chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain in shoulder joint.  No exterior bruising but all pain in joint.  Felt like the shot was too high and too deep in shoulder and not in arm.
Mom reported that there was redness and swelling encompassing most of the outer portion of the right arm between shoulder and elbow lasting over the course of several days (vaccinated Saturday 12/21 and cleared up approximately 12/25). Per the advice of their neighbor who is a pharmacist, they treated Patient with Benadryl until resolved. Reaction was reported to immunizing pharmacy when other family members stopped in to receive their influenza vaccines.
Pt developed rash morning after IZ administered. Pt has rash to trunk, bil legs & arms. Rash is pruritic. No other symptoms noted. Pt given BENADRYL to help with itching.
This case was reported by a lawyer and described the occurrence of numbness in a female subject of unspecified age who was vaccinated with LYMErix for prophylaxis. A physician or other health care professional has not verified this report.  On an unspecified date the subject received unspecified dose of LYMErix (unknown). An unspecified time after vaccination with LYMErix, the subject experienced numbness, tingling, fatigue, body pain, autoimmune disease, activities of daily living impaired, facial twitching, memory loss, arthralgia, head vibrating, migraine, myalgia, rash, muscle spasm, poor concentration, stiffness, rheumatological symptoms, neurological impairment, cognitive impairment and decreased activity level. At the time of reporting the outcome of the events were unspecified. The information in this case was receiving via a Statement of Injuries. Follow up information was received on 09 April 2007 via medical records. The subject was a female in her twenties at the time of vaccination with LYMErix. On 06 January 2006 radiologic examination of the brain was performed for an indication of "Lyme" and showed mildly decreased cortical perfusion. It was noted that findings were consistent with "Lyme disease, vasculitis, or medication side effects". On 27 March 2006, testing was positive for Lyme (IgM, Western Blot). The subject was evaluated on 25 October 2006 for Lyme disease. According to the subject's report, she had been in good health, and developed a rash in 1998 or 1999. She was told that she was negative for Lyme disease, and was vaccinated with LYMErix. Following vaccination, she developed a stiff neck and spin, numbness, burning, pins and needles, decreased memory and "word search", and body twitching. She had previously received doxycycline, which helped her symptoms. A history of "neurological Lyme, ? (multiple sclerosis), peripheral neuropathy" was noted. Upon evaluation, the subject endorsed fatigue, memory changes, paraesthesia of the hands and toes, myalgias of the neck and back, and arthralgias. Additional complaints included heart palpitations, poor circulation, insomnia, menstrual cramps, urinary frequency, and nocuturia. On 27 November 2006, assessment included Lyme disease, and treatment with Bicillin was initiated. This case was assessed to be medically significant by manufacturer based upon follow up information. The subject complained of heart palpitations, poor circulation, insomnia, menstrual cramps, urinary frequency, and nocturia. In November 2006 she was diagnosed with a urinary tract infection. These were considered to be incidental findings upon medical record review.
The night after getting the HPV his arm started getting swollen and warm. The redness continued to spread through the next couple of days. Went to ER.
generalized burning sensation; paresthesia / abnormal skin sensation; This case was reported by a nurse via call center representative and described the occurrence of burning sensation in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced burning sensation and paresthesia. On an unknown date, the outcome of the burning sensation and paresthesia were unknown.   It was unknown if the reporter considered the burning sensation and paresthesia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that couple of patients experienced generalized ,burning sensation, paresthesia, abnormal skin sensation following Shingrix administration. The reporter consented to follow up. No additional details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244470:same reporter
Chills, muscle aches, headache, and fatigue approximately 12 hours after vaccine was administered. Symptoms lasted for about 12 hours.
dizzyness within minutes. was told by nurse onsite  this was not an adverse reaction. the paperwork they gave stated otherwise. after about 30-40 mins the dizzyness subsided. no treatment.  chest pain. not sure if heart or lungs. was not due to eating as symptom was steadily getting worse across 3 days whether I ate or  not. was difficult to eat due to the pain.  didnt matter if was sitting, standing or laying down. felt like saran wrap around my heart...sqeezing it...with pain. pain  stayed centered in chest. behind sternum. still there, but tonight does seem a little better. was not intermittetent but was more pain sometimes and less pain sometimes.  longterm outcomes unkn.
This spontaneous report was received from nurse practitioner referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. on 21-JUL-2014 patient received improperly stored MMR II [lot # J010993/ exp. date 09/06/2015] exposed to 9.7 degree for 6 hours 20 minutes, subcutaneously (dose not reported). No other concomitant therapies reported. No adverse effects reported. The outcome of the events was unknown. No PQC reported. The case has been linked with the cases 1407USA012136, 1407USA014425, 1407USA014427, 1407USA014428, 1407USA014429, 1407USA014430, 1408USA000005, 1408USA000006, 1408USA000009, 1408USA000012, 1408USA000013, 1408USA000832, 1408USA000838, 1408USA000843, 1408USA000848 and 1408USA000853. Additional information has been requested.
A report has been received from a Health Professional concerning an 8 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on 27-Jan-2014. The patient was administered expired FLUMIST on 27-Jan-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
The pt received the varivax vaccine on 4/13/00. On 5/11/00, the pt developed a fever, hives and an oral vesicle and febrile seizure. The pt was evaluated at ER
very high temp-convuls-breathing stopped resuscitated-spent noc in hosp-shot given 4PM sx began 8PM now has speech/learning disabilities;
On July 30th, I started with rashes and hives.  PA treated with prednisone and antihisatamines. On meds for the next 14 days.
Day after injection tired and exhausted 2 days after injection fatigue 3 days post injection sores in mouth 4 days post injection ulcers in moth, swollen gums and wasn't able to put teeth together
This spontaneous report as received from a physician assistant via company representative refers to a 75 year or older female patient. Medical history and the concomitant medications of the patient were not provided. On an unspecified date, the patient was vaccinated with PNEUMOVAX 23 subcutaneous (lot number and expiry date not reported) (dose regimen, frequency and strength were not reported). Other suspect therapies included ZOSTAVAX (lot number and expiry date not reported) (dose regimen, frequency and strength was not reported). On an unspecified date, the patient experienced an allergic reaction. The patient was taken to the emergency room and sought medical attention. The patient was admitted to the hospital overnight, for observation. It was reported that the event was not an anaphylaxis. The treatment provided to the patient include epinephrine (route of administration unspecified). The outcome of event, allergic reaction was reported as recovered/resolved. Causality assessment between the event and the suspect products was not provided. Additional information has been requested.
Information has been received from a Registered Nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # K009182, expiry date 26-APR-2016, dose and route were unspecified). No adverse effects were reported. Additional information is not expected because there was no consent to contact.
Felt fatigue and tired on the way home. After 33 hours the vaccination, my both elbow swollen and red, hot to the tight. The next day, right inter wrist was swollen. They next it still did not go down. Then left inter wrist swell up as well. No redness around the site. It looked like Covid arm but not at the site.
This spontaneous report as received from a medical assistant also reported as healthcare worker refers to an unspecified group of patients of unknown demographics. Patients' medical histories were not provided. On an unknown date in 2014, the patients were vaccinated with doses of PROQUAD (dose, frequency, route of administration and lot # were not reported) that were exposed to a temperature excursion since 02-NOV-2014 (exact dates not provided) which was unknown to be supported or not supported at that time. Concomitant medication was not reported. The reporting medical assistant was not aware of any adverse effects. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a female nursing home resident with no known drug allergies who was vaccinated on an unspecified date with a second dose of pneumococcal vaccine 23 polyvalent (Lot # not reported).  It is unknown when she received the first dose.  Subsequently the patient experienced an injection site reaction.  The patient's arm was swollen from the shoulder to the elbow, petechiae formed over the entire arm and the area was hot to the touch.  The patient had no fever.  Unspecified medical attention was sought.  Additional information has been requested.
Information has been received from a Physician Assistant concerning a six month old baby (gender unknown).  On 15-MAY-2017 the patient was inadvertently vaccinated with GARDASIL 9, 1 DF, (dose, route and lot# unknown). No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
12 hours after injection, woke up with strong shivering. Did not check fever at the time. When I got up at 7:30 am, I checked my temperature several times and it was 103 degrees. I am no longer shivering.
11 cm x 11 cm area of erythema and edema to left upper arm tender, warm, firm to touch, small vesicle to edge of lesion with serous fluid - no distinct abscess or discharge.
Fever that lasted 24 hours. High temp. was 102 F. One dose of children's ibuprofen.
felt a little tired that evening, and then felt fine.; slept about 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EP6955) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: acid reflux" (unspecified if ongoing), notes: Verbatim: acid reflux; "Verbatim: IBSD", start date: Sep2016 (unspecified if ongoing), notes: Verbatim: IBSD; "some hamburger broke off in his throat in 2009 and caused scar tissue", start date: 2009 (unspecified if ongoing), notes: some hamburger broke off in his throat in 2009 and caused scar tissue; "he can't stand heat" (unspecified if ongoing), notes: he can't stand heat and his food has to be soft and cold, he can't eat warm foods. There were no concomitant medications. Vaccination history included: Flu shot (Prior Vaccinations (within 4 weeks): none he gets regular flu shot, had one Sep2020 and got one yesterday), administration date: Sep2020, for immunization, reaction(s): "every muscle in his body ached"; Flu shot (following prior vaccinations: one time the year they gave swine flu vaccine he got that and next day he had a  slight temperature and every muscle in his body ached. Caller does not have NDC, lot or expiry as it was years and years ago), administration date: Sep2020, for immunization, reaction(s): "slight temperature". The following information was reported: FATIGUE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "felt a little tired that evening, and then felt fine."; SOMNOLENCE (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "slept about 12 hours". The events "felt a little tired that evening, and then felt fine." and "slept about 12 hours" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Patient received his first dose on 17Mar2021 in his left arm around noon and he came home and felt fine until about 8 then got real tired and slept about 12 hours and then was ok.  No follow-up attempts are possible. No further information is expected.
the patient had only 1 dose previously, and it was given on 09Dec2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th December 2021, batch number HM24H).   On an unknown date, the patient did nor received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: the patient had only 1 dose previously, and it was given on 09Dec2021).  The outcome of the inappropriate schedule of vaccine administered was unknown.   Additional Information: GSK receipt date 31 Aug 2023 The pharmacist stated she had a patient walk into the pharmacy yesterday day before reporting asking about getting another Shingrix dose.  As per state records, the patient had only 1 dose previously. At the time of reporting, no additional doses have been administered. The reporter consented to follow up via email.   Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination.
The second dose of Jynneos vaccine was used eight weeks beyond use date; The patient received the second dose of Jynneos on 64 day; Case reference number US-BN-2023-000949 is a spontaneous case report initially received from a health care professional (reference number: USBAV23-0703) on 30-May-2023 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 01-Feb-2023, the patient was vaccinated with the first dose of Jynneos (batch number: FDP00019; expiration date: 31-Oct-2024), at a dose of 0.5 milliliter, subcutaneously, at an unknown site of administration, for smallpox/monkeypox prophylaxis.  On 06-Apr-2023, 64 days after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00019; expiration date: 31-Oct-2024), at a dose of 0.5 milliliter, subcutaneously, at an unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). It was reported that vaccine was used eight weeks beyond use date (explicitly coded as 'expired vaccine used').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 31-May-2023, included local case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the second dose of Jynneos, at a dose of 0.5 milliliter, subcutaneously, at an unknown site of administration (considered as inappropriate schedule of vaccine administered). It was reported that vaccine was used eight weeks beyond use date (considered as expired vaccine used). Expired product administered and inappropriate schedule of product administration are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Expired product administered and inappropriate schedule of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the second dose of Jynneos, at a dose of 0.5 milliliter, subcutaneously, at an unknown site of administration (considered as inappropriate schedule of vaccine administered). It was reported that vaccine was used eight weeks beyond use date (considered as expired vaccine used). Expired product administered and inappropriate schedule of product administration are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Expired product administered and inappropriate schedule of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.
Intense headache, extremely tired was unable to function on day following injection, no energy,  slept all day and don't ever sleep during the day. Foggy feeling, Headache lasted 4 days.
Pain after vaccine lingering and limiting  range of motion for over 2 weeks Patient seen by orthopedic doctor who prescribed Naproxen 375mg BID. MD didn't see orthopedic type injury or  problem of joint in x-rays. Patient was seen also by internist and will have ultrasound to check for tendonitis (scheduled for October)
Pt recvd vax & 10 days later devel a severe rash that itched over entire body & into scalp; treated w/cortisone; pt seen by dermatologist;
13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is second of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018407 same reporter, similar suspect drug and event; different patient
Difficulty breathing and chest pain began Saturday, 2/4, but I waited to see if it would go away. I went to the ER on Monday, 2/6, and was diagnosed with multiple blood clots in both lungs (pulmonary embolism). I was admitted for hospitalization. After they asked me many questions about possible causes, it was suggested I report it as a possible adverse effect from my COVID vaccines. I was prescribed eliquis and oxycodone and was discharged from the hospital.
Peripheral neuropathy. R/O GBS. Also received the smallpox vaccine the same day. He reports he had no adverse events to the smallpox immunization. He describes the classic major reaction and scabbing over of the lesion without problems. He does not recall the date when the scab fell off. He denies symptoms until Sunday 3/16/03 when he experienced an episode of coldness, with teeth chattering that lasted from 6PM to about 4PM the following day. The next day he felt numbness in both legs, numbness in and between the toes and on the bottom of the feet. He also reports significant swelling and pain in the feet, lower abdomen and testicles. He had intermittent episodes of sharp pain felt as an electrical shock down both legs into the feet. These symptoms continued for a week and then he developed a pins and needles feeling in the bottoms of the feet and slightly on the top of each foot. The symptoms worsened as the week progressed and by day seven 3/19/03 he was barely able to walk and could not wear his boots due to swelling of the feet. He was in port and stayed in his stateroom for 10 days to rest. he was first seen for medical evaluation on 3/28/03 by an MD where labs and foot x-rays were done and he was diagnosed with gout. He was sent home; he could not perform his duties due to pain and inability to ambulate. He arrived home on 3/31/03. Patient was evaluated on 4/1/03 and admitted to hospital for the above symptoms and feeling of fullness in the back of the throat. He also presented with uvular edema and had a 3 day course of IV decadron after which the throat symptoms resolved. He underwent numerous diagnostic tests outlined below. Of note is a significant, unexplained increase in LFT's during his hospitalization, which spontaneously returned to normal within a few days. On 4/14/03 he was transferred to another hospital. He continued this diagnostic work up and was discharged home on 4/19/03. The follow up received on 11/4/03 states pt has not improved and he has developed other medical problems in the last 6 months including unidentified pneumonia with fevers to 105 deg and 2 pulmonary emboli. He is now on continuous O2 and Coumadin therapy. He still is unable to walk without assistance, has swollen ankles, and describes chest pain, palpitations, bloating, generalized arthralgias, weight loss, headaches, insomnia, depression and pain and numbness in lower extremities. Last neurological evaluation on 9/25/03 states "pt represents an unfortunate and complicated clinical picture. He represents an acquired demyelinating axonal neuropathy. If he does not have spontaneous remission, the prognosis remains very guarded. More likely than not, he will have life-long disability even with significant recovery." Diagnosis: Sensory motor polyneuropathy, most likely toxic in nature "more likely than not, this represents a autoimmune reaction to vaccination." Comprehensive medical workup is pending. Litigation is pending.
Breakthrough Cases-I had just returned from a trip On Tuesday I started having symptoms. I did a home test on Tuesday morning which was positive. Symptoms were headache, cough, and a little congestion. I called my doctor and he prescribed Pavlovic. I was also taking Zinc, Vitamin D2, Vitamin C and I also took a Corisitan HBP for congestions. The doctor also recommended I sleep on my side and get up walk around. I retested yesterday and it is still showing as a faint positive. I feel like I completely recovered but I am still quarantine which I will remain until I am negative.  I was advised to monitor my temperature and pulse levels. I never had a fever, and my oxygen level was never below 95%.