chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling hot, Feeling of body temperature change, Hallucination
Clinical narrative: TIRED; SLIGHT HEADACHE; HALLUCINATING; COULD NOT MOVE; COULD NOT SPEAK; ALTERNATING BETWEEN HOT AND COLD; REMAINED AWAKE; ANXIETY; FEELING VERY HOT; FEVER; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20YA21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAY-2021 11:15 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAY-2021 evening around 19:00 or 20:00, the patient, had a fever, however he did not get a definite temperature reading because he did not use a thermometer. The patient felt very hot and began hallucinating or anxieties. It was reported that throughout the night he was alternating between hot and cold. The patient could not move or speak and the fever got worse during the night. The patient remained awake from that evening until the reporting morning. The patient took unspecified pain reliever and dosage was unknown but it was two tablets and was taken at 11 am on the reporting day. At the time of this report the patient felt tired and had a slight headache but he felt better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinating, could not move, could not speak, alternating between hot and cold, anxiety, feeling very hot, and fever on MAY-2021, was recovering from tired, and slight headache, and the outcome of remained awake was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210528105- Covid-19 vaccine ad26.cov2.s-Hallucinating. 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Poor quality sleep, Pyrexia, Speech disorder
Clinical narrative: TIRED; SLIGHT HEADACHE; HALLUCINATING; COULD NOT MOVE; COULD NOT SPEAK; ALTERNATING BETWEEN HOT AND COLD; REMAINED AWAKE; ANXIETY; FEELING VERY HOT; FEVER; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20YA21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 16-MAY-2021 11:15 for prophylactic vaccination. No concomitant medications were reported.  On 16-MAY-2021 evening around 19:00 or 20:00, the patient, had a fever, however he did not get a definite temperature reading because he did not use a thermometer. The patient felt very hot and began hallucinating or anxieties. It was reported that throughout the night he was alternating between hot and cold. The patient could not move or speak and the fever got worse during the night. The patient remained awake from that evening until the reporting morning. The patient took unspecified pain reliever and dosage was unknown but it was two tablets and was taken at 11 am on the reporting day. At the time of this report the patient felt tired and had a slight headache but he felt better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinating, could not move, could not speak, alternating between hot and cold, anxiety, feeling very hot, and fever on MAY-2021, was recovering from tired, and slight headache, and the outcome of remained awake was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210528105- Covid-19 vaccine ad26.cov2.s-Hallucinating. 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Petechiae
Clinical narrative: Petechiae starting on the left side of mouth, then spread around my whole mouth and by my right eye  by the next day, then to the forehead the following day. This was a 3 day period of the petechiae spreading before going to urgent care.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle cramps pretty intense started at around 10:00p.m..
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have been getting a headache every day for 2 to 3 hours ever since I got the second house
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: High blood pressure, over 180;  Pulse rate over 115,  Sweating, Dizziness, Chest pressure, Difficulty Breathing
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypertension
Clinical narrative: High blood pressure, over 180;  Pulse rate over 115,  Sweating, Dizziness, Chest pressure, Difficulty Breathing
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: Red, raised circular area around injection has been growing since a few hours following injection. It is itchy, and painful to touch, and warmer than the rest of my arm.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Pain
Clinical narrative: Heart pain 3-4 hours after injection. Heart pain subsides 13 hours after injection. Chest pain center near sternum, chest tightness in center of chest 8 hours after injection. Chest pain is ongoing since injection and is now day 5. The chest pain worsens when lifting heavy objects, bending over, and laying down.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Loss of personal independence in daily activities, Menstrual disorder
Clinical narrative: Extreme bleeding with first and second period after receiving second shot. Heavy cramping, extreme fatigue that affected normal daily activities. My menstrual cycle has been abnormal since receiving second vaccine.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Erythema, Pain, Rash macular
Clinical narrative: On the next morning body pains big red painful marks all over her arm, stomach soreness
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Tenderness
Clinical narrative: Rash, bump feeling tender and swollen
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Sleep disorder
Clinical narrative: I got my second dose of Phizer May 10th at facility. May 16th I started to have back pain over my left kidney. May 17th the pain was unbearable at night. I was not able to sleep. I went to the Clinic May 18th at 9am. I was diagnosed with Shingles.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED WITHIN 20 SECONDS OF RECEIVING PFIZER COVID-19 VACCINATION.  PATIENT'S FATHER AND STORE MANAGEMENT CALLED 911.  FATHER AND ADMINISTERING PHARMACIST MONITORED PATIENT; PATIENT REGAINED CONSCIOUSNESS SHORTLY AFTER FAINTING.  PARAMEDICS ARRIVED APPROXIMATELY 10 MINUTES LATER AND FURTHER ATTENDED TO PATIENT.  PARAMEDIC DIAGNOSED VASOVAGAL SYNCOPE.  PATIENT AND FATHER WENT WITH AMBULANCE TO HOSPITAL FOR FURTHER EVALUATION.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Nausea, Pyrexia, Swelling face
Clinical narrative: The lymph nodes in my throat and armpit on the left side started swelling rapidly, I had high fever and nausea. The onset seemed to be sudden and within 1 hour I was feeling very sick. I took 500mg acetaminophen. The next day I felt better but still had to take acetaminophen due to some fever and still swollen lymph nodes. The swelling on my lymph nodes did not fully go away for 3 days. My face was visibly swollen on the left side. I also had bad diarrhea on Thursday and Friday without any change in my diet. I don't know if that was a side effect too.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Malaise, Nausea, Pyrexia
Clinical narrative: The lymph nodes in my throat and armpit on the left side started swelling rapidly, I had high fever and nausea. The onset seemed to be sudden and within 1 hour I was feeling very sick. I took 500mg acetaminophen. The next day I felt better but still had to take acetaminophen due to some fever and still swollen lymph nodes. The swelling on my lymph nodes did not fully go away for 3 days. My face was visibly swollen on the left side. I also had bad diarrhea on Thursday and Friday without any change in my diet. I don't know if that was a side effect too.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pyrexia, Rash
Clinical narrative: I started with a fever at 1pm the day of vaccine and was tired. The next morning I woke up with a rash on my neck and had fever, and horrible diarrhea . At around 1, I got Benadryl, took two. The rash kept spreading. The rash spread and continued too until after I had safety taken Benadryl 3 times. It was on my neck, chest, and back of neck and inside elbow  of my right arm.  My rash cleared mostly by the next morning. But my diarrhea did not. And seems to have finally settled down kinda today. I have only had 4 trips today to the restroom with diarrhea. Other than that, I?m fine, you can still barely see my rash. I can tell it?s still slightly pink. But it?s gone enough.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Tremor
Clinical narrative: Patient received Moderna COVID-19 vaccine dose 1. After Pharmacist administered vaccine, Patient stayed in waiting room for 15 minutes for observation. Patient was conscious but called Pharmacist over due to patient was shaking and sweating. The pharmacist monitored patient while Clerk called 911. Paramedics arrived and checked/monitored patient's symptom and overall well being. Patient was taken to the emergency room.  Pharmacist contacted Patient around 07:20pm but unable to reach. Pharmacist contacted Patient's boyfriend who was present during shot. He stated that Patient was discharged two hours after and said Patient was doing well.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: -extreme body ache (lasting 3 days) -bad headache -lost of appetite for two days. -extreme fatigue and sleepiness -round redness around shot area which is very sensitive.  Looks like a rash but it is not. -swelling in shot  injection area with the redness. -extreme sensitivity to left arm in shot injected area. -I cannot lift my arm all the way up without pain and cannot lean on it or sleep on it without pain.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Sleep disorder, Somnolence
Clinical narrative: -extreme body ache (lasting 3 days) -bad headache -lost of appetite for two days. -extreme fatigue and sleepiness -round redness around shot area which is very sensitive.  Looks like a rash but it is not. -swelling in shot  injection area with the redness. -extreme sensitivity to left arm in shot injected area. -I cannot lift my arm all the way up without pain and cannot lean on it or sleep on it without pain.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Fatigue, Feeling cold, Headache
Clinical narrative: Late onset of headache, body aches and fatigue around 6 pm on 5-18. Around 11:50 pm on 5-18 muscle cramping with sharp pains in left arm and left leg. Around 12:15, I became feverish and unnaturally cold. Shortly after, my whole chest and neck felt tight and almost as if I had advanced stage bronchitis. I took 2 Benadryl, 4 tylenol and my 90mg inhaler before laying down under 3 winter blankets. Waking up the next morning at 6:40, I still had chest tightness but had a sore throat, coughing, and swollen neck glands. I took 2 more Benadryl and 2 Tylenol for the headache, body aches, and mild fever before driving my child to school at 7:20. I went to an appointment at 11:00 am on 5-19 and left there around 11:45 still suffering from muscle cramping and aches (though much mellower than before) and proceeded to the store to buy Dayquil cold and flu which alleviated all but the persistent headache, fatigue, and injection site tenderness.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Muscle spasms, Muscle tightness, Oropharyngeal pain
Clinical narrative: Late onset of headache, body aches and fatigue around 6 pm on 5-18. Around 11:50 pm on 5-18 muscle cramping with sharp pains in left arm and left leg. Around 12:15, I became feverish and unnaturally cold. Shortly after, my whole chest and neck felt tight and almost as if I had advanced stage bronchitis. I took 2 Benadryl, 4 tylenol and my 90mg inhaler before laying down under 3 winter blankets. Waking up the next morning at 6:40, I still had chest tightness but had a sore throat, coughing, and swollen neck glands. I took 2 more Benadryl and 2 Tylenol for the headache, body aches, and mild fever before driving my child to school at 7:20. I went to an appointment at 11:00 am on 5-19 and left there around 11:45 still suffering from muscle cramping and aches (though much mellower than before) and proceeded to the store to buy Dayquil cold and flu which alleviated all but the persistent headache, fatigue, and injection site tenderness.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Late onset of headache, body aches and fatigue around 6 pm on 5-18. Around 11:50 pm on 5-18 muscle cramping with sharp pains in left arm and left leg. Around 12:15, I became feverish and unnaturally cold. Shortly after, my whole chest and neck felt tight and almost as if I had advanced stage bronchitis. I took 2 Benadryl, 4 tylenol and my 90mg inhaler before laying down under 3 winter blankets. Waking up the next morning at 6:40, I still had chest tightness but had a sore throat, coughing, and swollen neck glands. I took 2 more Benadryl and 2 Tylenol for the headache, body aches, and mild fever before driving my child to school at 7:20. I went to an appointment at 11:00 am on 5-19 and left there around 11:45 still suffering from muscle cramping and aches (though much mellower than before) and proceeded to the store to buy Dayquil cold and flu which alleviated all but the persistent headache, fatigue, and injection site tenderness.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exfoliative rash, Fatigue, Influenza like illness, Pain, Pain in extremity
Clinical narrative: In addition to the expected flu-like and ISR in the R arm,  L arm painful, very itchy, scaly rash noticed on day 2--still persisting with cracking and peeling on day 5; fatigue still requiring daytime sleeping after a few hours of being up; R arm rash was a very faint pink but swelling and pain is persisting Symptoms that resolved by day 3 are sharp toe pain, flank pain, and pain with deep breathing
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Skin exfoliation
Clinical narrative: In addition to the expected flu-like and ISR in the R arm,  L arm painful, very itchy, scaly rash noticed on day 2--still persisting with cracking and peeling on day 5; fatigue still requiring daytime sleeping after a few hours of being up; R arm rash was a very faint pink but swelling and pain is persisting Symptoms that resolved by day 3 are sharp toe pain, flank pain, and pain with deep breathing
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Bed rest, Chills, Headache, Illness, Loss of personal independence in daily activities
Clinical narrative: Sickest I felt in half dozen years. Terrible headache and fever and chills started 9 hours after injection and 36 hours after vaccine I'm stuck in bed and can't function.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sickest I felt in half dozen years. Terrible headache and fever and chills started 9 hours after injection and 36 hours after vaccine I'm stuck in bed and can't function.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulation test, Full blood count normal, Mouth haemorrhage, Tension headache
Clinical narrative: Weird tension on head, bleeding through mouth fo a month and a have
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted after vaccine administration. After lying down for 20 minutes, patient felt back to normal.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Eye pruritus, Herpes zoster, SARS-CoV-2 test negative
Clinical narrative: Woke up am 2/17 with burning-itching rash on my midrift.  By 2/26 it had spread &  was clearly nasty enough to go to doctors - diagnosed with Shingles . [ Had only taken the old shingles vaccine - moved/changed doctors, never realized there was a new better one to take now.]  Did not realize I should report it to you til saw Dr  this week, she instructed my to report it.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Diarrhoea, Nausea, Pain
Clinical narrative: Days 2-5 fever, nausea, aches Days 8-11 fever, diarrhea, stomach pain Day 10 - vomiting. Day 14 - hives all over body
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Urticaria, Vomiting
Clinical narrative: Days 2-5 fever, nausea, aches Days 8-11 fever, diarrhea, stomach pain Day 10 - vomiting. Day 14 - hives all over body
Sex: U
Vaccine: COVID19
Symptoms: Nervous system disorder, Pain
Clinical narrative: SEVERE BODY PAIN; NERVE ISSUES; 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  (suspension for injection, route of admin not reported, batch number: Unk) 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 severe body pain, and nerve issues. The action taken with covid-19 vaccine was not applicable. The outcome of the severe body pain and nerve issues was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Heart rate irregular, Palpitations
Clinical narrative: Heart palpitations started two days after 2nd dose and have continued for three weeks. Fairly constant and heavy irregular heartbeat. Visited primary today, took blood for blood work, and will be getting an ecg next week.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Decreased appetite, Dizziness, Fatigue, Flushing
Clinical narrative: Fatigue, very High temp from 99-104 for two days, intense migraine(no light),  very dizzy- could not function, nauseated,-can?t eat, rash & flushed face & felt as if I was allergic with itching all over, could not rest, could not sleep due to migraine pain, face very itchy, neck stiffness hard to lift my arms parallel with my body! I had to take Benadryl which didn?t really affect my allergic reaction until the 3rd day I noticed it begin helping with the allergy symptoms! I had Covid twice & these side affects were as bad as my worst day in Covid! I am now scared to take the second shot!
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Movement disorder, Musculoskeletal stiffness, Nausea, Pruritus
Clinical narrative: Fatigue, very High temp from 99-104 for two days, intense migraine(no light),  very dizzy- could not function, nauseated,-can?t eat, rash & flushed face & felt as if I was allergic with itching all over, could not rest, could not sleep due to migraine pain, face very itchy, neck stiffness hard to lift my arms parallel with my body! I had to take Benadryl which didn?t really affect my allergic reaction until the 3rd day I noticed it begin helping with the allergy symptoms! I had Covid twice & these side affects were as bad as my worst day in Covid! I am now scared to take the second shot!
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Sleep disorder
Clinical narrative: Fatigue, very High temp from 99-104 for two days, intense migraine(no light),  very dizzy- could not function, nauseated,-can?t eat, rash & flushed face & felt as if I was allergic with itching all over, could not rest, could not sleep due to migraine pain, face very itchy, neck stiffness hard to lift my arms parallel with my body! I had to take Benadryl which didn?t really affect my allergic reaction until the 3rd day I noticed it begin helping with the allergy symptoms! I had Covid twice & these side affects were as bad as my worst day in Covid! I am now scared to take the second shot!
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Delayed response 1-week after injection (4/28/2021) - itchy, red, swelling at the site of the injection, redness and swelling went from site of injection (deltoid) down to elbow. Swelling and redness lasted 10-days (and then decreased to occasional redness and little swelling until day 14.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site bruising, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: A week after my vaccination, I have a subtle red rash and bruise still visible at the injection site. My arm muscle feels tired and week and almost a burning sensation. This sesatikn started with the rash. I did feel sore the day after my shot and these new symptoms didn?t start til later.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle fatigue, Muscular weakness, Rash erythematous
Clinical narrative: A week after my vaccination, I have a subtle red rash and bruise still visible at the injection site. My arm muscle feels tired and week and almost a burning sensation. This sesatikn started with the rash. I did feel sore the day after my shot and these new symptoms didn?t start til later.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Cardiac flutter, Dyspnoea, Headache
Clinical narrative: Headache, joint ache, heart arrhythmia, breathlessness. Major issues until 2/7/2021. Still have intermittent headaches and heart flutter that wasn't there before.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Headache, joint ache, heart arrhythmia, breathlessness. Major issues until 2/7/2021. Still have intermittent headaches and heart flutter that wasn't there before.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: CSF pressure increased, Diplopia, Intracranial pressure increased, Lumbar puncture, Magnetic resonance imaging abnormal
Clinical narrative: Patient developed visual symptoms the week following administration of the COVID vaccine. Symptoms included blurry vision and double vision. Patient did not seek care. Patient received 2nd dose of Moderna vaccine on 5/12 and had escalation in symptoms after that dose. Patient finally saw her PCP on 5/18 who immediately sent her to optometry where she was noted to have papilledema. She was sent to the ED where an MRI/MRV confirmed increased intercranial pressure without space occupying lesion. LP showed elevated opening pressure of 45/ Patient started on Diamox for presumed IIH.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Papilloedema, Venogram abnormal, Vision blurred
Clinical narrative: Patient developed visual symptoms the week following administration of the COVID vaccine. Symptoms included blurry vision and double vision. Patient did not seek care. Patient received 2nd dose of Moderna vaccine on 5/12 and had escalation in symptoms after that dose. Patient finally saw her PCP on 5/18 who immediately sent her to optometry where she was noted to have papilledema. She was sent to the ED where an MRI/MRV confirmed increased intercranial pressure without space occupying lesion. LP showed elevated opening pressure of 45/ Patient started on Diamox for presumed IIH.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bedridden, Diarrhoea, Illness, Migraine, Ocular hyperaemia
Clinical narrative: RIGHT EYE BLOODSHOT DUE TO A BLOOD VESSEL BURSTING IN THE EYE; BORDERLINE MIGRAINES; DIARRHEA; EXTREME ILLNESS FOR TWO WHOLE WEEKS; COULD NOT EVEN GET OUT OF BED FOR THE FIRST WEEK; This spontaneous report received from a consumer (daughter) concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery, and concurrent conditions included a little overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient had some alarming symptoms. She was extremely ill for two whole weeks. She was nauseous, vomiting, (subsumed under borderline migraine) had diarrhea and could not even get out of bed for the first week. After those extreme symptoms subsided she had one eye( her right eye) was completely bloodshot due to a blood vessel bursting in her eye. She called her primary care doctor and they told her that they were uncertain if that was even a symptom or not. She also had very painful headaches (subsumed under borderline migraine), borderline migraines and her primary care doctor told her that if it persisted or got any worse to go to the emergency room or possibly go in to the doctor's office. Reporter stated that blood clots were not something that really ran in their family bloodline. Patient hadn't had any real health problems other than having a hip replacement surgery and being a little overweight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from, diarrhea, extreme illness for two whole weeks, could not even get out of bed for the first week, and the outcome of right eye bloodshot due to a blood vessel bursting in the eye and borderline migraines, was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210532621-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Eye blood shot. 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, COVID19
Symptoms: Bedridden, Diarrhoea, Headache, Malaise, Migraine
Clinical narrative: RIGHT EYE BLOODSHOT DUE TO A BLOOD VESSEL BURSTING IN THE EYE; BORDERLINE MIGRAINES; DIARRHEA; EXTREME ILLNESS FOR TWO WHOLE WEEKS; COULD NOT EVEN GET OUT OF BED FOR THE FIRST WEEK; This spontaneous report received from a consumer (daughter) concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery, and concurrent conditions included a little overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient had some alarming symptoms. She was extremely ill for two whole weeks. She was nauseous, vomiting, (subsumed under borderline migraine) had diarrhea and could not even get out of bed for the first week. After those extreme symptoms subsided she had one eye( her right eye) was completely bloodshot due to a blood vessel bursting in her eye. She called her primary care doctor and they told her that they were uncertain if that was even a symptom or not. She also had very painful headaches (subsumed under borderline migraine), borderline migraines and her primary care doctor told her that if it persisted or got any worse to go to the emergency room or possibly go in to the doctor's office. Reporter stated that blood clots were not something that really ran in their family bloodline. Patient hadn't had any real health problems other than having a hip replacement surgery and being a little overweight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from, diarrhea, extreme illness for two whole weeks, could not even get out of bed for the first week, and the outcome of right eye bloodshot due to a blood vessel bursting in the eye and borderline migraines, was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210532621-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Eye blood shot. 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, COVID19
Symptoms: Nausea, Ocular hyperaemia, Vomiting
Clinical narrative: RIGHT EYE BLOODSHOT DUE TO A BLOOD VESSEL BURSTING IN THE EYE; BORDERLINE MIGRAINES; DIARRHEA; EXTREME ILLNESS FOR TWO WHOLE WEEKS; COULD NOT EVEN GET OUT OF BED FOR THE FIRST WEEK; This spontaneous report received from a consumer (daughter) concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip replacement surgery, and concurrent conditions included a little overweight. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient had some alarming symptoms. She was extremely ill for two whole weeks. She was nauseous, vomiting, (subsumed under borderline migraine) had diarrhea and could not even get out of bed for the first week. After those extreme symptoms subsided she had one eye( her right eye) was completely bloodshot due to a blood vessel bursting in her eye. She called her primary care doctor and they told her that they were uncertain if that was even a symptom or not. She also had very painful headaches (subsumed under borderline migraine), borderline migraines and her primary care doctor told her that if it persisted or got any worse to go to the emergency room or possibly go in to the doctor's office. Reporter stated that blood clots were not something that really ran in their family bloodline. Patient hadn't had any real health problems other than having a hip replacement surgery and being a little overweight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from, diarrhea, extreme illness for two whole weeks, could not even get out of bed for the first week, and the outcome of right eye bloodshot due to a blood vessel bursting in the eye and borderline migraines, was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210532621-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Eye blood shot. 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Rash papular
Clinical narrative: UNEXPLAINED HIVES/RASHES THROUGHOUT BACK AREA,  ELBOWS AREA, AND WRISTS.  RED, RAISED, WARM TO TOUCH, ITCHY, IRREGULAR SHAPE, AND CLUSTERS.  OBSERVES TO OCCUR AFTER NAPS OR SLEEP  NO PROFESSIONAL ATTENTION.  HOME REGIME OF ZYRTEC ONCE DAILY.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: UNEXPLAINED HIVES/RASHES THROUGHOUT BACK AREA,  ELBOWS AREA, AND WRISTS.  RED, RAISED, WARM TO TOUCH, ITCHY, IRREGULAR SHAPE, AND CLUSTERS.  OBSERVES TO OCCUR AFTER NAPS OR SLEEP  NO PROFESSIONAL ATTENTION.  HOME REGIME OF ZYRTEC ONCE DAILY.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Fever, nausea, headache, fatigue, and chills. Treated symptoms with Benadryl and Tylenol
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: The day after the vaccine was given I began experiencing the worst pain I'd ever experienced. On a scale of 1-10 it was easily between 18-20 from that day until the week point following the date of receiving the vaccine. I'm used to pain, being someone with more than one chronic pain condition but this was just off the scale. Then on the 8th day following the injection I woke up screaming, my scale doesn't go that high. However, I think it was a turning point, as my pain began improving from that point on. I'll admit I'm dreading the 2nd shot, but I will go through with it, otherwise what I suffered from the 1st shot was wasted effort.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Nausea, Paraesthesia, Tremor
Clinical narrative: chills, prickling skin (like the flu), intense body tremors, ligth nausea
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hyperhidrosis
Clinical narrative: HEAVY SWEATING, SEVER STOMACH PAIN
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Food aversion, Headache, Musculoskeletal discomfort, Nausea
Clinical narrative: - Nausea/Vomiting starting 10 hours after shot, lasting until 30 hours after shot.  Did not respond to Nauzene or Pepto-bismol. Continue to have food aversion.  - Extreme lower back and hip body aches (similar to severe period cramps) while not menstruating starting hour 18 and lasting until hour 32, mildly helped with Tylenol and heating pad.  - Severe headache (though not a migraine) on entire left side of head, traveling down left side of neck starting at hour 18 and lasting until hour 30, mitigated with Tylenol.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: - Nausea/Vomiting starting 10 hours after shot, lasting until 30 hours after shot.  Did not respond to Nauzene or Pepto-bismol. Continue to have food aversion.  - Extreme lower back and hip body aches (similar to severe period cramps) while not menstruating starting hour 18 and lasting until hour 32, mildly helped with Tylenol and heating pad.  - Severe headache (though not a migraine) on entire left side of head, traveling down left side of neck starting at hour 18 and lasting until hour 30, mitigated with Tylenol.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Dysphonia, Headache, Influenza like illness
Clinical narrative: THROAT HOARSE; SNEEZING; COLD; BACK PAIN; ARM SORENESS/ARM FELT SORE/PAIN IN LEGS; MILD HEADACHE; MUSCLE ACHES; FEVER OF 100.4; FLU LIKE SYMPOTOMS; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's past medical history included back surgeries, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced did not sleep well. On 06-MAY-2021, the subject experienced flu like sympotoms. On 06-MAY-2021, the subject experienced back pain. On 06-MAY-2021, the subject experienced arm soreness/arm felt sore/pain in legs. On 06-MAY-2021, the subject experienced mild headache. On 06-MAY-2021, the subject experienced muscle aches. On 06-MAY-2021, the subject experienced fever of 100.4. On an unspecified date, the subject experienced throat hoarse, sneezing, and cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F, 99.8-99.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from did not sleep well, and flu like sympotoms, and back pain, arm soreness/arm felt sore/pain in legs, and muscle aches on 10-MAY-2021, had not recovered from mild headache, and fever of 100.4, and the outcome of throat hoarse, sneezing and cold was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: THROAT HOARSE; SNEEZING; COLD; BACK PAIN; ARM SORENESS/ARM FELT SORE/PAIN IN LEGS; MILD HEADACHE; MUSCLE ACHES; FEVER OF 100.4; FLU LIKE SYMPOTOMS; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's past medical history included back surgeries, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced did not sleep well. On 06-MAY-2021, the subject experienced flu like sympotoms. On 06-MAY-2021, the subject experienced back pain. On 06-MAY-2021, the subject experienced arm soreness/arm felt sore/pain in legs. On 06-MAY-2021, the subject experienced mild headache. On 06-MAY-2021, the subject experienced muscle aches. On 06-MAY-2021, the subject experienced fever of 100.4. On an unspecified date, the subject experienced throat hoarse, sneezing, and cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F, 99.8-99.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from did not sleep well, and flu like sympotoms, and back pain, arm soreness/arm felt sore/pain in legs, and muscle aches on 10-MAY-2021, had not recovered from mild headache, and fever of 100.4, and the outcome of throat hoarse, sneezing and cold was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: THROAT HOARSE; SNEEZING; COLD; BACK PAIN; ARM SORENESS/ARM FELT SORE/PAIN IN LEGS; MILD HEADACHE; MUSCLE ACHES; FEVER OF 100.4; FLU LIKE SYMPOTOMS; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 58 year old male. The patient's weight was 175 pounds, and height was 70 inches. The patient's past medical history included back surgeries, and concurrent conditions included cigarette smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced did not sleep well. On 06-MAY-2021, the subject experienced flu like sympotoms. On 06-MAY-2021, the subject experienced back pain. On 06-MAY-2021, the subject experienced arm soreness/arm felt sore/pain in legs. On 06-MAY-2021, the subject experienced mild headache. On 06-MAY-2021, the subject experienced muscle aches. On 06-MAY-2021, the subject experienced fever of 100.4. On an unspecified date, the subject experienced throat hoarse, sneezing, and cold. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.4 F, 99.8-99.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from did not sleep well, and flu like sympotoms, and back pain, arm soreness/arm felt sore/pain in legs, and muscle aches on 10-MAY-2021, had not recovered from mild headache, and fever of 100.4, and the outcome of throat hoarse, sneezing and cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: CAN NOT BREATH; RASH ON  FACE; 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 allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced can not breath. On MAY-2021, the subject experienced rash on face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on face, and can not breath. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Mastication disorder, Pain in jaw, Swelling face
Clinical narrative: REALLY HARD TO CHEW AND NOT REALLY TO TALK BUT TO CHEW FOOD; EARACHE ON THE RIGHT SIDE OF MY FACE; PUFFY FACE; JAW PAIN; HEADACHE; 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  (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced headache. On 05-MAY-2021, the subject experienced jaw pain. On 05-MAY-2021, the subject experienced earache on the right side of my face. On 05-MAY-2021, the subject experienced puffy face. On an unspecified date, the subject experienced really hard to chew and not really to talk but to chew food. The action taken with covid-19 vaccine  was not applicable. The patient recovered from headache on 05-MAY-2021, had not recovered from jaw pain, earache on the right side of my face, and puffy face, and the outcome of really hard to chew and not really to talk but to chew food was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure measurement, Dyspnoea, Hypertension, Musculoskeletal discomfort
Clinical narrative: HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. 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: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: HIGH BLOOD PRESSURE; SHORTNESS OF BREATH; PAIN CONTINUES ALL OVER BODY; HIP PAIN; LEFT KNEE DISCOMFORT; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sickle cell trait.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A expiry: Unknown) dose was not reported,1 total administered on 05-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021(10 days later), the patient experienced left knee discomfort and hip pain, for which patient visited primary doctor, who referred him to an orthopedic. Orthopedic prescribed meloxicam; however, the patient took ibuprofen daily instead of it . On an unspecified date, the patient experienced pain all over body for which patient took oxycodone hydrochloride/paracetamol but discontinued due to constipation and for constipation patient took casanthranol/docusate sodium, then patient checked blood pressure and it was found 148/106 mmHg (high) so patient visited to emergency room where patient firstly checked for covid -19 test which was negative. For high blood pressure patient took amlodipine 10 mg daily. The patient took paracetamol for unknown indication.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain continues all over body, and the outcome of left knee discomfort, hip pain, shortness of breath and high blood pressure was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0: 20210532847-COVID-19 VACCINE AD26.COV2. S - High blood pressure. 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).