chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was having pain and a lump in my arm. It took a little while to go away. I did not get any treatment for it. On 08/13/2021 I was having horrible pains all over my body. I was coughing a lot and sneezing like 6 times in a row. It was really severe. I was feeling sick a few days after that. Then, one day I lost my taste and smell. I got the Covid test on 08/18/2021 at the doctor's office by 08/20/2021 they said it was positive. They did not give me any medications. I also had a blood test done- CBC, basa % rated as high 1.8, it was supposed to be 0.1. The BUN was 27 which is high, it was supposed to be between 7 and 19. I got this test on 09/01/2021.
sore throat; his upper arm started to hurt really bad; This is a spontaneous report from a contactable consumer reported for his  father via Pfizer-sponsored program. A 91-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 25Jan2021 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 29Jan2021 (day 4), patient experienced sore throat and his upper arm started to hurt really bad. He was not sure if it's because of the Covid vaccine or because his dad lifts very small weights. They did take Xrays, nothing was broken, but he wanted to know if the Covid vaccine could cause his dad's upper arm area to become super painful and then also he is supposed to get a Cortisone injection today and he wanted to know if that is alright to do or not as well, since reporter's dad developed a sore throat and a upper sore area after getting the Covid vaccine. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The outcome of the events was unknown.   Information of lot/batch no has been requested.  Follow-up attempts are completed. No further information is expected.
Red area measuring 6.25 inches by 7.5 inches, hot to touch, and swelling. No difficulty breathing or swallowing.
Pt recvd 3 doses of Engerix-B & 16APR92 devel swollen lymph nodes (neck) & 25APR92 devel a sore throat;
A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Dec-2013. It was reported that four patients were inadvertently administered with expired FLUMIST QUADRIVALENT which started on 04-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT to four patients is unknown. The report was considered to be non-serious.
Information has been received from a medical assistant and a physician concerning a female patient who on 06 Nov 2006 was vaccinated SC with a 0.65ml dose of varicella zoster virus vaccine live. The medical assistant reported that he had administered the varicella zoster virus vaccine live diluent without the vaccine to the patient. However, when confronted by the doctor, the medical assistant reported that the vaccine had been reconstituted before it had been given. The patient also experienced a burning sensation at the injection site. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
last dose of vaccine was 4/11/21. on 5/6 she awoke around 3am from sleep with burning sensation in left deltoid. this burning sensation is persistent and painful. feels better with supporting her arm and icing it. no other known cause. she also had some swelling which is now resolved.
Patient has extreme redness, swelling and pain/discomfort in the right shoulder at the site of the injection. The symptoms are ongoing as of this time 05/04/2017 1:00 PM.
Within 10 minutes of receiving vaccines he became clammy in waiting room and felt lightheaded and heavy arms. Was better within 30 minutes and went home with mother. Later that morning, mother called Dr. because patient also started having headache, nausea and fever of 99.8F.  Also c/o throat feeling little funny.  Dr. informed her to take patient to ER if any other complaints or increased concerns. Took Ibuprofen at 11am and then alternated every 3-4 hours when awake with Acetaminophen over weekend. Nausea and funny throat feeling went away after Headache left after 1st dose of Acetaminophen.  H/A was full feeling and hurt worse when bent over and with other movement of body. Fever got up to 101 that Friday evening and up to 102F over weekend (possibly Saturday) and was down to 99.8F Monday am (7/20/15).  States has red area today and arm itches where Varicella vaccine given in left arm.
Blood clot in arm; patient went to emergency room and was put on Eliquis 5mg twice daily
inj site swelled from golf ball size @ 3PM by 830PM it was size of football;went to ER treated w/ery-tab;
pt recv vax & exp soreness & heat @ inj site, devel redness @ the inj site & exp muscle aches to point could not lift arms;
patient got 2 doses of Havrix 7 weeks apart; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 13-month-old female patient who received HAV (Havrix) (batch number 2K57N, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAV (Havrix).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device and an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, a pediatric patient got 2 doses of Havrix 7 weeks apart, which led to shortening of vaccinaation schedule. The reporter consented to follow up.
Breakthrough case of COVID-19; on August 6, 2022 I woke up fine and then after moving around a bit my throat got scratchy and sore, and I took a COVID-19 home test and it was positive and I called my Dr. and they prescribed the PAXLOVID. I had a slight headache, a dry cough and very tired.
For both vaccine 1&2, within 3 hours, I had redness, swelling and immobility of my left arm. This extreme discomfort prevented me from lying on my arm or on my side for 3- 4 days each vaccine.  Each time I also developed within 24 hours (Day 2), body aches, fatigue, loss of appetite,  fevers of 100.3 (v1) and 101.7 (v2), body chills and night sweating when fevers broke the next day Day 3)..  For vaccine 2, on Day 3 morning, after a Fever broke after  of sweats,  I noticed an itching in my back by lower neck between shoulder blades. I thought it was a mosquito bite and scratched it. As I did, I felt my skin was raised and felt that it wasn?t a one bite, but was multiple  bites that covered about an 1.5? area. Finding it difficult to see, I took a photo of my back in the reflection of the mirror. And there was quite a swollen area about 2-3? trapezoid shaped raised bumps and skin area with what looked like bug bites, plus a trail of them from one corner. I still thought it was mosquitos, but the raised red skin concerned me. I sent photo to my DR and she quickly replied that it?s a shingles rash. She said to put calamine lotion on it daily and take a Zyrtec at night. She said it?s from dead virus, so I?m not contagious, and to look for more outbreaks, which there were none. She  relieved the rash should crust over within days and  take 7-14 days to resolve. She did say I should contact the pharmacy. I did and they told me to report via  this link.  On days 4&5, no other bumps or rashes noted, no other symptoms, arm is no longer swollen and can be raised and will though issue. Bumps are now crusted  over,  area still raised.  Visible to anyone looking.
Began sweating profusely within minutes over while body, hands ice cold but overall not feeling cold or hot, visibly shivering uncontrollably, throat discomfort - all resolved slowly over 4 hours following vaccination
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided. It was reported that on 15-DEC-2015, the patient was administered VARIVAX (Merck) (lot # K011082, expiration date: 08-AUG-2016, dose and route were not provided), that was improperly stored (temperature: 24.3 F, time frame: 57 hours; there was no previous temperature excursion). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
fever; lost appetite; red sore and hot arm; weakness; tiredness; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose received in May 2023 in left arm, refer case US2023103056).   On 23-JUL-2023, the patient received the 2nd dose of Shingrix (left arm). In JUL-2023, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: fever), appetite lost (Verbatim: lost appetite), skin warm (Verbatim: red sore and hot arm), weakness (Verbatim: weakness) and tiredness (Verbatim: tiredness). Rechallenge with Shingrix was positive. On 27-JUL-2023, the outcome of the fever, appetite lost, skin warm, weakness and tiredness were resolved.   It was unknown if the reporter considered the fever, appetite lost, skin warm, weakness and tiredness to be related to Shingrix.     It was unknown if the company considered the fever, appetite lost, skin warm, weakness and tiredness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023103056   Additional Information: GSK Receipt date: 27-JUL-2023 and 01-AUG-2023 The patient self-reported this case The patient received developed fever, lost appetite, red sore and hot arm, weakness and tiredness that lasted until the day of this report. The patient referred to health care professional (HCP). The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023103056:2nd case
Inappropriate schedule of vaccine administered; Chest discomfort; Felt like a bad case of indigestion; Fatigue; Low grade fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262), via unspecified route on left arm on 02Mar2021 at 13:15 (at the age of 78-year-old), as a single dose for COVID-19 immunisation. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262), as a single dose via unspecified route in left arm on 11Mar2021 (at the age of 78-year-old) (inappropriate schedule of vaccine administered) as a single dose for COVID-19 immunisation. Medical history included bronchiectasis, asthma, lymphocytic colitis. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 19:00 PM, the patient experienced fatigue, low grade fever, chills, felt like a bad case of indigestion and chest discomfort. It was reported that he patient still experienced these events 10 days after second vaccination. No treatment was received for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fatigue, low grade fever, chills, felt like a bad case of indigestion and chest discomfort was not recovered.   No follow-up attempts are needed. No further information is expected.
nausea, fatigue, tired. from about an hour after my vaccination for another 7-8 hours.
Body rash all over and itching. SOLU-MEDROL 250 mg IM X 1 on 9/28/09, BENADRYL 50 mg IM x 1 on 9/28/09.
I woke up with a headache (24hours) and swollen left arm. The arm had an approximately 3" red rash that was hot to the touch lasting 4 days. I became constipated for several days and resolved with Benefiber and Miralax. I had swollen glands in my left armpit and both sides of my neck lasting for 3 days. Mild nausea and dizziness for 24 hours. Evening of the 17th I ran a fever that reached 99.9 and had mild chills through 1 night.
Starting taking oral typhoid and after taking 2nd pill, noticed it had needed to be refridgerated-wasn't notified of this at the doctor's office, so called them back and they recommended restarting the pills. The night I took the first pill of the new batch, felt kind of sick but it didn't last long. the next day developed hives on my body. the hives spread all over my body, including head and face. Parts would go away-but then new hives would appear in different places. The doctor put me on Benadryl and Prednisone (Prednisone is tapering dose for 8 days) I took the second pill today (1/7/06)-I continue to have hives all over my body.
No additional AE; temperature excursion on ROT ATEQ and product administered; This spontaneous report was received from a medical assistant concerning a 4-months-old patient of unknown gender.   The patient's concurrent conditions, past drug reactions, allergies, medical history, and concomitant therapies were not provided.   On 07-JUN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # T033812 with expiration date of 29-DEC-2021), single dose  orally for prophylaxis (dose was not reported). The administered dose of the vaccine was exposed to a temperature excursion of 47 Fahrenheit degrees for 1 hour. No digital data logger was reported. The vaccine had not had any previous temperature excursions.  There were no adverse events or product quality complaint (PQC) reported.   This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA003944: US-009507513-2106USA004087: US-009507513-2106USA004039: US-009507513-2106USA004106:
10/22/09 Client called stating that she had a flu shot on 9/14/09 in L arm - she is rt handed. Said arm initially hurt at the injection site and when moving it to put shirt on and off. No redness, warmth evident. Said over past week pain is "subsiding with heat and use of MOTRIN, but not completely gone." Will continue to monitor and seek private doctor appt if not resolved. Given referral information.
no additional adverse event; the patient was inadvertently administered a dose of VAQTA that was expired; This spontaneous report has been received from a nurse regarding a 12 months old female patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.  On 22-JUL-2020, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot # S005725, expiration date 10-JUL-2020 (dose, frequency and route of administration not reported) as prophylaxis. No additional adverse event. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S005725; expirationdate: 10-JUL-2020; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
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 was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about September 2015 for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. "Shortly after" receiving the ZOSTAVAX, the patient was diagnosed as suffering from shingles. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, Fatigue, chills Narrative:
The injection site (about 2-3 inches in diameter) became red, firm, tender, itchy, and slightly swollen. This started a week after the injection, and is currently ongoing. The symptoms are all mild.
COVID-19; got her booster dose and then got COVID; got her booster dose; sick for about a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 63 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "recovered", described as "COVID-19"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "got her booster dose and then got COVID"; IMMUNISATION (medically significant), outcome "unknown", described as "got her booster dose"; ILLNESS (non-serious), outcome "recovered", described as "sick for about a week". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Caller reported that, her sister got her booster dose and then got COVID. Was sick for about a week, was fine. After the COVID-19 Vaccine patient tested positive for COVID.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pain/stiffness neck/shoulder of vaccinated arm - progressively got worse. Saw MD 1 week later - MD gave Tramadol - not f/u yet.
Upon presentation for the second dose of Shingrix, the patient mentioned that she had an adverse reaction to the first dose of Shingrix. She states that a large round spot with a knot appeared in the injection site. The knot/spot lasted for about 3 weeks. No medical treatment was sought and she used maintenance pain meds for pain relief when needed and the spot resolved on its own.
Lump in front of right ear detected 3/5/21. Diagnosed as Pleomorphic Adenoma.
This case involves an adult patient who accidentally received a child dose of suspect vaccine INFLUENZA USP TRIVAL A-B WHOLE VIRION VACCINE [FLUZONE (WHOLE)] (Suspension for injection, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination so had to get an adult dose too (product administered to patient of inappropriate age and extra dose administered) on an unknown date. Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. It was an actual medication error case due to inappropriate age at vaccine administration and extra dose administered. (on same day). It was reported that patient got two flu shots at once and didn't have a problem. At the time of report, the patients experienced no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.
Mother of patient called  Pharmacy around 9 am (04/17/21) to report daughter's condition and possibly adverse reaction of the first dose of COVID vaccine given 11:00 am 04/15/21 (Thursday);  Primary Care Physician was contacted as well to report what may be symptoms of Bells Palsy.  Symptoms were: drooping of one side of face and part of lips.  According to the mother, the PCP had prescribed Prednisone and other medications.
10 days p/vax pt devel rash, sore throat, swelling lt parotid, felt ill, sore throat & swelling subsided p/4 days;rash lasted 10 days;migratory joint pain (severe-required narcotics for relief) began on 5th day & lasted 10 days;
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L038534 with expiration date 19-AUG-2017; lot # L033694 with expiration date 06-JUN-2017; dose unknown; oral). The vaccine was improperly stored at 32 Fahrenheit for 41 minutes. No adverse effect was reported. This is one several reports received from the same reporter. Additional information has been requested.