chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced immediate pain upon administration of the vaccine and explained that it hurt worse than any flu shot she had received in the past. Patient is still experiencing pain after over a year, but it has regressed in severity.
Red rash noted adjacent to and below injection site after injection was administered. No swelling noted. Client denied SOB, itching, pain or other symptoms. Client monitored for 20 minutes and no changes to rash or worsening of symptoms. Explained mild vs serious allergic reaction and instructed to go to ER if symptoms worsen or if SOB develops.
Pt reports fever, severe chills, body aches, nausea and vomiting  starting 12 hours after vaccine and lasting about 24 hours
Intermittent left sided facial numbness and tingling on forehead, cheek, jawline and left half of tongue. No facial dropping or paralysis. After numbness goes away face is sore. Occurred day of vaccine 1/10 for 4 hours, 1/11 for 1 hour, 1/25 for 10 hours and 1/26 currently experiencing.
Case patient received first Pfizer COVID-19 vaccine on 12/10/2021, no known history of prior acute COVID infection. Case-patient developed MIS-C on 1/1/22 (illness onset). Case-patient met case definition for MIS-C, with evidence of clinically severe illness requiring hospitalization, with multisystem organ involvement (cardiac, hematologic, gastrointestinal & dermatologic). The case-patient experienced bradycardia, cervical lymphadenopathy, rash and vomiting. The case-patient was treated with IVIG, steroids and antiplatelets and survived after a 4 day hospitalization.
Patient has has seizures in the past, unknown to cause, but since the 1 st and 2nd subsequent dose patient is now having seizures daily . He had extremely high fever with the second dose
My exclusively breast fed son started showing signs of atopic dermatitis on his right cheek and legs approximately 24-36 hours after I received my second COVID-19 vaccine. His skin got progressively worse over the next 4 - 5 weeks--both cheeks were affected, his neck, his trunk and back, and his arms. His legs were least affected. We saw the pediatrician on 4/9/2021 because his rash/skin reaction was bright red and "streaky" on his arms. His face also looked a little puffy to me under his left eye. Due to the timeline of the events and the fact that his reaction progressed over the course of a couple of weeks, it seems likely that this could be a reaction from my breastmilk that contains antibodies. There is some primary literature available that describes IgA and IgE levels in breast milk over time after COVID-19 vaccination. One such research letter was recently published online on April 12, 2021: SARS-CoV-2?Specific Antibodies in Breast Milk After COVID-19 Vaccination of Breastfeeding Women.
This spontaneous report as received from a CMA (certified medical assistant) refers to a patient of unknown age and gender (no demographic details were provided). The patient's medical history was unknown. On 28-JUL-2012, 28-FEB-2013 and 28-MAR-2013, the patient was vaccinated with GARDASIL, 0.5 ml. GARDASIL was administered subcutaneously. The administration of GARDASIL on 28-MAR-2013 was a medication error. No adverse effects were reported. Additional information has been requested.
Cold sores, Severe Pain upper arm, High Fever, Cough, Sneezing, Runny nose, Malaise, Mucus congestion, Feeling of impeding Doom
after the first dose had broken out into hives from head to toe; This is a spontaneous report from a Pfizer sponsored program. A contactable Other Health Professional reported for a 12-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left deltoid on 04Jun2021 (at age of 12-year-old) (Batch/Lot Number: EW0186) as single dose for covid-19 immunisation. There was no medical history. The concomitant medications were not reported. The patient got the first dose of the Pfizer covid vaccine and after the first dose had broken out into hives from head to toe. They treated her with Benadryl but she is not better and therefore they will prescribe steroids. The outcome of the event was not recovered.; Sender's Comments: The causal association of the event urticaria in relation to suspected drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be totally excluded based on known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
local pain in the site of injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (local pain in the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 Vaccine (Dose-1) on 01-Mar-2021, Pfizer COVID-19 Vaccine (Dose 2, Lot number-EN6200) on 21-Mar-2021, Pfizer COVID-19 Vaccine (!st booster dose and Lot number- SF2588) on 22-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine, Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine. Concurrent medical conditions included Hypercholesteraemia (Recent change in status such as improvement or worsening: no) since 2005, GERD (Recent change in status such as improvement or worsening: improved since 2 years ago) and Osteoarthritis (Recent change in status such as improvement or worsening: no). Concomitant products included SIMVASTATIN for High cholesterol, ESTRADIOL, AMMONIUM LACTATE, CALCIUM and VITAMIN D NOS for an unknown indication.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced VACCINATION SITE PAIN (local pain in the site of injection). On 16-Apr-2022, VACCINATION SITE PAIN (local pain in the site of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking Ammonium Lactate for elbows.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-662810 (Patient Link).
Chest pain; abnormal heartbeat; shortness of breath; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 as dose 3 (booster), single (Lot number: GJ6743) at the age of 42 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: possibly Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Tetracycline, reaction(s): "known allergies Tetracycline"; Doxycycline, reaction(s): "known allergies Doxycycline". Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: Lot #FF8839, Route of Administration: Intramuscular), administration date: 27Sep2021, when the patient was 40-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: Lot #EW0178, Route of Administration: Intramuscular), administration date: 01Sep2021, when the patient was 40-year-old, for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 25Jan2023, outcome "not recovered"; HEART RATE ABNORMAL (non-serious) with onset 25Jan2023, outcome "not recovered", described as "abnormal heartbeat"; FATIGUE (non-serious) with onset 25Jan2023, outcome "not recovered"; DYSPNOEA (non-serious) with onset 25Jan2023, outcome "not recovered", described as "shortness of breath". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There was no other vaccine in four weeks. There was no other medications in two weeks. There as no covid prior vaccination. There was no covid tested post vaccination.
Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030368) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Caller stated that the confusion happened when after got shot, the vaccination provider told to schedule next shot and to come back in 2 months).    Concomitant medication was not provided. Caller stated that there was an issue at their pharmacy where they received the new Spikevax 2023-2024 vaccine. Reporter wants to make sure that they have received the correct vaccine and provided the lot number. Caller's husband came on the line and stated that the confusion happened when he got his shot, the vaccination provider told him to schedule his next shot and to come back in 2 months. They figured out that they were looking at the incorrect dosing schedule of the previous vaccinations and that both of them did not need to come back in 2 months. Caller wants to confirm with Moderna whether they received the new Spikevax 2023-2024 formula or not.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741521 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741521:Wife case
Baby brought to ED by squad.  Found unresponsive at home with no pulse.  Remained in asystole throughout resuscitation attempt.  10/24/2008 Autopsy report states COD as Undetermined, not c/w SIDS; manner of death undetermined.  Report also states pathological diagnoses: pulmonary edema, mild; minor skin injuries to face; small for developmental age by weight & head circumference; and terminal aspiration of gastric contents.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 29-AUG-2016, the patient was vaccinated with a dose of VARIVAX (strength, dose and frequency were unknown; lot number was reported as M006733 with expiration date 09-FEB-2018). VARIVAX was improperly reconstituted with "0.5 ml, from a separate, 10 ml single dose vial of Sterile Water for injection, for drug diluent use, manufactured by Hospira, lot # 54-152-DK with expiration date 01-JUN-2018" instead of the Merck supplied diluent. No adverse effect reported. This is one of the twelve reports that received from the same source. Additional information has been requested.
Child received pediatric dose of Pfizer COVID vaccine when he should have  received an adolescent/adult dose
Joint and muscle pain; difficulty walking; fatigue; some stomach pain for 1 week. Another week (this week) of fatigue but joint and muscle pain lessened; however stomach/abdominal pain has increased ?  bloating after eating, feeling full quickly, difficulty sleeping due to bloating and stomach pains, pressure on stomach/abdomen, increased stomach size, general fatigue and energy to walk upstairs.
Chills approx 6 hours after receiving shot Injection site tenderness (no redness or swelling noted) Muscle aches and joint pain at 8 hours At 12 hours, fatigue, nausea (20 minutes), headache, congestion, low grade temp 99.5, malaise  Hour 17 fever to 100.5 took 800 mg Advil and 1000 mg Tylenol.  Hour 24 all symptoms completely resolved only very mild injection site tenderness. Felt at baseline.  Afebrile.
Patient tested positive for COVID-19 on 7/15. She was seen in the ED on 7/20 for worsening shortness of breath, cough, and sore throat. While in the ED, she was placed on 1L O2. Patient was admitted from 7/20 - 7/23 for acute hypoxic respiratory failure due to COVID-19 pneumonia and acute exacerbation of HFpEF, newly diagnosed. Patient has been vaccinated and boosted against COVID-19. This meets criteria for vaccine breakthrough case review.
Initial symptoms shortly after vaccination was a sore arm. Symptoms that appeared approximately 24 hours after vaccine - headache, fatigue, chills, fever (100.4), clammy. All symptoms, except for sore arm, were gone within 24 hours
Fainted (05/31/21), pallpitations, heart skipping beats. Went to ER, high troponin levels. Tests done, blood work, chest x-ray, echocardiogram, ct scan, cardiac catheritization, cardiac MRI. Was admitted for two nights at the hospital. Released on 06/02/21
lt deltoid area very swollen & red; mom says swelling extends to shoulder & below inj site; lymph node under arm swollen-saw MD today; was given rx for ATB as precaution;
Patient received the vaccine on Tuesday 5/4/21. On Thursday evening 5/6/21 she noticed redness at the injection site.  It was mildly warm, red and slightly itchy.  Went to see her physician the next day, he circled the red area. It was about 4 inches in diameter.  She took benadryl and ibuprofen.  No signs up systemic reaction.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender not reported) who was inadvertently vaccinated with an expired dose of suspect vaccine 0.25 mL FLUZONE QUADRIVALENT lot UT5949JA via unknown route in the thigh on an unspecified date (reported as Monday). The patient's medical history and concomitant medications were not reported. No other vaccines were administered. It was an actual medication error due to expired vaccine used. It was unknown whether the patient had any harm or not. 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 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. List of documents held by sender: none.
All vaccines were administered normally. Pt tolerated well. After administering vaccines, it was found that HIB was expired. Expiration date was 10/08/23 and vaccine was given 10/16/23. Pt did not show any concerning signs or symptoms of any type of adverse reactions to the vaccines. We reached out to the help desk (Health Authority) and they informed us that patient will want to repeat this dose. Patients mother was informed and agrees to get this dose repeated and pts next well child exam.
Approximately three days after the Shingrix vaccine  I developed  what looked like a patch of Shingles rash on the right side of my body on my  waist above my hip bone. The patch was red and raised and hurt to the touch. Three days after that I stopped by the pharmacy to ask the pharmacist if this was normal. She told me to report the reaction. A week after recieiving the vaccine I still have the patch, it is still sore but not as bad.
Bacteria in eye; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group and medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE INFECTION BACTERIAL (non-serious), outcome "unknown", described as "Bacteria in eye". Additional information: As reported, "Bacteria in eye changing with new covid variant. Can the vaccine be the cause of the new covid variant. Covid protein resynthisied then cells dived. Covid protected cells ask other bacteria, stomach or eye bacteria that have existed with humans since the beginning. Then our friendly microbiome changes. No co existant? With body is bad science. Our micro bio is co habit. Quit allowing new covid administration and changes to our microbiome dna over concern before propper science."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
had side affect pain in my arm for three weeks; arm / could hardly use it,; couldn't sleep on it; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, mobility decreased and difficulty sleeping. On an unknown date, the outcome of the pain in arm, mobility decreased and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the pain in arm, mobility decreased and difficulty sleeping to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient had pain in arm for three weeks. The patient could hardly use it, and definitely he/she could not sleep on it. The patient stated that, but after the fact, he/she guessed it was worth it.
Violent diarrhrea continued from 3 pm on 9/19 and discontinuing about 8 am on 9/20. No nausea or stomache cramping.
I feel like crap; raised mark on arm where the shot was given about the size of a quarter; sore; aches and pains across his chest and muscles; aches and pains across his chest and muscles; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was unknown), via an unspecified route of administration on 08Mar2021 (at the age of 72 years-of-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced i feel like crap, raised mark on arm where the shot was given about the size of a quarter, sore, aches and pains across his chest and muscles. The patient wants to know if it was unusual for it to take a week for a raised mark on his arm to show up which starting yesterday (unspecified date), and he does not have a temperature. The patient wishes to be transferred to ED. The outcome of events was unknown.  Information on the lot/batch number has been requested.
First Hep A vaccine on 10/05/2005. On 11/07/05 after vaccine felt light headed on 11/08 woke up with hallucinations, could see air, numbness of foot and leg, blurred vision like out of focus, tired, fatigued, slurred speech. By 5 pm friend arrived with Nyquil and noticed glassy eyes, was still having hallucination was seeing smoke like people figures. Taken to the ER, there had problems breathing, still had hallucinations. Given steroids and IV released by night and doctor mentioned that it was a severe allergic reaction. At home, at 11pm, began to hallucinate again, was seeing walls that were not there and curtains took shape of people. Breathing problems reoccurred. On 11/9 at 2-3am hallucinations stopped. Have been having night sweats, hearing went rot, and vision is blurry.
HEART CONDITION; This spontaneous report received from a patient via social media concerned a 25 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was used to be healthy before vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart condition. The action taken with covid-19 vaccine was not applicable. The outcome of heart condition was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
3 x 31/2 inch red raised area Use warm compress and tylenol for any discomfort
This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 19-FEB-2019, the patient was vaccinated with improperly stored M-M-R II (lot # R019684, expiry date: 09-JUL-2020 also reported as 10-JUL-2020) for prophylaxis. Nurse has reported that M-M-R II was reconstituted with properly stored Sterile diluent. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported. The outcome of product storage error and no adverse event was unknown. This was nine of nine reports mentioned in the report. Lot number R019684 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Sender's Comments: US-009507513-1903USA009054: Master case #.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/24/2021 and 3/17/2021 .68/F PMHx DMII, HTN, morbidly obese, hypo and hyperthyroidism, asthma and depression. Covid-19 + was going to get monoclonal antibody infusion but sats were in the low 80's subsequently told to report to the ED.  Presented with acute hypoxic respiratory failure 2/2 Covid-19 PNA.  Tx'd w/decadron, Tocilizumab, remdisivir, Lovenox and O2. Per pt. request care not escalated beyond non-invasive ventilation. Expired 12/09/21.
Case completed covid vaccine series in APril 2021, then was hospitalized for COvid and subsequently died of Covid.
Patient came in to the store and said she got vaccines for shingrix and fluzone hd and said her arm was red peeling not painful a little sore and lasted a whole week and went away. The patient is fine now she just want to let us know. Patient said she did not need to go to the urgent care or er and she did not go see any doctors.