chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wednesday evening left arm began feeling numb and tingly, which woke her up all night-Thursday entire arm was numb and her left hand was sweating. She also felt her arm popping. She went to her physician and he put her on ibuprofen 800mg, Benadryl, and Methyl Prednisone.
Narrative:  72yo male homeless died at the hospital on 12/8/21 after determined to be DNR as pt had gone into multi-organ failure. Pt had received 3 covid vaccines on 3/5/21, 4/5/21, & 9/9/21 (full dose). This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccination administration.
Stated he was vaccinated on 06 Jan and keep the site covered at all times and practiced frequent handwashing. The area on arm is almost healed and he had very little drainage. He noticed that his rt eye was starting to turn red with clear drainage last Wed - 20 Jan, inc redness and drainage on 21 Jan, then during the weekend it spread to left  eye. He denies eye pain but reports photosensitivity. No problems with vision and drainage has remained clear. No other sx. Did see ophtho - and placed him on a steroid eye drop and anbx. Is feeling better this pm.
This spontaneous report was received from a registered nurse concerning a female patient of unknown age. Concurrent conditions and pertinent medical history were not provided. The nurse reported that about two years ago (approximately in 2013) the patient was vaccinated with the first and second dose of GARDASIL (lot numbers, expiration dates, and routes were not reported). The nurse stated that the patient was in office on 21-DEC-2015 to receive her third dose of GARDASIL (lot number, expiration date and route were not provided for the administered dose). Concomitant therapies were not provided. No adverse symptoms were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Hives neck, face, upper left chest. Raised welts, urticaria. Good relief with Benadryl 25mg po prn. No relief with Hydrocortisone cream. No difficulty breathing or swallowing.  Reaction continues into day 3. Notified my internist who is sending a request to be seen by an allergist. Internist recommends I withhold second dose of Moderna scheduled for April 10th.
This spontaneous report was received from a medical assistant referring to unspecified amount of patients of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or drug reactions. On unknown dates, the patients were vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) lot # M011666 with expiration date on 08-MAR-2018 (dose and route of administration were no provided) for prophylaxis; which was reconstituted with properly stored sterile diluent (MRK). The doses of M-M-R II were exposed to a temperature excursion of 47 degrees Fahrenheit (°F) to 77 °F during a time frame of 2 hours 45 minutes which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010122: US-009507513-1709USA010123.
Hives; itching of facial skin; vomiting; Diarrhoea; Nausea; Tachycardia; General malaise; weakness; temperature 100 degrees Fahrenheit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 33-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 19Apr2021 at 12:00 AM (at the age of 33-year-old) (Batch/Lot Number: Ew0158) as dose 1, single for covid-19 immunization. The patient medical history included anxiety. The patient not had any allergies. Concomitant medication(s) included sertraline 50 mg (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine in four weeks. Prior vaccination the patient not had covid and post vaccination the patient not tested for covid. On 19Apr2021, the patient experienced hives, itching of facial skin, vomiting, diarrhoea, nausea, tachycardia, general malaise, weakness and temperature 100 degrees fahrenheit . The patient underwent lab test on 19Apr2021 and procedures which included body temperature: 100 fahrenheit temperature. The patient received treatment for the events. Outcome for all the reported events were recovered on an unspecified in Apr2021.  No follow up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant and refers to 60 year old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-FEB-2016, the patient received dose of improperly stored ZOSTAVAX lot number L029484, expiry date: 06-NOV-2016; (the dose, dosage number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Baby received varicella vaccination 7/31/2009. 1 week later, she developed a swollen, red area at the injection site. 2 weeks after the vaccination, she developed a generalized rash consisting of small red bumps, some with white heads, on her arms, legs, back, forehead, and abdomen. It seems as though the rash is either an allergic reaction or mild case of chicken pox.
Symptoms: Alternating fever and chills (mild), full-body muscle ache (moderate), sensitivity to touch (moderate), dizziness (moderate), difficulty focusing (moderate-severe), fatigue (moderate-severe) headache (SEVERE). Treatment: Took the day after the shot off of work and slept a LOT (approx 18 hours on and off), stayed hydrated and fed. Did not take painkillers due to hearing it would interfere with vaccine uptake. Most symptoms except for headache had gone away by 30-hour mark. Only some lingering fatigue and achiness left over past 36-hour mark.
Pain in right arm. Took OTC Acetaminophen 250mg/Aspirin 250mg/Caffeine 65mg as regular intervals duration 2 days.
Information has been received from a consumer regarding her mother, who has no known allergies or pertinent medical history, who on 17-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  The patient was on no concomitant medication.  On 30-JUL-2007 the patient was diagnosed with shingles.  Unspecified medical attention was sought.  No lab studies were performed.  A the time of this report the patient had not recovered.  No other information was provided.  There was no product quality complaint involved.  Additional information has been requested.
72 y/o Female with sudden onset of "hot" feeling with flushed feeling. No shortness of breath, wheezes, stridor, nausea/vomiting, or near syncope. Pt was placed in chair and observed. Vital signs: BP 138/84, HR 72, Resp. 16, Room air O2 99%.  Symptoms resolved spontaneously. Pt observed x 30 min.
2 cm subcutaneous nodule lasting approximately 3 weeks with accompanying approximately 9-10 cm patch of swelling/redness lasting less than 1 week in left arm at injection site.
Temperature (101.5), chills and body aches for three days.  Treatment - went to Urgent Care Facility and took ibuprofen and Tylenol.
This spontaneous report as received from an Office Manager refers to unknown of patients of unknown age. It was reported that since approximately 05-SEP-2012, doses of improperly stored RECOBIVAX HB might have been administered to patients (doses, route and lot numbers not reported). The vaccine was exposed to 24F for more than two excursions since 05-SEP-2012, the exact period of time that vaccines were exposed to 24F is uncertain at this time, but the number of excursions totaled more than 2. This is one of several reports received from the same reporter (MARRS # 1210USA002523, 1210USA013249, 1210USA013250). Additional information has been requested.
This spontaneous report was received from Licensed practical nurse refers to multiple patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple patients were vaccine with improperly stored VARIVAX (lot number/expiry date and dosage were not reported). The vaccine had 4 excursions: 34 F for the first excursion, 34 F again for the second excursion, 33 F for the third and 31 F for the fourth excursion. The nurse did not know the amount of total time they were outside the recommended range and could not provide a worse case scenario. No data logger was used. No prior excursions reported other than the 4 total excursions given at the time of the call. No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
I experienced muscle weakness and tingling in my legs. I went to the ER and was given medication. The Toradol and the narcotic did not help. But the Gabapentin medication did provide relief.
From patient "my arm began to swell around the injection site in a large circle that felt hard. It also had fever and has turned several colors over the past 6 days. On Saturday, I was ill with fever and several blisters and fatigue. So bad I had to go back to bed in the afternoon. The problems have improved over the past 2 days or so, but the site is still swollen somewhat and is discolored."
Upper left arm sore, swollen, red area "size of hand", warm to touch, small number of petechiae and area blanches.
7Oct21 30 y/o male referred for history of adverse event following Pfizer COVID-19 vaccination on 8Sep21 with Pfizer vaccination.  The member reports that received the Pfizer COVID 19 vaccine at the MTF and within 8 minutes noticed profuse nasal drainage, notified the RN who brought to a treatment area for observation and observed then within a few minutes throat became extremely itchy and felt like was hard to swallow, not necessarily hard to breathe.  Was administered epi pen and EMS called to transport him to the ED.  Gave him steroids and discharged home.  Did not have any rash or itching outside of the throat.  In the morning after the vaccination, when woke felt better but had sneezing, itchy nose, itchy throat, nasal drainage, and in the afternoon morning noted had puffiness in his face which lasted for 24 hours.  Then had a flare of what seemed like typical allergy symptoms for him (in terms of allergic rhinitis) e allergy symptoms ever for about a week (has established severe seasonal allergies).  No history of any type of reaction to other medications, vaccines or foods.
12 hours after receiving the vaccine I started experiencing muscle and body aches, fever of 101.3, chills, hot/cold flashes, loss of appetite, the arm was sore and sensitive to the touch for 4 days straight, a really bad headache 24 hours after injection.
injection sight is hot like a fever; injection sight is very hard to the touch; injection sight is painful; injection sight is very swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (injection sight is hot like a fever), VACCINATION SITE INDURATION (injection sight is very hard to the touch), VACCINATION SITE PAIN (injection sight is painful) and VACCINATION SITE SWELLING (injection sight is very swollen) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection sight is hot like a fever), VACCINATION SITE INDURATION (injection sight is very hard to the touch), VACCINATION SITE PAIN (injection sight is painful) and VACCINATION SITE SWELLING (injection sight is very swollen). At the time of the report, VACCINATION SITE WARMTH (injection sight is hot like a fever), VACCINATION SITE INDURATION (injection sight is very hard to the touch), VACCINATION SITE PAIN (injection sight is painful) and VACCINATION SITE SWELLING (injection sight is very swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter   Reporter did not allow further contact
productive cough, nasal congestion, SOB, headache, body aches,  fever, stridor. MEDS: Albuterol MDI, Flonase, Tylenol. Symptoms resolved after 3 weeks
Child sitting in chair after receiving all 3 shots with mom at side. Child leaned to left, semi-conscious. Able to answer questions, states he was very hot and wanted a drink. Stood up to get water from faucet in room with nurse and mom at side. Child then left more weak, unable to get cup to mouth more than once. Leaned over sink, becoming too weak to stand. Was assisted to floor safely by nurse. Child returned to full consciousness after about 2 min. Allowed to rest. Got up to chair per self. Child just came from clinic following sports physical. Mom states child doesn't like shots, but has never reacted poorly. Has not eaten or drank anything yet this AM. Started football practice this week. Gave child a protein bar and pedialyte electrolyte replacement. Ate all of bar and a couple drinks of the juice. Allowed to sit for another 10 minutes. Color returned to face, stated feeling back to normal. Walked around office for 5 minutes before leaving. Mom very shaken. Reassurance provided.
Information has been received from a physician concerning a 20 year old female with endometriosis who on 15-AUG-2008 was vaccinated with the first dose of GARDASIL.  Concomitant suspect therapy included LUPRON DEPOT administered on 26-AUG-2008 (indication not reported).  Other concomitant therapy included meningococcal vaccine (unspecified).  On approximately 27-AUG-2008, "about 12 days after initial dose of GARDASIL vaccine" the patient experienced abdominal pain and shortness of breath.  On 02-SEP-2008 "last night" the patient visited hospital emergency room (ER) and was administered medication for abdominal pain.  Lab studies were performed with no results reported.  The patient was discharged from the emergency room.  The ER physician felt that the patient's visit was "probably related to patient's condition of endometriosis and LUPRON DEPOT vaccine."  The reporting physician was not the physician of record when the patient received the initial dose of HPV vaccine, as the patient was relocated due to hurricane.  At the time of this report, the patient's abdominal pain and shortness of breath persisted.  It was reported that the patient planned to received the next scheduled HPV vaccine and was scheduled to see the physician on 03-SEP-2008.  The patient's abdominal pain was considered to be an other important medical event since the event required pain medication in the ER.  Additional information has been requested.
Seizure started at 1644, stopped at 1646, emesis, followed by dizziness. Ambulance called, patient taken to hospital, A/Ox4 upon transfer with reported dizziness present still, vitals stable: 122/80, HR: 78, 97% saturation on room air.
Liquid part of PENTACEL was given in error to patient. No adverse reaction was noted.
Got flu shot appox 08:45 am 5-10 min later left arm was throbbing from shoulder to tips of fingers. About 1 hour after flu shot she began to feel ill. Headache started- took advil to try to avoid. Stomach was upset - Ran fever and got the chills. About 1 hour later, room began to spin. Thought she was going to pass out. Went home where she did become ill and then fell asleep. Slept until evening. Felt better Saturday.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On 03-SEP-2014, the patients were vaccinated with doses of (Oka/Merck) VARIVAX (lot # H020250 exp date 06-NOV-2014 also reported as 08-NOV-2014) (dose not reported) subcutaneously that were improperly exposed to 7 degrees C from 15-MAY-2013 to 03-SEP-2014. No known adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected. All follow ups requested to complete the case were received.
This is a spontaneous report from a contactable physician. A patient (age and gender unknown) received the first dose of PREVNAR 13 (Lot #916973) on an unknown date. Relevant medical history and concomitant medications were not reported. On an unknown date following vaccination the patient developed hives. The reporting physician, an allergist (not vaccinating physician), has requested QA follow-up. The outcome of the event was unknown at the time of this report. Follow-up (05APR2012): Follow-up attempts completed. No further information expected. Follow-up (06Apr2012): This is a follow-up report from Product Quality Complaint Group. This reporter reported that "Product Description: PREVNAR 13 PFS SUSPENSION 0.5MLX10-USA, UPC/NDC#: 00005-1971-02, Lot Number: 916973, Expiration Date: 1/2013." Follow-up (30May2012): This is a follow-up report from Product complaint group. This contactable physician reported that AE/PC: Physician stated that a patient experienced hives after receiving PREVNAR 13. He wonders if it could have been a batch specific reaction to lot 916973 Exp. Jan2013. The physician specifically requests that Pfizer QA follow-up to let him known whether there have been any issues reported for this specific lot number. He declined transfer to Pfizer Safety and declined to provide additional information at this time due to having patients waiting to be seen. However, he did state that he will be glad to provide additional information if Pfizer Safety and QA will follow-up by mail, phone, or email. He mentioned that he was not the physician who administered the vaccine as he is an allergist.
Constant headache fever ( 99.7) chills achy muscles no appetite Feeling somewhat better 48 hours later -- but not all better
Swollen lymph node. Extremely sore throat. Sweating. Fatigue. Headache. Stuffy and runny nose.
starting about 12 hours after the second Covid-19 vaccine injection in left arm:  fever,  body aches,  strong headache,  general "flu like symptoms"  about 24 hours afterr injection: cotinued fever,  continued body aches, continued headache, red rash on arm at injection site, swollen lymph nodes on left side of body, unable to sleep  36 hours after injection: slight fever, continued body aches, continued red rash at injection site, continued swollen lymph nodes, unable to sleep comfortably
angioedema left upper lip; dysphagia; This is a spontaneous report from a non-contactable physician. A 22-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular on 16Sep2021 at 18:00 (lot number was not reported) as dose number unknown, single for COVID-19 immunization.  Medical history included IDDM (type 1 diabetes mellitus), hypothyroidism and chronic kidney disease (CKD) all from unknown dates. The patient did not have any drug allergies. Concomitant medications included insulin (manufacturer unknown) and levothyroxine sodium (SYNTHROID) both taken for an unspecified indication, start and stop date were not reported.  The patient was not tested for COVID post vaccination. On 16Sep2021, at 20:00 the patient experienced angioedema left upper lip and dysphagia. The event resulted in a visit to the emergency room/urgent care. The patient received prednisone, Benadryl and Pepcid as treatment for the events. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Lip angioedema cannot be totally excluded.The impact of this report the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Tested positive for COVID 19 on June 27,2022 after testing negative for five days after my husband tested positive
Psychosis onset in November 2021 (two months after being given vaccine), unsuccessfully treated initially with lithium and then Abilify (which she did not stay on long enough to determine efficacy). She is now being involuntarily treated with olanzapine, which has improved but not eliminated symptoms (still some paranoid beliefs evident).
Pt received Afluria flu vaccine on 9/16/13 at 18:00. On 9/17/13 at about 16:00 started L shoulder itching. Note hive on L shoulder and hive red raised area on L side of neck x 3.
I HAD A BLURRY SPOT IN THE VISION OF MY RIGHT EYE.  IT DID NOT GO AWAY, SO I SAW AN EYE DOCTOR ON 05/22/2021 WHO FOUND THE CAUSE TO BE A "COTTON WOOL SPOT IN THE SUP ARCADE".  IT WAS AN EYE INFARCTION WHICH RESOLVED ITSELF IN 6-8 WEEKS AS HE PREDICTED.  BUT HE HAD ME SEE MY PCP, WHO RAN A BLOOD TEST THAT SHOWED 1/80 ANITNUCLEAR ANTIBODY MEASURE.  DR REFERRED ME TO A RHEUMATOLOGIST ON THE OFF CHANCE THIS COULD BE LUPUS.  THE RHEUMATOLOGIST FOUND NO CORROBORATING EVIDENCE OF LUPUS.  NO ONE COULD ATTRIBUTE THE INFARCTION OR THE ANA MEASURE TO THE VACCINATION WITHOUT A LARGER STUDY, BUT IT IS POSSIBLE.
Nausea, diarrhea, abdominal cramping H/A 24-48 hours.
Within 30 min of vaccine, pt began with non-stop coughing, red puffy face, scattered hives. Seen at 45min mark: no wheeze but prolonged expiratory phase. Received epinephrine shot (0.15ml), oral benedryl and oral prednisone.
Severe pain and body aches that had delayed onset. Had mild aching the first 48 hrs. But, 72 hours after receiving the vaccine the muscle aching and pain became very severe. This severe pain lasted an additional 24 hours and then decreased but aching continued. Side effects lasted in excess of  96 hrs. I have read reports that people with auto-immune disorders are experiencing delayed onset and longer duration of side effects, which is why I am reporting this. It would be helpful if there were data for people who have autoimmune disorders.
Left arm redness, soreness, swollen, hard knot, frequent headaches.  All symptoms still after 10 days and going.
A few hours after taking the first dose or oral typhoid vaccine; I experienced fever, chills, terrible stomach cramps, nausea, vomiting, diarrhea. This lasted for 20 hours. Now, 30hours after dose, I have jaw pain and stiffness. I have been unable to eat to eat or drink due to nausea.
45-60 second seizure - stiffening of entire body at approximately 1:00 pm on 10/16/2023