chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first two days after receiving my vaccine, I felt fine. On the third or fourth day, I started to experience diarrhea, fatigue and a low grade fever. The diarrhea and low grade fever came and went, but were still experienced. The fatigue lasted about 5 1/2 weeks total. I had a telehealth appointment with my physician and there wasn't much he could do. He told me to try antihistamine's, but they did not help and he also told me to stay hydrated. I feel as if we should have received more information about side effects or adverse events that were being experienced.
Hot flash while driving home.  Flushed face and ears and sailed through clothing.   Continued with ransoms hot flashes throughout the month.  Abdominal bloating and discomfort began the following week and still hasn?t subsided. ( Had abdominal and transvaginal ultrasound and colonoscopy and endoscopy after contacting gynocologist and GI doctor.   Had generalized feeling of having a bad hangover with random flushing making me feel faint and nauseated .  Didn?t make the connection to the vaccine at the time.   Also sought treatment at urgent care for generalized feeling awful and ear pain.and headache and nausea. Was put on amoxicillin  for potential sinus infection  with no relief .
first dose 07Dec2018, never received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 7th December 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The pharmacist reported that the patient never receive a second dose. Another dose was planned for on the day of reporting but has not been administered.   The reporter ended chat before any further details could be obtained. The reporter declined to had contact information saved in database. Additional supportive information: Till the time of reporting, the patient did not second dose of Shingrix, which led to incomplete course of vaccination.
PATIENT CALLED SAME DAY AFTER GETTING VACCINE COMPLAINING HER ARM WAS IMMOBILIZED. SHE WAS DIRECTED TO GO TO HER DOCTOR IF HER ARM WAS IMMOBILIZED. SHE CALLED THE PHARMACY A FEW DAYS LATER AND SPOKE TO THE PHARMACY MANAGER WHO TOLD HER TO SEE A DOCTOR AGAIN IF HER ARM WAS STILL  PAINFUL AND IMMOBILIZED AND ASKED IF THERE WAS ANYTHING WE COULD DO. SHE AGAIN CALLED THE PHARMACY 1/9/18 TO DESCRIBE THAT SHE HAD GOTTEN SOME MOBILITY BACK BUT SHE THINKS THE INJECTION WAS GIVEN TOO HIGH ON HER ARM.  AFTER SPEAKING WITH THE DOCTOR HE SAID SHE WAS SEEN IN THE OFFICE AND THERE WAS A SMALL BIT OF SWELLING IN HER ARM. HE SAID THE SHOT MAY HAVE BEEN GIVEN A TAD BIT HIGH (ONE FINGER TOO HIGH FOR THE 3 FINGER RULE) BUT THERE WAS NO REASON SHE SHOULD BE IMMOBILIZED. HE SAID THERE WAS NO MECHANISM HE COULD THINK OF THAT WOULD CAUSE A PATIENT TO HAVE AN IMMOBILIZED ARM EVEN IF IT WAS GIVEN A LITTLE BIT HIGHER UP ON THE ARM. THE DOCTOR SAID HE WOULD CALL THE PATIENT AND SEE HER AGAIN AND REFER HER TO A SPECIALIST IF SHE IS STILL HAVING IMMOBILITY PROBLEMS.
On the 4th day following the vaccine I woke up with swelling in my left armpit about the size of a golf ball.  Achiness on the left side of my face, neck and shoulders that lasted till the 8th day.   By the 14th day, the swelling in my left armpit had shrunk to the size of a large acorn with an enlarged vein like tissue protruding down my inner armpit.  This area was still sore.  On Day 21st I saw a doctor who suspected a blood clot and ordered an ultrasound at the hospital and blood work.  After an ultrasound for approximately an hour the technical did not detect a blood clot and sent me home. The doctor phoned me to tell me they did not find anything and that if the pain and swelling continues I could see a surgeon to have the enlarged area surgically removed.
There area was raised, like a pimple. It's still there.; My arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (There area was raised, like a pimple. It's still there.) and VACCINATION SITE PAIN (My arm was sore) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE MASS (There area was raised, like a pimple. It's still there.) and VACCINATION SITE PAIN (My arm was sore). At the time of the report, VACCINATION SITE MASS (There area was raised, like a pimple. It's still there.) and VACCINATION SITE PAIN (My arm was sore) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-395776, MOD-2021-395777 (Patient Link).
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 16:00 as dose 1, single (Batch/Lot number: unknown), in right arm and on 09Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Statins, reaction(s): "drug allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient did not received other medications in 2weeks.Patient received treatment as Paxlovid for covid 19.Treatment start date is 24Oct2022 and Treatment stop date is 28Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Extreme soreness in area of shot, headache, body aches the next day, cannot lift arm more than a few inches from body, nausea, abdominal,cramps, fatigue, dizziness
Terrible diarrhea, stomach cramps, gas, fever, burning eyes, dehydration.
had a severe allergic rxn to vax;broke out w/a severe case of rashes & blemishes covering 95% of body;
Extreme pressure during injection.  Two hours later,  I was in such extreme pain I could not use my arm.  It was very difficult to raise it at all.  This lasted 5 days. As of today, I am able to use my arm but there is still some pain.
Whelps left upper arm and upper back - midline between shoulder blades; Treatment - Benadryl`
Pfizer-BioNTech COVID-19 Vaccine EUA  Started getting a migraine at 0300. Turned worse by 0530. Got a fever ranging from 100.1-100.5 for the majority of the day. Fever dropped to 99.8 by 2000 that night. All day I had muscle tightness and stiffness to the point I could not function for work or move with out being in extreme pain.
Information has been received from a pharmacist concerning a female patient from another pharmacy who developed rash after receiving ZOSTAVAX vaccine (Oka/Merck) (Dose, Frequency, Therapy route, Lot # unspecified). It was unspecified if medical attention was sought. VZVID information provided. Caller was not interested at this time. Additional information has been requested.
11 year old generally healthy male who received DTaP and Varicella vaccines at PCP's office (Health Center) today and developed "sternal pain" and throat pain 10 minutes later. Sternal pain felt "like a burp," no associated palpitations, SOB, or any other symptoms. Never experienced respiratory difficulty, lightheadedness, vomiting, diarrhea, abdominal pain. Did have "mucus" in his mouth. No history of any allergic reactions, but father has many food allergies producing similar reactions. Received Benadryl 25mg at PCP's office then ~2 hours later in ED.  No other meds required.  Urticarial rash resolved within ~4 hours, no other symptoms in the ED.
Pt received an injection of HPV, about 5 min after injection, patient stood, passed out, hit head on cabinet before hitting the floor. LOC for about 2-3 min. Pt had some generalized tremors, eyes rolled, pt was slow to respond (> 5min) c/o HA transported to Hosp via ambulance.
I  went to the clinic had my 2nd shot. I waited my 15 minutes and went home. I was feeling fine some discomfort on my arm. A couple of months later I acquired Covid.  I was fatigued lost smell, and taste. I had a fever for more than one day. I was about 10 days like this with the symptoms.
patient was given adult dose at booster dose, instead of Pfizer 5-11 yr old dose no adverse side effects reported
chills; fatigue; headache; diarrhea; couldn't get out of bed for two days; lots of sweating; knot at injection site; body aching; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN (body aching), LETHARGY (couldn't get out of bed for two days), HYPERHIDROSIS (lots of sweating) and INJECTION SITE NODULE (knot at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (body aching), INJECTION SITE NODULE (knot at injection site) and INJECTION SITE PAIN (pain at injection site). On an unknown date, the patient experienced DIARRHOEA (diarrhea), LETHARGY (couldn't get out of bed for two days), HYPERHIDROSIS (lots of sweating), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, DIARRHOEA (diarrhea), PAIN (body aching), LETHARGY (couldn't get out of bed for two days), HYPERHIDROSIS (lots of sweating), INJECTION SITE NODULE (knot at injection site), HEADACHE (headache), INJECTION SITE PAIN (pain at injection site), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no relevant concomitant medications was reported. No treatment information was provided   Reporter did not allow further contact
arm got sore; had chills, but not bad, like any time she gets the flu shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm got sore) and CHILLS (had chills, but not bad, like any time she gets the flu shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015B20A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Sulpha).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm got sore) and CHILLS (had chills, but not bad, like any time she gets the flu shot). At the time of the report, PAIN IN EXTREMITY (arm got sore) and CHILLS (had chills, but not bad, like any time she gets the flu shot) outcome was unknown.            This case was linked to MOD-2021-072627 (Patient Link).   Reporter did not allow further contact
Shingrix: possible only 1 dose received; shingrix: developed Hives immediately; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of hives in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number h49ma, expiry date 29-SEP-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27-SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 27-SEP-2022, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hives (Verbatim: shingrix: developed Hives immediately). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Shingrix: possible only 1 dose received). The outcome of the hives was not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The pharmacist reported that a patient received 1st dose of Shingrix and developed hives immediately.  The patient said that she had it ever since then non- stop.  The healthcare professional was not sure if patient received the 2nd dose or not. The reporter did not consent to follow-up. There was a possibility that the patient recevied only one dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Large red area around vaccination site, dark spot in center. Started itching with a rash, burning sensation when I scratched it. Treated with ice pack then an anti-itch cream several times a day.  Symptoms lasted approximately 36 hours.
He got his vaccine, had no problems, just a little soreness of his arm.  Then approximately 2 weeks later he woke up and his legs started itching really bad and he started scratching it.  He put some hydrocortisone cream on it and was taking a pill for itching.  It would slow it down but as the days went on the itching continued.  His legs then a few days later swelled and looked like a baseball bat.  He went to the urgent care and the doctor there called an ambulance to transport him to the ER on 9/8/21 and was admitted to the hospital.  While in the hospital he was given a Morphine shot and then was admitted.  He was in the hospital until 9/13/21.  He did have a biopsy of his leg  and was referred to see a Dermatology group.  He was given a cortisone shot there and a prescription for some cream.   He was then referred to a wound care center for this coming Monday.   He was put on Hydroxyzine 25 mg every 8 hours, Oxycodone, Sulfadiazine, Cephalexin.  He did not have any problems with his legs prior to the vaccine.
Moderna was given to the patient on 2/21 at 2:19pm. Patient was only 15 years old and should of not  received the vaccine.  The Screener was given DOB, but she didn't realize that the patient was under 18 from DOB. The Vaccinator states she asked the patient if she was over 18, patient stated YES! Gave the vaccine with no issues.  On 2/22/21 per Dr, Patient is not having an adverse reaction and was seen by her Pediatrician today.
Numbness, tingling, cold on left side of body and face ( inj. site) twitching, sob, racing heart beat, dizziness, disconnection with self felt, problems with speech. Started 15 min. after inj. still have these symptoms 3 days later have some inprovement.  Went to ER given antihistamines only.
This spontaneous report as received from a physician refers to a female patient (the physician's wife) of unknown demographics. No information about medical history, drug reactions and allergies was specified. Physician reports that he administered a dose of ZOSTAVAX (lot#, dose, route not reported) to his wife, about 5 years ago (in approximately 2009) that was exposed to temperature outside of the proper storage range. No concomitant medications were reported. Physician states that his wife did not experience any adverse effects from the administration. There was no product quality complaint. The outcome was unknown. This is one of the two reports received from the same reporter (MARRS# 1409USA013224). Additional information has bee requested.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Visual Changes/Disturbances-Medium
Headache; Started to effect vision; Blood pressure; Nauseous; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received COVID vaccine Friday morning. Had headache and it started to effect vision. Took tylenol yesterday to help with the headache and it went away until about an hour ago, headache came back. Wondering if it was due to blood pressure or vaccine and what she should do. Was also feeling nauseous. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on an unspecified date. Therapeutic measures were taken as a result of headache. The outcome of the event headache was not recovered while of the other events was unknown.  Information about Lot/batch no has been requested.
No adverse effects.; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 22-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (batch/lot# S010702 with expiration date 16-JAN-2021; dose, frequency, route of administration were not reported) for prophylaxis (Product storage error). The temperature and time frame were unknown (late shipment). Information of previous temperature excursion was not provided. No adverse effects were reported. Data logger was not involved.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Date of refrigeration reported as 06-Aug-2021.   This case was linked to MOD-2021-365047 (Patient Link).
Skin rash on abdomen and both legs and feet; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 12Oct2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had known allergies to shellfish. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 20Sep2021 at 11:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 13Oct2021, the patient had skin rash on abdomen and both legs and feet. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event skin rash on abdomen and both legs and feet was not resolved at the time of this report.
Pt stated her "tongue felt thick" and felt her "heart racing" immediately after injection. Pt moved to observation area and offered oral diphenhydramine, pt declined. Pt BP and HR were initially elevated at 168//80 and 129. BP decreased to 140/80 and HR to 100 after five minutes of observation. Pt reported gradual improvement with symptoms for 30 minutes, until reporting a sudden worsening of angioedema, "tingling all over", tachycardia, and syncope. RN administered 0.5 mg of epinephrine IM to L upper thigh and called 911 for ambulance transport. Pt reported some improvement in symptoms after administration of epi, but symptoms not resolved. RN considered administering second epi dose, but deferred when ambulance and EMTs arrived five minutes after first dose of epi. Pt transported to local hospital for further follow up.
Sore, Achey and throwing up multiple times that time. Slept for 2 days after that and my arm continued to hurt. I almost thought I was sick with a bug but no one else in my home got sick.
Shaking chills; Arm pain at the injection site; Ill; This is a spontaneous report from a contactable physician (Patient). A male patient of an unknown age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiration date unknown) via unspecified route of administration, on 15Mar2021 at 12:00 at single dose for COVID-19 immunization. The patient had severe COVID in April 2020. Concomitant medication was not reported. After receiving the dose 1 of the Pfizer COVID-19 vaccine on 15Mar2021 at 12 noon on that day, twelve hours later the patient developed arm pain at the injection site followed by shaking chills from 2 am to 5 am. The patient was ill for 48 hours then recovered. The patient stated that he felt like when he had COVID. Event took place after use of product. The outcome of the event pain at the injection was unknown. The patient recovered from the events shaking chills and ill in 2021.  No follow-up attempts are needed. No further information was expected.