chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Injection site soreness; generalised body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), INJECTION SITE PAIN (Injection site soreness) and MYALGIA (generalised body ache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HEADACHE (Headache), INJECTION SITE PAIN (Injection site soreness) and MYALGIA (generalised body ache). The patient was treated with OXYCODONE at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) was resolving and INJECTION SITE PAIN (Injection site soreness) and MYALGIA (generalised body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Redness, itching and pain in left arm where the injection was given. Most of the anterior surface of the arm affected.
Began with tingling in left arm after administration. Developed in to numbness in all four extremities the day after administration.
1st booster he felt sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (1st booster he felt sore arm at the injection site) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Patient had no previous medical conditions.  Previously administered products included for Drug use for unknown indication: Moderna COVID-19 Vaccine (Dose 1) on 10-Feb-2021 and Moderna COVID-19 Vaccine (Dose 2) on 10-Mar-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 30-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced VACCINATION SITE PAIN (1st booster he felt sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (1st booster he felt sore arm at the injection site) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  After primary series caller did not experienced any adverse event, but after 1st booster he felt sore arm at the injection site and this symptom were still ongoing.  No concomitant medication reported. No treatment medication reported.   Reporter did not allow further contact
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Lot number: Gh9694) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jan2023) Positive, notes: positive antigen test occured on 01Jan2023; (20Dec2022) Positive, notes: twelve days after the initial day 0 for a positive Covid diagnosis using an at home antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000696 Same patient, different product and event;
About 24 hours after injection I developed severe side effects as a result. The side effects included; Fever (up to 103.0), body chills, SEVERE vertigo, weakness, back pain, abdominal pain (cramping), diarrhea and joint pain. The side effects took about 3 days to relieve with abdominal cramping and diarrhea lasting for about 1 week.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On the following below listed dates multiple unspecified patients were vaccinated with improperly stored GARDASIL lot # K014562 expiry date of 08-APR-2017. On 09-FEB-2016 and 13-FEB-2016 the GARDASIL, was exposed to a lowest temperature of + 1.0 degree centigrade for 29 minutes and 30 minutes respectively. On 10-FEB-2016, 11-FEB-2016, 14-FEB-2016 and 16-FEB-2016, GARDASIL, was exposed to a lowest temperature of +1.2 degree centigrade for 25 minutes, 22 minutes, 24 minutes and 34 minutes respectively. On 12-FEB-2016, GARDASIL, was exposed temperature of +1.3 degree centigrade for 21 minutes. On 15-FEB-2016, GARDASIL was exposed to a lowest temperature of +1.1 degree centigrade for 25 minutes. On 17-FEB-2016, GARDASIL, was exposed temperature of +0.0 degree centigrade duration not reported. On 18-FEB-2016 GARDASIL, was exposed to a lowest temperature of -1.0 degree centigrade for 12 hours  29 minutes. On 19-FEB-2016 GARDASIL was exposed to a lowest temperature of -1.1 degree centigrade for 12 hours 1 minute. Also reported that the vaccine was administered on an unspecified date from 20-FEB-2016 to 29-FEB-2016. Dosing details were not provided. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
102 Fever, crying, irritable, Not eating much, rash on back and neck. TYLENOL every 4 hours, Ibuprofen every 6 hours.
The first symptom was that I was extremely flushed in chest and face areas and extremely lethargic. The next day, extremely lethargic, nausea and diarrhea, that night, fever and chills, the next day diarrhea, nausea, swollen and tender armpit on the arm where I received the injection. On the next day, the nausea is lessened, no more diarrhea, but still have a very tender armpit and it is still swollen. Very lethargic.
Fever of 102 F x 2 days, Chills, Left arm extremely sore to point of inability to lift x 4 days , Headache and general weakness/dizziness x 4 days, Treatment with Advil for fever, fluids, rest.
COUGH, HA, CHILLS, ST, RN, CONGESTION, NIGHT SWEATS, FATIGUE, EAR PAIN, MUSCLE PAIN, COUGH
GAVE VACCINATION WITH EXPIRATION OF 11/01/2023 ON 11/17/2023. CALLED MERCK AND SPOKE TO REPRESENTATIVE AND WAS INFORMED IN HOUSE DAT SHOWS EFFICACY/POTENCY IS INTACT AND VACCINE IS VALID. ANY SIDE EFFECTS WOULD BE SIMILAR TO THAT OF SIMILAR VALID VACCINE. SPOKE TO PATIENT AND LET HER KNOW.
Starting 7 days after I received the vaccine, I noticed a fullness/pressure inside of my chest area that lasted for a couple of weeks. After that, it just remained at night for about a week then became more intermittent throughout the day after that. I didn't become concerned until I noticed while riding my bike, my chest started to hurt, which had never happened before. I made an appointment to see my PCP who, upon examination, thought I had myocarditis. He referred me to a cardiologist and prescribed a heart monitor to wear for 14 days in the interim. I visited the cardiologist and he suggested a full stress test and some other examinations of the heart. I had a nuclear stress test and an ECG done, and will review the results with him on 02/01/2022.
has no mobility; the injection was given incorrectly; experiencing severe pain in arm; her shoulder started hurting; has sirva; she has no mobility in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 20Mar2021 at 02:15 (age at the vaccination was 63 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sore arm, flu, shingle and pneumonia; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient was received first dose of BNT162B2 (Expiry Date, NDC number: unknown, Batch/lot number: U6202) in left arm on 27Feb2021 for covid-19 immunisation and no reaction experienced. On 20Mar2021, the patient experienced has no mobility, severe pain in arm was reported as worsened, her shoulder started hurting and has sirva (shoulder injury related to vaccine administration). Additional context was received as, the patient had the second shot on 20MAR2021, a couple hours after, patient started experiencing a severe pain in her arm, and patient figured it was a reaction from the shot, but it continued for way beyond normal recommendation, and patient shoulder started hurting, patient has no mobility, and patient son is a physician, and he examined patient and said patient had sirva, patient looked it up and it's exactly what patient has, the injection was given incorrectly, now has a problem with her shoulder. The patient was talking to her son, the pain was really bad, and patient has no mobility in the arm, she can only raise it so high, and patient spoke to her son yesterday, who gave her a check up and said a lot of times if injections are injected wrong, it goes into the shoulder capsule rather than deltoid muscle, and patient has all the symptoms of it, it's very painful, she can't do what she can do with the other arm, with the left arm, and she has had injections before, the flu, the first COVID, the pneumonia, the shingles, and that is usually just a sore arm and everything, but this is a problem. The patient thought it would go away, then a week went by, then another week went by, and therapeutic measures were taken as a result of pain in arm, shoulder pain, shoulder injury related to vaccine administration and took Advil (expiry is OCT 2022, lot: DF0846, they are 350 coated tablets and 200mg), patient would take two and it wouldn't do anything, and she has a high tolerance of pain, and it's getting worse. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior was none. Outcome of the events was not recovered.  Additional Information has been requested. Further information is expected.
Approximately 3.5 weeks after JANSSEN covid vaccine, patient developed an acute pulmonary embolism.
Patient reported to observation area for monitoring post-Injection.    No prior history of adverse reactions or allergic reactions to any medications, vaccines or injections.    She reported to myself (Dr.) at 4:05 pm with feeling of lightheadedness, flushing and racing heart beat.    Initial Exam: Vitals: 143/87, HR 114, O2 sat 100% CV: Tachycardia, regular. No m/r/g Respiratory: CTAB. No w/r/r Skin: Facial flushing but otherwise no rash or hives.  Oral: no tongue or lip swelling   Patient placed in supine position on stretcher, received water hard candy.    Repeat vitals @ 4:30: 151/84, HR 107, Sp O2 100% Exam: Unchanged.    After an additional 15 minutes of rest patient was able to ambulate without assistance and ultimately return to home via uber. Boyfriend was alerted.
Patient stated that she woke up in the early morning of July 30th with chills and achiness. Later that same day she took her temperature and was running a fever of 102 degrees. She was nauseated with fever, chills and body aches. She stated these signs and symptoms lasted for about 48 hours. She is better now.
pt recv vax & w/in 18hr pt devel an inj site rxn characterized by redness, swelling & induration;pt also exp flu like sx which caused pt to miss 1 day of work;pt recovered;
Vaccine brand: Pfizer/BioNTech, product: COVID 19 Treatment; Vaccine brand: Pfizer/BioNTech, product: COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL8982), on 09Feb2021 as dose 2, single (Lot number: EN5318) and on 13Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 14Apr2022 as dose 4 (booster), single (Lot number: 027L21A) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. Concomitant medication(s) included: TRAZODONE; LISINOPRIL; CETIRIZINE HYDROCHLORIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Vaccine brand: Pfizer/BioNTech, product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks: Multivitamin, Omega 3 (brand- Spring Valley). Antiviral details- Product: COVID 19 Treatment, Brand: Paxlovid (Treatment start date: 15Jun2022, Treatment stop date:19Jun2022). After about four and a half days of no symptoms, congestion and cough returned on 16Jun2022. Patient had no known allergies.; Sender's Comments: Based on the available reported information, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.
Severe fatigue, muscle pain, cold sweats, diarrhea. Injection site is swollen about 4 inches wide, painful, red and itchy. This began suddenly and is worsening
8cm area of erythema, edema and warmth to touch @ upper left arm @ vaccine site. Advised Benadryl Q6 H, and application of 1% hydrocortisone cream PRN pruritis.
Progressive flu-like SX. DX with ADEM at Hospital. Significant swelling in brain optic nerve inflamed. Tremors up and down body, Vertigo. (Onset SX end of Dec Cold like SX sinus infection and HA's. MRI, Spinal Tap. Steroids in Hosp x 5 days, still taking Med, will continue x 4 more wk. (Prednisone tapes 30mg to 0).  3/20/07 Received medical records from hospital which reveal patient experienced ataxia & tremor beginning 12/10 w/HA.  Saw PCP & dx w/sinusitis & started antibiotics.  Developed vomiting, dizziness & continued HA & was taken to outlying hospital on 12/24.  CT revealed sinus infection.  On 1/5/07 continued to be dizzy, had tremor & was leaning to right on ambulation.  Readmitted to outlying hospital.  Repeat CT scan showed sinusitis resolved.  D/C to f/u w/PCP.   Saw PCP on 1/8 & had stiff legged walk & was instructed to take to higher level of care hospital if no improvement.  Admitted 1/9/07-1/15/07.  Consults by neuro, optham & ID.  Treated w/high dose steroids.  Improved & d/c to home on tapering steroids to be f/u in neuro & opth clinics. FINAL DX: ADEM & optic neuritis of left eye.
Severe amount of fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (Severe amount of fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient experienced FATIGUE (Severe amount of fatigue). At the time of the report, FATIGUE (Severe amount of fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.
Sudden onset of high fever (103.5), extreme weakness, fatigue, loss of taste. Some soreness in arm but not at injection site (lower down just above elbow). Fever went up (102.6) and down (99.2) for the next 10-12 hours, could not sleep. No specific pains. Finally back to normal around 5 AM and no other issues.
10 minutes after shot my left quadricep went numb. I've had constant waves of numbness in my left quad & left leg only. I have also been very lightheaded since I received my shot on Friday. It feels much like vertigo and is constant causing nausea.
fever 103, body aches, chills, joint pain, fatigue,  headache started 8:30 pm on day of vaccine.  Fever all night.
pt found unresponsive & not breathing;CPR initiated;pt taken to hosp, CPR was cont & it was determined that some organ function returned;EEG had a near flat wave pattern;placed on ventilator; life support withdrawn 3/21/99; COD: SIDS
This spontaneous report was received from a physician concerning 3 patients of unknown age and gender. The patients' pertinent medical histories or concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with ZOSTAVAX (routes, doses, anatomical locations, lot/batch# were not reported). Co-suspect therapies or concomitant medications were not provided. On an unknown dates, the physician had vaccinated 3 unspecified patients with the vaccine, and all 3 of the patients broke out in shingles. It was unspecified how or when the physician found out that the patients had gotten shingles. The outcome of herpes zoster was unknown. No product quality complaint was involved. The relatedness between the event and suspect therapy was not provided. Additional information has been requested.
It was reported that a 43 year old female patient received a TD Adult vaccination, intradermal on 01/26/2001 at 11:30am. Reportedly on 01/27/2001 at 12pm, the pt developed redness and itching. The pt reportedly recovered from this experience. From follo wup #1 correspondence received on 03 Apr 2001, additional pt information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00438, U2001-00447 through U2001-00451, U2001-00453, U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Patient develop swelling and redness on posterior left arm treated with anti-histamines, ice and cephalexan.
Vaccine manufactured expiration date was 8/31/22. Vaccine was administered to patient on 10/3/22 after expiration date. No adverse reaction was reported by the patient.
Information has been received from a nurse concerning a 57 year old male with one kidney, renal insufficiency, hypertension, hyperlipidaemia, chronic ployps and drug hypersensitivity to sulfa and SUDAFED who on 24-OCT-2007 was vaccinated intramuscularly in the left arm with his first 0.5ml dose PNEUMOVAX 23 (lot# 657526/0555U). On 24-Oct-2007, the patient was concomitantly vaccinated with influenza virus vaccine (manufacturer unknown) in the right arm. Concomitant therapy included LIPITOR, LOTENSIN, hydrochlorothiazide (manufacturer unknown), aspirin and oxycodone. On the evening of 24-Oct-2007, post vaccination, the patient stated that his arm hurt at bedtime. On 25-Oct-2007, the patient presented to the office. The patient's arm was red and swollen. The doctor stated that the patient's arm had induration, slight calor and erythema. The patient was being treated with KEFLEX 500mg twice a day, BENADRYL and TYLENOL. The patient was to return to the doctor's office if symptoms worsen or did not improve. Additional has been requested.
8 month old patient received their 2nd dose of Rotarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 732L4, expiry date 25-APR-2025) for prophylaxis.   On 24-JUL-2023, the patient received the 2nd dose of Rotarix lyophilized formulation. On 24-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 month old patient received their 2nd dose of Rotarix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter reported that baby came in for 6 month vaccines and they were doing catch-up and the 8 month old patient received their dose of Rotarix. The reporter consented to follow up. The patient received 2nd dose of Rotarix above than the recommended age, which led to inappropriate age at vaccine administration.
33 y/o male presented to clinic 11 days post vaccination with pruritic papular rash to trunk-discrete erythematous papules approx. 15 chest/approx. 15 back-present x 2 day, also c/o fever x 4 days previous. No treatment.
c/o nausea and lightheadedness after injection given. Was fine after about 20 minutes.
Shortly following the second Covid vaccine I developed a herpetic ulcer in the cornea of my right eye. I went to the emergency room and then saw my optometrist for weeks following until it healed. Last week in September 2021 I developed a shingles rash on my right upper thigh and radiating pain in my right hip. I went to my primary care doctor at the Family medicine practice who took a sample to test for the zoster virus.
Patient received a 2nd flu shot for the 2021-22 season in error today 11/9/21 @ 16:00 that was meant for her son.  Technician had erroneously administered to this patient as her name was on the consent form for her son.  Patient had just received a flu shot at this same facility on 11/5/21. Discussed potential events/outcomes that could occur and advised patient to seek medical attention if symptoms worsen.
Lip tingling and lower lip swelling. Patient carries epinephrine but does not use it. She was treated in the emergency department with Benadryl 50 mg IM and solumedrol 125 mg IV.
4 hours after injection, pain in left armlasting 2 days. Day after injection, diarea lasting 24 hours. Day after injection, neck and back pain lasting 3 days Day after injection, headache lasting 4 days Day after injection, fingertips on right hand numb and tingling. Has not gone away