chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I tested positive for COVID-19 on 8/30/22. I had a sore throat, and congestion at first. Then, I developed a cough, nasal drip, diarrhea, body aches, and a fever. I never had trouble breathing though. That is when I decided to test for COVID-19 and tested positive. I called the doctor, and they told me I could take Paxlovid, but I declined. I took Alka-Seltzer Plus and Mucinex. My sense of smell is still altered, and I have lingering fatigue, but other than that I feel good.
It started as a rash all over my back two days post vaccine #1 on 1/9/2021. The rash started to go away but never fully did. I received my second vaccine on 1/28/21 and the next day on 1/29/21 the rash increased and spread to the back side of my legs, down my arms and up into my hairline/back of neck.
After 5 Minutes of receiving vaccines he developed blotchy erythematous rash at all 4 injection sites.
Symptoms (L) arm swollen and red, headache, dizziness. Signs - patches of erythema and warmth to upper arm 10cm x 8cm largest patch.
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), solution for injection, on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 04Mar2021 at 16:30 as dose 2, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Covid-19 treatment; Negative, notes: sound of Covid quickly after paxlovid and quarantining for 5 days from onset of symptoms then testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: sound of Covid quickly after Paxlovid and quarantining for 5 days from onset of symptoms then testing Negative. Got head cold starting about 4 days later. May have been that her husband had a rebound (as he had Started paxlovid 1 day before me) and she caught it from him. Unsure. He definitely brought the original virus to their house.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immed p/MMR had 15x15mm lump w/small wheal @ inject site-redness @ site; ice applied but no improvement; no wheezing, no other rash or wheals or any systemic rxn seen; call to MD given DPH; sx subsided w/in 5 mins;
Herpes outbreak orally; Rashes all over arms; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 04May2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic vestibular migraines from presumed COVID-19. The patient had no known allergies. Concomitant medications were not reported. On 04Sep2020, the patient underwent nasal swab test for COVID-19 and the result was negative. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 12: 30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021, within 3 weeks of vaccination, the patient had a trigger in herpes outbreak orally, which the patient thought would be of material interest regarding adverse events. It had not yet gone away so that had lasted almost 4 weeks and had no signs of subsiding despite treatment. The patient also had rashes all over arms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified antivirals and antibiotics. The clinical outcome of the events herpes outbreak orally and rashes all over arms were not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Approximately 10 min. post vaccine, she developed numbness & tingling in both hands, fingers, both feet & toes, lips, bruised sensation in throat, Metallic taste in mouth. Unable to lift left arm on Jan. 16, 2021.  Other symptoms have disappeared except the numbness, tingling in hand finger tips and  feet, toes.  Unable to return to full duty work as of 2/1/21. Modified duty.
This case was reported by a physician and described the occurrence of lupus like syndrome in a 42-year-old female subject who was vaccinated with (ENGERIX B, GlaxoSmithKline) for "worker's comp accident". On an unspecified date the subject received 1st dose of ENGERIX B (20 ug/ml, unknown route, unknown arm). Approximately 40 days after vaccination with ENGERIX B, the subject experienced lupus like syndrome. It was reported that the subject continued the vaccination series. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The physician considered the event was unrelated to vaccination with ENGERIX B.
9/22/15 01:00: Fever of 102 degrees F, chills, muscle aches, fatigue, congestion all began less than 12 hours after vaccination. Red, hard, warm area at injection site of approximately 6 cm. Also had sore throat, cough, laryngitis, pain swallowing. Was seen in urgent care and by primary care. Treated with albuterol and prednisone, and TYLENOL. Primary care felt reaction to vaccine.
The left hand and foot developed bruising spontaneously at 2 pm, finger went numb and white., with tingling.  Skin on hands reddened.  These symptoms continue today, the day after, though lessened. Hands remain tingly and redness of skin is ongoing.
Information has been received from a 29 year old female consumer who in April 2008, was vaccinated with the first dose of GARDASIL.  On June 2008, the patient received the second dose of GARDASIL.  After receiving the second dose the patient began to experience abnormal vaginal bleeding, abnormal pap smears and the feeling of "bugs crawling on her skin".  The symptoms had persisted since the second dose was administered.  The patient called her physician office, but had not spoken with them yet.  Additional information has been requested.
Approximately 30 hours after receiving the shot, I began to develop a fever (which ultimately spiked to 102), aches, chills, and extreme soreness in my left arm. This subsided by the next morning, however that evening (approx. 54 hours after the shot) I began to experience extreme dizziness to the point where I could not even lift my head off the pillow. Couldn't walk due to extreme dizziness. The dizzy spells continued for about a week (albeit not as severe as the initial dizziness.)
sore injection  site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose.        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 relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
He presents to the ED for evaluation of fatigue. He states he always feels fatigued and was advised in the past to follow up for a sleep study. He has not personally noticed any changes but his children were concerned about him being increasingly more fatigued over the past 2-3 days and advised him to seek medical attention. He does endorse a nonproductive cough that has also been present for the past 2-3 days. He denies any chest pain, shortness of breath, palpitations, lower extremity edema/pain, fever and/or chills. Patient has received 2 doses of the Pfizer COVID vaccine (7/20/21 & 8/10/21)but has not received a booster dose as of yet. Admitted to the hospital 1/28/22.  Discharged 1/31/22.
Woke up with dizziness/vertigo (couldn't walk straight, couldn't think straight, needed to hold onto things to support myself).  Symptoms have persisted (but severity has lessened) thru 5/7.   I received the second dose on 5/1, and symptoms started the morning of 5/4.  I'm still experiencing some dizziness today on 5/7.
Information has been received from a physician concerning a patient who on 14-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and experienced anaphylaxis after vaccination. It was unknown whether medical attention was sough. The recovery status was unknown. Additional information has been requested.
Sweating profusely, tingling and itching entire body, blurred vision , cluster headache, taste of metal in mouth, leg weakness
Thought was having a heart attack. Chest/heart pain, palpitations, dizziness, high blood pressure
Information has been received from a nurse concerning a female patient who on approximately Dec 5, 2002 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot# 644105/0820M). Subsequently, the patient developing symptoms of red, hot, painful to touch and swollen right arm from wrist to the site of injection. Unspecified medical attention was sought. The nurse requested that a  lot check be performed on lot #644105/0820M. The nurse also reported another patient that developed a red, hot, painful to ouch and swollen right arm from elbow to shoulder (WAES0212USA02156). The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards of the center for evaluation and research and was released. Additional information has been requested.
Body aches; Chills; Fever; Headache; This is a spontaneous report from a contactable other health care professional, the patient. A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number: Unknown), via an unspecified route of administration on Arm left on 15Mar2021 at 11:45 (51-years-old at the age of vaccination) as a single dose for COVID-19 immunisation. Medical history included allergy to Penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Mar2021 at 12:00 AM the patient experienced Body aches, Headache, Fever, Chills. Patient not received any treatment for the events. The clinical outcome of the reported events Body aches, Headache, Fever, Chills were not recovered at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
Patient developed redness and swelling at ANTHRAX injection site approximately 3-4 days post injection.
swelling; This is a spontaneous report based on information received by Pfizer from regulatory authority. A contactable Physician reported for a patient of unspecified age and gender received Unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Physician reported that patient was injected with Juvederm Voluma Xc. Two years later, the patient received the Pfizer COVID-19 vaccine and experienced swelling. The patient was treated with Lisinopril twice. Outcome of the event was Recovered.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
J96.01 - Acute respiratory failure with hypoxia  R57.9 - Shock  A41.9 - Sepsis, unspecified organism
Initial misuse report received from a healthcare professional on 13 February 2014. A 4-month-old patient (gender was not reported) had received a dose of PENTACEL and a dose of ActHIB on the same day. No adverse event was reported. Documents held by sender: none.
Hives/Rash on torso, arms and legs.  Unsure if related, but felt I should report just in case.
Rash, Diarrhea & NauseaVomiting Narrative:  Fatigue developed 1/3/2021 along with mild nausea/abd cramping. Then on 1/6/2021 at 6:00pm noticed slightly pink area at site of injection which has gotten slightly worse and has not resolved yet. Area of redness on right deltoid measures 6.5cm x 5.0cm.
S/p vaccination reports burning and tingling feeling in throat w/noted redness to forehead, bilateral cheeks, and hands;  IM Benadryl 0.25mg x 1 administered by MD denies any respiratory distress/ throat swelling/ none noted. O2 Sat 98% RA Medical monitoring x 30 min w/ minimal improvement Recommendation for patient to be further evaluated. Released from site facility for further f/up
Had DTaP-IPV and MMRV 6/1/2017. 6/2/2017 all day with c/o sore arms, headache, stomachache and tactile fever. Has been taking fluids, and acetaminophen and ice seem to help temporarily. Mom also notes that on DTaP side, there is a "softball sized brown lump" with a pink ring around it.
DIARRHEA; SWOLLEN FEET AND SWOLLEN LEGS; BODY ACHES; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a female 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea, swollen feet and swollen legs, body aches, fatigue, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, headaches, body aches, diarrhea, and swollen feet and swollen legs. This report was non-serious.
fluid around my heart/fluid on my heart/water on my heart; didn't get the second shot; medical history of asthma,/more frequents asthma attacks/my asthma bothered me; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (fluid around my heart/fluid on my heart/water on my heart) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Emphysema. Concurrent medical conditions included Asthma and COPD. Concomitant products included OXYGEN, GABAPENTIN, DILTIAZEM, CLONIDINE, PREDNISONE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), CLONAZEPAM and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 22-Jan-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 PERICARDIAL EFFUSION (fluid around my heart/fluid on my heart/water on my heart) (seriousness criterion medically significant), PRODUCT DOSE OMISSION ISSUE (didn't get the second shot) and ASTHMA (medical history of asthma,/more frequents asthma attacks/my asthma bothered me). At the time of the report, PERICARDIAL EFFUSION (fluid around my heart/fluid on my heart/water on my heart), PRODUCT DOSE OMISSION ISSUE (didn't get the second shot) and ASTHMA (medical history of asthma,/more frequents asthma attacks/my asthma bothered me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient concomitant information was water pill, nebulizer, steroid, night pill for asthma, Advair diskus, Advair emergency inhaler. Patient laboratory information was given an oxygen test that is normally 6 minutes. Patient said she had a pneumonia shot a month before her COVID-19 shot 'July they told about the fluid'. No treatment medication information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's history of emphysema remains a contributory factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, patient's history of emphysema remains a contributory factor.
Vaccine given 1-7-21 @ 3 PM. On 1-8 around 10 AM started to feel hot, got chills around 1 Pm. Eyes felt hot with shaking.  Subsided around 3 PM.  Felt fine. On 1-9 while at home around 10 AM my stomach growled and I stood and had explosive uncontrolled diarrhea.  One bout. Felt perfectly normal since.
pt relates that on 22JUN95 went to bed & awoke w/itching in lt arm; today has fist sized swelling over area;
Patient reported feeling itchy within 15 minutes of vaccination.  Given Benedryl; patient improved and was released to home.
PREVNAR 13 vaccine, severe swelling injection site from elbow to shoulder, difficulty breathing, headache and hives, required course of prednisone, nebulizer and inhaler
I had a little tenderness at the injection site for one day.  I started feeling sick on 01/17/2023 like I was getting a bad cold. I tested positive for COVID-19 with a home test on 11/18/2023.  I contacted my doctor and started me on Paxlovid.
Itchy, Hot, burning,  Red rash spreading down to elbow and around arm from injection site.  Applied ice and betamethasone cream. Rash lasted about 7 days.  Had 100.1 fever for a day and aches and pains and very tired.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 22 October 2014. A 29 year-old male subject whose past medical history included elevated cholesterol was found to have non-specific myocarditis 16 days after the subject had received on 26 January 2014: an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I on 11 February 2014 and an abnormal ECG and echocardiogram on 07 February 2014. Lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Herpes zoster; Products liability: manufacturing defect/defective design; Information has been received regarding a case in litigation from a lawyer and refers to a currently 73-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On approximately 17-SEP-2012 (reported as on or about 17-SEP-2012), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection(strength, dose, route of administration, lot number and expiry date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster.On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided.  The reporter consider the event of herpes zoster to be related to the suspected vaccine. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Herpes Zoster in a previously vaccinated individual. Patient had a painful, unilateral 1 dermatome rash lasting less than 4 weeks. Onset was 6/8/2017. Patient was not given an antiviral.
Joint aches, nausea, arm swelling/local pain, feverish, cold sweats.
THE PATIENT CAME IN YESTERDAY SAYING THAT SHE IS HAVING A SIGNIFICANT AMOUNT OF PAIN FOLLOWING HER PREVNAR VACCINE GIVEN ON 9/3/17. SHE SAID THAT SHE CALLED ON 9/5 AND SPOKE TO A PHARMACIST REGARDING HOW HER ARM WAS QUITE SORE AND SHE WAS UNABLE TO LIFT HER ARM ABOVE HER HEAD WITHOUT BEING IN A SIGNIFICANT AMOUNT OF PAIN. THE PHARMACIST SHE SPOKE WITH SAID THAT IT IS MORE THAN LIKELY JUST NORMAL SORENESS AT THE INJECTION SITE POST VACCINATION AND TO GIVE IT UP TO A WEEK TO GO AWAY THEN CALL THE DOCTOR IF IT WORSENS OR DOESN'T IMPROVE. SHE CAME IN YESTERDAY SAYING THAT IT HAS IMPROVED SOME BUT SHE STILL IS UNABLE TO LIFT HER ARM ABOVE HER HEAD. I ASKED HER WHERE THE VACCINE WAS GIVEN AND SHE POINTED TO THE CENTER OF HER RIGHT DELTOID MUSCLE SO IT WAS ADMINISTERED IN THE CORRECT SPOT (NOT TOO HIGH). SHE SAID IT WAS NOT WARM OR RED SO MORE THAN LIKELY NOT AN INFECTION. I TOLD HER TO DEFFINITELY CALL HER PCP TO GET EVALUATED ASAP AND WE WILL REPORT ACCORDING TO PFIZER/WYETH AND VAERS. I CALLED THE PATIENT'S PCP TO INFORM HIM AS WELL AND THE NURSE INDICATED THAT SHE SPOKE TO THE PATIENT TO GET MORE INFORMATION AND WOULD RELAY ALL INFORMATION WITH THE DOCTOR ONCE HE BECAME AVAILABLE.
Child was given the shot on 7/30. Spot of injection became red and inflamed. Became progressively worse. By 8/1 his whole thigh was red and purple, hot, and swollen. Was told by my pediatrician to draw a line around the area and if the swelling and redness went outside the line to go to the ER. We took my son to the ER, he was given Benadryl and Clindamycin to counter the reaction. He was diagnoses with a vaccine reaction in the ER.  Took two days for the swelling to subside. Shortly after this shot my child began having sleep issues, hyperactivity issues, and has since been diagnoses with sensory processing disorder, ADHD, and encephalitis like reactions.
The next day after the shot I started to get the aches almost like the flu.  Once I got home and into bed it went down hill from there.  I had aches, chills really bad, fever and stomach ache, nothing would get rid of the aches and chills  I tried everything.  It lasted about 24 hours.  I started to feel better the next day and but was still weak for about two day afterwards.  I am so nervous about the second dose which I am scheduled for next Friday.  I want the weekend to recover if I need to.