chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight headache; sore muscles; tired feeling all day; felt like a bee sting; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on the right arm on 24Feb2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamins, not every day of the week. The patient previously received first dose of BNT162b2 (COMIRNATY, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 24Feb2021 at 09:30, second shot when administered the patient felt like a bee sting for about 5 minutes and sore arm. Next morning, on 25Feb2021 the patient experienced slight headache, sore muscles and tired feeling all day. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt like a bee sting, sore arm, slight headache, sore muscles and tired feeling all day were recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Chills, cold sweats, nausea, headache, body ache, fever, sore arm,  for one week
1 hour after- light headed, headache 7 hours after- body chills, body ache, fatigue 14 hours later- fever 21 hours later- cramps, back ache 23 hours later- started period (last regular period stopped a week prior) heavy than usual flow
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (DTPa-HBV-IPV) (batch number BZ24H) for prophylaxis.   On 08-FEB-2023, the patient received DTPa-HBV-IPV. On an unknown date, an unknown time after receiving DTPa-HBV-IPV, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The patient age is reported that less than a year. The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
5- 10 minutes after vaccine, patient reported an itchy arm. 20 min after vaccine, patient reported slight itching in the mouth. Patient was seen by provider who recommended patient to wait 30 min and to receive 25 mg of Benadryl.  At time of departure- no more itching in mouth- no redness or swelling at injection site.
I RECEIVED A YELLOW FEVER VACCINE ON SATURDAY 7/16/2005, AND EVERY SINCE SUNDAY 7/17/2005 THERE HAS BEEN A LARGE FLAT RED SPOT THE SIZE OF AN EGG ON MY LEFT ARM AND ITS VERY PAINFUL,  ITCHY AND WARM.
fever x 3 days Tingling in all 4 limbs x 3 days joint pain x 3 days pins and needles in back x 3 days diarrhea x 1 day presented to office w/this on 7/14/07
A serious spontaneous report of erythema multiforme has been received from a physician concerning a three-year-old female, subsequent to FLUMIST.  Concomitant medications included mometasone furoate, loratadine and montelukast for allergic rhinitis and congestion (patient had a prescription but physician was not sure if the patient took montelukast).  On 17-Oct-2008, the patient received FLUMIST.  She never received FLUMIST before.  The following day on 18-Oct-2008, the child developed a rash which progressed and was described as a bullseye rash all over body.  On 19-Oct-2008, the patient was hospitalized for erythema multiforme.  The patient was hospitalized for three days.  The reporting physician did not have the patient's hospital records.  On 24-Oct-2008, the patient recovered from erythema multiforme.  Additional information received on 25-Nov-2008 was incorporated into the above narrative: a diagnosis, concomitant medication, medical history, and demographics. Follow up was obtained the Lot Number was not available.
At 5:30 pm started feeling off with a mild headache. Progressed to nausea and more pronounced headache. By 7:30 pm, chills (really just feeling cold and unable to warm up) and fever. Fever reduced with medicine. Woke up with headache and fatigue. Fatigue lasted almost entire next day; I slept almost all day after vaccine and that night. Woke up 2 days after vaccine largely ok, but my heart would beat very hard during strenuous activities (exercise, going up the stairs). Felt same significant increase in my heart rate during exercise 3 days after vaccine. By 4th day, was able to exercise as normal. However, on Monday 2/1, had sore throat for the day  my external throat muscles, like the SCM, vs something internal)
09/16/22 presents to ED for "abdominal pain". PMHx of "CVA, hyperlipidemia, hypertension, hypothyroidism."
Moderna Booster was administered after 12 hours of puncture. Moderna vial from 1/5/2022 that had first puncture at 0830; booster dose was giving to a patient 1/6/2022 at 1030. Patient was monitored 15-25 minutes after administration and denied any adverse effects or symptoms. Patient will be made aware and Moderna manufacturer was called and report was filed.
severe nose bleed; This is a spontaneous report received from a contactable consumer (patient's fiance). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. She stated patient got the second dose of Pfizer on 03Jun2021. It was almost 2 hours ago. Now he was having a severe nosebleed. It was not stopping. She states this never happened before. It didn't happen the first time he got a dose and he has never had a problem with bleeding through the nose. The outcome of the event was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2017, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. In March 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the her injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earning capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Shortly after patient received vaccine, their arm appeared red at injection site. Mom stated this was a normal reaction for patient. Mom later noticed that patients arm was swollen and hard. Mom took patient into doctor where he was prescribed antibiotics for a bacterial infection from the needle injection.
Patient was 12 years old and received the dose for the 5-11 year olds - no adverse effects.
nausea; vomiting; body ache; exhaustion; next 2 days horrible headache with 2 migraine sat and sunday; Monday still headache but not as bad.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Oct2023 as dose 1, single (Batch/Lot number: unknown), in right arm for influenza immunisation. The patient's relevant medical history included: "Known allergies: Nuts" (unspecified if ongoing), notes: Known allergies: Nuts; "Known allergies: mouth sores" (unspecified if ongoing), notes: Known allergies: mouth sores; "Cholesterol" (unspecified if ongoing), notes: cholesterol medi. Concomitant medication(s) included: PROZAC; WELLBUTRIN; LEVOTHYROXINE. The following information was reported: HEADACHE (non-serious) with onset Oct2023, outcome "recovering", described as "Monday still headache but not as bad."; MIGRAINE (non-serious) with onset Oct2023, outcome "not recovered", described as "next 2 days horrible headache with 2 migraine sat and sunday"; PAIN (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering", described as "body ache"; FATIGUE (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering", described as "exhaustion"; NAUSEA (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering"; VOMITING (non-serious) with onset 18Oct2023 at 05:00, outcome "recovering". Therapeutic measures were taken as a result of nausea, vomiting, pain, fatigue, migraine, headache.  Additional information: Patient experienced the nausea, vomiting, body ache and exhaustion first day, next 2 days same side effects without vomiting. next 2 days horrible headache with 2 migraine sat and sunday. Monday still headache but not as bad. Medication did not touch the paid of the migraine. Patient was treated with tylenol, then tried ibupophen, then tried Flexeril. Patient did not had COVID prior vaccination and not tested positive for Covid.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a physician concerning a 3 year old male who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). The patient had a breakthrough of varicella all over the body "the next day" after receiving the vaccination. The physician also noticed pock marks inside the throat area. No additional adverse event information was reported. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Case number PHEH2013US020760 is an initial spontaneous report received from a consumer on 03 Oct 2013. This report refers to a 68-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with flu vaccine (manufacturer and batch number: unknown) intramuscularly in 1999. After vaccination, her arm was swollen, red and she had a rash. She also stated she had pain in her arm and shortness of breath. Her physician told her not to take flu shot again. She stated that she also had the same reaction in the past with tetanus shot (other manufacturer, batch number: unknown) and therefore received the antidote to tetanus shot. Outcome, seriousness and causality of the events were not reported.
Patient experienced an elevated temperature up to 104 degrees F 24hrs post vaccination along with some reported confusion.  Over the next 48 hrs temperature fluctuated between 102-103 degrees.  She reports confusion and difficulty with movement to lower extremities.  Per her report she "felt like she had a stroke".  Presented to the ER on 4/3/21 due to chest pain, no physical findings diagnosed with the exception of potential psychosis per patient report.  Over the next week, patient reports experiencing seizure-like activity and pronounced difficulty with speech (stutter).  Again went to ER an 4/10/21.  Diagnosed with conversion disorder.  on 4/13/21, seizure like activity persisted along with speech disturbances.  ER referred to outpatient neurology.  Additional symptoms experienced include headache and weight loss since 3/26/2021
pt devel varicella;dx was varicella per chart;pt came in w/varicella rash all over body;
Systemic: Allergic: Rash Generalized-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: pt stated that about 3 days after her first vaccine the tip of her tongue got numb and she got a rash on her chest. the numbness of the tongue only lasted a few hours and the rash was gone by the next day. about a week after her first vaccine, she started getting pain in her toes and then in her inner thighs. the pain lasted for about a week. she took some ibuprofen when the pain first started which she said helped a little, but then didn't take anymore. she said the pain wasn't bad at all
This study case was received from the investigator on 27 September 2012. A 22 year-old male subject was found to have other acute pericarditis, unspecified disease of pericardium and non-specific myocarditis 12, 12 and 15 days respectively after the subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 03 May 2012. On 10 April 2012 the subject was also vaccinated with ANTHRAX 2 (manufacturer, lot number, route and site of administration not reported), Japanese Encephalitis 2 (manufacturer, lot number, route and site of administration not reported). Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 00.05 on 18 May 2012, a normal ECG on 15 May 2012 and a normal Echocardiogram on 18 May 2012. 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.
Patient received Boostrix vaccine at pharmacy today at approximately 1110am. Pharmacist intern administering the vaccine alarmed me to the patient having an adverse reaction or an episode where her eyes went open and dilated, but was unresponsive and went limp in the chair, First thought patient had a fainting spell until patient did "rocking convulsions" and while "moaning", then abruptly stopped, where it seemed she had blocked her breathing with tongue. Intern was attempting to lift her from chair into lying position when patient grabbed counter and came to. Event lasted approx. 1min following 1 to 2 minutes after vaccination. Patient came to slowly, and was able to respond again. Hands were cold and we monitored her BP periodically until 12p, which showed low blood pressure (baseline not known) and lower than usual pulse. Patient was monitored periodically by checking her BP and pulse. She was given water and a food bar to make sure she was recovering. Patient was asked to stay so we could make sure she was going to be safe before leaving. She stated her boyfriend would be coming to pick her up, and we suggested her go to medical provider at an emergency room or urgent care to be evaluated properly.  Patient seemed fully alert and oriented and was not having any difficulty speaking, vision problems or issues with her extremities, however we did not attempt to have the patient stand up since the BP readings were on the lower side. We continued monitoring her BP and noticed her BP was returning to normal but her pulse was lower than usual. Boyfriend talked to his mom and they asked us to call EMS. Paramedics arrived and took patient to ER.
First vaccine digestive symptoms and minor aches; very sore left arm lasted 7 days; 2nd vaccine: 102 degree fever on next day; aches and pains all over; could barely get out of bed; inability to eat at all for 24 hours; digestive symptoms: gas, acid refulx, nausea; giant burps. By next day, very painful electric transitory pains (seconds) in core of my vascular formation in my upper left leg. This is a congenital defect that responds to estrogen, but also some medicines like synthroid, which I do not take after getting reaction with just 3 pills. Successfully moderated Hashimoto's with strict gluten-free and dairy-free diet. I have never experience such severe leg pain and massive swelling, still happening today. Th The only other time that I have experienced these short intermitent "electric" pains was during infertility treatment at age 40, more than 30 years ago. I suspect something in the adjuvant. I hope that this will exit my body because the sudden swelling and severe pain is not something I can endure. It barely beats dying from Covid-19. My quality of life is wrecked for the time being. I suspect that this vaccine has caused an autoimmune attack on my vascular malformation; that my T cells have gone beserk. I'd be willing to have my antibodies against Covid checked and I'll bet I have more than average! The havoc for people with autoimmunity and Moderna vaccine is serious. I despair and hope that it won't have a lasting impact on my health. I will volunteer to be studied, but no more Moderna vaccine for me! I trusted the medical establishment and government and this has not worked out well!
Right thigh had redness and soreness, symptoms started 11/06/2012, Dr. treated reaction with Benadryl and Advil or Motrin.
Severe muscle pain, severe headache, nausea, abdominal pain, fatigue, and unable to sleep.
I was given the patient's chart and  it was the wrong chart.  I thought I was drawing up a Covid Moderna Bivalent for the patient I had been talking to previously in the waiting room.  So I drew up the Covid-19 Moderna Bivalent injection and called out her name and she got out of her seat and followed me into the exam room.  I asked her about her health issues and wrote that on her chart.  I then told her what I was giving her and she said why was she getting another one.  I explained that the antibodies wear off after a few months and this particular one was manufactured to be effective against the newer strains  and she ok to give.  She then asked why she is not getting the other vaccines talked about with the front office and I told her I would go check on that.  Then I gave her a copy of her Immunization Registry record and she stated,"This is not my name."  At that time I repeated, "This is not your name?"  and she said no, it is not!  I asked her why she got up in the waiting room when I called out the name and she said "I must have misunderstood you."   So, at that time I asked her to wait in the exam room while I went to get the correct chart.   I then received her correct chart and  drew up the correct immunizations and took them into her room and administered them to her after explaining that I had given her the wrong shot the first time.  She asked if it would hurt her and I explained to her that it would not hurt, but she might have a more robust reaction since she had already had a bivalent Covid booster injection given to her in Sept 22
Hives and chills lasting  for extended period (still has them as of today 10-17-19).
Itchiness and small rash on forehead; Itchiness and small rash on forehead; This is a spontaneous report from a contactable nurse (Patient). A 35-year-old female patient received bnt162b2 (lot number: EJ1685), intramuscularly at left arm, 1st dose on 20Dec2020 08:00 AM, at single dose, for COVID-19 immunization. No COVID prior vaccination, COVID tested post vaccination, known allergies, or other medical history. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination and after vaccination. Not pregnant at the time of vaccination. There were no concomitant medications. The patient experienced itchiness and small rash on forehead on 21Dec2020 01:00. The event was reported as non-serious. Therapeutic measures were taken as a result of itchiness and small rash on forehead, treatment included: allergy medicine PO (Oral). The outcome of the events was unknown.
CLIENT REPORTS HE HAD A LOW GRADE FEVER AND WAS ACHY FOR THREE DAYS. HAD A LUMP ON HIS ARM WHERE THE TDAP WAS GIVEN. PLAYED TWO SOCCER GAMES DURING THIS TIME, SAID MAY HAVE BEEN ACHY FROM THAT. THEN DEVELOPED A LARGER AREA OF REDNESS ON HIS ARM. LUMP GONE TODAY.ARM APPEARED BLOTCHY ON THE SHOULDER, RED ON THE BICEP AREA OF THE ARM DOWN TO THE ELBOW. SLIGHT HEAT IN THE AREA. ADVISED TO SEE HIS DR TODAY FOR EVALUATION.
ADMINISTRATION ERROR; This spontaneous report received from a health care professional concerned patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patients received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 20-JUN-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the subjects experienced administration error. The action taken with covid-19 vaccine was not applicable. The outcome of administration error was not reported. This report was non-serious. This case, from the same reporter is linked.
Severe lower back pain for 2 weeks. Now it is still there but less severe. Neighbor had same issue.
After 4 days, I developed a rash around my collar area/neck.  Actually looked more like a burn, and itched slightly.
This spontaneous report was received from a physician via a company representative concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). Concomitant therapies were not provided. On an unknown date, the patient developed "a mild case of shingles". At the time of the report, the patient' outcome was unknown. Additional information has been requested.
Received H1N1 FLUMIST on 12/06/09. Second dose with first dose 11/15/09. On 12/9/09 developed tingling sensation back of neck, causing client to "twitch" head back and forth to stretch neck which decreased the tingling sensation. 12/17/09 Dr. visit with rx prednisone pack. 12/21/09 tingling continues but less intense.
Beginning within a couple of hours nausea.  By evening fever, joint ache and headache.  Continued Saturday, reduced symptoms on Sunday but unable to do usual activities.  Returned to work Monday as no fever in the morning.  Low grade fever and headache this afternoon, some joint ache and nausea
sensation of edema in legs & aching in both knees & metatarsals were initial s/s; edema did devel in knees & thighs;