chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Loss of consciousness, Malaise
Clinical narrative: FEVER; PASSED OUT/ 'FELT REALLY BAD/TERRIBLE/HORRIBLE, VITALS VERY LOW, FELT WARM, SWEAT, CHILLS, FELT WEAK, FEELING TIRED/EXHAUSTION; CRASHING TO THE FLOOR; LEFT BUTT CHEEK HURTS; This spontaneous report received from a patient concerned a 40 year old female.. The patient's height, and weight were not reported. The patient's past medical history included passed out, and other pre-existing medical conditions included the patient had passed out when getting blood work done previously. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 09-APR-2021 13:15 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Vital signs measurement (NR: not provided) Not reported.  On 10-APR-2021, the patient experienced passed out/ felt really bad/terrible/horrible, vitals very low, felt warm, sweat, chills, felt weak, feeling tired/exhaustion. On 10-APR-2021, the patient experienced crashing to the floor. On 10-APR-2021, the subject experienced left butt cheek hurts. On 11-APR-2021, the subject experienced fever. the patient woke up in the morning, and while washing her hands in the bathroom, she began to feel really bad and started to lower herself down and she passed out, then she ended up crashing to the floor, she did not hit her head, and her left butt cheek got hurt. Her husband called emergency medical services (EMS) who treated her until she regained consciousness. Patient also stated that she felt terrible and horrible. Emergency medical services recommended that she be taken to the hospital for further evaluation, but she declined. She had a history of passing out after bloodwork, but had never had this delayed of a reaction with bloodwork or any reaction to the flu shot. EMS called and her vitals were all very low. She did not go to the hospital. She felt improved and had been taking it easy at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crashing to the floor on 10-APR-2021, and was recovering from passed out/ felt really bad/terrible/horrible, vitals very low, felt warm, sweat, chills, felt weak, feeling tired/exhaustion, left butt cheek hurts, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420904-covid-19 vaccine ad26.cov2.s-Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: FAINTING; DIZZINESS; This spontaneous report received from a patient via a company representative concerned multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch no/Lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced dizziness and fainted, they came back to consciousness. There was no information about the patients who experienced these symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting and dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420968-covid-19 vaccine ad26.cov2.s-Fainting. 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Heart rate, Heart rate increased, Panic attack
Clinical narrative: PANIC ATTACKS(DIZZINESS, WHOLE BODY TREMBLING, RACING HEART RATE, DIFFICULTY BREATHING); HEART RATE 175 BPM; BRAIN FOG; This spontaneous report received from a patient concerned a 35 old female. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy, and other pre-existing medical conditions included the patient did not have any history of anxiety.  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, one total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 it was stated that the patient experienced something similar to panic attacks only while driving, brain fog, lightheadedness, dizziness, whole body was trembling and racing heart of 175 BPM, patient took about 2 hours to get heart rate down. On same day the friend drove her to hospital because she was lightheaded and needed to get help getting in car. Patient received vitals and fluids in hospital and her blood report was normal. ON 11-Apr-2021, after 10 -15 minutes into driving patient felt lightheadedness and dizziness again and felt like she couldn't breathe. It was stated by the patient that motion seems to trigger because it happens while driving. Patient had to take deep breaths for 1.5 hours to get her heart rate down. Laboratory data included: Blood test (NR: not provided) Normal, and Heart rate (NR: not provided) 175 BPM. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from panic attacks (dizziness, whole body trembling, racing heart rate, difficulty breathing), brain fog, and heart rate 175 bpm. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210421092-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Panic attacks, Heart rate 175 BPM, Brain fog. 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: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, COVID-19, Chills, Coagulation test
Clinical narrative: STOMACH PAIN; NAUSEA; CHILLS; HEADACHE; FELT FEVERISH; SWOLLEN THROAT/COULD NOT MOVE WATER; ITCHY THROAT; This spontaneous report received from a physician concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, concurrent conditions included severe allergy to food, and mild asthma, and the patient had no allergic reaction to any other vaccinations or injections.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included epinephrine for severe allergy to food. On APR-2021, after 3-4 hours post vaccination the patient experienced mild headache. About 8 hours post vaccination, the patient's headache became severe (reported as severity 10/10 by patient) and patient felt feverish and chill but no temperature was measured. The patient took 2 tablet of Tylenol and 1 tablet of Advil before went to the emergency room (ER) around 10 hours post vaccination. The patient received unspecified drug intravenously (IV) and oral Benadryl. Around 11 hours post vaccination, patient discharged from the ER. On the way home, the patient felt his throat itch and swollen and could not move water down to throat. The patients symptoms of swollen throat significantly  relieved when he got home (10 minute walk from ER to the front door and a short car ride by his friend) and he went to bed without using his epipen. Next day, patient felt mild headache after waking up and no other symptoms. At day three, APR-2021, he only felt very mild headache in the back of his head and severity was about 1% of that degree of the most severe time of day one. On 13-APR-2021, the patient felt stomach pain, nausea and headache. Severity was mild for all events. On same day, he went to ER for blood tests. All tests (including platelet count and clotting) were normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, felt feverish, swollen throat, and itchy throat on APR-2021, and headache, stomach pain, and nausea on 13-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210421214-covid-19 vaccine ad26.cov2.s-Chills, Headache, Felt feverish. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pharyngeal swelling, Platelet count, Pyrexia
Clinical narrative: STOMACH PAIN; NAUSEA; CHILLS; HEADACHE; FELT FEVERISH; SWOLLEN THROAT/COULD NOT MOVE WATER; ITCHY THROAT; This spontaneous report received from a physician concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, concurrent conditions included severe allergy to food, and mild asthma, and the patient had no allergic reaction to any other vaccinations or injections.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included epinephrine for severe allergy to food. On APR-2021, after 3-4 hours post vaccination the patient experienced mild headache. About 8 hours post vaccination, the patient's headache became severe (reported as severity 10/10 by patient) and patient felt feverish and chill but no temperature was measured. The patient took 2 tablet of Tylenol and 1 tablet of Advil before went to the emergency room (ER) around 10 hours post vaccination. The patient received unspecified drug intravenously (IV) and oral Benadryl. Around 11 hours post vaccination, patient discharged from the ER. On the way home, the patient felt his throat itch and swollen and could not move water down to throat. The patients symptoms of swollen throat significantly  relieved when he got home (10 minute walk from ER to the front door and a short car ride by his friend) and he went to bed without using his epipen. Next day, patient felt mild headache after waking up and no other symptoms. At day three, APR-2021, he only felt very mild headache in the back of his head and severity was about 1% of that degree of the most severe time of day one. On 13-APR-2021, the patient felt stomach pain, nausea and headache. Severity was mild for all events. On same day, he went to ER for blood tests. All tests (including platelet count and clotting) were normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, felt feverish, swollen throat, and itchy throat on APR-2021, and headache, stomach pain, and nausea on 13-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210421214-covid-19 vaccine ad26.cov2.s-Chills, Headache, Felt feverish. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: STOMACH PAIN; NAUSEA; CHILLS; HEADACHE; FELT FEVERISH; SWOLLEN THROAT/COULD NOT MOVE WATER; ITCHY THROAT; This spontaneous report received from a physician concerned a 22 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, concurrent conditions included severe allergy to food, and mild asthma, and the patient had no allergic reaction to any other vaccinations or injections.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included epinephrine for severe allergy to food. On APR-2021, after 3-4 hours post vaccination the patient experienced mild headache. About 8 hours post vaccination, the patient's headache became severe (reported as severity 10/10 by patient) and patient felt feverish and chill but no temperature was measured. The patient took 2 tablet of Tylenol and 1 tablet of Advil before went to the emergency room (ER) around 10 hours post vaccination. The patient received unspecified drug intravenously (IV) and oral Benadryl. Around 11 hours post vaccination, patient discharged from the ER. On the way home, the patient felt his throat itch and swollen and could not move water down to throat. The patients symptoms of swollen throat significantly  relieved when he got home (10 minute walk from ER to the front door and a short car ride by his friend) and he went to bed without using his epipen. Next day, patient felt mild headache after waking up and no other symptoms. At day three, APR-2021, he only felt very mild headache in the back of his head and severity was about 1% of that degree of the most severe time of day one. On 13-APR-2021, the patient felt stomach pain, nausea and headache. Severity was mild for all events. On same day, he went to ER for blood tests. All tests (including platelet count and clotting) were normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, felt feverish, swollen throat, and itchy throat on APR-2021, and headache, stomach pain, and nausea on 13-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210421214-covid-19 vaccine ad26.cov2.s-Chills, Headache, Felt feverish. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Diarrhoea haemorrhagic, Fatigue
Clinical narrative: Bloody diarrhea; STOMACH CRAMPS; VOMITING; DIARRHEA; NAUSEA; EXTREME HEADACHE; FLUSHED; CHILLS; Muscle burning sensation; FATIGUE; Pricking skin sensation; BODY ACHE; This spontaneous report received from a patient concerned a 53 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: 201A21A) dose was not reported, administered on 07-APR-2021 at 14:30 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021 at 22:00, the patient had body aches, all her big muscles were burning/had pain, extreme headache, flushed, fatigue, chills, and prickly skin. She has received ibuprofen and drinking ginger ale since 22:00 to try to keep things down. On 09-APR-2021, she got up with stomach cramps, diarrhea, nausea, vomiting, continuous body aches/burning muscles, extreme headache, chills, fatigue, prickly skin and flushed. On 10-APR-2021, she still had slight headache, prickly skin, body aches, chills, worse stomach cramps, diarrhea and vomiting and blood in the diarrhea. She tried to call family doctor but they were closed. She will go to doctor or emergency room on Monday (12-APR-2021). If bleeding in diarrhea gets worse, she will go to ER this weekend.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed, muscle burning sensation, fatigue, and nausea on 09-APR-2021, and had not recovered from body ache, pricking skin sensation, chills, diarrhea, vomiting, bloody diarrhea, stomach cramps, and extreme headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421312-covid-19 vaccine ad26.cov2.s -blood in diarrhea. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Myalgia, Nausea, Pain
Clinical narrative: Bloody diarrhea; STOMACH CRAMPS; VOMITING; DIARRHEA; NAUSEA; EXTREME HEADACHE; FLUSHED; CHILLS; Muscle burning sensation; FATIGUE; Pricking skin sensation; BODY ACHE; This spontaneous report received from a patient concerned a 53 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: 201A21A) dose was not reported, administered on 07-APR-2021 at 14:30 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021 at 22:00, the patient had body aches, all her big muscles were burning/had pain, extreme headache, flushed, fatigue, chills, and prickly skin. She has received ibuprofen and drinking ginger ale since 22:00 to try to keep things down. On 09-APR-2021, she got up with stomach cramps, diarrhea, nausea, vomiting, continuous body aches/burning muscles, extreme headache, chills, fatigue, prickly skin and flushed. On 10-APR-2021, she still had slight headache, prickly skin, body aches, chills, worse stomach cramps, diarrhea and vomiting and blood in the diarrhea. She tried to call family doctor but they were closed. She will go to doctor or emergency room on Monday (12-APR-2021). If bleeding in diarrhea gets worse, she will go to ER this weekend.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed, muscle burning sensation, fatigue, and nausea on 09-APR-2021, and had not recovered from body ache, pricking skin sensation, chills, diarrhea, vomiting, bloody diarrhea, stomach cramps, and extreme headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421312-covid-19 vaccine ad26.cov2.s -blood in diarrhea. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vomiting
Clinical narrative: Bloody diarrhea; STOMACH CRAMPS; VOMITING; DIARRHEA; NAUSEA; EXTREME HEADACHE; FLUSHED; CHILLS; Muscle burning sensation; FATIGUE; Pricking skin sensation; BODY ACHE; This spontaneous report received from a patient concerned a 53 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: 201A21A) dose was not reported, administered on 07-APR-2021 at 14:30 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021 at 22:00, the patient had body aches, all her big muscles were burning/had pain, extreme headache, flushed, fatigue, chills, and prickly skin. She has received ibuprofen and drinking ginger ale since 22:00 to try to keep things down. On 09-APR-2021, she got up with stomach cramps, diarrhea, nausea, vomiting, continuous body aches/burning muscles, extreme headache, chills, fatigue, prickly skin and flushed. On 10-APR-2021, she still had slight headache, prickly skin, body aches, chills, worse stomach cramps, diarrhea and vomiting and blood in the diarrhea. She tried to call family doctor but they were closed. She will go to doctor or emergency room on Monday (12-APR-2021). If bleeding in diarrhea gets worse, she will go to ER this weekend.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed, muscle burning sensation, fatigue, and nausea on 09-APR-2021, and had not recovered from body ache, pricking skin sensation, chills, diarrhea, vomiting, bloody diarrhea, stomach cramps, and extreme headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421312-covid-19 vaccine ad26.cov2.s -blood in diarrhea. 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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Feeling abnormal, Pain, Rheumatoid arthritis
Clinical narrative: SHORTNESS OF BREATH; OUT OF BODY FEELING; EPIGASTRIC PAIN; POSSIBLE RHEUMATOID ARTHRITIS FLARE; STINGING IN THE RIGHT ARM; This spontaneous report received from a patient concerned a 53-year-old not Hispanic or Latino white female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, gastroesophageal reflux disease (GERD), hashimoto's thyroiditis, possible sjogren's, penicillin allergy and sulfa drugs (sulfonamide) allergy, and other pre-existing medical conditions included opiates allergy causing rash.  The patient experienced drug allergy when treated with Azithromycin, Ciprofloxacin and Levofloxacin for an unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 in right deltoid for prophylactic vaccination.  Concomitant medications included Acetylsalicylic acid (Aspirin) to prevent blood clot, and Prednisone for an unknown indication.  On 09-APR-2021, the patient experienced stinging in the right arm for a few seconds while getting the vaccine shot, then pain in left arm, stomachache in the night, profound weakness in the legs, heaviness in both legs and both arms, shortness of breath, out of body feeling, severe pain in the epigastric area. It was reported that vaccine could have triggered a rheumatoid arthritis reaction in legs hands, feet and arms. The feeling of weakness and heaviness in the arms and legs were still on going, and the reaction with Aspirin occurred about 30 minutes ago but became better once she took a liquid antacid. The patient took the Aspirin to prevent clots because she was on prednisone, which was read on the news that blood clots may form after getting the vaccine. She attributed the heaviness of the arms and legs as a possible rheumatoid arthritis flare. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging in the right arm, and epigastric pain on an unspecified date in APR-2021, was recovering from out of body feeling, and had not recovered from shortness of breath, and possible rheumatoid arthritis flare. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421350-covid-19 vaccine ad26.cov2.s-possible rheumatoid arthritis flare. 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.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECT COVID-19 INFECTION; 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 Date: UNKNOWN) dose was not reported, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an APR-2021, the patient was diagnosed with suspected covid-19 infection, and on unspecified date patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product complaint number: 90000176122. This case, from the same reporter is linked to 20210423095.; Sender's Comments: V0: 20210423108-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer (company representative) concerned a 47 year old  male. The patient's height, and weight were not reported. The patient's concurrent conditions included obese.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported,1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported.  On 09-APR-2021,the patient died from heart attack. 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).; Sender's Comments: 20210423780 -covid-19 vaccine ad26.cov2.s-heart attack. 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).; Reported Cause(s) of Death: HEART ATTACK
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Breast pain, Influenza like illness
Clinical narrative: FLU LIKE FEELING; PAIN IN RIGHT BREAST UNDER ARM; This spontaneous report received from a patient concerned a 52 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced flu like feeling. On 12-APR-2021, the subject experienced pain in right breast under arm. Laboratory data included: Body temperature (NR: not provided) 103.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like feeling, and pain in right breast under arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: WORSE CHILLS; WORSE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. . The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced worse chills, and worse headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worse chills and worse headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: PUFFY LYMPH NODES UNDER ARM; SWOLLEN AT INJECTION SITEX; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included level 1 endometrial cancer, and concurrent conditions included bee allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 13:30 for prophylactic vaccination. Concomitant medications included sertraline. On 08-APR-2021, the subject experienced swollen at injection site. On 10-APR-2021, the subject experienced puffy lymph nodes under arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from swollen at injection site, and puffy lymph nodes under arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Fatigue
Clinical narrative: BONES HURT; SO TIRED; 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: 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 bones hurt, and so tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bones hurt and so tired was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Malaise, Pain in extremity
Clinical narrative: BACK SORE; PAIN IN HIPS DOWN BOTH POSTERIOR LEGS; DID NOT FEEL GOOD; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced back sore. On 12-APR-2021, the subject experienced pain in hips down both posterior legs. On 12-APR-2021, the subject experienced did not feel good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not feel good, and was recovering from back sore, and pain in hips down both posterior legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CALF PAIN; This spontaneous report received from a patient concerned a 65 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: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for discomfort in left calf, and leg pain, and colecalciferol for drug used for unknown indication. On 10-APR-2021, the subject experienced calf pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from calf pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Sensitive skin
Clinical narrative: BODY ACHE; SENSITIVE SKIN; HURT TO EVEN WASH HANDS; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced sensitive skin. On 07-APR-2021, the subject experienced hurt to even wash hands. On 07-APR-2021, the subject experienced tiredness. On 08-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache, hurt to even wash hands, and sensitive skin, and the outcome of tiredness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS ON  ARM; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Batch number was not reported has been requested.No concomitant medications were reported. On 12-APR-2021, the subject experienced redness on arm. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, swelling at injection site, and redness on arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: WEAKNESS (NO STRENGTH); SEVERE SHAKY CHILLS; SEVERE HEADACHE; TIREDNESS; BODY ACHES; LOSS OF APPETITE; 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 alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient had no abuse or illicit usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043821A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced severe shaky chills. On 12-APR-2021, the subject experienced weakness (no strength). Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, severe shaky chills, severe headache, tiredness, and weakness (no strength) on 13-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: WEAKNESS (NO STRENGTH); SEVERE SHAKY CHILLS; SEVERE HEADACHE; TIREDNESS; BODY ACHES; LOSS OF APPETITE; 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 alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient had no abuse or illicit usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043821A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced severe headache. On APR-2021, the subject experienced tiredness. On 11-APR-2021, the subject experienced severe shaky chills. On 12-APR-2021, the subject experienced weakness (no strength). Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, loss of appetite, severe shaky chills, severe headache, tiredness, and weakness (no strength) on 13-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Neck pain, Pain in extremity
Clinical narrative: LEG PAIN FROM BUTTOCK THROUGH WHOLE LEG; SEVERE ARM PAIN; MUSCLE ACHE; HEADACHE; LYMPH NODE IN ARMPIT ENLARGED; NECK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lymph node in armpit enlarged. On 09-APR-2021, the subject experienced neck pain. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced severe arm pain. On 12-APR-2021, the subject experienced leg pain from buttock through whole leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lymph node in armpit enlarged on 10-APR-2021, and neck pain, severe arm pain, muscle ache, and headache, and had not recovered from leg pain from buttock through whole leg. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram head, Fibrin D dimer, Headache, Heart rate increased
Clinical narrative: LEG PAIN FROM BUTTOCK THROUGH WHOLE LEG; SEVERE ARM PAIN; MUSCLE ACHE; HEADACHE; LYMPH NODE IN ARMPIT ENLARGED; NECK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lymph node in armpit enlarged. On 09-APR-2021, the subject experienced neck pain. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced severe arm pain. On 12-APR-2021, the subject experienced leg pain from buttock through whole leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lymph node in armpit enlarged on 10-APR-2021, and neck pain, severe arm pain, muscle ache, and headache, and had not recovered from leg pain from buttock through whole leg. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Muscle spasms, Pain in extremity, Palpitations, Rash
Clinical narrative: LEG PAIN FROM BUTTOCK THROUGH WHOLE LEG; SEVERE ARM PAIN; MUSCLE ACHE; HEADACHE; LYMPH NODE IN ARMPIT ENLARGED; NECK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lymph node in armpit enlarged. On 09-APR-2021, the subject experienced neck pain. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced severe arm pain. On 12-APR-2021, the subject experienced leg pain from buttock through whole leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lymph node in armpit enlarged on 10-APR-2021, and neck pain, severe arm pain, muscle ache, and headache, and had not recovered from leg pain from buttock through whole leg. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: LEG PAIN FROM BUTTOCK THROUGH WHOLE LEG; SEVERE ARM PAIN; MUSCLE ACHE; HEADACHE; LYMPH NODE IN ARMPIT ENLARGED; NECK PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lymph node in armpit enlarged. On 09-APR-2021, the subject experienced neck pain. On 09-APR-2021, the subject experienced muscle ache. On 09-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced severe arm pain. On 12-APR-2021, the subject experienced leg pain from buttock through whole leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lymph node in armpit enlarged on 10-APR-2021, and neck pain, severe arm pain, muscle ache, and headache, and had not recovered from leg pain from buttock through whole leg. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Injection site pain, Pain
Clinical narrative: INJECTION SITE PAIN; CHILLS; BODY ACHES; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and cigarette smoker, and other pre-existing medical conditions included does not abuse drug or illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced injection site pain. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 13-APR-2021, was recovering from body aches, and flu like symptoms, and had not recovered from injection site pain. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Axillary pain, Burning sensation, Decreased appetite
Clinical narrative: STOMACH PAIN; LEFT LEG CRAMP; KNEE ACHE; TIRED; FEVER; FELT FOGGY AND DAZE; LOSS OF APPETITE; EYE PAIN; DIARRHEA; STOMACH FLU; VOMITING; HOT FLASHES ON BACK; HEADACHE; BODY TREMBLING; ARM BURNING; LYMPH NODE PAIN; UNDER ARM PAIN; INJECTION SITE WARM; ARM SORE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included sore arm, injection site redness, and hand numbness, and concurrent conditions included asthma. The patient was previously treated with tetanus vaccine for tetanus.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 15:00 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, and salbutamol sulfate for asthma.  On 07-APR-2021, the subject experienced body trembling. On 07-APR-2021, the subject experienced arm burning. On 07-APR-2021, the subject experienced lymph node pain. On 07-APR-2021, the subject experienced under arm pain. On 07-APR-2021, the subject experienced injection site warm. On 07-APR-2021, the subject experienced arm sore. Treatment medications included: paracetamol. On 08-APR-2021, the subject experienced eye pain. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced stomach flu. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced hot flashes on back. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced felt foggy and daze. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100.1 T. On 10-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced left leg cramp. On 10-APR-2021, the subject experienced knee ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, and vomiting on 08-APR-2021, and hot flashes on back on 11-APR-2021, had not recovered from headache, and stomach pain, and the outcome of body trembling, arm burning, arm sore, lymph node pain, under arm pain, injection site warm, eye pain, stomach flu, fever, left leg cramp, knee ache, felt foggy and daze, loss of appetite and tired was not reported. This report was non-serious.