chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; EXTREME HEADACHE; FEVER; This spontaneous report received from a patient via a company representative 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, 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 body aches, chills, extreme headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, extreme headache, and fever. This report was non-serious. This case, from the same reporter is linked to 20210534648.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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: 205A21A  expiry: UNKNOWN) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Peripheral swelling
Clinical narrative: SWELLING IN BOTH LEGS AND FEET; FLUID RETENTION; This spontaneous report received from a consumer concerned a 57 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced swelling in both legs and feet. On 19-MAY-2021, the subject experienced fluid retention. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in both legs and feet, and fluid retention. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: FEELING AWFUL; BONE PAIN; JOINT PAIN; FEVER; HEADACHE; FATIGUE; MUSCLE PAIN; 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: 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 an unspecified date, the subject experienced feeling awful, bone pain, joint pain, fever, headache, fatigue, and muscle pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from feeling awful, bone pain, joint pain, fever, headache, fatigue, and muscle pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: FEELING AWFUL; BONE PAIN; JOINT PAIN; FEVER; HEADACHE; FATIGUE; MUSCLE PAIN; 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: 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 an unspecified date, the subject experienced feeling awful, bone pain, joint pain, fever, headache, fatigue, and muscle pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from feeling awful, bone pain, joint pain, fever, headache, fatigue, and muscle pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hypersomnia, Pain, Pyrexia
Clinical narrative: SPENT ALMOST 30 HOURS IN BED; EVERYTHING HURT FROM TEETH TO TOES; MASSIVE HEADACHE (THINK ELECTRIC PINK HAND GRENADE); FEVER OF 101 (F); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced spent almost 30 hours in bed. On 19-MAY-2021, the subject experienced everything hurt from teeth to toes. On 19-MAY-2021, the subject experienced massive headache (think electric pink hand grenade). On 19-MAY-2021, the subject experienced fever of 101 (f). Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from spent almost 30 hours in bed, fever of 101 (f), and everything hurt from teeth to toes, and had not recovered from massive headache (think electric pink hand grenade). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Menstruation delayed, Pyrexia
Clinical narrative: DELAYED MENSTRUAL CYCLE; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 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 delayed menstrual cycle, chills, fever, and fatigue. The action taken with covid-19 vaccine  was not applicable. The patient recovered from delayed menstrual cycle, and was recovering from fever, chills, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Depressed mood, Fatigue, Migraine, Nausea
Clinical narrative: DOWN AND OUT FOR 3 DAYS; MAJOR MIGRAINE; NAUSEA; EXTREME FATIGUE; 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 down and out for 3 days, major migraine, nausea, and extreme fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of the down and out for 3 days, major migraine, nausea and extreme fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: LOTS OF BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 lots of body aches, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and lots of body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional and concerned 9 patients. The weight, height, and medical history were not reported. The 9 patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported) dose, Batch number was not reported and has been requested. Start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. It was reported that, nine other people at doctor's office had low antibody levels (suspected immunological vaccine failure) post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210540152.; Sender's Comments: V0.20210542105-covid-19 vaccine ad26.cov2.s -suspected immunological vaccine 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.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pain, Swelling
Clinical narrative: chronic pain; nauseous; headache; dizzy; everything was foggy; swelling; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, osteoarthritis, rheumatoid arthritis, obese, high blood pressure, diabetes type 2, and co-morbidities.  The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. . The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced dizzy. On 15-MAY-2021, the subject experienced everything was foggy. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced nauseous. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced chronic pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache, and swelling, and the outcome of dizzy, nauseous, everything was foggy and chronic pain was not reported. This report was non-serious. This report was non-serious. This case, involving the same patient is linked to 20190513035 and 20191219543.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: chronic pain; nauseous; headache; dizzy; everything was foggy; swelling; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, osteoarthritis, rheumatoid arthritis, obese, high blood pressure, diabetes type 2, and co-morbidities.  The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. . The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced dizzy. On 15-MAY-2021, the subject experienced everything was foggy. On 15-MAY-2021, the subject experienced swelling. On 15-MAY-2021, the subject experienced nauseous. On 15-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced chronic pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from headache, and swelling, and the outcome of dizzy, nauseous, everything was foggy and chronic pain was not reported. This report was non-serious. This report was non-serious. This case, involving the same patient is linked to 20190513035 and 20191219543.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Somnolence, Vomiting
Clinical narrative: VOMITING; SLEEPINESS; FEVER; NAUSEA; EXCESSIVELY TIRED; This spontaneous report received from a consumer concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type-2 diabetes, and thyroid issues. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included metformin for type-2 diabetes. On 20-MAY-2021, the subject experienced vomiting. On 20-MAY-2021, the subject experienced sleepiness. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced excessively tired. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, nausea, vomiting, excessively tired, and sleepiness, and the outcome of sick was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Pyrexia, Splinter haemorrhages
Clinical narrative: BLOOD LINES BELOW NAIL TO END OF MIDDLE AND RING FINGER; FINGER SWELLING TO BOTH HANDS/RIGHT HAND SWOLLEN; LEFT ARM PAIN; FEVER; PAIN BELOW SHOULDER BLADE; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced pain below shoulder blade. On 22-MAY-2021, the subject experienced blood lines below nail to end of middle and ring finger. On 22-MAY-2021, the subject experienced finger swelling to both hands/right hand swollen. On 22-MAY-2021, the subject experienced left arm pain. On 22-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAY-2021, was recovering from finger swelling to both hands/right hand swollen, had not recovered from pain below shoulder blade, and blood lines below nail to end of middle and ring finger, and the outcome of left arm pain was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: RADIATING PAIN; LEGS TENDER; SEVERE HEADACHE RADIATING TO NECK; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and concurrent conditions included blind, disabled, hypertension, and mushroom allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204AZIA expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject experienced radiating pain. On 22-MAY-2021, the subject experienced legs tender. On 22-MAY-2021, the subject experienced severe headache radiating to neck. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from legs tender, severe headache radiating to neck, and radiating pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, Nausea
Clinical narrative: FALL; HEAD INJURY/HIT HEAD; NAUSEA; DIZZINESS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205a21a, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced dizziness. On 09-MAY-2021, the subject experienced fall. On 09-MAY-2021, the subject experienced head injury/hit head. On 09-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizziness on 09-MAY-2021, and fall, head injury/hit head, and nausea. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED VACCINE AFTER EXPIRED AT ROOM TEMPERATURE; This spontaneous report received from a health care professional concerned 3 male patients. 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced administered vaccine after expired at room temperature. The action taken with covid-19 vaccine  was not applicable. The outcome of administered vaccine after expired at room temperature was not reported. This report was non-serious. This case, from the same reporter is linked to 20210545147.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Paraesthesia
Clinical narrative: DIZZINESS; BLURRY VISION; FEVER; FATIGUE; TINGLY ALL OVER HER BODY; CHILLS; NAUSEA; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heartburn, and allergic to codeine, and other pre-existing medical conditions included the patient was on unspecified acid-reflux medication and was not pregnant at the time of report. The patient experienced drug allergy when treated with pantoprazole, and oseltamivir phosphate for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced tingly all over her body. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced fatigue. On 21-MAY-2021, the subject experienced dizziness. On 21-MAY-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly all over her body, chills, and nausea on 20-MAY-2021, and fever, and fatigue on 21-MAY-2021, and had not recovered from dizziness, and blurry vision. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: DIZZINESS; BLURRY VISION; FEVER; FATIGUE; TINGLY ALL OVER HER BODY; CHILLS; NAUSEA; This spontaneous report received from a consumer concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included heartburn, and allergic to codeine, and other pre-existing medical conditions included the patient was on unspecified acid-reflux medication and was not pregnant at the time of report. The patient experienced drug allergy when treated with pantoprazole, and oseltamivir phosphate for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced tingly all over her body. On 19-MAY-2021, the subject experienced chills. On 19-MAY-2021, the subject experienced nausea. On 20-MAY-2021, the subject experienced fever. On 20-MAY-2021, the subject experienced fatigue. On 21-MAY-2021, the subject experienced dizziness. On 21-MAY-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingly all over her body, chills, and nausea on 20-MAY-2021, and fever, and fatigue on 21-MAY-2021, and had not recovered from dizziness, and blurry vision. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OPEN VIALS WERE LEFT IN THE REFRIGERATOR OVERNIGHT; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced open vials were left in the refrigerator overnight. On 23-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine  was not applicable. The outcome of the out of specification product use and open vials were left in the refrigerator overnight was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: ADMINISTRATION ERROR (15MINS PAST THE 2HR INDICATED ROOM TEMPERATURE HOLDING TIME); This spontaneous report received from a consumer 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 expiry date: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced administration error (15mins past the 2hr indicated room temperature holding time). The action taken with covid-19 vaccine  was not applicable. The outcome of administration error (15mins past the 2hr indicated room temperature holding time) was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: INJECTION SITE SWELLING IN LEFT ARM 4 TO 5 INCHES WIDE AND 2 INCHES LONG; INJECTION SITE RED IN LEFT ARM 4 TO 5 INCHES WIDE AND 2 INCHES LONG; FEVERISH; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-MAY-2021, the subject experienced injection site swelling in left arm 4 to 5 inches wide and 2 inches long. On 19-MAY-2021, the subject experienced feverish. On 19-MAY-2021, the subject experienced injection site red in left arm 4 to 5 inches wide and 2 inches long. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from injection site swelling in left arm 4 to 5 inches wide and 2 inches long, and injection site red in left arm 4 to 5 inches wide and 2 inches long, and the outcome of feverish was not reported. This report was non-serious.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Musculoskeletal pain, Odynophagia, Pyrexia
Clinical narrative: DIFFICULTY BREATHING; PAIN ON SWALLOWING; MUSCULOSKELETAL PAIN; FEVER; HEADACHE/SWOLLEN HEAD FEELING; This spontaneous report received from a patient concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced difficulty breathing. On MAY-2021, the subject experienced pain on swallowing. On MAY-2021, the subject experienced musculoskeletal pain. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache/swollen head feeling. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from fever, headache/swollen head feeling, difficulty breathing, pain on swallowing, and musculoskeletal pain. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Dysgeusia, Dyspnoea, Dysstasia
Clinical narrative: TROUBLE BREATHING; CAN'T STAND; CAN'T WALK; BRAIN FOG; STRONG ODOR IN THE URINE; CHEMICAL SMELL IN NOSE AND MOUTH; CHEMICAL TASTE IN NOSE AND MOUTH; BODY ACHE; SORE THROAT; LOOSING MEMORY; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced can't stand. On 10-APR-2021, the subject experienced can't walk. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced strong odor in the urine. On 10-APR-2021, the subject experienced chemical smell in nose and mouth. On 10-APR-2021, the subject experienced chemical taste in nose and mouth. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced loosing memory. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from trouble breathing, can't stand, can't walk, brain fog, strong odor in the urine, chemical smell in nose and mouth, chemical taste in nose and mouth, body ache, sore throat, loosing memory, and headache on MAY-2021, and had not recovered from weakness. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait inability, Headache, Oropharyngeal pain, Pain
Clinical narrative: TROUBLE BREATHING; CAN'T STAND; CAN'T WALK; BRAIN FOG; STRONG ODOR IN THE URINE; CHEMICAL SMELL IN NOSE AND MOUTH; CHEMICAL TASTE IN NOSE AND MOUTH; BODY ACHE; SORE THROAT; LOOSING MEMORY; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced can't stand. On 10-APR-2021, the subject experienced can't walk. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced strong odor in the urine. On 10-APR-2021, the subject experienced chemical smell in nose and mouth. On 10-APR-2021, the subject experienced chemical taste in nose and mouth. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced loosing memory. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from trouble breathing, can't stand, can't walk, brain fog, strong odor in the urine, chemical smell in nose and mouth, chemical taste in nose and mouth, body ache, sore throat, loosing memory, and headache on MAY-2021, and had not recovered from weakness. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Urine odour abnormal
Clinical narrative: TROUBLE BREATHING; CAN'T STAND; CAN'T WALK; BRAIN FOG; STRONG ODOR IN THE URINE; CHEMICAL SMELL IN NOSE AND MOUTH; CHEMICAL TASTE IN NOSE AND MOUTH; BODY ACHE; SORE THROAT; LOOSING MEMORY; WEAKNESS; HEADACHE; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing. On 10-APR-2021, the subject experienced can't stand. On 10-APR-2021, the subject experienced can't walk. On 10-APR-2021, the subject experienced brain fog. On 10-APR-2021, the subject experienced strong odor in the urine. On 10-APR-2021, the subject experienced chemical smell in nose and mouth. On 10-APR-2021, the subject experienced chemical taste in nose and mouth. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced loosing memory. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from trouble breathing, can't stand, can't walk, brain fog, strong odor in the urine, chemical smell in nose and mouth, chemical taste in nose and mouth, body ache, sore throat, loosing memory, and headache on MAY-2021, and had not recovered from weakness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: MUSCLE ACHES; HEADACHE; CHILLS; LOW GRADE FEVER; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced low grade fever. On 22-MAY-2021, the subject experienced muscle aches. On 22-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills on 22-MAY-2021, and had not recovered from low grade fever, headache, and muscle aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; SEVERE 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, fever, and severe headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aches, fever, and severe headache. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Headache, Hot flush, Hyperhidrosis
Clinical narrative: COLD SWEATS; HOT FLASHES; HOT SWEATS; HAND WARM TO TOUCH; HIVE REACTION ON LEFT THIGH TO LEFT ANKLE; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, marijuana occasionally, non-alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient never had any flu shots .The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced cold sweats. On 21-MAY-2021, the subject experienced hot flashes. On 21-MAY-2021, the subject experienced hot sweats. On 21-MAY-2021, the subject experienced hand warm to touch. On 21-MAY-2021, the subject experienced hive reaction on left thigh to left ankle. On 21-MAY-2021, the subject experienced tired. On 21-MAY-2021, the subject experienced headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tired, cold sweats, hot flashes, headache, hot sweats, hive reaction on left thigh to left ankle, and hand warm to touch. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Urticaria
Clinical narrative: COLD SWEATS; HOT FLASHES; HOT SWEATS; HAND WARM TO TOUCH; HIVE REACTION ON LEFT THIGH TO LEFT ANKLE; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, marijuana occasionally, non-alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient never had any flu shots .The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced cold sweats. On 21-MAY-2021, the subject experienced hot flashes. On 21-MAY-2021, the subject experienced hot sweats. On 21-MAY-2021, the subject experienced hand warm to touch. On 21-MAY-2021, the subject experienced hive reaction on left thigh to left ankle. On 21-MAY-2021, the subject experienced tired. On 21-MAY-2021, the subject experienced headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tired, cold sweats, hot flashes, headache, hot sweats, hive reaction on left thigh to left ankle, and hand warm to touch. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: DROWSINESS; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced drowsiness. On 20-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from drowsiness, and tiredness on 20-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210544414.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Disturbance in attention, Dizziness, Headache
Clinical narrative: HARD TO READ/CONCENTRATE; HEADACHE; DISCOMFORT WITH DIZZINESS; FEVER; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38.5 Degree Celsius, and Body temperature decreased (NR: not provided) 38 and 37.8 Degree Celsius. On 16-MAY-2021, the subject experienced discomfort with dizziness. On 16-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced hard to read/concentrate. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 16-MAY-2021, was recovering from headache, and discomfort with dizziness, and the outcome of hard to read/concentrate was not reported. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HARD TO READ/CONCENTRATE; HEADACHE; DISCOMFORT WITH DIZZINESS; FEVER; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 38.5 Degree Celsius, and Body temperature decreased (NR: not provided) 38 and 37.8 Degree Celsius. On 16-MAY-2021, the subject experienced discomfort with dizziness. On 16-MAY-2021, the subject experienced headache. On an unspecified date, the subject experienced hard to read/concentrate. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever on 16-MAY-2021, was recovering from headache, and discomfort with dizziness, and the outcome of hard to read/concentrate was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Dizziness, Vision blurred
Clinical narrative: DOUBLE VISION; BLURRED VISION (HAD TROUBLE LOOKING AT THINGS); FEELING DIZZY; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: acetylsalicylic acid. On 20-MAY-2021, the subject experienced double vision. On 20-MAY-2021, the subject experienced blurred vision (had trouble looking at things). On 20-MAY-2021, the subject experienced feeling dizzy. The action taken with covid-19 vaccine  was not applicable. The outcome of the double vision, blurred vision (had trouble looking at things) and feeling dizzy was not reported. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: DOUBLE VISION; BLURRED VISION (HAD TROUBLE LOOKING AT THINGS); FEELING DIZZY; This spontaneous report received from a consumer concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: acetylsalicylic acid. On 20-MAY-2021, the subject experienced double vision. On 20-MAY-2021, the subject experienced blurred vision (had trouble looking at things). On 20-MAY-2021, the subject experienced feeling dizzy. The action taken with covid-19 vaccine  was not applicable. The outcome of the double vision, blurred vision (had trouble looking at things) and feeling dizzy was not reported. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site pain
Clinical narrative: WEAKNESS; TIREDNESS; PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 01-JUL-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject  experienced pain at site of injection. On 20-MAY-2021, the subject experienced weakness. On 20-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine was not applicable. The patient recovered from pain at site of injection on MAY-2021, had not recovered from weakness, and the outcome of tiredness was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE VERY WARM TO TOUCH; BODY ACHING; CHILLS; FEVER; HEADACHE; INJECTION SITE RED; INJECTION SITE SWOLLEN; 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  (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced injection site very warm to touch. On 17-MAY-2021, the subject experienced body aching. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced fever. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced injection site red. On 17-MAY-2021, the subject experienced injection site swollen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aching, chills, fever, and headache on 19-MAY-2021, and had not recovered from injection site red, injection site swollen, and injection site very warm to touch. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: INJECTION SITE VERY WARM TO TOUCH; BODY ACHING; CHILLS; FEVER; HEADACHE; INJECTION SITE RED; INJECTION SITE SWOLLEN; 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  (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAY-2021, the subject experienced injection site very warm to touch. On 17-MAY-2021, the subject experienced body aching. On 17-MAY-2021, the subject experienced chills. On 17-MAY-2021, the subject experienced fever. On 17-MAY-2021, the subject experienced headache. On 17-MAY-2021, the subject experienced injection site red. On 17-MAY-2021, the subject experienced injection site swollen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from body aching, chills, fever, and headache on 19-MAY-2021, and had not recovered from injection site red, injection site swollen, and injection site very warm to touch. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE KEPT AT ROOM TEMPERATURE FOR OVER 2 HOURS AFTER FIRST PUNCTURE; ADMINISTRATION OF IMPROPERLY STORED VACCINE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 23/JUN/2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the subject experienced administration of improperly stored vaccine. On an unspecified date, the subject experienced vaccine kept at room temperature for over 2 hours after first puncture. The action taken with covid-19 vaccine  was not applicable. The outcome of the administration of improperly stored vaccine and vaccine kept at room temperature for over 2 hours after first puncture was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544367, 20210544466, 20210544591 and 20210544384.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain
Clinical narrative: ACHEY; MILD HEADACHE; LIGHT HEADED/DIZZINESS; This spontaneous report received from a patient concerned a 37 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 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, treatment medications included: paracetamol. On 20-MAY-2021, the subject experienced light headed/dizziness. On 21-MAY-2021, the subject experienced achey. On 21-MAY-2021, the subject experienced mild headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from achey, and mild headache on 21-MAY-2021, and was recovering from light headed/dizziness. This report was non-serious.