chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Injection site pain, Lacrimation increased, Vision blurred
Clinical narrative: one of her contact lenses started to be blurry; burning eyes; watery eyes; soreness in the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (burning eyes), LACRIMATION INCREASED (watery eyes), VISION BLURRED (one of her contact lenses started to be blurry) and INJECTION SITE PAIN (soreness in the site of injection) in a 70-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 reported medical history.).   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE PAIN (soreness in the site of injection). On 15-Feb-2021, the patient experienced EYE IRRITATION (burning eyes) and LACRIMATION INCREASED (watery eyes). On 16-Feb-2021, the patient experienced VISION BLURRED (one of her contact lenses started to be blurry). At the time of the report, EYE IRRITATION (burning eyes), LACRIMATION INCREASED (watery eyes), VISION BLURRED (one of her contact lenses started to be blurry) and INJECTION SITE PAIN (soreness in the site of injection) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swollen red spot on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen red spot on arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen red spot on arm). At the time of the report, VACCINATION SITE SWELLING (swollen red spot on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: itching at injection site; swelling at injection site; hot to touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE WARMTH (hot to touch at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038k20A and 013l20A) for COVID-19 vaccination.     Concurrent medical conditions included Lymphoma. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and CLONAZEPAM (KLONOPIN) 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 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE WARMTH (hot to touch at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE SWELLING (swelling at injection site) and VACCINATION SITE WARMTH (hot to touch at injection site) was resolving.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue
Clinical narrative: brief period of chills; tired all day; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHILLS (brief period of chills) and FATIGUE (tired all day) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) 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) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 11-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (brief period of chills) and FATIGUE (tired all day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-Jan-2021, DIARRHOEA (diarrhea) had resolved. On 11-Feb-2021, CHILLS (brief period of chills) and FATIGUE (tired all day) had resolved.            No concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Diarrhea; Extremely itchy injection site; Red injection site; Swollen injection site; Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Extremely itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Cholesterol, AMLODIPINE, METOPROLOL, LISINOPRIL and SPIRONOLACTONE for Hypertension, ACETYLSALICYLIC ACID (BABY ASPIRIN), PANCREATIN (CREON), CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]), VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], RESVERATROL, UBIDECARENONE (COQ10 [UBIDECARENONE]), MAGNESIUM and VITAMIN B NOS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Extremely itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. On 08-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, DIARRHOEA (Diarrhea), VACCINATION SITE PRURITUS (Extremely itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site) and VACCINATION SITE SWELLING (Swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medicines include Amlodipine, Metoprolol, Lisinopril and Spironolactone for her high blood pressure; Atorvastatin for cholesterol; a baby aspirin a day; Creon 24000 for her pancreas and many over-the-counter vitamins (B, D, B12, magnesium, C, resveratrol, CoQ10). Treatment medicine include Hydrocortisone.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative, Dizziness, Dyspnoea, Headache
Clinical narrative: Trouble breathing; dizziness; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) 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. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Event caused after administering second dose of vaccine.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Antibody test negative: negative Negative.         Concomitant medications were not reported.  Treatment information was not provided/unknown.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up information included reporter details, patient demographic details and laboratory data.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Oct-2020 and the estimated date of delivery was 11-Jul-2021. On 12-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy.  On 12-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.  The date of positive pregnancy test was 29-Oct-2020   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2021: Internal review on 19JUL2021 resulted in updates to pregnancy details.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Upper respiratory tract infection
Clinical narrative: Upper respiratory tract infection; tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection) and COVID-19 (tested positive for COVID) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection) and COVID-19 (tested positive for COVID). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory tract infection) and COVID-19 (tested positive for COVID) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Patient went to the urgent care for an upper respiratory tract infection to avoid getting bronchitis in the future. Patient stated this was very common for her at this time of the year and did not have any symptoms she did not normally have. Patient denied any symptoms post vaccination and stated she had no fever after the vaccination. She has been taking medications prescribed by the urgent care and her infection has been improving. Treatment information was not provided. Patient reported feeling pretty good.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021:; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the events of URI and positive for COVID, are assessed as unlikely related.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: warm, hot; itchy; real red looking; Extended rash on arm, real red looking; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm, hot), PRURITUS (itchy), ERYTHEMA (real red looking) and RASH (Extended rash on arm, real red looking) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included METHOTREXATE for Polymyalgia rheumatica.    On 03-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 INJECTION SITE WARMTH (warm, hot), PRURITUS (itchy), ERYTHEMA (real red looking) and RASH (Extended rash on arm, real red looking). At the time of the report, INJECTION SITE WARMTH (warm, hot), PRURITUS (itchy), ERYTHEMA (real red looking) and RASH (Extended rash on arm, real red looking) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive in October 2020.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patients rheumatologist told her to suspend the medication after the vaccine administration for a week  Other concomitant medication included Cholesterol medicine  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: TCR was received patient stated significant information that she feels fine now no additional information was received and outcome changed from unknown to recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Urticaria
Clinical narrative: Urticaria eczema; Urticaria eczema; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Urticaria eczema) and ECZEMA (Urticaria eczema) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 016m20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 05-Jul-1980 and Penicillin allergy. Concomitant products included VITAMINS NOS (MULTIVITAMINUM) from 09-Jan-1980 to an unknown date and VITAMIN D3 from 04-Jan-2019 to an unknown date.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced ECZEMA (Urticaria eczema). On 22-Jan-2021 at 8:15 AM, the patient experienced URTICARIA (Urticaria eczema). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, URTICARIA (Urticaria eczema) and ECZEMA (Urticaria eczema) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up received on 27-Apr-2021: Patient demographics, medical history, concomitant medications and event outcomes were updated.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: left with the vaccine still in her lab coat pocket and drove off. administered 4 doses after she brought it back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (left with the vaccine still in her lab coat pocket and drove off. administered 4 doses after she brought it back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PRODUCT STORAGE ERROR (left with the vaccine still in her lab coat pocket and drove off. administered 4 doses after she brought it back). On 09-Feb-2021, PRODUCT STORAGE ERROR (left with the vaccine still in her lab coat pocket and drove off. administered 4 doses after she brought it back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a reaction to the Moderna vaccine; A spontaneous report was received from a consumer about a reaction to the Moderna vaccine and some questions about the reaction   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   No Laboratory details was provided.  No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event was unknown
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Migraine, Myalgia, Vomiting
Clinical narrative: Body was weak; Throwing up; Chills; teeth chattering; migraines; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), MYALGIA (Body aches), ASTHENIA (Body was weak), VOMITING (Throwing up) and CHILLS (Chills) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lupus-like syndrome (conservatively coded in current condition as it is mentioned as patient suffers from lupus), Rheumatoid arthritis, Depression, Blood pressure high and Migraine.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MIGRAINE (migraines), MYALGIA (Body aches), VOMITING (Throwing up), CHILLS (Chills) and CHILLS (teeth chattering). On an unknown date, the patient experienced ASTHENIA (Body was weak). At the time of the report, MIGRAINE (migraines), MYALGIA (Body aches), ASTHENIA (Body was weak), VOMITING (Throwing up), CHILLS (Chills) and CHILLS (teeth chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included anti-depression medication, high blood pressure medications and migraine prevention medication.  Treatment information included episodic migraine medication.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) 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], PARACETAMOL (TYLENOL), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), OMEPRAZOLE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 05-Sep-2020 and the estimated date of delivery was 12-Jun-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 20-Jan-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Updated reporter Information, pregnancy details, suspect product details and concomitant medications.
Sex: M
Vaccine: COVID19
Symptoms: Surgery
Clinical narrative: Unknown minor surgery; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (Unknown minor surgery) 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 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 SURGERY (Unknown minor surgery). The patient was treated with CEPHALEXIN HCL at an unspecified dose and frequency. At the time of the report, SURGERY (Unknown minor surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness at injection site; A spontaneous report was received from a consumer, concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness at injection site.   The patient's medical history was not provided. The current medical history included (UTI) urinary tract infection for which the patient's treatment included cefalexin (500mg) and paracetamol. No relevant concomitant medications were reported. The patient went to Urgent Care for UTI on the day before 2nd dose of vaccine was scheduled and was started on antibiotic for UTI . Nurse said it would be ok to start taking the antibiotic the day before the 2nd dose of COVID vaccine  On an unknown date, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient reported experiencing tenderness at injection site.   On 12 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection with no side effects.  Action taken with mRNA-1273 was not applicable as the patient had already received both scheduled doses  The outcome of the event, tenderness at injection site was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  MOD-2021-018804:same reportrer, For Husband/Male patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Pain; fever; chill; severe headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea) 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-Feb-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 PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test (positive-negative): positive (Positive) tested + month ago.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Pain; fever; chill; severe headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea) 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-Feb-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 PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (Pain), PYREXIA (fever), CHILLS (chill), HEADACHE (severe headache) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test (positive-negative): positive (Positive) tested + month ago.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Lymphadenopathy
Clinical narrative: Red rash that is very itchy; It has spread a bit and it is a skin reaction; It is itchy and warm to the touch; It is itchy and warm to the touch; large red swollen reaction at the injection site; large red swollen reaction at the injection site; swelling in her left side of the lymph node in her mouth and throat; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red rash that is very itchy), SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch) and INJECTION SITE SWELLING (large red swollen reaction at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (had many of her lymph nodes removed on that side).   On 09-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 12-Feb-2021, the patient experienced RASH PRURITIC (Red rash that is very itchy), SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch), INJECTION SITE SWELLING (large red swollen reaction at the injection site), INJECTION SITE ERYTHEMA (large red swollen reaction at the injection site) and LYMPHADENOPATHY (swelling in her left side of the lymph node in her mouth and throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Red rash that is very itchy) had resolved and SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch), INJECTION SITE SWELLING (large red swollen reaction at the injection site), INJECTION SITE ERYTHEMA (large red swollen reaction at the injection site) and LYMPHADENOPATHY (swelling in her left side of the lymph node in her mouth and throat) outcome was unknown.            No concomitant medication was reported.  The patient informed everything was fine. Rash disappeared.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Additional information : added patient demographics, medical history, dose start date, additional event(s) On 14-Jul-2021: Follow up received via email contains significant information of outcome of an event (rash)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Skin reaction
Clinical narrative: Red rash that is very itchy; It has spread a bit and it is a skin reaction; It is itchy and warm to the touch; It is itchy and warm to the touch; large red swollen reaction at the injection site; large red swollen reaction at the injection site; swelling in her left side of the lymph node in her mouth and throat; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Red rash that is very itchy), SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch) and INJECTION SITE SWELLING (large red swollen reaction at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (had many of her lymph nodes removed on that side).   On 09-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 12-Feb-2021, the patient experienced RASH PRURITIC (Red rash that is very itchy), SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch), INJECTION SITE SWELLING (large red swollen reaction at the injection site), INJECTION SITE ERYTHEMA (large red swollen reaction at the injection site) and LYMPHADENOPATHY (swelling in her left side of the lymph node in her mouth and throat). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Red rash that is very itchy) had resolved and SKIN REACTION (It has spread a bit and it is a skin reaction), INJECTION SITE WARMTH (It is itchy and warm to the touch), INJECTION SITE PRURITUS (It is itchy and warm to the touch), INJECTION SITE SWELLING (large red swollen reaction at the injection site), INJECTION SITE ERYTHEMA (large red swollen reaction at the injection site) and LYMPHADENOPATHY (swelling in her left side of the lymph node in her mouth and throat) outcome was unknown.            No concomitant medication was reported.  The patient informed everything was fine. Rash disappeared.   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: Additional information : added patient demographics, medical history, dose start date, additional event(s) On 14-Jul-2021: Follow up received via email contains significant information of outcome of an event (rash)
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Flushing, Hypertension, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (dizzy), FLUSHING (Face became flushed and hot), HYPERTENSION (His blood pressure was high), PAIN IN EXTREMITY (soreness in his arm) and BACK PAIN (Slight soreness in his back) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Heart attack and Blood pressure high. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DIZZINESS (dizzy), FLUSHING (Face became flushed and hot), HYPERTENSION (His blood pressure was high), PAIN IN EXTREMITY (soreness in his arm) and BACK PAIN (Slight soreness in his back). At the time of the report, DIZZINESS (dizzy), FLUSHING (Face became flushed and hot), HYPERTENSION (His blood pressure was high), PAIN IN EXTREMITY (soreness in his arm) and BACK PAIN (Slight soreness in his back) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment medications included Tylenol. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-101401 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up information included outcome of the events
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: momentary sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (momentary sore throat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (momentary sore throat). At the time of the report, OROPHARYNGEAL PAIN (momentary sore throat) outcome was unknown.            No concomitant medication were reported
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dizziness, Erythema, Fatigue, Pain
Clinical narrative: Dark urine; Congested throat; Dizziness; Body aches; Fever; Fatigue; Redness on face; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), ERYTHEMA (Redness on face) and PAIN (Body aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (Redness on face). On 17-Feb-2021, the patient experienced CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), ERYTHEMA (Redness on face), PAIN (Body aches), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            Treatment details included None.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Throat tightness
Clinical narrative: Dark urine; Congested throat; Dizziness; Body aches; Fever; Fatigue; Redness on face; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), ERYTHEMA (Redness on face) and PAIN (Body aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (Redness on face). On 17-Feb-2021, the patient experienced CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), PAIN (Body aches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, CHROMATURIA (Dark urine), THROAT TIGHTNESS (Congested throat), DIZZINESS (Dizziness), ERYTHEMA (Redness on face), PAIN (Body aches), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            Treatment details included None.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: still has red blotches all over; Vagina had an itch; red rash; black rash on legs,feet are black, her toes are black, her nails are black; so hot to touch; peel; arm is swollen and hot; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch) and SKIN EXFOLIATION (peel) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch), SKIN EXFOLIATION (peel) and PERIPHERAL SWELLING (arm is swollen and hot). At the time of the report, VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch), SKIN EXFOLIATION (peel) and PERIPHERAL SWELLING (arm is swollen and hot) 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Follow up information was received and events were added.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Vulvovaginal pruritus
Clinical narrative: still has red blotches all over; Vagina had an itch; red rash; black rash on legs,feet are black, her toes are black, her nails are black; so hot to touch; peel; arm is swollen and hot; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch) and SKIN EXFOLIATION (peel) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch), SKIN EXFOLIATION (peel) and PERIPHERAL SWELLING (arm is swollen and hot). At the time of the report, VULVOVAGINAL PRURITUS (Vagina had an itch), RASH ERYTHEMATOUS (red rash), RASH (black rash on legs,feet are black, her toes are black, her nails are black), INJECTION SITE WARMTH (so hot to touch), SKIN EXFOLIATION (peel) and PERIPHERAL SWELLING (arm is swollen and hot) 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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Follow up information was received and events were added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: heart rate went up to 120 bpm; fever of 101 F; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate went up to 120 bpm) and PYREXIA (fever of 101 F) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bradycardia. Concurrent medical conditions included Spice allergy and Adhesive tape allergy. Concomitant products included METFORMIN, METOPROLOL and ROPINIROLE.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Jan-2021, the patient experienced HEART RATE INCREASED (heart rate went up to 120 bpm) and PYREXIA (fever of 101 F). At the time of the report, HEART RATE INCREASED (heart rate went up to 120 bpm) and PYREXIA (fever of 101 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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 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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Alcoholic (1 drink/month). Concurrent medical conditions included Migraine (worsening) since 2014, Hypothyroidism since 2016 and Bipolar disorder since 2006. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), TRAZODONE and ACETAMINOPHEN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 20-Nov-2020 and the estimated date of delivery was 25-Aug-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2020, Pregnancy test: positive (Positive) Positive. On 15-Jan-2021, Ultrasound foetal: abnormal (abnormal) fetal tachycardia. On 27-Jan-2021, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Estimated conception date of patient was on 02 Dec 2020. No of fetus was found to be one.   Treatment information was not provided.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Nausea, Rash macular
Clinical narrative: weakness; nausea; vomitting; red blotchy skin,blotches under the skin on both arms and legs that look like bruises; tired; shivering; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomitting), RASH MACULAR (red blotchy skin,blotches under the skin on both arms and legs that look like bruises), FATIGUE (tired) and CHILLS (shivering) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced NAUSEA (nausea), VOMITING (vomitting), RASH MACULAR (red blotchy skin,blotches under the skin on both arms and legs that look like bruises), FATIGUE (tired) and CHILLS (shivering). On 12-Feb-2021, the patient experienced ASTHENIA (weakness). At the time of the report, NAUSEA (nausea), VOMITING (vomitting), RASH MACULAR (red blotchy skin,blotches under the skin on both arms and legs that look like bruises), FATIGUE (tired), CHILLS (shivering) and ASTHENIA (weakness) outcome was unknown.            No relevant concomitant medications were reported  Treatment details included medication for nausea.