chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a father concerning his 16 month old white daughter, with no medical history and no allergies, who on 05-OCT-2006, at 1:00 pm, was vaccinated with a first intramuscular (also reported a subcutaneous) 0.5 ml dose of Varivax (Lot# 652871/0430F). Concomitant vaccine included a dose of PREVNAR. There was no illness at the time of vaccination and no adverse event following prior vaccination. On 06-OCT-2006 the patient developed a fever and a rash. Subsequently, the patient recovered. No product quality complaint was involved. Follow-up information from a the patient's mother indicated that on 05-OCT-2006, at 4:30 pm, the patient was fussy for about 24 hours. The following day, on 06-OCT-2006, the patient had a fever and had blisters on her feet and hands. It was reported that the patient's aunt thought that the patient had hand, foot, and mouth disease. It was reported that the patient had recovered. There were no laboratory or diagnostic tests performed as the patient was not brought in to be examined. Additional information is not expected.
Patient had a positive rapid covid test done at work 4 days ago but needs a PCR to confirm per workplace protocols, sore throat, dry cough, chills, headache, shortness of breath with exertion, body aches, loss of smell, sinus congestion, nasal congestion, chest congestion, chest tightness, chest pain, patient was seen at urgent care 6 days ago for ear infection and was given antibotics for the infection.  symptoms starting on 1/2/2022
COVID vaccine clinic  Staff member presented for Covid vaccine and approximately 5 minutes after receiving dose, experienced diaphoresis,  light headedness and palpitations, then stated that she felt her throat swelling. Epinephrin was drawn up but not administered. A Rapid Response was called and they evaluated her and suggested she go to ED for further eval. Staff member refused further treatment and left area ambulatory in stable condition . WB"
Patient started experiencing the follow symptoms about 6 to 8 hours after administration of the second Shingrix dose on 12/6/2019: headaches, vomiting, nausea, chills, bullseye rash at the site of injection. Three days later (12/9/2019) all of the symptoms have dissipated except for red bullseye rash at the site of injection.
Patient had painful, warm and swelling at the site of injection for 4 days. No MD follow up as patient is feeling better.
Patients Pfizer booster dose provided to patient 12/03/21. Patient became febrile ~90 minutes after his 3rd Pfizer dose. Fever persisted for 7 days with reduction in lymphocytes (nadir 0.3 12/09/21) and neutrophils (nadir 1150 12/09/21) . Patient was concurrently receiving long-term IV antibiotics (vancomycin) in transitional care unit setting for known MRSA blood stream infection and ankle infection through 12/17/21. Fever resulted in team assessing patient for worsening infection (repeat chest xray, CT abdomen, CT chest, ankle xray, repeat blood cultures) - no significant findings from repeat testing. Vancomycin was adjusted to daptomycin on 12/09/21. Afebrile next day, recovery of lymphocytes and neutrophils noted 12/12/21. Management of event (due to vaccine vs. antibiotic ADR) completed during transitional care hospitalization; did not prolong planned hospitalization.
A couple days after the 2nd shot I got a bad sore throat, headache across front of my face, moved into my hands tingly and aching then into my feet same tingly aching, then into my back and across front of stomach and lower legs ached. No over the counter pain meds helped. Symptoms lasted about 48 hours, bad enough you can't sleep and can't get relaxed. I have kept a journal and the exact same symptoms have happened 10 more times since then. I went to the doctor on February 13, 2019 with symptoms and he ran labs for, inflammatory stuff and everything was negative. I did not have any swelling in joints. I went back to the doctor august 9, 2019 when I had symptoms again and they reran labs and even checked for lyme disease. All negative. I am in excellent health except for these weird events that happen at random. In July 2019 I burned two fingers lightly and within hours the whole body ache crap kicked in again. I think when |I got the 2nd vaccine it messed with my nervous system and now when something stressful happens my stress reducers are not able to kick in because that vaccine is stopping them. Is there a doctor at Clinic who can help me? The local doctor prescribed Sulindac but without a diagnosis I don't feel that's the right treatment. I need your help.
Information has been received from a physician concerning a 20 year old female who on 05-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil (yeast). Concomitant therapy included hormonal contraceptives (unspecified). The physician reported that the patient was extremely nervous about getting the shot. Later that evening, within 12 hours, the patient broke out in hives. The physician told the patient to go to the emergency room (ER). The patient went to the ER and was given BENADRYL for the hives. The physician reported that the patient was fine, but does not plan to give the patient anymore shots. There was no lot number provided. At the time of this report, it was noted that the patient was "fine after she had received BENADRYL. Additional information has been requested.
Rash to Left lateral leg - around knee and upper shin, and also on right top of shoulder proximal to base of neck. Rash started out as red bumps, now evolved to growing into large areas, raised, red, swollen, itchy, warm.  I did not take anything for this, nor did I apply anything to it other than warm water during my shower.
Approximately 20 minutes after the shot was administered my tongue began to feel tingly and thick.  It made swallowing feel awkward but there was difficulty in breathing.  When I got home, about 35-40 minutes after shot was administered I took some Benadryl.  About 1 1/2 hours I felt back to normal.
swollen lymph nodes, purple spot like the size of a quarter under left arm. Then swelling goes down 3 1/2 inches and about 2 1/2 inches wide. EXTREME fatigue...sleeping 12 hours plus 1 or 2 naps., no energy. Swelling is also under right arm but smaller. headaches, blurry vision, dizzy, out of balance. There are many lumps under my arm pits. All I want to do is sleep. After first shot, I got the second on March 12, 2021 and third 10/25/2021. I don't know if I should get the fourth.  . Each vaccination has been worse, fever from 99.3 to 100.8 comes and goes. Severe body aches also come and go.  Somedays I mostly stay in bed. THE MAIN THING I WANT TO KNOW IS SHOULD I GET THE 4TH VACCINATION...I'M I GOING TO GET MORE ILL?
Received vaccine on 7/25/23; Patient passed out morning of 7/26/23, was found to have very low blood pressure and was admitted to hospital Wednesday 7/26/23 through Saturday 7/29/23; Patient blood pressure gradually increased during admission, reportedly the physicians at hospital thought vaccine could have lead to this adverse event and did not find anything else they felt was responsible for patient passing out.
Bad headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) and NAUSEA (Nauseous) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported adverse event).    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 18-Jan-2021, the patient experienced HEADACHE (Bad headache) and NAUSEA (Nauseous). At the time of the report, HEADACHE (Bad headache) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Case number PHEH2013US020738 is an initial spontaneous report received from a pharmacist on 02 Oct 2013 and a follow up report from the pharmacist received on 06 Nov 2013: This report refers to multiple patients of unknown age and gender. They were vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) intramuscularly on 02 Oct 2013. The pharmacist reported that these patients received flu vaccinations from opened and unopened multi dose vials of flu vaccine that was stored improperly with ice packs during a flu clinic intensive. The ice packs melted during the day and the duration of exposure to room temperature of the MDVs was estimated at 8 hours. At the time of this report, pharmacist was unsure of the identity of the MDVs was FLUVIRIN or another flu vaccine, but they insisted that FLUVIRIN was one of many flu vaccines that were provided at their facility. The reporter did not have any patient information to provide nor any additional information related to number of people who may have been vaccinated inadvertently. No further information about outcome, seriousness and causality was provided. The pharmacist confirmed that there was no adverse event. Follow up report from the pharmacist received on 06 Nov 2013: The pharmacist confirmation regarding the adverse event was updated.
Fever and intense chills, soreness in muscles and joints in legs. Took 650mg of Tylenol and the chills subsided half an hour to an hour later. Hot and cold flashes persisted throughout the night, but fever and leg pain had resolved by morning.
Lymph node in neck became swollen. Feeling tried and exhausted and dizzy all day. Cannot perform normal daily functions because of tiredness and near syncope.11/12/2009 MD records for 10/20/2009, patient with c/o's lump lt side of neck. PE noted a small, mobile, 1cm mass. Tx: observation Dx neck mass ICD-9 code 784.2
Gastrointestinal issues; Anxiety; Face movements; Nose tingling on the left side; Mouth tingling on the left side; He feels like his muscles move on the inside; Migraine; Vomiting; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Gastrointestinal issues), ANXIETY (Anxiety), DYSKINESIA (Face movements), PARAESTHESIA (Nose tingling on the left side) and PARAESTHESIA ORAL (Mouth tingling on the left side) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, LEVOTHYROXINE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Gastrointestinal issues), ANXIETY (Anxiety), DYSKINESIA (Face movements), PARAESTHESIA (Nose tingling on the left side), PARAESTHESIA ORAL (Mouth tingling on the left side), MUSCLE DISCOMFORT (He feels like his muscles move on the inside), MIGRAINE (Migraine), VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Gastrointestinal issues), ANXIETY (Anxiety), DYSKINESIA (Face movements), PARAESTHESIA (Nose tingling on the left side), PARAESTHESIA ORAL (Mouth tingling on the left side), MUSCLE DISCOMFORT (He feels like his muscles move on the inside), MIGRAINE (Migraine), VOMITING (Vomiting), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Went to ER and was treated for migraine and GI with injections and also Tylenol
parasthesia/tingling/burning in bilateral torso, face, upper & lower extremities which ocurred 3 hours after Moderna vaccine on 4/26/21. Symptoms persist
Information has been received from a physician's assistant concerning a 14 year old female with a history of a seizure when she was 10 years old who on 21-AUG-2009 was vaccinated with a 0.5 mL dose of GARDASIL (lot # 659054/0311Y). Secondary suspect vaccination given on the same date included doses of VARIVAX (Merck), VAQTA (Merck), MENACTRA, and ADACEL. The patient had a seizure right after getting the vaccinations. She was taken to the emergency room and was given phenytoin 100 mg BID (manufacturer/description unknown). They wanted the patient to follow up with a neurologist. Therapy with GARDASIL Was discontinued. Subsequently, the patient recovered from seizure. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.  9/25/09 PCP medical records received DOS 8/21/09. Assessment: Unspecified epilepsy without mention of intractable epilepsy. Patient was sent to ER for seizures after vaccine administration. 12/9/09 Received ER medical records of 8/21/09. FINAL DX: Records reveal patient very scared of receiving shot & experienced seizure like activity same day.  Not on seizure meds.  Dilantin restarted, d/c to home & referred to PCP  12/16/09 Medical records received for dates 9/3/09 to 9/16/09 DX: seizure disorder. Pt presented w/ seizure after gardasil vax dose 1. ER recs received for date 8/21/09 DX: seizure. pt was receiving vax, pt stated scared of needle, and had aseizure.
The vial for Pfizer booster for 5-11 years of age did not have enough diluent added to the vial- 0.13 mL was added to the vial instead of the correct 1.3 mL. Patient therefore got a higher dose of vaccine. Family was notified, and they report that patient had no adverse effects.
The patient had and a known SARS-CoV-2 vaccine sometime in February 2021. she then started having a mild diarrhea and some nasal congestion early in March 2021 and she had abrupt passing away on 3/5/2021.  Autopsy was not performed.
Pt lost consciousness approximately 2 minutes after vaccine with full body myoclonic jerks for 30 second duration.  Pt had confusion for 10 minutes, HR 50 bpm, diaphoretic. Pt transported to ED.
103.7 fever  3 days / swollen arm 4 days/ every joint muscle in exstreme pain 3 days/ fatigue all day for 4days alternated tynol and advil got fever down to only 101   /stayed in bed for 72 hours  arm and shoulders are still sore this is second time in my life that this has happened to me first time was at age 23
Therapy non-responder  This case was reported by a nurse and described a female subject of unspecified age who did not respond to immunization to separate injections of hepatitis B vaccine (manufacturer unspecified) and hepatitis A vaccine (manufacturer unspecified).  On an unspecified date the subject received a dose of hepatitis B vaccine (dose number and lot number not provided). On an unspecified date, the subject received a dose of hepatitis A vaccine (dose number and lot number not provided).  On an unspecified date in 2005, at an  unspecified time after vaccination with hepatitis B vaccine and hepatitis A vaccine, titers for hepatitis B surface antibody and hepatitis A antibody were negative.
angiodema. hospitalized overnight. During the hospitalization pt was started on an epi gtt and given MTP 125 mg. He had subsequent hyperglycemia, and increased his rate on his insulin pump to 2 U/hr (from 0.83 U/hr). Pt then decreased his rate to 1.4 U/hr while on the epi gtt, and then to 1.1 U/hr when off of the epi gtt. He also strengthened his carb ratio from 1:12 to 1:10 last night.Pt reports he had postprandial hyperglycemia overnight after his meal, but then BG corrected overnight. Pt reports fasting this morning is in the 110s. This morning's breakfast on 1:10 CR with well controlled BG.
2nd dose administered >36 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >36 days after 1st dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >36 days after 1st dose). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >36 days after 1st dose) had resolved.            Concomitant medications were reported as lot of medications but the names were not provided. Patient did not have any allergies and there were no COVID positive test reported.   This case was linked to MOD-2022-473316 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Updated patient's Date of birth and reporter information.
Soreness at injection site, one 10 minute shivering event 10 hours after vaccination, tiredness.
One week after first Moderna Covid19 shot He got Shingles in right eye and on right forehead which lasted for 5 and one half weeks with many blisters and screaming horrifying pain. Intraoculalar pressure was 31 when examined by ophthalmologist
Body aches; fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 15-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0191) via an unspecified route of administration in the arm right (reported as right arm) on 14Jun2021 11:45 (at the age at vaccination of 15-year-old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with covid-19 and post the vaccination, the patient was not tested for covid-19. On 15Jun2021 13:00, patient experienced body aches and had a fever. Patient did not receive any treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Shot was administered very high on the arm, practically in the shoulder socket or ligament.  Shot was extremely painful when administered.  I still have considerable pain in the shoulder/muscles, radiating down my back.  Movement is affected in that shoulder.  The pain comes and goes during the day, but is severe enough to wake me several times in the middle of the night.  I have continued to excercise and stretch the affected muscles but it is painful to do that.  I mentioned it to my doctor approx 2 weeks after the shot, who told me to continue to monitor it and continue stretching.  I really can't afford to go to an orthopedist at this time.
Blood/mucus in stool within 24 hours. Clinically, I presume this is incidental milk-protein induced allergic colitis, but given onset within 24 hours of rotavirus vaccination, I deemed this appropriate to report. Mother breastfeeding and had eaten significant amount of ice cream shortly before onset. Resolved with maternal dairy elimination.
4:32 PM 10/29/08 - Dad called , his daughter slipped off her chair at preschool onto floor and had a seizure did recover and is alert.  Dad is 15 min away - will pick her up and take her to Pediatric ER- 911 nurse called PRN
DIZZINESS; WEAKNESS; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced dizziness. On 21-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, weakness, headache, chills and nausea was not reported. This report was non-serious.
Patient was administered and Expired vaccine; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered and Expired vaccine) and NO ADVERSE EVENT (no adverse event) in a 77-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered and Expired vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered and Expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered and Expired vaccine).    No concomitant medication was reported.  No treatment information was reported. Date of expiration of the vaccine was reported as 23-MAY-2023.
Allergic reaction on injection site; A report was received from a nurse concerning a 62-year-old female patient who received her first of two planned doses of mRNA-1273 vaccine and experienced allergic reaction on the injection site.  The patient's medical history was not provided. Concomitant products reportedly used by the patient included, fish oil and black seeds.  On 23 DEC 2020, the patient received her first of two planned doses of mRNA-1273 vaccine (batch# 011J20A) in the left arm for prophylaxis of COVID-19 infection.  On 01 JAN 2021, the patient developed  an allergic reaction on the injection site. The reporter mentioned It was uncomfortable; the site was swelling and red, looking like a rash.  Treatment for the event included Diphenhydramine and cold compression with ice packs.   Any action taken regarding the vaccine as a result of the event was not reported.  The outcome of the event was considered resolved on 05 JAN 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Patient was flushed and red within the first 5- 10 minutes with a metallic like taste in her mouth, returned to nurse. When patient returned to nurse she was itchy and had hives on her chest and going up her neck onto her face. No breathing difficulty or throat tightening at that time noted. Patient took Benadryl and reported to feel better in 15 minutes.
Within 15 minutes of receiving vaccine, client became dizzy, got a head ache. Client's heart rate was 104 bpm and blood pressure was 191/116. Oxygen stat was 95% on room air. EMTs had client lay down. Client was also given a cookie and some juice.  Client was with EMTs for an hour. Blood pressure lowered to 175/110, and pulse to 80 bpm. Client refused EMTs taking her to the hospital. Client and client's daughter were advised to take client to hospital. Client stated that her daughter would take her to hospital.