chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via unspecified route of administration in the left arm on 26Mar2021 at 13:11 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medication within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 13:28, 17 minutes after shot received, the patient experienced very slight lips swell (both top and bottom), not visible but felt to the patient; slight throat swell on left side, not visible, but felt to the patient and chest a little heavy/slight air restriction, not much, like when the oxygen is reduced in the room when too much bleach is used and a window needs to be opened. No therapeutic measures were taken as a result of the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lip swelling, pharyngeal swelling and chest discomfort were recovered on 26Mar2021 at 14:08.   No follow-up attempts are needed. No further information is expected.
Above vac. given 8:00 am 9/1/21 then realized vac. expired 8/31/21. Reported to Moderna awaiting further instruction.
Welts all over body / Urticaria; Flucelvax given on 10Oct2021; Flucelvax given on 10Oct2021; The initial safety information received was reporting only non-serious adverse drug reaction. Upon receipt of follow-up information on 26Oct2021, this case now contains a serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (the patient) and nurse. A 12-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm on 10Oct2021 12:00 (Lot Number: FC3182, at the age of 12-years-old) as dose 1, single for COVID-19 immunization; influenza vaccine inact sag 3v (FLUCELVAX), via an unspecified route of administration in the left arm on 10Oct2021 (Lot number was not reported), as dose 1, single for immunization. Medical history included: ongoing egg allergy. The patient did not have COVID prior to vaccination. Family medical history included her dad had hives with first COVID injection/ vaccine. There were no concomitant medications. On 11Oct2021 08:00 (also reported as 11:00), the patient experienced welts all over body, also reported as urticaria. Treatment included dexamethasone acetate (DECADRON) intramuscular (IM) injection 1 mg, diphenhydramine 50 mg oral. Treatment also included diphenhydramine hydrochloride (BENADRYL), prednisone, and famotidine. The clinical course was as follows: hives started 11Oct2021 morning, seen at urgent care 11Oct2021, given DECADRON IM, prednisone, BENADRYL. Seen at primary care physician office on 12Oct2021, still had hives. Added famotidine to the regimen (H2 blocker). A nurse reported the patient provided information regarding the reported adverse event. The nurse considered BNT162B2 to have a casual effect to the adverse event. The outcome of urticaria was recovering. The patient was not tested for COVID post-vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided and known safety profile, a causal association between BNT162B2 and the reported hives cannot be completely excluded. The impact of this report on 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 RAs, Ethics Committees, and Investigators, as appropriate.
pt to hospital with increasing SOB and CP; somnolent; required intubation; morbidly obese; COVID positive, sepsis, shock, ARDS; ABX; vasopressors; pt's condition declined and she passed away in the hospital
Fever, Rash - Information has been received from a health professional concerning a 12 month old male with who was born primaturely, who on 22 Jan 2001, was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation 0.5 mg sc in the right arm lot # 633822/1168k and the first dose of varicella virus vaccine live lot # 636357/0532k 0.5 ml sc in the left arm.  On 22 jan 2001.  the patient was also vaccinated with the fourth dose of hib conjugate vaccine o.5 ml im in the rights thigh lot 58133a.  On 02 feb 2001, the patient was seen secondary to red rash that was present for one day.  The rash started on abdomen, spread to chest, diaper area, back, up & down extremitives, face, and neck.  The patient's palms and soles were spared.  The rash consisted of small discrete red papules, without vesicles or pustules.  On threee days prior to devlopment of rash on 30 Jan 2001, the patient  developed a fever for 3 days.  subsequently, the patient recovered.  Additional information has been requested.
Patient received vaccination and was monitored for adverse events after approximately 20 minutes patient presented with tingling in lips, tightness in throat and wheezing.  Patient self administered 25 mg diphenhydramine orally and was given Dexamethasone 4mg IM left deltoid as per standing orders and onsite provider orders.
Kidneys problems; This is a spontaneous report from a contactable consumer. This contactable consumer reported for her grandmother. A 101-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Feb2021 (At the age of 101-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced kidneys problems. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Information has been received from a licensed practical nurse concerning an 8 year old male with no known drug allergies and a history of "normal childhood illnesses" who on 11/22/1996 was vaccinated with a dose of varicella vaccine SC. There were no concomitant medications. After exposure to another child with chicken pox, the pt developed a case of typical chicken pox lesions on trunk and extremities estimated to be 100-200 lesions. The physician documented questionable vaccine failure. The pt was instructed to continue symptomatic treatment. The pt sought unspecified medical attention. Additional info has been requested.
A Fib - My Apple watch started going off. It lasted for four or five hours. I went to a primary care physician at my clinic. He recommended me to the cardiologist and she started me on cholesterol medication - Repatha - an injectable that is not a statin. I have had three shots and I seem to be tolerating it. And Eliquis - a blood thinner. My weight loss regimen.
NP @ clinic reports child presented with circular hives and severe itching that started during nite of vaccine and got worse-txd with PREDNISONE on 11/5/09.
Client became clammy and pale. States that she felt "weird" after her shots. Denies headaches, blurred vision but stomach ache per she states that she did not eat today and has been here since 7 am. Ice pack given, snacks. VS complete. Resolved s/s at discharge.
mom states that got shots around 1015AM on 16FEB93 & cried ever since x/for falling asleep for about 1 hr in the car; lt thigh was swollen from the knee to hip mom took pt to MD; MD felt was allerg react & pt had ear infect;
Fever (101.1 highest) , Head congestion and scratchy throat, chills, body aches, fatigue, diarrhea, and nausea. Arm site had red patch with knot as well as  pain and itching.  Took Theraflu as well as Acetaminophen. Symptoms lasted approximately 48 hours  except arm which lasted more like 72 hours.
I have Covid arm. My arm hurts. My arm is swollen, red,  and itchy and is raised. It is the size of an orange or maybe a little bigger. Yesterday I felt like I was ran over by a car. I can upload a picture if you need to see it.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. In June 2018, several days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported via webform. The age at vaccination was not reported. The age group was not provided, but was captured adult as per vaccine indication. The reporter stated that, they had a patient with a confirmed case (documented case) of shingles several days after SHINGRIX administration (in the buttocks, not injection site) back in June 2018. The case has resolved and the patient was requesting her second dose of SHINGRIX. The reporter was asking, did the GlaxoSmithKline (GSK) have a recommendation on such a scenario. The reporter had seen in the studies, most patients did receive the second dose but she wanted to confirm. This case was already reported to VAERS. No additional information was provided. This case has been linked to the US2018GSK153079, reported by the same reporter.
Stomach pain presented on 3/30/21, and I was diagnosed with appendicitis on 3/31/21 and had immediate surgery to remove my ruptured appendix. After two days in hospital, I was released to go home, and I am recovering well.
After getting the Vaccine he fell down when he was in the store, with his father and so the father brought him back to the pharmacy and he had hit his back of head during the fall.  And because of this he was little pale in color and he had no local reaction to the vaccine on his arm and he was communicating with us. we did call the ems services and they took him  to the ambulance and per father he was let go after some time in the ambulance once he felt better.
I had swelling that started in my ankle and foot on the left side. I had an orthopedic appointment and mentioned the swelling to my doctor and they said it could be from the knee because I was going to have knee surgery because of two tears I have in my meniscus. On July 13th I was scheduled to have my knee surgery. So I went in for the surgery and my ankle and foot were swollen a lot more so the doctors didn't do the knee surgery. They sent me to vascular doctor and they found no blood clot. I went to another vascular doctor and they confirmed I had no blood clot. I had pain in both legs at the time. The vascular doctor though it could have been the cholesterol medication I had started, and told me to stop taking it so I did. After several weeks the swelling didn't go away so the doctor didn't think the medication started the swelling. I went back to taking the cholesterol medication, and I was put on prednisone. After that the swelling had went down but when I stopped the prednisone medication the swelling came back. I was out of work for one week because of the swelling. It didn't make a difference though because i was still experiencing the swelling. My left wrist is swollen now too, and the swelling is not going away in my wrist either. When the doctors did the x-ray and bloodwork they didn't find anything.
The issues I had with my sinus worsened. I tired Sudafed aspirin, inhaler, fluticasone, propionate, 2x cough medicines, pain medication, prednisone, and several antibiotics, nothing worked. ENT said I was a long hauler.
Severe swelling, pain involving arm from shoulder to elbow fever, myalgia, malaise.
A report was received from a healthcare professional on 3/14/2006, regarding a 67 year old female vaccinee. No details were provided regarding the vaccines medical history or concomitant medication. On 11/17/2005 the vaccinee received a 0.5 ml Fluvirin vaccination in the deltoid. On 11/25/2005, 2 weeks of receiving the flu shot the vaccinee visited her doctor with symptoms of positive body aches, headache and swelling in right let. The symptoms had started after vaccination and the vaccinee self medicated with Advil for the pain. A diagnosis of acute rheumatoid arthritis was made. The vaccinee had no incidence of arthritis before the vaccination. The vaccinee had lab work performed (details not provided). The vaccinee has been prescribed prednisone and referred to a rheumatologist. The vaccinees arthritis is ongoing of the times of report.
Pt. came in 10 days after receiving the vaccine and complained of severe arm and shoulder pain.  He has been putting ice on it, which has seemed to help.  We checked in with him at day 12, and he said the pain was improved, but still present.  He mentioned that it seemed to be worse after a period of inactivity.
Information has been received from a physician concerning a 23 week old male, with no significant medical history, who, on 16-Jun-2006 was vaccinated with an oral, 2.0 ml, first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot#653661/0146F).  Concomitant vaccination administered on 16-Jun-2006 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of Hib conj vaccine (tetanus toxoid) (ACTHIB), and a dose if hepatitis B virus vaccine rHBsAg (yeast).  On 14-Jul-2006 the patient was vaccinated with a second 2.0 ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  There were no concomitant vaccinations given on 14-Jul-2006.  In July 2006 the patient was noted to have fallen out of a shopping cart.  On 02-Aug-2006 the patient developed a fever.  The patient was taken to the emergency room where an x-ray and labs (not further specified) were normal.  No formal diagnosis was made and the patient was simply thought to have a virus.  On 17-Aug-2006 the patient was vaccinated with a third 2.0 ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  Concomitant vaccinations administered on 17-Aug-2006 included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of Hib conj vaccine (tetanus toxoid) (ACTHIB), a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) and a dose of poliovirus vaccine inactivated (IPOL).  On 28-Sep-2006 the patient developed vomiting and irritability.  The patient was subsequently hospitalized due to persistent vomiting.  While hospitalized intussusception was diagnosed and reduced via Barium enema.  The patient recovered within 24 hours and was discharged to home.  At the time of the report the patient was noted to be doing fine by the physician.  The physician indicated that he would provide additional information, including medical records if it became available.  No product quality complaint was involved. No other information was  provided.  Additional information has been requested.
nausea; vomit; fatigue; This is a spontaneous case received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she experienced side effects 5 days after the administration of the second dose of the Pfizer's COVID-19 vaccine, she started with nausea and vomit for 24 hours and fatigue for several days. It was reported that now she feels fine. The outcome of events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was severely sick 24 hours after receiving FLUVIRIN and PNEUMOVAX. Symptoms included excessive sweating, weakness, headache, pt almost required a hospital visit, it resolved 3 days later.
Fever 100; cough; fatigue; This is a spontaneous report from a contactable Nurse (patient). A 33-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right arm on 20Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included Hashimotos, PCOS, hyperlipidemia. Concomitant medication the patient received within 2 weeks of vaccination included levothyroxine sodium (LEVOTHYROXIN), neomycin hydrochloride;polymyxin b sulfate (neomycin and polymyxin b sulfates otic solution).  The patient previously took ciprofloxacin hydrochloride (CIPRO) and experienced drug allergy. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever 100, cough, fatigue, all on 22Dec2020 13:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included pyrexia: fever 100. AE resulted in: None of the above. It was unknown if treatment received for the adverse event. Serious (NO). Seriousness criteria-Results in death (NO). Seriousness criteria-Life threatening (NO). Seriousness criteria-Caused/prolonged hospitalization (NO). Seriousness criteria-Disabling/Incapacitating (NO). Seriousness criteria-Congenital anomaly/birth defect (NO).
Covid arm; arm was a little sore; arm is swollen; arm is red; arm is itchy; A spontaneous  report was received from a consumer  regarding  a female patient who had Injection site rash , Peripheral swelling , Erythema , Pruritus , Pain in extremity .  The patient's medical history is not mentioned .   Concomitant product use was not provided .  The patient received their 1st dose of mRNA-1273 on  (date unknown ) , unknown batch number and  2 nd dose  was taken on  25/Feb/2021 batch no unknown  for prophylaxis of COVID-19 infection.  Caller states she is reporting having Covid arm, her arm is swollen, red, and itchy. It seems to be going away but still itchy.  She received her first dose and her arm was a little sore.   These effects are with her second shot she received on 25feb2021 and symptoms started on 26feb2021.  Treatment given was unknown .  He gave her consent for follow up .  Lab parameters were not provided .   No other reactions reported.   Action taken with mRNA-1273 in response to the event was not provided.
Information has been received from a consumer who reported that her 25 year old daughter was vaccinated with her first dose of GARDASIL in August 2010 (lot number not reported). Concomitant medication included "YAZMINE." It was reported that one day after receiving the vaccine her daughter experienced "severe stomach and intestinal pain and within one week, she experienced ulcerative colitis and was bleeding." It was reported that a colonoscopy and biopsy were performed (date and results not reported). The mother reported that her daughter experienced "pain and misery." Her daughter was seen by a gastroenterologist and had "her colon removed on 14-NOV-2011." The mother reported that her daughter got worse until the colon was removed. The mother reported that her daughter spent twelve days in the hospital. At the time of this report the patient was recovering and additional doses of GARDASIL will not be reintroduced. Additional information has been requested.
Shivering, fever, injection site tenderness, malaise, diffuse shingle-like rash (arms, neck, trunk) with burning, puritis, and stinging.  The rash began on the third day after vaccine administration and has continued thru day 10.
Patient went into rapid afib at around 8 pm (6 hours after vaccination) Rate up to 180-190.  Became hypotensive with BP as low as 76/56.  Went to ER.  Hospitalized overnight for observation
Headache; Sore neck; Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced headache, neck pain and pain in arm. On an unknown date, the outcome of the headache, neck pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the headache, neck pain and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-Aug-2022 Reporter's Comments: This case was reported by patient's wife via interactive digital media. The reporter stated that the patient received the 2nd Shingrix shot on Friday and was still had headache, sore neck and sore arm. The reporter wanted to know if this was common. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
just tired nothing at all; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (just tired nothing at all) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (just tired nothing at all). At the time of the report, FATIGUE (just tired nothing at all) outcome was unknown.            On unknown date, before the first dose, mammogram was performed on patient with abnormal results showing small mass on her left arm.  No Relevant concomitant medications was reported.  Treatment information was not provided.
Administration without previous shaking; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate reconstitution technique (Verbatim: Administration without previous shaking). The outcome of the inappropriate reconstitution technique was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Mar-2023 The health care professional called in to ask for information about the reconstitution of Boostrix prior to administration. The reporter asked if they had information about the safety/efficacy of Boostrix if it was administered without previous shaking as mentioned in the package insert. The adverse event filed as conservative since the reporter was not sure that the vaccine was administered without the proper reconstitution. The follow-up could not be possible as no contact details were available. The patient received a dose of Boostrix without proper reconstitution, which led to inappropriate reconstitution technique.
Patient awoke the next morning reporting limited hearing in left ear.  Patient's wife described a feeling similar to trapped water, but patient had not been swimming or doing anything that would explain the loss of hearing ability. Patient was advised to be examined by a medical provider as soon as possible.