chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Troponin
Clinical narrative: I had unexplained pain in left side (possibly left lung). I went to urgent care and they drew blood and were worried about blood clots, so they sent me to emergency room. Emergency room gave me CT scan and found blood clots in my right lung and put me on blood thinner. My last two bowel movements have been black, so I am worried about internal bleeding. Diagnosis: Other acute pulmonary embolism without acute cor pulmonale (HCC). Medicines given: Alum & Mag Hydroxide-Simeth (Maalox Max) Last given at 8:14 PM; Fentanyl citrate Last given at 8:45 PM; Isovue-370 (Lopamidol) Last given at 8:35 PM; lidocaine viscous (XYLOCAINE) Last given at 8:14 PM.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulopathy, Computerised tomogram, Computerised tomogram thorax, Electrocardiogram, Faeces discoloured
Clinical narrative: I had unexplained pain in left side (possibly left lung). I went to urgent care and they drew blood and were worried about blood clots, so they sent me to emergency room. Emergency room gave me CT scan and found blood clots in my right lung and put me on blood thinner. My last two bowel movements have been black, so I am worried about internal bleeding. Diagnosis: Other acute pulmonary embolism without acute cor pulmonale (HCC). Medicines given: Alum & Mag Hydroxide-Simeth (Maalox Max) Last given at 8:14 PM; Fentanyl citrate Last given at 8:45 PM; Isovue-370 (Lopamidol) Last given at 8:35 PM; lidocaine viscous (XYLOCAINE) Last given at 8:14 PM.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Lipase, Metabolic function test, Pain, Pulmonary embolism
Clinical narrative: I had unexplained pain in left side (possibly left lung). I went to urgent care and they drew blood and were worried about blood clots, so they sent me to emergency room. Emergency room gave me CT scan and found blood clots in my right lung and put me on blood thinner. My last two bowel movements have been black, so I am worried about internal bleeding. Diagnosis: Other acute pulmonary embolism without acute cor pulmonale (HCC). Medicines given: Alum & Mag Hydroxide-Simeth (Maalox Max) Last given at 8:14 PM; Fentanyl citrate Last given at 8:45 PM; Isovue-370 (Lopamidol) Last given at 8:35 PM; lidocaine viscous (XYLOCAINE) Last given at 8:14 PM.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin I
Clinical narrative: I had unexplained pain in left side (possibly left lung). I went to urgent care and they drew blood and were worried about blood clots, so they sent me to emergency room. Emergency room gave me CT scan and found blood clots in my right lung and put me on blood thinner. My last two bowel movements have been black, so I am worried about internal bleeding. Diagnosis: Other acute pulmonary embolism without acute cor pulmonale (HCC). Medicines given: Alum & Mag Hydroxide-Simeth (Maalox Max) Last given at 8:14 PM; Fentanyl citrate Last given at 8:45 PM; Isovue-370 (Lopamidol) Last given at 8:35 PM; lidocaine viscous (XYLOCAINE) Last given at 8:14 PM.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Angiogram normal, Cerebrovascular accident, Computerised tomogram head, Computerised tomogram head normal
Clinical narrative: Pt came to the ER on 4/13/21 after receiving the vaccine on 4/8/21 with a pressure headache and stroke like symptoms. Left sided weakness and limping.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Gait disturbance, Haemoglobin decreased, Headache, Hemiparesis
Clinical narrative: Pt came to the ER on 4/13/21 after receiving the vaccine on 4/8/21 with a pressure headache and stroke like symptoms. Left sided weakness and limping.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Intensive care, Magnetic resonance imaging head normal, Nausea, Peritonsillar abscess
Clinical narrative: Pt came to the ER on 4/13/21 after receiving the vaccine on 4/8/21 with a pressure headache and stroke like symptoms. Left sided weakness and limping.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count normal, Pyrexia, Speech disorder, Tonsillar cyst, Ultrasound Doppler normal
Clinical narrative: Pt came to the ER on 4/13/21 after receiving the vaccine on 4/8/21 with a pressure headache and stroke like symptoms. Left sided weakness and limping.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Venogram, Venogram normal, White blood cell count normal
Clinical narrative: Pt came to the ER on 4/13/21 after receiving the vaccine on 4/8/21 with a pressure headache and stroke like symptoms. Left sided weakness and limping.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Dysarthria, Headache, Muscular weakness
Clinical narrative: Pt came to the ER on 4/13/21 after receiving the vaccine on 4/8/21 with a pressure headache and stroke like symptoms. Left sided weakness and limping.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Gait disturbance, Head discomfort, Headache, Hemiparesis
Clinical narrative: Pt came to the ER on 4/13/21 after receiving the vaccine on 4/8/21 with a pressure headache and stroke like symptoms. Left sided weakness and limping.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Nausea, Neurological symptom
Clinical narrative: Pt came to the ER on 4/13/21 after receiving the vaccine on 4/8/21 with a pressure headache and stroke like symptoms. Left sided weakness and limping.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Fibrin D dimer, Pulmonary embolism
Clinical narrative: Headache, shortness of breath which were progressively worsening, evaluated in ER at hospital and found to have two sub-segmental PE's.  He was started on oral anticoagulation with xarelto and discharged home in stable condition.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral normal, Angiogram pulmonary abnormal, Condition aggravated, Dyspnoea, Fibrin D dimer
Clinical narrative: Headache, shortness of breath which were progressively worsening, evaluated in ER at hospital and found to have two sub-segmental PE's.  He was started on oral anticoagulation with xarelto and discharged home in stable condition.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Platelet count decreased, Pulmonary embolism
Clinical narrative: Headache, shortness of breath which were progressively worsening, evaluated in ER at hospital and found to have two sub-segmental PE's.  He was started on oral anticoagulation with xarelto and discharged home in stable condition.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: LUMP IN SHOULDER
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Induration
Clinical narrative: LUMP IN SHOULDER
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: TIREDNESS; DRUG USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a parent concerned a 17 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: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced drug use in unapproved age group. On 09-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug use in unapproved age group and tiredness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Product use issue
Clinical narrative: TIREDNESS; DRUG USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a parent concerned a 17 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: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced drug use in unapproved age group. On 09-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug use in unapproved age group and tiredness was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient received J&J Covid-19 vaccine on Thursday. Was well andvisiting with friends on Sunday. Did not attend scheduled physical therapy appointment on Monday. Was found dead in apartment on Tuesday by family.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Abnormal behaviour, Aggression, Aphasia, Blood test normal, Catatonia
Clinical narrative: Pt received the 2nd covid vaccine on 4/7/2021.  48 hours after the shot, pt began to have diarrhea, hot flashes and mental state changed.  96 hours after the vaccine she had a terrible migraine and progressed to a catatonic state.  Monday (96 hours later) pt went to hospital and was in the hospital for observation for 48 hours.  Drs reported this to VAERS and have no clue why the pt is in the current state.  Pt is currently in the psych ward all per spouse.   Pt did not have an problems with the 1st vaccine.  the 2nd vaccine was lot 028A21A which was a short dated Lot per CDC and corporate.  Spouse wanted to report this lot.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Computerised tomogram head normal, Defaecation urgency, Defiant behaviour, Dissociative disorder, Emotional distress
Clinical narrative: Pt received the 2nd covid vaccine on 4/7/2021.  48 hours after the shot, pt began to have diarrhea, hot flashes and mental state changed.  96 hours after the vaccine she had a terrible migraine and progressed to a catatonic state.  Monday (96 hours later) pt went to hospital and was in the hospital for observation for 48 hours.  Drs reported this to VAERS and have no clue why the pt is in the current state.  Pt is currently in the psych ward all per spouse.   Pt did not have an problems with the 1st vaccine.  the 2nd vaccine was lot 028A21A which was a short dated Lot per CDC and corporate.  Spouse wanted to report this lot.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Gait disturbance, Grunting, Hot flush, Injection site pain, Irritability
Clinical narrative: Pt received the 2nd covid vaccine on 4/7/2021.  48 hours after the shot, pt began to have diarrhea, hot flashes and mental state changed.  96 hours after the vaccine she had a terrible migraine and progressed to a catatonic state.  Monday (96 hours later) pt went to hospital and was in the hospital for observation for 48 hours.  Drs reported this to VAERS and have no clue why the pt is in the current state.  Pt is currently in the psych ward all per spouse.   Pt did not have an problems with the 1st vaccine.  the 2nd vaccine was lot 028A21A which was a short dated Lot per CDC and corporate.  Spouse wanted to report this lot.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Magnetic resonance imaging head normal, Mental status changes, Migraine, Mood swings, Nervousness
Clinical narrative: Pt received the 2nd covid vaccine on 4/7/2021.  48 hours after the shot, pt began to have diarrhea, hot flashes and mental state changed.  96 hours after the vaccine she had a terrible migraine and progressed to a catatonic state.  Monday (96 hours later) pt went to hospital and was in the hospital for observation for 48 hours.  Drs reported this to VAERS and have no clue why the pt is in the current state.  Pt is currently in the psych ward all per spouse.   Pt did not have an problems with the 1st vaccine.  the 2nd vaccine was lot 028A21A which was a short dated Lot per CDC and corporate.  Spouse wanted to report this lot.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Panic reaction, Parosmia, Personality disorder, Prosopagnosia, Psychiatric evaluation
Clinical narrative: Pt received the 2nd covid vaccine on 4/7/2021.  48 hours after the shot, pt began to have diarrhea, hot flashes and mental state changed.  96 hours after the vaccine she had a terrible migraine and progressed to a catatonic state.  Monday (96 hours later) pt went to hospital and was in the hospital for observation for 48 hours.  Drs reported this to VAERS and have no clue why the pt is in the current state.  Pt is currently in the psych ward all per spouse.   Pt did not have an problems with the 1st vaccine.  the 2nd vaccine was lot 028A21A which was a short dated Lot per CDC and corporate.  Spouse wanted to report this lot.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Pyrexia, Refusal of treatment by patient, Sleep disorder, Staring, Urine analysis normal
Clinical narrative: Pt received the 2nd covid vaccine on 4/7/2021.  48 hours after the shot, pt began to have diarrhea, hot flashes and mental state changed.  96 hours after the vaccine she had a terrible migraine and progressed to a catatonic state.  Monday (96 hours later) pt went to hospital and was in the hospital for observation for 48 hours.  Drs reported this to VAERS and have no clue why the pt is in the current state.  Pt is currently in the psych ward all per spouse.   Pt did not have an problems with the 1st vaccine.  the 2nd vaccine was lot 028A21A which was a short dated Lot per CDC and corporate.  Spouse wanted to report this lot.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Catatonia, Diarrhoea, Hot flush, Mental status changes, Migraine
Clinical narrative: Pt received the 2nd covid vaccine on 4/7/2021.  48 hours after the shot, pt began to have diarrhea, hot flashes and mental state changed.  96 hours after the vaccine she had a terrible migraine and progressed to a catatonic state.  Monday (96 hours later) pt went to hospital and was in the hospital for observation for 48 hours.  Drs reported this to VAERS and have no clue why the pt is in the current state.  Pt is currently in the psych ward all per spouse.   Pt did not have an problems with the 1st vaccine.  the 2nd vaccine was lot 028A21A which was a short dated Lot per CDC and corporate.  Spouse wanted to report this lot.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Blood pressure increased, Chest pain, Dyschezia
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysuria, Hypoaesthesia, Oxygen consumption decreased, Pain, Pain in extremity
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Pyrexia, Renal pain, Skin discolouration, Swelling face
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Myocardial strain, Pulmonary embolism, Pulmonary hypertension
Clinical narrative: Felt sick with covid like symptoms beginning 4/2, Shortness of breath began 4/3, received negative covid test on 4/7, went to ER on 4/12, CT scan showed MASSIVE bilateral Pulmonary embolism, Angiogram of heart showed right side under stress at 50%.  4/13 Surgery - catheterized directed thrombosis to dissolve clots. Discharged from hospital 4/15
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arteriogram coronary abnormal, Catheter directed thrombolysis, Computerised tomogram thorax abnormal, Dyspnoea, Fibrin D dimer
Clinical narrative: Felt sick with covid like symptoms beginning 4/2, Shortness of breath began 4/3, received negative covid test on 4/7, went to ER on 4/12, CT scan showed MASSIVE bilateral Pulmonary embolism, Angiogram of heart showed right side under stress at 50%.  4/13 Surgery - catheterized directed thrombosis to dissolve clots. Discharged from hospital 4/15
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pulmonary embolism, SARS-CoV-2 test negative, Surgery
Clinical narrative: Felt sick with covid like symptoms beginning 4/2, Shortness of breath began 4/3, received negative covid test on 4/7, went to ER on 4/12, CT scan showed MASSIVE bilateral Pulmonary embolism, Angiogram of heart showed right side under stress at 50%.  4/13 Surgery - catheterized directed thrombosis to dissolve clots. Discharged from hospital 4/15
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: DIZZINESS; VERTIGO; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042az1a, and batch number: 042AZ1A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced dizziness. On 11-APR-2021, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and vertigo. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: REACTION TO COVID-19 VACCINATION; This spontaneous report received from a health care professional concerned a 43 year old male. The patient's weight was 77.3 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (form of admin unknown, oral, batch number: ZM021B0101 expiry: 30-NOV-2023) 10 mg, daily, and therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total 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. Concomitant medications included tadalafil. On MAR-2021, the patient experienced reaction to covid-19 vaccination. On 13-MAR-2021 to 14-MAR-2021, the patient was hospitalized. It was reported that patient was hospitalized one day after receiving covid vaccination due to reaction. patient could not recall exact date of vaccination or hospitalization but stated approximately 2.5 weeks ago. The patient was discharged on 14-MAR-2021.The patient was hospitalized for 1 day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of reaction to covid-19 vaccination was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210408385-covid-19 vaccine ad26.cov2.s-reaction to covid-19 vaccination. 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: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Migraine, Pyrexia, Vomiting
Clinical narrative: MIGRAINE; VOMITING; HEAVY CHILLS; FEVER OF 102.6; This spontaneous report received from a patient concerned a 29 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 the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced migraine. On 03-APR-2021, the subject experienced vomiting. On 03-APR-2021, the subject experienced heavy chills. On 03-APR-2021, the subject experienced fever of 102.6. Laboratory data included: Body temperature (NR: not provided) 102.6 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine, vomiting, heavy chills, and fever of 102.6 on 05-APR-2021. 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: Appendicitis
Clinical narrative: APPENDICITIS; 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 administration not reported, batch number: unknown) dose was not reported, administered on 2021 for prophylactic vaccination. 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 in 2021 (3 weeks after the vaccination), the patient developed appendicitis and ended up in the emergency room (ER) (hospitalization date unspecified) and underwent a surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from appendicitis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:-20210408818- Covid-19 vaccine ad26.cov2.s-appendicitis. 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: Chills, Loss of consciousness, Myalgia
Clinical narrative: BLACKED OUT MOMENTARILY; CHILLS; MUSCLE SORENESS; 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 radiation treatment for an unspecified cancer. 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 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-APR-2021, at 7 pm the patient experienced chills, muscle soreness.  On 04-APR-2021, around 08:00 AM the patient was blacked out momentarily and visited an emergency room for the same. Treatment medications (dates unspecified) included: paracetamol used for chills, muscle soreness.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blacked out, and the outcome of chills and muscle soreness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210408864-covid-19 vaccine ad26.cov2.s -black out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pain, Seizure
Clinical narrative: POUNDING HEADACHE; CONVULSION; BODYACHES; WEAKNESS; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibromyalgia, Crohn's disease, and migraine. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose, administered on 31-MAR-2021 (Wednesday) on left arm for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021 on Wednesday, the patient experienced severe chills to the extent of teeth chattering ,body shaking and convulsion, due to which her husband kept covering with blankets. At 19:00, she developed pounding headache. She experienced body aches. As per her doctor, fibromyalgia might exacerbate the body aches due to which she stayed in bed for 2 days. She also experience weakness and nausea. On 02-Apr-2021 (Friday), she was finally able to cook. She was still experiencing weakness, nausea and excruciating headache for which she was not sure if it was due to vaccine or from migraine that she had. The patient also informed that she underwent unknown test for six times on unknown dates and the test result was found to be negative. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, convulsion and had not recovered from weakness, nausea, and pounding headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409019 -COVID-19 VACCINE AD26.COV2.S- convulsion. 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 events.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Rash
Clinical narrative: FACIAL PARALYSIS; RASH AROUND HER EARS; This spontaneous report received from a pharmacist 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 administration not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  The pharmacist reported that on an unspecified date patient got some facial paralysis, rash around ears. Pharmacist need to get more information about the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the facial paralysis and rash around her ears was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210409588-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Facial paralysis. 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: Chills, Headache, Heart rate increased, Malaise, Pain
Clinical narrative: HEART RACING/HEART RATE HIGH; BAD HEADACHE; MILD FEVER; BODY ACHE; CHILLS; MALAISE; 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 patient takes no medications and has no medical conditions.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced body ache. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced malaise. On 04-APR-2021, the subject experienced mild fever. On 04-APR-2021 03:00, the subject experienced heart racing/heart rate high. On 04-APR-2021 03:00, the subject experienced bad headache. Laboratory data (dates unspecified) included: Heart rate increased (NR: not provided) >90 /min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, bad headache, and mild fever on 04-APR-2021, was recovering from malaise, and had not recovered from heart racing/heart rate high. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: HEART RACING/HEART RATE HIGH; BAD HEADACHE; MILD FEVER; BODY ACHE; CHILLS; MALAISE; 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 patient takes no medications and has no medical conditions.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced body ache. On 04-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced malaise. On 04-APR-2021, the subject experienced mild fever. On 04-APR-2021 03:00, the subject experienced heart racing/heart rate high. On 04-APR-2021 03:00, the subject experienced bad headache. Laboratory data (dates unspecified) included: Heart rate increased (NR: not provided) >90 /min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, bad headache, and mild fever on 04-APR-2021, was recovering from malaise, and had not recovered from heart racing/heart rate high. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Electrocardiogram, Feeling abnormal
Clinical narrative: CHILLS; SHOULDER PAIN; HEADACHE; NAUSEATED; PASSED OUT; HEARING LOSS GETTING WORSE; CHEST PAINS; SWELLED UP; RINGING IN LEFT EAR; TREMBLING; BRAIN FOG; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes and arthritis in the lower back. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, and expiry: unknown) dose was not reported, administered on left arm on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, 30 minutes post-vaccination, the patient passed out and was rushed to the hospital and later she recovered. On the same day, the patient also experienced chest pains, chills, brain fog, trembling, nausea, shoulder pain that was shooting up and down between shoulder and elbow, ringing in left ear, developed swelling; headache and hearing loss in left ear that got worse. Electrocardiogram (EKG) was performed for chest pains (result unknown). At the hospital, she was given treatment that included Benadryl (diphenhydramine hydrochloride), many different shots (unspecified) and 'intravenous' (IV). The patient was at the hospital for about 8 hours. The patient was sent to a hearing specialist for her hearing loss. On 21-MAR-2021, the patient recovered from the events chest pains, chills, swelled up', nausea and trembling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains, chills, swelled up, nauseated, trembling and passed out, and had not recovered from brain fog, shoulder pain, headache, left ear hearing loss, and ringing in left ear. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409641- covid-19 vaccine ad26.cov2.s - passed out. 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: Headache, Hypoacusis, Loss of consciousness, Nausea, Swelling
Clinical narrative: CHILLS; SHOULDER PAIN; HEADACHE; NAUSEATED; PASSED OUT; HEARING LOSS GETTING WORSE; CHEST PAINS; SWELLED UP; RINGING IN LEFT EAR; TREMBLING; BRAIN FOG; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes and arthritis in the lower back. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, and expiry: unknown) dose was not reported, administered on left arm on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, 30 minutes post-vaccination, the patient passed out and was rushed to the hospital and later she recovered. On the same day, the patient also experienced chest pains, chills, brain fog, trembling, nausea, shoulder pain that was shooting up and down between shoulder and elbow, ringing in left ear, developed swelling; headache and hearing loss in left ear that got worse. Electrocardiogram (EKG) was performed for chest pains (result unknown). At the hospital, she was given treatment that included Benadryl (diphenhydramine hydrochloride), many different shots (unspecified) and 'intravenous' (IV). The patient was at the hospital for about 8 hours. The patient was sent to a hearing specialist for her hearing loss. On 21-MAR-2021, the patient recovered from the events chest pains, chills, swelled up', nausea and trembling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains, chills, swelled up, nauseated, trembling and passed out, and had not recovered from brain fog, shoulder pain, headache, left ear hearing loss, and ringing in left ear. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409641- covid-19 vaccine ad26.cov2.s - passed out. 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: Tinnitus, Tremor
Clinical narrative: CHILLS; SHOULDER PAIN; HEADACHE; NAUSEATED; PASSED OUT; HEARING LOSS GETTING WORSE; CHEST PAINS; SWELLED UP; RINGING IN LEFT EAR; TREMBLING; BRAIN FOG; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes and arthritis in the lower back. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, and expiry: unknown) dose was not reported, administered on left arm on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, 30 minutes post-vaccination, the patient passed out and was rushed to the hospital and later she recovered. On the same day, the patient also experienced chest pains, chills, brain fog, trembling, nausea, shoulder pain that was shooting up and down between shoulder and elbow, ringing in left ear, developed swelling; headache and hearing loss in left ear that got worse. Electrocardiogram (EKG) was performed for chest pains (result unknown). At the hospital, she was given treatment that included Benadryl (diphenhydramine hydrochloride), many different shots (unspecified) and 'intravenous' (IV). The patient was at the hospital for about 8 hours. The patient was sent to a hearing specialist for her hearing loss. On 21-MAR-2021, the patient recovered from the events chest pains, chills, swelled up', nausea and trembling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pains, chills, swelled up, nauseated, trembling and passed out, and had not recovered from brain fog, shoulder pain, headache, left ear hearing loss, and ringing in left ear. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409641- covid-19 vaccine ad26.cov2.s - passed out. 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain assessment
Clinical narrative: RIGHT SIDED HEADACHE AND LEFT TEMPLE PAIN; This spontaneous report received from a consumer concerned a 22 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced right sided headache and left temple pain. Laboratory data included: Pain scale (NR: not provided) 5 to 6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right sided headache and left temple pain. 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Palpitations
Clinical narrative: FEVER; HEART RACES; SHORTNESS OF BREATHE; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history of vaccine allergy. 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 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heart races. On 25-MAR-2021, the subject experienced shortness of breathe. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced tired. On 25-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart races, shortness of breathe, tired, and headache, and the outcome of fever and chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; HEART RACES; SHORTNESS OF BREATHE; CHILLS; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no history of vaccine allergy. 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 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced heart races. On 25-MAR-2021, the subject experienced shortness of breathe. On 25-MAR-2021, the subject experienced chills. On 25-MAR-2021, the subject experienced tired. On 25-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart races, shortness of breathe, tired, and headache, and the outcome of fever and chills was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Syncope, Tremor, Vomiting
Clinical narrative: SYNCOPE (PASSED OUT) TWICE; MUSCLE SPASMS; VOMIT ONCE; SHAKING; SHIVERING; 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: 043821A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, in APR-2021, the patient experienced shaking, shivering, muscle spasms, syncope (passed out) twice and threw up (vomit) one time about 8 hours ago.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, shivering, muscle spasms, passed out twice, and vomit once. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210410013--COVID-19 VACCINE AD26.COV2.S-Syncope (passed out)twice. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Diarrhoea, Heart rate, Oxygen saturation
Clinical narrative: SEIZURE; DIARRHEA; This spontaneous report received from a patient concerned a 37 years old male. The patient's height, and weight were not reported. The patient's concurrent condition included fear of needle. 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 1 total on 05-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, after receiving vaccination, the patient experienced seizure (fainting, tremor, tachycardia and bladder incontinence) and diarrhea. Upon examination of his vitals, heart rate was 112, showing tachycardia, blood pressure (BP) was 135/83, oxygen saturation was at 98 and glucose was 90. The patient was taken to the emergency room where he was released after evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 05-APR-2021, recovered with sequelae from seizure on 05-APR-2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210411486, 20210411395 and 20210410874.; Sender's Comments: V0: 20210410630 -COVID-19 VACCINE AD26.COV2.S- seizure. 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 events.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURE; DIARRHEA; This spontaneous report received from a patient concerned a 37 years old male. The patient's height, and weight were not reported. The patient's concurrent condition included fear of needle. 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 1 total on 05-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 05-APR-2021, after receiving vaccination, the patient experienced seizure (fainting, tremor, tachycardia and bladder incontinence) and diarrhea. Upon examination of his vitals, heart rate was 112, showing tachycardia, blood pressure (BP) was 135/83, oxygen saturation was at 98 and glucose was 90. The patient was taken to the emergency room where he was released after evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 05-APR-2021, recovered with sequelae from seizure on 05-APR-2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210411486, 20210411395 and 20210410874.; Sender's Comments: V0: 20210410630 -COVID-19 VACCINE AD26.COV2.S- seizure. 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 events.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Heart rate increased
Clinical narrative: LEG CRAMPS; HEAVY LEGS; MUSCLE ACHES; DIARRHEA; CHILLS; INCREASED HEART RATE; NAUSEA; HEAVY ARM; INJECTION SITE PAIN; TIRED; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced heavy arm. On 01-APR-2021, the subject experienced injection site pain. On 01-APR-2021, the subject experienced tired. On 01-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced increased heart rate. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced nausea. On 03-APR-2021, the subject experienced diarrhea. On 04-APR-2021, the subject experienced muscle aches. On 05-APR-2021, the subject experienced heavy legs. On 06-APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased heart rate, chills, injection site pain, tired, headache, and nausea on 02-APR-2021, diarrhea on 03-APR-2021, heavy arm on 01-APR-2021, and muscle aches on 05-APR-2021, and had not recovered from heavy legs, and leg cramps. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.