chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain in extremity, Rash pruritic, Sensory disturbance, Ultrasound scan
Clinical narrative: SENSITIVITY AT THE TOP OF THE HEAD; PRESSURE IN THE HEAD; OVERWHELMING AMOUNT OF HEAT COMING FROM HER BODY; UNSTEADY; ITCHING RASH; STABBING HEADACHE; DIZZINESS; FOGGINESS; BRUISING; FLUSHED FACE; EXTREME RIGHT KNEE SWELLING; LEG PAIN; DISTENDED VEINS; BALANCE IS OFF; PULSATING SENSATION; HIVES TO ARMS; 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 sulfa allergy, and other pre-existing medical conditions included the patient had family history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A214 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced balance is off. On APR-2021, the subject experienced pulsating sensation. On APR-2021, the subject experienced hives to arms. On 07-APR-2021, the subject experienced extreme right knee swelling. On 07-APR-2021, the subject experienced distended veins. On 07-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced bruising. On 08-APR-2021, the subject experienced flushed face. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced fogginess. On 10-APR-2021, the subject experienced stabbing headache. On 11-APR-2021, the subject experienced unsteady. On 11-APR-2021, the subject experienced sensitivity at the top of the head. On 11-APR-2021, the subject experienced pressure in the head. On 11-APR-2021, the subject experienced overwhelming amount of heat coming from her body. On 11-APR-2021, the subject experienced itching rash.  On 12-APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and Diagnostic ultrasound (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching rash, distended veins, dizziness, stabbing headache, fogginess, flushed face, and overwhelming amount of heat coming from her body, had not recovered from extreme right knee swelling, leg pain, unsteady, bruising, sensitivity at the top of the head, and pressure in the head, and the outcome of hives to arms, balance is off and pulsating sensation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vasodilatation
Clinical narrative: SENSITIVITY AT THE TOP OF THE HEAD; PRESSURE IN THE HEAD; OVERWHELMING AMOUNT OF HEAT COMING FROM HER BODY; UNSTEADY; ITCHING RASH; STABBING HEADACHE; DIZZINESS; FOGGINESS; BRUISING; FLUSHED FACE; EXTREME RIGHT KNEE SWELLING; LEG PAIN; DISTENDED VEINS; BALANCE IS OFF; PULSATING SENSATION; HIVES TO ARMS; 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 sulfa allergy, and other pre-existing medical conditions included the patient had family history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A214 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced balance is off. On APR-2021, the subject experienced pulsating sensation. On APR-2021, the subject experienced hives to arms. On 07-APR-2021, the subject experienced extreme right knee swelling. On 07-APR-2021, the subject experienced distended veins. On 07-APR-2021, the subject experienced leg pain. On 08-APR-2021, the subject experienced bruising. On 08-APR-2021, the subject experienced flushed face. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced fogginess. On 10-APR-2021, the subject experienced stabbing headache. On 11-APR-2021, the subject experienced unsteady. On 11-APR-2021, the subject experienced sensitivity at the top of the head. On 11-APR-2021, the subject experienced pressure in the head. On 11-APR-2021, the subject experienced overwhelming amount of heat coming from her body. On 11-APR-2021, the subject experienced itching rash.  On 12-APR-2021, Laboratory data included: CT scan (NR: not provided) Unknown, and Diagnostic ultrasound (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching rash, distended veins, dizziness, stabbing headache, fogginess, flushed face, and overwhelming amount of heat coming from her body, had not recovered from extreme right knee swelling, leg pain, unsteady, bruising, sensitivity at the top of the head, and pressure in the head, and the outcome of hives to arms, balance is off and pulsating sensation was not reported. 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: M
Vaccine: COVID19
Symptoms: Abdominal pain, Pain in extremity
Clinical narrative: SHARP PAIN TO ABDOMINAL AREA ON  BOTH SIDES; RIGHT LEG PAIN (THIGH); 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) dose was not reported, administered on 10-APR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced sharp pain to abdominal area on both sides. On 13-APR-2021, the subject experienced right leg pain (thigh). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp pain to abdominal area on both sides, and right leg pain (thigh). This report was non-serious.; Sender's Comments: V0: medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Bone pain, Dizziness
Clinical narrative: INCREASED BLOOD PRESSURE; BONE PAIN IN LEFT ARM; DIZZY; This spontaneous report received from a patient concerned a 73-year-old male. The patient's height, and weight were not reported. The patient's past medical history included heart stent for heart attack. The patient was non-alcohol user, and non-smoker. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 10-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced significant increase in blood pressure (200/110)/headache and bone pain in left arm (vaccine was administered on right arm). On the same day, he also experienced headache and felt dizzy. Laboratory data included: Blood pressure (NR: not provided) 200/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy on 10-MAR-2021, and had not recovered from increased blood pressure, and bone pain in left arm. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210430234-COVID-19 VACCINE AD26.COV2.S- Increased blood pressure. 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: MEDICAL HISTORY.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram head, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: FEELING OF A LIGHTENING BOLT(ZAP) THROUGH BODY; CHILLS; LOW FEVER; HEADACHE; SWOLLEN GLANDS; This spontaneous report received from a patient concerned a 63 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, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, Laboratory data included: Computerized tomogram head (NR: not provided) Normal. On 09-APR-2021, the subject experienced swollen glands. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced low fever. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced feeling of a lightening bolt (zap) through body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, low fever, swollen glands, and feeling of a lightening bolt(zap) through body. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance
Clinical narrative: FEELING OF A LIGHTENING BOLT(ZAP) THROUGH BODY; CHILLS; LOW FEVER; HEADACHE; SWOLLEN GLANDS; This spontaneous report received from a patient concerned a 63 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, and batch number were not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, Laboratory data included: Computerized tomogram head (NR: not provided) Normal. On 09-APR-2021, the subject experienced swollen glands. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced low fever. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced feeling of a lightening bolt (zap) through body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, low fever, swollen glands, and feeling of a lightening bolt(zap) through body. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Hot flush, Hypertension, Pulse pressure increased
Clinical narrative: HIGH BLOOD PRESSURE; PULSE PRESSURE OF 106; FEELING OF FLUSH; DELTOID/SHOULDER SITE SORENESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting, the patient had no known allergies and the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced feeling of flush (she stated that it felt like a heat coming through), high blood pressure of 103/101 (units unknown) and pulse pressure 106 (units unknown). She also experienced the deltoid/shoulder site soreness which lasted for 1 to 2 days. On an unspecified date she went to emergency room, she had blood pressure 240/140: high (units unknown) and pulse pressure (units unknown).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deltoid/shoulder site soreness on 13-APR-2021, was recovering from feeling of flush, had not recovered from high blood pressure, and the outcome of pulse pressure of 106 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210430543-covid-19 vaccine ad26.cov2. s-High blood pressure This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: VISUAL DISTURBANCE; COMPLEX MIGRAINE; HAD DIFFICULTY FINDING WORDS; NOT FEELING NORMAL; FATIGUE; COMPLEX HEADACHES; CHILLS; BODY ACHES; 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 pre-existing medical conditions included the patient had no previous history of migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced visual disturbance. On 13-APR-2021, the subject experienced complex migraine. On 13-APR-2021, the subject experienced had difficulty finding words. On 13-APR-2021, the subject experienced not feeling normal. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced complex headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from visual disturbance, complex migraine, and had difficulty finding words, and body aches, and chills on 13-APR-2021, had not recovered from fatigue, and not feeling normal, and the outcome of complex headaches was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Visual impairment
Clinical narrative: VISUAL DISTURBANCE; COMPLEX MIGRAINE; HAD DIFFICULTY FINDING WORDS; NOT FEELING NORMAL; FATIGUE; COMPLEX HEADACHES; CHILLS; BODY ACHES; 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 pre-existing medical conditions included the patient had no previous history of migraines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced visual disturbance. On 13-APR-2021, the subject experienced complex migraine. On 13-APR-2021, the subject experienced had difficulty finding words. On 13-APR-2021, the subject experienced not feeling normal. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced complex headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from visual disturbance, complex migraine, and had difficulty finding words, and body aches, and chills on 13-APR-2021, had not recovered from fatigue, and not feeling normal, and the outcome of complex headaches was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Dizziness, Haemoptysis
Clinical narrative: TINGLY/NUMB HANDS; DIZZINESS; HIGH BLOOD PRESSURE; COUGHED UP 3 DARK GREEN CHUNKS THAT HAD SOME BLOOD; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hysterectomy, type 2 diabetes, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F. On 06-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative.  On 12-APR-2021, the subject experienced covid-19 infection. On 12-APR-2021, the subject experienced coughed up 3 dark green chunks that had some blood. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 14-APR-2021, the subject experienced tingly/numb hands. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure (NR: not provided) 156/81. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 175/83. Treatment medications (dates unspecified) included: guaifenesin, and oxycodone hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, tingly/numb hands, and covid-19 infection, and the outcome of high blood pressure and coughed up 3 dark green chunks that had some blood was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Paraesthesia, SARS-CoV-2 test, SARS-CoV-2 test negative
Clinical narrative: TINGLY/NUMB HANDS; DIZZINESS; HIGH BLOOD PRESSURE; COUGHED UP 3 DARK GREEN CHUNKS THAT HAD SOME BLOOD; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hysterectomy, type 2 diabetes, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F. On 06-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative.  On 12-APR-2021, the subject experienced covid-19 infection. On 12-APR-2021, the subject experienced coughed up 3 dark green chunks that had some blood. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 14-APR-2021, the subject experienced tingly/numb hands. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure (NR: not provided) 156/81. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 175/83. Treatment medications (dates unspecified) included: guaifenesin, and oxycodone hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, tingly/numb hands, and covid-19 infection, and the outcome of high blood pressure and coughed up 3 dark green chunks that had some blood was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Injection site pain, Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: PROVIDER HIT THE BONE/BONE HURTS; SORE ARM NEAR SHOULDER; PROVIDER HIT THE MUSCLE; INJECTION SITE PAIN STILL HURTS SINCE 4 WEEKS; This spontaneous report received from a patient concerned an 85 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: 18050221 or 1805022) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced provider hit the bone/bone hurts. On 19-MAR-2021, the subject experienced sore arm near shoulder. On 19-MAR-2021, the subject experienced provider hit the muscle. On 19-MAR-2021, the subject experienced injection site pain still hurts since 4 weeks. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm near shoulder, injection site pain still hurts since 4 weeks, and provider hit the bone/bone hurts, and the outcome of provider hit the muscle was not reported. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; FELT TERRIBLE; This spontaneous report received from a patient concerned a 43 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 allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced felt terrible. On 14-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) POSITIVE. On 15-APR-2021, the subject experienced confirmed covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of felt terrible was not reported. This report was non-serious. This report was associated with product quality complaint: 90000176502. The suspected product quality complaint has been confirmed to be this report indicates a medical adverse event for the patient. while a positive covid test result was received after vaccination, insufficient time (14 days) had elapsed for the patient to achieve immunity therefore this report is not considered a lack of effect. approval to void this record due to no pqc identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Feeling abnormal, Feeling cold, Feeling hot
Clinical narrative: PASSED OUT; VERY HOT FEELING; SKIN WAS BURNING LIKE SEVERE SUNBURN ( ON WAIST, SHOULDER, ARM, HAND, BELLY, NECK, BREAST,  AND FACE); BODY DRAINED; SKIN REDNESS; GOOSE BUMPS; FEELING COLD; SCRATCHED BODY; HEADACHE; FELT LIKE FAINTING BUT DID NOT FAINT; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 165 pounds, and height was 154.94 centimeters. The patient's concurrent conditions included high blood pressure, diabetes, penicillin allergy, nonsmoker, and non-alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: 20-JUN-2021) .5 ml, administered on 30-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the patient experienced dizziness (felt like fainting but did not faint). Then 15 minutes later, she was fine. On 31-MAR-2021, the patient experienced headache. On 03-APR-2021, three hours into the work, she felt very very hot and her skin was burning like severe sunburn. It was waist, shoulder, arm, hand, belly, neck, breast, and face were hot and red. She scratched the body and was really warm and skin was really red. After 40 min, the patient's body went to back to normal. After 5 min, patient started feeling really cold and goose bumps on her arms that lasted for 30 minutes. After that episode she went home and felt her body was drained and passed out. The patient felt better on 04-APR-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 04-APR-2021, very hot feeling, skin was burning like severe sunburn ( on waist, shoulder, arm, hand, belly, neck, breast, and face), body drained, skin redness, goose bumps, feeling cold, and scratched body on 03-APR-2021, and felt like fainting but did not faint on 30-MAR-2021, and was recovering from headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210430845-covid-19 vaccine ad26.cov2.s-Passed out. -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Piloerection, Scratch, Skin burning sensation
Clinical narrative: PASSED OUT; VERY HOT FEELING; SKIN WAS BURNING LIKE SEVERE SUNBURN ( ON WAIST, SHOULDER, ARM, HAND, BELLY, NECK, BREAST,  AND FACE); BODY DRAINED; SKIN REDNESS; GOOSE BUMPS; FEELING COLD; SCRATCHED BODY; HEADACHE; FELT LIKE FAINTING BUT DID NOT FAINT; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 165 pounds, and height was 154.94 centimeters. The patient's concurrent conditions included high blood pressure, diabetes, penicillin allergy, nonsmoker, and non-alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: 20-JUN-2021) .5 ml, administered on 30-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the patient experienced dizziness (felt like fainting but did not faint). Then 15 minutes later, she was fine. On 31-MAR-2021, the patient experienced headache. On 03-APR-2021, three hours into the work, she felt very very hot and her skin was burning like severe sunburn. It was waist, shoulder, arm, hand, belly, neck, breast, and face were hot and red. She scratched the body and was really warm and skin was really red. After 40 min, the patient's body went to back to normal. After 5 min, patient started feeling really cold and goose bumps on her arms that lasted for 30 minutes. After that episode she went home and felt her body was drained and passed out. The patient felt better on 04-APR-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 04-APR-2021, very hot feeling, skin was burning like severe sunburn ( on waist, shoulder, arm, hand, belly, neck, breast, and face), body drained, skin redness, goose bumps, feeling cold, and scratched body on 03-APR-2021, and felt like fainting but did not faint on 30-MAR-2021, and was recovering from headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210430845-covid-19 vaccine ad26.cov2.s-Passed out. -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).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Incorrect route of product administration, Injection site pain
Clinical narrative: SLEEPLESSNESS; SWEATING; EXTREME MUSCLE CRAMPING; CHILLS; EXTREME MUSCLE PAIN; FEVER; HEADACHE; NAUSEA; PAINFUL INJECTION SITE; INJECTION SITE SWELLING; OFF LABEL USE; INCORRECT ROUTE OF DRUG ADMINISTRATION; 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, subcutaneous, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced extreme muscle cramping. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced extreme muscle pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced painful injection site. On APR-2021, the subject experienced injection site swelling. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced incorrect route of drug administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme muscle pain, chills, sweating, fever, headache, nausea, sleeplessness, painful injection site, incorrect route of drug administration, injection site swelling, extreme muscle cramping and off label use was not reported. This report was non-serious. This case, from the same reporter is linked.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site swelling, Insomnia, Muscle spasms, Myalgia, Nausea
Clinical narrative: SLEEPLESSNESS; SWEATING; EXTREME MUSCLE CRAMPING; CHILLS; EXTREME MUSCLE PAIN; FEVER; HEADACHE; NAUSEA; PAINFUL INJECTION SITE; INJECTION SITE SWELLING; OFF LABEL USE; INCORRECT ROUTE OF DRUG ADMINISTRATION; 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, subcutaneous, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced extreme muscle cramping. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced extreme muscle pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced painful injection site. On APR-2021, the subject experienced injection site swelling. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced incorrect route of drug administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme muscle pain, chills, sweating, fever, headache, nausea, sleeplessness, painful injection site, incorrect route of drug administration, injection site swelling, extreme muscle cramping and off label use was not reported. This report was non-serious. This case, from the same reporter is linked.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Pyrexia
Clinical narrative: SLEEPLESSNESS; SWEATING; EXTREME MUSCLE CRAMPING; CHILLS; EXTREME MUSCLE PAIN; FEVER; HEADACHE; NAUSEA; PAINFUL INJECTION SITE; INJECTION SITE SWELLING; OFF LABEL USE; INCORRECT ROUTE OF DRUG ADMINISTRATION; 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, subcutaneous, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On APR-2021, the subject experienced sleeplessness. On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced extreme muscle cramping. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced extreme muscle pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced painful injection site. On APR-2021, the subject experienced injection site swelling. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced incorrect route of drug administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme muscle pain, chills, sweating, fever, headache, nausea, sleeplessness, painful injection site, incorrect route of drug administration, injection site swelling, extreme muscle cramping and off label use was not reported. This report was non-serious. This case, from the same reporter is linked.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: CHILLS; TIRED; FEVER; HEADACHE; NAUSEA; DIZZINESS; SEVERE HEART RACING; PASSING OUT; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 110 pounds, and height was not reported. The patient's concurrent conditions included migraines, non alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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: 1805022, and  expiry: 25-MAY-2021) .5 ml, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced severe heart racing. On 13-MAR-2021, the subject experienced passing out. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021 06:00, the subject experienced chills. On 13-MAR-2021 06:00, the subject experienced tired. On 13-MAR-2021 06:00, the subject experienced fever. On 13-MAR-2021 06:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe heart racing, passing out, and nausea on 13-MAR-2021, dizziness, chills, and fever on 14-MAR-2021, tired on 15-MAR-2021, and headache on 17-MAR-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Presyncope, Pyrexia
Clinical narrative: CHILLS; TIRED; FEVER; HEADACHE; NAUSEA; DIZZINESS; SEVERE HEART RACING; PASSING OUT; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 110 pounds, and height was not reported. The patient's concurrent conditions included migraines, non alcohol use, and non smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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: 1805022, and  expiry: 25-MAY-2021) .5 ml, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced severe heart racing. On 13-MAR-2021, the subject experienced passing out. On 13-MAR-2021, the subject experienced dizziness. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021 06:00, the subject experienced chills. On 13-MAR-2021 06:00, the subject experienced tired. On 13-MAR-2021 06:00, the subject experienced fever. On 13-MAR-2021 06:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe heart racing, passing out, and nausea on 13-MAR-2021, dizziness, chills, and fever on 14-MAR-2021, tired on 15-MAR-2021, and headache on 17-MAR-2021. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Myalgia
Clinical narrative: MUSCLE PAIN; TROUBLE BREATHING; LIGHT-HEADEDNESS/DIZZINESS; 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced trouble breathing. On 09-APR-2021, the subject experienced light-headedness/dizziness. On 14-APR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headedness/dizziness on 09-APR-2021, and had not recovered from muscle pain, and trouble breathing. 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: U
Vaccine: COVID19
Symptoms: Chills, Dehydration, Fatigue, Feeling abnormal, Headache
Clinical narrative: CHILLS; FEVER; HEADACHE; NAUSEA; FATIGUE; FOGGY FEELING IN HEAD; BODY SORENESS/MILD PAIN; DEHYDRATION; SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight was 140 pounds, and height was 65 inches. 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 12-APR-2021 16:00 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 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced foggy feeling in head. On 13-APR-2021, the subject experienced body soreness/mild pain. On 13-APR-2021, the subject experienced dehydration. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021 03:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head, body soreness/mild pain, dehydration, chills, fever, headache, nausea, and fatigue on 13-APR-2021, and was recovering from sore arm. 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: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; NAUSEA; FATIGUE; FOGGY FEELING IN HEAD; BODY SORENESS/MILD PAIN; DEHYDRATION; SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight was 140 pounds, and height was 65 inches. 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 12-APR-2021 16:00 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 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced foggy feeling in head. On 13-APR-2021, the subject experienced body soreness/mild pain. On 13-APR-2021, the subject experienced dehydration. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021 03:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head, body soreness/mild pain, dehydration, chills, fever, headache, nausea, and fatigue on 13-APR-2021, and was recovering from sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Decreased immune responsiveness, Feeling abnormal, Nausea, Viral infection
Clinical narrative: POSSIBLE INFECTION DUE TO LOW IMMUNITY; CAUGHT ANOTHER VIRUS; CONSTIPATION; FELT VERY BAD; NAUSEA; This spontaneous report received from a parent concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and other pre-existing medical conditions included no known drug allergies and was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered on 10-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient felt very bad, had some constipation followed by nausea and it continued until 12-APR-2021. On 13-APR-2021, the patient felt better, then On 15-APR-2021, the patient got admitted to the hospital for possible infection due to low immunity and caught another virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constipation, felt very bad, and nausea on 13-APR-2021, and the outcome of possible infection due to low immunity, caught another virus was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210431111-Covid-19 vaccine ad26.cov2.s-Possible infection due to low immunity and caught another virus. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Investigation, Ophthalmological examination, Visual impairment
Clinical narrative: STROKE LIKE SYMPTOMS; VISION ABNORMAL; This spontaneous report received from a consumer via social media concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total administered 11-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 12-APR-2021, Monday afternoon, the patient felt symptoms similar to an stroke and at the end of the evening he felt normal. It was reported that only his vision was out of place. The physicians could not explain what was wrong as everything looked normal in test and scan (unspecified). According to them it was a side effect of vaccine. Laboratory data included: Eye exam (NR: not provided) Normal, and Investigation (NR: not provided) Normal.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke like symptoms on 12-APR-2021, and had not recovered from vision abnormal. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210431142-Covid-19 vaccine ad26.cov2.s-stroke like symptoms  . This events is considered unassessable. The events 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 events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye irritation, Eye pain, Headache, Myalgia
Clinical narrative: FEELING LIKE SINUS INFECTION; HEADACHE; NIGHT SWEATS; PAIN IN LEFT EYE; BURNINIG IN  BOTH EYES; PINK EYE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23/JUN/2021) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced night sweats. On 08-APR-2021, the subject experienced pain in left eye. On 08-APR-2021, the subject experienced burninig in both eyes. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced pink eye. On 09-APR-2021, the subject experienced feeling like sinus infection. On 09-APR-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 recovered from night sweats on 10-APR-2021, and muscle aches on 09-APR-2021, had not recovered from headache, and feeling like sinus infection, and the outcome of pain in left eye, burninig in both eyes, fever and pink eye was not reported. This report was non-serious.; Sender's Comments: v0- Medical assessment comment is not required as per standard operating procedures, as case is assessed as non-serious.