chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a medical assistant (M.A) concerning a 6 months male patient with a history of premature birth who "two weeks ago", on approximately 17-OCT-2011 was vaccinated orally with a dose of ROTATEQ (Lot number and dose not reported). The physician reported that the patient's mother had taken the patient to another pediatrician to receive ROTATEQ immunization on an unknown date. The physician reported that few days after the patient received ROTATEQ developed an elevated temperature of 103 degrees. The patient had episodes of vomiting and was not eating (previously reported as the baby was vomiting and eating issues prior to the immunization, the condition seemed to have gotten worse). The patient was admitted to the hospital with a diagnosis of an ileus. The patient was treated with intravenous fluids and PEDIALYTE. The patient recovered and was discharged from the hospital on 31-OCT-2011. The patient was scheduled for a follow-up visit with the physician. Ileus diagnosis was considered to be immediately life threatening by the reporter. Additional information has been requested.
Felt extremely loopy; Tingling down both arms; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) in the right arm on 05Mar2021 at 16:30 and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) in the right arm on 26Mar2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol succinate (TOPROL), diltiazem hydrochloride (DILTIZEM), losartan (MANUFACTURER UNKNOWN), montelukast sodium (SINGULAIR) and loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not have a history of allergies to medications, food or other products. On 05Mar2021 (as soon as injected), the patient felt extremely loopy and tingling down both arms, still had tingling in both arms from elbows to finger tips which was not constant but it was happened every day at different times since injection. The tingling after second dose was more noticeable and after 7 days patient still have it.  Adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event extremely loopy was resolved after 2 hours on 05Mar2021. The clinical outcome of event tingling in both arms from elbows to finger tips was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
4/12/2023   I appeared to have a severe cold. I had coughing, possible fever, pink eye and felt sick.  I went to the doctor and was prescribed antibiotic drops for my eyes and a Z-Pack. I took a COVID test which was negative.  Over the week-end, it moved into my left ear and I developed into an ear infection. The antibiotic did not help, but the pink eye did clear up. The ear infection, the following week, became pretty severe with drainage. I took 2 more at home COVID tests that came back negative.  I went back to the doctor about a week later and was prescribed antibiotic drops for my ears and Amoxicillin.  My left ear infection did clear up and I began feeling better. The ear infection may have perforated my ear which I have not fully recovered from. I went to an ENT doctor because of fluid in my ear. He said it can take a long time to go away. I still feel like I have blockage and fluid in that ear. I was given exercises to do for my ear. I still have issues with my coughing.  have an appointment to go back on May 24, 2023.
she received her first dose of GARDASIL 9 on 11-NOV-2019. Then on 13-DEC-2019, the patient received her second dose of GARDASIL 9/ second dose given outside of dosing schedule; Her arm was sore; Severe pain/ patient stated while the needle was in her amr it hurt a lot; This spontaneous report was received from a consumer referring to herself, a 42-year-old female patient. The patient's concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. The patient had none pertinent medical history, drug reactions nor allergies, and concurrent conditions were not reported.  On 11-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, by intramuscular route, in an unspecified arm as prevention of human papillomavirus (HPV) (lot number R011631 has been verified to be valid, expiration date reported and validated as 12-DEC-2020). It was reported that while the needle was in her arm, "it hurt a lot" also reported as "severe pain" (injection site pain) (severe), and afterward her arm was sore (pain in extremity). It was reported that the patient recovered the following day.  Then on 13-DEC-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, by intramuscular route, as prevention of HPV (anatomical location was not reported; lot number R011631 has been verified to be valid, expiration date reported and validated as 12-DEC-2020) (inappropriate schedule of product administration), however she felt no pain.  It was reported that the patient did not sought medical attention, and did not received treatment. Laboratories diagnostics or studies were not performed.    The causal relationship between the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the pain in extremity and injection site pain was not reported.
Soreness, after midnight the fever and shivering started. Pain more at the site and some nausea.
pt c/o redness, pain & swelling @ inj site >usual;MD observed;
left arm pain at the injection site; could not move her arm at all; it has spread up to her shoulder.; This is spontaneous report received from a contactable consumer (patient) reported for herself that a 64-years-old female patient received BNT162B2, dose 2, via an unspecified route of administration, administered in left arm on 02Apr2021 10:45 AM (Lot Number: ER8734) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot # EN6207) in the left arm on 14Mar2021, before noon, for COVID-19 immunisation. Caller had a hard time reading this Lot number on the card that was provided to her. She stated the first Lot number was covered up a little by the second Lot number. She verified that this was the Lot number. She gets magnifying glass to read card. The patient received the second dose of the Pfizer-BioNtech Covid-19 vaccine on Friday, she had left arm pain at the injection site and it had spread up to her shoulder. She had her second shot this past Friday and her left arm hurt so bad where the shot was, she can feel it up to her shoulders. It was not swollen, she just felt it. She asked if she should keep taking Acetaminophen. She stated yesterday and this morning she was fine but then after she moves, it hurts again. She stated she can feel it and it was hard to move at night, she keeps her arm on a pillow. She stated she does have very small arms. Caller did not specify her start date of adverse event onset but that her symptoms were still ongoing and that her treatment medications helped. Treatment included: Caller stated she has used ice packs and has taken Acetaminophen Extra Strength (Lot # SEA041, Expiry Mar2024) and Ibuprofen, (Lot # OCE3209A, Expiry Jan2022), and Acetaminophen PM (Lot # PPA014, Expiry Sep2021) for treatment. Caller stated that the Ibuprofen was every 6 hours, the Acetaminophen Extra Strength was in between 5-6 hours, and the Acetaminophen PM she took a couple of nights ago and last night. Caller stated her treatment medications help. Caller's arm hurting was ongoing. Caller stated the Acetaminophen PM helped her sleep, not all night but some sleep. She was having a really hard time moving at night, she could not move her arm at all and would keep it on a pillow and then yesterday she felt fine. This morning trying to do a few things she felt good and then once she got going, she said forget it, and had to take two Acetaminophen right now. She had really small arms. She didn't know how long it should last. The outcome of the event "left arm pain at the injection site" was not recovered, of the event "could not move her arm at all" was recovered. The outcome of the other event was unknown.  No follow-up attempts are possible. No further information is expected.
pt had vax in lt arm on 20OCT95 upper lt arm reddened & tender to touch; pt has not been able to lie on arm since vax;
swollen arm, red, itching, sore to touch which lasted for about 5 days after injection
post vax x 2wk pt had sx of stroke-dizziness, nausea, failed eyesight, loss of balance, dx w/demyelination disease/MS
I got it at 9 and was fine all day. I woke up at 3 to go the the bathroom. I passed out standing at the sink trying to take a Tylenol and hit my chin and chest--major pain. My husband came in because I knocked something down and I was all fuzzy and felt like cotton in my ears. He said I sounded drunk. I sat for a bit and when I tried to get up my legs gave out and I came to to my husband asking if I need an ambulance because I had a seizure.
Whole body/joint/muscle pain, weakness (can't even hold his head up), all he could do was sleep, chills/cold, listless, lithargic, confused/trouble concentrating, loss of appetite, headache, forgets to take his meds. These symptoms lasted almost 2 weeks before he began to feel better. But have recurred every 2 - 3 weeks, for a period of 3 - 7 days each, since the original episode. The symptoms have gradually become less severe, and the last 2 episodes in (September and October) have diminished to 2 days in duration and symptoms have mostly narrowed to sleepiness and weakness.
Patient with hx of SVT stood up after receiving COVID-19 vaccine and did not feel well - sat back down.  put pulse ox on and HR was 180.  Pt vagaled twice, HR sitting in the 90s - brought to ED for evaluation.
Swollen and painful lymph nodes on left side. Appeared upon waking up the day after the vaccine and are still persisting 5 days post-vaccination. The pain makes it so I can not let my arm rest at my side.
Fully vaccinated patient admitted through ED for mild COVID and management of acute kidney injury due to solitary kidney.  Discharged without O2.
Lost peripheral vision in the left eye; stroke in arterial blood vessel in brain; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN STEM STROKE (stroke in arterial blood vessel in brain) and VISUAL FIELD DEFECT (Lost peripheral vision in the left eye) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03721A) for COVID-19 vaccination.     Concurrent medical conditions included Cervical dystonia and Herniated disc (Cervical, L5/S1 disc.).    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milligram/kilogram. On 24-Jun-2021, the patient experienced BRAIN STEM STROKE (stroke in arterial blood vessel in brain) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced VISUAL FIELD DEFECT (Lost peripheral vision in the left eye) (seriousness criterion hospitalization). At the time of the report, BRAIN STEM STROKE (stroke in arterial blood vessel in brain) and VISUAL FIELD DEFECT (Lost peripheral vision in the left eye) outcome was unknown.            No concomitant medication reported. The patient was admitted in the hospital for stroke testing and treatment.  Very limited information regarding this event/s has been provided at this time. 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. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. 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. Further information has been requested.
Feeling Worse; This spontaneous case was reported by an other and describes the occurrence of MALAISE (Feeling Worse) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 12-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. In March 2021, the patient experienced MALAISE (Feeling Worse). At the time of the report, MALAISE (Feeling Worse) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Fluzone High-Dose Quadrivalent given to 60 years old female patient/ NO AE; Fluzone High-Dose Quadrivalent given to 60 years old female patient/ NO AE; Initial information received on 19-Aug-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 60-years-old female patient who received a 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] Injection (batch number: UJ454AA, expiry date: 30-Jun-2021) via an unknown route it the left deltoid on 19-Aug-2020 for prophylactic vaccination. Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration and it was a case of overdose (latency: same day).  At the time of reporting, the patient had no side effects.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recv 4APR94 & the same day devel a rash on chest & pain in shoulders & all joints; sx resolved in approx 2 days; No further details were provided;
Pt complained of painful vaccination. Days later, discomfort persisted. Despite taking Aleve for pain/stiffness, discomfort persisted. A month and several days later, was still painful and stiff. Patient feels vaccination was a little too high in her deltoid.
Patient received her first dose on 3/22/21 at approximately 1644. Patient states that she stayed at the clinic for 15 minutes (until 1700) but felt fine so she proceeded to the parking lot. Patient states that when she went into her car she started feeling as if she had an itchy throat; she states that at that time she was not very concerned until she brought it up to her husband and he encouraged her to go back inside to be evaluated. Patient arrived to nurse at approximately 1709, patient reported to nurse that she had tightness of throat but denied being unable to swallow. At 1711 oral Benadryl was administered. At this time patient was reporting being tachycardic and short of breath, nurse assessed her oxygenation status, which was at 99%, and her heart rate was at 104. Nurse encouraged patient to deep breath and try to relax. At 1718 Patient reported that her tightness was getting worst, it was getting more difficult for her to swallow. At this time, this nurse collaborated with another nurse for course of action of which we decided to administer 0.5 mg of epinephrine and call 9-1-1. At 1720 Epinephrine was administered intramuscular into the right deltoid. Patient at this time stated that her tightness had expanded into her chest and was progressively getting worst. At 1724 Lung sounds at this time were still clear and her oxygenation status was 99% with heart rate of 125. At 1725 EMS personnel took over care for the patient, after they further assessed they made the decision to transfer the patient to a nearby hospital for further evaluation. At approximately 1729 emergency personnel wheeled out patient on a stretcher.
The evening of the injection, arm to my hand hurt, shaking, cold, acid reflux, chest wall pain
After receiving the second dose of vaccine, blood glucose levels were uncontrollable. I am on a Continuous Glucose Monitor (CGM) which reads my bloodsugars every 5 minutes. That device prevented me from going into diabetic ketoacidosis, however I was unable to get my bloodsugars below 300 for almost a 24 hour period after receiving the vaccine. Insulin boluses and increased basal amounts of 95% increases were ineffective.
Patient stated that she had a syncope episode 5 minutes after being vaccinated.  Complaining of nausea, vomiting', skin pale and diaphoretic. EMT arrived to her vehicle and vitals were taken BP 117/70, Pulse 60, RR 14, Pulse o2 96% . LOCx4. Patient was given 50 mg of Benadryl,  After an hour of observation and constant assessment, patient requested that symptoms were not improved, Complained that her hands were tingling and symptoms progress another set of vitals were taken and patient vitals sustained within normal limits, EMS was called and she was taken to emergency room.
Pfizer-BioNTech COVID -19 Vaccine EUA  I began getting a  rash on my left arm the morning following my shot which has spread to the right arm.  The rash is red welts with  accompanied itching.   OTC Benadryl taken for rash.
Pt turned 12 the day before mass vaccination. Wrong dose of Pfizer given for age.
Sweating; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EN5318, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 05Feb2021 at 14:00 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. Medical history included Parkinson's disease (patient thinks she was diagnosed 3 years ago). The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 06Feb2021, the patient experienced sweating. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Big (baseball size), red, round, sore area on left arm where vaccinated (deltoid). Lasted 2-3 days, then went away.
EXPIRED DOSE GIVEN; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced expired dose given. The action taken with covid-19 vaccine was not applicable. The outcome of expired dose given was not reported. This report was non-serious.
On 04/11/2023,  instead of receiving a Moderna COVID monovalent 1st dose in the primary series, the patient received a Moderna COVID bivalent vaccine in error.  The patient did not exhibit any s/s of an adverse event.  Patient was notified of error and instructed she needs to receive another primary 1st dose.
Debilitating frontal headache, accompanied by nausea and vomiting, and fatigue for 16 hours
BAD TASTE IN MOUTH AND THROAT; STOMACH PAIN; BODY ACHE; FEVER; FATIGUE; HEADACHE; FEELS LIKE KNOT RIGHT BELOW HEART; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included high blood pressure, and hypothyroidism. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced feels like knot right below heart. Laboratory data included: Body temperature (NR: not provided) 99.9. On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced stomach pain. On 10-APR-2021, the subject experienced bad taste in mouth and throat. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, fever, and fatigue on 09-APR-2021, had not recovered from stomach pain, and bad taste in mouth and throat, and the outcome of headache and feels like knot right below heart was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
30 mins after the vaccine, I was driving, and my neck started itching with burning. I noticed hives on my neck. It spread to my face and cheeks. I took Benadryl as advised by my doctor. That last 1 day and went away the next day. The next day my arm was hurting and throbbing with shooting pain on my right shoulder blade and up and down my arm. I noticed I had swelling on my back shoulder joint. I tried to massage it and it was really swollen like the size of my fist. I went to my doctor that week and then went to an orthopedic doctor and had an MRI. I went to Physical Therapy. I was diagnosed with cerva. I went to physical therapy for 3 months. I had pain meds as well. I had issues sleeping and pain. I was also told it was lymphoma.  To this day, I still have the lymphoma. I have seen multiple doctors over this. I had another MRI last week to see if it was possible to get it removed which is still in review with my orthopedic surgeon.
pt adm to hosp on 1OCT97 w/1wk history of back pain progressing to weakness;dx w/GBS;
Info has been received from a health professional concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent. Subsequently the pt developed "severe" local injection site reactions involving swelling, redness and soreness. The pt was not hospitalized. Unspecified medical attention was sought. The reporter also described the experiences of 2 other pts who were also vaccinated with pneumococcal vaccine 23 polyvalent (WAES #0211USA02311 and 0212USA00646). Additional info has been requested.
This spontaneous report was received from a other health care professional (nurse) regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug/allergies were not reported. On 12-DEC-2018, the patient was vaccinated with improperly stored M-M-R II (dose, route of administration not reported) lot # N032427and expiration date: 16-NOV-2019 for prophylaxis (product storage error) which was reconstituted with properly stored Merck sterile diluent. No adverse event was reported. Temperature was reported as 9 °C to 25°C with time frame 1.5 hours, there was no previous temperature excursion. Data logger was present. This is one of several reports received from the same reporter.