chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (dose, lot #, expiration date were not reported) orally. Then, on an unknown date the patient was vaccinated with the second dose of ROTATEQ (dose, lot #, expiration date were not reported) orally. The reporter stated that the patient received a total of 2 doses of ROTATEQ and was subsequently hospitalized in an unspecified hospital on an unknown date. The pharmacist reported also that on an unknown date, the patient was diagnosed with unspecified metabolic disorder. The outcome of the adverse event as well as the relatedness were not reported. Additional information has been requested.
Patient came into office for Covid vaccine. They had started the Pfizer 6 mo-4 year series outside of our office. We do not carry this vaccine. We carry Moderna 6 mo-5 year. Moderna 6 mo-5 year was accidentally given to this patient as a 3rd dose. There have been no reports of any adverse reactions or symptoms from the family
Nurse administered Pfizer Bivalent Booster when patient was due for Pfizer Second Dose in primary series.  Parents were made aware of incident. Patient is scheduled to talk to a provider.
On Oct. 12, 2021, I was diagnosed with a heart block - 2:1 AV block -  at an annual PCP check up.  One year ago, at same PCP check up, I had a totally normal ECG.  I have no cardiac medical history or risk factors.  I have no cardiac family history.  I required a pacemaker, which was placed on Oct. 15, 2021. Symptoms were minimal - just gradual fatigue and some palpitations.  These were first noted in June, 2021 but may have been going on longer. Unclear if due to having all 3 Pfizer vaccines (earlier dates were 12/23/20 and 1/13/2021)
Case number PHEH2014US024100 is a combined initial and follow up spontaneous report from a nurse received on 02 Dec 2014 and from quality assurance department (QA reference number: 340811) received on 03 Dec 2014. This report refers to a 66-year-old female patient. Her current conditions included type 2 diabetes and elevated cholesterol with values at normal limits and were being managed. She went for cardiac work up, 1-2 weeks prior to vaccination and everything was normal. She did not have any blockages, no complaints of chest pains, but had fever. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on 04 Nov 2014. On the same date, since vaccination she was feeling ill and had flu. On an unknown date, she had fever. On 13 Nov 2014, she was burning up with fever, had taken off her night gown (Not typical behaviour), drank water, went to sofa, threw up en route and had cardiac arrest. Her husband performed CPR (cardiopulmonary resuscitation) and called the ambulance. In the emergency room, she was being resuscitated, but she died on the same day. No autopsy was performed. It was reported that something caused pulmonary edema. She had no congestive heart failure and not on any diuretics. The outcome of the events fever, feeling ill, flu and threw up was not reported. The outcome of the events pulmonary edema and cardiac arrest reported as death. The seriousness of the events fever, feeling ill, flu and threw up was not reported. The causality of the events was not reported.
I started having very painful low back - around my SI joints on both sides. And then back would spasm around my whole lower back and I couldn't walk. It happened three weekends - and I was down for the count on Saturday and Sunday in the March and April timeframe. Worse symptoms in April. I sought care with PCP and saw a physical therapist - I did about 10 sessions - and she thought I might be hyper mobile and told me it might be hEDS .  ended up seeking care with a genetic team who diagnosed me with hyper mobile EDS. Now once a week, I get a massage: myofascial release to help me to not have spasms so that I can't walk about once a week. I moved all my exercise into the water - it's easier on my joints. I go to PT and massage and I  have referrals to see other specialists - to check out things that are correlated with EDS. I will go to cardiology for sleep evaluation and will be checked out for  Dysautonomia - It's a chronic issue that needs symptom managed.
chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (Body aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and MYALGIA (Body aches). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and MYALGIA (Body aches) outcome was unknown.            The concomitant medications reported included blood pressure medication and medication for allergies.   This case was linked to MOD-2021-415972, MOD-2021-414551 (Patient Link).
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 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 3 (booster), single (Lot number: GH9693) at the age of 71 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 01Oct2021 as dose 1, single (Lot number: FF2589), in right arm and on 04Apr2022 as dose 2, single (Lot number: F55683) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2023) Negative; (08Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid used from 29Aug2023 to 03Sep2023 as treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300296334 Same reporter/patient/drug, different AE/different dose.;
Numbness and tingling in his extremities with heaviness and a feeling of weakness. Started about 4 hours after H1N1 vaccine and has been intermittent.  12/2/09 DC summary and medical records received for date 11/30/09 to 12/2/09. DX: acute inflammatory demyelinating polyradiculopathy/GBS. Presenting c/o history: developed viral illness approx 2wks ago w/ sore throat, cough, chest tightness, chills, nasal congestion. Pt was tx for sx, then, 1wk ago received H1N1 vax and pt states within 4hrs of vax developed progressively ascending paresthesias in legs and hands and into buttocks region lasting 3 days. Pt has had numbness and tingling in extremities and persistent diarrhea. Admission assessment: pt looks slightly ill. (+)nasal congestion, cough. (+) distal weakness, distal hypo reflexes.  12/2/09 Medical records received for date 11/16/09 to 11/23/09. OV 11/16/09 DX: URI. SX: pt. c/o cold sx x5 days ago, earache, sore throat, chest tightness, loose stool, myalgias. OV 11/23/09 DX: left leg/arm tingling. SX: left leg and arm tingling x24hrs.
Left upper lip edema on evening following vaccination. Suspect related to food almost completely resolved by office visit on the following day 3/29/11. BENADRYL 25 mg po x 1.
Small rash near injection site; arm sore over 2 weeks after injection; mild brain fog - failing to do some routine things I've been doing for years without thinking...microwave empty coffee cup; not putting down toilet seat; not emptying trash can; not putting water in coffee pot to brew.
A non-serious, spontaneous report of administered full dose of FLUMIST into one nostril was received from a health professional concerning a two-year-old female. Neither medical history nor concomitant medications were reported. On 03-Oct-2010, the patient received a full dose in one nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 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.
Got the first dose of the Moderna vaccine on 16Jul2021 and have not gotten the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 16Jul2021 and have not gotten the second dose yet) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 16Jul2021 and have not gotten the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine on 16Jul2021 and have not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment information was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up received on 01-SEP-2021. No new information
Dizzy, Fell down several times in shower, can't walk, extremely dry mouth, fatigue, hot (no fever)
Mother narrates persistent elevated fever to 105+, 3 hrs. continuous crying after vaccines administered. Mother also describes "wierd" behavior, not responding to her name and rolling around on the ground within hours after vaccine administration.
Dizziness, nausea that has been ongoing for  2 weeks with no resolution still; going to doctor tomorrow to start bloodwork.
I received a diagnosis of very unpleasant SHINGLES; itching and moderate pain, in particular in my right breast; itching and moderate pain, in particular in my right breast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious) with onset 16Feb2022, outcome "not recovered", described as "I received a diagnosis of very unpleasant SHINGLES "; PRURITUS (non-serious), BREAST PAIN (non-serious) all with onset 16Feb2022, outcome "not recovered" and all described as "itching and moderate pain, in particular in my right breast". The events "i received a diagnosis of very unpleasant shingles ", "itching and moderate pain, in particular in my right breast" and "itching and moderate pain, in particular in my right breast" were evaluated at the physician office visit. Therapeutic measures were taken as a result of herpes zoster, pruritus, breast pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient don't have known allergies. Ae treatment: 2 weeks Rx of 2 grams Valacyclovir and 2 weeks 3.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Lymph nodes were tender at left side of axilla; Pain at injection site; Swelling at injection site; Itching at the injection site; Increased redness/erythema at injection site; Warm to the touch injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic sinusitis and Eczema. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), ALBUTEROL [SALBUTAMOL], CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and VITAMIN D3 for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site). On an unknown date, the patient experienced LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE JOINT WARMTH (Warm to the touch injection site), LYMPH NODE PAIN (Lymph nodes were tender at left side of axilla), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Increased redness/erythema at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) had resolved.        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.   Treatment for the event included steroids.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19 APR 2021 contains significant information
Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included 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 and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK 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 and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient had shingles after receiving the two shingles shots. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown.
- Low fever (99.4-99.8 degrees F) during evenings each night after the vaccine, treated with one dose of 500 mg Tylenol - Increased irratibility, anxiety, muscle tension in neck and chest off and on (1 episode lasting about 10 min every 1-2 hrs). Starting occuring ~ 48 hours after receiving vaccine. Current treatment is laying down until the anxiety passes as needed per episode.
Information has been received from a healthcare professional and a 24 year old Caucasian female consumer who on 6/30/00, was vaccinated with 1 dose of varicella virus vaccine live. It was noted that the pt was not treated for varicella antibodies prior to vaccination. On 7/6/00, the pt learned that she was pregnant. At 6 weeks, the pt had an ultrasound done which was normal. On 8/26/00, at approx. 9 weeks from the LMP, the pt had a spontaneous abortion. It was unknown if the products of conception were examined or if the fetus was normal. There were no maternal adverse events. No further information is available.  Follow up on 06/29/2001: "Lot # for vaccine 1 is not provided."
12 days after my J&J vaccine I began to experience intestinal pains.  It turned out to be appendicitis.  It actually ruptured and I'm now on antibiotics and will have to have it removed in about 6 weeks.
My symptoms began with sore throat and progressed to congestion, a bad cough, fatigue, a low grade fever accompanied with chills and minor aches and pains. It felt like a mild flu. I couldn't work for a couple of days. My throat got really painful for one day to the point that it would wake me up at night. After a few days, the symptoms began to wind down. The cough lasted 5 or 6 days though and was pretty severe. I spoke with my doctor who advised that I take the antivirals, but I was not able to find them in my area and I did not pursue any further as my symptoms began to subside after a few days.
fever/Had temperature of 101; Chills; Lost my sense of taste; Body ache; This is a spontaneous report from a contactable consumer (patient). This 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302, Expiration Date: 31Mar2021) at 0.3 mL single use in right deltoid on 21Jan2021 for COVID-19 immunisation. The first dose was on 31Dec2020 and experienced night sweat, even after her first dose they had not gone away. She had had night sweat every single night to the point she had to get her clothes off and change (refer to AER 2021111645). Medical history included factor V leiden, it's a blood clotting "supporter" (not clarified); asthma. Concomitant medication was not reported. Patient had temperature of 101, chills, lost her sense of taste and body ache in Jan2021. Patient received her second vaccine on the 21Jan2021 on Thursday and she had all the typical side effects startling on Friday with fever, chills, had a temperature of 101 and all the simple stuff and she lost her sense of taste on Saturday evening and it hadn't returned yet and she was trying to see if that was a possible side effect of the vaccine or what. When probed if the events had been worsened, improved or persisting, patient stated so improved for everything except one. So she got the sot on Thursday and it worsened meaning the fever started Thursday night, Friday all day she had a fever of 101, body ache and chills all that stuff but Saturday her fever went away but she lost her sense of taste on Saturday, so the fever and everything was OK. Patient had taken naproxen and ibuprofen. The outcome of events was reported as recovered in Jan2021.
Pt received vaccine on 10/18/2000 and later on the pt experienced discomfort in the arm of injection. The site of the injection was warm and swollen. The pt developed a temperature of 102 F, headache, and nausea. On 10/19/2000 the pt came to the Dr's office, still felt feverish, arm still swollen with some improvement, some induration, and erythema.
Patient waited 15 minute required observation time, walk toward front of store he stated eyes went black, legs gave out.  this happened 20 minutes from time of injection.  Checked blood pressure and it was 130/88.  Patient was pale and shaky.  He then stated he was ok and walked from the store escorted by two friends
Child got HPV vaccine L deltoid around 1135am. At 11:59 am mom shouted he fainted. He fell forward and hit his chin on the ground. Approx 1 inch laceration that will require stitches to child and 1-2 loose teeth. Patient cleaned and bandage and sent to ER for treatment.
She received flu vaccine 9/22/2011 - 40 minutes later she c/o feeling jittery, sweating & feeling light headed with faintness - she did not faint  - her B/P sitting in wheel chair was 158/92. Lying BP 150/100 & recheck BP 150/104. This was taking place in factory where we had a flu shot clinic. She had not declared allergy to eggs (she had as a child). She can not eat eggs now - We called EMS because she was not feeling better. She refused to be transported to hospital stating she was much better. She signed AMA waiver. I called her 9/23/11 - she said no further problems.
fatigue, night sweats, dizziness, temp. 103.0.  left arm swollen with pain
WITHIN 15-20 MINUTES OF RECEIVING THE SECOND VACCINATION,  SHE BECAME "HOT",   FLUSHED IN THE FACE, AND FELT LIKE SHE HAD A "LUMP" IN HER THROAT. SHE DID HAVE SOME COUGHING  WITH REPEATED ATTEMPTS TO CLEAR HER THROAT. A NURSE AND FELT IT BEST TO USE AN INHALER THAT WAS SUPPLIED IN THE ANAPHYLAXIS KIT BROUGHT TO THE CLINIC WITH THE VACCINES. SHE DID 2 PUFFS OF A VENTOLIN INHALER AND TOOK BENADRYL 25MG BY MOUTH.  THE SYMPTOMS DID NOT WORSEN AND  SHE SAID SHE FELT BETTER WITHIN AN HOUR OF TAKING THE MEDICATIONS. THE ONLY COMPLAINT THAT SHE HAD WAS EXCESSIVE DROWSINESS SECONDARY TO THE BENADRYL.
w/in 24 hrs of vax lt thigh swelling redness @ the site of inject, fever 102, vomiting, lethargy; relieved in 2 days, used DPH & Motrin;
during COVID, second shots were being administered over 1 year later; This case was reported by a consumer via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patients experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The reporter reported this case via interactive digital media. The reporter stated that during COVID, second shots were being administered over 1 year later per GlaxoSmithKline. Additional supportive information: The patients received 2nd doses of Shingrix vaccine later than the recommended interval during Covid. The follow-up would not possible, as no contact, details were available. This case has been linked with case US2022AMR074988 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR074988:same reporter