chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; Cough; redness at injection site; body aches; chills; Fever of 101.6 for 2 days; Headache; swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), COUGH (Cough), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, AMLODIPINE and ROSUVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (diarrhea), COUGH (Cough), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches), CHILLS (chills), PYREXIA (Fever of 101.6 for 2 days), HEADACHE (Headache) and INJECTION SITE SWELLING (swollen at injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 06-Mar-2021, DIARRHOEA (diarrhea), INJECTION SITE ERYTHEMA (redness at injection site), MYALGIA (body aches), CHILLS (chills), PYREXIA (Fever of 101.6 for 2 days) and INJECTION SITE SWELLING (swollen at injection site) had resolved. At the time of the report, COUGH (Cough) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: 101.6 (High) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Headache, Arthralgia, DATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:
Slight sore arm after the vaccine. June15,2021 in am felt really sick, nausea, diarrhea, and pain in lower back and left side. The shingles sore erupted on the left lower back. Lots of pain and deep sores.  Saw doctor on 3rd of July 2021. We were having a heat wave. She gave antiviral and took for 10days. It cleared up. You Shingrix on 14JUL2012. I never had shingles before. Still residual problems with shingles and itchy on sores that healed, but still have nerve damage that can last for 6 months.
Headache, Myalgia, Arthralgia, Fever, injection site pain Narrative:  Other Relevant History:
I have Hashimoto's thyroiditis, Huntington's disease, Addison's disease, Epstein Barr, adhesive disorder, regenerative disorder, bladder cancer, hyperthyroidism, an 8.6cm tumor in liver, blood clots and tumors in my brain lungs and spine, scoliosis, kyphosis, spinal stenosis, spinal bone spurs, spinal degeneration, internal bleeding untreated due to medical office then telling another medical office I'm a drug addict who then told medical center who involved the law officials all the way up to the government slandering my name and destroying my reputation and family relationships and more importantly causing me to be at the center of psychological warfare that is terrorizing the world which has resulted in my being given intentionally the bubonic plague, pneumonic plague, hantavirus, Ebola, smallpox, typhoid fever, etc after being bit over a hundred times by the brown recluse, black widow, Asian jumping spider, and Korean backwoods spider also centipede and millipede bites, biochemical warfare! I still have not received any help and my life expectancy is hours not days at this point please send help.
dizziness, syncopal episodes, clenching fists,  light headed, HA, vomiting, concussion from fainting
This spontaneous report as received from an Emergency Medical Technician (EMT) refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients received improperly stored doses of M-M-R II (dose, route of administration, lot number and expiration date were not reported). It was stated that the vaccines underwent a temperature excursion of 63 degrees Fahrenheit for 564 hours. No previous excursion was reported. No data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
The vaccine was Moderna.  I have pain from shoulders to toes.  It is better but up until 2 days ago if i sneezed my whole upper torso was in pain.  My right thumb is sore and turning out(No pain before or turning out). I wake up with both hands fingers up inch very painful.  I have shortness of breath when I exert myself or bend over.  My legs hurt. when climbing stairs.  I had none of these before the vaccine.
Product Complaint; Large golf ball sized whelp at site; Erythema streak across chest and up neck; Feeling "drunk, like a weird state of awareness."; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number T9N35, expiry date 30th June 2020) for prophylaxis. This case was associated with a product complaint.   On 3rd October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 3rd October 2019, less than an hour after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site urticaria, erythema and feeling drunk. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site urticaria, erythema, feeling drunk and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site urticaria, erythema and feeling drunk to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient demographic details were not provided. The age at vaccination was not reported. The age group was selected as an adult as the patient was employee. The pharmacy manager stated that, within minutes after vaccination, the patient experienced large golf ball sized whelp at site, erythema streak across chest and up neck and felt drunk like a weird state of awareness. The reporter stated that all 9 employees received dose from same batch number and was warm transferred to the response center for documentation of potential product complaint. The pharmacy manager did not have any patient-specific details available at the time of this call, but stated safety could follow up. The reporter consented to follow up. This case was 8 of 9 linked cases reported by same reporter.
Extensive severe rash with blisters to the bilateral upper extremities, chest, back, and face.  Rash erupted approximately 9 hours after vaccine administered. Worsened over the course of two days to have blisters. Denies burning of rash, is pruritic.
the patient fainted; had no energy when she left the office; This spontaneous report was received from a medical assistant and refers to a 11-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was not provided.      On 01-AUG-2023 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # X005044 and expiration date 02-JAN-2025, 0.5 milliliter, intramuscularly for prophylaxis (site of administration was not provided).    On 01-AUG-2023, the patient experienced asthenia and syncope (medically significant). Patient was standing up when vaccine was given, and immediately after giving the dose as the health care professional  (HCP) turned to grab cotton/bandage the patient fainted and fell to the floor (syncope). Patient was unconscious for several seconds. Once feeling better patient was given water and patient's vitals were checked. Vitals were all within normal limits. Labs were also drawn to check blood sugar and anemia, both tests came back normal. HCP reported to the FBE that this patient came into the office very energetic and had no energy when she left the office (asthenia). The outcome of syncope and asthenia was reported as recovered. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the events was not applicable.   The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided.   Upon internal review event syncope was considered medically significant based on list. ; Sender's Comments:  US-009507513-2308USA003657:
Information has been received from a nurse concerning a 22 month old male who on 06-MAY-2008 was vaccinated with a dose of VARIVAX (Merck) (lot number, injection site and route not reported) and a dose of MMR (MSD). On approximately 30-OCT-2008, also reported as 4 days ago and late October 2008, the patient developed rash. The rash covered the right leg (upper thigh) and buttocks. On 03-NOV-2008, the patient was seen in the office and was diagnosed with shingles. Laboratory test included culture (result unspecified). The patient's shingles persisted. Additional information has been requested.
Initial ADE was faxed 1/24/13. After taking 1 capsule diphenhydramine 25mg all symptoms cleared up until 1/30/13 when patient got hives and a large red, raised area around injection site. Patient was prescribed MEDROL dose pack, BENADRYL 50 mg QHS & hydrocortisone 1% cream to be applied during the day on 1/31/13. On 2/5/13 patient has recovered but has darkened area approx 1 1/2" x 1 " around injection site.
HYPOTENSION 4/12/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION
Deltoid area of arm is red, hot and swollen 5 inch by 3 inch area when pt came back to clinic 48 hours after vaccine.
She is starting to feel like some slight chest pain; soreness in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 16 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (non-serious) with onset 14Oct2023, outcome "unknown", described as "She is starting to feel like some slight chest pain"; PAIN IN EXTREMITY (non-serious) with onset 14Oct2023, outcome "unknown", described as "soreness in her arm". Therapeutic measures were taken as a result of chest pain, pain in extremity.  Additional information: The reporter stated, "I just want to call if I can get more information? My daughter received the updated covid vaccine yesterday afternoon and she felt some soreness in her arm, but she is normal. But right now, she is starting to feel like some slight chest pain."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Initial information received on 06-Feb-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 16 years old male patient who received 0.5 ml vaccines FLUBLOK QIV (lot number: QPAA1803 , expiry date: 31-May-2019) instead of INFLUENZA VACCINE via intramuscular route in right deltoid on 31-Dec-2018 since there were out of stock of the regular flu shot. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administration. It was unknown if any adverse event occurred or not following the 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.
Pt received PNEUMOVAX on 9/15/10 at 9:35 AM at office. Pt called on 9/17/10 at 2:30 PM stating yesterday 9/16/10 that she could not lift her arm, developed a rash under her right arm, right arm was sore to touch and had chest pain. Pt states she still has rash on her right arm and her arm still hurts to touch. Pt refused to come into office. Spoke to Dr. Pt was advised to take ADVIL, apply cool compress to area, apply cortisone 3 to 4 X a day to area and to call office if pt develops a fever.
Patient parent reports swelling in R arm starting the morning after vaccination. Patient parent was instructed in the use of cool compress, advil or tylenol to reduce discomfort.
Information has been received from a nurse practitioner concerning an over 60 year old patient who on 22-SEP-2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 24-SEP-2007 the patient developed shingles in a small area low on the right side of the patient's back. The shingles were not painful. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
I woke up with a severe sore throat/neck, 2 days after the shot. This severe pain began to the left side of my throat, in the thyroid area and lasted for about a month. The severe pain moved to my right thyroid for another 2 months. It was painful to eat and to talk.  I also had irregular heart beats, that were not flutters, but wild flip flops about a month and half later. I nearly blacked out and it felt like it had speeded up. I called my clinic and the triage nurse said if I ever had the same reaction, to get to the ER. Idid, the next day I had another episode. I went to the hospital.
at 11pm the night of the vaccine I started to have a throbbing headache, chills, night sweats fever, and body aches. At about 2:30am I took ibuprofen and by 3:00am all the symptoms were gone.
Patient received ZOSTAVAX in right upper arm 9/11/14. Developed rash localized to upper right chest which was a little raised and itchy. Rash resolved in 1-2 weeks.
Itching; Swelling of injection site; Sore throat; This is a spontaneous report from a contactable other hcp (patient). A 35-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3248 and Expiration Date was not reported), via an unspecified route of administration administered in Arm Left on 18Jan2021 as dose 2, single for COVID-19 immunization. Medical history included , food allergy from an unknown date and unknown if ongoing Verbatim known allergies: Almonds , arthropod sting from an unknown date and unknown if ongoing Verbatim known allergies: bee stings , glucose tolerance impaired from an unknown date and unknown if ongoing other medical history : Pre-diabetes. The patient's concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0140 and Expiration Date was not reported), via an unspecified route of administration administered in Arm Left on 26Dec2020 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Post vaccination the patient was not tested for COVID 19. On 18Jan2021, the patient experienced itching, swelling of injection site and sore throat. Patient received treatment of Ibuprofen for adverse events.The outcome of the events was recovered in 2021.  Follow-up attempts completed. No further information expected.
Pain, redness, swelling, fever, headache, fatigue. Shoulder to elbow.
STROKE LIKE SYMPTOMS; LESIONS ON HIS BRAIN; EXTREME PAIN; FACE, ARM AND LEG NUMBNESS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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: Unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after vaccine administration, a few week later the patient had extreme pain. Few months later he experienced lesions on his brain, stroke like symptoms and face, arm, and leg numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme pain, lesions on his brain, stroke like symptoms, and face, arm, and leg numbness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210752712-COVID-19 VACCINE AD26.COV2.S-stroke like symptoms. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
the patient had "multiple hospitalizations"; Celiac; seizure; cannot digest complex carbohydrates; loss of speech; This spontaneous report was received from a patient's mother and refers to a infant male patient of unknown age. He had none pertinent medical history and none drug reactions and allergies. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The patient took no concomitant medications. On an unspecified date in March 2011, he was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection in arm for prophylaxis. On an unknown date in March 2011, 5 days later, the patient lost his speech. On an unspecified date in March 2011, he experienced a "permanent injury" as the patient cannot digest complex carbohydrates and unspecified adverse event due to which he sought medical attention and had multiple hospitalizations for an unknown duration. He remains on a strict diet as a treatment. On an unknown date, he had labs for celiac, electroencephalogram (EEG) to find out if he had a seizure, neurologist "did every panel he could think of", complete neurological work up and test for heterozygotes C677T performed. Results were not provided. The patient received vitamin A and cod liver oil as a treatment. The reporter was requesting to speak with a scientist regarding the ingredients in measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), she wanted to know the exact ingredient that caused her sons reaction in order to determine if it is safe to give her son the Pfizer Covid vaccine for children. She threatened to hire lawyers if she can not speak with a scientist. The outcome of adverse event, seizure and coeliac was unknown. The outcome of carbohydrate intolerance was reported as not resolved. The outcome of loss of speech was reported as recovered. Relatedness between the events and suspect vaccine was not provided.  Upon internal review, the events of celiac and seizure were considered to be medically significant.
redness that has been spreading; warm to touch; was painful for first day.  pain has diminished but it is still warm to touch an red
Rapid heart rate; This is a spontaneous report from a contactable consumer (the patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9266), via an unspecified route of administration in the right arm on 17Feb2021 12:00 (at the age of 69-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: past history of breast cancer. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient had no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 13:30, the patient experienced rapid heart rate. The clinical course was as follows: About 1.5 hours after having the vaccine (17Feb2021 13:30), the patient's heart was pounding rapidly. It went from around 94-110 BPM (beats per minute) to 138-140 BPM. This continued for about an hour, fluctuating up and down, and finally lowered. She did not know if this was anything to worry about, since she couldn't get a hold of a doctor. Since it lowered, she guessed it might have been just a basic side effect. She didn't have any other adverse effects. No treatment was received for the event. The clinical outcome of rapid heart rate recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Initial report was received 23 October 2008 from a health care professional. A 57-year-old female patient had received an intramuscular left deltoid injection of FLUZONE SV 2008-2009, lot number U2764AA and five minutes later, she developed shortness of breath, facial flushing, her throat felt tight and her mouth felt dry. She was evaluated by her physician and her symptoms resolved within one hour. The patient had no concurrent illness and had not been taking any concomitant medications. The patient had a history of multiple medication allergies (medications not specified) and she had received FLUZONE in the past. According to the reporter, the patient requested a preservative free vaccine. The patient's recovery status was reported as unknown at the time of the report. Documents held by sender: None
This was a flu vaccine but they did not give me any paperwork with the brand/dose/lot.  Symptoms began within 15 hrs, headache, high fever (102), severe muscle aches and fatigue.  Persisted and continuing through today, Friday,48 hours and counting.
Breakthrough case of Covid-19. Cough, runny nose, irritated trachea or esophagus but NOT a sore throat, very slight headache initially and some post-nasal drip.
Headache, NauseaVomiting, facial flushing Narrative:  facial flushing; observed for 45 minutes; reports headache and nausea, has hx of migraines - resolved within on week
Rashes, welts, itchiness over body. Looks like covid like rash.
Fever; This is a spontaneous report from contactable consumer a Pfizer sponsored program. A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162b2 for COVID-19 immunization. It was reported that I had a caller on the other line, and she was calling for his son (consumer) because his son experienced fever after getting the second dose vaccine. That's the only concern, he was calling about. In response, reporter stated, I was only interested what I can do about, I was not interested about the Drug (Safety) Report. I was just concern about his fever and I am not concern about reporting. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Patient reports having the following side-effects after 7 A.M. (11/16/16). Fever (100 degrees F), headache, stiff neck, swollen glands on left side of neck.