chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Pain in extremity
Clinical narrative: HALF-DOLLAR SIZE BRUISE ON LEFT UPPER THIGH; MILD HEADACHE OFF AND ON LASTING  SECONDS; SORENESS IN THE LEFT ARM FROM INJECTION; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and dulaglutide. On 10-MAY-2021, the subject experienced soreness in the left arm from injection. On 11-MAY-2021, the subject experienced half-dollar size bruise on left upper thigh. On 11-MAY-2021, the subject experienced mild headache off and on lasting seconds. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from soreness in the left arm from injection, and half-dollar size bruise on left upper thigh, and the outcome of mild headache off and on lasting seconds was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: LIGHTHEADED; NOT FEELING RIGHT; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced lightheaded. On MAY-2021, the subject experienced not feeling right. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, lightheaded and not feeling right was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021 04:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: VOMITING; PAINFUL HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 23 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced vomiting. On 11-MAY-2021, the subject experienced painful headache. On 11-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 11-MAY-2021, was recovering from fever, and had not recovered from painful headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Tremor
Clinical narrative: SHAKES; CHILLS; SOME MILD NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced shakes, chills, and some mild nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes, chills, and some mild nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Pyrexia
Clinical narrative: SICK; FEVER; HEADACHE; TIRED; This spontaneous report received from a parent concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sick, fever, headache, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, tired and sick was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: CLOT IN LUNGS; This spontaneous report received from a pharmacist concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the patient experienced clot in lungs, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210522762 - Covid-19 vaccine ad26.cov2.s - CLOT IN LUNGS . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain
Clinical narrative: DIARRHEA; BODY ACHES; HEADACHES; This spontaneous report received from a consumer concerned a 67 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1812072 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced diarrhea. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headaches, diarrhea, and body aches. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: VERY WEAK; FEVER; BAD HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced very weak, fever, and bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, bad headache and very weak was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Injection site reaction, Injection site swelling
Clinical narrative: VEINS POPPED UP IN BOTH FEET LOOKS LIKE VARICOSE VEINS; NODULES IN HANDS AND FEET; HARD AT INJECTION SITE; FEET TURNED RED-PINK COLOR FROM FEET TO CALVES; TIRED; INJECTION SITE SWELLING; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient's blood group was o- type. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced veins popped up in both feet looks like varicose veins. On 07-MAY-2021, the subject experienced nodules in hands and feet. On 07-MAY-2021, the subject experienced hard at injection site. On 07-MAY-2021, the subject experienced feet turned red-pink color from feet to calves. On 07-MAY-2021, the subject experienced tired. On 07-MAY-2021, the subject experienced injection site swelling. On 07-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from nodules in hands and feet on MAY-2021, hard at injection site, and feet turned red-pink color from feet to calves on 07-MAY-2021, and headache on 08-MAY-2021, was recovering from tired, and injection site swelling, and had not recovered from veins popped up in both feet looks like varicose veins. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Varicose vein
Clinical narrative: VEINS POPPED UP IN BOTH FEET LOOKS LIKE VARICOSE VEINS; NODULES IN HANDS AND FEET; HARD AT INJECTION SITE; FEET TURNED RED-PINK COLOR FROM FEET TO CALVES; TIRED; INJECTION SITE SWELLING; HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient's blood group was o- type. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced veins popped up in both feet looks like varicose veins. On 07-MAY-2021, the subject experienced nodules in hands and feet. On 07-MAY-2021, the subject experienced hard at injection site. On 07-MAY-2021, the subject experienced feet turned red-pink color from feet to calves. On 07-MAY-2021, the subject experienced tired. On 07-MAY-2021, the subject experienced injection site swelling. On 07-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from nodules in hands and feet on MAY-2021, hard at injection site, and feet turned red-pink color from feet to calves on 07-MAY-2021, and headache on 08-MAY-2021, was recovering from tired, and injection site swelling, and had not recovered from veins popped up in both feet looks like varicose veins. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Laboratory test interference
Clinical narrative: INFLAMMATORY ARTHRITIS ON JOINTS; This spontaneous report received from a patient concerned a 75 year old male. The patient's weight was 216 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included iodine contrast allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was previously treated with lisinopril, and prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate. On 12-MAR-2021, the subject experienced inflammatory arthritis on joints. On 16-APR-2021, Laboratory data included: Laboratory test interference NOS (NR: not provided) inflammatory arthritis on his joints. Treatment medications included: prednisone acetate. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammatory arthritis on joints. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Fibromyalgia, Myalgia
Clinical narrative: COUGH WITH DEEP INSPIRATION; GENERAL TIREDNESS; MUSCLE ACHES; FEVER; FIBROMYALGIA; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Concomitant medications included naproxen for rheumatoid arthritis. On 10-MAY-2021, the subject experienced cough with deep inspiration. On 10-MAY-2021, the subject experienced general tiredness. On 10-MAY-2021, the subject experienced muscle aches. On 10-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 11-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.2 F.  On an unspecified date, the subject experienced fibromyalgia. The action taken with covid-19 vaccine  was not applicable. The outcome of the general tiredness, muscle aches, cough with deep inspiration, fever and fibromyalgia was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COUGH WITH DEEP INSPIRATION; GENERAL TIREDNESS; MUSCLE ACHES; FEVER; FIBROMYALGIA; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Concomitant medications included naproxen for rheumatoid arthritis. On 10-MAY-2021, the subject experienced cough with deep inspiration. On 10-MAY-2021, the subject experienced general tiredness. On 10-MAY-2021, the subject experienced muscle aches. On 10-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 11-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.2 F.  On an unspecified date, the subject experienced fibromyalgia. The action taken with covid-19 vaccine  was not applicable. The outcome of the general tiredness, muscle aches, cough with deep inspiration, fever and fibromyalgia was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: LOSS OF APPETITE; HEADACHE; FEELS WARM TO THE TOUCH; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included skin allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no drug use or drug illicit usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 14:00 for prophylactic vaccination. Concomitant medications included levothyroxine for drug used for unknown indication.  On 06-MAY-2021, the subject experienced feels warm to the touch. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced fatigue. On 07-MAY-2021, the subject experienced headache. On 09-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 11-MAY-2021, treatment medications included: ascorbic acid, ibuprofen, and nicotinamide/pyridoxine hydrochloride/riboflavin/thiamine hydrochloride. On 12-MAY-2021, the subject experienced loss of appetite. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, and fatigue on 12-MAY-2021, had not recovered from headache, and feels warm to the touch, and the outcome of loss of appetite was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: LOSS OF APPETITE; HEADACHE; FEELS WARM TO THE TOUCH; CHILLS; FATIGUE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included skin allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no drug use or drug illicit usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 14:00 for prophylactic vaccination. Concomitant medications included levothyroxine for drug used for unknown indication.  On 06-MAY-2021, the subject experienced feels warm to the touch. On 06-MAY-2021, the subject experienced chills. On 06-MAY-2021, the subject experienced fatigue. On 07-MAY-2021, the subject experienced headache. On 09-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 11-MAY-2021, treatment medications included: ascorbic acid, ibuprofen, and nicotinamide/pyridoxine hydrochloride/riboflavin/thiamine hydrochloride. On 12-MAY-2021, the subject experienced loss of appetite. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, and fatigue on 12-MAY-2021, had not recovered from headache, and feels warm to the touch, and the outcome of loss of appetite was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Insomnia
Clinical narrative: DIDN'T SLEEP WELL; BODY ACHES; FATIGUE; HEADACHE WITH NO FEVER; FELT LIKE NOT ABLE TO TAKE DEEP BREATH; FELT LIKE HEAVY WEIGHT ON CHEST; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced felt like not able to take deep breath. On MAY-2021, the subject experienced felt like heavy weight on chest. On 11-MAY-2021, the subject experienced didn't sleep well. On 11-MAY-2021, the subject experienced body aches. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced headache with no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from didn't sleep well, body aches, fatigue, and headache with no fever, and the outcome of felt like not able to take deep breath and felt like heavy weight on chest was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pain
Clinical narrative: DIDN'T SLEEP WELL; BODY ACHES; FATIGUE; HEADACHE WITH NO FEVER; FELT LIKE NOT ABLE TO TAKE DEEP BREATH; FELT LIKE HEAVY WEIGHT ON CHEST; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced felt like not able to take deep breath. On MAY-2021, the subject experienced felt like heavy weight on chest. On 11-MAY-2021, the subject experienced didn't sleep well. On 11-MAY-2021, the subject experienced body aches. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced headache with no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from didn't sleep well, body aches, fatigue, and headache with no fever, and the outcome of felt like not able to take deep breath and felt like heavy weight on chest was not reported. This report was non-serious.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vasodilatation
Clinical narrative: BULGING FEET VEINS; HEADACHES; TIREDNESS; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgeries, and left elevated diaphragm, and concurrent conditions included prostate cancer, and diabetes, and other pre-existing medical conditions included does the patient have any allergies? :: yes provide details of the allergies :: codeine. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced tiredness. On 11-MAY-2021, the subject experienced bulging feet veins. On 11-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headaches, and bulging feet veins, and the outcome of tiredness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Pain in extremity, Paraesthesia
Clinical narrative: NERVE TINGLING IN LEFT THIGH; LEFT LEG PAIN CENTRED IN KNEE; GENERAL WEAKNESS; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included low thyroid, penicillin allergy, sulfa drugs allergy, and allergy to mango, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with naproxen. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 42A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced chest tightness. On 11-APR-2021, the subject experienced nerve tingling in left thigh. On 11-APR-2021, the subject experienced left leg pain centred in knee. On 11-APR-2021, the subject experienced general weakness. On 10-MAY-2021, treatment medications included: meloxicam. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chest tightness, and had not recovered from left leg pain centred in knee, nerve tingling in left thigh, and general weakness. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: HARD SPOT AT INJECTION SITE; HOT AROUND INJECTION AREA; REDNESS AROUND INJECTION SITE; ARM PAIN AROUND INJECTION SITE; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hard spot at injection site, hot around injection area, redness around injection site, and arm pain around injection site. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from hard spot at injection site, redness around injection site, hot around injection area, and arm pain around injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine  was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included neck injury. and concurrent conditions included migraines, non-smoker, and non-alcohol consumer, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included bad back, and concurrent conditions included high blood pressure, high cholesterol, intolerant to statin, non smoker, and non alcohol user, and other pre-existing medical conditions included on medication for high blood pressure and high cholesterol and no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced burning sensation in both legs and feet. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from burning sensation in both legs and feet. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: SWELLING ARM; CHEST PAIN; SWELLING OF CHEST; PAIN IN ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included swelling in chest, and chest pain, and other pre-existing medical conditions included the veins in chest wall are involved and could take up to 6 weeks to resolve. this person was still in pain and swelling continues and was now being asked to see a cardiologist. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced swelling arm, chest pain, swelling of chest, and pain in arm. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain in arm, swelling arm, chest pain, and swelling of chest. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: NAUSEA; DIARRHEA; VOMITING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the subject experienced diarrhea. On 11-MAY-2021, the subject experienced vomiting. On an unspecified date, the subject experienced nausea. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Does not have the results back, and COVID-19 rapid POC test (NR: not provided) negative. The action taken with covid-19 vaccine was not applicable. The outcome of the vomiting, diarrhea and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Allergy to metals, Multiple chemical sensitivity, Taste disorder
Clinical narrative: DISTORTED TASTE OF FOODS FIVE; SENSITIVITY TO CHEMICAL ODORS; SENSITIVITY TO METALS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced distorted taste of foods five, sensitivity to chemical odors, and sensitivity to metals. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from distorted taste of foods five, sensitivity to chemical odors, and sensitivity to metals. This report was non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: LEFT ELBOW PAIN AND PAIN FROM SHOULDER TO WRIST; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, alcohol use, and smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAR-2021, the subject experienced left elbow pain and pain from shoulder to wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left elbow pain and pain from shoulder to wrist. This report was non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Peripheral coldness, Pyrexia
Clinical narrative: HANDS WERE FREEZING; SORE BODY; HEADACHE; FEVER; PAIN IN THE MUSCLES; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight, height, and medical history were not reported. The patient was previously treated with quetiapine fumarate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZ1(A/I), and expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced hands were freezing. On 12-MAY-2021, the subject experienced sore body. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced fever. On 12-MAY-2021, the subject experienced pain in the muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hands were freezing on 12-MAY-2021, and had not recovered from headache, fever, pain in the muscles, and sore body. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a pharmacist concerned a 16 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On 12-MAY-2021, the subject experienced off label use. On 12-MAY-2021, the subject experienced product administered to subject of inappropriate age. The action taken with covid-19 vaccine  was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Epistaxis, Fatigue, Feeling abnormal, Malaise
Clinical narrative: LEFT CALF PAIN; THICKENED SALIVA; NOSE BLEED, RIGHT NOSTRIL; WEAK; TIRED; FEELS NOT NORMAL; FELT SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-APR-2021 to Left Arm for prophylactic vaccination. The batch no is not reported but a follow-up will be requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced felt sick. On an unspecified date, the subject experienced left calf pain, thickened saliva, nose bleed, right nostril, weak, tired, and feels not normal. The action taken with covid-19 vaccine was not applicable. The outcome of the left calf pain, thickened saliva, nose bleed, right nostril, weak, tired, feels not normal and felt sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Salivary hypersecretion
Clinical narrative: LEFT CALF PAIN; THICKENED SALIVA; NOSE BLEED, RIGHT NOSTRIL; WEAK; TIRED; FEELS NOT NORMAL; FELT SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-APR-2021 to Left Arm for prophylactic vaccination. The batch no is not reported but a follow-up will be requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced felt sick. On an unspecified date, the subject experienced left calf pain, thickened saliva, nose bleed, right nostril, weak, tired, and feels not normal. The action taken with covid-19 vaccine was not applicable. The outcome of the left calf pain, thickened saliva, nose bleed, right nostril, weak, tired, feels not normal and felt sick was not reported. This report was non-serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Taste disorder
Clinical narrative: VACCINE TASTE (STRONG BITTER ODOR); INJECTION SITE REACTION; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced vaccine taste (strong bitter odor). On 08-MAY-2021, the subject experienced injection site reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine taste (strong bitter odor) on 12-MAY-2021, and injection site reaction. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned an adult male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 18:45 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate, Heart rate decreased
Clinical narrative: BODY ACHES; HARD TO BREATHE; DIZZINESS; HIGH HEADACHE; LOW HEART RATE; MIGRAINE; This spontaneous report received from a consumer concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced migraine. On MAY-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) Low. On 07-MAY-2021, the subject experienced body aches. On 07-MAY-2021, the subject experienced hard to breathe. On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced high headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from migraine, and the outcome of high headache, body aches, hard to breathe, low heart rate and dizziness was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: BODY ACHES; HARD TO BREATHE; DIZZINESS; HIGH HEADACHE; LOW HEART RATE; MIGRAINE; This spontaneous report received from a consumer concerned a 33 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced migraine. On MAY-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) Low. On 07-MAY-2021, the subject experienced body aches. On 07-MAY-2021, the subject experienced hard to breathe. On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced high headache. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from migraine, and the outcome of high headache, body aches, hard to breathe, low heart rate and dizziness was not reported. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: BURNING SENSATION DOWN IN LEFT LEG; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced burning sensation down in left leg. The action taken with covid-19 vaccine  was not applicable. The outcome of burning sensation down in left leg was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Injection site pain, Muscle twitching
Clinical narrative: ON/OFF KNEE AND LEG SWELLING; ON/OFF DIARRHEA; ON/OFF STOMACH HURTING; ON/OFF PERSISTENT HEADACHE; INJECTION SITE SORE ARM; MUSCLES TWITCHING WHERE GOT SHOT; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included chorionic villus sampling, and concurrent conditions included cholesterol, diabetes, chronic obstructive pulmonary disease, and gout. The patient experienced drug allergy when treated with quetiapine fumarate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced muscles twitching where got shot. On 02-APR-2021, the subject experienced injection site sore arm. On 03-APR-2021, the subject experienced on/off persistent headache. On 04-APR-2021, the subject experienced on/off knee and leg swelling. On 04-APR-2021, the subject experienced on/off diarrhea. On 04-APR-2021, the subject experienced on/off stomach hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscles twitching where got shot on 20-APR-2021, and injection site sore arm on 16-APR-2021, and was recovering from on/off persistent headache, on/off knee and leg swelling, on/off diarrhea, and on/off stomach hurting. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: ON/OFF KNEE AND LEG SWELLING; ON/OFF DIARRHEA; ON/OFF STOMACH HURTING; ON/OFF PERSISTENT HEADACHE; INJECTION SITE SORE ARM; MUSCLES TWITCHING WHERE GOT SHOT; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included chorionic villus sampling, and concurrent conditions included cholesterol, diabetes, chronic obstructive pulmonary disease, and gout. The patient experienced drug allergy when treated with quetiapine fumarate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-APR-2021, the subject experienced muscles twitching where got shot. On 02-APR-2021, the subject experienced injection site sore arm. On 03-APR-2021, the subject experienced on/off persistent headache. On 04-APR-2021, the subject experienced on/off knee and leg swelling. On 04-APR-2021, the subject experienced on/off diarrhea. On 04-APR-2021, the subject experienced on/off stomach hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscles twitching where got shot on 20-APR-2021, and injection site sore arm on 16-APR-2021, and was recovering from on/off persistent headache, on/off knee and leg swelling, on/off diarrhea, and on/off stomach hurting. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: Rash; Allergic reaction; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant). On 18-Jan-2021, the patient experienced RASH (Rash). At the time of the report, HYPERSENSITIVITY (Allergic reaction) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was mentioned. The patient stated 2 days after receiving the vaccine she went to the emergency room for an allergic reaction and 10 days after vaccination she developed a rash.; Sender's Comments: This case concerns an adult female with a serious unexpected hypersensitivity and nonserious expected rash. Latency 2 days after mRNA-1273. Based on 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.