chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received from a physician via a company representative and refers to a premature infant female patient of unknown age. Her medical history, concurrent conditions and concomitant drugs were not reported. She was possibly vaccinated with other unspecified vaccines. On an unknown date, the patient was vaccinated with ROTATEQ, oral (exact dose, lot# and expiration date were not provided) for routine vaccination for rotavirus. It was reported that the patient completed the 3-dose series, however, it was unknown at what point the adverse event occurred within the 3-dose series. On an unknown date after receiving ROTATEQ, the patient was hospitalized for unspecified number of days because she would not stop vomiting. The outcome of vomiting was reported as recovered on an unknown date. The reporter did not provide causality assessment between the event and ROTATEQ. The event was considered to be life-threatening by the reporter. She was confident that the adverse event was life-threatening since the patient was a premature infant who needed to be hospitalized due to vomiting.
Administration Error: "Off label" administration The nurse Administered the third dose of a patient on the report, without the due corroboration of the vaccination card, since the patient had been administered an initial series of the MODERNA vaccine the patient received a third dose of the pharmaceutical PFIZER, When they should receive the MODENRA. Guide establishment for third dose administration of Immunocompromised patients.
Nausea, emesis, diarrhea, low grade fever, tired body aches, chills, sore throat, chest felt heavy and hurts when exhales. Symptoms developed 10/10 Sun & Mon. 10/11. MEDROL dose pack, hoarseness persisted. Referral to ENT and voice therapist 11/10 & 12/1 respectively.
1/6 Vaccination Gradually, in the R arm at the injection site, my arm went form a small soreness to a big knot, warm to touch. Went to ER. Infection in arm. Given medication for 10 days for treatment. After course of medication, I have had no issues.
SARS-CoV-2 / COVID-19 mRNA IM (Pfizer-BioNTech)  Date Status Dose VIS Date Route Site Manufacturer Lot# Given By Verified By 3/13/2021 Given 0.3 mL EUA 12/2020 IM RD Pfizer, Inc EN6208 RN --
Dizziness, fatigue.  Lasted through the evening of 4/12/2021.  Was better by morning of 4/13/2021
fever; myalgia; just didn't feel well; This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, myalgia and feeling unwell. On an unknown date, the outcome of the fever, myalgia and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the fever, myalgia and feeling unwell to be related to Shingrix. Additional details were provided as follows: The case was reported by the physician who reported for himself. The age at vaccination was not reported. The patient experienced fever, myalgia during 24 hours following vaccination. The patient also did not feel well. At the time of reporting the patient was fine. The reporter consented to follow up. The patient also received the 2nd dose of Shingrix and experienced no problems with it.
Started with body fatigue so I went to bed. Very restless and couldn't get comfortable because my arm hurt.. Sometime during the night I woke up with a crashing headache  and I felt as if I couldn't move.  At first I thought it to be a dream until I tried to sit up nd everything hurt and my head especially. My chest hurt when I tried to breath deeply.  I had chills and couldn't stop shaking although I did eventually. With my body and head aching I was afraid to move because I felt nauseous.The next morning I called a friend, I took naproxen sodium, 200 mg as directed. It is now the following morning and I have a dull headache and slight body aches.  The first dose nothing.
Moderate pain  at injection site 24hrs  post. 6 days post vaccination: Swollen, moderately painful, Axillary lymph node  on injected arm (left).  8 days post vaccination: itchy rash on both arms
The night of the shot a red knot formed where the injection was given.  I had sore muscles and had no energy.  By Sunday, the red knot was gone and I felt great on Sunday and Monday (8/1 and 8/2).  I woke up on 8/3 (Tuesday) and the red knot is back at the area of injection.  I once again feel fatigue and muscle aches.
dose #1 has set off a flare up of left knee arthritic pain - moderate to severe at times- Currently being managed with NSAI and CBD oil
Patient called in describing a rash all over chest, neck, armpits and back. Later rash moved to arms but not to legs or torso. Says rash started the night she got the vaccines but was not significant enough to mention when she returned 2 days later for TB read. Rash is red slightly raised bumps 1/2 inch around. Some bumps are dry and at night it burns. Taking Benadryl. No other symptoms. Patient is from out of the country dose not know immunization status. Had chickenpox as a child. Patient had been taking Benadryl allergy and Benadryl allergy and sinus at night, 2 capsules every other day. Since 12/28/06 she had taken 2 capsules in the morning and at night every day. At night the rash burns, it seems the warmer she gets the more it burns. The Benadryl made the bumps/rash feel tingly and numb. She has not been hiking recently, she has not changed lotions or detergents, she has not worn new clothes, she changed shampoos, but returned to her usual shampoo after the rash started. Advised to see doctor 12/29/06. Called patient on 1/3/07. Patient reported feeling better. Said that the rash was disappearing.
I was fine but the next day I had a cough and I started hyperventilating from all the coughing. I went to the Urgent care and my O2 levels were in the 60s. They told me if they didn't improve I'd be sent to the hospital. O2 improved. My arm swelled up at the injection side and it was hot and hard under the site. I put ice packs on it for 2 days and its gone way down.
This case was reported by a consumer and described the occurrence of influenza in an adult male subject who was vaccinated wtih influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. In November 2012 the subject received unspecified dose of influenza vaccine (unknown). In February 2013, approximately three months after vaccination with influenza vaccine, the subject experienced influenza and vaccination failure. The subject's spouse reported "my husband (the subject) and I both got the flu shot in November and I got the pneumonia shot three years ago. Well, I went into the hospital two weeks ago with pneumonia for eight days and came home and was home for three days and he came down with the flu. He is not allowed around me at all. If I get the flu I am going to get it ten times worse so, we are really trying to avoid it as much as possible this year has been really bad because of this crazy weather pattern." This case was assessed as medically serious by GSK. At the time of reporting the outcome of the influenza was unspecified. For case regarding the spouse please see case A0981843A.
? hives on left lower arm. Treated with po Benadryl at 22:10. Temperature 99F, pulse 98 and respirations 20. No redness and not raised around injection site. No difficulty with respirations.
Tachycardia 140's occurred for both vaccine; This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK9231; Expiration Date: 30Apr2021) via intramuscular in Deltoid Left on 20Jan2021 09:10 (age at vaccination was 41 Years old) as SINGLE for covid-19 immunization. On 20Jan2021 at 8:10 (one hour prior to 2nd vaccine), the patient administered with unspecified antipyretic (unknown dose). The patient medical history was unknown whereas, relevant tests was reported as none. The patient's concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK5730 Expiration: 31Mar2021) via intramuscular in deltoid on 28Dec2020 11:00 (age at vaccination was 41 Years old) as SINGLE for covid-19 immunization and experienced GI issues, sore arm, chills, shivering, high fevers, tachycardia, head aches, nasal/sinus congestion, fatigue, dehydration, dizziness, sore throat. The patient experienced tachycardia 140's occurred for both vaccines on an unspecified date in 2021 and was resulted in physician office visit for the event. The outcome of the event tachycardia was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L021214, expiry date: 10-JUN-2017 and lot # L019127, expiry date: 27-MAY-2017) (incorrect product storage). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been received from the same reporter.
Seen in our office on 10/28/08 for 4 year WCU.  Recieved Dtap, MMr, FLu, IPOL, and Varivax.  Woke up on 10/31/08 with left upper arm swellung, red and indurated.  Seen in our office and prescibed Augmentin.
Felt lightheaded.  Bottle of water was given to patient; after drinking, she felt better. Left stable
The pt experienced swelling of the left leg, moves leg,  but not freely as right leg. The pt was taken to the MD for exam. The pt also ran a fever.
3OCT97 mom called clinic w/concern that pt was having shaking spells;pt had 8 spells on 3OCT97, 4OCT97, 5OCT97;none since then;pt let out a little cry, became stiff w/eyes rolled back, glassy stare;
Two nights after injection, had terrifying nightmare, 3 nights a bad dream, nightmares, bad dreams waking me up with a rapid heart beat and fast pressured breathing, and vivid dreams continued for approximately 10 -12 nights  had 2 nights with vivid dreams. On 2/5/21, woke at about 4:50 am with rapid heart beat that changed into AFib and elevated blood pressure. Heart beat reached 151 bpm and subsided about 30 minutes after getting out of  bed.
I woke up at 5AM with pain in my outer left thigh and swelling. The pain would subside when walking or moving around and increase when sitting down. By 6PM I was limping and swollen from my toes to my belly button, I went to the ER which could not admit me due to the beds being full with COVID-19 patients, a blood profile was done which was inconclusive so I was told to follow up with my doctor as soon as possible. I woke up that night at 2:30AM with my left side so swollen I could not get out of bed and when I did or was able to get out of bed I was unable to use my left leg. I went to a Vascular specialist who performed an Ultrasound where a blood clot was discovered.
pt recvd vax;w/in 24 hrs p/ vax,exp n,v,& cramps;sx lasted several days & resolved
itching in head and arms, swelling in hands and feels like something is "stuck" in throat, mild abdominal pain, symptoms getting worse
patient reported to have hives 1 hour after getting vaccine and stated that hives went away the following day.
No adverse effect reported.; patient was inadvertently administered a dose of PROQUAD, instead of MMR II and VARIVAX; patient was inadvertently administered a dose of PROQUAD, instead of MMR II and VARIVAX; This spontaneous report was received from a nurse regarding a 14-year-old patient of unknown gender. There was no information reported about the patient's concomitant medications, pertinent medical history and drug reactions or allergies.   On 30-JUL-2019, the patient was inadvertently administered a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Lot number reported as: S003176 and expiration date reported as: 30-JUL-2020) (dose and route were not provided) for prophylaxis, instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). No adverse effect reported.
I had diarrhea approximately 4 hours after my second dose. I also experienced dizziness and a feeling like I was going to faint at about midnight. My face felt a little numb in the morning, around 6:00 am. I also am experiencing fatigue.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no drug reactions/allergies. On 25-MAY-2013, the patient was vaccinated with a dose of ZOSTAVAX (Lot number was reported as J001002, expiry date was 25-APR-2014, route and dose were not reported). On 26-MAY-2013, the patient developed a varicella like rash around the injection site. The patient sought medical attention (contacted pharmacist). The outcome of a varicella like rash around the injection site was reported as not recovered/not resolved. Additional information has been requested.
weakness, couldn't walk, dehydrated, fall, ambulance brought patient to the Emergency Department.
Pain in throat, unsure if anxiety or swelling. BP 101/65 (pulse 72). Given Benadryl.
Shot was administered in hospital clinic.  Shot was given and patient was told to wait for 15 minutes prior to leaving clinic.  Within 10 minutes, there was severe dizziness and the patient lost consciousness.  When parent arrived, the patient had been placed in a chair, with no head or side supports.  Skin color was grey and eyes were rolled to back of head.   Paramedics arrived within 4-5 minutes and were prepared to take patient to hospital.  They had to administer emergency oxygen as pulse ratio was 30 and oxygen level was less than 85.   The staff of the clinic did little to assist and the monitor in the room did nothing at all to assist the patient.   After administering oxygen, the patient slowly recovered consciousness and refused treatment to be transported to the hospital approximately 15  minutes after regaining consciousness.   In the subsequent week, trouble with vision and dizziness occurred randomly for approximately one week.  Family doctor advised to see specialists about vision.  Vision has since  Hospital clinic was called for emergency report and patient was told they do not prepare the reports for non-hospital patients.  Emergency report was obtained from local paramedics that assisted during the emergency showing life saving treatment was required.
experienced swelling to the size of a 50 cent piece at the site of injection; tenderness and the site being hot; tenderness and the site being hot; Product Complaint; nausea; This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA64AZ, expiry date 31st October 2021) for prophylaxis. This case was associated with a product complaint.   On 3rd March 2020, the patient received the 2nd dose of Bexsero (intramuscular) .5 ml. On 3rd March 2020, immediately after receiving Bexsero, the patient experienced nausea. On 4th March 2020, the patient experienced injection site swelling, injection site tenderness, injection site warmth and pharmaceutical product complaint. On an unknown date, the outcome of the nausea, injection site swelling, injection site tenderness, injection site warmth and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the nausea, injection site swelling, injection site tenderness and injection site warmth to be related to Bexsero.  Additional details were provided as follows: The patient experienced swelling to the size of a 50 cent piece at the site of injection that started The patient noted tenderness and the site being hot, also noted nausea right after the vaccination on the same day but no vomiting. The patient called into the office, but hasn't been seen.  The health care professional reviewed prescribing information of the events reported and the post marketing information. No product to return and no replacement at the time of reporting. The reporter consented to follow up. This case has been linked with case US2020040984, reported by the same reporter.   Follow up information was received from QA department on 11th March 2020: Conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated.
GRAND MAL; SEIZURES; FAINT; CHEST PAIN; FLUSHED; This spontaneous report received from a health care professional concerned 49 patients of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2019, post-vaccination many patients needed to be seen by EMS for various medical incidents such as faint, flushed, chest pain. Later it was 49 people needing EMS attention and several seizures and 1 grand mal experienced took place after covid-19 vaccine ad26.cov2.s vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, faint, flushed, chest pain and grand mal was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210342978-Covid-19 vaccine ad26.cov2.s-Grand mal, seizure and faint. These events are considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Significant veryigo; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 19Nov2021 at 16:00 (Lot number: FJ8757) at the age of 44 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). Concomitant medication included: VALTREX.  The following information was reported: VERTIGO (non-serious) with onset 23Nov2021, outcome "recovered with sequelae" (an unknown date in 2021), described as "Significant veryigo". Therapeutic measures were not taken as a result of vertigo.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Severe diarrhea (4 expulsions within 20 minutes) and  vomiting (3 expulsions within 20 minutes)
This initial non-serious spontaneous case, was received on 28-Nov-2017, from other health professional, concerning a 24-year-old adult female pregnant patient. The patient's concomitant medication included prenatal vitamins for an unknown indication. The patient's LMP (last menstrual period) was reported as 07-Mar-2017. On 16-Oct-2017, the pregnant patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195218, expiry date: 30-Apr-2018), and a second dose of flu vaccine was given to the patient within one season on 27-Oct-2017. It was reported that no adverse event has occurred. The patient's EDD (estimated date of delivery) was reported as 12-Dec-2017.
Received second Covid vaccine at 0800, at 0807 I started to feel faint, lightheaded, palpitations. I loss consciousness and then was awakened by medical emergency team from hospital. My heart rate was 145 and BP was elevated around 180/90?s. They took me to the ER where they ran lab work, all unremarkable except Troponin elevated 0.18. They did ECHO which was normal, they did chest CT which was normal. They admitted me to watch Troponin levels in which they ran a second and it was 0.16. They never ran another and they discharged me same day. I currently still have chest tightness.
Patient called and stated that arm around area where she got her vaccine on 1/21/22 is itchy and red, but it didn't start until 2 days after her shot. She had no issues with the other Moderna shots.
pt recv vax 19JUN95 & 18APR97 pt devel breakthrough chickenpox up to trunk;pt exp a fever of 102 for two days, as well as a h/a;
Patient experiencing tightness in throat approximately 20 minutes following first dose of Pfizer. Patient stated she began to experience tingling in left arm. Patient given 50mg IM Benadryl at 4:07 pm.  Patient reports symptoms were relieved at 4:20 pm.
Warm, red and inflamed rash at site of injection started 1/20/21; 12 days after my 1st dose of covid vaccine on 1/8/21.
tested positive for covid; tested positive for covid; This is a spontaneous report from a non-contactable consumer or other non-health care professional via Medical Information Team. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date in Dec2020 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: e10140) via an unspecified route of administration on an unspecified date in Jan2021 both as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter mentioned that, on an unspecified date, the three patients at the skilled nursing facility tested positive for Covid after receiving both doses. Reporter also mentioned that all three patients received the same lot number. Reporter wanted to know if there is any information on that specific lot number and any problems with that lot number. Reporter stated that he reported. Reporter also wanted to know if there is any data on the efficacy of the vaccine in the older population. On an unspecified date, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361018 Same reporter/drug, different patient/event.;US-PFIZER INC-2021363888 Same reporter/drug, different patient/event.
Severe shoulder and chest pain, enough to have me believe I might be having a heart attack.  Fever, chills, and unremitting pain.   I've never experience anything like this as a result of any immunization. It was truly terrifying.
Nausea, vomiting, muscle aches approx 4 1/2 hrs. after receiving injection.  No SOB, no chest pain or wheezing.  Sx had passed by morning.
After the vaccine had been administered, plunger depressed, a small amount of vaccine remained in the syringe and a small amount was evident on the patient's arm.  The syringe did not retract.
Symptoms of Chills, Fatigue, Fever (101.1), Headache, muscle/body aches, nausea lasted until 02/14/2021.
Tachycardia that is still occurring. Allergic Reaction approximately 1-2 hours later. Throat itching and tightening. Took Diphenhydramine. Severe headache that lasted the first two days. It started 1-2 hours after vaccination. moderate headaches persist approximately two weeks later. Diarrhea for the first 24 hours. It started about 6 hours after vaccination.
Cellulitis. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.