chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Migraine, Nausea, Vomiting
Clinical narrative: nausea; vomiting; Migraine got worse with nausea and vomiting; This spontaneous case was reported by a physician and describes the occurrence of MIGRAINE (Migraine got worse with nausea and vomiting), NAUSEA (nausea) and VOMITING (vomiting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MIGRAINE (Migraine got worse with nausea and vomiting). On an unknown date, the patient experienced NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MIGRAINE (Migraine got worse with nausea and vomiting), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Negative.     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 information  provided. No Treatment information  provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: red blisters on my bilateral tongue /red blisters on my bilateral inner cheek; This spontaneous case was reported by an other health care professional and describes the occurrence of BLISTER (red blisters on my bilateral tongue /red blisters on my bilateral inner cheek) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced BLISTER (red blisters on my bilateral tongue /red blisters on my bilateral inner cheek). At the time of the report, BLISTER (red blisters on my bilateral tongue /red blisters on my bilateral inner cheek) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     No concomitant medications were reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A patch of skin on his shoulder which was pink and about 2.5-3 inches long and 1.5-2 inches wide; It itched like crazy; A spot of inflammation right at the spot where I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (A patch of skin on his shoulder which was pink and about 2.5-3 inches long and 1.5-2 inches wide), VACCINATION SITE PRURITUS (It itched like crazy) and VACCINATION SITE SWELLING (A spot of inflammation right at the spot where I got the shot) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (A patch of skin on his shoulder which was pink and about 2.5-3 inches long and 1.5-2 inches wide), VACCINATION SITE PRURITUS (It itched like crazy) and VACCINATION SITE SWELLING (A spot of inflammation right at the spot where I got the shot). At the time of the report, VACCINATION SITE DISCOLOURATION (A patch of skin on his shoulder which was pink and about 2.5-3 inches long and 1.5-2 inches wide), VACCINATION SITE PRURITUS (It itched like crazy) and VACCINATION SITE SWELLING (A spot of inflammation right at the spot where I got the shot) outcome was unknown.        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 medications.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 14-Dec-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 14-Jun-2020 and the estimated date of delivery was 21-Mar-2021. On 24-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-sixth week of the pregnancy.  On 24-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Estimated date of conception was on 26-Jun-2020. Number of fetus was found to be one.  Concomitant product also included coonid.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnancy). At the time of the report, PREGNANCY (Pregnancy) had not resolved.        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.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Myalgia, Vaccination site pain
Clinical narrative: flu like; dizziness; muscle pain; soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), MYALGIA (muscle pain) and VACCINATION SITE PAIN (soreness in the injected arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history). Concomitant products included FINASTERIDE and TERAZOSIN for an unknown indication.   On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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, the patient experienced INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), MYALGIA (muscle pain) and VACCINATION SITE PAIN (soreness in the injected arm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like), DIZZINESS (dizziness), MYALGIA (muscle pain) and VACCINATION SITE PAIN (soreness in the injected arm) outcome was unknown.            No Treatment information  provided   This case was linked to MOD21-037913 (Patient Link).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Tingling that radiate from shoulder to upper back; burning pains that radiate to  shoulder and upper back.; Severe pain on left arm (same arm as the injection); Shoulder pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling that radiate from shoulder to upper back), BURNING SENSATION (burning pains that radiate to  shoulder and upper back.), VACCINATION SITE PAIN (Severe pain on left arm (same arm as the injection)) and ARTHRALGIA (Shoulder pain) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-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. In February 2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling that radiate from shoulder to upper back), BURNING SENSATION (burning pains that radiate to  shoulder and upper back.), VACCINATION SITE PAIN (Severe pain on left arm (same arm as the injection)) and ARTHRALGIA (Shoulder pain). The patient was treated with IBUPROFEN for Shoulder pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling that radiate from shoulder to upper back), BURNING SENSATION (burning pains that radiate to  shoulder and upper back.), VACCINATION SITE PAIN (Severe pain on left arm (same arm as the injection)) and ARTHRALGIA (Shoulder pain) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medicines were provided.  Action taken with mRNA-1273 in response to the event was not applicable
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site swelling, Pain in extremity, Rash macular
Clinical narrative: Friday was the worst day in terms of size of the welt/hard spot, Sunday it was gone completely; Soreness in arm; Swelling about diameter of golf ball where shot was given; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Friday was the worst day in terms of size of the welt/hard spot, Sunday it was gone completely), PAIN IN EXTREMITY (Soreness in arm), INJECTION SITE SWELLING (Swelling about diameter of golf ball where shot was given), HEADACHE ( Headache) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Friday was the worst day in terms of size of the welt/hard spot, Sunday it was gone completely), PAIN IN EXTREMITY (Soreness in arm), INJECTION SITE SWELLING (Swelling about diameter of golf ball where shot was given), HEADACHE ( Headache) and FATIGUE (Tired). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Friday was the worst day in terms of size of the welt/hard spot, Sunday it was gone completely), PAIN IN EXTREMITY (Soreness in arm), INJECTION SITE SWELLING (Swelling about diameter of golf ball where shot was given), HEADACHE ( Headache) and FATIGUE (Tired) 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 assessment. No concomitant medications were reported.   Patient developed welt/hard spot that was bigger in size and it was gone on Sunday but again came back even larger than before and measured 2.5 inches in length and 1.5 inches in height and was warm to touch.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Head discomfort, Malaise, Nausea, Pain in extremity
Clinical narrative: just had to go to bed and sleep it off; spells of feeling car sick; nausea; swimming head; way worse than just feeling dizzy; soar arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soar arm), MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head) and DIZZINESS (way worse than just feeling dizzy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (soar arm). On 01-Feb-2021, the patient experienced MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head) and DIZZINESS (way worse than just feeling dizzy). On 05-Feb-2021, the patient experienced SOMNOLENCE (just had to go to bed and sleep it off). On 26-Jan-2021, PAIN IN EXTREMITY (soar arm) had resolved. At the time of the report, MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head), DIZZINESS (way worse than just feeling dizzy) and SOMNOLENCE (just had to go to bed and sleep it off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: just had to go to bed and sleep it off; spells of feeling car sick; nausea; swimming head; way worse than just feeling dizzy; soar arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soar arm), MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head) and DIZZINESS (way worse than just feeling dizzy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (soar arm). On 01-Feb-2021, the patient experienced MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head) and DIZZINESS (way worse than just feeling dizzy). On 05-Feb-2021, the patient experienced SOMNOLENCE (just had to go to bed and sleep it off). On 26-Jan-2021, PAIN IN EXTREMITY (soar arm) had resolved. At the time of the report, MALAISE (spells of feeling car sick), NAUSEA (nausea), HEAD DISCOMFORT (swimming head), DIZZINESS (way worse than just feeling dizzy) and SOMNOLENCE (just had to go to bed and sleep it off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash was back on shoulder and chest; Rash on shoulder and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash was back on shoulder and chest) and RASH (Rash on shoulder and chest) in an 80-year-old female patient who received mRNA-1273 (MODERA COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hernia. Concomitant products included OMEPRAZOLE for Hernia, LEVOFLOXACIN (LEVOXIN), ATORVASTATIN, CALCIUM and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced RASH (Rash on shoulder and chest). On 09-Feb-2021, the patient experienced RASH (Rash was back on shoulder and chest). At the time of the report, RASH (Rash was back on shoulder and chest) and RASH (Rash on shoulder and chest) outcome was unknown. Not Provided      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.   Treatment included Benadryl
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Allergic reaction; Rash; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), HYPERSENSITIVITY (Allergic reaction) and RASH (Rash) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Benadryl.) and Hearing reduced.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itching) and RASH (Rash). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, PRURITUS (Itching) and RASH (Rash) had resolved and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Benadryl, another medication similar to Benadryl, Pepcid   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up document was received as TCR. New event was included and outcome of rash and itching were updated. It contains significant information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dry throat, Dysgeusia, Dyspnoea, Vision blurred
Clinical narrative: Tasted medicine in mouth; Felt weak; Felt like throat was closing; Felt blurry; Hardly could breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Tasted medicine in mouth), ASTHENIA (Felt weak), DRY THROAT (Felt like throat was closing), VISION BLURRED (Felt blurry) and DYSPNOEA (Hardly could breath) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M2OA) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Psoriasis (Patient takes the injection for Psoriasis).    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSGEUSIA (Tasted medicine in mouth). 02-Feb-2021, the patient experienced ASTHENIA (Felt weak), DRY THROAT (Felt like throat was closing), VISION BLURRED (Felt blurry) and DYSPNOEA (Hardly could breath). At the time of the report, DYSGEUSIA (Tasted medicine in mouth), ASTHENIA (Felt weak), DRY THROAT (Felt like throat was closing), VISION BLURRED (Felt blurry) and DYSPNOEA (Hardly could breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received on 15-JULY-2021 .Event outcome was updated unknown to resolved.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site erythema
Clinical narrative: Red rash developed in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash developed in the arm of the injection) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red rash developed in the arm of the injection). At the time of the report, VACCINATION SITE ERYTHEMA (Red rash developed in the arm of the injection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 98°f (High) 98°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Cold clothes on the rash.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Vaccination site pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Coronary stent placement (Left descending artery) in 2005 and Defibrillator/pacemaker insertion (Pacemaker defibrillator) in 2010. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL SUCCINATE, ASPIRIN [ACETYLSALICYLIC ACID] and NITROGLYCERIN for Heart disease, unspecified, TAMSULOSIN HCL for Kidney stone, ONDANSETRON HCL for Kidney stone and Nausea, CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Sinus disorder and Allergy, ACETAMINOPHEN;HYDROCODONE, CARMELLOSE SODIUM, GLYCEROL (REFRESH RELIEVA), VITAMIN D3 and ACETAMINOPHEN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021 at 11:06 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.            Concomitant medication include Hydrocodone-Acetaminophen 5-325 MG per tablet for dosage of 1tablet every 4 hours as needed for pain and Multivitamins 50+ (Compare to Centrum Silver) for dosage of 1PM.  Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication was informed.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Updated reporter information , patient demographics, medical history . Updated product start date  . Added concomitant medications . Updated outcome of the events from unknown to recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash; Itches like crazy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itches like crazy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itches like crazy). At the time of the report, VACCINATION SITE RASH (Rash) and VACCINATION SITE PRURITUS (Itches like crazy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Benadryl
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant during vaccination two; pregnant during vaccination one; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant during vaccination one) and EXPOSURE DURING PREGNANCY (pregnant during vaccination two) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 092A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 06-Aug-2021. On 26-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant during vaccination one). On 25-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant during vaccination two). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant during vaccination one) and EXPOSURE DURING PREGNANCY (pregnant during vaccination two) outcome was unknown.            No relevant Concomitant medications were provided. No Treatment Information provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 27-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Pruritus, Pyrexia
Clinical narrative: redness inside of arm to elbow; swelling; Chills; Fatigue; Vomit; itching inside of arm to elbow; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), CHILLS (Chills), FATIGUE (Fatigue), VOMITING (Vomit) and ERYTHEMA (redness inside of arm to elbow) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 25-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. On 23-Feb-2021, the patient experienced PYREXIA (fever), FATIGUE (Fatigue), VOMITING (Vomit) and PRURITUS (itching inside of arm to elbow). On 24-Feb-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced ERYTHEMA (redness inside of arm to elbow) and SWELLING (swelling). On 25-Feb-2021, PYREXIA (fever) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (Fatigue), VOMITING (Vomit), ERYTHEMA (redness inside of arm to elbow), SWELLING (swelling) and PRURITUS (itching inside of arm to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  No treatment medication was provided
Age: 78.0
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vomiting
Clinical narrative: redness inside of arm to elbow; swelling; Chills; Fatigue; Vomit; itching inside of arm to elbow; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever), CHILLS (Chills), FATIGUE (Fatigue), VOMITING (Vomit) and ERYTHEMA (redness inside of arm to elbow) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.   On 25-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. On 23-Feb-2021, the patient experienced PYREXIA (fever), FATIGUE (Fatigue), VOMITING (Vomit) and PRURITUS (itching inside of arm to elbow). On 24-Feb-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced ERYTHEMA (redness inside of arm to elbow) and SWELLING (swelling). On 25-Feb-2021, PYREXIA (fever) and CHILLS (Chills) had resolved. At the time of the report, FATIGUE (Fatigue), VOMITING (Vomit), ERYTHEMA (redness inside of arm to elbow), SWELLING (swelling) and PRURITUS (itching inside of arm to elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided  No treatment medication was provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Nasopharyngitis, Nausea, Pain, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had bad reaction by the evening of the, out cold, did not really wake up again until Friday), NASOPHARYNGITIS , HYPERSOMNIA, NAUSEA (extremely nauseated) and PAIN (right arm hurts) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Illegible and 030M20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION, NASOPHARYNGITIS, HYPERSOMNIA, NAUSEA (extremely nauseated) and PAIN (right arm hurts). At the time of the report, VACCINATION COMPLICATION, HYPERSOMNIA (had bad reaction by the evening of the, out cold, did not really wake up again until Friday,), NAUSEA (extremely nauseated) and PAIN (right arm hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information  provided. No Treatment information  provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: Red cheeks; Warm cheeks; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red cheeks) and FEELING HOT (Warm cheeks) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, SIMVASTATIN, CICLOSPORIN (RESTASIS), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL, BIOTIN, COLECALCIFEROL (VITAMIN D 3) and ZINC 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 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ERYTHEMA (Red cheeks) and FEELING HOT (Warm cheeks). At the time of the report, ERYTHEMA (Red cheeks) and FEELING HOT (Warm cheeks) outcome was unknown.            No Treatment information  provided
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of   in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-026080 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-JUL-2021 , Containing Non-significant follow-up appended
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Nausea, Pain
Clinical narrative: severe headache; very ill; some body aches; fatigue; xtremely nauseate, unable to eat almost for 2 week; run and continue to run fever for 2 weeks, 2 and 3 degrees more than normal; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill), PAIN (some body aches), FATIGUE (fatigue), NAUSEA (xtremely nauseate, unable to eat almost for 2 week) and PYREXIA (run and continue to run fever for 2 weeks, 2 and 3 degrees more than normal) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ILLNESS (very ill), PAIN (some body aches), FATIGUE (fatigue), NAUSEA (xtremely nauseate, unable to eat almost for 2 week) and PYREXIA (run and continue to run fever for 2 weeks, 2 and 3 degrees more than normal). On an unknown date, the patient experienced HEADACHE (severe headache). At the time of the report, ILLNESS (very ill), PAIN (some body aches), FATIGUE (fatigue), NAUSEA (xtremely nauseate, unable to eat almost for 2 week), PYREXIA (run and continue to run fever for 2 weeks, 2 and 3 degrees more than normal) and HEADACHE (severe headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe headache; very ill; some body aches; fatigue; xtremely nauseate, unable to eat almost for 2 week; run and continue to run fever for 2 weeks, 2 and 3 degrees more than normal; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill), PAIN (some body aches), FATIGUE (fatigue), NAUSEA (xtremely nauseate, unable to eat almost for 2 week) and PYREXIA (run and continue to run fever for 2 weeks, 2 and 3 degrees more than normal) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ILLNESS (very ill), PAIN (some body aches), FATIGUE (fatigue), NAUSEA (xtremely nauseate, unable to eat almost for 2 week) and PYREXIA (run and continue to run fever for 2 weeks, 2 and 3 degrees more than normal). On an unknown date, the patient experienced HEADACHE (severe headache). At the time of the report, ILLNESS (very ill), PAIN (some body aches), FATIGUE (fatigue), NAUSEA (xtremely nauseate, unable to eat almost for 2 week), PYREXIA (run and continue to run fever for 2 weeks, 2 and 3 degrees more than normal) and HEADACHE (severe headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-026020, MOD-2021-026068 (E2B Linked Report).; Sender's Comments:  MOD-2021-026068:same reporter, different patient and event MOD-2021-026020:same reporter, different patient and event
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Dizziness, Mobility decreased
Clinical narrative: Feel dizzy; Feel weak; had pain; body temperature was 102°F.; had a reaction and said it was like having covid-19 all over again; Also mentioned that could not move legs,; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), DIZZINESS (Feel dizzy), ASTHENIA (Feel weak) and PAIN (had pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 07-Feb-2021, the patient experienced COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), PAIN (had pain) and PYREXIA (body temperature was 102°F.). On 08-Feb-2021, the patient experienced DIZZINESS (Feel dizzy) and ASTHENIA (Feel weak). At the time of the report, COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), DIZZINESS (Feel dizzy), ASTHENIA (Feel weak), PAIN (had pain) and PYREXIA (body temperature was 102°F.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 102°f °F High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information  provided
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Feel dizzy; Feel weak; had pain; body temperature was 102°F.; had a reaction and said it was like having covid-19 all over again; Also mentioned that could not move legs,; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), DIZZINESS (Feel dizzy), ASTHENIA (Feel weak) and PAIN (had pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN, METOPROLOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 07-Feb-2021, the patient experienced COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), PAIN (had pain) and PYREXIA (body temperature was 102°F.). On 08-Feb-2021, the patient experienced DIZZINESS (Feel dizzy) and ASTHENIA (Feel weak). At the time of the report, COVID-19 (had a reaction and said it was like having covid-19 all over again), MOBILITY DECREASED (Also mentioned that could not move legs,), DIZZINESS (Feel dizzy), ASTHENIA (Feel weak), PAIN (had pain) and PYREXIA (body temperature was 102°F.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 102°f °F High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information  provided
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Vaccination site bruising
Clinical narrative: Sharp pain on right side of chest; Arm hurt severely; Arm was bruised; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Sharp pain on right side of chest), PAIN IN EXTREMITY (Arm hurt severely) and VACCINATION SITE BRUISING (Arm was bruised) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007m209) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (On left side.) in 1999, Heart attack (Heart attack with two stents on right side.) in 2009, Heart attack in 2017 and Bypass surgery (Heart attack and stent on left side next to bypass surgery.) in 2017. Concurrent medical conditions included Stent placement (Heart attack and two stents on right side) since 2009 and Stent placement (Heart attack and stent on left side next to bypass surgery.) since 2017.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CHEST PAIN (Sharp pain on right side of chest), PAIN IN EXTREMITY (Arm hurt severely) and VACCINATION SITE BRUISING (Arm was bruised). At the time of the report, CHEST PAIN (Sharp pain on right side of chest), PAIN IN EXTREMITY (Arm hurt severely) and VACCINATION SITE BRUISING (Arm was bruised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information  provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: redness; hardness of the injection site; tenderness; swelling/ a little bit raised; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness), INJECTION SITE INDURATION (hardness of the injection site), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling/ a little bit raised) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness), INJECTION SITE INDURATION (hardness of the injection site), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling/ a little bit raised). At the time of the report, INJECTION SITE ERYTHEMA (redness), INJECTION SITE INDURATION (hardness of the injection site), INJECTION SITE PAIN (tenderness) and INJECTION SITE SWELLING (swelling/ a little bit raised) 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 information  provided. No Treatment information  provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a nurse and describes the occurrence of DIZZINESS (Dizziness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia and HSV infection. Concomitant products included ACYCLOVIR [ACICLOVIR] for HSV infection, ATORVASTATIN CALCIUM (LIPITOR) and ASA for Hyperlipidemia, LISINOPRIL for Hypertension, CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021: Address was updated, Patient demographics, ethnic group and race were added, Medical history and dose 2 information was added, concomitant medication was added, event outcome was changed from unknown to not recovered.