chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Red arm; This is a spontaneous report from a contactable consumer (the patient's mother). A 13-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 13-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm, red arm. It was reported that, his arm was hurting him and it was red and sore. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Storage of vaccine was in refrigerator instead of the recommended location of the freezer and therefore out of temperature range 11/30/2022 and vaccine given 1/12/2023. Vaccine given intermuscular instead of subcutaneous.
I became very flush all over my body and a spike up of my blood pressure late the next afternoon after the injection and lasted for several hours. I felt like I was sunburned on the outside of my skin.
Patient was not 18 at time of vaccination. Does not turn 18 until 5/12/21.
Patient presented to clinic approx.15 hours after LUA injection with localized swelling in LUA. Patient states that she experienced chills approx 4hrs after injection. No hives, No itching, No SOB. Patient given hot/cold compression Ibuprofen and Benadryl.
I took my daughter to a physician she had never been to before. While we were there the nurse suggested my daughter get the GARDASIL injection. I asked her 2 X's what are the side effects of this injection and she said only a slight chance of redness and swelling at the injection site. The Dr came in and AGA IN I asked her about ANY side effect of the GARDASIL, shot and she assured me that there was SIDE EFFECT. I said yes IF you ARE SURE there is NO CHANCE of any side effects.. 3 times I asked her BEFORE the injection. As soon as my daughter got the shot within SECONDS she felt sick. She became hot and clammy. At the check out desk at the Dr's, she felt very weak and dizzy..I asked the receptionists to call back and tell the Dr how my daughter was feeling, the Dr said it would pass. Within 10 minutes after the shot my daughter had extremely bad leg pain on the right side and could not walk. When we got home she felt very SAD and tired. During the night my daughter started throwing up. I called the ER and they said that that was not a normal reaction to an injection. That was Monday night, today is Wednesday and she still is having A LOT of symptoms and problems including muscle weakness, feeling sick, nauseous, chest pain, swollen glands, stomach pain. She went for blood work today and tomorrow a visit to the Dr who gave her the shot. This is CRAZY, she is suffering for what reason???? Because a Dr gave an injection WITHOUT either knowing- ignorantly-what can happen as a side effect on just not TELLING us. THIS MEDICATION SHOULD BE REMOVED..I my daughter should continue to suffer ANYTHING from this injection the makers will be SUED by US.  6/9/09 Medical records received DOS 5/18/09 to 5/20/09. Pt in for 14 yr WCC with 2-3 c/o coughing congestion. Vax given. Returned next day with c/o arm not feeling right since injections. Returned again 5/21/09 with c/o myalgias, abdominal pain and R-sided (illegible) pain and feeling ill since vax. PE . T=99.9. Assessment: Allergy.  Myalgia.  H/A. ? reaction to Gardasil.
Cellulitis which developed at site of injections approximately 2 days after they were given. Patient did respond to antibiotic therapy.
Pt was administered PPSV23 and waited in the office 15 minutes after administration- no reaction reported at that time. Pt called in the afternoon and reported he had a golf-ball sized knot at the injection site. Pt went to ER and speaking with him after that day he stated the knot was decreasing in size.
Did her Covid the day after my second shot, which was the date listed above. A very mild case. I discovered I was Pregnant between the 2 shots. On Friday 2/5 I noticed my right breast was very tender and had a red quarter sized area under my nipple where there as also a bean sized tender mass. Saw my OB Monday 2/8 after the redness spread and it was more tender, and Ducati discharge. Started on dicloxicillin x2 weeks. US of the right breast showed severe mastitis. Redness increased 2 days later with pain increasing. Still no fever or feeling bad. Started on Bactrim DS and started improving. Today 2/18 still With very mildly tender mass below the nipple back to quarter size.  Pregnancy is normal this far.
HIBERIX at 15 months and a second at 18 months; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-month-old female patient who received Hib (Hiberix) (batch number PJ7ER, expiry date 13th November 2022) for prophylaxis.   Concomitant products included haemophilus B conjugate vaccine (tetanus) (Hiberix).   On 27th January 2022, the patient received the 2nd dose of Hiberix (intramuscular) .5 µl. On 27th January 2022, unknown after receiving Hiberix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter stated that, the patient received a Hiberix injection at 15 months old and a second Hiberix injection on the day of reporting, which led to extra dose administered. The reporter stated, the patient was supposed to receive the Hepatitis A vaccine on the day of reporting. The reporter consented to follow up.
Ache in back of left leg.  Thought it was a muscle strain from working in yard.  Did not go away so went to Clinic February 2nd, 2021. They asked me my symptoms and then sent me for a Sonagram and discovered a DVT and later a Pulmonary Embolism in my right lower lung. I am now on Eliquis.
A non-serious, spontaneous report of administered expired FLUMIST was received from a other health professional concerning a ten-year-old female. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 14-Feb-2011: Reporter confirmed that there was no late occurrence of adverse events.
he can still take his second dose of Shingrix was late dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he can still take his second dose of Shingrix was late dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Aug-2023 The consumer called on the day of reporting to see if he an still take his second dose of Shingrix. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Pain on the injection site; chill; nausea; lightheaded; This is a spontaneous report from a contactable physician via a Pfizer colleague. The Pfizer colleague received from a friend a video where the physician (also the patient) was interviewed on 25Dec2020 after getting the Pfizer/BioNtech vaccination and he reported the symptoms described below.  An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unkown, expiry date not reported), via an unspecified route of administration on the left arm on 24Dec2020 at a single dose for COVID-19 immunisation. Medical history was unknown. It was unknown if the patient was allergic to medication, food or other products and it was not known if the patient was diagnosed with COVID-19 before vaccination or if the patient had been tested for COVID-10 since the vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 24Dec2020, the patient experienced pain on the injection site (was still ongoing on 25Dec2020); also chill, nausea and lightheadedness which all disappeared 30 minutes after the injection. Clinical outcome of pain on the injection site was unknown, while for the other events was recovered on 24Dec2020.  The batch/lot number was unknown as it was not available or not provided by the reporter at the time of report completion. Follow-up attempts are not possible. No further information is expected.
This spontaneous report received from a patient concerned a 73 year old male. 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, batch number: 1802070, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 on Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced rash on chest/back/neck/stomach. On 07-APR-2021, the subject experienced red rash. On 07-APR-2021, the subject experienced itchy rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on chest/back/neck/stomach, red rash, and itchy rash. This report was non-serious.
88 yo M with pmhx CAD, HTN, a.fib presented today for monoclonal antibody infusion after testing COVID positive on 11/12. In the ED, patient was given 1L NS bolus and 6mg decadron IV Patient endorses SOB, 1x diarrhea today, and cough x 7d productive of yellow sputum. Patient denies HA, CP, palpitations, fevers, nausea, vomit and chills.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose number unknown , single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose number unknown , single (Batch/Lot number: unknown), in left arm, on 28Sep2021 as dose number unknown , single (Batch/Lot number: unknown), in left arm and on 17Mar2022 as dose number unknown , single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SIMVASTATIN; PANTOPRAZOLE (other medication in 2weeks). There was no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 30Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 30Mar2022, outcome "not recovered" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Mar2022) Positive; (07Apr2022) Negative; (13Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was Tested positive for Covid 30Mar2022, and immediately began treatment with Paxlovid. Tested negative 8 days later. Symptoms returned 12Jun and tested positive morning of 13Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
NASAL CONGESTION, SINUS PRESSURE, FEVER, CHEST CONGESTION, COUGH
I don?t know if all or any are vaccine related, I just know all but the swelling started after 3/23 shot. Random dizziness, nausea, headache, ache between shoulders and chest, leg swelling. Threw up several times 4/10.
Arm sore, first day. Next day, started to radiate up neck and down arm x two weeks. At two weeks, numbness and tingling down your and into your fingertips, thumb and forefinger. Some wrist pain. No redness or swelling; no fever. Relief by taking ADVIL; however, did not affect the numbness and tingling. Range of motion is fine.
About thirty-six hours after receiving the second Moderna shot, I awoke around 1 AM with a sharp pain in my upper stomach area and felt nauseated. I began to vomit and continued to vomit every two hours for the next 14 hours or so. I felt fatigued and developed a fever and chills, which persisted for more than a week. Initially, I did not seek treatment because many of my symptoms matched those of an immune response to the vaccine. A couple of the medical professionals I spoke to encouraged me to wait it out. But after 8 days of increasingly high fevers (up to 103.4) and severe and prolonged chills, I went to the emergency room, where they diagnosed me with a ruptured appendix.
rash , swelling, itching, redness at the injection site 10 days after shot given
Estimated due date is June 20th 2022.  Found out at 20 weeks that she has cysts in her kidney without any family history of kidney or renal disease. I got the shot while 5.5 weeks pregnant.
on antibiotics for a sinus infection; This is a follow up report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number/ Expiry Date: Not Provided), via an unspecified route of administration on 18Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced on antibiotics for a sinus infection. The caller stated that he is enquiring if he can still get the second dose of the vaccine as he is scheduled for his second dose on Friday, which will be 22 days since first. He is on antibiotic therapy for sinus infection, he has a 12-day prescription, he started it 9 days ago, last dose is supposed to be Saturday the day after the vaccine and wants to know if it is okay to get the second dose. He added that he got the first dose of the vaccine last 18Mar2021 and his second dose is scheduled on 09Apr2021. Upon checking, his second dose is scheduled more than 21 days after the first dose. Therapeutic measures were taken as a result of on antibiotics for a sinus infection. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Injection painful at time of administration with bleeding and bruising occurring immediately. Shortly thereafter, site observed to be hot to touch with silver-dollar sized redness and swelling at site. In ensuing days, starting very soon, experienced muscle and joint aching. Heat persisted until 12/09/02. Some nausea, intermittently. Redness and swelling persisted for about 5 days and associated soreness at site.
HEAVY POST NASAL DRIP; HEAVY NIGHT SWEATING; TINNITUS IN HEARING; LITTLE TO NO PAIN IN THE INJECTION SITE MUSCLE; TEMPERATURE 97.6 BEFORE AND AFTER DAYS OF SHOT; LOST 4LBS (POUNDS); INJECTION SITE MUSCLE FIRM AND HARD; HEAR VERY FAINT THINGS NOW; EARS FEEL LIKE THEY WERE  ALWAYS DRAINING; URINE DARK; STOOL DARK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On AUG-2021, the patient experienced lost 4lbs (pounds). On AUG-2021, the patient experienced injection site muscle firm and hard. On AUG-2021, the patient experienced hear very faint things now. On AUG-2021, the patient experienced ears feel like they were always draining. On AUG-2021, the patient experienced urine dark. On AUG-2021, the patient experienced stool dark. On AUG-2021, the patient experienced little to no pain in the injection site muscle. On AUG-2021, the patient experienced temperature 97.6 before and after days of shot. Laboratory data included: Body temperature (NR: not provided) 97.6. On 09-AUG-2021, the patient experienced heavy night sweating. On 09-AUG-2021, the patient experienced heavy post nasal drip. On 09-AUG-2021, the patient experienced tinnitus in hearing. The action taken with covid-19 vaccine was not applicable. The outcome of the heavy night sweating, lost 4lbs (pounds), injection site muscle firm and hard, heavy post nasal drip, tinnitus in hearing, hear very faint things now, ears feel like they were always draining, urine dark, stool dark, little to no pain in the injection site muscle and temperature 97.6 before and after days of shot was not reported. This report was non-serious.
At 1700 hours client reported to school nurse a slight tingling and purplish color to her right palm.  Client had received her flu vaccination (0.5cc GSK) in her right deltoid muscle at 1621 hours.  I assisted with the assessment of the client's condition.  Client reported no respiratory distress.  Her lungs were clear to auscultation.  Client's skin was pink, warm, and dry, with the exception of her right palm.  Her right palm was cool to the touch and slightly purple in color.  Client could move all the fingers without problems or discomfort.  Her range of motion was normal.  Client denied any other complaints or symptoms.  Her vital signs were taken at 1702 hours:  Blood pressure-128/78, Pulse-90, Repsirations-20.  Client reported she had history of injury last month to her right shoulder, possible dislocation, and a head concussion.  However, client states she felt well before getting her flu shot.  RN monitored the client for another 15 minutes.  Vital signs repeated at 1717 hours: Blood pressure-100/60, Pulse-80, Respirations-16.  The purple color to the client's palm was improving and the tingling feeling slightly less per the client.  She was released at 1720 hours.  Follow up phone call the next day (11/8/13 @ 1115 hours) revealed no problems per the client's mother.
Information has been received from a LPN concerning a 6 year old male with no past medical history who on 10/20/95 was vaccinated with varicella virus vaccine live (069297/0437B) in the thigh. There were no illnesses at the time of vaccination. The LPN stated that the pt "now has chickenpox". In follow-up, the LPN reported that on 5/8/01, the pt "broke out with chickenpox with 20-40 spots". The LPN reported that the pt recovered from his experience on 5/13/01. Unspecified medical attention was sought. No further information is available.
Pt believes she became pregnant on 1/19/01 after receiving varicella virus vaccine on 12/14/00. Pt's last menstrual period was on 1/5/01. The pt planned to see her health care provider on 2/2/01. The OB/GYN reported the pt had no previous pregnancies. No fetal heart beat was detected on two ultrasounds. The pt had a spontaneous abortion on 3/13/01, 9 5/7 weeks from her last menstrual period. The products of conception were examined. It was not known if the fetus was normal. No further info is available.
Vomiting, tremors in arms & legs for 1-2 minutes with moaning and lethargy following.
Information was received 25-JUL-2016 regarding a case in litigation for GARDASIL from a lawyer and the mother of a 15 year old girl (see case # 1503USA006173, same reporter and case # 1607USA010909, same reporter). This mother reported she went to medical literature searches and she found research that was done by a professor at a university who researched reports of GARDASIL adverse reactions. The professor found that Gardasil was contaminated and caused adverse reactions as a result. Additional information is not expected.
It was reported that a pt (2 of 3) received a Tripedia vaccination (date not specified). Reportedly, the pt developed a local reaction at the injection site (onset not specified).
Achiness; More of a reaction; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), VACCINATION SITE REACTION (More of a reaction), FATIGUE (Tired) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A, 039D21A and 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder, Neurological disorder NOS and Immunocompromised.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achiness), VACCINATION SITE REACTION (More of a reaction), FATIGUE (Tired) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; NAPROXEN for Adverse event, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achiness), VACCINATION SITE REACTION (More of a reaction), FATIGUE (Tired) and PYREXIA (Fever) outcome was unknown.            Patient takes medication for a cardiac condition, medication for a neurological condition, lowdose steroid and antibiotics Patient also reported getting flu shot two weeks before taking booster dose. Patient also used ice and cool compresses for treatment.   This case was linked to MOD-2021-373406 (Patient Link).
Patient came into pharmacy on 4-6-22 to report that her left arm has been swollen and warm to the touch since she received the vaccine. Patient has only been taking naproxen and had not yet consulted a physician.  Pharmacist instructed patient to contact doctor immediately to be evaluated for possible cellulitis.
Chest pains, shortness of breath, arm pain, increased heartbeats started within a few hours of vaccine. Went to ER the next night at about 8 pm after symptoms increased. Was admitted to hospital the next morning for observation.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 19-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 26-Jan-2011. On 05-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
On arm where injected swollen, red, warm to touch, hard, about two inches around, occasionally itchy. Woke up on Saturday with it sore and it was raised. I took a shower and noticed it was red beyond band aid. Slowly got bigger through day and has been this size since. I take a daily allergy pill so didn?t take anything more.  Have tried cool compress but doesn?t help. Today 3/29/2021 has gotten very hard.
Pt RTC within about 15 minutes of administration of vaccines with significant bilateral edema of both sets of eyelids. Complained that started feeling bad with cough and numbness of eyelids. Lungs CTA, no respiratory distress and no hives noted.