chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in today to report that her flu vaccine was administered too high. She said it didn't hurt at first, however that evening her shoulder progressed to swell and over night the swelling spread up the side of her left neck. She said she could not move her for the first 2 days, but range of motion has progressively come back. She iced it and took tylenol. She did not go in to the provider over the weekend, but waited until Monday and had her shoulder looked at by her PA. At this time, it is still a bit sore, but much better. She just wanted to let us know.
Swelling in left deltoid area. Slight redness and warm to touch. Ice applied, ibuprofen and BENADRYL given PO.
This is a spontaneous report from contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for 3 patients. This is 1st of 3 reports. A patient of unspecified age and gender started received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness, swollen and feels warm at the injection site on an unspecified date after pneumococcal 13-val conjugate vaccine (dipht crm197 protein) administration. The events were non serious and the outcome was recovered. The information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018424203 same reporter, event, drug for different patients. US-PFIZER INC-2018424204 same reporter, event, drug for different patients.
Pt complained of pain and soreness to right upper arm.  Small blister noted, area reddened and firm.
Received immunizations at 10:15 am. 10:20 am:  passed out and fell out of chair in waiting room -alert after about 10 seconds - recumbent B/P=130/72;P=72; alert and oriented x3, pale, diaphoretic.  10:30 am:  sitting B/P=120/80; P=84;; color pink.  10:35 am: sitting B/P=110/70;P=84; pink color. 10:40am: dizzy while sitting; recumbent B/P=120/74; P=72 - Mom gave soft drink and candy bar.  10:50 am: B/P=  102/78; P=72. 11:05am: B/P=102/70; P=74; pink in color;  alert and oriented x3;PEERLA; superficial abrasion of right cheek;  11:10am: discharged home with Mom.  To return to Private MD if problems or ER if needed.
Eye floaters; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (Eye floaters) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Eye floaters.    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 VITREOUS FLOATERS (Eye floaters). At the time of the report, VITREOUS FLOATERS (Eye floaters) was resolving.            No treatment medications were reported. No concomitant medications were reported. Patient may be looked after with eye drop or something better.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Additional document attched On 23-Jun-2021: Received additional information
pt recv vax 10JUN97 & 19JUN97 mom calls states pt devel inc temp 103 1wk p/vax;19JUN t101 p/APAP;very fussy;fine prickly heat like rash on abd & legs;not eating, soft stool x 2;vomit x 1;
12 minutes after immunizations while she was with her mother in the front waiting room she became dizzy and lost consciousness bumping her right cheek on the rounded edge of a wooden coffee table. She remained semi-responsive for 30 seconds or so. Ultimately became conversant and relatively oriented though she had difficulty remembering what day it was and initially what month it was. Ice pack was applied to her right cheek. There was a tiny point of bleeding and swelling. Malar bones appeared normal. She was observed in the office for almost 2 hours but became somewhat dizzy and nauseous when she sat up. The patient admitted part of her discomfort was emotional. We did ultimately take her to the emergency room in a wheelchair. She seemed to be improving actually at that point.
SIRVA (SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION); CURRENTLY GETTING MRI DONE AND POSSIBLY LOOKING AT THERAPY; PENDING OUTCOMES/RESULTS
This spontaneous report as received from a medical assistant refers to a 9 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009323:Original Case : 1902USA009323.
After the vaccine I had bad pain in my arm. That weekend I start developing a cough it took me about three weeks to get over. I never had a fever just a bad cough. I was told I had bronchitis.
The morning after receiving the injection, the injection site was red, slightly swollen, warm to touch and sore.  During the day, the site became more sore and the redness continued to enlarge.  Last night, my arm was so sore, it was difficult to lay on my right side.  Today, the redness is much larger, is swollen and itching.  It is still sore to touch.
This is a spontaneous report by a contactable physician. A 60-year-old female patient received on 22Jan2015 first dose of PREVNAR 13 (lot number J67646, expiration date 22Mar2016, NDC number 0005197101) at 0.5 ml single dose in left arm intramuscular. No other vaccine was administered on the same date. Previously, the patient had never had a reaction to anything. She was not ill at the time. History included diabetes, hypertension, high cholesterol and gastroesophageal reflux disease (GERD), all ongoing. Concomitant medications included benazepril 20 mg for hypertension, insulin glargine at 25 DF daily for diabetes, insulin lispro at 5 DF before meals for diabetes, omeprazole 40 mg for GERD, amlodipine 5 mg for hypertension, simvastatin at 20 mg daily for high cholesterol, hydrochlorothiazide 25 mg daily for hypertension and metformin 1000 mg twice daily for diabetes. On 22Jan2015, the shot was administered and within a few hours the patient had a local and systemic reaction. It was reported also that the patient experienced on 22Jan2015 warmth, erythema, edema, chills, headache, myalgia, fatigue, difficulty moving arm and rash. Vaccination was given in the left upper arm where the local reaction took place. The raised rash was 2cm by 6cm and rectangle shaped. It was also very warm. Treatment included TYLENOL and ALEVE to manage her symptoms and warm compresses. The patient came into the clinic on 26Jan2015 for a follow-up visit and was improving. Outcome for all events was reported as improved.
He received 2 doses of Pfizer COVID 19 vaccine and has just received a positive PCR test.  A breakthrough case.; He received 2 doses of Pfizer COVID 19 vaccine and has just received a positive PCR test.  A breakthrough case.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 80 year-old male patient received bnt162b2 (BNT162B2) (Lot number: unknown) at the age of 80 years as dose 2, single and (Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 21Nov2021, outcome "unknown" and all described as "He received 2 doses of Pfizer COVID 19 vaccine and has just received a positive PCR test. A breakthrough case.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (02Nov2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, sars-cov-2 test positive. No covid prior to vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Altered mental status Narrative:  Pt reported negative SE from his dose #1 of covid vaccine on 2/9/2021 at his dose #2 appointment. Pt reported serious altered mental status for 24 hours post injection. Reports unable to perform adls or simple functions like eating, dressing or self care. Pt then refused his covid dose #2.
Patient requested to be given covid 19 Bivalent vaccine d/t to his comorbidities, LVN informed patient that new covid 19 vaccine would be out soon. At the time I was not aware that the Bivalent was no longer authorized being that I administered the vaccine 9/12/23 at 448 pm and then I received an email stating the Bivalent was no longer authorized since 09/11/23. I received that specific email 9/12/23 at 7pm.
Progressive neuropathy of feet followed by ulcerating lesions to left foot and leg. Neuropathy began approximately 2 weeks after second vaccine dose and slowly progressed.  On Oct 26 he was evaluated for skin changes by his primary care physician. On November 25th he was first admitted to Hospital. He was admitted to the hospital from 12/1-12/5 and diagnosed by biopsy with livedoid vasculopathy, which is associated with COVID-19 infection, and with the vaccine. Due to intractable pain, he is readmitted on 12/29
Got pneumonia on June 14, 2020.  Went to ER and received antibiotics.
had a cold ever since the booster dose/didn't know she was suppose to wait 8 months to even get the booster shot, she just went and they gave it to her; She has been sick with a cold; cold/had a cold for a week; had a cold ever since the booster dose/didn't know she was suppose to wait 8 months to even get the booster shot, she just went and they gave it to her; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0183), via an unspecified route of administration, administered in Arm Left on 23Aug2021 11:00 (at the age of 52-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included ongoing High blood pressure (Diagnosed about 15 years ago). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Batch/Lot Number: EW0182) administered in Arm Left on 21May2021 (at the age of 51-year-old) as dose 1, single and the second dose of bnt162b2 (Batch/Lot Number: EW0183) administered in Arm Left on 14Jun2021 (at the age of 51-year-old) as dose 2, single for covid-19 immunisation and after second dose she slept all day, and her arm was hurting. Additional vaccines administered on same date of the Pfizer suspect was reported as none. On 24Aug2021 at 09:00, the caller experienced cold ever since the booster dose was administered and she asked if that was a normal side effect. Caller reported she had the booster shot and has had a cold for a week. The caller remarked that she did not know she was supposed to wait 8 months to even get the booster shot, she just went, and they gave it to her. She wanted to know if this was normal. She stated she had been sick with a cold since she had the dose. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. The outcome of event cold was not recovered, and sickness was unknown.   Follow-up attempts are completed. No further information is expected.
Patient reports she received 1st Moderna Covid 19 vaccine lot number 039K02A on 1/7/2021 at 1450 in the center in her left arm. She reports she noted dizziness at 2000 that evening lasting until 1400 on 1/08/2021. She reports she also developed shaking chills and headache which ended at 1100 on 1/8/2021. Patient reports she called out of work due to chills on 1/8/2021. Patient reports her symptoms have resolved other than some mild arm soreness.
At 9PM I began itching, the itching was followed by red blotchy skin all over my body. Treated with Benedryll. Woke feeling nauseated, had chills.
Extreme generalized constant pain in upper right arm from elbow, up arm, up neck to base of skull. Not localized (like at injection site), more muscular in nature. I have never had a reaction to a flu shot before. I will be going to an urgent care later. I had to call off work as I am a nurse and cannot lift anything due to the pain.
Back pain; extremely painful back muscle spasms; minor pain; This is a spontaneous report from a contactable consumer (patient). A 75 -year-old female patient (not pregnant at time of vaccination) received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265), via an unspecified route of administration (on right arm) on 30Jan2021 12:30 (at the age of 75 -years-old), single dose for COVID-19 immunization. Concomitant medication included levothyroxine sodium (L THYROXINE), rosuvastatin, magnesium. Back pain, extremely painful back muscle spasms. Started minor pain 3 days after vaccine didn't associate it with vaccination, very painful and spasms on day 6. Have not had any back injury or strain that patient was aware of. It was reported that adverse events started 04Feb2021 19:00. Patient just wanted to be sure if ok to take 2nd vaccination. The outcome of the events was not recovered. No treatment given for any of the adverse events. The events were assessed as non-serious by the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
7 days after vaccine, body ache and headache, temperature of 99.4 which is higher than my typical temp.
The patient experienced an episode of syncope secondary to administration of Pfizer COVID-19 vaccine, approximately five minutes after vaccination. The patient reported lightheadedness while seated, crouched down with elbows on knees while holding their head by the temples, attempted to catch their breath for approximately three minutes, turned to rest their head on the seat of the cushioned seat, then lost consciousness approximately one minute later. A trained first responder immediately arrived on the scene, transitioned the patient to a supine position, maintained airway, took their pulse, and spoke with the patient until consciousness was regained. Paramedics arrived on the scene to check vitals and released the patient without escort.
Information has been received from a 62 year old female Registered pharmacist, with a history of childhood chickenpox and no allergies, whose husband was vaccinated with zoster vaccine live (Oka/Merck) on 26-APR-08. The pharmacist's concomitant medications included ramipril, levothyroxine Na and multivitamins (unspecified). On approximately 29-APR-2008 the pharmacist experienced a rash which looked like classic chickenpox. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify whether it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. The specimen was collected on 06-MAY-2008 from a papular lesion on the right forearm when the rash was 8 days old and the vesicles were gone. It was reported that the patient had a rash of scattered vesicles (approximately 20 in number) distributed on both flanks, right forearm, and right thigh and the patient was afebrile. It was noted that the patient had recently been exposed to a vaccinee (her husband had no rash) and was not recently exposed to chickenpox or shingles. The PCR results for the specimen from the papular lesion were reported as an inadequate specimen, negative for B-globin, no strain identified. Follow-up information was received from the pharmacist on 19-MAY-2008. She explained that she had suspected that the PCR results might be inadequate since she was recovering at the time the samples were obtained. On 19-MAY-2008, the pharmacist reported that she was totally recovered. The pharmacist explained that her rash looked like classic chickenpox, and itched frantically at every spot; however, she did not have a fever or headache at any time. She confirmed that her husband never developed a recognizable rash nor did he have any itching. No further information is available.
Dizziness, headache, very tired for about 8 hours - chills - nausea.
Patient received the vaccine, then was admitted to hospital with significantly elevated CK and muscle aches. No other known medication causes or acute injury that could have contributed- vaccine not 100% able to be notified as the cause, but area around vaccine was significantly red and patient stated symptoms started after vaccination.
730PM pt recv vax & showed sl redness, hot to touch w/raised 3 area  from site @ 830PM;MD ordered DPH;
16 hours after receiving booster heart racing to 180 and uncontrollable palpitations
With first dose given on 02/04/2021 there was mild soreness at injection site. With second dose given on 02/27/2021 there was only mild soreness at the injection site until the morning of 02/28/2021. At this time I started to experience fatigue and malaise. This gradually worsened throughout the day although no additional symptoms developed until the following day.  When I awoke at around 7:00 am on the morning of 03/01/2021 the feeling of fatigue and malaise were gone however, I noticed significant swelling with minor discomfort in my left armpit area. At 8:00 pm on the same day only mild swelling persists, without discomfort.
THE PT WAS GIVEN 3 VACCINES (TDAP, GARDASIL, MENACTRA). WHEN THE PT WAS LEAVING SHE FAINTED IN THE HALLWAY. PT GIVEN SMELLING SALTS, COOL WASH CLOTHS AND SUGAR CUBES. DR. OBSERVED THE PT FOR 30 MINUTES AND SENT HOME TO REST FOR THE DAY. THE PT HAD ONE ABRASION ON HER CHIN FROM THE FALL.
Patient Spanish speaking, used language line for interpretation: Right arm - I  haven't been able to move it, it's swollen, has thick parts that are hot and red.  It's getting better, today I can move my arm but it still hurts.   Have a fever, dizziness, and headache that started on Saturday.
Elevated (doubled) bilirubin; This is a spontaneous report received from a contactable pharmacist.   A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) dose 1 via an unspecified route of administration, on 18Mar2021 and dose 2 on 08Apr2021 as a single dose, for covid-19 immunisation. Medical history of the patient included metastatic breast cancer and Gilbert disease. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced elevated (doubled) bilirubin after her vaccine series. Outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021473014 same reporter/drug/AE, different patients(2nd of 3 patients);US-PFIZER INC-2021473015 same reporter/drug/AE, different patients (3rd of 3 patients);US-PFIZER INC-2021473013 same reporter/drug/AE, different patients (1st of 3 patients)
Unilateral hearing and vision issues; Unilateral hearing and vision issues; Allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004105 (Novavax).  A female patient received BNT162B2, as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1), for COVID-19 Immunization. The following information was reported: HYPOACUSIS (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "Unilateral hearing and vision issues"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy". Additional information: It was reported that the patient experienced unilateral hearing and vision issues and had an allergy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt devel facial edema & periorbital edema; eyes almost closed shut p/4 hrs; DPH given; No resp sx;
Vaccine expiration date was extended to 4/3/22 and had been kept frozen up until date of administration which was 4/7/22. Moderna contacted and Moderna advised that vaccine was still viable and no revaccination was necessary.  No adverse side effects were reported from patient.
Kidney infection; Wheezing in chest; her blood pressure is so low right now they can't even transfer her to the hospital that can actually perform the surgery she needs; became very weak and didn't tell anyone/too weak to get up; mother was swollen from head to toe with edema; mother was swollen from head to toe with edema; fell using her walker on Wednesday/fell again; Laceration of face; having issues with her kidneys and has progressively declined since; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history using her walker. Concomitant medications were not reported.  The consumer reported that her mother had the COVID-19 Vaccine on 21Jan2021. She was now hospitalized and was due to have the second vaccine on 11Feb2021 and stated that her mother was completely unstable for the second vaccine.  After receiving the COVID-19 vaccine, medically, she seemed fine. Then, she progressively has gotten worse. First EMS was called. This was about less than a week later after receiving the vaccine. Then, she was admitted into the hospital with a kidney infection and she has progressively declined. She has no idea if it was related to the COVID-19 vaccine or not. She initially called regarding the second COVID-19 vaccine. She didn't know what would happen if her mother didn't show up for her second vaccine. She didn't know if she would get on the "never going to get the vaccine" list or what as her mother was just so unstable. On an unspecified date, her blood pressure was so low right now they can't even transfer her to the hospital that can perform the surgery she needs. The reporter stated that she has no idea if this was COVID related or what. She began having problems less than a week later after receiving the COVID-19 vaccine, she mentioned Wednesday. On 27Jan2021, her mother began having issues with her kidneys and has progressively declined since. Consumer stated her mother was swollen from head to toe with edema on an unspecified date and that was how this all kind of started. Her mother became very weak and didn't tell anyone. She fell using her walker on Wednesday and the EMS was called. Her mother told the EMS she wasn't hurt but was just too weak to get up and EMS got her up.  Her primary care doctor sent her for an x-ray, and she had some wheezing in her chest. She was given an antibiotic for that. The patient fell again, and the EMS was called and had some face lacerations and stuff, so she was taken to the hospital. Consumer confirmed her mother was admitted into the hospital and was first diagnosed with a kidney infection and it has progressively gotten worse. Outcome of event kidney infection was not recovered; and outcome of the rest of events was unknown.  Information on lot/Batch number has been requested.