chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: NAUSEA; HIGH FEVER; VOMITING; DEHYDRATED; This spontaneous report received from a physician concerned a 43-year-old White Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic back pain. The patient experienced drug allergy when treated with cefaclor and prochlorperazine. On 2020, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: unknown) dose was not reported, administered on 16-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient experienced vomiting and in the afternoon she was dehydrated. On the same day at 23:00, the patient experienced nausea and high fever. Physician stated that she was taken care in the clinic for almost a day and ended up in hospital the day after. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, vomiting, high fever, and dehydrated on 18-MAR-2021. This report was serious (Hospitalization Caused / Prolonged). This case is associated with product quality complaint (PQC) number 90000178598. The suspected product quality complaint has been confirmed to be voided as adverse events were reported but there is no claim of a product quality issue with Janssen covid-19 vaccine. Voided no PQC was identified within the reported complaint reported. complaint is approved for void. based on the PQC evaluation/investigation performed.; Sender's Comments: V0 20210509100 -COVID-19 VACCINE AD26.COV2.S- Vomiting, Dehydration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210509100-COVID-19 VACCINE AD26.COV2.S- Nausea, High Fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: HEADACHE; INJECTION SITE PAIN; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 160 pounds, and height was 167 centimeters. The patient's concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have any drug abuse/illicit drug use. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAY-2021, the subject experienced headache. On 03-MAY-2021, the subject experienced injection site pain. On 03-MAY-2021, the subject experienced fever. On 03-MAY-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 99, 6 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-MAY-2021, and was recovering from headache, injection site pain, and tiredness. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chronic sinusitis, Throat irritation
Clinical narrative: BURNED LIKE HOLY HELL; CHRONIC SINUSITIS; SCRATCHY THROAT; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 204A@1A, expiry: 23-JUN-2021) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced burned like holy hell. On 27-APR-2021, the subject experienced chronic sinusitis. On 27-APR-2021, the subject experienced scratchy throat. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from chronic sinusitis, and scratchy throat, and the outcome of burned like holy hell was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be confirmed nothing was identified within the reported complaint reported. complaint is approved for void based on the  evaluation/investigation performed.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Myalgia, Pyrexia, SARS-CoV-2 antibody test positive
Clinical narrative: PARTIAL DOSE INJECTED; CHILLS; FELT SICK; MUSCLES PAIN; FEVER; This spontaneous report received from a consumer concerned a 32 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, Expiry: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced partial dose injected. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced felt sick. On 26-MAR-2021, the subject experienced muscles pain. On 26-MAR-2021, the subject experienced fever. On 14-APR-2021, Laboratory data included: COVID-19 antibody test positive (NR: not provided) 21, and COVID-19 virus test negative (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, felt sick, muscles pain, and fever on 28-MAR-2021, and the outcome of partial dose injected was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Underdose
Clinical narrative: PARTIAL DOSE INJECTED; CHILLS; FELT SICK; MUSCLES PAIN; FEVER; This spontaneous report received from a consumer concerned a 32 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, Expiry: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced partial dose injected. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced felt sick. On 26-MAR-2021, the subject experienced muscles pain. On 26-MAR-2021, the subject experienced fever. On 14-APR-2021, Laboratory data included: COVID-19 antibody test positive (NR: not provided) 21, and COVID-19 virus test negative (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, felt sick, muscles pain, and fever on 28-MAR-2021, and the outcome of partial dose injected was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: WHOLE FINGER TIP TURNS DARK PURPLE; 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 not reported, batch number: Unknown) dose was not reported, administered on 14-APR-2021 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 whole finger tip turns dark purple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of whole finger tip turns dark purple was not reported. This report was non-serious.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included celiac disease, atherosclerosis, hypertension, hypercholesterolemia, and iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25-MAY-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack
Clinical narrative: PANIC ATTACK (INVOLUNTARY MOVEMENTS/DIZZINESS/UNABLE TO WALK/FEELING DRUGGED); This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included paxil allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting.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 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Antipsychotics (unspecified). On 05-MAY-2021, the subject experienced panic attack (involuntary movements/dizziness/unable to walk/feeling drugged). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from panic attack (involuntary movements/dizziness/unable to walk/feeling drugged) on 05-MAY-2021. This report was non-serious.; Sender's Comments: V0.Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Medication error
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; PREDRAWN AND LEFT OUT OVER NIGHT (ABOUT 12 HOURS); MEDICATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced expired product administered. On 05-MAY-2021, the subject experienced inappropriate schedule of drug administration. On 05-MAY-2021, the subject experienced medication error. The action taken with covid-19 vaccine  was not applicable. The outcome of the expired product administered, inappropriate schedule of drug administration and medication error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210513592.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Confusional state, Ear pain, Injection site pain, Pyrexia
Clinical narrative: CONFUSION STATE AS CLOSED TO SUFFERING OF DEMENTIA; PAIN IN BOTH EARS; INJECTION SITE PAIN; HIGH FEVER; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 145 pounds, and height was 162 centimeters. The patient's past medical history included covid 19, and concurrent conditions included fibromyalgia, contrast dye allergy, kiwi allergy, raw shellfish anaphylaxis, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no history of drug abuse or illicit drug use.  The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 206AZIA, and  expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced confusion state as closed to suffering of dementia. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced high fever. On 30-APR-2021, the subject experienced pain in both ears. Laboratory data included: Body temperature (NR: not provided) 104 F. On 01-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 104 F, 103 F.  Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from confusion state as closed to suffering of dementia, injection site pain, high fever, and pain in both ears on 02-MAY-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING IN THE LEGS FROM KNEE CAP TO FEET AND IN HANDS; PAIN IN LEGS AND IN HANDS; BAD HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tingling in the legs from knee cap to feet and in hands, pain in legs and in hands, and bad headache. The action taken with covid-19 vaccine was not applicable. The outcome of the tingling in the legs from knee cap to feet and in hands, bad headache and pain in legs and in hands was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased
Clinical narrative: CHEST PAIN; RAPID HEARTBEAT; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, alcohol use three glasses of wine per week, and non smoker, and other pre-existing medical conditions included patient had no surgeries, illnesses. heart problems or medication use also she had no known allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: unknown) dose was not reported, administered on 06-MAY-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced chest pain. On 07-MAY-2021, the subject experienced rapid heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, and rapid heartbeat on 07-MAY-2021. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Heart rate, Heart rate increased
Clinical narrative: BODY PAIN; NAUSEA; FATIGUE; SLIGHT COUGH; CHILLS; ELEVATED HEART RATE; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced elevated heart rate. On 08-MAY-2021, the subject experienced slight cough. On 08-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) 140, 100. On 08-MAY-2021 03:00, the subject experienced body pain. On 08-MAY-2021 03:00, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from elevated heart rate, and had not recovered from nausea, body pain, slight cough, fatigue, and chills. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: BODY PAIN; NAUSEA; FATIGUE; SLIGHT COUGH; CHILLS; ELEVATED HEART RATE; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced elevated heart rate. On 08-MAY-2021, the subject experienced slight cough. On 08-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced fatigue. Laboratory data included: Heart rate (NR: not provided) 140, 100. On 08-MAY-2021 03:00, the subject experienced body pain. On 08-MAY-2021 03:00, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from elevated heart rate, and had not recovered from nausea, body pain, slight cough, fatigue, and chills. This report was non-serious.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Neck pain, Pyrexia
Clinical narrative: BACK OF NECK WARM TO TOUCH; PAIN ON BACK OF NECK; HEADACHE; FEVER; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: acetylsalicylic acid, and ibuprofen. On 06-MAY-2021, the subject experienced back of neck warm to touch. On 06-MAY-2021, the subject experienced pain on back of neck. On 06-MAY-2021, the subject experienced headache. On 06-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever on MAY-2021, and had not recovered from headache, back of neck warm to touch, and pain on back of neck. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: VACCINE ADMINISTERED OUTSIDE OF THE HOLD TIME FROM PUNCTURED VIAL; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the subject experienced vaccine administered outside of the hold time from punctured vial. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine administered outside of the hold time from punctured vial was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Myalgia, Painful respiration
Clinical narrative: EXCRUCIATING PAIN IN BONES; PRODUCE PAIN ON DEEP BREATHING; EXCRUCIATING PAIN IN JOINTS; EXCRUCIATING PAIN IN MUSCLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced excruciating pain in bones. On 2021, the subject experienced produce pain on deep breathing. On 2021, the subject experienced excruciating pain in joints. On 2021, the subject experienced excruciating pain in muscles. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from excruciating pain in joints, excruciating pain in muscles, excruciating pain in bones, and produce pain on deep breathing. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included tested positive for covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAY-2021, the patient tested positive for Covid-19. His symptoms were mild and he was self-isolating (coded as suspected clinical vaccination failure and suspected covid-19 infection). The testing facility never asked the patient whether he had been vaccinated. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint :90000178874.; Sender's Comments: V0- 20210516365-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Groin pain, Headache, Pain assessment, Pain in extremity
Clinical narrative: HEADACHE; LOWER BACK PAIN; PAIN IN GROIN AREA; LEG PAIN; This spontaneous report received from a patient concerned a 25 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: 1805018, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced lower back pain. On MAY-2021, the subject experienced pain in groin area. On MAY-2021, the subject experienced leg pain. Laboratory data included: Pain scale (NR: not provided) 7/8 out of 10. On 07-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 07-MAY-2021, and the outcome of leg pain, lower back pain and pain in groin area was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-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.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Sensory disturbance
Clinical narrative: TICKLING ON HAND AND FEET; DIZZINESS; CONSTANT MILD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin 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 22-APR-2021, the subject experienced dizziness. On 22-APR-2021, the subject experienced constant mild headache. On MAY-2021, the subject experienced tickling on hand and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant mild headache, and dizziness, and the outcome of tickling on hand and feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ALMOST DIED; 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: Unknown) dose was not reported, administered on 05-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 almost died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from almost died. 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Fatigue, Illness
Clinical narrative: BLOOD SUGAR SPIKE; TERRIBLE SICKNESS; TOTAL FATIGUE; This spontaneous report received from a patient concerned a 70 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 administration not reported, batch number: 1808980, expiry: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced terrible sickness. On 01-APR-2021, the subject experienced total fatigue. On 15-APR-2021, the subject experienced blood sugar spike. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from total fatigue on 15-APR-2021, and had not recovered from terrible sickness, and blood sugar spike. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Off label use
Clinical narrative: EXPIRED VACCINE ADMINISTERED; VACCINE GIVEN TWICE AFTER THE 6 HOUR WINDOW; OFF LABEL USE; This spontaneous report received from a physician 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced expired vaccine administered, medication error, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered, medication error and off label used was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: DOSE OF JNJ VACCINE GIVEN 8-9  HOURS AFTER FIRST PUNCTURE; DOSE OF JNJ VACCINE GIVEN 8 TO 9  HOURS AFTER FIRST PUNCTURE AFTER RECOMMENDED SHELF LIFE LIMIT OF 6 HOURS IN FRIDGE; This spontaneous report received from a pharmacist concerned a 41 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, intramuscular, batch number: 205a21a, and expiry: 23-JUN-2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced dose of JNJ vaccine given 8-9 hours after first puncture. On 09-MAY-2021, the subject experienced dose of JNJ vaccine given 8 to 9 hours after first puncture after recommended shelf life limit of 6 hours in fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose of JNJ vaccine given 8-9 hours after first puncture and dose of JNJ vaccine given 8 to 9 hours after first puncture after recommended shelf life limit of 6 hours in fridge was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dry mouth, Feeling abnormal, Influenza
Clinical narrative: FELT LIKE LEGS WILL BUCKLE UNDER  HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT  OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Muscular weakness, Pruritus, Urticaria
Clinical narrative: FELT LIKE LEGS WILL BUCKLE UNDER  HER WHEN GOING TO RESTROOM; HIVES; ITCHING; INSOMNIA; DOES NOT FEEL HERSELF; ANXIETY; DRY MOUTH DESPITE DRINKING A LOT  OF WATER AS DIRECTED; WEAKNESS; 24 HOUR FLU; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced 24 hour flu. On 06-MAY-2021, the subject experienced dry mouth despite drinking a lot of water as directed. On 06-MAY-2021, the subject experienced weakness. On 07-MAY-2021, the subject experienced itching. On 07-MAY-2021, the subject experienced insomnia. On 07-MAY-2021, the subject experienced does not feel herself. On 07-MAY-2021, the subject experienced anxiety. On 07-MAY-2021, the subject experienced hives. On 08-MAY-2021, the subject experienced felt like legs will buckle under her when going to restroom. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hour flu on 08-MAY-2021, and insomnia, was recovering from hives, and felt like legs will buckle under her when going to restroom, and had not recovered from itching, anxiety, does not feel herself, dry mouth despite drinking a lot of water as directed, and weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SEVERE ARM PAIN; This spontaneous report received from a patient concerned a 61-year-old female. The patient's weight was 180 pounds, and height was 61 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 04ZAZ1A 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 severe arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: ACHES AND PAINS; HEADACHE; EXTREME EXHAUSTION; This spontaneous report received from a patient concerned a 36 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the patient experienced aches and pains. On 06-MAY-2021, the patient experienced headache. On 06-MAY-2021, the patient experienced extreme exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains, headache, and extreme exhaustion on MAY-2021. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness
Clinical narrative: FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 97.5 F. The action taken with covid-19 vaccine  was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Muscle spasms, Paraesthesia
Clinical narrative: PINS AND NEEDLES IN FEET THAT MOVED UPWARD; GENERALIZED MUSCLE CRAMPING; RAPID HEART RATE; 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 24-MAR-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 pins and needles in feet that moved upward. On APR-2021, the subject experienced generalized muscle cramping. On APR-2021, the subject experienced rapid heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from generalized muscle cramping, pins and needles in feet that moved upward, and rapid heart rate. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION OF VACCINE 1 HOUR AND HALF AFTER  EXPIRY TIME; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced administration of vaccine 1 hour and half after expiry time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine 1 hour and half after expiry time was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea
Clinical narrative: DIARRHEA; CHILLS; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 10:00 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 08-MAY-2021, the subject experienced diarrhea. On 08-MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from chills, and diarrhea. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Body temperature, Chills, Headache, Magnetic resonance imaging
Clinical narrative: THERAPEUTIC RESPONSE DECREASED; ACHY; SHIVERING; CHILLS; HEADACHE; FEVER; 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: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, Laboratory data included: Antibody test (NR: not provided) no antibodies. On 30-APR-2021, Laboratory data included: Antibody test (NR: not provided) no antibodies. On an unspecified date, the subject experienced therapeutic response decreased, achy, shivering, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F, 103 F, and MRI (NR: not provided) no blood clots. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy, fever, shivering, chills, headache and therapeutic response decreased was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Therapeutic response decreased
Clinical narrative: THERAPEUTIC RESPONSE DECREASED; ACHY; SHIVERING; CHILLS; HEADACHE; FEVER; 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: 1808978, and expiry: 13/JUN/2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, Laboratory data included: Antibody test (NR: not provided) no antibodies. On 30-APR-2021, Laboratory data included: Antibody test (NR: not provided) no antibodies. On an unspecified date, the subject experienced therapeutic response decreased, achy, shivering, chills, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F, 103 F, and MRI (NR: not provided) no blood clots. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy, fever, shivering, chills, headache and therapeutic response decreased was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: COMPLETELY NUMB 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 (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAY-2021, the subject experienced completely numb lips. The action taken with covid-19 was not applicable. The patient had not recovered from completely numb lips. This report was non-serious.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: THROBBING PAIN IN RIGHT SHOULDER; This spontaneous report received from a patient concerned a 92 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis in shoulder, alcohol user, and non smoker, and other 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: 18040Z0, and expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced throbbing pain in right shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from throbbing pain in right shoulder. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Insomnia, Rash, Rash pruritic
Clinical narrative: INSOMNIA; ITCHY BUMP; ONE INCH OF REDNESS ON STOMACH/GENERAL REDNESS THROUGHOUT THE BODY/HARD TO TOUCH BUMPS THROUGHOUT THE BODY; 4-5 INCHES OF INFLAMMATION ON  NECK; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206a21s, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride. On 04-MAY-2021, the subject experienced 4-5 inches of inflammation on neck. On 04-MAY-2021, the subject experienced itchy bump. On 04-MAY-2021, the subject experienced one inch of redness on stomach/general redness throughout the body/hard to touch bumps throughout the body. On 09-MAY-2021, the subject experienced insomnia. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from itchy bump, one inch of redness on stomach/general redness throughout the body/hard to touch bumps throughout the body, insomnia, and 4-5 inches of inflammation on neck. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis allergic, Hypersensitivity, Pruritus, Rash pruritic, Skin mass
Clinical narrative: INSOMNIA; ITCHY BUMP; ONE INCH OF REDNESS ON STOMACH/GENERAL REDNESS THROUGHOUT THE BODY/HARD TO TOUCH BUMPS THROUGHOUT THE BODY; 4-5 INCHES OF INFLAMMATION ON  NECK; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206a21s, and expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride. On 04-MAY-2021, the subject experienced 4-5 inches of inflammation on neck. On 04-MAY-2021, the subject experienced itchy bump. On 04-MAY-2021, the subject experienced one inch of redness on stomach/general redness throughout the body/hard to touch bumps throughout the body. On 09-MAY-2021, the subject experienced insomnia. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from itchy bump, one inch of redness on stomach/general redness throughout the body/hard to touch bumps throughout the body, insomnia, and 4-5 inches of inflammation on neck. This report was non-serious.