chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: NECK TIGHT FEELING ON RIGHT SIDE IN GLAND AREA WHEN SWALLOWS; LEFT EYE WATERING CONSTANTLY WHILE AWAKE; NO APPETITE; PAIN AT INJECTION SITE; NAUSEA; MUSCLE ACHES; SHARP STABBING PAIN IN HEAD; HEADACHE; BODY ACHES; PAIN BACK OF LEFT LEG NEAR KNEE; FEVER; This spontaneous report received from a patient concerned a 57 year old female. 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: EL043A21A,  expiry: not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021 16:45, the subject experienced fever. On 11-APR-2021, the subject experienced pain back of left leg near knee. On 11-APR-2021 04:00, the subject experienced body aches. On 11-APR-2021 04:00, the subject experienced sharp stabbing pain in head. On 11-APR-2021 04:00, the subject experienced headache. On 12-APR-2021, the subject experienced neck tight feeling on right side in gland area when swallows. On 12-APR-2021, the subject experienced left eye watering constantly while awake. On 12-APR-2021, the subject experienced no appetite. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp stabbing pain in head on 12-APR-2021, and had not recovered from pain at injection site, neck tight feeling on right side in gland area when swallows, fever, headache, body aches, nausea, left eye watering constantly while awake, pain back of left leg near knee, muscle aches, and no appetite. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Influenza
Clinical narrative: FLU SYMPTOMS; UPSET STOMACH; HEADACHES; This spontaneous report received from a patient concerned a 66 year old female. 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Vaccinated at the right arm. No concomitant medications were reported. On an unspecified date, the subject experienced flu symptoms, upset stomach, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu symptoms, headaches and upset stomach was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Abdominal rigidity, Malaise
Clinical narrative: MAJOR ABDOMINAL/STOMACH PAIN; POSSIBLE STOMACH SPASM; NOT FEELING WELL; UPSET STOMACH; 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, 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 major abdominal/stomach pain, possible stomach spasm, not feeling well, and upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from major abdominal/stomach pain, not feeling well, and possible stomach spasm, and the outcome of upset stomach was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: HEAD ACHE; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 year old female. 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced head ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and head ache on APR-2021. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Nausea
Clinical narrative: NAUSEA; FATIGUE; MUSCLE SORENESS ALL OVER BACK; LOW ENERGY; This spontaneous report received from a patient concerned a 45 year old female. 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: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced muscle soreness all over back. On 11-APR-2021, the subject experienced low energy. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle soreness all over back on 12-APR-2021, and had not recovered from fatigue, low energy, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Insomnia, Pain
Clinical narrative: COUGH; CHILLS; FEVER; HEADACHE; BODY ACHE; COULD NOT SLEEP; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart failure, and concurrent conditions included defibrillator implanted. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced could not sleep. On 13-APR-2021, the subject experienced body ache. On 13-APR-2021, the subject experienced cough. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, headache, chills, fever, cough, and could not sleep. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: COUGH; CHILLS; FEVER; HEADACHE; BODY ACHE; COULD NOT SLEEP; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included heart failure, and concurrent conditions included defibrillator implanted. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced could not sleep. On 13-APR-2021, the subject experienced body ache. On 13-APR-2021, the subject experienced cough. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, headache, chills, fever, cough, and could not sleep. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: NAUSEA; BEDRIDDEN; MUSCLE ACHE; FEVER; CHILLS; 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 not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 15:00 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 08-APR-2021 23:00, the subject experienced chills. On 09-APR-2021, the subject experienced bedridden. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle ache, fever, bedridden and nausea was not reported. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Dizziness, Hyperhidrosis
Clinical narrative: SWEATING; VOMITING; TREMBLING; SEVERE MIGRANE; LIGHT HEADEDNESS; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. no drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced trembling. On 10-APR-2021, the subject experienced severe migrane. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, vomiting, trembling, severe migrane, light headedness, weakness, chills, and fever on 10-APR-2021. This report was non-serious.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pyrexia, Tremor, Vomiting
Clinical narrative: SWEATING; VOMITING; TREMBLING; SEVERE MIGRANE; LIGHT HEADEDNESS; WEAKNESS; CHILLS; FEVER; This spontaneous report received from a parent concerned a 25 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. no drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced weakness. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced trembling. On 10-APR-2021, the subject experienced severe migrane. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, vomiting, trembling, severe migrane, light headedness, weakness, chills, and fever on 10-APR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWELLING ARM; 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: 201a21a, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swelling arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: AFTER VACCINATION CAN FEEL TASTE OF IT; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced after vaccination can feel taste of it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of after vaccination can feel taste of it was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: SEVER LOWER BACK AND NECK MUSCULAR PAIN; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported.  On 13-APR-2021 07:30, the subject experienced sever lower back and neck muscular pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sever lower back and neck muscular pain. This report was non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE ARM SORENESS; This spontaneous report received from a patient concerned a 28 year old female. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site arm soreness. This report was non-serious. This case, from the same reporter is linked to 20210424282.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Contusion, Headache, Pain
Clinical narrative: LARGE BRUISE ON THE SOLE OF THE FOOT; BURNING ON THE BOTTOM OF THE FOOT; THROBBING FOOT; VEIN POPPED UP FEELING ON FOOT; ACHINESS; CHILLS; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no current medications. no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 11:27 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced low grade fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 12-APR-2021, the subject experienced large bruise on the sole of the foot. On 12-APR-2021, the subject experienced burning on the bottom of the foot. On 12-APR-2021, the subject experienced throbbing foot. On 12-APR-2021, the subject experienced vein popped up feeling on foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, chills, low grade fever, and headache on 12-APR-2021, had not recovered from burning on the bottom of the foot, throbbing foot, and large bruise on the sole of the foot, and the outcome of vein popped up feeling on foot was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensory disturbance, Skin burning sensation, Vasodilatation
Clinical narrative: LARGE BRUISE ON THE SOLE OF THE FOOT; BURNING ON THE BOTTOM OF THE FOOT; THROBBING FOOT; VEIN POPPED UP FEELING ON FOOT; ACHINESS; CHILLS; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no current medications. no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 11:27 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced achiness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced low grade fever. On 11-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.3 F. On 12-APR-2021, the subject experienced large bruise on the sole of the foot. On 12-APR-2021, the subject experienced burning on the bottom of the foot. On 12-APR-2021, the subject experienced throbbing foot. On 12-APR-2021, the subject experienced vein popped up feeling on foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, chills, low grade fever, and headache on 12-APR-2021, had not recovered from burning on the bottom of the foot, throbbing foot, and large bruise on the sole of the foot, and the outcome of vein popped up feeling on foot was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain in extremity
Clinical narrative: DIARRHEA; SORE ARM; 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: not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and sore arm on 11-APR-2021, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Tremor
Clinical narrative: FEELING WEIRD; TREMBLING; SHAKING; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, allergy to codeine, non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no history of 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced trembling. On 06-MAR-2021, the subject experienced shaking. On an unspecified date, the subject experienced feeling weird. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from trembling, and shaking, and the outcome of feeling weird was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORENESS IN ARM; VERY TIRED; This spontaneous report received from a consumer concerned a 48 year old female. 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 04-APR-2021 for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. On 04-APR-2021, the subject experienced very tired. On 06-APR-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in arm, and very tired. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: PAINFUL KNOT ON PREVIOUS VERICOSE VEINS ON LEFT LEG (KNOT WAS SORE TO THE TOUCH); This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included varicose vein. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced painful knot on previous vericose veins on left leg (knot was sore to the touch). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful knot on previous vericose veins on left leg (knot was sore to the touch). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a health care professional concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 13-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report received from a patient concerned a 39 year old female. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced thrown up. On 09-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.9 F. On 12-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, thrown up and fever was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: HIVES; FEVER; ACHES; This spontaneous report received from a patient concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: not reported) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: diphenhydramine hydrochloride. On 03-APR-2021, the subject experienced aches. On 03-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and fever on 04-APR-2021, and was recovering from hives. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Fatigue, Headache, Injection site swelling
Clinical narrative: JOINT PAIN WITH FLEXION- INCREASED ON LEFT ELBOW; HEADACHE; FATIGUE; INJECTION SITE SWELLING; PAIN IN ARMPIT (LYMPH NODE); 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 not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced pain in armpit. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced injection site swelling. On 11-APR-2021, the subject experienced joint pain with flexion- increased on left elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site swelling, and joint pain with flexion- increased on left elbow, and the outcome of headache, fatigue and pain in armpit was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pain, Insomnia, Myalgia
Clinical narrative: INSOMNIA; INJECTION SITE REDNESS; FATIGUE; MYALGIA, MUSCLE PAIN; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 64 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: 1805029 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced injection site pain. On 29-MAR-2021, the subject experienced fatigue. On 29-MAR-2021, the subject experienced myalgia, muscle pain. On 07-APR-2021, the subject experienced insomnia. On 07-APR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain, fatigue, myalgia, muscle pain, insomnia, and injection site redness. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Heart rate, Heart rate increased, Hypoaesthesia
Clinical narrative: ARM SORENESS; HIGH HEART RATE WHILE RUNNING; NUMBNESS IN LEFT LEG; CHEST PAIN; POSSIBLE WEAKNESS; This spontaneous report received from a patient. 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: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced possible weakness. On MAR-2021, the subject experienced high heart rate while running. On MAR-2021, the subject experienced numbness in left leg. On MAR-2021, the subject experienced chest pain. Laboratory data included: Heart rate (NR: not provided) 192 high speed while running. On 06-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, high heart rate while running, numbness in left leg, chest pain and possible weakness was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM SORENESS; HIGH HEART RATE WHILE RUNNING; NUMBNESS IN LEFT LEG; CHEST PAIN; POSSIBLE WEAKNESS; This spontaneous report received from a patient. 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: 1802070 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced possible weakness. On MAR-2021, the subject experienced high heart rate while running. On MAR-2021, the subject experienced numbness in left leg. On MAR-2021, the subject experienced chest pain. Laboratory data included: Heart rate (NR: not provided) 192 high speed while running. On 06-MAR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm soreness, high heart rate while running, numbness in left leg, chest pain and possible weakness was not reported. This report was non-serious.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: SORE ARM; NAUSEA; This spontaneous report received from a patient concerned a 62 year old of unspecified 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: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: SWOLLEN LIPS; TINGLING LIPS; 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 not reported, batch number: unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, the subject experienced swollen lips. On 13-APR-2021, the subject experienced tingling lips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen lips and tingling lips was not reported. This report was non-serious.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: SORE ARM; LIGHT HEADACHE; This spontaneous report received from a patient concerned a 55 year old of unspecified 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: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headache on 10-APR-2021, and had not recovered from sore arm. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: Extreme dizziness, off balance, nausea. Has not let up at all. When to dr. He is sending me for mri/contrast on brain. April 28, 2021 Went to another ent Dr and he has put me on Methyiprdnisolone.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Urinary incontinence
Clinical narrative: Patient was fine immediately after vaccination. She left our vaccination room to sit down and wait 15 minutes and for some reason did not sit down, but kept walking, then proceeded to lay herself down in an aisle of the store. She says she passed out. I only witnessed her being awake. She urinated herself. She asked for a pillow and cold wash cloth. We got her those. We tried to get her a snack and a juice, but she didn't take those. I had a technician call an ambulance and pressed a button we have that calls the police as well. The police arrived first. The ambulance crew took her out into their truck to be evaluated and said she was fine, but had her mom come pick her up because they just didn't want her to drive. She did tell me before I gave her the shot that she passes out from vaccines.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Feeling cold, Hyperventilation, Musculoskeletal chest pain
Clinical narrative: (My normal temp 97.7) Thursday: Woke up freezing during night with temp of 96.5. Woke in morning whole body hurt to move. Temp steadily increased during day to 101. Took tylonol. Also my shoulder really hurt and rash started. Consumed complete upper arm almost to elbow. Hard, red, hot, welt and itchy.  Early evening slight heavy in breathing and ribs in back hurt. Friday: some improvement, still sore all over. Arm same. Saturday: feeling better about 75-80%. Arm same. Sunday much better just tired. Monday arm improving but growing around arm.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Skin induration, Skin warm
Clinical narrative: (My normal temp 97.7) Thursday: Woke up freezing during night with temp of 96.5. Woke in morning whole body hurt to move. Temp steadily increased during day to 101. Took tylonol. Also my shoulder really hurt and rash started. Consumed complete upper arm almost to elbow. Hard, red, hot, welt and itchy.  Early evening slight heavy in breathing and ribs in back hurt. Friday: some improvement, still sore all over. Arm same. Saturday: feeling better about 75-80%. Arm same. Sunday much better just tired. Monday arm improving but growing around arm.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: (My normal temp 97.7) Thursday: Woke up freezing during night with temp of 96.5. Woke in morning whole body hurt to move. Temp steadily increased during day to 101. Took tylonol. Also my shoulder really hurt and rash started. Consumed complete upper arm almost to elbow. Hard, red, hot, welt and itchy.  Early evening slight heavy in breathing and ribs in back hurt. Friday: some improvement, still sore all over. Arm same. Saturday: feeling better about 75-80%. Arm same. Sunday much better just tired. Monday arm improving but growing around arm.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Erythema, Pruritus, Urticaria
Clinical narrative: 4 hours post vaccination developed severe itching, next morning  after shower full body hives back and stomach, under arms, behind knees and full body redness. Saw PMD and they stated to use Benadryl for relief 3 days later. Called dermatology and they gave her cream (trimcinolone acetonide) to help with hives along with allegra and symptoms have resolved after 17 days.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: 4 hours post vaccination developed severe itching, next morning  after shower full body hives back and stomach, under arms, behind knees and full body redness. Saw PMD and they stated to use Benadryl for relief 3 days later. Called dermatology and they gave her cream (trimcinolone acetonide) to help with hives along with allegra and symptoms have resolved after 17 days.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness, fell from feeling faint; h/o vasovagal episodes after shots. BPs 79/31 (pulse 50), 103/52 (pulse 46). O2 sat 100%.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Caused severe swelling , and pain in my arm pit on the right side where the shot was administered.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Deep Vein Thrombosis in lower right leg
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Tingling in left hand, forearm and left foot almost immediately after being administered shot. Symptoms continue to persist a few hours after shot.
Sex: F
Vaccine: COVID19
Symptoms: Application site discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: GENERAL FATIGUE; ARM PAIN; SWELLING; REDNESS; TENDER TO TOUCH; CHILLS; BAD HEADACHE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, treatment medications included: diphenhydramine/paracetamol, and ibuprofen. On 10-APR-2021 22:00, the subject experienced chills. On 10-APR-2021 22:00, the subject experienced bad headache. On 11-APR-2021, the subject experienced tender to touch. On 11-APR-2021, the subject experienced general fatigue. On 11-APR-2021, the subject experienced arm pain. On 11-APR-2021, the subject experienced swelling. On 11-APR-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, bad headache, general fatigue, arm pain, swelling, redness and tender to touch was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: GENERAL FATIGUE; ARM PAIN; SWELLING; REDNESS; TENDER TO TOUCH; CHILLS; BAD HEADACHE; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, treatment medications included: diphenhydramine/paracetamol, and ibuprofen. On 10-APR-2021 22:00, the subject experienced chills. On 10-APR-2021 22:00, the subject experienced bad headache. On 11-APR-2021, the subject experienced tender to touch. On 11-APR-2021, the subject experienced general fatigue. On 11-APR-2021, the subject experienced arm pain. On 11-APR-2021, the subject experienced swelling. On 11-APR-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, bad headache, general fatigue, arm pain, swelling, redness and tender to touch was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Hypertension, Hypoaesthesia, Neck pain
Clinical narrative: Developed high blood pressure 168/100 (MAP 101)around 40 mins after vaccination which lasted more than an hour. I had pain from my left shoulder , left neck up to the base of my left head like throbbing pain. My left ear felt numb and warm since i was slightly reddish up to my arms. I didn't have to take any antihistamine since it subsided after half an hour.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Developed high blood pressure 168/100 (MAP 101)around 40 mins after vaccination which lasted more than an hour. I had pain from my left shoulder , left neck up to the base of my left head like throbbing pain. My left ear felt numb and warm since i was slightly reddish up to my arms. I didn't have to take any antihistamine since it subsided after half an hour.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: FEVER; CHILLS; FATIGUE; VERY BAD HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was not reported and height was 67 inches. The patient's concurrent conditions included non alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced very bad headache. On 13-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-APR-2021, and had not recovered from fatigue, very bad headache, and fever. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: After 2nd dose, pt. describes severe muscle tightness and weakness.  Could not stand up without the aid of his arms, low back was especially tight and felt like" contacted".  Sought was seeing chiropractor about back pain more in the mid back prior but went to the ED with this new pain.  Was put on Prednisone, Flexeril, Lidocaine. and Tylenol.  Continued to have pain when standing and weakness requiring a walker or cane.  No one is sure this is related to the vaccine but the symptoms worsened within about 24 hours of the second dose.  Improving now but still limited by weakness and pain.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Computerised tomogram normal, Ear congestion, Facial pain
Clinical narrative: Bad headache, right side of face pain, vision issues, chest pain, blocked right ear, went to er, did tests "all ok". 5 days later and still feel awful everyday. Minor to moderate headaches, low grade fever, minor chest pain, heart racing, fatigue, brain fog.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Full blood count normal, Headache, Palpitations
Clinical narrative: Bad headache, right side of face pain, vision issues, chest pain, blocked right ear, went to er, did tests "all ok". 5 days later and still feel awful everyday. Minor to moderate headaches, low grade fever, minor chest pain, heart racing, fatigue, brain fog.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Visual impairment
Clinical narrative: Bad headache, right side of face pain, vision issues, chest pain, blocked right ear, went to er, did tests "all ok". 5 days later and still feel awful everyday. Minor to moderate headaches, low grade fever, minor chest pain, heart racing, fatigue, brain fog.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Memory impairment
Clinical narrative: Mild arm pain at injection site.  I also gave been having difficulty the past 2 weeks trying to recall certain words or remember people's names. It's been enough that I noticed and it is out of character for me. It just feels off. It's not normal and I don't have memory recall issues. I hope it goes away.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Urticaria
Clinical narrative: skin hives and burning down arm, back and chest her feet swelled
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ear, nose and throat examination, Electromyogram, Magnetic resonance imaging head, Muscle spasms
Clinical narrative: Since day 3 after the vaccine I have had cramping and twitching in arms, legs, feet, hands. Since Day 7 I have had a tremor in my neck and face. At times my throat /neck feels like it is swollen. I have had tinnitus since about Day 7. I have had no treatment. Drs. do not know what to do.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Neuropathy peripheral, Pharyngeal swelling, Swelling, Tinnitus
Clinical narrative: Since day 3 after the vaccine I have had cramping and twitching in arms, legs, feet, hands. Since Day 7 I have had a tremor in my neck and face. At times my throat /neck feels like it is swollen. I have had tinnitus since about Day 7. I have had no treatment. Drs. do not know what to do.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Ultrasound Doppler
Clinical narrative: Since day 3 after the vaccine I have had cramping and twitching in arms, legs, feet, hands. Since Day 7 I have had a tremor in my neck and face. At times my throat /neck feels like it is swollen. I have had tinnitus since about Day 7. I have had no treatment. Drs. do not know what to do.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint contracture, Paraesthesia, Throat tightness, Urinary incontinence
Clinical narrative: was given Pfizer-BioNTech COVID-19  in right arm duty  1. within 2 minutes of shot, my throat began closing and lasted 20 minutes 2. next morning I awakened with right hand severely contracted and had a tingling sensation; I forced my hand to open and close to relieve contraction 3. .then all  day, I lost control of my bladder and had to use several pads to catch the  flowing urine;
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry skin, Joint contracture, Throat tightness, Urinary incontinence
Clinical narrative: was given Pfizer-BioNTech COVID-19  in right arm duty  1. within 2 minutes of shot, my throat began closing and lasted 20 minutes 2. next morning I awakened with right hand severely contracted and had a tingling sensation; I forced my hand to open and close to relieve contraction 3. .then all  day, I lost control of my bladder and had to use several pads to catch the  flowing urine;