPETITE (couldn't eat or drink) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient had no known allergies.  The patient's past medical history included Heart attack (2 years prior to report) and Shoulder replacement on 15-Dec-2020. Previously administered products included for an unreported indication: FLU (receives flu short yearly). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (A bad night with his stomach). On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache), DECREASED APPETITE (couldn't eat or drink) and HYPERTENSION (blood pressure became elevated). On 21-Feb-2021, HYPERTENSION (blood pressure became elevated) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (A bad night with his stomach), DIARRHOEA (diarrhea), CHILLS (chills), MYALGIA (muscle ache) and DECREASED APPETITE (couldn't eat or drink) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood pressure measurement: elevated (High) elevated; resolved that same day. On 21-Feb-2021, Heart rate: elevated (High) elevated; resolved that same day.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient takes 9 concomitant medications; two are reported. The patient did not take any treatment medications.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Pruritus
Clinical narrative: Itching around elbow; Swelling around elbow; Redness; A spontaneous report was received from a Consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, itching around elbow, swelling around elbow.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 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 developed Redness, Itching around elbow, Swelling around elbow.  Treatment details included Caller self administered topical medicine.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, redness,  itching around elbow, swelling around elbow was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant and received both doses of the Moderna Covid 19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received both doses of the Moderna Covid 19 vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-May-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received both doses of the Moderna Covid 19 vaccine). On 22-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received both doses of the Moderna Covid 19 vaccine) had resolved.            Concomitant medication was not reported. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Follow up received and added vaccine first dose details
Sex: F
Vaccine: COVID19
Symptoms: Cough, Paraesthesia oral, Vaccination site erythema
Clinical narrative: tingling in her lips; hacking cough which got worse and she felt hoarse; arm was red around two inches in diameter around the site of injetion; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in her lips), COUGH (hacking cough which got worse and she felt hoarse) and VACCINATION SITE ERYTHEMA (arm was red around two inches in diameter around the site of injetion) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PARAESTHESIA ORAL (tingling in her lips), COUGH (hacking cough which got worse and she felt hoarse) and VACCINATION SITE ERYTHEMA (arm was red around two inches in diameter around the site of injetion). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PARAESTHESIA ORAL (tingling in her lips) and COUGH (hacking cough which got worse and she felt hoarse) was resolving and VACCINATION SITE ERYTHEMA (arm was red around two inches in diameter around the site of injetion) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided. Treatment included Tylenol and cough drops. It was still red around the injection site as of 01-Feb-2021. It was also reported that most of her symptoms improved over the next 4 days.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) had not resolved.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling hot, Joint warmth, Urticaria, Vaccination complication
Clinical narrative: hives all over her arm, and they were hot to the touch and itched, knee joints were hot; hives all over her arm, and they were hot to the touch and itched; mettalic taste in mouth; felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell; knee joints were hot; bumps that itch; but the injection site is still swollen and is more pink vs red; injection site is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), DYSGEUSIA (mettalic taste in mouth), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell) and JOINT WARMTH (knee joints were hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 24-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 FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), DYSGEUSIA (mettalic taste in mouth), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell), JOINT WARMTH (knee joints were hot), VACCINATION SITE MASS (bumps that itch), VACCINATION SITE ERYTHEMA (but the injection site is still swollen and is more pink vs red) and VACCINATION SITE SWELLING (injection site is still swollen). On 31-Jan-2021, DYSGEUSIA (mettalic taste in mouth) had resolved. On 01-Feb-2021, FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell), JOINT WARMTH (knee joints were hot) and VACCINATION SITE MASS (bumps that itch) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (but the injection site is still swollen and is more pink vs red) and VACCINATION SITE SWELLING (injection site is still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medication not reported.    Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Follow-up received on 02-Feb-2021 and does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: hives all over her arm, and they were hot to the touch and itched, knee joints were hot; hives all over her arm, and they were hot to the touch and itched; mettalic taste in mouth; felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell; knee joints were hot; bumps that itch; but the injection site is still swollen and is more pink vs red; injection site is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), DYSGEUSIA (mettalic taste in mouth), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell) and JOINT WARMTH (knee joints were hot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 24-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 FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), DYSGEUSIA (mettalic taste in mouth), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell), JOINT WARMTH (knee joints were hot), VACCINATION SITE MASS (bumps that itch), VACCINATION SITE ERYTHEMA (but the injection site is still swollen and is more pink vs red) and VACCINATION SITE SWELLING (injection site is still swollen). On 31-Jan-2021, DYSGEUSIA (mettalic taste in mouth) had resolved. On 01-Feb-2021, FEELING HOT (hives all over her arm, and they were hot to the touch and itched, knee joints were hot), URTICARIA (hives all over her arm, and they were hot to the touch and itched), VACCINATION COMPLICATION (felt like a truck had hit me, I hurt all over, and I was so tired that I could barely make it to the couch, and then I fell), JOINT WARMTH (knee joints were hot) and VACCINATION SITE MASS (bumps that itch) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (but the injection site is still swollen and is more pink vs red) and VACCINATION SITE SWELLING (injection site is still swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medication not reported.    Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: Follow-up received on 02-Feb-2021 and does not contain any new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm at the injection site; hard at the injection site; 3.5 inches diameter bright red flush at the injection site; swollen at the inejction site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE ERYTHEMA (3.5 inches diameter bright red flush at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE SWELLING (swollen at the inejction site) and VACCINATION SITE INDURATION (hard at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included ABALOPARATIDE (TYMLOS) and ACETYLSALICYLIC ACID (CARTIA [ACETYLSALICYLIC ACID]) for an unknown indication.    On 24-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 VACCINATION SITE ERYTHEMA (redness at the injection site). On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (3.5 inches diameter bright red flush at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE SWELLING (swollen at the inejction site) and VACCINATION SITE INDURATION (hard at the injection site). The patient was treated with PARACETAMOL (TYLENOL) on 24-Jan-2021 for Vaccination site erythema, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 31-Jan-2021 for Vaccination site erythema, at a dose of UNK dosage form. On 26-Jan-2021, VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (3.5 inches diameter bright red flush at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE SWELLING (swollen at the inejction site) and VACCINATION SITE INDURATION (hard at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Eight hours after the shot patient experienced redness at the injection site (lasted 2 days). On 31-Jan-2021 a 3.5 inches diameter bright red flush appeared again at the injection site. It was warm, swollen and hard.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Shoulder injury related to vaccine administration
Clinical narrative: EXCRUCIATING PAIN GOING UP TO THE SHOULDER AND NECK AND THEN DOWN AGAIN; A Nurse Practitioner thought it was SIRVA caused by; A spontaneous report was received from a Consumer concerning a 90-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced excruciating pain going up to the shoulder and neck and then down again and Nurse Practitioner thought it was SIRVA caused by the needle going in too far.  The patient's medical history included high blood pressure and allergic to tramadol/acetaminphen. Concomitant medications reported were Digoxin, Apixaban and Doxazosin.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the event excruciating pain going up to the shoulder and neck and then down again and Nurse Practitioner thought it was SIRVA caused by the needle going in too far.  Treatment details included Tramadol / Acetaminophen and Tylenol  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), excruciating pain going up to the shoulder and neck and then down again and Nurse Practitioner thought it was SIRVA caused by the needle going in too far were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe neck pain; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Severe neck pain) and PYREXIA (Low grade fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-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 NECK PAIN (Severe neck pain) and PYREXIA (Low grade fever). At the time of the report, NECK PAIN (Severe neck pain) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vaccination site warmth
Clinical narrative: her arm was sore; 8 inches wide red; warm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was sore), ERYTHEMA (8 inches wide red), VACCINATION SITE WARMTH (warm) and PYREXIA (fever) 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 23-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 PAIN IN EXTREMITY (her arm was sore), ERYTHEMA (8 inches wide red), VACCINATION SITE WARMTH (warm) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (her arm was sore), ERYTHEMA (8 inches wide red), VACCINATION SITE WARMTH (warm) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Patient's first name was corrected and patient declined further follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 (Headaches). At the time of the report, HEADACHE (Headaches) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the injection site; A spontaneous report was received from a Consumer concerning a 60 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the event soreness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of event, soreness at the injection site was unknown..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: It is uncomfortable, but not horrible; Very warm to touch; It was itchy to touch; Appeared a big circular rush in the shoulder area, where the vaccine was administered; Painful at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (It is uncomfortable, but not horrible), VACCINATION SITE WARMTH (Very warm to touch), VACCINATION SITE PRURITUS (It was itchy to touch), VACCINATION SITE PAIN (Painful at the injection site) and VACCINATION SITE RASH (Appeared a big circular rush in the shoulder area, where the vaccine was administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Painful at the injection site). On 31-Jan-2021, the patient experienced DISCOMFORT (It is uncomfortable, but not horrible), VACCINATION SITE WARMTH (Very warm to touch), VACCINATION SITE PRURITUS (It was itchy to touch) and VACCINATION SITE RASH (Appeared a big circular rush in the shoulder area, where the vaccine was administered). At the time of the report, DISCOMFORT (It is uncomfortable, but not horrible), VACCINATION SITE WARMTH (Very warm to touch), VACCINATION SITE PRURITUS (It was itchy to touch), VACCINATION SITE PAIN (Painful at the injection site) and VACCINATION SITE RASH (Appeared a big circular rush in the shoulder area, where the vaccine was administered) had resolved.            Concomitant product use was not provided. No treatment was received by the patient.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Updated reporter information, patient demographics. Added second dose details  and newevent. The outcome of the event(s)  changed from uknown to recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pruritus
Clinical narrative: Right forearm began tingling; Itchy; Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Right forearm began tingling), PRURITUS (Itchy) and PAIN IN EXTREMITY (Painful arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 PARAESTHESIA (Right forearm began tingling), PRURITUS (Itchy) and PAIN IN EXTREMITY (Painful arm). On 01-Feb-2021, PARAESTHESIA (Right forearm began tingling) and PRURITUS (Itchy) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient did not receive any treatment.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash pruritic, Swelling
Clinical narrative: Itching on my neck/extremely itchy; Neck reddish; Neck bumpy; Rash on my right wrist which was also very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on my right wrist which was also very itchy), PRURITUS (Itching on my neck/extremely itchy), ERYTHEMA (Neck reddish) and SWELLING (Neck bumpy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) for Arthritis.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH PRURITIC (Rash on my right wrist which was also very itchy). On 27-Jan-2021, the patient experienced PRURITUS (Itching on my neck/extremely itchy), ERYTHEMA (Neck reddish) and SWELLING (Neck bumpy). The patient was treated with HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency; ALCOHOL at an unspecified dose and frequency and ALOE VERA at an unspecified dose and frequency. In January 2021, RASH PRURITIC (Rash on my right wrist which was also very itchy) had resolved. At the time of the report, PRURITUS (Itching on my neck/extremely itchy), ERYTHEMA (Neck reddish) and SWELLING (Neck bumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient got a rash on her wrist few days later which was also vert itchy and she scratched it which led to bleed. The bleed lasted for a day.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; A spontaneous report was received from a Consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm.  The patient's medical history was not provided. Concomitant medications reported were clonidine, carvedilol, amlodipine, atorvastatin calcium, levothyroxine sodium, sodium bicarbonate, synthroid for drug use for unknown indication.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 012120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the events sore arm.  Treatment details included NONE  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, sore arm was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.