chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Sinus disorder
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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Joint swelling, Oedema peripheral, Peripheral swelling
Clinical narrative: SWELLING OF THE HAND; SWELLING OF THE ANKLE; SWELLING OF LEFT TOE; GOUT; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced gout. On 23-MAR-2021, the subject experienced swelling of the hand. On 23-MAR-2021, the subject experienced swelling of the ankle. On 23-MAR-2021, the subject experienced swelling of left toe. Treatment medications (dates unspecified) included: colchicine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the hand, swelling of left toe, gout, and swelling of the ankle. 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.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: BAD MUSCLE SPASMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced bad muscle spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad muscle spasms. 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.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: PAINFUL KNOT ON HAND; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included intermittent chest pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prevention of covid-19. No concomitant medications were reported. On 27-MAR-2021, the subject experienced painful knot on hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful knot on hand. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Facial pain, Fatigue, Headache
Clinical narrative: COULD NOT MOVE; CHILLS; HEADACHES- PIERCING ON THE RIGHT SIDE; NOT GOOD; TIRED; NAUSEAS; SHORTNESS OF BREATH; MOUTH WATERING; CHEEKS SORE; BODY ACHES; 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 concurrent conditions included asthma, and other pre-existing medical conditions included brio in am from 2015 due to overuse of pesticide at work. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma.  On MAR-2021, treatment medications included: ibuprofen. On 22-MAR-2021, the subject experienced shortness of breath. On 22-MAR-2021, the subject experienced mouth watering. On 22-MAR-2021, the subject experienced cheeks sore. On 22-MAR-2021, the subject experienced body aches. On 22-MAR-2021, the subject experienced not good. On 22-MAR-2021, the subject experienced tired. On 22-MAR-2021, the subject experienced nauseas. On 23-MAR-2021, the subject experienced could not move. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced headaches- piercing on the right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move, and chills on 25-MAR-2021, shortness of breath, mouth watering, cheeks sore, not good, tired, nauseas, and headaches- piercing on the right side, and body aches on 05-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Malaise, Nausea, Pain, Salivary hypersecretion
Clinical narrative: COULD NOT MOVE; CHILLS; HEADACHES- PIERCING ON THE RIGHT SIDE; NOT GOOD; TIRED; NAUSEAS; SHORTNESS OF BREATH; MOUTH WATERING; CHEEKS SORE; BODY ACHES; 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 concurrent conditions included asthma, and other pre-existing medical conditions included brio in am from 2015 due to overuse of pesticide at work. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma.  On MAR-2021, treatment medications included: ibuprofen. On 22-MAR-2021, the subject experienced shortness of breath. On 22-MAR-2021, the subject experienced mouth watering. On 22-MAR-2021, the subject experienced cheeks sore. On 22-MAR-2021, the subject experienced body aches. On 22-MAR-2021, the subject experienced not good. On 22-MAR-2021, the subject experienced tired. On 22-MAR-2021, the subject experienced nauseas. On 23-MAR-2021, the subject experienced could not move. On 23-MAR-2021, the subject experienced chills. On 23-MAR-2021, the subject experienced headaches- piercing on the right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move, and chills on 25-MAR-2021, shortness of breath, mouth watering, cheeks sore, not good, tired, nauseas, and headaches- piercing on the right side, and body aches on 05-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. 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 and Expiry Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stroke. It was reported that the patient had a stroke 10 days after receiving the J&J vaccine The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2.s -Stroke. 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: M
Vaccine: COVID19
Symptoms: Chest pain, Product storage error, Troponin increased
Clinical narrative: HIGH TROPONINS; CHEST PAINS; PRODUCT WAS NOT PROPERLY STORED FROM RECEIPT TO ADMINISTRATION(PRODUCT STORAGE ERROR); This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry Date: UNKNOWN) dose was not reported, 1 total, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-APR-2021, the patient went to emergency room for pains in the chest on same day the patient was admitted overnight in hospital due to high level of troponins. The patient might got catheterized. It was also stated that product was not properly stored from receipt to administration (product storage error). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pains, high troponins and product was not properly stored from receipt to administration (product storage error) was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210431465-Covid-19 vaccine ad26.cov2.s-Chest pain and high troponin .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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cold sweat, Contusion, Diarrhoea, Dysstasia
Clinical narrative: UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE SOMETHING HAPPENED; ARM PAIN; BURNING HEAT OFF BODY; BRUISING AT UPPER SPINE/YELLOW BRUISING DOWN LOWER LEFT LEG; SEVERE PAIN UP NECK AND DOWN  BACK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive to antibiotics, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced bruising at upper spine/yellow bruising down lower left leg. On 04-MAR-2021, the subject experienced severe pain up neck and down back. On 04-MAR-2021 14:00, the subject experienced burning heat off body. On 05-MAR-2021, the subject experienced arm pain. On 07-MAR-2021, the subject experienced cold sweat. On 07-MAR-2021, the subject experienced could not stand up from floor. On 07-MAR-2021, the subject experienced severe diarrhea. On 07-MAR-2021, the subject experienced felt like something happened. On 19-MAR-2021, the subject experienced upper spine was very tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper spine was very tender, bruising at upper spine/yellow bruising down lower left leg, and severe pain up neck and down back on 07-APR-2021, burning heat off body on 04-MAR-2021, and cold sweat, could not stand up from floor, and severe diarrhea on 07-MAR-2021, and the outcome of arm pain and felt like something happened was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Musculoskeletal pain, Pain in extremity, Spinal pain
Clinical narrative: UPPER SPINE WAS VERY TENDER; COLD SWEAT; COULD NOT STAND UP FROM FLOOR; SEVERE DIARRHEA; FELT LIKE SOMETHING HAPPENED; ARM PAIN; BURNING HEAT OFF BODY; BRUISING AT UPPER SPINE/YELLOW BRUISING DOWN LOWER LEFT LEG; SEVERE PAIN UP NECK AND DOWN  BACK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sensitive to antibiotics, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 and expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced bruising at upper spine/yellow bruising down lower left leg. On 04-MAR-2021, the subject experienced severe pain up neck and down back. On 04-MAR-2021 14:00, the subject experienced burning heat off body. On 05-MAR-2021, the subject experienced arm pain. On 07-MAR-2021, the subject experienced cold sweat. On 07-MAR-2021, the subject experienced could not stand up from floor. On 07-MAR-2021, the subject experienced severe diarrhea. On 07-MAR-2021, the subject experienced felt like something happened. On 19-MAR-2021, the subject experienced upper spine was very tender. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upper spine was very tender, bruising at upper spine/yellow bruising down lower left leg, and severe pain up neck and down back on 07-APR-2021, burning heat off body on 04-MAR-2021, and cold sweat, could not stand up from floor, and severe diarrhea on 07-MAR-2021, and the outcome of arm pain and felt like something happened was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: BOTH LOWER EAR LOBES BRUISED; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced both lower ear lobes bruised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both lower ear lobes bruised. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Cough, Dyspnoea
Clinical narrative: DRY COUGH; CHEST TIGHTNESS; PAIN AT INJECTION SITE; HEADACHE; BODY ACHES; SWEATS; FEVER; CHILLS; FATIGUE; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included stopped birth control pill 30 days ago, and other pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A and 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 shortness of breath. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 22:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced sweats. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced dry cough. On 03-APR-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache on 04-APR-2021, sweats, and chills, fatigue, and pain at injection site on 03-APR-2021, and had not recovered from dry cough, chest tightness, and shortness of breath. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Injection site pain, Pain
Clinical narrative: DRY COUGH; CHEST TIGHTNESS; PAIN AT INJECTION SITE; HEADACHE; BODY ACHES; SWEATS; FEVER; CHILLS; FATIGUE; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included stopped birth control pill 30 days ago, and other pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A and 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 shortness of breath. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 22:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced sweats. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced dry cough. On 03-APR-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache on 04-APR-2021, sweats, and chills, fatigue, and pain at injection site on 03-APR-2021, and had not recovered from dry cough, chest tightness, and shortness of breath. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DRY COUGH; CHEST TIGHTNESS; PAIN AT INJECTION SITE; HEADACHE; BODY ACHES; SWEATS; FEVER; CHILLS; FATIGUE; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's past medical history included stopped birth control pill 30 days ago, and other pre-existing medical conditions included the patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A and 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 shortness of breath. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fatigue. On 01-APR-2021 22:00, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.4 F. On 02-APR-2021, the subject experienced body aches. On 02-APR-2021, the subject experienced sweats. On 02-APR-2021, the subject experienced pain at injection site. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced dry cough. On 03-APR-2021, the subject experienced chest tightness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache on 04-APR-2021, sweats, and chills, fatigue, and pain at injection site on 03-APR-2021, and had not recovered from dry cough, chest tightness, and shortness of breath. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle spasms, Pain, Pyrexia, Thrombosis
Clinical narrative: BLOOD CLOT; LEG CRAMPS; ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included overweight, high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced a mild fever. On 08-APR-2021, the patient was achy and had a mild headache. The headache continued for several day and became pretty bad for about two days. On an unspecified date in Apr-2021 the patient was treated with Tylenol for headache. On 12-APR-2021, the patient experienced leg cramps in her right leg. On 15-APR-2021, the patient had an ultrasound and a blood clot was found in her right leg. The patient started on Apixaban (Eliquis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on an unknown date in APR-2021, and the outcome of blood clot, ache, leg cramps and fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 50-year-old female was found to have blood clot in her right leg 9 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. There was reported mild fever, headache, and "aches" 1 to 2 days after vaccination that was treated with Tylenol.  The symptom reported was leg cramps on right leg 5 days after vaccination, and ultrasound showed blood clot in her right leg 3 days after the symptom of cramps was noted.  No other laboratory/diagnostic test reported.  The patient was treated with apixaban.  The outcome of blood clot in leg was not reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: BLOOD CLOT; LEG CRAMPS; ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included overweight, high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced a mild fever. On 08-APR-2021, the patient was achy and had a mild headache. The headache continued for several day and became pretty bad for about two days. On an unspecified date in Apr-2021 the patient was treated with Tylenol for headache. On 12-APR-2021, the patient experienced leg cramps in her right leg. On 15-APR-2021, the patient had an ultrasound and a blood clot was found in her right leg. The patient started on Apixaban (Eliquis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on an unknown date in APR-2021, and the outcome of blood clot, ache, leg cramps and fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 50-year-old female was found to have blood clot in her right leg 9 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. There was reported mild fever, headache, and "aches" 1 to 2 days after vaccination that was treated with Tylenol.  The symptom reported was leg cramps on right leg 5 days after vaccination, and ultrasound showed blood clot in her right leg 3 days after the symptom of cramps was noted.  No other laboratory/diagnostic test reported.  The patient was treated with apixaban.  The outcome of blood clot in leg was not reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Dyspnoea, Pain in extremity, Pulmonary oedema
Clinical narrative: BLOOD CLOT; LEG CRAMPS; ACHE; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included overweight, high blood pressure, and high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced a mild fever. On 08-APR-2021, the patient was achy and had a mild headache. The headache continued for several day and became pretty bad for about two days. On an unspecified date in Apr-2021 the patient was treated with Tylenol for headache. On 12-APR-2021, the patient experienced leg cramps in her right leg. On 15-APR-2021, the patient had an ultrasound and a blood clot was found in her right leg. The patient started on Apixaban (Eliquis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on an unknown date in APR-2021, and the outcome of blood clot, ache, leg cramps and fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 50-year-old female was found to have blood clot in her right leg 9 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. There was reported mild fever, headache, and "aches" 1 to 2 days after vaccination that was treated with Tylenol.  The symptom reported was leg cramps on right leg 5 days after vaccination, and ultrasound showed blood clot in her right leg 3 days after the symptom of cramps was noted.  No other laboratory/diagnostic test reported.  The patient was treated with apixaban.  The outcome of blood clot in leg was not reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle spasms, Pain, Pyrexia, Thrombosis
Clinical narrative: Patient received J&J vaccine at 4/6/21. She began complaining of calf pain 1 week later. She was diagnosed with DVT and started on Eliquis 10 mg PO BID x 7 days on 4/15/21, followed by 5 mg PO BID on 4/22/21.   She continued to complain of shortness of breath. CT chest was done to rule out PE. She was diagnosed with PE and sent to the emergency room for a continuous heparin drip (despite adequate anticoagulation with Eliquis)  She is saturating  at 97% on room air. Her BP is stable. She is afebrile  Of note, she is morbidly obese Her height is 64 in (5' 4") Her weight is 106 kg (233 lbs) Her BMI is 39.99 kg/m2  She is not on any hormone replacement therapy, contraceptives, etc. Her last known use of oral contraceptives was 10 years ago. She is not an active smoker
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: Patient received J&J vaccine at 4/6/21. She began complaining of calf pain 1 week later. She was diagnosed with DVT and started on Eliquis 10 mg PO BID x 7 days on 4/15/21, followed by 5 mg PO BID on 4/22/21.   She continued to complain of shortness of breath. CT chest was done to rule out PE. She was diagnosed with PE and sent to the emergency room for a continuous heparin drip (despite adequate anticoagulation with Eliquis)  She is saturating  at 97% on room air. Her BP is stable. She is afebrile  Of note, she is morbidly obese Her height is 64 in (5' 4") Her weight is 106 kg (233 lbs) Her BMI is 39.99 kg/m2  She is not on any hormone replacement therapy, contraceptives, etc. Her last known use of oral contraceptives was 10 years ago. She is not an active smoker
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Dyspnoea, Pain in extremity, Pulmonary oedema
Clinical narrative: Patient received J&J vaccine at 4/6/21. She began complaining of calf pain 1 week later. She was diagnosed with DVT and started on Eliquis 10 mg PO BID x 7 days on 4/15/21, followed by 5 mg PO BID on 4/22/21.   She continued to complain of shortness of breath. CT chest was done to rule out PE. She was diagnosed with PE and sent to the emergency room for a continuous heparin drip (despite adequate anticoagulation with Eliquis)  She is saturating  at 97% on room air. Her BP is stable. She is afebrile  Of note, she is morbidly obese Her height is 64 in (5' 4") Her weight is 106 kg (233 lbs) Her BMI is 39.99 kg/m2  She is not on any hormone replacement therapy, contraceptives, etc. Her last known use of oral contraceptives was 10 years ago. She is not an active smoker
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECT OF THE VACCINE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced side effect of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect of the vaccine was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation test, Contusion, Haematochezia, Injection site pain, Skin mass
Clinical narrative: BLOOD IN STOOL; TENDER LUMP ABOVE HIS LEFT EYEBROW; FACIAL CONTUSION; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included Human immunodeficiency (HIV) infection, seasonal allergy, medical marijuana, alcohol use (glass of wine with dinner), non smoker, and bleeding issues.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042AV1A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 19:30 to right arm for prophylactic vaccination. Concomitant medications included atazanavir sulfate for antiviral, emtricitabine/tenofovir alafenamide fumarate for antiviral, cetirizine hydrochloride for seasonal allergies, amlodipine besilate, and topiramate. He stopped his antivirals medications two days prior to this report and three days after vaccination. On APR-2021, the patient experienced injection site pain. On 10-APR-2021, around noon he noticed a lump above left eyebrow/facial contusion, described as a raised portion the size of a pea, with a red portion an inch by and half. It was tender. It was still present at the time of this report but improved. On 11-APR-2021, after a bowel movement, he noticed fresh blood in the stool around the faeces and afterwards he wiped. On 13-APR-2021, he contacted his healthcare professional (HCP) and they did a coagulation test (NR: not provided) and it was within normal range. He mentioned that the bleeding was a little worse but his HCP was going to retest in a few days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 12-APR-2021, was recovering from tender lump above his left eyebrow, and facial contusion, and had not recovered from blood in stool.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210431872-Covid-19 vaccine ad26.cov2.s-Blood in stool. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Off label use, Product administered to patient of inappropriate age
Clinical narrative: FELT AWFUL; VOMITING/ THREW UP; DIZZY; HIGH FEVER; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; NAUSEA/ FELT LIKE THROW UP; This spontaneous report received from a patient concerned a 16 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced nausea/ felt like throw up. On 10-APR-2021, the subject experienced inappropriate age at vaccine administration. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced high fever. On 11-APR-2021 06:00, the subject experienced vomiting/ threw up. On 12-APR-2021, the subject experienced felt awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting/ threw up, high fever, dizzy, felt awful, and nausea/ felt like throw up, and the outcome of inappropriate age at vaccine administration and off label use 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: FELT AWFUL; VOMITING/ THREW UP; DIZZY; HIGH FEVER; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; NAUSEA/ FELT LIKE THROW UP; This spontaneous report received from a patient concerned a 16 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced off label use. On APR-2021, the subject experienced nausea/ felt like throw up. On 10-APR-2021, the subject experienced inappropriate age at vaccine administration. On 11-APR-2021, the subject experienced dizzy. On 11-APR-2021, the subject experienced high fever. On 11-APR-2021 06:00, the subject experienced vomiting/ threw up. On 12-APR-2021, the subject experienced felt awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting/ threw up, high fever, dizzy, felt awful, and nausea/ felt like throw up, and the outcome of inappropriate age at vaccine administration and off label use 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: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Magnetic resonance imaging, Nausea, Pain
Clinical narrative: SEVERE ABDOMINAL PAIN; VOMITING; BODY ACHES; NAUSEA; This spontaneous report received from a patient concerned a 53-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient was non-alcohol user, and non-smoker. The patient experienced drug allergy (itching and redness) when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808480, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) which was negative. On 13-APR-2021, the patient experienced severe abdominal pain, body aches and nausea and he went to Emergency room where he received IV pain medication and they performed MRI (Magnetic resonance imaging) and did blood work. Both were normal. Patient returned to the emergency room with severe pain after he took Tylenol and he vomited. He was administered with IV (intravenous) pain medication and started IV fluids. New blood work was done on 14-APR-2021 which was negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe abdominal pain, vomiting, body aches, and nausea on 15-APR-2021 and the outcome of drug allergy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Severe abdominal pain, Vomiting, Body aches. 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: UNDERLYING DISEASE. V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: SEVERE ABDOMINAL PAIN; VOMITING; BODY ACHES; NAUSEA; This spontaneous report received from a patient concerned a 53-year-old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. The patient was non-alcohol user, and non-smoker. The patient experienced drug allergy (itching and redness) when treated with morphine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808480, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) which was negative. On 13-APR-2021, the patient experienced severe abdominal pain, body aches and nausea and he went to Emergency room where he received IV pain medication and they performed MRI (Magnetic resonance imaging) and did blood work. Both were normal. Patient returned to the emergency room with severe pain after he took Tylenol and he vomited. He was administered with IV (intravenous) pain medication and started IV fluids. New blood work was done on 14-APR-2021 which was negative. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe abdominal pain, vomiting, body aches, and nausea on 15-APR-2021 and the outcome of drug allergy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Severe abdominal pain, Vomiting, Body aches. 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: UNDERLYING DISEASE. V0 20210431932- COVID-19 VACCINE AD26.COV2.S-Nausea. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate decreased, Hyperhidrosis
Clinical narrative: HEART RATE DROPPED TO 36-37 BEATS/MINUTES; SWEATING PROFUSELY; DIZZINESS/ LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  Patient reported that, he got the Janssen vaccine on Monday 12-April -2021.Right after vaccination patient started experiencing lightheadedness, sweating profusely, heart rate dropped to 36-37 beats/minutes.he did not see his MD and did not go to ED(emergency department) Patient was feeling much better right now. He was not on any chronic medications. Laboratory data included: Pulse rate (NR: not provided) 36-37 beats/minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate dropped to 36-37 beats/minutes, sweating profusely, and dizziness/ lightheadedness. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210431941-covid-19 vaccine ad26.cov2. s-heart rate dropped. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Headache, Lymphadenopathy, Myalgia
Clinical narrative: CELLULITIS OF ARM; SWOLLEN AND PAINFUL LYMPH NODES; SEVERE MUSCLE ACHES; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 160 pounds, and height was 64 inches.  The patient's past medical history included left arm cellulitis, and concurrent conditions included penicillin, alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021,patient Body temperature (NR: not provided) 103.4 f and 100 f.  Patient called and reported that, received Janssen covid 19 vaccine on April 1, 2021 after 2 weeks later still have a 5 cm lump on left arm ( it was hot, red and painful), swollen and painful lymph nodes, 103.4 fever for 24 hours after the vaccine.a low grade fever for 2 additional days under 100. patient also experienced severe muscle aches to lower body and a severe headache for 24 hours.Patient visited to physician on April 12, 2021 and they prescribed antibiotics. Patient was diagnosed with left arm cellulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from severe muscle aches on 03-APR-2021, and severe headache on 02-APR-2021, had not recovered from swollen and painful lymph nodes, and the outcome of cellulitis of arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210431961-covid-19 vaccine ad26.cov2.s-cellulitis of the arm. 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.