chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On the evening of November 24, 2003 client developed a fever of 102.6.  Initially noted clients faced flushed.  Complained of being cold.  No chills, or rash.  Physician called when fever 101.9.  Instructed by on call physician to administer Tylenol.  Client given Acetaminophen 1000mg.  Two hours after medicated, fever had increased to 102.6.  Called physician on call.  Continue to assess client.  If fever reached 103 client was to be seen in the Emergency Room at local hospital.  Other symptoms associated with fever increased respirations, B/P, and pulse rate.  Temperature when client was ready for sleep was 101.9.  Temperature in am 100.  Low grade fever of 99.4-99.8 until afternoon of November 25, 2003.
Initial misuse report received from a healthcare professional on 23 October 2013. The cases were received on 21 March 2014. A patient had received a dose of Tetanus Toxoid on an unspecified date. It was reported that the patient received an expired dose of vaccine. No adverse event was reported. List of documents held by sender: none.
After I received the vaccine I noticed that the site was red, raised and slightly swollen and warm to touch. After 1 week the site is still like this making me not want to get the second dose.
This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. The patient had an unspecified heart condition (cardiac disorder). On an unknown date, the patient was vaccinated with ZOSTAVAX, one dose once to prevent shingles (dose, route and anatomical location of administration were not reported). Concomitant therapies included unspecified medications reported as "a lot of different med's". On an unknown date, the patient developed shingles (herpes zoster). No Product Quality Complaint (PQC) was involved. The outcome of herpes zoster was unknown. This is one of several reports received from the same source. Additional information has been requested.
Received 2nd shot. Area where shot was injected is raised, warm and itchy. Size is about equal to a half dollar.
Pt c/o tingling/numbness in right arm about 10 minutes after vaccine. Stated had the same reaction with first vaccine.
Given PM of 11/30/11 came back 12/3/11 said had small blister like on upper arm, little red size of 1/2 dime had used NEOSPORIN. Told see Dr if not better saw Dr on 12/5 used BACTROBAN oint. It was 1 1/2" from injection site: where he pulled Band Aid off. Shape was shape of end of Band Aid said burned.
She received the SHINGRIX shot at 11 am on 3/8/19. Prior to receiving the shot, she had watched a patient educational video explaining expected adverse effects. She woke up on Sunday morning , 3/10/19, feeling "hot" under her left arm. It hurt as something touched it. It then had a "bug bite" like area on her shoulder blade that looked like a mosquito bite. She noticed the rash on her back today, 3/12/19, and called our office. She sent a photo, but she was unable to come in because of work and distance from our office. She is going to try to see a dermatologist today or tomorrow closer to home. Although Valtrex was called in for her, she was hesitant to take it because she "does not like medications".
Patient started having abdominal pain on March 26, 14 days after vaccination.  Went to ER on March 29 and was admitted.  Diagnosed with blood clot in spleen.  Discharged from hospital on March 31.
About 4hrs post immunizations, child started crying and was unconsolable for an hour, then extremely fussy (if mom changed position, would start crying again) until about 6:30 or 7pm. Child then "started to come out of it" (according to mother) child slept well at night and was fine today.
Extreme fatigue after first shot. Body aches, head discomfort, and extreme arm soreness. Better on third day, but unusually tired in evening. Unusual Fatigue has persisted fourth, fifth, sixth days after. I feel weaker, cannot do typical activities well (tennis, vinyasa yoga) and just feel tired after simple workouts. I feel VERY hungry even though I?m not as physically active as usual. It?s very frustrating not having my usual energy after the ?low symptom? shot. Very concerned about getting 2nd in 3 weeks.
Tues Sept 8 I received flu shot about 2 pm. THey gave me the HIGH DOSE -> vom 6 pm-8:30 pm I was ice cold and shaked and shook and teeth rattled and hard knot on right side where 9-8-15 About 2 pm received mega dose flu shot for seniors at 5 pm to 8:30 pm had terrible shakes and shingles and teeth rattling so cold fingers my hands and feet got cold. It was awful I thought I would die it felt like my Bells Palsy was coming back it was awful I do not know if I will ever take another one.
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after receiving vaccine patient hospitalized for sustained ventricular tachycardia. Administered  one shock, electrolytes replaced, antiarrhythmic medications adjusted, and patient discharged to home medically stable in normal sinus rhythm with cardiology follow-up in place.
TRANSIENT CEREBRAL ISCHEMIA ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
heart damage; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INJURY (medically significant), outcome "unknown", described as "heart damage".  Clinical Course: Reporter stated that I also have a nephew and a niece that have heart damages because of these shots, so no comments needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 67-year-old female patient who received SHINGRIX (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 1st August 2018, the patient received SHINGRIX. On 7th September 2018, 37 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovering/resolving. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that, her patient noted a rash around the site where SHINGRIX was injected.
tachycardia,face flushed,p94,BP 128/90 (states norm is 90/60),burning & itchy eyes 5-10mins following vax;observed closely for 30mins-P72,BP 120/72,less flushing & less burning;
Missed period. FYI:  no possibility of being pregnant- also have not missed a period or been late since teenager.  No sign of period symptoms. Getting concerned about fertility since I'm trying to get pregnant very soon.
I felt nauseated right away and threw up about 2 hours later.  After that just the arm pain at the injection site
Fifteen minutes after receiving the vaccine, the patient's hands felt numb and uncoordinated, she felt unsteady on her feet, and suddenly developed a painful knot in her lower back which cased pain to radiate up her back. A nurse who was nearby in the store steadied her and called an ambulance for her. She did not leave in the ambulance, but an EMT did stay with her until the pain subsided and she regained her balance, which took around 15 minutes. She never had any other issues and did not seek any follow up care.
Pt received ZOSTAVAX injection at approx 2 PM on 5/23/08. Pt reports that 1-2 hrs later, she developed headache. She took TYLENOL but said it resolved the next day. She also experienced flu like symptoms - body ache and chills on 5/24 which lasted for approx 24 hrs. Pt experienced a slightly raised area around injection site which was itchy within 1 hour after injection on 5/30. The area was flat, non itchy but still red.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/18/2023 HYPERVOLEMIA R09.02 HYPOXIA 4/3/2023 HYPERVOLEMIA
Stated felt "itchy", sweating.  Gave 25mg PO benadryl
I got the shot on Friday, 4/9/2021 at about 930 am. I had a severe migraine the night of and severe body aching to where I was just laying in bed crying. Saturday, 4/10/2021 I felt okay. Sunday 4/11/2021 I felt perfect and thought I was okay. This morning, Monday 4/12/2021 I woke up at 4am in a puddle of sweat, and started puking at 530am. I puked at least every hour multiple times. My whole body felt as if it was vibrating, or falling asleep (the worst feeling I've ever had.)
Diarrhea, Nausea Vomiting "sweat/cold" Narrative:
Patient was administered DTaP and IPV in right thigh 11/20/02. Presented at clinic 11/27/02 with 7cmx8cm erythema, tender to touch and mild induration. Complained of pain at bedtime 11/26/02. Rx Keflex 250mg for 10 days and warm compresses.
Patient fully vaccinated and admitted to the hospital with COVID-19. Patient had previously been admitted with COVID but was not significantly hypoxic and was discharged home on steroids. Patient was then readmitted with worsening dyspnea secondary to COVID.
3 hours after shot, left arm started hurting a lot and got worse during the afternoon. Next morning right side of neck was hurting and difficult to move neck freely without discomfort. Mild headaches came and went. Used heating pad on and off for neck. Ice pack for headache. Steady improvement but Monday morning still slight neck issues. Have submitted note to the doctor for discussion.
On evening of vaccination, developed swelling, itching, with some pain at site with swelling involving much of arm. Felt dizzy. Fell twice without injury. Itching has resolved. Overall symptoms improved 65%.
Felt flushed and noted (L) posterior neck pain within minutes of receiving vaccine. No urticaria or angloedemia; it remained ambulatory; nil vs. no subsequent c/o.
Woke up next day (7-4-07) feeling chills - aching - felt worse as day went on - c/o nausea, weakness, malaise, headache. Site of shot red (approx 6" dia) warm to touch and sl hard. Began to feel better is 7 days. Arm remains sl red (1" dia) and hard with sl warmth. Talked with Dr.
Left arm experienced severe soreness and loss of mobility starting 2 days after vaccination. Patient states it is still sore, however, it is about 50% better than it was and is able to use her left arm in a limited capacity. She favors lifting with right arm.
"I watch a customer  get his Vaccine at 1:13pm while I waited for mine at 1;35. He seemed happy  and moved to the recovery area allowed for 20 minutes rest to see if there were any reactions. He complained after 10 minutes of having a fever and asked for cold, cold water. He was sweating and his T-shirt looked very wet, At this point the pharmacist attended him and called 911. I heard a staff member of the Shop say that was the 6th one to have a reaction that week that they knew about.  I got up and left and did not get my vaccine. "
Patient developed erythema multiforme 10 days after varicella and MMR immunizations.
COVID vaccine breakthrough case. Janssen 4/10/21 043A21A, and boosted Pfizer 11/19/2021 FH8028 and Moderna 11/30/21 012H21B
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored GARDASIL 9, (lots and expirations were unspecified). the vaccine was stored at a temperature of 33 F for a time frame of 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse effect reported. This is one of the four reports received from the same reporter. Additional information has been requested.
HIVES WHERE THE INJECTION WAS GIVEN; HIVES UNDER LEFT EAR; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included allergy to strawberry/allergy to chocolate/allergy to shellfish, and tylenol with codeine allergy. The patient experienced drug allergy when treated with codeine, and paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced hives where the injection was given. On 11-MAR-2021, the subject experienced hives under left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives where the injection was given, and hives under left ear. This report was non-serious.
Left upper-outer thigh 6x5 cm area red much improved was much bigger 9x8 per mom Sat. Right outer thigh - 3x3 cm area - per mom quarter size hot red. Both sites today mildly pink.
I started to get my period every 2 weeks  which is very unusual. because of the certain birth control i am on, i have not had a period in almost 5 years, and now as soon as i got the vaccine i started to get my period, and it?s not the normal once a month, it?s every 2 weeks .
9MAY96 mom called to report onset last evening of pt's lt deltoid area being red,warm,swollen;ROM limited in lt UE-cannot elevate lt arm completely-activity level not diminished;pt not complaining of discomfort;denies fever;
This spontaneous report was received from a medical assistant regarding unspecified patients. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored PROQUAD (Lot# M022402, M044019 and N012616) (dose and route were not reported) for prophylaxis. The vaccine was exposed to a temperature of 6 Fahrenheit to 14 Fahrenheit for 15 minutes and 15 Fahrenheit to 46 Fahrenheit for 3 hours and 30 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. No additional information provided. No product quality complaint involved. This is one of the several cases from the same reporter.; Sender's Comments: US-009507513-1708USA008563: US-009507513-1708USA008361:
ringing in the ears; slight headache; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient received the first dose of bnt162b2 (Batch/lot number: EH9899), via an unspecified route of administration (reported as one injection to left arm) on 16Dec2020 at a single dose for COVID-19 vaccination. Medical history included allergy. Concomitant medication included prednisolone acetate (PREDNISOLONE ACETATE, Manufacturer: Pacific Pharma. NDC: 60758119-05, Lot: E88990, Exp. date: Feb2023) 1%, four eyedrops a day until she is out, 7 days at most or a week for allergy. The nurse called as a patient about the Pfizer COVID-19 vaccine, which she received on 16Dec and had a headache - only a slight headache, the day after and ringing in her ears that has not gone away. She says it was her first injection of the vaccine. The patient says she was given the vaccine through her work, and says she had a headache that evening and then a slight headache the next day. She says that the ringing in the ear, she noticed the next day in the morning. She says it is hard to tell if the ringing is just one ear or not, the ringing is staying about the same, and is more in her right ear. She says she has not had treatment for either the headache or the ringing in her ears, and the headache improved on its own. She had no new medications and didn't receive any other vaccines when she got this one. She says that she went to the eye doctor in the past week and he started her on eye drops, she has never been on prednisone for allergies, and for her eyes he gave her prednisone drops and allergy drops. She says she started that medication on the evening she got it, Monday 21Dec. She would like to know if there could be some type of allergy, she doesn't know if she should take the second dose of the vaccine. She says she doesn't know if there is something she should do for the ringing in her ears, like a common treatment or anything, or if others have been reporting this. She says she saw on the website that one side effect said ringing in ears, but she isn't sure if the website was either of those provided by call handler for further information. The outcome of the events slight headache was resolving while ringing in the ears had not resolved.
Information has been received from a physician via a field representative referring to a 4 month old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 30-JUN-2016, the only four months old patient was vaccinated with a dose of human papillomavirus (HPV) vaccine  (manufacturer unknown) (dose, dose number and route were not reported (inappropriate schedule of drug administration). It was unknown if the patient received GARDASIL, GARDASIL 9 or another hpv vaccine (unspecified) (manufacturer unknown) (product origin unknown). The patient did not experience any effects. Additional information has been requested.
Patient developed a raised red spot at site of injection. On the afternoon the day after the injection it was 1 inch by her estimate. When I saw her 2 days after it was raised, indurated 5x5 1/2 cm. I saw her again day 3 and it was now 8.5x7cm with more induration. I started her on BENADRYL and SEPTRA for a DDX of reaction vs cellulitis. I saw her day 4. The erythema was still 15x7 but fading and felt better.
Pt recv vax on 1/17/98; on same day pt exp myalgia, aching, abdominal pain & nausea
Administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition reported).    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 06-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml). On 06-Mar-2021, ACCIDENTAL OVERDOSE (Administered 1ml of the Moderna Covid19 vaccine instead of just 0.5ml) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments:
Headache, Arthralgia, Fever, injection site pain, fatigue Narrative: Employee reports injection site pain/discomfort, fever (101.9 F), chills, headaches, joint pain, and fatigue. No medications were taken for symptoms per report. Has fully recovered.
Patient had tingling sensations all over the body. Also pain in the back of her head. Per patient's family members she passed out for about 5 seconds. EMS was called and patient's vital signs were all ok. Patient refused to go to hospital with EMS.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX the patient began to experience post herpetic nerve pain. Thereafter, the patient was diagnosed with a shingles outbreak on both of his legs and on his back, which lead to significant scarring. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Tested positive for Covid-19; Tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 14Apr2021 as dose 2, single (Lot number: EP6955), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 24Jun2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "recovering" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) Positive, notes: Nasal Swab; (11Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: No other vaccine in four weeks and Covid prior vaccination. Patient had Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Estimated due date:  07/16/2021 About 5 hours after the vaccine my arm started to hurt and I started having all body aches and chills, never had a fever.  Very fatigued. At night I threw up and about 2AM I woke up drenched in sweat and I did not take my temperature. I woke up around 7AM and I had a migraine for about 2/3 hours - pounding headache. I took Tylenol, My body was really achy and my arm was like it was dead. General malaise, fatigue, it felt like I had a hangover, from my pounding headache. I threw up once again in the afternoon. Not sure if pregnancy related or the vaccine. Sunday morning I started feeling a little better. Saturday I felt horrible.
pt recvd vax on 22MAR95 11AM & devel high fever w/grand mal convuls @ around 8PM 22MAR95; pt was brought to hosp-spinal tap done;
WHOLE BODY SORENESS; FATIGUE; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced whole body soreness. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from whole body soreness, and fatigue on APR-2021, and had not recovered from soreness at injection site. This report was non-serious.
Information has been received from a health care worker concerning a 6 year old female with no known medical history who on 30-AUG-2000 was vaccinated SC in the right thigh with a first dose of Varivax (lot # 634502/0538K). There was no illness at the time of vaccination. On 13-APR-2006 the patient developed chickenpox. No further information was provided. Additional information was received and indicated that on 13-APR-2006 the patient developed chickenpox and was seen for a doctor's visit. No laboratory tests were performed. Subsequently in April 2006 the patient made a full recovery. No further information is expected.