chrisvoncsefalvay/vaers-outcomes huggingface dataset:
09/18/2013 Dnr passed out just after injecting Tetanus vaccine, but before retracting needle. Dnr was sitting on exam table with back against wall and didn't fall. Aministrator of vaccine was abe to support dnr and withdraw needle. Dnr was helped to lying down position on his back. He came to within about 10 seconds. Vital signs were taken, legs were elevated, and oral water was administered. After lying down approximately 30 minutes he sat up, vomited, and stated he felt much better and his VS returned to a  normal level after having been in the low range.
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 31-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Have two red blotches; Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Have two red blotches) and MYALGIA (Arm is sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Have two red blotches) and MYALGIA (Arm is sore). At the time of the report, RASH MACULAR (Have two red blotches) and MYALGIA (Arm is sore) outcome was unknown.            No medical history reported. No concomitant drugs reported. No treatment drugs reported.    Reporter did not allow further contact
This spontaneous report was received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L026408 with expiration date: 15-JUL-2017 (doses and routes of administration were not reported) for prophylaxis. There were no adverse effects reported. The administered doses of vaccine experienced a temperature excursion of more than 5 Fahrenheit but less than 14 Fahrenheit for 3 hours. There was no Data logger involved or previous temperature excursion reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Information has been received from a registered nurse referring to a 16 month old male patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies.   On 15-FEB-2017, the patient was vaccinated with a dose of PROQUAD (lot # M036159, expiration date: 12-FEB-2018, in the right leg, dose and route were unknown) and a dose of M-M-R II (in the left leg, dose, route, lot# and expiration date were unknown)both for prophylaxis.  On 15-FEB-2017, the patient at night time experienced redness and swelling in his right and left leg. The nurse stated that the patient's mother gave her child advil for 2 days. The redness and swelling in the right and left leg was no longer present. The patient recovered from the events on an unknown date of February 2017. No lab diagnostics studies performed. The patient did not seek medical attention. Causality was not provided. Additional information has been requested.
Two days after the vaccine I had an elevated resting heart rate of 100-110 when it?s usually in the 60?s. I had an extreme headache but three days later on May 1 it became lightheadedness and almost a feeling of being numb headed. I do have autonomic issues but the sensation in my head was different than anything I have from my prexisting health issues. It?s like I?m cloudy, spaced out,  and numb in my head. Sitting can make it a little better, but regardless of posture I feel spaced out and numb headed and much more tired than ever before. It?s a very pronounced feeling and makes me feel like I?m not as oriented as I should be doing daily activities such as driving or just basic tasks around the home. It?s what I guess some describe as brain fog. I have had memory issues from covid infections, but not this numb and spaced out feeling. I had four other Pfizer covid vaccines and this did not happen to me. This is new with this biovalent vaccine.
Several itch red dots on sole of right foot; Several itch red dots on sole of right foot; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew8736) via an unspecified route of administration in the right arm on 11May2021 at 16:30 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). Concomitant medications included melatonin (MANUFACTURER UNKNOWN) 5mg a night and unspecified postnatal vitamins; both for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 13May2021 at 12:00, the patient experienced several itch red dots on sole of right foot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event.  The clinical outcome of the event several itch red dots on sole of right foot was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
joints hurts a lot; slight fever, 100F; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), ARTHRALGIA (joints hurts a lot) and PYREXIA (slight fever, 100F) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced ARTHRALGIA (joints hurts a lot) and PYREXIA (slight fever, 100F). At the time of the report, CHILLS (chills), ARTHRALGIA (joints hurts a lot) and PYREXIA (slight fever, 100F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
My son recieved the shot in his right leg. He was complaining of pain around the area. By the night time he was limping. He woke up and can barely put pressure on the leg without wincing in pain.
Approximately 26 hours after receiving the 2nd dose of the pediatric Pfizer/BioNTech COVID19 vaccine, female child was getting dressed and as I (her mother) was brushing her hair, she turned around and told me, "I don't feel good" and then fainted. At first I wasn't sure what happened, so I got her onto the floor and then called 911 and by the time they answered (likely approximately 30-45 seconds from the onset of symptoms) she was responsive again. The ambulance arrived within minutes and she was evaluated by the EMTs. The EMTs then called the ER doctor that said she should be brought to the emergency room to be seen by the doctor.
vaccine exposed to 31 degrees Fahrenheit for a couple of days with no A/E; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a pharmacist via a consumer via physician via phone call (under Medical Information Inquiry Number: 00864185).  This case is linked to cases 2021SA392836, 2021SA392839 and 2021SA392842(CLUSTER).  This case involves a 66 years old male patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 13-Nov-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ764AC and expiry date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?"  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Chills, fever of 100, severe injection site muscle soreness, nausea, aching, headache, nausea, purulent conjunctivitis, fatigue.
Shoulder and arm pain, aching joints and muscles, diarrhea, abdominal pain, tiredness  - lasted on and off for over a week. Pronounced some days.
2nd shot. A little over an hour severe cramping,  freezing,  dizzy, feels like I need to puke or use bathroom and can't do either.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) and concerned a 36 year old female. The patient's height and weight were not reported. The patient's past medical history included: surgery for retinal detachment and concurrent conditions included: asthma, depression and sulfa drug allergy. The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered to the left arm on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 34 years old. Concomitant medications included bupropion (drug started on NOV-2020). The patient also received non-company suspect vaccine included: Moderna covid-19 vaccine (dose number in series 2) (form of administration, route of administration and batch number were not reported, expiry: unknown) dose was not reported, administered to the left arm on OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 35 years old. The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 15-AUG-2022 to 19-AUG-2022 for treatment of COVID-19. It was reported that the patient had rebound covid after finishing the Paxlovid and tested negative for two days on 20-AUG-2022 and on 21-AUG-2022, after finishing the treatment. The patient mentioned on 22-AUG-2022, the third day in the raw, she tested positive without symptoms (coded as suspected covid-19 infection) (dose number in series 2).   The action taken with covid-19 vaccine ad26.cov2.s was not applicable, (Moderna Covid-19 Vaccine) was not applicable and with Paxlovid was drug discontinued. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Headache, Myalgia & Rash Narrative:  Swelling left hand. Glands in neck swollen. The swelling in her neck was still present on 9/27/21.
The symptoms began about 4pm and rapidly worsened over the next few hours. We were in the ER by 12am. Hives; Swelling of ears, feet, and around eyes; High fever; fatigue. ER doctor prescribed Prednisone, Benadryl, and Tylenol. Follow up with Primary Doctor the day following ER visit resulted in no further testing or treatment options given.
I had chills the night of March 25. They continued the next day. I also lost my sense of taste for about 5 days.
The site is red, raised, warm to touch and has a palpable knot. Arm is sore in the general area between the shoulder and my elbow.  Patient has been using ibuprofen and tylenol as recommended to manage pain and swelling. Symptoms will be monitored and followed up with by pharmacy and medical staff of patient.
Both knees swollen - 2 wks after started administering H1N1 Mist. Dr Appt 10-19-09 - Dr - ? reason - for swelling and pain - 10-29-09 Dr - ? diagnosis - take ALEVE. Finally given MEDROL dose pk 11-6-09
Confirmed, verbally, x 2 with the gentleman that he had received Pfizer 1 and Pfizer 2 vaccine doses.  The gentleman met the criteria for moderately or severely immunosuppressed.  Unable to confirm, electronically the first 2 Pfizer doses until at a later date.  When the individual giving the third dose went to place it into Database, records indicated that he had received Moderna vaccination.
Patient went into cardiac arrest on 08/21/2021. Patient seen by wife "going down" and CPR was started within minutes. CPR performed prior to arrival to emergency room and after, patient also intubated. Patient non-responsive on arrival to hospital.  Patient ultimately died.
Mother noticed the area (right thigh) where shot was given appeared as a red 3cm induration with irregular borders - Dr. recommended warm compresses to area and call if no improvement.
Patient had Td booster 7/6/03 at ER. Reports previous booster 13 years ago. Next day, awoke with painful erythema/induration.
Pain  on injected site to shoulder up to left side of the neck for 3 days now.
Developed shingles. One day after vaccine: fatigue, intermittent headache on one side of head, achy body, tingling sensitive scalp, stiff neck. Two days after vaccine: rash and swollen lymph nodes behind and in front of ear, in a line down neck, and at collarbone. Rash on one side of body only, in a band from the back of neck, across ear, down side of jaw and neck to collarbone. Slight pain and sensitivity in entire arm where I received the vaccine, which is the same side of body as rash. Three days after vaccine: rash continues, some blisters erupt.  Four days after vaccine: rash is worse, tingling and burning, painful welts;visited clinic and diagnosed with shingles and prescribed topical medications.
As she was just eating she stated that her sense of taste is dulled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 18May2021 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: HYPOGEUSIA (non-serious) with onset 18May2021, outcome "unknown", described as "As she was just eating she stated that her sense of taste is dulled".  Additional information: It was reported that, Caller was a son calling in regard to his 56-year-old mother who received the Pfizer COVID 19 vaccine today, about 5 hours ago. He reported that she had been fine since having the vaccine but that as she was just eating, she stated that her sense of taste was dulled. He would like to know if this had been reported and should we seek medical care. It was reported, relayed to caller that if they were concerned with the symptoms to seek health care with an HCP or possibly an ENT doctor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: still tested positive after 10 days. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not receive other medication in 2 weeks. The patient received Anti-viral treatment as Paxlovid from 19May2023 to 23May2023 for Covid-19. No Known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Presented at 0905 for vaccine.  0912: Staff were called to the patient vaccine area. Patient did seem vaso vagal post vaccine (loss of color and diaphoretic), patient then appeared to have a Grand Mal type seizure with arm contracture and vomiting x4. Patient was unresponsive for around a minute. Only meds patient: BCP Patient accompanied by her mother.  o2 98%  HR 81   BP taken at 920 130/80.   0935:  Patient seemed post-dictal, very sensitive to touch and disconnected. As per Mother, the patient had a history of a prior Grand Mal seizure 4 years ago; that was never worked up. Patient complaining that she is "Very Lightheaded."   Spoke with patients primary PCP MD, she stated that it was not likely a seizure and that it was extreme vaso-vagal response and that the patient could go home if now drinking and responsive.   Patients mother also spoke with PCP and I gave her the option to decline EMS or to go be evaluated. Patients mother chose for her to be evaluated.   EMS was contacted by the local police who were working the vaccine clinic.  Vitals taken by EMS:  BP 127/61  Blood Glucose 97  0955:  EMS arrived / Patient transported to ED.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX. On 20th November 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the patient experienced pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold were unknown. It was unknown if the reporter considered the pain in arm, pain in spine, pain localized, low back pain, nausea, influenza-like symptoms, loss of energy, musculoskeletal disorder, dizziness, feeling hot and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient experienced pain and tenderness in arm. Less than a month after receiving SHINGRIX, the patient experienced spine pain, waist pain, lower back pain, nausea, flu-like symptoms, lack of pep, trouble with legs, dizziness, feeling hot and feeling cold. This case has been linked with case US2018223390 (reporter's son), reported by same reporter.
Right leg swelling  below knee , feels like needles around right ankle, call heart doctor had a scan of both legs found no blood clots have tried using  a extra water pill to bring down swelling but it comes back the next day.
Redness, minor swelling and itching at injection site. Applied OTC 1% Hydrocortisone anti-itch cream and itching resolved. Repeated 12 hours later with same results.
On 17MAY16 at roughly 1530 a PT received the wrong vaccination. The PT was administered an IPV vaccination subcutaneously in lieu of  his scheduled IPPD.
Post vax, mom reports infant cried non-stop for 3 hours after on 2/23/2000. Denied fever, local reaction or seizures. Denies high pitch cry.
Pt recv vax on 11/6/98; 20 min post vax pt exp numb & tingling around mouth to cheeks & forehead, tachycardia; tx=Benadryl
Patient awoke Saturday am 4/6/19 with feeling like she had "been hit by a truck", low grade temp, severe myalgia, Rash noted on left inner forearm approximately the size of an entire hand.  Rash right flank and abdominal wall 3 hands large.  C/o itching.  This lasted the entire day into the evening.  Finally felt somewhat better on Sunday 4/7/19.  No other symptoms of GI or respiratory.   This patient is in the medical field - a surgeon - and has never had any type of reaction to a vaccine previously.