chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sores on the tongue and slight swelling of the tongue. Saw doctor on 12/6/2021 who prescribed Zyrtec. Sores and swelling were mostly gone by 12/7/2021
Affected my eyes.  They felt gainy, watering, red, sore, burning.  This happened one other time about ? 7-8-9 years ago.  I have Fuchs Dystery.
Pt recvd a series of 3 inject of Engerix-B 14NOV91 30 min following 3rd dose c/o arm feeling dead or not there; This feeling lasted 8-12 hrs; As of 15NOV91 pt had normal feeling again; no tx required; pt found to be neg when needle stuck;
Intense pain in arm. Limited mobility. Unable to sleep on left side. Pain is worse at night and in the mornings. Also, experiencing dizziness and loss of balance at times.
pt came to report in person that the flu shot she got on 9/6/19 was giving her a lots of reactions that she'd never had before. She complained of muscle ache of the whole body, more on the upper thigh, legs, painful + swelling on other parts of body + chills. She only took Advil due to liver problem. She did not want to disclose other meds.
Stomach pain; Gastrointestinal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and GASTROINTESTINAL PAIN (Gastrointestinal pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate To Severe Adult Crohn's Disease).   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and GASTROINTESTINAL PAIN (Gastrointestinal pain). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and GASTROINTESTINAL PAIN (Gastrointestinal pain) was resolving.            There was no reported medical history.  Concomitant medications details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   It was reported that the patient had stomach pain and colon pain.  The reporter's causality for the event(s) of STOMACH PAIN and COLON PAIN was not provided for Humira.  No treatment medication were provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Pfizer bivalent COVID  vaccine vial was punctured on Friday 11/18/22 at approximately 10am and 6 doses drawn up into syringes. These syringes were stored at room temperature. Dose administered to the patient on 11/21/22 was from a syringe that had been drawn up on Friday 11/18 and stored at room temp.  Pfizer contacted for stability information, which they did not have for these storage conditions. Patient is being contacted for re-vaccination.
No adverse effects were reported; patient received GARDASIL 9 on the following dosing schedule: first dose on 7/14/17, and second dose on 7/5/2019; This spontaneous report as received from a nurse refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 14-JUL-2017, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On 05-JUL-2019, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dosage form (exact dose, route of administration, lot number and expiration date were not provided) for prophylaxis. No adverse effects were reported.
Sudden onset of severe left upper abdominal pain lasting about 7 hours- it was incapacitating; curled up in a ball and just waited it out. No appetite; able to take sips of water. No nausea, vomiting or diarrhea. It eventually faded away. Had episodic fatigue and occasional headaches for the next 1 1/2 week.
Cold sore blisters in the right nostril, the right side above the lip, right side corner of the lip, and chin. Burning eyes. Right side lymph nodes in the neck are swollen. Sore throat, headache. Right side stabbing pain in the ovary area.
Swollen nodules in throat; Swollen nodules in throat; administration date=29Mar2021, dose number=1  29Mar2021, number=2; administration date=29Mar2021, dose number=1  29Mar2021, number=2; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old (also the age at time of vaccination) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 29Mar2021 (Batch/Lot Number: EN6208) as DOSE 1 and on 29Mar2021 (Batch/Lot Number: ER8732) as DOSE 2, both given via an unspecified route of administration administered in arm right,  SINGLE for COVID-19 immunization.  Medical history included none. Concomitant medications were not reported.  On 21Apr2021, the patient had swollen nodules in throat. The patient had negative nasal swab on 30Jul2021. Prior to vaccination, was the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events of swollen nodules in throat. Outcome of the events of swollen nodules in throat was not recovered.   Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid (start date: 21Oct2023, stop date: 26Oct2023).  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353007 same patient, different drug, different event;
pt began vomiting & having diarrhea soon p/vax given;It has persisted for several weeks now;4 visits to MD & several medical bills have resulted as well;irritability & weight loss have resulted for pt;
Seen 11/12/2003 for soreness right arm one week post tetanus diptheria- persistant discomfort right deltoid. Told to take Ibuprofen PRN as she had not previously. Resolved itself finally 12/3/03 right arm still somewhat sore).
pt recv vax 16MAY95 & on 25MAY95 devel a low fever w/a temp of 99.2, severe back pain, weakness in limbs, & a heavy feeling in limbs;26MAY95 pt recovered;
Two days later, patient reported "buzzing " sensation to her face. Primarily right side of face and down to chin. Had increased weakness to her right side and right pupil sluggish. She was sent to the ED and then returned to our facility the same day when no acute issues were found. Per patient, similar symptoms to one of her previous strokes. Per husband, patient had a heart attack after her initial Covid vaccination series (pfizer) and did not want her to get the booster but patient wanted it so chose to go with the Moderna for the booster since it was a smaller dose.
This is a spontaneous report received from a contactable consumer (parent). A 12-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0172), at the age of 12, via an unspecified route of administration, in right arm, on May 14, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The parent called on behalf of her son who is 12 years old. The patient received his first dose. The consumer wanted to know if her son experienced a reaction to the vaccine, should he get second dose. He has not eaten all day. He did not shower before the hives. He did not do anything different or do anything different. The patient did not take any other product. The parent spoke with her son's primary care provider. The doctor does not think this reaction was from the vaccine but she believes it could be related to the vaccine. On May 14, 2021, patient had a sore arm. On May 17, 2021, he had itching, felt something in his throat and hives. Treatment was received for the event hives. The patient did not go for any investigation assessment. The parent gave the antihistamine; and the hives are going down slowly. Parent asked was there anything else to alleviate her son's discomfort and itchiness. The outcome of urticaria, oropharyngeal discomfort: recovering; while other events: unknown. Follow-up (Jul 5, 2021): Follow-up attempts completed. No further information expected.
feeling sick; This is a spontaneous report from a contactable consumer (Patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 08Jan2021 for COVID-19 immunisation. Patient received Pfizer Covid-19 vaccine first and 2nd dose and experienced strong side effects yesterday and feeling sick (on 29Jan2021) today but not like yesterday. The outcome of event was unknown.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
immediate pain and noted a hematoma at the injection site, over the next several hours the pain increased and I was unable to move the arm, started to feel sick about 6 hours later, that night had (covid like symptoms-I had it before and it felt the same) severe body aches, rigors, chills, fever 102, dizzy, nausea, h/a, the next morning I was unable to function and the left arm was very difficult to move, sinus pressure, mild cough
Dizziness, lightheaded,  HA-throbbing. Waited 15 mins extra. Evaluated by EMS- Cleared
No adverse effects after does shot. 12 hours after second shot symptoms began: chills, slight nausea, extreme tiredness, slight headache, back ache. Nausea lasted a few hours, chills stopped after 12 hours, extreme tiredwas gone the next morning when I woke up at 10 am. Slight headache in the morning on days 2 and 3
Left arm at injection site swollen, red, tender with a large knot in the muscle after injection and persisted for 1-2 weeks after; area still red, not swollen, small 2 cm knot still present.
feeling dizziness; weakness; he has fallen a couple of times; runny nose; My head is full; increasingly frustrated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021907889 (Pfizer).  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12May2021 (Lot number: EW0182, Expiry date: Unknown) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "stent put in heart" (unspecified if ongoing), notes: Had a stent put in his heart 10 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EW0182), administration date: 21Apr2021, when the patient was 81 years old, for Covid-19 immunisation.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "feeling dizziness"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; FALL (non-serious), outcome "unknown", described as "he has fallen a couple of times"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "My head is full"; FRUSTRATION TOLERANCE DECREASED (non-serious), outcome "unknown", described as "increasingly frustrated". Therapeutic measures were taken as a result of rhinorrhoea.  Additional Information: Patient received both doses of the vaccine on 21Apr2021 and 12May2021. About a week or so after the second dose he reports feeling dizziness, weakness, and he has fallen a couple of times. This has occurred for the last three weeks. Patient also stated that patient got his Covid 19 Vaccines and has been noticing the last couple of weeks that he is having dizziness and weakness. Asks if that would have anything to do with the vaccine. The dizziness and weakness has started within the last 3 weeks, and he fell down a couple of times. Patient started getting frustrated with the questions for the report. Patient also states that he didn't have any dizziness or weakness before getting the vaccines. The caller received the second dose of the Covid 19 vaccine 12May2021 and has been feeling dizzy and their nose is running. Caller states for the last couple of weeks, he has been taking Flonase and other stuff and it won't stop. Clarified that he filed the report about the dizziness and runny nose yesterday when he called. Caller does not have reference number from previous report. The health center he goes to recommended that he take it. He's got diabetes and high blood pressure. Had a stent put in his heart 10 years ago. There was a product complaint to report. Product strength and count size dispensed was not provided. There is a medical information request.  Follow-up attempts are completed. No further information is expected.
Bleeding at injection, then extensive bruising (contusion) still continuing 11 days since the vaccine was administered. (Reaction to vaccine itself was a bit of aches, pains, slight fever, gone after 24 hours).
assistant gave ADACEL to a 3 year old with no reported adverse event; already received the 4 doses of DTaP and was mistakenly administered ADACEL with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 years old female patient and it was reported that assistant gave diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] to a 3 year old and already received the 4 doses of diphtheria, tetanus and acellular pertussis vaccine [Dtap] and was mistakenly administered Adacel with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria, tetanus and acellular pertussis vaccine produced by unknown manufacturer (batch/lot number, expiry date, strength, formulation, route: not reported) in unknown administration site for prophylactic vaccination (immunization). 3 other doses of the same vaccine were administered on unknown dates.  On 21-Feb-2023, assistant gave 0.5 mL of suspect diphtheria-2/tetanus/5 AC pertussis vaccine suspension for injection (1X; batch/lot number: U7624AA and expiry date: 06-Dec-2024; strength: unknown) via intramuscular route in the left thigh for prophylactic vaccination (immunization) to a 3 year old (product administered to patient of inappropriate age) and the patient had already received the 4 doses of dtap and was mistakenly administered adacel with no reported adverse event (inappropriate schedule of product administration) (latency: same day).   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event   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 guidelines. 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.
Patient reported sudden onset of left sided headache 7/10 pain.  CBG last evening was 120.  Current VS: 36.8, 65, 18, 135/86, 98%.  B/P 15 minutes later:  125/79.  CG drank a large amount of water and 2 juices and felt better shortly thereafter.
Inconsolable crying as though she were in pain; swelling, redness, and hot at the injection site, sore leg.  Crying lasted almost 3 hours until she fell asleep.  Gave her infant Tylenol around 7pm.  She was not interested in eating much for about 24 hours after the injection.  Lethargic and sore the next day. Still sore the 3rd day.
Acute renal failure due to biopsy proven acute interstitial nephritis after first dose of Moderna Vaccine. Patient received vaccine 3/22/21 and presented to 4/9/21 with acute renal failure. She was started on dialysis. She received a renal biopsy that confirmed the diagnosis. She remains on dialysis support at the time of this writing
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender.  No information was provided regarding the patient´s (pt´s) concomitant medications, concurrent conditions or medical history. On or about 01-AUG-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, anatomical location and lot # were not provided) by a pharmacist as recommended for the long-term prevention of shingles and zoster related conditions. Subsequently, on an unspecified date, the patient was treated in a local medical center for shingles.  As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The pt had not recovered from shingles.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Shortness of breath starting one day after vaccination, worsened over 4 days, admitted to ED 4 days post-vaccination, found to have acute hyperoxemic respiratory failure, treated with supplemental oxygen, albuterol/ipratroprium, methylprednisone, bactrim, CTX/doxy, diuretics., diagnostic work up includes ILD,  DAH, pneumonia  Work up and hospital stay not completed, outcome unknown at this time
Client called clinic 7/15/21 complaining of congestion, headache, and fatigue. Client states he expected to have these symptoms but now his family is exhibiting the same symptoms. Client was wondering if he passed his symptoms to his family. Client was educated that he cannot pass his symptoms from his COVID shot to his family, but that his family probably picked up a cold around the same time he received his vaccine.
7 year old given Boostrix/Boostrix in 2022, Tdap in 2021, not received any DTaP or Tdap prior; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number MY5G5, expiry date 31st January 2023) for prophylaxis.   Previously administered products included Tdap vaccine (received a dose of Tdap of unknown brand in September 2021 at age of 6 years from another provider and no further details were available regarding the dose ).   On 22nd March 2022, the patient received Boostrix. On 22nd March 2022, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 27-May-2022 Reporter's comment: The patient was a refugee and prior to the dose of Tdap given in September of 2021, had not received any DTaP or Tdap doses.  The pharmacist stated that Boostrix was given to a 7 years old patient. No further details were provided at the time of the call. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Boostrix at 7 years old age, which led to inappropriate age at vaccine administration.
This spontaneous report was received from a Nurse refers to an unspecified number of an unspecified patients of an unknown age and gender. On an unknown date, an unspecified number of an unspecified patients were vaccinated with improperly stored PNEUMOVAX 23 injection 25/0.5 y (unspecified units) prefilled syringes lot # K020800 (expiry date: 05-JUN-2016) (dosage not reported). Temperature excursion reported was 56 F for 6 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
When I got the shot, I felt a severe burning sensation. I didn?t feel anything from the 1st dose, but I did get a rash.   5/22-23: 101.5 fever, chills, body aches, jaw pain   5/24-26: felt back to normal other than slight fatigue and jaw pain   5/27- severe chills, aches, fever came back and jaw pain   5/28- flu symptoms remain + and bleeding gums throughout mouth + sores   5/29- flu symptoms subside but gums are more inflamed and red
Feeling ill by the time I returned home after receiving the Covid shot. Upset stomach, nausea, loss of appetite  weakness, chills, sweats, shaking, headache, soreness and aching in back and neck, tingling, numbness, sensation of cold in arm that received the injection, pain, loss of strength.   24 hours bed rest. Increased fluids, acetaminophen, naproxen. Still sore, achy, feeling weak nearly 48 hours after receiving the shot.
This case was reported by a nurse via sales rep and described the occurrence of chills in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, influenza-like symptoms and pruritus. On an unknown date, the outcome of the chills, influenza-like symptoms and pruritus were unknown. It was unknown if the reporter considered the chills, influenza-like symptoms and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX and reported chills, flu like symptoms, and itching around his waist.