chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to touch; Itching on her arm; Area near injection site was swollen ( Swollen arm); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), PRURITUS (Itching on her arm) and VACCINATION SITE SWELLING (Area near injection site was swollen ( Swollen arm)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, CALCIUM CITRATE MALATE;MAGNESIUM CITRATE MALATE, VITAMIN D [VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch), PRURITUS (Itching on her arm) and VACCINATION SITE SWELLING (Area near injection site was swollen ( Swollen arm)). On 27-Feb-2021, PRURITUS (Itching on her arm) and VACCINATION SITE SWELLING (Area near injection site was swollen ( Swollen arm)) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Levothyroxine for thyroix, Calcium citrate magnesium for bone strength, Vitamin D for supports bone strength and multivitamin for dietary supplement is the indication for use for concomitant medications Treatment details included antihistamine.   This case was linked to MOD-2021-096600 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Follow-up was received on 28-APR-2021 which updated patient demographics, medical history, 2nd dose details updated and concomitant medications, treatment medication and update the out come for events  swollen arm and itchy was recovered.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Its very very hot; It's going around inside of her arm; Itching; The rash started small around the injection site.; The redness spread and became huge; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021.    A spontaneous report was received from a consumer concerning a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events small rash started around the injection site, the redness spread and became huge, it was going around inside of her arm, it's very very hot and rash is taking 3 quarters of the arm and it's spreading underneath.  The patient was allergic to penicillin. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced rash started small rash started  around the injection site, the redness spread and became huge and going around inside of her arm, it was very very hot and the rash was taking 3 quarters of the arm and it's spreading underneath.  Treatment details included Benadryl gel (topical) and tablet (by mouth).  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of events were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain
Clinical narrative: malaise /is not feeling well; she is having body aches; a dull headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise /is not feeling well), PAIN (she is having body aches) and HEADACHE (a dull headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (malaise /is not feeling well), PAIN (she is having body aches) and HEADACHE (a dull headache). At the time of the report, MALAISE (malaise /is not feeling well), PAIN (she is having body aches) and HEADACHE (a dull headache) outcome was unknown.            No concomitant medications reported.  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not reported. Treatment information not provide by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Patient denied consent for further follow up.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: area of the injection red; area of the injection hard (the size of a softball); area of the injection tender to touch; itching at the area of the injection; minor soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minor soreness at the injection site), VACCINATION SITE PRURITUS (itching at the area of the injection), VACCINATION SITE ERYTHEMA (area of the injection red), VACCINATION SITE INDURATION (area of the injection hard (the size of a softball)) and VACCINATION SITE PAIN (area of the injection tender to touch) in a 79-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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (minor soreness at the injection site). On 19-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the area of the injection). On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (area of the injection red), VACCINATION SITE INDURATION (area of the injection hard (the size of a softball)) and VACCINATION SITE PAIN (area of the injection tender to touch). On 13-Feb-2021, VACCINATION SITE PAIN (minor soreness at the injection site) had resolved. On 22-Feb-2021, VACCINATION SITE PRURITUS (itching at the area of the injection) outcome was unknown. At the time of the report, VACCINATION SITE ERYTHEMA (area of the injection red), VACCINATION SITE INDURATION (area of the injection hard (the size of a softball)) and VACCINATION SITE PAIN (area of the injection tender to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: soreness; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), PYREXIA (fever) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (soreness), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PAIN (soreness), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment medications were not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Illness, Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: Hair loss; Sick; Legs wanted to give out; Arm was sore; Body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALOPECIA (Hair loss), ILLNESS (Sick), LIMB DISCOMFORT (Legs wanted to give out), PAIN IN EXTREMITY (Arm was sore) and MYALGIA (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ILLNESS (Sick), LIMB DISCOMFORT (Legs wanted to give out), PAIN IN EXTREMITY (Arm was sore) and MYALGIA (Body aches). On 30-Jan-2021, the patient experienced ALOPECIA (Hair loss). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 times. On 23-Jan-2021, ILLNESS (Sick), LIMB DISCOMFORT (Legs wanted to give out), PAIN IN EXTREMITY (Arm was sore) and MYALGIA (Body aches) had resolved. At the time of the report, ALOPECIA (Hair loss) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Patient took Tylenol 2X and felt better  The patient reported that the physician said alopecia was due to COVID which she had in October.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Added historical condition. The outcome of the event alopecia changed from unknown to not resolved.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash localized in my arm pits.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash localized in my arm pits.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information.  Concomitant products included SERTRALINE, ATORVASTATIN and PANTOPRAZOLE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Rash localized in my arm pits.). On 05-Feb-2021, RASH (Rash localized in my arm pits.) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. No treatment information provided.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Rash on his torso and head also itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on his torso and head also itching) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 RASH PRURITIC (Rash on his torso and head also itching). At the time of the report, RASH PRURITIC (Rash on his torso and head also itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27-Apr-2021 included Updated contact information. On 14-Jul-2021: Follow-up information received on 14-JUL-2021; Patient's initials updated as per Follow-up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Dizzy all day; Body rash on full torso and back; Headache; Achy; Sore arm; Fatigue for two days; A spontaneous report  was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, achy /pain, sore arm /pain in extremity, fatigue for two days /fatigue, body on full torso /rash and back, dizzy all day /dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) headache, achy, sore arm, fatigue for two days. On 16 Feb 2021, the patient experienced the event(s) body on full torso and back. On 21 Feb 2021, the patient experienced the event(s) dizzy all day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue for two days was resolved on 15 Feb 2021. The outcome of event(s), body on full torso and back was resolved on18 Feb 2021. The outcome of event(s), dizzy all day was resolved on 21 Feb 2021 . The outcome of event(s), headache, achy, sore arm was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Dizzy all day; Body rash on full torso and back; Headache; Achy; Sore arm; Fatigue for two days; A spontaneous report  was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, achy /pain, sore arm /pain in extremity, fatigue for two days /fatigue, body on full torso /rash and back, dizzy all day /dizziness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) headache, achy, sore arm, fatigue for two days. On 16 Feb 2021, the patient experienced the event(s) body on full torso and back. On 21 Feb 2021, the patient experienced the event(s) dizzy all day.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fatigue for two days was resolved on 15 Feb 2021. The outcome of event(s), body on full torso and back was resolved on18 Feb 2021. The outcome of event(s), dizzy all day was resolved on 21 Feb 2021 . The outcome of event(s), headache, achy, sore arm was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Exposure during pregnancy, Ultrasound abdomen
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 1, para 0) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 041LZ0A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (2 drinks a week) on 21-Aug-2020. Concurrent medical conditions included Drug allergy (Sulfa drugs was reported.). 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 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Aug-2020 and the estimated date of delivery was 24-May-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood glucose: normal (normal) normal. In 2021, Ultrasound abdomen: normal (normal) normal.         No treatment information was provided. Previous pregnancies were not present.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: SORE ARM; Tiredness; Hurting for like 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (SORE ARM), FATIGUE (Tiredness) and PAIN (Hurting for like 2 days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (SORE ARM), FATIGUE (Tiredness) and PAIN (Hurting for like 2 days). At the time of the report, INJECTION SITE PAIN (SORE ARM), FATIGUE (Tiredness) and PAIN (Hurting for like 2 days) outcome was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Warm to the touch and it was below the site of injection; Delayed type of reaction where she developed a red splotch; Slight tenderness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch and it was below the site of injection), VACCINATION SITE PAIN (Slight tenderness at the site of injection) and VACCINATION SITE ERYTHEMA (Delayed type of reaction where she developed a red splotch) in a 76-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.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slight tenderness at the site of injection). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch and it was below the site of injection) and VACCINATION SITE ERYTHEMA (Delayed type of reaction where she developed a red splotch). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch and it was below the site of injection), VACCINATION SITE PAIN (Slight tenderness at the site of injection) and VACCINATION SITE ERYTHEMA (Delayed type of reaction where she developed a red splotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium increased
Clinical narrative: Potassium levels are elevated; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD POTASSIUM INCREASED (Potassium levels are elevated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 BLOOD POTASSIUM INCREASED (Potassium levels are elevated). At the time of the report, BLOOD POTASSIUM INCREASED (Potassium levels are elevated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Injection site hypersensitivity, Nausea, Vaccination site erythema
Clinical narrative: Llittle redness; Confusion; sensitivity at the injection site in her arm; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), INJECTION SITE HYPERSENSITIVITY (sensitivity at the injection site in her arm), CHILLS (Chills), NAUSEA (Nausea) and VACCINATION SITE ERYTHEMA (Llittle redness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included LAMOTRIGINE for Bipolar disorder.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced CONFUSIONAL STATE (Confusion), INJECTION SITE HYPERSENSITIVITY (sensitivity at the injection site in her arm), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Llittle redness). At the time of the report, CONFUSIONAL STATE (Confusion), INJECTION SITE HYPERSENSITIVITY (sensitivity at the injection site in her arm) and VACCINATION SITE ERYTHEMA (Llittle redness) had resolved and CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            Patient took 10 medications for unknown indication reported by reporter. Patient took a nice shower and that did the trick. The redness is gone and no longer is sensitive to the touch as before   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Follow up received on 18MAR2021, updated patients date of birth and additional events little redness and sensitivity at the injection site in her arm and treatment done for those events. On 27-Apr-2021: Follow up received on 27FEB2021, no new information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Muscle spasms, Tremor, Vaccination site pain
Clinical narrative: had arm, legs, hand, thigh and general muscle cramps; Shaking; Stomach aches; MUSCLE CRAMPS; Chills; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (had arm, legs, hand, thigh and general muscle cramps), TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach aches), MUSCLE SPASMS (MUSCLE CRAMPS) and CHILLS (Chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030N720A and 025J20-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (had arm, legs, hand, thigh and general muscle cramps), TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach aches), MUSCLE SPASMS (MUSCLE CRAMPS), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, MUSCLE SPASMS (had arm, legs, hand, thigh and general muscle cramps) had resolved and TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach aches), MUSCLE SPASMS (MUSCLE CRAMPS), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Myalgia, Pruritus, Pyrexia
Clinical narrative: Swelling on face; itchiness on face; chills; body aches; fever; redness on face; A spontaneous report was received from a consumer concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, body aches/Myalgia, fever/Pyrexia, redness on face/Erythema, itchiness on face/Pruritus, swelling on face/Swelling face.  The patient's medical history was not provided. Concomitant medications reported were Diphenhydramine, Methylprednisolone for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M29A) intramuscularly in the left arm shoulder deltoid muscle for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) chills, body aches, fever, redness on face, itchiness on face, Swelling on face.The patient went to see her Physician on friday 19 Feb 2021 for facial swelling  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, body aches, fever, redness on face, itchiness on face, swelling on face was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling on face; itchiness on face; chills; body aches; fever; redness on face; A spontaneous report was received from a consumer concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, body aches/Myalgia, fever/Pyrexia, redness on face/Erythema, itchiness on face/Pruritus, swelling on face/Swelling face.  The patient's medical history was not provided. Concomitant medications reported were Diphenhydramine, Methylprednisolone for drug use for unknown indication.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 030M29A) intramuscularly in the left arm shoulder deltoid muscle for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) chills, body aches, fever, redness on face, itchiness on face, Swelling on face.The patient went to see her Physician on friday 19 Feb 2021 for facial swelling  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, body aches, fever, redness on face, itchiness on face, swelling on face was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: woke up in the middle of the night with terrible itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (woke up in the middle of the night with terrible itch) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PRURITUS (woke up in the middle of the night with terrible itch). At the time of the report, PRURITUS (woke up in the middle of the night with terrible itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment include none. No concomitant medicine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness on R am; Tingling on R arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on R am) and PARAESTHESIA (Tingling on R arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced HYPOAESTHESIA (numbness on R am) and PARAESTHESIA (Tingling on R arm). At the time of the report, HYPOAESTHESIA (numbness on R am) and PARAESTHESIA (Tingling on R arm) 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 assessment.  No concomitant medications were reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity
Clinical narrative: arm soreness; lightheaded; general weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), DIZZINESS (lightheaded) and ASTHENIA (general weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), DIZZINESS (lightheaded) and ASTHENIA (general weakness). At the time of the report, PAIN IN EXTREMITY (arm soreness), DIZZINESS (lightheaded) and ASTHENIA (general weakness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over body/huge welts everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over body/huge welts everywhere) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE, ATORVASTATIN and PANTOPRAZOLE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives all over body/huge welts everywhere). At the time of the report, URTICARIA (Hives all over body/huge welts everywhere) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Report cross-linked to MOD-2021-021974.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27-Apr-2021 included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: hurt immediately; huge blob of red; itched; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hurt immediately /pain, huge blob of red /vaccination site swelling, itched, unsightly /vaccination site pruritus.  The patient's medical history was not provided. Concomitant medications were not reported.  On 17 Feb 2021, approximately 1 day prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the patient experienced the event(s) hurt immediately, huge blob of red, itched, unsightly.  Treatment include, diphenhydramine, itch cream, acetaminophen, Antihistamine  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.   The outcome of event(s), hurt immediately, huge blob of red, itched, unsightly was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral mucosal blistering, Vaccination site induration
Clinical narrative: shingle like blisters and bumps in mouth on upper right side; shingle like blisters; bumps on right arm under injection site; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL BLISTERING (shingle like blisters and bumps in mouth on upper right side), VACCINATION SITE INDURATION (bumps on right arm under injection site) and HERPES ZOSTER (shingle like blisters) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A-716) for COVID-19 vaccination.     Concomitant products included VALACYCLOVIR [VALACICLOVIR] for an unknown indication.    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 INDURATION (bumps on right arm under injection site). On 18-Jan-2021, the patient experienced ORAL MUCOSAL BLISTERING (shingle like blisters and bumps in mouth on upper right side) and HERPES ZOSTER (shingle like blisters). On 21-Jan-2021, ORAL MUCOSAL BLISTERING (shingle like blisters and bumps in mouth on upper right side) and HERPES ZOSTER (shingle like blisters) had resolved. At the time of the report, VACCINATION SITE INDURATION (bumps on right arm under injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were provided  Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followup received on 08-JUL-2021 & Contains non Significant NNI; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-021980:Crosslinked (MOD21-14971)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Respiratory tract congestion
Clinical narrative: Congested in the morning in her chest; dry cough; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Congested in the morning in her chest) and COUGH (dry cough) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. In January 2021, the patient experienced RESPIRATORY TRACT CONGESTION (Congested in the morning in her chest) and COUGH (dry cough). At the time of the report, RESPIRATORY TRACT CONGESTION (Congested in the morning in her chest) and COUGH (dry cough) outcome was unknown.            No concomitant medications or treatment details reported.; 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: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vaccination site pain
Clinical narrative: Stomach cramp; Nausea; Soreness and pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramp), NAUSEA (Nausea) and VACCINATION SITE PAIN (Soreness and pain at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramp), NAUSEA (Nausea) and VACCINATION SITE PAIN (Soreness and pain at the injection site). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramp) and NAUSEA (Nausea) had resolved and VACCINATION SITE PAIN (Soreness and pain at the injection site) 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.   Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Nasty metal taste in mouth; A spontaneous report was received from a consumer, concerning a female patient of 56 year age, who received Moderna's COVID-19 vaccine and experienced nasty metal taste in mouth.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis .  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event nasty metal taste in mouth, was considered to be not unknown at the time of this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Malaise, Pyrexia
Clinical narrative: Unwell; Chills; Fever; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Unwell), CHILLS (Chills), PYREXIA (Fever) and ASTHENIA (Weakness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to mRNA-1273. On an unknown date, the patient experienced MALAISE (Unwell), CHILLS (Chills), PYREXIA (Fever) and ASTHENIA (Weakness). At the time of the report, MALAISE (Unwell), CHILLS (Chills), PYREXIA (Fever) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Non significant follow up received on 27-APR-2021, no new information
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash erythematous, Rash papular
Clinical narrative: warm; 6 inches long and 3 inches wide; raised in few spots/ 4inches long and 3 inches wide; red; A spontaneous report  was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red/Erythema, warm/Feeling hot, 6 inches long and 3 inches wide/Rash papular , was there for 2 nights after i noticed, came back again, raised in few spots, 4inches long and 3 inches wide/Rash erythematous.  The patient's medical history was not provided. Concomitant medications reported were levothyroxine, Paroxetine, Lorazepam  for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Lot# 025L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) red, warm, 6 inches long and 3 inches wide, was there for 2 nights after I noticed, came back again, raised in few spots, 4inches long and 3 inches wide.It cleared up again.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), red, warm, 6 inches long and 3 inches wide was there for 2 nights after i noticed, came back again, raised in few spots, 4inches long and 3 inches wide was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site is warm to the touch; Injection site is swollen and is two and half inches in diameter size; This spontaneous case was reported by a consumer and describes the occurrence of   in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first 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.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD21-035149 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pruritus, Tenderness, Urticaria
Clinical narrative: 4 hours later I started to itch and scratch; Felt low for few days; My fingernail feels tender; Then after 2 hours later (6 hours later from shot) large hives appeared on upper torso, chest and on brain; A spontaneous report was received from a consumer concerning a 66-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events 4 hours later i started to itch and scratch/Pruritus, then after 2 hours later (6 hours later from shot) large hives appeared on upper torso, chest and on brain/Urticaria , felt low for few days/Asthenia, my fingernail feels tender/Tenderness.  The patient's medical history was not provided. Concomitant medications reported were Vitamin C for drug use for unknown indication.  On 19 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left non dominant arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) 4 hours later i started to itch and scratch, then after 2 hours later (6 hours later from shot) large hives appeared on upper torso, chest and on brain, felt low for few days, my fingernail feels tender.  Treatment details included ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), 4 hours later i started to itch and scratch, then after 2 hours later (6 hours later from shot) large hives appeared on upper torso, chest and on brain, felt low for few days, my fingernail feels tender was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: chills; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Cholesterol high and Hypertension. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (chills), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.            Concomitant products also included Cholesterol Medicine 5mg, Blood pressure Medicine 5mg.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: Arm sore; Injection site bruising; A spontaneous report was received from a nurse concerning a 71 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Injection site bruising and sore arm. The patient's medical history included covid-19 and liver transplantation. Products known to have been used by the patient were not reported. The patient received their first of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 25 Jan 2021, intramuscularly for prophylaxis of COVID-19 infection. On an unknown date the patient experienced injection site bruising and sore arm. While receiving the vaccine the patient told the nurse "you came all the way down to the bone". The sore become black and blue later on. No treatment information was provided.   No relevant laboratory details were included. Action taken with the drug in response to the events were not reported. The outcome of the events were unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling at injection site size of 1/2 baseball; Redness at injection site; Weird type of pain at injection site; Pain at injection site progresses to shoulder; Pain at injection site that comes and goes; A spontaneous report was received from a consumer concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness at injection site/Vaccination site erythema, swelling at injection site size of 1 2 baseball/Vaccination site swelling, weird type of pain at injection site/Vaccination site pain, pain at injection site progresses to shoulder/Arthralgia, pain at injection site that comes and goes/Vaccination site pain.  The patient's medical history was not provided. Concomitant medications reported were High Blood Pressure Medication, acetylsalicylic acid, curcumin for drug use for unknown indication.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) redness at injection site, swelling at injection site size of 1 2 baseball, weird type of pain at injection site, pain at injection site progresses to shoulder, pain at injection site that comes and goes.  Treatment details included paracetamol, Cold Pack.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), redness at injection site, swelling at injection site size of 1 2 baseball, weird type of pain at injection site, pain at injection site progresses to shoulder, pain at injection site that comes and goes was recovered on 22 Feb 2021.