chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of an unknown age and gender. Medical history and concurrent conditions were not reported. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of ROTATEQ lot # K015816 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. The healthcare professional informed that the total excursion time for this lot was 63 hours. This is one of several reports from the same reporter. Additional information has been requested.
Gave second dose 1 week before actually due. Not due until 9/28/21
The pt developed pain, warm to touch, swelling and itching at injection site from top of shoulder to elbow. On 05/09/2002, redness and swelling went to middle of upper arm to middle of forearm. The pt was put on Keflex.
acthib that was a given to a 15 month old patient instead of pentacel with no reported adverse event; Initial information received on 18-Apr-2023 regarding an unsolicited valid  non-serious case received via pharmacist.  This case involves 15 month old patient who was  given acthib [Act-Hib] instead of pentacel with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection dose series 4 at dose 0.5 ml (strength, route, batch number, expiry date:unknown via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date , acthib  was a given to a 15 month old patient instead of pentacel (wrong product administered) same day latency with no reported adverse event.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.   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.
Had swelling after pneumonia shot. Size of ? and felt faint, applied ice. Swelling resolved. Case closed.
Became very dizzy early in the morning. Along with lightheaded. Took two Tylenol. Dizziness was off and on for two days. At its worst I also felt nauseated
I've received flu shots for years, with minimal side effects. Around October 2017, I received a flu shot at work. It was administered more in the tricep than on the side of the arm. I mention it, because it was unusual. Over the first week, moderate localized soreness diminished, but crept down my left arm, almost to my hand. Over the 2nd week, the soreness gradually diminished, changing to a numbness & tingling the crept further down, into my pinky & ring fingers. One day, I felt the same numbness & tingling radiate up to the left side of my face, but that lasted less than a day. Now, September 2018, I still have the numbness & tingling down my arm into the pinky & ring fingers. It varies from day to day. The range is from mild to barely noticeable. Today, it is on the upper end of my normal range, and I'm noticing a very mild numbness on the left side of my face as well. As I'm writing, I'm even noticing a tingle in my other two fingers. I'm hyper-aware today or just an unusually "tingly" day. I don't know. Note - last night & today, I am experiencing symptoms of a head cold that has run through my office. In general the impact has not gone beyond the numbness & tingling. Other than the first two weeks, I feel that my range of motion, strength and grip are nearly normal. p.s. I have a cyst in my left arm which I always point out when receiving a shot.  They usually just move a bit to the side.  This person went more 'under' the arm - thus the tricep location.  I often wonder if that was related to the adverse reaction.  Not criticizing - seemed like a good idea at the time.  p.p.s.  Thinking I'll skip the shot this year, and go back to it in 2019, depending on how this progresses, but my mom is 90, and my granddaughter is 2, so I might get it this year. undecided.
Pt presented 10 d. after vaccines with >3cm smallpox lesion, mild to moderate erythema, subj. c/o SOB on exertion, fatigue, malaise, intermittent chest pressure, generalized aches & pains. VSS, SpO2 98% RA, CBC WNL; card enzymes: neg troponin, (+) myoglobin, (-) CKMB, unable to run CK; mildly elevated LFTs - AST 139, ALT 39; t bili & GGT nl; CXR nl.
Shaking and nausea on day of injection. Day 2 nosebleed. Days 2, 3, 5, 8, 9 breakthrough menstrual bleeding. Day 5 nosebleed. Day 9 nosebleed. Nosebleeds continued approx every 3 days, breakthrough bleeding every 1-4 days. Menstrual cramping severe every month after shot. Irregular menstrual periods. No doctors will officially recognize this outcome.
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 27 August 2014, the subject received an unspecified dose of BOOSTRIX (0.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 11 February 2014. The subject was exposed to the vaccine at 28 weeks and 1 day gestation. At the time of reporting, the pregnancy was ongoing. Follow-up information received on 06 October 2014: VAERS details were provided.
Lymph node in injection arm swollen and painful. Dull ache present in entire arm. Began two days after injection, became significantly more unpleasant on day 7.  It is still day 7 at the time of this writing.
Arm rash on injection arm; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: lot/batch number: EN 6198) via an unspecified route of administration in the left arm on 21Feb2021 at 18:00 (at the age of 36-year-old) and her second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot/batch number: EN 6206) via an unspecified route of administration in the left arm on 14Mar2021 at 18:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included juvenile idiopathic arthritis, uveitis, sjogrens and pituitary adenoma. She was allergic to penicillin, erythromycin, Ceclor, Keflex, naproxen, doxycycline and Valtrex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included multivitamins was taken for an unknown indication 02 days before the vaccination. On 17Mar2021 at 07:00, the patient had experienced arm rash on injection arm. It was reported that the patient did not receive treatment for the event. The clinical outcome of the event arm rash on injection arm was not resolved. No follow up attempts are possible. No further information is expected.
PATIENT RECEIVED ADDITIONAL DOSE OF MODERNA. HE EXPERIENCED THE NORMAL RASH THAT CAN OCCUR AFTER SHOT AND SEVERE BRUISING THAT HE DID NOT REPORT AT THE TIME. IT RESOLVED. THEN THIS WEEK THE BRUISING HAS COME BACK SPREADING THROUGHOUT THE WHOLE UPPER ARM AND IT APPEARS HE POSSIBLY HAS A HEMATOMA CLOSE TO THE ANTECUBITAL FOSSA. PT IS RECEIVING CHEMO AND INFORMED US ON 10/1 THAT ON THE DATE OF HIS SHOT HE HAD LOW PLATELETS. NP ONCOLOGY WAS CONTACTED THEY ASKED PATIENT TO COME TO THE INFUSION CENTER FOR EVALUATION.
I woke up on 2/13/23 and experienced a very runny nose. A slight dry scratchy throat. 2/14 I lost sense of taste and smell which caused me to test. I tested positive on an at home COVID-19 test. Televisit with doctor. Doctor prescribed PAXLOVID and to treat symptomatically, otherwise symptoms were the same. After about 2 days symptoms got noticeably better. Never spiked a fever. Symptoms gradually improved until a day after the PAXLOVID finished. After the PAXLOVID ran out, the runny nose went back to wat it was before, but gradually improved over the course of a week.
Otherwise healthy 18 yo male who developed urticaria roughly 33 hrs after receiving 2nd dose. Urticaria involved trunk, upper extremities and neck. No systemic symptoms (no wheezing, angioedema, vomiting, lightheadedness, etc). No other obvious cause of urticaria, but urticaria onset seems rather delayed to be due to Pfizer COVID-19 vaccination
Patient initially had some abdominal pain, which she attributed to be anxious/nervous about getting the shot.  Within 2-3 hours of the shot, she developed a rash on her neck, abdomen, and wrists.  She said she never felt SOB or like her throat was closing.  She was already taking Benadryl for eczema, and said the rash resolved in 48 hours.
Sore throat and difficulty swallowing; no fever or nasal symptoms. No treatment indicated?
pt had COVID Moderna vax on Monday March 8.. Later that day she had an injection at her dentists office of possibly novacaine. Pt  on Thursday March11 pt developed a rash that has progressed over the 2 days subsequently. She has had no changes in medications which she takes chronically for diabetes and hypertension.  She has had no change in soaps and no new foods that she has had contacts with.  She has no previous history of allergic reaction to any foods or medications.  She was unaware of any insect bites.  She describes the rash as being pruritic and that has progressed since Thursday.  She has not taken any medication for the rash
Tachycardia. BP increased to 201/147. Hemiplegic migraine. ED thought initially I was having a stroke. I do have a history of migraines but this was significantly more significant/impactful than previous episodes. I also had significant copious vaginal bleeding that is very unusual for me.  I was sick for a over a week after with difficulty thinking, visual disturbances and dizziness.
Moderate to severe fever (reaching at least 100.4 degrees F) debilitating headache resulting in inability to drive or perform basic motor functions well
On 10/27/08, at another visit, the patient's mother reported that the varicella injection site had grown to approx. 10-12 cm. There was redness to the area and there was not any pain associated with this.  On 10-27-08 the physician noted that the swelling was remarkably smaller, approx. 1-2 cm, with minimal redness.
Tetanus-Diphtheria (Left arm) 11 Sept 03 Approximately 3-4 hours after receipt of vaccination, service member noted that her "jaw felt tight on both sides." Stated it was painful to chew.  Does not recall any swelling or click when opening mouth.  Took Tylenol for 4-5 days with some relief.  Reports mild erythema and tenderness at site of tetanus vaccination for about a week. Since then, the stiffness has improved but she still notices it upon awakening in the morning and late in the evening.  Has not experienced any similar jaw pain in the past.  Denies any teeth grinding.  Last dental exam August 2003-no cavities or decay at that time, but she is scheduled for oral surgery for reconstruction after return from 1 year assignment.  Denies any ear or neck pain. Has a history of migraines/tension headaches but has not noticed any increase in headaches since receipt of vaccinations. Of note, she is certain that she received a TD booster in March 2002 for deployment but it was not recorded in medical record. Treatment: Tylenol, warm compresses. Follow-up with primary care provider.
client received immunizations. Had vomiting after receiveing immunization. Had c/o throat hurting. BP 100/60, P 92, R 32, EMS called, client left after assessment was ambulatory, no transport, no problems when left with mother. Mother states later he has HX of vomiting when upset or mad.
Information has been received from a medical assistant concerning a female who on approximately 05-MAR-2007 was vaccinated with the first dose of Gardasil. On approximately 05-MAR-2007 the patient fainted in the waiting room 10 minutes after vaccination. The patient was recovering. The patient will discontinue further series of the vaccine. Additional information has been requested. This is in follow-up to report (s) previously submittedon 4/13/2007.  No Further information expected. It was reported that another female fainted after GARDASIL vaccination (WAES 0403USA04745).
Shaking after Shingirx; Chills after shingrix; Lack of appetite after shingrix; Pounding headache after shingrix; This case was reported by a physician via call center representative and described the occurrence of tremor in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tremor, chills, appetite absent and pounding in head. On an unknown date, the outcome of the tremor, chills, appetite absent and pounding in head were recovered/resolved.   It was unknown if the reporter considered the tremor, chills, appetite absent and pounding in head to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but the age vaccination could be 60 or 61 years. The chatter reported 4 days of shaking chills, lack of appetite,  pounding headache after dose 1 of Shingrix. The chatter was healthcare professional and patient and refused to give any additional details including their name. The reporter did not gave permission to follow up.
CRAMPS IN LEGS AND TOE / CRAMPS EVERY NOW AND AGAIN EVERYWHERE; SEVERE ABDOMEN / STOMACH CRAMPS; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 230 pounds, and height was 73 inches. The patient's concurrent conditions included: grass molds allergy (grass molds in the springtime some allergy symptoms. fall is worse with taking meds), alcohol use (0.5 in a week), and non-smoker, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient never had cramps issue. 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 01-APR-2021 16:51 for covid-19 prophylaxis. Age at time of vaccination 54 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced cramps in legs and toe / cramps every now and again everywhere, and severe abdomen / stomach cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramps in legs and toe / cramps every now and again everywhere, and severe abdomen / stomach cramps. This report was non-serious.
This spontaneous report was received from a pharmacist concerning an unknown number of patient, of an unknown gender and age. Medical history and concurrent medications were not reported. On an unknown date the patient was vaccinated with a dose of COMVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported.  Pharmacist reported that, on an unknown date, an unspecified number of patients received improperly stored COMVAX. No symptoms reported.  This is one (1) of 3 (three) reports from the same source (MARRS 1408USA009356, 1408USA013073 and 1408USA013074). Additional information has been requested.
Within several hours after receiving PNEUMOVAX developed pain & swelling in arm around injection site. By next day, redness surrounded upper arm circumference & swelling worse. Seen 3 days later & red swollen area 4 inches x 2 inches in diameter. Warm to touch.
Nausea - immediately after  Headache at 9:30 am Fever at 6:30 pm Body aches 6:30 pm Arm pain/soreness 9:00 am
5 mins after shot, there was tingling and burning in neck and left side of face, difficulty swallowing. After two hours I had numbness and drooping of the left side of my face, lip and teeth. Severe headache. High bp. 50mg of benadryl and deconomine IV were given. Medrol dose pack to follow and benadryl for on week. I still have joint pain, severe knee pain, neck pain and constant headache. Follow up on 06/23/04 states: "Left arm "rock hard and red" from injection site to wrist. Also experienced some diarrhea. Told she was probably allergic to some vaccine component. In 2001, after 1st dose of ANA vax, pt "blacked out" was treated with epinephrine and stayed overnight in hospital for observation."
Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received second dose of the Moderna Covid-19 Vaccine past the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that Moderna Covid-19 vials were moved from the freezer to the fridge on 06-May-2021. The 30-day expiration date was on 05-Jun-2021. Patient received their second dose of the Moderna Covid-19 Vaccine on 09-Jun-2021.  Concomitant medication not provided.  Treatment information not provided.
Itchy, erythematous pustule burning rash over upper chest area along dermatome.
CONFIRMED COVID-19; This spontaneous report received from a patient concerned a 24 year old female. The patient's weight was 150 pounds, and height was 70 inches. The patient's concurrent conditions included social drinker, and non-smoker, and other pre-existing medical conditions included patient did not have any known drug allergies. patient did had any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206a21a, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced confirmed covid-19. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 20-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per the standard procedure as the case is assessed as non-serious.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown demographics. The patient's concomitant conditions or medical history were not reported. On 12-OCT-2015, the patient was vaccinated with a dose of Liquid PEDVAXHIB with expiration date on 06-AUG-2015 (dose, route, anatomical location and lot were not provided). No adverse effect was reported. Additional information has been requested.
Have been experiencing headaches and problems with speech. Have a tightening feeling in his chest. Was giving antibiotics.
a little bit of soreness at the injection site; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on left arm on 18Jan2021 at single dose for COVID-19 immunization and apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date and ongoing at an unspecified dose and frequency for an unspecified indication. Medical history included Afib years ago, heart rate abnormal (reported as heart rate); and sleeping with oxygen but has not had any trouble breathing which was ongoing. Concomitant medications included propranolol hydrochloride (MANOPROLOL; also reported as MONOPROLOL) for Afib and unspecified medication to control heart rate. The patient reported that he got the first dose of COVID vaccine with no problems but had a little bit of soreness at the injection site the next day (19Jan2021). The patient was taking apixaban and mentioned that he did don't know if that was important or not. The action taken in response to the event for apixaban and the outcome of the event was unknown.
Complaining of generalized itching and rash to back of both upper arms that began about 4/27/00. Most recent symptoms that developed are swelling to joints in fingers, ankles and both feet.
Havrix adult administered to 18 months-old; Havrix adult administered to 18 months-old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 18-month-old patient who received HAV (Havrix adult) (batch number W006214, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The registered nurse reporter that the pediatric patient received Havrix adult dose. The reporter had no patient or product other than lot number (which was not registering as a lot number in database). The reporter reported that it was unknown Havrix was solution or PFS. The reporter consented to follow up. Additional Supportive Information: The pediatric patient received Havrix adult dose, which led to overdose and adult product administered to child.
PARAPLEGIA & NEUROPATHY , SXS STARTED 8/2021, 2 MONTHS AFTER GETTING FIRST MODERNA COVID VACCINE, FACILITY UNKNOWN, INJECTION SITE UNKNOWN
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # L010595, expiration date 12-NOV-2016) were administered to an unspecified number of patients. No adverse effects have been reported. The reporter stated that there was no product quality complaints involved. This is one of several cases from the same reporter. Additional information is not expected, because the reporter refused additional contact.