chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: had hives on one side of her body (left) within 24 hours then on both thighs and down; This spontaneous case was reported by a consumer and describes the occurrence of   in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      on 14Jan2021 she reports hives on her right thigh and down.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant product use was not provided by the reporter. No treatment information was provided.  Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: her arm went red; her arm hurt, was painful; arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (her arm went red), PAIN IN EXTREMITY (her arm hurt, was painful) and PERIPHERAL SWELLING (arm swelling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Redness (a little redness in her other arm after receiving the flu, shingles, and pneumonia vaccine).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ERYTHEMA (her arm went red), PAIN IN EXTREMITY (her arm hurt, was painful) and PERIPHERAL SWELLING (arm swelling). At the time of the report, ERYTHEMA (her arm went red), PAIN IN EXTREMITY (her arm hurt, was painful) and PERIPHERAL SWELLING (arm swelling) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: large, reddened, itchy area, oval about 2 inches by 3 inches; large, reddened, itchy area; slight swollen on the left deltoid; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (large, reddened, itchy area, oval about 2 inches by 3 inches), VACCINATION SITE ERYTHEMA (large, reddened, itchy area) and VACCINATION SITE SWELLING (slight swollen on the left deltoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (large, reddened, itchy area, oval about 2 inches by 3 inches), VACCINATION SITE ERYTHEMA (large, reddened, itchy area) and VACCINATION SITE SWELLING (slight swollen on the left deltoid). At the time of the report, VACCINATION SITE PRURITUS (large, reddened, itchy area, oval about 2 inches by 3 inches), VACCINATION SITE ERYTHEMA (large, reddened, itchy area) and VACCINATION SITE SWELLING (slight swollen on the left deltoid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No 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 events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: shoulder is a little sore; vaccine it stung really bad; swollen; vaccination site swelling; A spontaneous report was received from a consumer, concerning a female patient of 57 age, who received Moderna's COVID-19 vaccine and experienced Lump below injection spot the size of a small tennis ball, shoulder is a little sore, swollen, vaccine it stung really bad.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 03-JAN-2021, the patient received her first dose of the Moderna vaccine mRNA-1273 in the left arm. (lot number 012L20A) via unknown route for COVID-19 infection prophylaxis.  On an 13-JAN-2021, the patient experienced Lump below injection spot the size of a small tennis ball, shoulder is a little sore, swollen, vaccine it stung really bad. She has taken Ibuprofen(Advil) as a treatment medication. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the events, Lump below injection spot the size of a small tennis ball, shoulder is a little sore, swollen, vaccine it stung really bad was considered to be not resolved at the time of this report.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching in the arm; Redness 3 inches wide in the arm; A spontaneous report was received from a consumer concerning a 59-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching in arm/pruritus and redness (3 inches wide) in the arm/erythema.  The patient's medical history, was not provided by the reporter. No concomitant medications were reported.   On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : 027L20A)  for prophylaxis of COVID-19 infection.   On an unknown date, some days after receiving the vaccine the patient experienced itching and redness (3 inches wide) in the arm.  Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, itching and redness (3 inches wide) in the arm are unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: I saw a large red welt around injection site; woke up with the injection site itching; following day I had injection site pain for about 14 hours; A spontaneous report (United States) was received from a Consumer concerning a  73 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced following events injection site pain, injection site pruritis, injection site reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 09-01-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On 10-01-2021, The patient experienced injection site pain for about 14 hours.  On 16-01-2021, patient woke up with injection site itching. On 17-01-2021, Patient saw a large red welt Patient took Benadryl and put cold compress on it throughout the day.  Action taken with mRNA-1273 in response to the events was not reported.   On 10-01-2021, injection site pain for about 14 hours resolved.  On 16-01-2021, patient woke up with injection site itching event outcome unknown.  On 17-01-2021, Patient saw a large red welt. Next day it was still there but a lighter red color, event recovering/ resolving.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site joint pain, Vaccination site pain
Clinical narrative: soreness and pain is more wide spread to the shoulder; a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little sore) and VACCINATION SITE JOINT PAIN (soreness and pain is more wide spread to the shoulder) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (a little sore). On 15-Jan-2021, the patient experienced VACCINATION SITE JOINT PAIN (soreness and pain is more wide spread to the shoulder). At the time of the report, VACCINATION SITE PAIN (a little sore) and VACCINATION SITE JOINT PAIN (soreness and pain is more wide spread to the shoulder) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided Treated the events with Cool packs.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Pruritus, Vaccination site pain
Clinical narrative: Numbness on her upper lip; Numbness on upper nose; Itching on her chest and legs; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness on her upper lip), HYPOAESTHESIA (Numbness on upper nose), PRURITUS (Itching on her chest and legs) and VACCINATION SITE PAIN (Sore arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Skin cancer (Had operation to remove skin cancer and had been numb in that area before) and Operation NOS (Operation to remove skin cancer).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (Numbness on her upper lip), HYPOAESTHESIA (Numbness on upper nose), PRURITUS (Itching on her chest and legs) and VACCINATION SITE PAIN (Sore arm). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA ORAL (Numbness on her upper lip), HYPOAESTHESIA (Numbness on upper nose), PRURITUS (Itching on her chest and legs) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included diphenhydramine.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Pruritus, Swelling
Clinical narrative: Redness; Swelling; Discomfort; Itching; A spontaneous report was received from a (consumer) concerning a 30 years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (erythema, Swelling, Discomfort, Pruritus).     The patient's medical history was not provided. No relevant concomitant medications were reported.    On 4/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection.  On an unknown date, The patient experienced the events  Erythema and swelling  at the injection site which was resolved after a few days. A few days later the patient again developed more erythema and swelling in a larger area along with some discomfort and pruritus.  Ibuprofen and Benadryl was taken by the patient and after that she has got a lot better.  Action taken with mRNA-1273 in response to the events was not reported.   On unknown date, the erythema, swelling, discomfort and pruritus) was resolved.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Bit sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Bit sore) in a male 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.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Bit sore). At the time of the report, PAIN (Bit sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Received the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in October 2020 and the estimated date of delivery was 02-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Received the vaccine while pregnant) had resolved. Not Provided      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 treatment information was provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19 screening, Injection site mass, Malaise, Memory impairment
Clinical narrative: felt not so good/felt worse as the day progressed; I was shaking; I can't remember much of the day; slept 17 hours; my injection site had the lump a size of a goose egg/down to the size of a quarter; muscles hurt; joints hurt; injection site red; injection site tender; This spontaneous case was reported by a dental hygienist and describes the occurrence of MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours) and INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours), INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter), MYALGIA (muscles hurt), ARTHRALGIA (joints hurt), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PAIN (injection site tender). On 17-Jan-2021, MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours), MYALGIA (muscles hurt) and ARTHRALGIA (joints hurt) outcome was unknown. At the time of the report, INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PAIN (injection site tender) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, COVID-19 screening: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medication include "Ibuprofen"
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Somnolence, Tremor, Vaccination site erythema, Vaccination site pain
Clinical narrative: felt not so good/felt worse as the day progressed; I was shaking; I can't remember much of the day; slept 17 hours; my injection site had the lump a size of a goose egg/down to the size of a quarter; muscles hurt; joints hurt; injection site red; injection site tender; This spontaneous case was reported by a dental hygienist and describes the occurrence of MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours) and INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in September 2020.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours), INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter), MYALGIA (muscles hurt), ARTHRALGIA (joints hurt), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PAIN (injection site tender). On 17-Jan-2021, MALAISE (felt not so good/felt worse as the day progressed), TREMOR (I was shaking), MEMORY IMPAIRMENT (I can't remember much of the day), SOMNOLENCE (slept 17 hours), MYALGIA (muscles hurt) and ARTHRALGIA (joints hurt) outcome was unknown. At the time of the report, INJECTION SITE MASS (my injection site had the lump a size of a goose egg/down to the size of a quarter), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PAIN (injection site tender) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, COVID-19 screening: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medication include "Ibuprofen"
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pain, Swelling
Clinical narrative: redness; fatigue; Headache; Pain; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain), SWELLING (swelling), ERYTHEMA (redness), HEADACHE (Headache) and FATIGUE (fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Iodine allergy, Allergy to antibiotic, Allergy to antibiotic and Latex allergy.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN (Pain), SWELLING (swelling) and HEADACHE (Headache). On 09-Jan-2021, the patient experienced ERYTHEMA (redness) and FATIGUE (fatigue). On 09-Jan-2021, PAIN (Pain) outcome was unknown. On 10-Jan-2021, ERYTHEMA (redness) and HEADACHE (Headache) outcome was unknown. At the time of the report, SWELLING (swelling) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment Tylenol and ice
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Vaccination site pain, Vaccination site rash
Clinical narrative: Arm was red; Itchy arm; Swollen arm; Pain on injection site; Rash on injection site; Skin reaction around the injection site; A spontaneous report was received from a consumer concerning a 59-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin reaction around injection site/vaccination site reaction, rash on injection site/vaccination site rash, pain on injection site/vaccination site pain, arm was red/erythema, itchy/pruritus and swollen/peripheral swelling.  The patient's medical history, was not provided by the reporter. No concomitant medications were reported.   On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, seven days after injection, the patient experienced skin reactions around the injection site.  On 19 Jan 2021, the patient started having rash, pain on injection site. Her arm was red, itchy and swollen.   Treatment for the events were not reported. She went to the urgent care.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, skin reactions around the injection site, rash, pain on injection site, arm was red, itchy and swollen were unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Arm was red; Itchy arm; Swollen arm; Pain on injection site; Rash on injection site; Skin reaction around the injection site; A spontaneous report was received from a consumer concerning a 59-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced skin reaction around injection site/vaccination site reaction, rash on injection site/vaccination site rash, pain on injection site/vaccination site pain, arm was red/erythema, itchy/pruritus and swollen/peripheral swelling.  The patient's medical history, was not provided by the reporter. No concomitant medications were reported.   On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number : unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, seven days after injection, the patient experienced skin reactions around the injection site.  On 19 Jan 2021, the patient started having rash, pain on injection site. Her arm was red, itchy and swollen.   Treatment for the events were not reported. She went to the urgent care.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, skin reactions around the injection site, rash, pain on injection site, arm was red, itchy and swollen were unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal chest pain
Clinical narrative: terrible deep pain in my rib cage; arm was extremely sore for about 4 days; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (terrible deep pain in my rib cage) and LIMB DISCOMFORT (arm was extremely sore for about 4 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2020, the patient experienced MUSCULOSKELETAL CHEST PAIN (terrible deep pain in my rib cage) and LIMB DISCOMFORT (arm was extremely sore for about 4 days). At the time of the report, MUSCULOSKELETAL CHEST PAIN (terrible deep pain in my rib cage) and LIMB DISCOMFORT (arm was extremely sore for about 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Vomiting
Clinical narrative: extreme diarrhea; feeling sick; vomiting; A spontaneous report was received from a Consumer concerning a 79 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- vomiting, diarrhea, and malaise.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 16/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 18 Jan 2021, Caller states that her husband got the Moderna virus immunization on 16 Jan 2021. Then, he started vomiting and then he had experienced with extreme diarrhea. Upon calling back on 18Jan2021 at 1453 EST: Caller states her husband is still in bed sick on 18 Jan 2021. He started feeling sick at 7 o'clock at night on 16 Jan 2021.  Laboratory details were not  provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   Recovering, ongoing, not resolved or unknown outcomes: At the time of this report, the outcome of the events- diarrhea, vomiting and malaise were not recovered/ not resolved.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Soreness to injection site; Rash on either side of groin; A spontaneous report was received from a consumer concerning a 79Years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness to injection site and rash on either side of groin.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, 1 day prior to the onset of the event soreness to injection site the patient received their first of two planned doses of mRNA-1273 (011L20A) intramuscularly in the left deltoid shoulder muscle for prophylaxis of COVID-19 infection.  On the same day, on the day of vaccine administration, the patient experienced soreness at the injection site.  On an unknown date, the patient developed a rash on either side of groin.  Treatment for the event included 1 percent hydrocortisone to treat the event rash on either side of groin.  Action taken with mRNA-1273 in response to the event was not reported.  The event rash on either side of groin was recovering/resolving (rash was getting better).  The outcome of the event soreness to injection site 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   No treatment information for the event was provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AE's for this 32 year old female. Patient will continue to be contacted for further monitoring of AE's during pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Product leakage
Clinical narrative: Felt some of the vaccine leak out of the injection site; A spontaneous report  was received from a pharmacist, concerning a male patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and felt some of the vaccine leaked out of the injection site.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   On an unspecified date, after the administration of vaccine, when the syringe was pulled out of the injection site, the patient felt that some of the vaccine had leaked out from the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, some of the vaccine leak out of the injection site, was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of product leakage for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 612L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. No known allergies. ). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 15-Jan-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 25-Dec-2020 and the estimated date of delivery was 01-Oct-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       At the time of this report prenatal care was not yet established.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is still hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is still hurting) 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 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is still hurting). At the time of the report, PAIN IN EXTREMITY (Arm is still hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm after the injection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm after the injection). On 17-Jan-2021, VACCINATION SITE PAIN (Sore arm after the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  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 this event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia, Throat irritation
Clinical narrative: Pain; Scratchy Throat; headache; Nausea; Fever; Case reference number MOD-2021-008855 is a clinical trial case report which refers to a 68 Years old Female patient.  The patient experienced Headache which resulted in .  This occurred while participating in Protocol   -   .  The patients relevant medical history included: No adverse event   .  The patients started Moderna COVID-19 Vaccine on  .  Some  11 days  later, the patient developed Headache.'  Relevant laboratory results included   and relevant physical signs . The patient experienced the following serious criteria:   The eventual diagnosis made was Headache .  The patient was treated for the event with TYLENOL .The action taken for Moderna COVID-19 Vaccine was  Unknown on  . The event(s) were:   . An autopsy was performed on  . .  The investigator considered the Headache  did not declare related to the study drug/placebo.  In the investigators opinion other possible factors included and the patients age/history or other factors.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema
Clinical narrative: Redness; soreness; A spontaneous report was received from a Consumer's wife concerning a 82 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, hardness, and soreness. The patient's medical history includes, he is a  heart patient and on blood thinner.  On 17th JAN 2021 to the onset of the events, the patients received their first of two planned doses of mRNA-1273 intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 18th JAN 2021 , The patient reported the events redness, hardness, and soreness. Treatment Hydrocodone  Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, redness, hardness, and soreness was not provided
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Feeling cold, Peripheral swelling
Clinical narrative: Started feeling really cold; Pain at the armpit in which she receive the vaccine; Swelling at the armpit in which she receive the vaccine; Shaking and could not get warm, experienced chills; Fever over 101.3; A spontaneous/solicited report was received from a healthcare facility staff member concerning a 25-Years old, female patient who developed Started feeling really cold/ Feeling cold, Shaking and could not get warm, experienced chills/ Chills, Fever over 101.3/ Pyrexia, Pain at the armpit in which she receive the vaccine/ Axillary pain, Swelling at the armpit in which she receive the vaccine/ Peripheral swelling.    The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 7-Jan-2021.  On 7-Jan-2021, approximately few hours to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 07-Jan-2021, Patient experienced shaking and could not get warm. Patient experienced chills and a fever over 101.3-degree F. Treatment for the event included Tylenol.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event(s), developed Started feeling really cold/ Feeling cold, Shaking and could not get warm, experienced chills, Fever over 101.3, Pain at the armpit in which she receive the vaccine, Swelling at the armpit in which she receive the vaccine were considered recovered/resolved on 09-Jan-2021.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Started feeling really cold; Pain at the armpit in which she receive the vaccine; Swelling at the armpit in which she receive the vaccine; Shaking and could not get warm, experienced chills; Fever over 101.3; A spontaneous/solicited report was received from a healthcare facility staff member concerning a 25-Years old, female patient who developed Started feeling really cold/ Feeling cold, Shaking and could not get warm, experienced chills/ Chills, Fever over 101.3/ Pyrexia, Pain at the armpit in which she receive the vaccine/ Axillary pain, Swelling at the armpit in which she receive the vaccine/ Peripheral swelling.    The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on 7-Jan-2021.  On 7-Jan-2021, approximately few hours to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 07-Jan-2021, Patient experienced shaking and could not get warm. Patient experienced chills and a fever over 101.3-degree F. Treatment for the event included Tylenol.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event(s), developed Started feeling really cold/ Feeling cold, Shaking and could not get warm, experienced chills, Fever over 101.3, Pain at the armpit in which she receive the vaccine, Swelling at the armpit in which she receive the vaccine were considered recovered/resolved on 09-Jan-2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash, Vaccination site pain, Vaccination site rash
Clinical narrative: Upper Torso Rash; Rash is still going on the injection site; Some Injection site pain; Injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Some Injection site pain), RASH (Upper Torso Rash), INJECTION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE RASH (Rash is still going on the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) 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 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Some Injection site pain) and INJECTION SITE ERYTHEMA (Injection site was red). On 16-Jan-2021, the patient experienced RASH (Upper Torso Rash) and VACCINATION SITE RASH (Rash is still going on the injection site). On 16-Jan-2021, VACCINATION SITE PAIN (Some Injection site pain) had resolved. At the time of the report, RASH (Upper Torso Rash), INJECTION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE RASH (Rash is still going on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   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 the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal chest pain, Vaccination site movement impairment
Clinical narrative: pain in her right rib; Arm Stiffness on Injection Site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (pain in her right rib), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm Stiffness on Injection Site) and FATIGUE (Fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (pain in her right rib), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm Stiffness on Injection Site) and FATIGUE (Fatigue). At the time of the report, MUSCULOSKELETAL CHEST PAIN (pain in her right rib), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm Stiffness on Injection Site) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Chills; Hives (big red circle) about 6 inch long (4 inch wide) in the injection site; Injection site swelling; Hives (big red circle) about 6 inch long (4 inch wide) in the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VACCINATION SITE URTICARIA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Jan-2021, the patient experienced CHILLS (Chills), VACCINATION SITE URTICARIA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), VACCINATION SITE URTICARIA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Hives (big red circle) about 6 inch long (4 inch wide) in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. patient took diphenhydramine twice a day starting 15Jan2021; 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: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red spot on his arm, "7 day itch"; red spot on his arm, "7 day itch"; red spot on his arm after first shot and a little bit of swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (red spot on his arm after first shot and a little bit of swelling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE SWELLING (red spot on his arm after first shot and a little bit of swelling). At the time of the report, VACCINATION SITE SWELLING (red spot on his arm after first shot and a little bit of swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported No treatment medications were reported
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: External ear pain, Lymph node pain
Clinical narrative: Nodes around the ear, like insect bites; Pain around the ear in the same side of injection; This spontaneous case was reported by a consumer and describes the occurrence of EXTERNAL EAR PAIN (Pain around the ear in the same side of injection) and LYMPH NODE PAIN (Nodes around the ear, like insect bites) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced EXTERNAL EAR PAIN (Pain around the ear in the same side of injection). On 18-Jan-2021, the patient experienced LYMPH NODE PAIN (Nodes around the ear, like insect bites). At the time of the report, EXTERNAL EAR PAIN (Pain around the ear in the same side of injection) and LYMPH NODE PAIN (Nodes around the ear, like insect bites) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications were reported. Treatment for the events was not provided by the reporter
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Aches and pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches and pain all over her body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced MYALGIA (Aches and pain all over her body). On 13-Jan-2021, MYALGIA (Aches and pain all over her body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.