chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left arm pain at site Very swollen Lymph nodes, caused inflammation and circulation in left arm Could not hold arm up to stop pain, could not have it down at a normal position without pain Pain was more like build up pressure Took Several days to one week to go down Happened about 12 hours after injection (I did have weird tingling in my throat when I was waiting after the injection was done during my second shot) Seen by doctor, given prescription strength Aleve for swelling and pain It took almost 48-72 hours to feel back to normal and able to function without pain.  I could not wear a bra or anything tight or restricting during the time. Extreme tiredness and exhaustion during that time.   Booster shot I had same thing happen with arm and lymph nodes, except it did not happen for 48 hours after injection. I had tiredness for the first 24 hours after booster, then swelling kicked in.
Patient experienced dizziness at the time of the injection, and also experienced more dizziness as well as trouble breathing about 24 hours after injection.
expired Quadracel was given to a 5 year old accidentally, no AE; Initial information received on 22-Aug-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a five years old male patient who accidentally received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5248AA, Exp. Date 21-Aug-2019) via intramuscular route in the left deltoid, on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  It was reported that 5 year old was given a dose of Quadracel that expired yesterday. The patient was not administered any other vaccines.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Documents held by the sender: none.
doesn't believe vaccine was given in muscle; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, Caller was a nurse and noticed that the injection doesn't look like it was given in the muscle. She stated nothing indicates she got a shot, no muscle soreness and wants to know what Pfizer recommends. She stated this is her 2nd dose. Provided number and cold transferred for AE due to wait times, since caller doesn't believe vaccine was given in muscle the patient experienced doesn't believe vaccine was given in muscle on an unspecified date with outcome of unknown.    Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt experienced itching on hands, then raised hives on neck, eyelids and got puffy then itching on belly and legs. MD suggested to take 2 Benadryl 25mg. Pt saw MD at about 3:30 pm.
Had pain immediately following the injection 5/10 and is ongoing today. The pain radiates to her left shoulder blade. Reports it is an annoying and nagging pain. 48 hours after the injection she had a red rash over her trunk and on both arms. The rash was itchy. She took Benadryl for the rash and it resolved after two days.
Insomnia, headaches, ear ringing, muffled hearing and plugged ears.
A lot of pressure in the head area of ??the temple. and headache, arm covid inflammation, dark spot after the 1st dose on the arm, stomach pain, high fever, weakness in the whole body
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program, PFIZER FIRST CONNECT. A contactable pharmacist reported similar events for three patients. This is the third of the three reports. A patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Jan2021, for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. On an unspecified date in 2021, after the first vaccination, the patient had COVID-19 confirmed by positive COVID-19 test and was put on isolation. The outcome of the event was unknown. The reporting pharmacist was wondering if there was a need to hold off the second dose of vaccination or if it could be administered on 07Feb2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity after the first vaccine dose.,Linked Report(s) : US-PFIZER INC-2021148508 same drug and event, different patient;US-PFIZER INC-2021148568 same drug and event, different patient
The infant was taken to the PMD on 02/28/01 with a rash and a fever within 24 hours after his Prevnar injection. The patient is crying, irritable, chokes easily, dime sized, red maculo-papular rash to the abdomen, buttocks, and shoulder since the night before, also blisters on the buttocks. Difficulty breathing this AM while eating. PMD feels it is a reaction to the vaccine does not recommend to repeat vaccine, also diagnosed pharyngitis.
Hospitalized at Hospital with suspected vaccine-strain VZV infection, which was confirmed by specimen analysis at CDC's laboratory.
Erythematous pruritic rash approx. 3in diameter over injection site of right deltoid that resolved after 48hrs.
Tinnitus; Headache; Foggy; Sore arm; Swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 16:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. Concomitant medications included norethisterone acetate, ethinylestradiol (AUROVELA 1/20) from an unknown date for birth control, omeprazole (PRILOSEC), and vitamins nos (MULTIVITAMIN) both from an unknown date for an unspecified indication. 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. On an unknown date in 2021, the patient experienced headache/foggy, sore arm and some swelling for 3-4 days. On an unknown date in May2021, 1 week or so prior to the second shot, the patient experienced tinnitus, the patient have never had it before, and it has not resolved. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache/foggy, sore arm and some swelling recovered on an unspecified date in 2021. Whereas, that of tinnitus was not recovered.  Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
When received the shot burned, Sore arm for 5 days. At day 9 arm swelled with hives from elbow to shoulder. Very itchy. Put cold compresses on it, took Benadryl, and took Motrin. Woke next morning with cold sores all over chin, so I took Valtrex. The next day the arm looked better, almost cleared up. Cold sores remained for 1 week with medication they didn't brake open and went away.
Myalgia, "not feeling well, having aches and pains all over" Narrative:
shortness of breath/somewhat having difficulty of breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/somewhat having difficulty of breathing) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B321A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESILATE (VASALAT) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE + SALMETEROL) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced DYSPNOEA (shortness of breath/somewhat having difficulty of breathing). At the time of the report, DYSPNOEA (shortness of breath/somewhat having difficulty of breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
Fever, body aches, stomach pain, nausea and vomiting. Started approximately 3.5 hours after receiving SHINGRIX. Pt took two 81 mg aspirin at onset of symptoms, then 2 more about 4.5 hours later. Returned to clinic about 20 hours later with continued symptoms. Prescribed Ondansetron for the nausea/vomiting and advised to take OTC ibuprofen for the fever and body aches.
She did not have an adverse reaction to the vaccine. On 10/31/2023 is when her respiratory illnesses started. She had croup first, asthma was flared up; strep throat infection and mono. As of today, she is feeling well.
Contracted COVID 19 twice post full immnization, first time was in September 2021 and the second time was 11/10/2021. URI symptoms
Very lethargic around 6pm day of shot Flu like symptoms from 7pm to 8 am  Fever broke after that and started to feel better Still lethargic until 2 days later
post herpetic pain all the time; it stings and burns all the time; cannot sleep; This case was reported by a consumer and described the occurrence of post zoster pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in between the live vaccine and Shingrix patient had bad case of shingles). Previously administered products included shingles vaccine (received live shingles vaccine in 2012) and Shingrix with an associated reaction of post herpetic neuralgia (received 1st dose in 2017, refer case US2021048483).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced post zoster pain, pain burning and sleeplessness. The patient was treated with lidocaine hydrochloride (Lidocaine Gel). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the post zoster pain, pain burning and sleeplessness were unknown.   It was unknown if the reporter considered the post zoster pain, pain burning and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient received Shingrix and had post herpetic pain all the time, it stings and burns all the time and could not sleep.  The patient treated with lidocaine gel did not relieve pain.  The patient received 1st dose Shingrix and it boosted immune system but the second shot did not.  The reporter did not consent to follow up.  The lot and expiry not provided by caller.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021048483:same reporter
sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A, 025A21A and 091D2A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm after first dose). The patient was treated with CORTISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm after first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications reported was high blood pressure pill and thyroid pill.   This case was linked to MOD-2021-375439, MOD-2021-375557 (Patient Link).
Fever to 103F, h/a & emesis 12hrs p/vax given lasting 24hrs then fine;
Swollen lymph nodes in armpit and chest of the injection arm. feels like edema to the touch and tender when arm is in a lowered position.
Immediate heart pain, nausea, difficulty breathing, pain in arm radiating down to fingers, numb fingers and hand pain. Staff came and put monitor on me in less than a minute due to heart racing and dizzy. Stayed at facility over injectors watch named "private". Facility called me for next few days to see how I was progressing. I was having all the above issues and made appointments with my doctor. I continued to have leg pain on left side, numb fingers and radiating arm pain.
INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED OUTSIDE OF RECOMMENDED STORAGE AREA; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 21-OCT-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced incorrect product storage, and vaccine administered outside of recommended storage area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and vaccine administered outside of recommended storage area was not reported. This report was non-serious.
I was itchy above my belly button; This is a spontaneous report from a contactable consumer or other non-HCP.   A 74-years-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 as a DOSE 1, SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I was itchy above my belly button. Caller called earlier and reported the information about his wife's problem. Ever since she had the vaccine she's had been extremely itchy. Her first shot was on 24Feb2021 and then they postponed the second to 24Mar2021. After the first shot she was itchy and was itchy for 2 weeks. I told them that, but they gave her the second shot and she got itchy again. They told him to go to pharmacy to get Benadryl. Caller went to a doctor instead but all the doctors were gone. He got her some children's Benadryl. She's was like a puppy with fleas. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
There was a temperature excursion on 4/21/2020. I unfortunately did not discover this excursion until I came back this week from leave.  The dose was given from an open, multi dose vial. This dose and opened vial was deemed unusable by manufacturer and health department. Patient is to be re-vaccinated per manufacturer and health department recommendation.  The patient's physician will be reaching out to the patients parents to explain what happened and to have them come back for their Polio vaccine. At this time the parents have not reported any adverse reactions from the vaccine that was given.
Acute respiratory failure with hypoxia Plan to discharge with steroid burst to be completed in 3 more days.  Also ordered Spiriva and albuterol inhaler.  Recommend he follow-up with primary care or pulmonary clinic for further evaluation including pulmonary function testing. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
p/vax pt exp approx 25 lesions which cleared up in a couple of days;pt sought unspecified medical attention;lesions scabbed over p/3 days &  pt exp a fever of 101;
A non-serious spontaneous report of "received some H1N1 LAIV liquid in her eye" was received from a registered nurse/health professional concerning an approximately nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 21-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. While receiving the vaccine, the patient jerked her head around and some H1N1 mist got into her eye. The eye was immediately flushed with water or saline. There was no adverse event associated with this medication error; therefore, reporter causality assessments are not applicable and the event was considered resolved.
Tenderness at shot site during the day, light fever and exhaustion in the evening leading to no sleep despite exhaustion due to fever dreams and light chills during the night.  Subsided by 0400, slept until about 1130.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-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) at an unspecified dose. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In 2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the event of fever was not reported for cosuspect humira. No treatment medications were reported. 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.   This case was linked to MOD-2022-621576 (Patient Link).   Reporter did not allow further contact
Onset urticaria approximately 12 hours after vaccine; urticaria worsened - seen in office at 3pm 8/27.  Generalized urticaria face, extremities, trunk not c/w drug (Amox) rash in my opinion.
Patient experienced extreme tiredness, whole body aches, even bones & joints, on Sat had red raised rash that ran from injection site to elbow, back & legs sore, hurt to touch her back, too tired to leave home. Now on Tues 11/14/17 she is still too tired to do normal activities and is sore, but not as much actively hurting.
got them right now; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had shingles 7 times. The patient had Shingles vaccine and got them right now. The patient had to wait 6 months before he/she could get the shot. The patient stated a shot did not stop them and he/she hope this was the last time. The follow-up could not be possible as no contact details were available.
Injection site pain/swelling; Injection site pain/swelling; arm pain; severe muscle aches and muscle fatigue x3 days; severe muscle aches and muscle fatigue x3 days; low grade fever nightly x3 days; headache; eye balls ached; some nausea; diarrhea; fatigue; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received bnt162b2 (COVID 19), dose 1 via an unspecified route of administration, administered in left arm on 16Jul2021 18:15 (Lot Number: EW0181) as dose 1, single at the age of 60-year-old for COVID-19 immunisation. The patient was not pregnant. Medical history included HTN (hypertension),  hypothyroidism, DJD (degenerative joint disease), secondary hyperparathyroidism, known allergies PCN (penicillin). No other vaccine in four weeks. There were other medications in two weeks. There were concomitant medications. The patient experienced injection site pain/swelling, arm pain, severe muscle aches and muscle fatigue x3 days (as reported), low grade fever nightly x3 days (as reported), headache, eye balls ached x4 days, some nausea x3 days (as reported); diarrhea and fatigue persisting x2 weeks on 16Jul2021 21:00. No treatment received. No covid prior vaccination. No Covid tested post vaccination. The patient underwent lab tests and procedures which included fever: low grade. The outcome of severe muscle aches and muscle fatigue x3 days, low grade fever nightly x3 days, some nausea was recovered on 18Jul2021. The outcome of diarrhea and fatigue was recovered in Jul2021. The outcome of other events was recovered in2021.   No follow-up attempts are needed. No further information is expected.
1700 throat swollen, malaise, numbness on left side. Seen in ER, given BENADRYL and steroids.