chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient described Rash and itching approximately 2.5 hr after she received the pfizer covid -19 vaccine first dose. She received 1 dose of Diphenhydramine 25mg po. Few minutes later she complained difficulty sallowing and given Epinephrine 0.3mg IM and EMT was called in. She was transported to ER by EMTs
sore arm; pounding headache/throbbing headache/woke up with a horrible headache/ it was extremely painful; hand was shaking so badly, it was like I had Parkinson; it was trembling so bad; stiff neck and shoulder muscle/shoulder and neck was still very stiff and sore; my shoulder and neck was still very stiff and sore; my shoulder and neck was still very stiff and sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EN6199) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Patient on very low dose blood pressure pill; "brain aneurysm" (unspecified if ongoing); "Parkinson's" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; HEADACHE (non-serious), outcome "not recovered", described as "pounding headache/throbbing headache/woke up with a horrible headache/ it was extremely painful"; TREMOR (non-serious), outcome "unknown", described as "hand was shaking so badly, it was like I had Parkinson; it was trembling so bad"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered", described as "stiff neck and shoulder muscle/shoulder and neck was still very stiff and sore"; NECK PAIN (non-serious), ARTHRALGIA (non-serious), outcome "not recovered" and all described as "my shoulder and neck was still very stiff and sore". Therapeutic measures were taken as a result of pain in extremity, headache, musculoskeletal stiffness, neck pain, arthralgia. Additional information: Consumer stated that, she had a sore arm and a stiff neck and shoulder muscle but the worst thing she had was at 03:00 in the morning, she woke up with a horrible headache, throbbing headache and exactly it was as bad as when she had a ruptured brain aneurysm, it was extremely painful. So, she got up to take a Tylenol and was trying to pour a Tylenol into her hand, her hand was shaking so badly that was holding a bottle, it was like she had Parkinson and the pill end up going all over the floor because it was shaking, trembling so bad. Caller was worried about receiving the second dose due to her reaction to the first dose. Caller was thinking of taking Johnson and Johnson as her second shot instead of the Pfizer. Caller stated that, she took Tylenol and then in the morning when she got up, her shoulder and neck was still very stiff and sore, so she took some Ibuprofen in the morning.  No follow-up attempts are possible. No further information is expected.
after Covid vaccination, patient start complains of tingling in the mouth. no lip numbness, no angioedema. denies CP/SOB But states, heart racing. vital sign-BP at 1555 186/98 HR 92. patient alert x 4. They told to patient if you walk you don't have to pay but if you will go by ambulances you have to pay. I told to EMS she will go by ambulances but EMS convinced her to walk. patient agreed with EMS advised and sign AMA for EMS. she declined company with nurse to go to the ER and patient walked to the E herself with stable condition. Relief nurse called for report to ER nurse.  speaking full sentences. Benadryl 50 mg PO given and continue monitored. Recheck BP 192/100,HR 88. patent still complaining tingling in the mouth and gasping air as per patient. Continue monitoring. no acute distress noted. called EMS to take patient in the ER for further evaluation. EMS checked on her and said everything is ok. EMS asked to patient do you wanna walk to the ER or by ambulances?
Patient developed large rash around injection site following day. Warm to touch, mild edema. Treated for cellulitis.
Initial misuse report received from a healthcare professional on 05 July 2013. A 19-year-old patient was administered a dose of MENACTRA vaccine that had expired in May 2013. No adverse event was reported. Documents held by sender: none.
Day of shot Left arm was sore  after few hours  Suddenly felt chills  Around 930 pm and muscle ache then joint pain by 1030 pm  Feverish but no fever Felt so weak by 11 pm  Next day  Woke up with joint pain and muscle pain slowly went away after advil came back around 7 pm then took advil by 8 pm  all pain disappeared
Client came into office to have tst read.  Client state she just noticed localized reaction of approsimately 4"x3" redness and swelling on backside of left arm.  Advised cool compress, ibuprofen for pain and swelling and to contact the pcp if signs and symptoms persist or worsen.
Minimal Change Disease; swelling; This case was reported by a consumer via call center representative and described the occurrence of minimal change disease in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number XC972, expiry date 29th August 2021) for prophylaxis.   On 16th February 2019, the patient received Shingrix. On 18th February 2019, 2 days after receiving Shingrix, the patient experienced minimal change disease (serious criteria hospitalization and GSK medically significant) and swelling (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the minimal change disease was not recovered/not resolved and the outcome of the swelling was unknown.   It was unknown if the reporter considered the minimal change disease and swelling to be related to Shingrix.  Additional details were provided as follows: The patient was very healthy and active prior to receiving Shingrix. Around 18th February 2019 to 20th February 2019 after receiving shingrix vaccine, the patient suddenly experienced swelling all over body. On 1st march 2019, 13 days after shingrix vaccine, kidney biopsy was performed and minimal change disease was diagnosed. The patient had been treated with high doses of steroids but 12 weeks after initiating treatment, the symptoms had not improved at all.  Steroids were usually very effective in treating this condition, so his physician was trying to find a new treatment protocol.
Diffuse upper arm redness, swelling, hive like reaction, with warmth and pain
nausea; vomiting; low grade temperature; This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for 2 patients. This is the 2nd of 2 reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history and concomitant medications were not reported. Two days after vaccination the patient experienced nausea, vomiting and low grade temperature. The outcome of the reported 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-2020139308 same reporter/drug/event, different patient
Chief Complaint Patient presents with ? STROKE     Patient arrives via EMS from home, and woke up to left sided weakness, facial droop and slurred speech. last known well 2300 last night. POC 131. Per EMS patient was given baby ASA from family at home.     HPI 82-year-old female with medical history significant for breast cancer in 90 and 15, lung cancer in 15, ovarian cancer in 88, HTN, DM type II, nephrolithiasis; presents the ED via EMS from home with left-sided weakness and facial droop.  Patient last known well is 2300 on 1/26/2022.  Patient states she woke up this morning and was unable to move her left side.     Review of Systems  Constitutional: Denies fever or chills Head: Denies trauma ENT:      Eyes: Denies visual changes      Ears: Denies hearing loss      Nose: Denies rhinorrhea or congestion Throat: Denies sore throat, hoarseness, or swollen neck Respiratory: Denies cough or shortness of breath Cardiovascular: Denies chest pain, palpitations, or LE edema Gastrointestinal: Denies nausea, vomiting, diarrhea, or abdominal pain Genitourinary: Denies dysuria or urinary frequency changes Musculoskeletal: Denies malaise, myalgia, or pain Neurological: Denies Headache.  Admits to left-sided paralysis Skin: Denies rashes
first dose got only the sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (first dose got only the sore arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088021A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (first dose got only the sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (first dose got only the sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported by the reporter.   This case was linked to MOD-2021-419682 (Patient Link).
Patient was brought to urgent care at 1545 on 10/26/18 with swelling around his eyes. While the patient was in the check in process, he also developed swelling of the upper lip. After treatment, patient began to show signs of resolution of edema within 25 minutes of Benadryl administration.
5 minutes after receiving her first dose of Pfizer COVID19 vaccination, the patient reported feeling that her heart was pounding. She checked her Fitbit watch and her heart rate was in the 110s-120sh. She also reported having mild chest pressure. Denies any lightheadedness or any other symptoms. She does have a history of anxiety/panic attacks. She reports that her symptoms are similar to previous panic attacks.
Information has been received from a physician concerning unvaccinated 11 month old female twin who's family member was vaccinated with a dose of varicella virus vaccine live and subsequently developed a rash (WAES0506USA00565). In April 2005, the patient developed chickenpox. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. The physician also reported a case of chickenpox in the patient's unvaccinated twin sister (WAES0506USA00565).
This is a spontaneous report from a contactable consumer. A patient of unspecified age ethnicity and gender received PREVNAR 13 (expiration date: Oct2018), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The reporter said not to take prescription due to history of folks we know who took it and had permanent muscle soreness. The outcome of the event was unknown.
hot and cold; very ill; felt horrible; Clammy; feeling odd, kind of wonky, woozy; Diarrhea; Fall; pretty badly bruised / bruise has gone above her knee to her ankle; Weak and could not get out of bed; Sleeping a lot; Dizziness; Headache; Chills; Vomiting; Queasy; This is a spontaneous report from a contactable consumer reporting for herself.  A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Mar2021 11:05 (Batch/Lot Number: EP7534; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation  .  Medical history included hypersensitivity , immune system disorder , respiratory disorder , cytogenetic abnormality  , endocrine disorder Endocrine abnormalities , diabetes mellitus , obesity  , anxiety, hypersensitivity. Concomitant medication(s) included alprazolam (XANAX) at 5 mg daily, taken for anxiety, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) at 60 mg daily taken for anxiety, start and stop date were not reported.  The patient experienced fall  on 05Apr2021 with outcome of recovered with sequelae , pretty badly bruised / bruise has gone above her knee to her ankle  on 05Apr2021 with outcome of unknown , headache on 16Mar2021 with outcome of recovering , chills on 16Mar2021 with outcome of not recovered , vomiting on 16Mar2021 with outcome of recovering , queasy  on 16Mar2021 with outcome of not recovered , diarrhea on an unspecified date with outcome of recovering , weak and could not get out of bed  on 17Mar2021 with outcome of recovering , dizziness  on 16Mar2021 with outcome of not recovered , sleeping a lot  on 17Mar2021 with outcome of not recovered , hot and cold  on an unspecified date with outcome of unknown , very ill  on an unspecified date with outcome of unknown , felt horrible  on an unspecified date with outcome of unknown , clammy  on an unspecified date with outcome of unknown , feeling odd, kind of wonky, woozy  on an unspecified date with outcome of unknown.  The events fall and contusion were considered Important Medical Events. The remaining events were non serious.  No follow-up attempts are possible. No further information is expected.
Patient stated he started to feel itchy about 7 minutes after shot was administered. Stated his neck and upper arms felt itchy. Patient was given 25 mg oral Benadryl, observed for 23 additional minutes, and left the pharmacy feeling well. No visible redness was observed by responding RPh
After my vaccine, I had a severe burning sensation throughout my body, similar feeling after I would have any substance that has casein protein in it due to sensitivity. My right kidney was in severe pain, so I went to the emergency room. I couldn't sit up or walk. I would lose my train of thought and had delayed speech. I couldn't think or speak properly. I was extremely fatigue, had body chills and sweats and a fever. They gave me the COVID-19 antibodies. They gave me fluids to help as I was dehydrated. They only tested me for COVID-19 on 10/13/2021 and I got my results for COVID-19 on 10/15/2021 for positive for the virus. I was discharged the same day and sent home to rest
This spontaneous report received from a company representative 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-JUN-2021, the the died from unknown cause of death. The father suspected that the death might be related to the Janssen Covid-19 vaccine. An autopsy was planned to be performed.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20210637036- covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient arrived at pharmacy on 11/7 to report adverse event starting on 11/4/23. The itching started on her right arm a few hours after administration. She had swelling in her lips and her chest became tight. She went to urgent care.
Information has been received from a physician via a field employee referring to a male patient of unknown age. Information about medical history, concurrent condition and concomitant medication was unknown. On 30-JAN-2019 the patient was vaccinated with M-M-R II (dose, frequency, route and lot# unspecified) for prophylaxis, which was reconstituted by sterile diluent injection (lot# and expiration date unspecified). On an unknown date in 2019 the patient developed a rash. No treatment was given for the event. The outcome of rash and the causality were unknown.
Started feeling  weird 1 hour later. Felt like I was getting sick. Thought it was because I needed to eat. Started getting a really bad headache. Around 2 to 3pm had this weird feeling going through my body. As the vaccine was doing something, then my tongue felt numb. I stopped eating. I couldn't  eat anymore. I felt sick and nauseous. Needed to lay down. I was scared to fall asleep because of my tongue. Still felt bad that evening. Went to work the next day. I felt bad in the morning. I tried to stay. I could not. I just felt bad as though I was sick. Still felt nauseous, headache, my body was aching.and fatigued
This case was reported in a literature article and described the occurrence of anti-neutrophil cytoplasmic antibody positive vasculitis in a 75-year-old female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). The subject's medical history included chronic obstructive pulmonary disease. In August 2012, the subject received unspecified dose of Influenza vaccine (unspecified) (unknown route, site of injection and batch number). 4 weeks after vaccination with Influenza vaccine (unspecified), the subject developed progressive fatigue and was found to have an elevated serum creatinine. She also complained of epistaxis, nasal crusting, poor appetite and nausea. She underwent esophagogastroduodenoscopy which revealed duodenitis and was placed on omeprazole. Her nausea improved, but she continued with poor appetite and lost 17 pounds. In January 2013, 5 months after vaccination with Influenza vaccine (unspecified), the subject was evaluated for acute kidney injury. Her urinalysis revealed proteinuria and hematuria with red blood cell casts. Her serologies revealed a positive perinuclear ANCA. Her physical exam was remarkable for conjunctival pallor. Examination of the rest of the systems was unremarkable. Renal biopsy was performed and revealed necrotizing and crescentic pauci-immune glomerulonephritis. The subject was diagnosed as having ANCA associated vasculitis (AAV) (p/myeloperoxidase type). This case was assessed as medically serious by GSK. The subject was treated with hemodialysis, Methylprednisone, prednisone, cyclophosphamide and Plasmapheresis. After three months of therapy, the subject was still dialysis dependent. At the time of reporting, the subject was in a end-stage renal disease. The temporal association of AAV to influenza vaccination suggests that the vaccine might serve as a trigger for development of AAV in predisposed individuals.
headaches with dizziness; headaches with dizziness; felt feverish; itchiness we're I got my 2nd shot; Diarrhea; stomachache; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 (Age at vaccination: 16 years) via an unspecified route of administration, administered in Arm Right on 03Jun2021 12:00 (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included allergy of big amounts of biotin. The patient concomitant medications was not reported. Historical vaccination included previously the patient received bnt162b2 (BNT162B2), dose 1 (Age at vaccination (years): 16) via an unspecified route of administration, administered in Arm Right on 13May2021 12:30 PM (Batch/Lot Number: EW0179 and Expiry date:Unknown) as 1st DOSE, SINGLE for Covid-19 immunization. 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 has not been tested for COVID-19. On 04Jun2021, after second dose, first day diarrhea and stomachache. On 05Jun2021 (2nd day) she felt feverish but was not too bad and also itchiness where she got her 2nd shot. On 06Jun2021,(on the 3-4 day) the patient had headaches with dizziness .The patient did not received treatment for the events. The outcome of the events was resolved on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Moderna Covid-19 Vaccine EUA March 4 sore upper arm, March 5 flu like muscle aches, March 6 very tired, March 7 very tired second half of the day, March 8 itchy warm rash upper arm applied hydrocortisone as instructed on Moderna info site ,needed to apply for 5 days until resolved.
Patient presented to Facility after about 2 weeks of DOE (worsening). Patient reports yellowing of skin and eyes over this time period. Patient saw PCP March 2021 with normal CBC at that time. Patient diagnosed with Coomb's positive immune mediated warm Auto Immune Hemolytic Anemia (AIHA). Infectious disease consult: Recent COVID vaccine administration PTA. Suspect that AIHA is more likely driven by malignancy than acute infectious process vs. reactivation, but w/o EBV PCR at time of serology, difficult to say. PATIENT'S VACCINE INFORMATION UNKNOWN; NOT RECORDED ON DATABASE
This case was reported by a physician via a sales representative and described the occurrence of cellulitis in a 34-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccines (multiple other childhood vaccines - manufacturer unspecified) given on the same date as INFANRIX. On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml in an unknown thigh. Within a couple of days of vaccination with INFANRIX, the subject experienced cellulitis. Signs included injection site redness, hot (injection site hot to touch) and swelling. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with KEFLEX. The subject resolved on therapy. Product complaint was noted. The site claimed good aseptic technique was followed and there was no change in the appearance of the vaccine administered. It was reported that cellulitis was probably related to treatment with INFANRIX. A note was made that other childhood vaccines were given at the same time, but infections have occurred only at either INFANRIX or KINRIX injection sites or that leg affected. Four subjects received INFANRIX from lot number AC14B126AA with expiration date 03 March 2013 and one subject each received KINRIX from lot number AC20B168AA with expiration date 02 December 2012 and lot number AC20B164BA with expiration 13 October 2012 (six subjects affected in total ranging in age from 15 months to 8 years). Additionally, no other subjects have received these vaccines from these lots and "not" had cellulitis with the exception of three subjects the site is still trying to locate.