chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; BODY ACHES; NAUSEA; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol user, non smoker, high blood pressure, anemia, pre- diabetes, and vitamin d deficiency, and other pre-existing medical conditions included no known drug allergies were reported.no drug abuse or illicit usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: CV7528 BCHD) dose was not reported, administered on 26-MAR-2021 for COVID-19 vaccination. No concomitant medications were reported. On 26-MAR-2021; the subject experienced chills. On 26-MAR-2021 the subject experienced fever. On 26-MAR-2021, the subject experienced nausea after one hour post vaccination. On 26-MAR-2021;the subject experienced body aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, chills, and body aches. This report was non-serious. Parent Case no: 02065321
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT LIKE SHE GOT RAN OVER BY A TRUCK; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced felt like she got ran over by a truck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like she got ran over by a truck was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: FEVER; CHILLS; 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 left arm on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 100.2 (unit not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: ARM IS STILL REALLY SORE FROM THE INJECTION.; 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 (injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced arm is still really sore from the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm is still really sore from the injection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: LOW GRADE FEVER; UNCONTROLLED CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry : UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced uncontrolled chills. Treatment medications included: paracetamol. On 27-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, and the outcome of uncontrolled chills was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Emotional distress, Fatigue
Clinical narrative: BECAME EXTREMELY SHAKY; LOWER BACK MUSCLE PAIN; WAS DISTRESSED; HAD CHILLS; HIP PAIN; FEVER; LITTLE TIRED; VERY COLD; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 in afternoon for prophylactic vaccination in left arm. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced little tired. On 27-MAR-2021, the subject experienced very cold. On 27-MAR-2021 01:15, the subject experienced became extremely shaky. On 27-MAR-2021 01:15, the subject experienced lower back muscle pain. On 27-MAR-2021 01:15, the subject experienced was distressed. On 27-MAR-2021 01:15, the subject experienced had chills. On 27-MAR-2021 01:15, the subject experienced hip pain. On 27-MAR-2021 01:15, the subject experienced fever. On 27-MAR-2021 04:30, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from became extremely shaky, lower back muscle pain, was distressed, had chills, hip pain, and fever on 27-MAR-2021, had not recovered from little tired, and the outcome of very cold was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Nervousness, Pyrexia
Clinical narrative: BECAME EXTREMELY SHAKY; LOWER BACK MUSCLE PAIN; WAS DISTRESSED; HAD CHILLS; HIP PAIN; FEVER; LITTLE TIRED; VERY COLD; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 in afternoon for prophylactic vaccination in left arm. No concomitant medications were reported.  On 27-MAR-2021, the subject experienced little tired. On 27-MAR-2021, the subject experienced very cold. On 27-MAR-2021 01:15, the subject experienced became extremely shaky. On 27-MAR-2021 01:15, the subject experienced lower back muscle pain. On 27-MAR-2021 01:15, the subject experienced was distressed. On 27-MAR-2021 01:15, the subject experienced had chills. On 27-MAR-2021 01:15, the subject experienced hip pain. On 27-MAR-2021 01:15, the subject experienced fever. On 27-MAR-2021 04:30, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from became extremely shaky, lower back muscle pain, was distressed, had chills, hip pain, and fever on 27-MAR-2021, had not recovered from little tired, and the outcome of very cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: MINIMAL REACTION; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced minimal reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minimal reaction was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Injection site pain
Clinical narrative: ARM PAIN AND SORENESS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On FEB-2021, Laboratory data included: Antibody test (NR: not provided) No Igm or Igg detected. On 06-MAR-2021, the subject experienced arm pain and soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain and soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: CRAMPS IN LEGS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-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 MAR-2021, the subject experienced cramps in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramps in legs on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; NAUSEA; HEADACHE; FEVER; SORENESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced soreness. On 21-MAR-2021, the subject experienced chills. On 21-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced body ache. On 21-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the soreness, chills, headache, fever, nausea and body ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: CHILLS; RASH; FEVER OF 102; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number Unk) dose was not reported, administered on 27-MAR-2021 16:00 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced rash. On 28-MAR-2021, the subject experienced fever of 102. On 28-MAR-2021, the subject experienced headache. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever of 102, headache, fatigue, nausea and rash was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: CHILLS; RASH; FEVER OF 102; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number Unk) dose was not reported, administered on 27-MAR-2021 16:00 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced rash. On 28-MAR-2021, the subject experienced fever of 102. On 28-MAR-2021, the subject experienced headache. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever of 102, headache, fatigue, nausea and rash was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FELT MISERABLE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt miserable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt miserable was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Swelling
Clinical narrative: ARMPIT SWELLING; ARMPIT PAIN; SORE ACROSS THE SHOULDER; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 (Vaccinated in left arm) for prophylactic vaccination. No concomitant medications were reported. On 28-MAR-2021, the subject experienced armpit swelling. On 28-MAR-2021, the subject experienced armpit pain. On 28-MAR-2021, the subject experienced sore across the shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the armpit swelling, armpit pain and sore across the shoulder was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECTS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: PATIENT IS EXPERIENCING LEG CRAMPS IN BOTH LEGS AROUND THE  CALF AREA; 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 25-MAR-2021, the subject experienced subject is experiencing leg cramps in both legs around the calf area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from patient is experiencing leg cramps in both legs around the calf area. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Rash, Urticaria
Clinical narrative: HIVES ALL OVER UPPER BODY(CHEST, BACK, ARMS, UNDER HER CHIN); VERY TIRED AND SLEPT MOST OF THE DAY; RASH; DEVELOPED ITCHINESS ON HER CHEST AND UNDER HER BREASTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination in left arm. No concomitant medications were reported. On 24-MAR-2021 21:00, the subject experienced developed itchiness on her chest and under her breasts. On 25-MAR-2021, the subject experienced rash. On 25-MAR-2021, the subject experienced very tired and slept most of the day. On 25-MAR-2021 03:00, the subject experienced hives all over upper body (chest, back, arms, under her chin). On 25-MAR-2021 03:30, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very tired and slept most of the day, rash, developed itchiness on her chest and under her breasts, and hives all over upper body(chest, back, arms, under her chin). This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Capillary fragility, Chills, Gastroenteritis viral, Hypophagia
Clinical narrative: POPPED/BURST CAPPILLARIES IN CHEEKS; MIGRAINE; INJECTION SITE REDNESS; INJECTION SITE SORENESS; INJECTION SITE SWELLING; HOT TEMPERATURE; PETECHIAE ON HER CHEEKS AND ARMS; CHILLS; URINE OUTPUT DECREASED; VOMITING, LOSS OF APPETITE/NAUSEA, DEHYDRATION, LOWER ABDOMINAL PAIN, SWELLING IN ABDOMEN; ORAL INTAKE REDUCED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immunocompromised, nausea, vomiting, migraine, lupus, drug allergy to tegretol, ritalin, adderall , sporanox, latex contact long term and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and  expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included ondansetron for vomiting, and nausea, and promethazine for vomiting, and nausea. On 28-MAR-2021, the subject experienced vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen. On 28-MAR-2021, the subject experienced oral intake reduced. On 28-MAR-2021, the subject experienced urine output decreased. On 28-MAR-2021, the subject experienced petechiae on her cheeks and arms. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced hot temperature. On an unspecified date, the subject experienced popped/burst capillaries in cheeks, migraine, injection site redness, injection site soreness, and injection site swelling. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oral intake reduced, and hot temperature, and injection site redness, injection site soreness, and injection site swelling on 21-MAR-2021, was recovering from vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen, chills, urine output decreased, popped/burst capillaries in cheeks, and petechiae on her cheeks and arms, and the outcome of migraine 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Migraine, Petechiae
Clinical narrative: POPPED/BURST CAPPILLARIES IN CHEEKS; MIGRAINE; INJECTION SITE REDNESS; INJECTION SITE SORENESS; INJECTION SITE SWELLING; HOT TEMPERATURE; PETECHIAE ON HER CHEEKS AND ARMS; CHILLS; URINE OUTPUT DECREASED; VOMITING, LOSS OF APPETITE/NAUSEA, DEHYDRATION, LOWER ABDOMINAL PAIN, SWELLING IN ABDOMEN; ORAL INTAKE REDUCED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immunocompromised, nausea, vomiting, migraine, lupus, drug allergy to tegretol, ritalin, adderall , sporanox, latex contact long term and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and  expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included ondansetron for vomiting, and nausea, and promethazine for vomiting, and nausea. On 28-MAR-2021, the subject experienced vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen. On 28-MAR-2021, the subject experienced oral intake reduced. On 28-MAR-2021, the subject experienced urine output decreased. On 28-MAR-2021, the subject experienced petechiae on her cheeks and arms. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced hot temperature. On an unspecified date, the subject experienced popped/burst capillaries in cheeks, migraine, injection site redness, injection site soreness, and injection site swelling. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oral intake reduced, and hot temperature, and injection site redness, injection site soreness, and injection site swelling on 21-MAR-2021, was recovering from vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen, chills, urine output decreased, popped/burst capillaries in cheeks, and petechiae on her cheeks and arms, and the outcome of migraine 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine output decreased
Clinical narrative: POPPED/BURST CAPPILLARIES IN CHEEKS; MIGRAINE; INJECTION SITE REDNESS; INJECTION SITE SORENESS; INJECTION SITE SWELLING; HOT TEMPERATURE; PETECHIAE ON HER CHEEKS AND ARMS; CHILLS; URINE OUTPUT DECREASED; VOMITING, LOSS OF APPETITE/NAUSEA, DEHYDRATION, LOWER ABDOMINAL PAIN, SWELLING IN ABDOMEN; ORAL INTAKE REDUCED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included immunocompromised, nausea, vomiting, migraine, lupus, drug allergy to tegretol, ritalin, adderall , sporanox, latex contact long term and thyroid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and  expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included ondansetron for vomiting, and nausea, and promethazine for vomiting, and nausea. On 28-MAR-2021, the subject experienced vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen. On 28-MAR-2021, the subject experienced oral intake reduced. On 28-MAR-2021, the subject experienced urine output decreased. On 28-MAR-2021, the subject experienced petechiae on her cheeks and arms. On 28-MAR-2021, the subject experienced chills. On 28-MAR-2021, the subject experienced hot temperature. On an unspecified date, the subject experienced popped/burst capillaries in cheeks, migraine, injection site redness, injection site soreness, and injection site swelling. Laboratory data (dates unspecified) included: Blood test (NR: not provided) NORMAL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oral intake reduced, and hot temperature, and injection site redness, injection site soreness, and injection site swelling on 21-MAR-2021, was recovering from vomiting, loss of appetite/nausea, dehydration, lower abdominal pain, swelling in abdomen, chills, urine output decreased, popped/burst capillaries in cheeks, and petechiae on her cheeks and arms, and the outcome of migraine 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: F
Vaccine: COVID19
Symptoms: Groin pain, Pain in extremity
Clinical narrative: SEVERE,INTENSE PAIN IN LEG OR GROIN AREA; SEVERE,INTENSE PAIN IN LEG OR GROIN AREA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 an unspecified date, the subject experienced severe, intense pain in leg or groin area, and severe, intense pain in leg or groin area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe,intense pain in leg or groin area, and severe,intense pain in leg or groin area. 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.
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Eye pruritus, Headache
Clinical narrative: LEFT EYE BLEEDING; ITCHY EYE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 195 pounds, and height was 175 centimeters. The patient's concurrent conditions included sulfonamide allergy, seasonal allergy, and alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with Aspirin (acetylsalicylic acid), erythromycin, and Tylenol (paracetamol).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 at Left deltoid for prevention of covid-19 disease. No concomitant medications were reported.  On 10-APR-2021, the patient experienced headache and the pain was tolerable but did not take medication for it. On the same day, the patient's left eye was bleeding and it was spreading but later on it got better because the spreading stopped. The patient also reported that the bleeding might be because of the seasonal allergy and rubbed the eye because it was itchy. The patient had never experience eye bleeding before. The patient's attending physician did not inform about the situation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye bleeding, and itchy eye, and had not recovered from headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210425458-COVID-19 VACCINE AD26.COV2.S-Left eye bleeding. 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, UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Eye infarction, Fatigue, Pain in extremity
Clinical narrative: MICRO INFARCTION/SLIGHT DROOP ON RIGHT SIDE OF LIP/RIGHT EYE CLOSING ALONE; BOTH LEG PAIN BEHIND HER KNEES; EXTREMELY TIRED; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, total 1 dose, administered on 06-APR-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 07-APR-2021, the patient was extremely tired. On 08-APR-2021, she experienced leg pain on both legs behind her knees. On 10-APR-2021, both the event both leg pain behind her knees and extremely tired. On 12-APR-2021, her right eye started to close on its own, along with a slight drop on her right side of her lips. The doctor, he recommended her to take aspirin and ordered lab work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from both leg pain behind her knees, and extremely tired on 10-APR-2021, and had not recovered from micro infarction/slight droop on right side of lip/right eye closing alone. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210427668-Covid-19 vaccine ad26.cov2.s- MICRO INFARCTION/SLIGHT DROOP ON RIGHT SIDE OF LIP/RIGHT EYE CLOSING ALONE. 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Auditory disorder, Paranoia
Clinical narrative: HEARING THINGS; PARANOIA; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis c, paranoia, and hearing things, and concurrent conditions included haldol allergy, and mental health, and other pre-existing medical conditions included mental health patient.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 14:00 for prophylactic vaccination. Concomitant medications included alprazolam. On an unspecified date, the subject experienced hearing things, and paranoia. Treatment medications (dates unspecified) included: aripiprazole lauroxil. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paranoia, and hearing things. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Decreased appetite, Dizziness, Pyrexia
Clinical narrative: DIZZINESS; APPETITE WAS POOR THAT THERE WAS DIFFICULTY IN FINISHING A MEAL; FEVER; COUGHING; WEAKNESS; This spontaneous report received from a patient concerned a 66 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: 1805018, and expiry: 25-MAY-2021) dose was not reported, administered administered to the right arm, on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced weakness. On 29-MAR-2021, the subject experienced coughing. On 29-MAR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced appetite was poor that there was difficulty in finishing a meal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-APR-2021, and had not recovered from weakness, coughing, appetite was poor that there was difficulty in finishing a meal, and dizziness. 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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included epileptic seizures when seeing flashing lights, he had no prior history of stroke or any surgery, and concurrent conditions included high blood pressure, and type 2 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered, on 16-MAR-2021 around 10:30 in the morning for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-MAR-2021, the patient had stroke. The reporter did not know what kind of stroke the patient had. He was not found immediately when he had the stroke and when patient arrived at the hospital he was paralyzed on the left side and was put on the feeding tube and ventilator and moved to hospice after 8 days. On 09-APR-2021, the patient died from stroke. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210428085-COVID-19 VACCINE AD26.COV2.S -Stroke. 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, UNDERLYING DISEASE.; Reported Cause(s) of Death: Stroke
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Seizure
Clinical narrative: FEELING UNWELL; GENERALISED SEIZURE; This spontaneous report received from a physician concerned a 21-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included absence seizures (last episode was in 2012), and asthma. The patient was previously treated with ethosuximide for absence seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the patient experienced generalized seizure that lasted about 10 minutes or maybe a little longer. On an unspecified date, the patient was feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the generalized seizure and feeling unwell was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210428279- covid-19 vaccine ad26.cov2.s-GENERALISED SEIZURE- 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, UNDERLYING DISEASE
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: TUNNEL VISION; EXTREME BODY ACHE; DIZZINESS; VOMITING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight was 112 pounds and height was 66 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 at11:30a.m.in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The parent reported that the patient on 10-APR-2021 experienced tunnel vision, extreme body ache, dizziness, vomiting, chills, headache and nausea for which eight hours later patient went to the emergency room where the patient was given two bags of intravenous fluid and rotated ibuprofen and paracetamol when awake. The patient was also given Benadryl at evenings.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tunnel vision on 11-APR-2021, and vomiting, and chills on 10-APR-2021, was recovering from extreme body ache, headache, and dizziness, and had not recovered from nausea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210428952- covid-19 vaccine ad26.cov2.s-Tunnel vision, extreme body ache, dizziness, vomiting. These events are considered unassessable. The events have 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. 20210428952- covid-19 vaccine ad26.cov2.s-chills, headache, nausea. These events are labeled per RSI and are therefore considered potentially related.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision, Vomiting
Clinical narrative: TUNNEL VISION; EXTREME BODY ACHE; DIZZINESS; VOMITING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 19 year old female. The patient's weight was 112 pounds and height was 66 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 at11:30a.m.in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The parent reported that the patient on 10-APR-2021 experienced tunnel vision, extreme body ache, dizziness, vomiting, chills, headache and nausea for which eight hours later patient went to the emergency room where the patient was given two bags of intravenous fluid and rotated ibuprofen and paracetamol when awake. The patient was also given Benadryl at evenings.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tunnel vision on 11-APR-2021, and vomiting, and chills on 10-APR-2021, was recovering from extreme body ache, headache, and dizziness, and had not recovered from nausea. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210428952- covid-19 vaccine ad26.cov2.s-Tunnel vision, extreme body ache, dizziness, vomiting. These events are considered unassessable. The events have 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. 20210428952- covid-19 vaccine ad26.cov2.s-chills, headache, nausea. These events are labeled per RSI and are therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhagic stroke
Clinical narrative: HEMORRHAGIC STROKE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient experienced hemorrhagic stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hemorrhagic stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-hemorrhagic stroke. 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: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Diplopia, Dizziness, Magnetic resonance imaging, Nausea
Clinical narrative: STROKE IN THE CEREBELLUM; LOW PLATELET COUNT OF 90,000; DIZZINESS; NAUSEA; DOUBLE VISION; This spontaneous report received from a consumer concerned a male of unspecified age  The patient's weight and height were not provided. Medical history included 5-6 episodes of double vision. Concurrent conditions included inner ear syndrome.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) 1 total, dose was not reported, administered on 16-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the patient experienced double vision and could not move. He was taken to hospital and it was discovered that he had a stroke in the cerebellum confirmed via a magnetic resonance imaging scan. On 31-MAR-20201 the patient developed low platelet counts of 90,000 and was hospitalized. On an unspecified date the patient also experienced dizziness and nausea. At the time of reporting his vision was still blurred and he had double vision. He could not drive. He had 5-6 episodes of double vision in the past couple months but the cause was determined to be inner ear syndrome. The patient was discharged from hospital on an unspecified date and was awaiting an appointment with his neurologist and would follow-up with his primary care physician.  he action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from double vision, and the outcome of stroke in the cerebellum, low platelet count of 90,000, dizziness, nausea, was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This male patient of unspecified age was hospitalized for cerebellar stroke and low platelet count 15 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  Symptoms reported were double vision, blurred vision, "could not move", dizziness, nausea.  There was prior history of episodic double vision due to an unspecified inner ear syndrome for the past couple of months prior to vaccination.  Platelet count was 90,000; MRI showed stroke in the cerebellum.  No other laboratory tst results reported.  No treatment reported. Outcome of the events were not reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per organization 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
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: STROKE IN THE CEREBELLUM; LOW PLATELET COUNT OF 90,000; DIZZINESS; NAUSEA; DOUBLE VISION; This spontaneous report received from a consumer concerned a male of unspecified age  The patient's weight and height were not provided. Medical history included 5-6 episodes of double vision. Concurrent conditions included inner ear syndrome.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25/MAY/2021) 1 total, dose was not reported, administered on 16-MAR-2021 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the patient experienced double vision and could not move. He was taken to hospital and it was discovered that he had a stroke in the cerebellum confirmed via a magnetic resonance imaging scan. On 31-MAR-20201 the patient developed low platelet counts of 90,000 and was hospitalized. On an unspecified date the patient also experienced dizziness and nausea. At the time of reporting his vision was still blurred and he had double vision. He could not drive. He had 5-6 episodes of double vision in the past couple months but the cause was determined to be inner ear syndrome. The patient was discharged from hospital on an unspecified date and was awaiting an appointment with his neurologist and would follow-up with his primary care physician.  he action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from double vision, and the outcome of stroke in the cerebellum, low platelet count of 90,000, dizziness, nausea, was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This male patient of unspecified age was hospitalized for cerebellar stroke and low platelet count 15 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  Symptoms reported were double vision, blurred vision, "could not move", dizziness, nausea.  There was prior history of episodic double vision due to an unspecified inner ear syndrome for the past couple of months prior to vaccination.  Platelet count was 90,000; MRI showed stroke in the cerebellum.  No other laboratory tst results reported.  No treatment reported. Outcome of the events were not reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per organization 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