chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: SORE THROAT; BURNING EYES; BODY ACHES OR BODY WAS PAINFUL TO THE TOUCH; MIGRAINE; NIGHTMARES THROUGHOUT THE NIGHT; DIZZY; FEELING COLD; SHAKING; CHILLS; INJECTION SITE PAIN; FEVER OR BODY WAS BURNING UP LIKE A FURNACE; FELT FATIGUED; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and other pre-existing medical conditions included the patient had no known allergies. 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 09-APR-2021 15:50 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches or body was painful to the touch. On 09-APR-2021, the subject experienced migraine. On 09-APR-2021, the subject experienced nightmares throughout the night. On 09-APR-2021, the subject experienced dizzy. On 09-APR-2021, the subject experienced feeling cold. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever or body was burning up like a furnace. On 09-APR-2021, the subject experienced felt fatigued. On 09-APR-2021 19:00, the subject experienced burning eyes. On 10-APR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning eyes, nightmares throughout the night, dizzy, chills, fever or body was burning up like a furnace, and felt fatigued on 10-APR-2021, was recovering from injection site pain, body aches or body was painful to the touch, migraine, and sore throat, and the outcome of feeling cold and shaking was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Palpitations, Pyrexia
Clinical narrative: MINOR HEART PALPITATIONS; HIGH FEVER; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 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, 1 total, administered on 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain at injection site. On 07-APR-2021, the subject experienced minor heart palpitations. On 07-APR-2021, the subject experienced high fever. Laboratory data included: Body temperature (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor heart palpitations, and high fever on APR-2021, and was recovering from pain at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling hot, Hypoaesthesia, Lacrimation increased
Clinical narrative: STINGING; RIGHT (SHOT ARM) BEGAN TO ACHE; BURNING PAIN IN NECK; NUMBNESS FACIAL; TINGLING IN HANDS AND FEET; SWOLLEN LYMPH NODE; SORE THROAT; RIGHT EYE WATERS; RUNNY NOSE; RIGHT SIDE FEELS NUMB; HOT LEFT FOOT; BURNING PAIN IN LOWER BACK; FATIGUE; 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced numbness facial. On APR-2021, the subject experienced tingling in hands and feet. On APR-2021, the subject experienced swollen lymph node. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced right eye waters. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced right side feels numb. On APR-2021, the subject experienced hot left foot. On APR-2021, the subject experienced burning pain in lower back. On APR-2021, the subject experienced fatigue. Treatment medications included: menthol. On 07-APR-2021, the subject experienced stinging. On 07-APR-2021, the subject experienced right (shot arm) began to ache. On 07-APR-2021, the subject experienced burning pain in neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning pain in neck, and burning pain in lower back, and the outcome of stinging, right (shot arm) began to ache, numbness facial, tingling in hands and feet, swollen lymph node, sore throat, right eye waters, runny nose, fatigue, right side feels numb and hot left foot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: STINGING; RIGHT (SHOT ARM) BEGAN TO ACHE; BURNING PAIN IN NECK; NUMBNESS FACIAL; TINGLING IN HANDS AND FEET; SWOLLEN LYMPH NODE; SORE THROAT; RIGHT EYE WATERS; RUNNY NOSE; RIGHT SIDE FEELS NUMB; HOT LEFT FOOT; BURNING PAIN IN LOWER BACK; FATIGUE; 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced numbness facial. On APR-2021, the subject experienced tingling in hands and feet. On APR-2021, the subject experienced swollen lymph node. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced right eye waters. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced right side feels numb. On APR-2021, the subject experienced hot left foot. On APR-2021, the subject experienced burning pain in lower back. On APR-2021, the subject experienced fatigue. Treatment medications included: menthol. On 07-APR-2021, the subject experienced stinging. On 07-APR-2021, the subject experienced right (shot arm) began to ache. On 07-APR-2021, the subject experienced burning pain in neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning pain in neck, and burning pain in lower back, and the outcome of stinging, right (shot arm) began to ache, numbness facial, tingling in hands and feet, swollen lymph node, sore throat, right eye waters, runny nose, fatigue, right side feels numb and hot left foot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia, Rhinorrhoea
Clinical narrative: STINGING; RIGHT (SHOT ARM) BEGAN TO ACHE; BURNING PAIN IN NECK; NUMBNESS FACIAL; TINGLING IN HANDS AND FEET; SWOLLEN LYMPH NODE; SORE THROAT; RIGHT EYE WATERS; RUNNY NOSE; RIGHT SIDE FEELS NUMB; HOT LEFT FOOT; BURNING PAIN IN LOWER BACK; FATIGUE; 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced numbness facial. On APR-2021, the subject experienced tingling in hands and feet. On APR-2021, the subject experienced swollen lymph node. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced right eye waters. On APR-2021, the subject experienced runny nose. On APR-2021, the subject experienced right side feels numb. On APR-2021, the subject experienced hot left foot. On APR-2021, the subject experienced burning pain in lower back. On APR-2021, the subject experienced fatigue. Treatment medications included: menthol. On 07-APR-2021, the subject experienced stinging. On 07-APR-2021, the subject experienced right (shot arm) began to ache. On 07-APR-2021, the subject experienced burning pain in neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning pain in neck, and burning pain in lower back, and the outcome of stinging, right (shot arm) began to ache, numbness facial, tingling in hands and feet, swollen lymph node, sore throat, right eye waters, runny nose, fatigue, right side feels numb and hot left foot was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: TEMPERATURE GOING UP TO 100.7; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. The patient's past medical history included possible covid-19 infection, and concurrent conditions included depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included mirtazapine for depression. On APR-2021, the subject experienced temperature going up to 100.7. Laboratory data included: Body temperature (NR: not provided) 100.7 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temperature going up to 100.7. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Pain in extremity, Pyrexia, Sensitive skin
Clinical narrative: SOMNOLENCE; SENSITIVE SKIN; SORE LEFT ARM; LOSS OF ENERGY; FEVER 97 - 99.1 F; 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 08-APR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced somnolence. On 09-APR-2021, the subject experienced sensitive skin. On 09-APR-2021, the subject experienced sore left arm. On 09-APR-2021, the subject experienced loss of energy. On 09-APR-2021, the subject experienced fever 97 - 99.1 F. Laboratory data included: Body temperature (NR: not provided) 99.1 F, 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensitive skin, and loss of energy on 10-APR-2021, had not recovered from sore left arm, and the outcome of somnolence and fever 97 - 99.1 F was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: SOMNOLENCE; SENSITIVE SKIN; SORE LEFT ARM; LOSS OF ENERGY; FEVER 97 - 99.1 F; 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 08-APR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced somnolence. On 09-APR-2021, the subject experienced sensitive skin. On 09-APR-2021, the subject experienced sore left arm. On 09-APR-2021, the subject experienced loss of energy. On 09-APR-2021, the subject experienced fever 97 - 99.1 F. Laboratory data included: Body temperature (NR: not provided) 99.1 F, 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensitive skin, and loss of energy on 10-APR-2021, had not recovered from sore left arm, and the outcome of somnolence and fever 97 - 99.1 F was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination; and ustekinumab (solution for infusion, 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. As per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms. This report was non-serious. This case, involving the same patient is linked to 20210410447.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: SHAKES; FEVER BROKE; 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 shakes, and fever broke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever broke and shakes was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Pain
Clinical narrative: DIZZY; FOGGY MINDED; ACHES; NAUSEA; 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 was not reported, administered on 01-APR-2021 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 APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced foggy minded. On APR-2021, the subject experienced aches. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches, and nausea, and had not recovered from dizzy, and foggy minded. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: FAINTED; This spontaneous report received from a parent. The reporter obtained the information from news/media. 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) dose, 1 total, start therapy date were not reported 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 an unspecified date, the parent reported that the patient had fainted in doctor's office 10 minutes after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fainted was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422263-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. This event is considered unassessable. The event 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.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: DRUG USE FOR UNAPPROVED DOSING REGIMEN TO 17 YEAR OLD; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 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, and batch number: 205A21A 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 drug use for unapproved dosing regimen to 17 year old. On 10-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug use for unapproved dosing regimen to 17 year old and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Confusional state, Discomfort, Headache, Myalgia
Clinical narrative: FELT CONFUSED; BODY WAS LIKE HEAVY; SLEEPY; CHILLS; HEADACHE; HIGH FEVER; MUSCLE ACHE; 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced felt confused. On APR-2021, the subject experienced body was like heavy. On APR-2021, the subject experienced sleepy. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced high fever. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt confused, body was like heavy, sleepy, chills, headache, high fever, and muscle ache on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: FELT CONFUSED; BODY WAS LIKE HEAVY; SLEEPY; CHILLS; HEADACHE; HIGH FEVER; MUSCLE ACHE; 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the subject experienced felt confused. On APR-2021, the subject experienced body was like heavy. On APR-2021, the subject experienced sleepy. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced high fever. On APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt confused, body was like heavy, sleepy, chills, headache, high fever, and muscle ache on APR-2021. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Lethargy, Pain
Clinical narrative: BODY ACHES; LETHARGY; FEVER; SORENESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 42 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced soreness at injection site. On 08-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.0 F. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, lethargy, fever, and headache on 09-APR-2021, and had not recovered from soreness at injection site. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; LETHARGY; FEVER; SORENESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 42 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: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced lethargy. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced soreness at injection site. On 08-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.0 F. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, lethargy, fever, and headache on 09-APR-2021, and had not recovered from soreness at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: CHILLS; MUSCLE ACHES; FEVER; VERY TIRED; 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, expiry date: UNKNOWN) 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 chills. On 10-APR-2021, the subject experienced muscle aches. On 10-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 102. On APR-2021, the subject experienced very tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, muscle aches, fever and very tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: BODY ACHES; MALAISE; FATIGUED; This spontaneous report received from a consumer concerned a 61 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, intramuscular, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prevention of covid 19. No concomitant medications were reported. On 08-APR-2021, the subject experienced malaise. On 08-APR-2021, the subject experienced fatigued. On 10-APR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from malaise, body aches, and fatigued. This report was non-serious. This case, from the same reporter is linked to 20210422648.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Syncope
Clinical narrative: FAINTED/PASSED OUT; NOT FEELING QUITE RIGHT; VERY TIRED; This spontaneous report received from a parent concerned a white and Not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included faint, and concurrent conditions included seizure, non-alcohol user, and non-smoker. The patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with erythromycin, and ketamine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A201A, expiry: UNKNOWN) dose was not reported, 1 total, administered on right arm on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported by the patient' parent that, on 12-APR-2021, within 5 minutes after vaccination the patient had fainted/passed out. On the same day, the patient was not feeling quite right and was very tired.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fainted/passed out, very tired, and not feeling quite right. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422792-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted/Passed out. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Flushing, Headache
Clinical narrative: FLUSHED FACE; ACHINESS THROUGHOUT THE BODY; CHILLS; RASH ON THE INSIDE OF THIGHS; HEADACHE; FEVER; TIREDNESS; 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced flushed face. On APR-2021, the subject experienced achiness throughout the body. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced rash on the inside of thighs. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced tiredness.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, flushed face, rash on the inside of thighs, fever, chills, tiredness and achiness throughout the body was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: FLUSHED FACE; ACHINESS THROUGHOUT THE BODY; CHILLS; RASH ON THE INSIDE OF THIGHS; HEADACHE; FEVER; TIREDNESS; 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced flushed face. On APR-2021, the subject experienced achiness throughout the body. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced rash on the inside of thighs. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced tiredness.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, flushed face, rash on the inside of thighs, fever, chills, tiredness and achiness throughout the body was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: TIREDNESS; FEVER 99.2 - 100.9; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid 19. 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 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 APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced fever 99.2 - 100.9. Laboratory data included: Body temperature (NR: not provided) 99.2 . On 12-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 100.9 . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 99.2 - 100.9, and tiredness. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash, Rubber sensitivity
Clinical narrative: LATEX  ALLERGY; RASH; TIRED; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included drug abuse, and concurrent conditions included penicillin allergy, hives, sulfa allergy, welts, latex allergy, alcoholic, and nonsmoker. The patient was previously treated with metamfetamine for drug abuse. 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 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced latex allergy. On 09-APR-2021, the subject experienced rash. On 09-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash, and tired, and the outcome of latex allergy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425218.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Epistaxis, Headache, Paranasal sinus discomfort
Clinical narrative: BLOODY NOSE; REALLY BAD COUGH; FEELS LIKE A SINUS INFECTION; HEADACHE; This spontaneous report received from a patient concerned a 50 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 expiry: UNNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced headache. Treatment medications included: ibuprofen. On 13-APR-2021, the subject experienced bloody nose. On 13-APR-2021, the subject experienced really bad cough. On 13-APR-2021, the subject experienced feels like a sinus infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bloody nose on 13-APR-2021, and the outcome of headache, really bad cough and feels like a sinus infection was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: FEEL WORSE; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case. No concomitant medications were reported. On an unspecified date, the subject experienced feel worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feel worse. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Headache, Hypoaesthesia
Clinical narrative: NUMBNESS ON FINGERS AND FINGER TIPS; BODY ACHE; TIGHTNESS ON FOREARM; SWOLLEN ARMPIT; SORE AND TENDER LEFT ARMPIT; FEVER; HEADACHES; CHILLS; This spontaneous report received from a patient concerned a 51 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: 202421A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced swollen armpit. On 09-APR-2021, the subject experienced sore and tender left armpit. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced tightness on forearm. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 11-APR-2021, the subject experienced numbness on fingers and finger tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and headaches on 10-APR-2021, chills on 11-APR-2021, and fever on 09-APR-2021, and had not recovered from tightness on forearm, swollen armpit, sore and tender left armpit, and numbness on fingers and finger tips. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Swelling
Clinical narrative: NUMBNESS ON FINGERS AND FINGER TIPS; BODY ACHE; TIGHTNESS ON FOREARM; SWOLLEN ARMPIT; SORE AND TENDER LEFT ARMPIT; FEVER; HEADACHES; CHILLS; This spontaneous report received from a patient concerned a 51 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: 202421A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced swollen armpit. On 09-APR-2021, the subject experienced sore and tender left armpit. On 09-APR-2021, the subject experienced body ache. On 09-APR-2021, the subject experienced tightness on forearm. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) 100.2 F. On 11-APR-2021, the subject experienced numbness on fingers and finger tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and headaches on 10-APR-2021, chills on 11-APR-2021, and fever on 09-APR-2021, and had not recovered from tightness on forearm, swollen armpit, sore and tender left armpit, and numbness on fingers and finger tips. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: LEFT HAND NUMBNESS; TINGLING OF THE TIPS OF THE LEFT HAND FINGERS; SORE RIGHT ARM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included acid reflux for more than 10 years, alcohol user 4 times a week, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no 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: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 09-APR-2021 16:15 for prophylactic vaccination. Concomitant medications included omeprazole for acid reflux.  On 09-APR-2021, the subject experienced sore right arm. On 13-APR-2021, the subject experienced left hand numbness. On 13-APR-2021, the subject experienced tingling of the tips of the left hand fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left hand numbness on 13-APR-2021, was recovering from sore right arm, and had not recovered from tingling of the tips of the left hand fingers. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersomnia, Pyrexia
Clinical narrative: SLEPT MOST OF THE DAY; SWEATED 3LB OF WATER; FEVER; 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, 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 11-APR-2021, the subject experienced slept most of the day. On 11-APR-2021, the subject experienced sweated 3lb of water. On 11-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, slept most of the day, and sweated 3lb of water. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hypertension, Pain in extremity
Clinical narrative: TIRED; HEADACHE; LIGHT HEADED; HYPERTENSION; HIVES ON CHEST AND NECK; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included grave's disease. 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 07-APR-2021 13:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine for grave's disease.  On 07-APR-2021, the subject experienced light headed. On 07-APR-2021, the subject experienced hypertension. On 07-APR-2021, the subject experienced hives on chest and neck. On 07-APR-2021, the subject experienced sore arm. Treatment medications included: diphenhydramine hydrochloride. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, and hypertension on 07-APR-2021, hives on chest and neck on 08-APR-2021, sore arm on 10-APR-2021, and tired, and headache on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: TIRED; HEADACHE; LIGHT HEADED; HYPERTENSION; HIVES ON CHEST AND NECK; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included grave's disease. 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 07-APR-2021 13:30 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine for grave's disease.  On 07-APR-2021, the subject experienced light headed. On 07-APR-2021, the subject experienced hypertension. On 07-APR-2021, the subject experienced hives on chest and neck. On 07-APR-2021, the subject experienced sore arm. Treatment medications included: diphenhydramine hydrochloride. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed, and hypertension on 07-APR-2021, hives on chest and neck on 08-APR-2021, sore arm on 10-APR-2021, and tired, and headache on APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Allergic respiratory disease, Body temperature, Cough, Fatigue, Headache
Clinical narrative: SHAKING; RESPIRATORY ALLERGIES; COUGHING; ARMPIT PAIN; INSIDE OF PALM FELT WEIRD WITH DULL PAIN; TIRED; HIVES ON SKIN; STRONG HEADACHE; FELT NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 20 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 09-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced respiratory allergies. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced inside of palm felt weird with dull pain. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced hives on skin. On APR-2021, the subject experienced strong headache. On APR-2021, the subject experienced felt nauseous. On APR-2021, the subject experienced fever.  Laboratory data included: Body temperature (NR: not provided) 103 F.  On 09-APR-2021 20:30, the subject experienced shaking.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 09-APR-2021 21:30, and strong headache, and fever, had not recovered from armpit pain, and the outcome of hives on skin, cough, respiratory allergies, felt nauseous, tired and inside of palm felt weird with dull pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain in extremity, Pyrexia, Tremor
Clinical narrative: SHAKING; RESPIRATORY ALLERGIES; COUGHING; ARMPIT PAIN; INSIDE OF PALM FELT WEIRD WITH DULL PAIN; TIRED; HIVES ON SKIN; STRONG HEADACHE; FELT NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 20 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 09-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced respiratory allergies. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced inside of palm felt weird with dull pain. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced hives on skin. On APR-2021, the subject experienced strong headache. On APR-2021, the subject experienced felt nauseous. On APR-2021, the subject experienced fever.  Laboratory data included: Body temperature (NR: not provided) 103 F.  On 09-APR-2021 20:30, the subject experienced shaking.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 09-APR-2021 21:30, and strong headache, and fever, had not recovered from armpit pain, and the outcome of hives on skin, cough, respiratory allergies, felt nauseous, tired and inside of palm felt weird with dull pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: SHAKING; RESPIRATORY ALLERGIES; COUGHING; ARMPIT PAIN; INSIDE OF PALM FELT WEIRD WITH DULL PAIN; TIRED; HIVES ON SKIN; STRONG HEADACHE; FELT NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 20 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 09-APR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced respiratory allergies. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced armpit pain. On APR-2021, the subject experienced inside of palm felt weird with dull pain. On APR-2021, the subject experienced tired. On APR-2021, the subject experienced hives on skin. On APR-2021, the subject experienced strong headache. On APR-2021, the subject experienced felt nauseous. On APR-2021, the subject experienced fever.  Laboratory data included: Body temperature (NR: not provided) 103 F.  On 09-APR-2021 20:30, the subject experienced shaking.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking on 09-APR-2021 21:30, and strong headache, and fever, had not recovered from armpit pain, and the outcome of hives on skin, cough, respiratory allergies, felt nauseous, tired and inside of palm felt weird with dull pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hypersensitivity, Vomiting
Clinical narrative: VOMITING; HOT AND COLD FLASHES; ALLERGIC REACTION; This spontaneous report received from a consumer 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 08-APR-2021 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 APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced hot and cold flashes. On APR-2021, the subject experienced allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, hot and cold flashes and allergic reaction was not reported. This report was non-serious.