chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated 2 weeks later, he had a rash all over his body that hurt when touched. He also had muscle aches and fatigue. He believes he had a stroke but not seek any medical attention for any of his symptoms. He is better now but wanted the pharmacy to know. I encouraged the patient to seek medical attention. He said he will in a few weeks.
Passed out for 1 minute after booster shot; Both her arms hurt bad after booster shot; Lower back pain after booster shot; Felt bad after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for 1 minute after booster shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Blood pressure high and High cholesterol.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced FEELING ABNORMAL (Felt bad after booster shot). On 06-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for 1 minute after booster shot) (seriousness criterion medically significant), PAIN IN EXTREMITY (Both her arms hurt bad after booster shot) and BACK PAIN (Lower back pain after booster shot). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for 1 minute after booster shot), FEELING ABNORMAL (Felt bad after booster shot), PAIN IN EXTREMITY (Both her arms hurt bad after booster shot) and BACK PAIN (Lower back pain after booster shot) outcome was unknown.            No concurrent and treatment medication was reported by patient. Patient had not seen a doctor.  Company's comment: This case concerns a 64 year-old female patient with a history of hypertension and hypothyroidism who experienced the unexpected serious event of loss of consciousness. The event occurred approximately 2 days after the third dose of mRNA-1273.   The rechallenge was not applicable as no additional dosing will be administered. The medical history of hypertension and hypothyroidism remain confounders for loss of consciousness. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-378085 (Patient Link).; Sender's Comments: This case concerns a 64 year-old female patient with a history of hypertension and hypothyroidism who experienced the unexpected serious event of loss of consciousness. The event occurred approximately 2 days after the third dose of mRNA-1273.   The rechallenge was not applicable as no additional dosing will be administered. The medical history of hypertension and hypothyroidism remain confounders for loss of consciousness. The benefit-risk relationship of mRNA-1273 is not affected by this report.
My right big toe swelled up, and the joint turned red. It became painful. I had an infection on the back of my leg, so I thought it was related but it wasn't. I went to the doctor on 11/8/2021 at Care. The test the doctor took said it wasn't gout, but the doctor said he was really sure it was gout.  The doctor prescribed me with prednisone 5mg, 9 pills totaled, but I take 3 days of 2 pills and then 3 days of 1 pill. The doctor also prescribed doxycycline mono 100mg capsule for 1 cap 2xday for 10 days.
I take a flu shot every year and had a little sore; Initial information was received on 25-Oct-2020 regarding an unsolicited valid non-serious case from the patient via social media.  This case is linked to case 2020SA300788 (the same patient).  This case involves a patient (age and gender unknown), who took a flu shot every year and had a little sore (Injection site pain), while the patient received vaccine Influenza Vaccine.  Medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient took a flu shot every year and had a little sore (Injection site pain).  Details of laboratory data were not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was unknown.   There will be no information available on batch number for this case.
3 days later I am sitting at work and my vision just completely blurred out of focus and I had a severe head ache like a migraine, which I have never had before, and it lasted until the end of the day. The next morning it was gone. I was really fine then I had my second dose 3 weeks later and it started again and it was a worse head ache and it continued to happened sporadically. I continue to have those problems and it seems to be related to positions like bending over. I went to see my doctor and they did an MRI and then they sent me to a neurologist and they did not see anything in the MRI so they are sending me to get a CAT scan. The day after the second dose I had like very bad flu like symptoms, head ache, body aches.
I was on day 2 of my period on the day I got vaccine dose #1. I had no symptoms immediately following vaccination at around 3PM other than a very sore arm at the injection site. At around 12AM, I woke up experiencing chills and headache. I fell back asleep but woke up later at around 2AM. I got out of bed to urinate and as I was finishing, I experienced extreme and sudden lightheadedness which led to a loss of conciousness and I subsequently fell off the toilet and onto my bathroom floor. I came to and began experiencing the worst abdominal cramps that I have ever had in my life, as well as headache, nausea, and chills. My husband helped me to sit up, but I felt that I was about to pass out again and laid back down. I drank a glass of water and took an Advil, and after about 30 minutes of experiencing severe symptoms, I felt strong enough to sit up, and eventually to walk back to bed. I wear a that measures heart rate and my heart rate during this time dropped to as low as 44bpm (resting is normally around 55bpm). Since the episode I have felt much better, although still a bit "off". I have yet to visit my doctor but plan to seek advice prior to getting the second dose.
Immediately after the injection site swelled, bright red, hot to touch. Next day another reaction happens else where in his body. The doctor said this is more than a site reaction as the large hives were traveling across the body. Benedryl was taken and steroid cream was placed on reactions. 3 days later both spots started to reduce in size and the Itching subsided
Brysen is here because  he had his shots Friday and that evening he developed a huge red area in the vicinity of the shots. It was itchy and his thigh was swollen all the way back to his butt. The next day she called us and was told to use Benadryl and cold compresses. The redness and swelling have gone down significantly. The area was hard and hot to the touch over the weekend. He had a low grade fever his mom thinks and was sweating quite a bit in his sleep. The sore place is not itchy anymore but it is sore to the touch. He also says it hurts to walk and run. Last night he began to complain of a sore in his mouth, and today he says he has lots of sores in his mouth and it hurts to eat but not to drink.
Difficulty in breathing; Wheezing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing) and WHEEZING (Wheezing) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DYSPNOEA (Difficulty in breathing) and WHEEZING (Wheezing). At the time of the report, DYSPNOEA (Difficulty in breathing) and WHEEZING (Wheezing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
side effect in right or left arm (not clear) after 1st dose; Feel weak; like I got a shot on my hip; Slept through 20 some hours; Hive on both hands; injection site tender; Mild ache in lower extremities: Hips to knees; Hip tender and warm to touch; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees), FEELING HOT (Hip tender and warm to touch) and VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-Jan-2021, the patient experienced URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees) and FEELING HOT (Hip tender and warm to touch). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose), ASTHENIA (Feel weak), MUSCULOSKELETAL DISCOMFORT (like I got a shot on my hip) and HYPERSOMNIA (Slept through 20 some hours). At the time of the report, URTICARIA (Hive on both hands), VACCINATION SITE PAIN (injection site tender), MYALGIA (Mild ache in lower extremities: Hips to knees) and FEELING HOT (Hip tender and warm to touch) had not resolved and VACCINATION COMPLICATION (side effect in right or left arm (not clear) after 1st dose), ASTHENIA (Feel weak), MUSCULOSKELETAL DISCOMFORT (like I got a shot on my hip) and HYPERSOMNIA (Slept through 20 some hours) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Fatigue 9pm Chills 10pm Headache, dry mouth, body aches 1am woke me from sleep Headache, nausea, fever, sweating, body aches, tingling 8am Slept 30 hours and then felt better just very mild fever and left sided neck pain
Information has been received from a physician concerning a patient who was vaccinated with the first dose of Rotateq at four months of age but did not receive the vaccine at two months. It was reported that the patient's mother did not want the child to be vaccinated but the nurse accidentally gave the patient the dose at four months "assuming it was part of routine vaccination". There was no product quality complaint. Additional information has been requested.
About 15 minutes after vaccination patient was out in our waiting room and had vasovagal episode where she hit her head hard against floor. Witnessed by mom and brother. Brother (14 year old) states sister's eyes rolled back. Front desk staff did not witness fall but hear hit. Front desk staff alerted me (RN) to assess patient. When I got to patient pt was alert but diaphoretic and laying down. Vital signs taken and stable but patient was confused initially and afterwards patient was still confused about whether or not she received shot. Pt was alert to location and date. Unable to perform d stick but pt had water and kept on floor until evaluated in office by PA. Advised to call EMS due to possible head injury. Parent agreeable to EMS and trip to hospital.
Breaking out into a rash/ they look like little blotches or welts; breaking out into a rash/ they look like little blotches or welts; This is a spontaneous report from a contactable pharmacist, the patient. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Dec2020 as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that a couple days after receiving the first dose of vaccination she started breaking out into a rash. It started off small on her wrist, then went away, then spread to her legs and went away, then to her neck and went away. The rash went all through her body, face and eyes. She still had the rash and was taking prednisone (MANUFACTURER UNKNOWN). The rash was all over, it looked like little blotches or welts. The patient asked if it was okay to get the second dose of vaccination after this reaction. The outcome was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
felt lousy; she had aches and pains/ still felt achy; an issue with her vision; she couldn't read the small print on her credit card statement and things were blurry; muscle ached; Bone ached; she had aches and pains/ arm was so sore; she experienced tenderness at the site/ stung at the injection site; deadly ill/ sick; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (For tolerance of 1st dose refer case US2020019100).   On 29th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, 3 hrs after receiving Shingrix, the patient experienced feeling unwell, muscle pain, bone pain, pain in arm and injection site pain. On 31st January 2020, the patient experienced pain, abnormal vision and blurred vision. On an unknown date, the patient experienced feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell, pain, muscle pain, bone pain and feeling bad were recovered/resolved and the outcome of the abnormal vision and blurred vision were not recovered/not resolved and the outcome of the pain in arm and injection site pain were unknown.   It was unknown if the reporter considered the feeling unwell, pain, muscle pain, bone pain, abnormal vision, blurred vision, feeling bad, pain in arm and injection site pain to be related to Shingrix.  Additional information received were as follows: This case was reported by patient herself. On 29th January 2020 at 2:00 PM, the patient received a dose of Shingrix. Post vaccination the patient felt lousy with sore arm and had stung and tenderness at the injection site.  The arm was so sore when lifting things. The patient was sick, deadly ill and every bone and muscle ached and she had pains which subsided but she noticed an issue with her vision at that time.   The patient claimed that she put glasses on and she couldn't read the small print on her credit card statement and things were blurry which she never experienced prior to the vaccination.  The patient's vision issues remain unchanged. The patient felt achy and sick but her symptoms were better. At the time of reporting all the side effects resolved except for the vision concerns.   The patient wondered if the vaccine was too strong for her small frame.
On 5/13/2021 patient developed a cough in the evening. Patient woke up not feeling well on 5/14/2021, and also had nausea and vomiting. Patient was driving a vehicle when he had a seizure. No prior history of seizures. Drifted off the road, no significant damage to vehicle. Patient post-ictal following seizure, seizure activity was witnessed by bystanders. CT brain showed small subdural hematoma. A CTA chest performed due to hypoxemia and tachycardia at Hospital  showed Multifocal groundglass type nodular infiltrates throughout the right lung involving the upper lobe, middle lobe, and lower lobe, minimal left lower lobe patchy infiltrate, as well as patient's known thymoma. These multifocal groundglass infiltrates were not previously mentioned on a CT chest performed on 4/10/2021.  Patient was transferred to this facility for evaluation by neurosurgery. Patient was mildly tachycardic, hypoxemic to 88% on room air, and tachypneic. Patient reported decreased sense of taste & smell for 1 month, which he attributed to his losartan use.  A covid/flu/rsv PCR on 4/10/2021 was negative, and a viral respiratory pathogen panel with covid PCR was negative on 5/14/2021, as was an antigen & NAAT for COVID on 5/14/2021.  Patient was treated with antibiotics and admitted for further management.
I had a strange, constant swooshing noise in my left ear. My Dr suspected it was bacterial and prescribed antibiotics. After 24 hours, the noise stopped. My Dr also recommended I take a Covid test, out of an abundance of caution.
Pt reports feeling a "little shakey" with itching to face/top of head/back of neck and dry mouth. Self administered chlortrimeton, an allergy medication that she usually takes Qday for cat allergies. Within 15 minutes she reported itchy feeling had resolved.
Patient attended the vaccine clinic and was inadvertently given a 22 mcg dose of Pfizer's COVID-19 vaccine (pediatric dose is 10 mcg). She was with her dad and completed the 15 min observation period without any unusual symptoms. I spoke to her dad via telephone about what happened and advised them to monitor her symptoms over the next 7 days. If she exhibits any unusual or persistent symptoms or they have any concerns they should reach out to the pediatrician/family doc, or go to the ED. I spoke to her dad the next day and he reported that patient was doing well.
Patient had hives. Patient took 25 mg of benadryl . Ambulance was called and she declined treatment
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX (batch number D3L5G ?, expiry date 29th November 2020 GSK note: the reported lot number did not match with any GSK lot number). The patient's past medical history included varicella (Dermant Chiken pox in the past). Concomitant products included BYSTOLIC and lamotrigine. On 15th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 16th May 2018, 1 days after receiving SHINGRIX, the patient experienced chills and fever. On 20th May 2018, the patient experienced injection site rash and injection site erythema. On an unknown date, the outcome of the injection site rash and injection site erythema were not recovered/not resolved and the outcome of the chills and fever were recovered/resolved. It was unknown if the reporter considered the injection site rash, injection site erythema, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a mild rash on her arm that is pinkish in color and the rash appeared in four spots near the injection site on her arm. The red spot or rash increased this morning. The patient's body temperature was recorded as 100.5 degree F. The patient experienced fever and chills last week. The patient had CDC done which came back in the normal range. The dermatologist wanted to start her regimen of VALTREX which she planned on starting today. The patient had denied permission to contact their physician.
Initial reported received on 31 October 2014 and follow up information received on 06 November 2014 and 08 November 2014 from an investigator participating in a trial. An 83-year-old male subject was diagnosed with Hematochezia on 30 October 2014 i.e. 20 days after the subject had received first dose of FLUZONE QUADRIVALENT (lot number, route and site of administration not reported), 10 October 2014. The event appeared after visit 1. The subject's medical history was not reported. The subject had no concomitant medications. The subject had associated symptom of severe anemia from 30 October 2014. The subject was hospitalized on 30 October 2014. The subject's wife reported that the subject experienced a possible TIA (Transient Ischemic Attack) and was seen at the emergency room . The subject's labs were done and severe anemia was diagnosed. The subject was sent to the hospital in ICU where he received 2 units of blood as a corrective measure. The subject's further diagnostic tests would be done. The subject's complementary investigations were not reported. The subject recovered from the event of Hematochezia on 04 November 2014. According to the investigator, the event was not related to the study vaccine, trial procedure. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow-up information received on 13 November 2014: The subject had medical history of coronary heart disease, cardio vascular attacks, atrial fibrillation, hypertension, arthritis, enlarged prostate, alzheimer, dyslipidemia and prostate cancer. Concomitant medications were Finasteride, Pravastatin, Furosemide, NAMENDA, ARICEPT, Losartan, Famotidine, XARELTO. Carvedilol and Aspirin. Subject's wife reported a possible ischemic attack (previously reported as TIA) and was seen at the ER. Labs done, severe anemia was diagnosed and sent to the hospital, in intensive care receiving 4 units of blood (previously reported as 2 units of blood). Complementary investigations were colonoscopy which was unremarkable, CBC showed hematocrit and hemoglobin improved, echocardiogram showed ejection fraction of 30%, carotid duplex scan showed no evidence of carotid artery disease and CT scan abdomen and pelvis was unremarkable. It was reported that the subject was discontinued with XARELTO. The subject had received 4 units of blood (previously reported as 2 units of blood). The associated symptom of severe anemia was resolved on 04 November 2014 and the subject was discharged from the hospital on the same day i.e. 04 November 2014. According to the investigator, the event was not related to the concomitant medications. Follow up information received on 04 December 2014 and 09 December 2014. The subject had received first dose of FLUZONE QUADRIVALENT intramuscularly in left deltoid region (batch number UI158AA) on 10 October 2014.
UNKNOWN/ASYTOLE Narrative:  Please refer to section 6. 68y/o male with h/o severe peripheral vascular disease with previous left AKA 2/3/20, s/p bilateral bypasses in the past. Pt recently underwent right AKA on 1/12/21. Per Hospital remote data 1/10/21 pt c/o shortness of breath, CXR demonstrated right lower lobe opacity & left basilar infiltrate. Pt s/p >10 days emperic IV abx. Moderna vaccine 0.5ml IM was administered via left deltoid on 1/22/21 around 16:21. On 1/23/21@05:14 code blue was called as pt found to be unresponsive, breathless and pulseless, facial cyanosis noted, CPR started immediately.Pt found to be in asystole. ACLS guideline followed but no return of spontaneous circulation, At 05:32 pt remained pulseless and breathless and was pronounced. Autopsy currently pending.