chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated at a clinic for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient was not responsive, she was awake but not responding to her mother or me, she was vomiting, her arm was twitching. She was bradycardic, low pulse in the 30s, and low blood pressure according to EMT.
26 hours after his first Pfizer COVID19 shot, my son had a sudden sharp stomach pain and nausea. He became very dizzy and nearly fainted. He couldn't see for a few seconds but was conscious. The dizziness and lightheadedness lasted a fewminutes. The nausea lasted about 15 minutes. This has never happened before to my son.
pt recv vax 24OCT95 & that evening pt devel pain on side;pt was evaluated by MD who dx pleurisy coincident w/administration of vax;
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Pt recieved 3rd dose of Pfizer vaccine. Had no reaction with first 2 doses in Dec/Jan. When got 3rd dose pt broke out in hives ALL OVER body taking Benadryl around the clock and prednisone dose pak. Itchy and welps all over body started night after got vaccine. Still experiencing allergic reaction.
I21.4 ACUTE NON ST ELEVATION MI 4/9/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA ADHD, UNSPECIFIED
arm hurts, bone aches, middle of arm to fingertips to center of back on lt side;T105, vomit, diarrhea x 2 days, severe bone aches;
Nurse administered 0.25ml instead of 0.5ml around 2:30pm for patients first dosage in the series. Patient came back around 5:30pm for another 0.25ml of Moderna
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 41 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was not administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Patient appears to be having a mild generalized vaccinia reaction with a few papule rashes throughout his body that are mildly pruritic.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 51-year-old female house keeper who on 09-OCT-2006 was vaccinated intramuscularly in the left deltoid with a third dose of Recombivax HB (lot# 647547/0031P). Subsequently, the patient experienced adverse experience. It was unspecified if medical attention was sought. No outcome was reported. Additional information has been requested.
Pain in arm. Couldn't lift arm. Went to my doctor name, address and phone number reported.
This spontaneous report received from a patient via other company (Pfizer Inc.) concerned a 49 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: underactive thyroid, and drug allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, 1 total administered on an unspecified date in MAR-2021 to right arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received dose 2 with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in SEP-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 48 years old. The batch number was not reported and has been requested. Concomitant medications included levothyroxine for underactive thyroid. On 25-JUL-2022, the patient experienced suspected covid-19 infection along with symptoms of altered sense of taste and also experienced trouble swallowing, and diarrhea (Dose number in series 2). The patient was treated with non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 26-JUL-2022 to 27-JUL-2022 for treatment of COVID-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and treatment with Paxlovid was withdrawn. The patient recovered from suspected covid-19 infection, trouble swallowing, and diarrhea on 28-JUL-2022. This report was non-serious.
Call from staff 10 am 11/20 states "both patient's hands are swollen and turning white and her joints hurt". Saw Dr. and he recom to stop vaccines or only vaccinate one vaccine at a time. He ordered Solu-Medrol dose pack.2/24/09-records received-office visit 11/20/08 C/O edema located on hands, fingers and upper arms. Swelling begain hour after receiving vaccines. Right knee pain, onset months ago, years ago. Onset sudden sustained inury while active, hyperextension and no treatment. Falls at times with weight bearing activities. Ankle and foot symptoms date of onset uncertain. Oral contraception. Impression. dergangement knee. Return as needed. No additional visits noted.
Baseball size, red, swollen area after DTaP. Rx Motrin and cool packs.
Received vaccine at 9:15am and observed symptoms of severe rash on chest and neck with swelling in throat at 10:00am.
The next morning I started to have some pain in my right calf which worsened throughout the day.  The following day I went to the ER with a DVT.  I was given  Xarelto for treatment.
Red blotches/blistering and slight swelling on 1st and 2nd toe of right foot (looks similar to "Covid toes"). Started as swelling of 2nd toe with some pain on Tuesday, February 2nd. Progressed to red blistering on 1st and 2nd toe, the swelling subsided somewhat by today (February 8th). Slight pain remains through today (Feb. 8th).   No prescribed treatment. Took Advil periodically for swelling, tried to keep feet warm.
Vaccine Breakthrough   COVID + 7/28/21.  Inpatient hospitalization for hypoxia.
chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received Menactra on 08/31/2005, on 09/24/2005 developed 103 degrees fever.  Went to primary care physician who suggested may relate to the vaccine.  No other symptoms.
about five hours after  arm stiffened up ,fingers tingled, then i couldn't move it.Knew it would be sore at area given but my whole arm was affected.Call daughter in law ( nurse) said it's common.This was not.When I went to bed around 10PM I had the chills ,thought maybe because I had to put ice on it (site) was very warm.Had slight fever when I went to bed, sweated most of the night.Morning(dec.7th threw up breakfast and had slight fever of 99.8.(took Acetaminophen 1cap)Can Now raise my arm from elbow down but still having hard time raising arm, cant use left arm to even brush hair.I move it(left) with rt hand to get muscle moving.I'm still struggling with it today.Hope tomorrow will get even better.
09/20/2011 Severe. Had temp of 103F and seizures 1 week after vaccine.
Lost vision like 3 mins after vax at the drive through shot center, paramedics were with me for about 20 mins to  make sure blood pressure was okay and vision was 100% better. Besides the body aches and diarrhea on 4/3 and 4/4, On 4/6 I had the worst migraine ever where I lost 1/3 of my vision for about an hour and my right side of my body went numb for about 15 mins. I've been having migraines more frequently than I ever have and unsure if it is vaccine related or just extra stress. I have been trying to reduce screen time as much as I can but hard when I work full-time and in grad school and use the computer all the time. I also have been taking motrin/tylenol for the pain and lay down to let the pain pass.
Today she told me that she started itching and mild infection in gum and piercing parts on her arm again. She had this problem before with the first dose of Moderna.
I have developed a localized rash around the injection site. It has not spread yet though is a bit hot. Its raised and splotchy.
Given Varivax 6/26 developed typical vesicles on 7/10, more on 7/11 and 7/12. Sibling had same course.
constant headache; had body pain & aches; extreme fatigue; pain in entire upper arm; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: en6202; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 24Feb2021 15:00 (at the age of 51-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient received the historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: el9269; Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 03Feb2021 17:00 (at the age of 51-year-old) as 1st dose, single dose for COVID-19 immunization. The patient had no other medical history. Concomitant medications in two weeks included acetylsalicylic acid (ASPIRIN 81) at a dose of 81 mg, atorvastatin (ATORVASTATIN), multi vitamin. There was no other vaccine on same date or in four weeks of product. The patient did not had COVID prior to vaccination. The patient has not been tested for COVID post vaccination. On 25Feb2021 12:00, the patient experienced constant headache, body pain and aches, extreme fatigue, pain in entire upper arm. Reportedly, constant headache, started 25Feb2021 12pm still present (26feb2021), had body pain & aches, extreme fatigue, pain in entire upper arm until 26Feb2021 06:00, headache still present 26Feb2021 at 20:00. No treatment was given for adverse event. The clinical outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
PT BROKE OUT IN A RASH ON THE EVENING OF 3/9/03, ALL OVER BODY, BUT MAINLY ON ARMS AND CHEST.  PT  STATED HE WENT TO MILITARY HOSPITAL FOR TREATMENT.  NO SPECIFIC CAUSE FOR RASH WAS EVER DETERMINED.  PT WAS GIVEN A BENADRYL SHOT AT THE HOSPITAL.  HE ASLO WAS GIVEN BENADRYL PILLS FOR FURTHER OUTBREAKS.
Patient reports by Friday evening (R) deltoid at injection site was hot, swollen, red, numb - "she put ice on it for 1 hr." Was painful to sleep on. She left as a message.
Patient felt lightheadedness, dizziness, vomiting, and shakes the next day after spending a few hours in the sun on a hot day. Unsure of correlation to flu shot but reporting to err on the side of caution.
Injection site reaction; Led to a rash; Shingles outbreak; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site reaction (Verbatim: Injection site reaction), injection site rash (Verbatim: Led to a rash) and shingles (Verbatim: Shingles outbreak). The outcome of the injection site reaction, injection site rash and shingles were not reported.   It was unknown if the reporter considered the injection site reaction, injection site rash and shingles to be related to Shingrix.     It was unknown if the company considered the injection site reaction, injection site rash and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-APR-2023 The reporter was a physician assistant. The patient had injection site reaction which led to a rash that presented as a shingles outbreak. The follow-up permission denied.
Starting 8 days after MMR+V vaccination, patient experienced 102F fever followed by morbilliform rash on abdomen. At 10 days rash expanded to whole body. Fever ranged from 99 to 102 degrees for 8 to 13 days after injection. Patient vomited twice on day 13.
1st dose in 2019, hasn't got the 2nd; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 1st October 2019 of batch number PR5B2 and expiry date 8th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in 2019, hasn't got the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-Mar-2023 The reporter consented to follow-up via email. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Patient incorrectly given greater than 12 years old Pfizer first dose COVID-19 injection, rather than 5 to 11-year-old dose at vaccine clinic.
Chronic headache for over 5 weeks post vaccine (2/10 to 4/10 px 50% of waking hours.)
Tinnitus within minutes of receiving the vaccine. I received the 2nd vaccine today, but I am still experiencing the tinnitus from the first injection.
No adverse side effects noted during clinic visit. Patient lives with mother who is RN and she will monitor for side effects
cough; enlarged lymphnodes; long term breathing issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "enlarged lymphnodes"; RESPIRATORY DISORDER (non-serious) with onset 2022, outcome "unknown", described as "long term breathing issues". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the first booster, the patient developed a cough that has turned into long term breathing issues with enlarged lymph nodes. Patient received Pfizer vaccine as second booster dose   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
20 yr old patient presented to PCP for flu vaccination, however, also requested Pneumococcal vaccine due to history of asthma. Patient ordered both flu vaccine and pneumococcal vaccine by MD. RN administered Pneumococcal polysaccharide 23 valent vaccine IM in patient's right deltoid and influenza quadrivalent vaccine in patient's left deltoid on 9/6. On 9/10, patient emailed provider complaining "over past three days area around PNEUMOVAX vaccine site has turned red and began to swell. Patient noted it has started to spread". Patient presented to PCP on 9/11 complaining of 5 days of fever (102.5 at home), body aches, and rash, right arm pain (4-5/10) over vaccination site. MD noted "4x5 cm area on right upper with erythema, warmth, swelling, induration, and tenderness. No fluid pockets palpated. No drainage". Patient reported taking ibuprofen and TYLENOL with minimal improvements. MD diagnosed cellulitis and prescribed cephalexin 250mg PO QID x 10 days. Unknown if cellulitis is resolved as no documentation in chart.
Itchy skin and 4 inch raised red lesion that started at the site of the injection and is moving toward my hand. Currently right above my elbow. Appeared about 5 days after vaccine and is worsening.
c/o - passing out and while shaking - transfer care to paramedics & they call the ambulance, but patient refuses to go to the ER.  Symptom resolved and pt. went home.
Post vaccination patient started to feel flushed, light headed and dizzy- Patient skin pale vitals T 98.7, 113/56, HR51, B/S144, 02 96
This case was reported by a other health professional via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that there were multiple doctors within the practice that had patients that are reporting adverse events with SHINGRIX. Most of the adverse events are from the VIS list. The health care professional did not have patient information or specific adverse event and said that she would gather all of the information and call GlaxoSmithKline medical information.
High fever of 103.3F, headache ("top of head") and nausea, within 3 hours, post vax.
Red eyes, tightness of chest, coughing, headache, body aches, chills and sweating during the night.
Urinary tract Infection; Kidney Infection; did not receive second dose; A spontaneous report was received from a consumer, who was also a 60-years-old Female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who had Urinary tract Infection, did not receive second dose (Product omission issue) and Kidney Infection.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 04 Feb 2021, prior to the onset of the symptoms, the patient received her first of the two planned vaccine doses of mRNA-1273 (Batch number: 010M20A) via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021, the patient was admitted to hospital for two days for urinary tract infection and kidney infection.   On an unknown date, the patient was discharged, and treatment for the events included higher antibiotics and other treatment during hospitalization and post discharge from hospital. Higher antibiotics was continuing at the time of report.  It was reported that the patient was due for her second of the two vaccine doses on 03 Mar 2021, however, she did not receive the second dose.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, Urinary tract infection, Kidney Infection, and did not receive the second dose, was not reported.; Reporter's Comments: This report refers to a case of Product omission issue for mRNA-1273, lot # 010M20A. Additionally, patient experienced Urinary tract infection and Kidney infection and was hospitalized.  Based on the current available information and infectious nature of reported event both events were assessed as unlikely related. The subject's gender can be a confounding factor in leading to increased risk of UTI.
This spontaneous report as received from a medical assistant regarding a multiple unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ lot # K022990, expiration date- 04-MAY-2016. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt felt nauseous, dizzy with abdominal cramping 30 minutes. After vaccination T 97.9, BP 110/80, R 16, P 84. Skin warm and dry - tongue moist. Has bad taste in mouth - no SOB or difficulty swallowing. No swelling or rash at injection site.
"Pt w/ hx of allergies to seafood, sunscreen, and tetracycline. 35mins post vaccination, pt c/o dizziness and mild itchiness in the throat. Vitals: @12:35 BP 124/76, HR 60, RR 18, SpO2 97% on RA -- > @12:45 110/74, 64, 18, 97% on RA -- > @13: 05 129/82, 57, 97% on RA Pt was given 25mg PO Benadryl @12:50.  Pt symptoms resolved.  Pt stable and released from the vaccination site."
01Jan91 pt vax w/ MMR; 14Jan91 devel fever 101F + maculopapular rash over entire body.
At approximately 1010 the client lied down on the bleachers and reported feeling dizzy and not well, he was also visibly clammy.  He stated he usually feels that way after medical situations such as vaccinations and blood draws. Client was offered to go to a more private area and refused. MRC volunteer got cool paper towels to place on his forehead and client requested to continue  to lay down where he was. After about 10 minutes client wanted to sit back up and reported he was not as dizzy any more. He sat up with ease and no difficulty and he stated he was not feeling as dizzy. After sitting for a few minutes he received notification that his observation period was over and he stated that he was ready to go. I assisted him down the bleachers and out of the outreach facility, he had a steady gait and stated he was feeling, much better. He left the facility with his partner.