chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 26th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were received as follows: The case was reported by the patient's husband. The patient felt a little fatigued after 1st dose. For tolerance to 2nd dose, refer case US2019012853.
5cm area of induration around site of MMR, VARIVAX injection, no allergic rxn, no wheezing, swelling, or urticaria. Tx with BENADRYL 9mg & cleared in 20 min. C/W local reaction.
felt bad; tired; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced feeling bad and tiredness. On an unknown date, the outcome of the feeling bad was unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the feeling bad and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient received her first dose of Shingrix in May.  The patient felt bad, and was tired with that administration but it was resolved. The emergency room visit was required. The reporter consented to follow up. This case has been linked with cases US2019172796, US2019172789 and US2019173375 reported by the same reporter
After second dose, 101.5 temperature, extreme fatigue, extensive muscle aches, headache, chills, heart rate elevated, skipping beats and then unexplained tachycardia when at rest this lasted until the first week of June 2021, they in August, I started getting warnings on my iWatch that I was having tachycardia 120 bpm. Tachycardia continues after 4th dose; I am presently under doctor supervision.
Lasting fatigue. Developed a rapid resting heart rate 109 and higher BPM; placed on medication to slow heart. Blurred vision for 3 months. Sexual disfunction.
Patient with a syncopal event while taking a hot shower- LOC estimated approx 3 minutes- recovered quickly.
persistant inconsolable crying, shaking & trembling 4 hrs; resolved on own;
Chronic fatigue; trouble sleeping; dizziness; nausea; Symptoms seem to getting worse; Dose 1 on 28Jun2021 06:45PM and Dose 2 on 28Jun2021; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER BIONTECH, Solution for Injection,Batch/Lot Number: EW0196) via an unspecified route of administration, administered in Arm Left on 28Jun2021 at 18:45 (at the age of 40-year-old)  as Dose 1,Single and received bnt162b2 (PFIZER BIONTECH, Solution for Injection,Batch/Lot Number: CA6780) via an unspecified route of administration, administered in Arm Left on 28Jun2021 as Dose 2,Single for COVID-19 immunization. The patient's medical history included none from an unknown date and unknown if ongoing. There were no concomitant medications. No other vaccines received within 4 weeks prior to the COVID vaccine.No other medications the patient received within 2 weeks of vaccination.On 02Jun2021, the patient experienced chronic fatigue, trouble sleeping, dizziness, nausea symptoms seem to getting worse. Vaccination occurred in inappropriate schedule. Treatment for the adverse events included Prednisone/Atarax. The outcome of the events was not recovered.
Sore left arm and swollen node (left collarbone area) same side as where vaccination was administered.
Ringing in the ears; Neck soreness; Soreness of injection site; Fatigue; Creak in the neck; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021. The most recent information was received on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Creak in the neck), TINNITUS (Ringing in the ears), NECK PAIN (Neck soreness), VACCINATION SITE PAIN (Soreness of injection site) and FATIGUE (Fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient has never been diagnosed with/ tested positive for COVID-19.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and SIMVASTATIN from 25-Mar-2018 to an unknown date for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Creak in the neck), NECK PAIN (Neck soreness), VACCINATION SITE PAIN (Soreness of injection site) and FATIGUE (Fatigue). On 10-Apr-2021, the patient experienced TINNITUS (Ringing in the ears). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Creak in the neck), TINNITUS (Ringing in the ears), NECK PAIN (Neck soreness) and VACCINATION SITE PAIN (Soreness of injection site) had not resolved and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported tinnitus predominately on his  left side ear/head on or around 10-Apr-2021 in the a.m. It was constant to this day. It did fluctuate from being extremely loud to moderately loud, but noticeable 24 hrs a day.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information received on 28 APR 2021 updated suspect drug batch number. On 29-Jun-2021: Follow up received on 29-JUN-2021 - New event of Neck soreness added. Event outcome , Patient race , Concomitant medication updated. Event onset of tinnitus was updated. Clinical course updated.
Prevanar in the left arm-no sensation.  Fluzone vaccination-immediately felt soreness. Experienced fatigue after making it home. Felt feverish an hour later. Pain increased in right arm.  Slept for hours. Fever was 101. Experienced nausea. Within 45 minutes to an hour, she experienced vomiting and diarrhea. Intense stomach cramps. Vomiting and diarrhea subsided around 3 am. Also experienced chills. Around 5 or 6 am, the nausea subsided. The fatigue and the pain in right arm lasted for 3 days. Also developed rash around the midsection, below the breast. A little itchiness.
Severe pain and swelling at injection site within hour, much more than comparable tetanus shot, necessitating Extra-Strength Tylenol throughout the night. By 10:00 am following day (01/15/2019), started experiencing chills, headache, nausea, neck pain, low back pain, buttock pain, leg aches, fatigue. Necessitated going to bed and continuation of Extra-Strength Tylenol. As of 05:30 pm, symptoms continue.
pt recv vax 4AUG95 & pt broke out w/chickenpox 20JAN97 & was seen by MD 21JAN97;
All over body rash about two days after the shot. Started on my lower back & has spread all over ( back, arms, face, stomach, vaginal, butttom legs and tights. Looked like heat or small acne bumps  at first but now measles/ chicken pox?s  like.  Has a mild itch. I?ve taken Benadryl nightly (since 4-8/21) and rubbed down in Sarana anti itch lotion ( since 4-8-21). Bump seem to get worse throughout the day,  and seems to settle after taking  Benadryl.
Generalized hives, rashes, small bumps and red spots, itching, on neck, stomach, back, thighs.
Information has been received from a physician concerning a 17 year old female patient with headache who on 09-OCT-2006 was vaccinated with a first dose 0.5 mL of Gardasil and on 04-DEC-2006 with a second dose 0.5 mL of Gardasil. In last week of January 2007, patient was dizzy, felt paralyzed, fell and needed to hold onto something to walk. This lasted for 5 minutes. This was immediately followed with nausea and a "wavy like vision that looked like a kaleidoscope." This lasted for 30 minutes, possible vasovagal reaction. On 04-DEC-2004 she also had her ears pierced. She was seen by her internist and then a neurologist. She had blood tests, magnetic resonance imaging (MRI) and electroencephalography (EEG), all were negative. Patient's diagnosis was basal artery migraine. She was treated with Periactin. The patient was reported as recovering. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 5/14/2007. No additional information is expected.
The 31st I woke up and thought I had a cold. My daughter is visiting and she suggested a COVID19 test and it was negative. On Saturday night I took another test because I developed a cough, nausea, and lost my appetite and that test was bright positive. I called tele-health because of my age. They suggested I take PAXLOVID and asked me a bunch of questions but I wasn't really feeling well. They ended up sending the prescription but told me not to take it that night until I had stopped my cholesterol medicine for 24 hours. The next morning after taking it I felt like a different person. I did keep coughing for another day and wasn't really sleeping well but now I feel pretty good. I do still cough occasionally and my nose is a little runny but overall I'm pretty good. I also had a pretty bad headache during that time and just took some TYLENOL for that, my doctor had previous told me not to take any NSAIDS.
Post menopause X2 years  8/17/2021 Started bleeding heavily for 1 week then still spotting to date.
PATIENTS RECEIVED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients (7 patients). 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: 1805031, expiry: 26-MAY-2021) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  28-MAY-2021, the subject experienced subjects received expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patients received expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612634, 20210611858 and 20210614876.
PATIENT PRESENTED TO THE PHARAMCY WITH ERYTHEMA ON  BELOW THE DELTOID AREA  SEVERAL DAYS AFTER RECEIVING THE MODERNA COVID-19 BOOSTER. THE PATIENT ALSO COMPLAINED ABOUT ITCHINESS ON THE SAME ARM. I ASSESSED THE SITUATION AND ADVISED THE PATIENT TO APPLY A COLD COMPRESSED  TO AREA  IN ADDITION TO TAKING BENEDRY TO RELIEVE  REDNESS AND ITCH.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 15-JUN-2015, the patient was vaccinated with unspecified number of improperly stored dose of MMR II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. Additional information has been requested.
Vaccine was given at 12:45pm.  At 3:45pm my heart started racing at 180 bmp and didn't stop till I took 80mg of Betapace four hours later.  Heart returned to normal rhythm at 9:15pm.
Localized reaction to flu shot. 3 inch area of erythema with mild edema and warmth.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: FP6955), in left arm, on 09Apr2021 as dose 2, single (Lot number: FP6955), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITIN [LORATADINE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) Negative; (20May2022) Positive, notes: Symptoms were gone after course of Paxlovid treatment but returned 4 days later (20May2022). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Paxlovid treatment received for covid-19 treatment from 11May2022 to 15May2022. Symptoms were gone after course of Paxlovid treatment but returned 4 days later (20May2022). Symptoms included sinus congestion, persistent cough and sore throat. Symptoms were less severe than initial symptoms (no achy feeling, no tiredness).
an expired Daptacel vaccine is given to a patient; Initial information received on 01-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA124198, 2019SA123826, 2019SA124197 and 2019SA124200 (same reporter).  This case involves a 17 months old male patient who was vaccinated with a 0.5 ml dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot C5171AA and Exp. Date 23-Mar-2019) via unknown route in the left thigh on 24-Apr-2019.  The patient's medical history not reported and no concomitant medications reported as none.  It was an actual medication error case due to expired vaccine used.  It was unknown whether the patient experienced any adverse event post vaccination.  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.
I noticed approximately 3 weeks after vaccination that I had diminished lung capacity with more difficulty breathing. In October, I went to the urgent care for acute bronchial issue. While at urgent care I received a negative COVID test, blood work, and chest x-ray. I went to my doctor and my doctor looked at my chest x-ray which indicated cloudiness and went to get a CT Scan to rule out cancer. It was determined it was a bronchial infection possible pneumonia. I was prescribed some medications that did not help. The cough suppressant did help some. Since late November it eventually did get better.
Around 8 hours after the first Moderna shot I started experiencing the pins and needles feeling over most of my body. Nearly 4 weeks later I am still having them with intermittent numbness of hands and left foot at night.
I had shot and still got them / Suspected Vaccination failure; still got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient had shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.
A non-serious spontaneous report of administration of expired FLUMIST and URI manifested with cough, running nose and sore throat has been received from a physician concerning a four-year-old patient, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 12-Dec-2012. On 9-Jan-2012, the patient had cough, on 13-Feb-2012 the patient had runny nose and sore throat. The patient was diagnosed with URI. The outcome of the events administration of expired FLUMIST was recovered and URI was unknown.
Patient's behavior appears more in line with focalized or petit mal seizure activity. Gran Mal activity NOT witnessed.
10/6/21- 2PM- Brain fog, lethargic, midnight-chills, arm aches, body aches, felt cold  (took Tylenol about 3AM and continued use until 10/8/21 PM) 10/7/21 noticed swelling and redness below site of shot- about 2 inches X 2 inches,  10/9/21 felt normal and able to continue regular activities
About 9:00 pm there was onset of nausea. Patient went to bed and at 9:30 pm began vomiting. This continued throughout the night, episodic about 12 times. The facility nurse came in and reported fever of 102 degrees at 10:30 pm and again at 12:00 am. Gave patient sips of water which she could not hold down. Put on "sea bands" at 1:00 am to help relieve nausea which helped enough to give patient Tylenol to help reduce fever. Vomiting subsided at about 2:00 am. At 10:00 am patient had some diarrhea and when she drank a sip of juice she vomitted twice. There was lingering nausea throughout the day but patient improved throughout the weekend.
no adverse event; Past lot that had also been expired that was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient).    No concomitant medication was provided.  ID number was reported as 80777027399. The lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # J014129, expiration date 07-NOV-2015 and lot # K007781, expiration date 28-MAY-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
vaccination site pain; Little fatigue; Poison Sumac Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DERMATITIS CONTACT (Poison Sumac Rash), VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (Little fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Sumac rash (10 or so years age). Concurrent medical conditions included Diabetes (Improvement A1C down to 6.0) since 04-Sep-2019. Concomitant products included METFORMIN HCL from 04-Sep-2019 to an unknown date, ATORVASTATIN, MELOXICAM, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.    On 01-Mar-2021 at 11:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021 at 8:00 PM, the patient experienced DERMATITIS CONTACT (Poison Sumac Rash). On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (Little fatigue). The patient was treated with PREDNISONE (oral) on 22-Mar-2021 at a dose of 1 dosage form. On 03-Apr-2021, DERMATITIS CONTACT (Poison Sumac Rash) had resolved. At the time of the report, VACCINATION SITE PAIN (vaccination site pain) and FATIGUE (Little fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       The patient reported that was working in the yard several weeks later trimming hedge. Unknowingly came in contact with poison sumac. The patient experienced rash and blisters resulting in a visit to immediate care facility.   This case was linked to (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up information received updated patient details, added event (sore arm), concomitant medications, treatment medication(Prednisone). On 24-May-2021: Follow up received updated patient details, medical history, vaccine details, concomitant  medication details, added new event and updated event details. On 02-Jul-2021: Follow-up received updated event outcome.
intense chest pain, shortness of breadth, severe bloating, dermatographia, intense skin irritation / itchyness  all occurred with 7 days of booster vaccine dose and did not subside for 6 months +   allergist physician at a local Medical Center refused to acknowledge any symptom other than dermatographia, prescribed double dose of zyrtec, claimed dermatographia was 'idiopathic' despite being statistically impossible to rule out vaccine as the cause  zyrtec minimized symptoms acutely, but exacerbated symptoms anytime the zyrtec dose was close to wearing off