chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 72 year old Caucasian female with hyperlipidemia, metabolic syndrome, hypothyroidism, seasonal allergies and no known allergies who on June 23 2004 at 16:40 was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant therapy included fluticasone propionate (Flonase), fexofenadine hydrochloride (Allegra), levothyroxine Na (Synthroid), estradiol (Estraderm), calcium (unspecified) (+) vitamin D (unspecified), vitamins (unspecified) and Foltex. There was no illness at the time of vaccination. On June 24 2004 in the am, the patient's right arm was red and sore. She was seen in the office on June 25 2004 with red band around the upper arm that was painful and warm to touch. There were no diagnostic laboratory tests performed. Treatment received was warm compresses. The outcome was recovered on approximately June 27 2004. There was no product quality complaint involved. Follow up information from a health professional indicated that on June 24 2004 the patient's right upper extremity was swollen and red. described as a 6 inch wide red band around the arm. The arm was warm to the touch and tender according to the patient. No further information has been requested.
Mother reported hives onset within 48 hours of vaccination. Patient is currently being managed by her pediatrician (over the counter hydrocortisone, children's diphenhydramine, cetirizine).
Information has been received from a physician concerning a 59 year old male patient with hypertension and a history of amputation and no drug reactions/allergies who on 30-NOV-2011, was vaccinated with the first dose of RECOMBIVAX HB (lot # 671032/0908AA, expiration date: 05-APR-2014), 0.5 mL, IM. Concomitant therapy included unspecified antihypertensive medication. On 05-DEC-2011, the patient experienced body aches which lasted through 06-DEC-2011. On 07-DEC-2011, the patient developed fever of 101F which lasted for 3 days, to 09-DEC-2011. The patient sought unspecified medical attention. No laboratory diagnostic studies were performed. No treatment was given for the AEs. On 10-DEC-2011, the patient fully recovered from these symptoms. Additional information has been requested.
Recvd PC from mom 31Mar91 reporting,pt had DTP/OPV/HIB/MMR 28Mar91 that /p noon T 103F& Fri 103.3F& Sat T 101-102F.Rash Sun on abdo,back,chest,shoulders,face.Rash raised bumps.Swollen nodes behind ear-eye pinkish-sensitive to light-nose run
Received 2nd dose of Shingrix in the afternoon on 2/4/2021 after work. Woke up at 4 am on 2/5 feeling dizzy & not feeling well. Sx persisted even after eating breakfast. Checked her BP at 9:30 am and this was 89/46. Went to ER & BP was 93/69. Was given IV fluids there & sent home.   Had similar episode after first dose of Shingrix on 7/8/2020. Went to the ER on 7/9 AM after unwitnessed syncopal episode at home that reportedly lasted just a few seconds, and also preceded by dizziness.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 17-year old female patient with a diagnosis of costochondritis (Tietze's Syndrome) who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the right arm, route not reported), on 25-FEB-2014 at 2:30 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient did not repeat vaccination dose. No adverse event was reported for the patient. The outcome was reported by the reporter as recovered on 25-APR-2014. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
Once arrived at home, from Dr office, having diarrhea, vomiting and temp 101. Took to ER. Diagnosed with "stomach virus" per mom. Giving TYLENOL and PEDIALYTE.
Approx 2-3 hrs p/vax felt weak & tired on 5MAR; cont to feel tired & had 2 episodes of diarrhea; also achy joints & a h/a for the day; cont to feel lethargic & had intermittent h/a until 11MAR94;
Initial unsolicited report received from a physician on 5 November 2015. This case is linked with case number 2015SA179107, 2015SA179116 (same reporter, different patients). This case involve a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiration date, dose, dose number and site of administration were not reported) intramuscularly on an unspecified day in 2015. The patient's medical history and concomitant medication were not reported. On an unspecified day in 2015, following the vaccination, the patients experienced symptoms of vomiting, diarrhea, and chills. On an unspecified date, the patient was hospitalized. Laboratory investigation and corrective treatment were not reported. On an unspecified date, the patient recovered from events. List of documents held by sender: none.; Sender's Comments: This is a case of vomiting, diarrhea and chills following INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE administration. All of the mentioned events are listed after the vaccine. However, patient demographics, time to event onset, investigational laboratory details, medical history would help assess the case better. Based on the information provided, the case cannot be completely assessed.
pt recv vax 5JUL96 & 10JUL96 pt exp bilat parotid gland swelling w//no other sx;initially parotitis was thought to be r/t vax w/MMR;
Approximately 10 minutes after receiving vaccine, patient became very hot and sweaty, nauseous, and dizzy. We laid her down flat on the floor with a pillow and got her some water. We checked her blood pressure, and it was approximately 90/58. Patient says her BP usually runs very low. She stated she had just been for a 4 mile run in 90+ degree heat, had not eaten much that morning, and had not drank much water. After about 20 minutes, she began vomiting. After about 40 minutes from time of vaccine, her son picked her up and took her to a nearby ER at her request. I called her the following day, and she had recovered.
Today 11/21/07 saw redness at injection site, had itching legs and arms. No SOB. (R) arm 5cm x 5cm red warm area. (Is on steroid dose pack).
On vacation, experienced inner ear discomfort and moderate right-side numbness of tongue for several days. Onset of severe symptoms several days later, as described below. (In retrospect, these are known early indications of Bell's Palsy.)  Awoke on 11/26/10 with substantial right facial weakness, which degenerated further over the course of the next several days until I had complete/nearly complete right facial paralysis. Specifically: I could not close my eye (needed to be taped shut at night), move the right side of my mouth, nose, cheek, forehead, etc. The initial diagnosis (I was traveling with physicians) was Bell's Palsy, and upon return to the U.S. I saw a neurologist who confirmed the Bell's Palsy diagnosis. I was graded at level 5 or 6 on the House-Brackmann Scale. Per doctor's advice, I treated immediately upon onset with high-dose prednisone and upon return to the U.S. one day after onset, Valcyclovir 4x/day for 10 days. I also began a fish oil supplement and a high dose of Methylcobalamin (Vitamin B12).   I recovered beginning the middle of the third week post-onset, reached full recovery at four weeks.
given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.  Additional details were reported as follows: Age at vaccination was not applicable. The patient received a dose of Hiberix where it was reconstituted with sterile water instead of saline water, which led to inappropriate reconstitution technique and incorrect dose administered. It is one of the 9 cases, reported by the same reporter. Consent to follow up was granted.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter
On 4/6 around 7pm I started getting a headache so I took a 600mg ibuprofen and laid down. The fan was blowing on me and it made me feel really cold. Then I got the chills and bundled up. And then the body aches started really bad. I could barely walk to the bathroom. I went to bed. The next morning I called in to work and stayed in bed all day. I could barely wake long enough to go to the bathroom and still body aches bad. I slept till about 8pm. When I ate and went back to bed.
multiple symptom onset date 12/18/21. covid test positive 12/20/21. Mandatory quarantine 10 days, from symptom onset.
This case was reported by a nurse via call center representative and described the occurrence of sickness in a 61-year-old female patient who received Flu Seasonal QIV Dresden. The patient's past medical history included immunocompromised. Previously administered products included oral steroids. Concurrent medical conditions included asthma. Concomitant products included TUMS, Vitamin B12, Vitamin D3, Aspirin, ibuprofen, Levothyroxine, omeprazole, Montelukast, ALLEGRA, biotin, COMBIVENT, DYMISTA, ESTRACE, MUCINEX DM, SPIRIVA, SYMBICORT, ZOLOFT, ALBUTEROL Nebulizer, ATROVENT Nebulizer, Calcium Chews, epinephrine and hydrochlorothiazide. On 2nd October 2017, the patient received Influenza vaccine (intramuscular). On 3rd October 2017, 1 days after receiving Influenza vaccine, the patient experienced sickness (serious criteria life threatening), wheezing (serious criteria life threatening), asthma aggravated (serious criteria life threatening), sleep loss (serious criteria life threatening), urination involuntary (serious criteria life threatening), fecal incontinence (serious criteria life threatening), headache (serious criteria life threatening), chest pain (serious criteria life threatening), cough (serious criteria life threatening) and vomiting (serious criteria life threatening). In October 2017, the patient experienced sleeplessness. On an unknown date, the outcome of the sickness, wheezing, asthma aggravated, sleep loss, urination involuntary, fecal incontinence, headache, chest pain, cough and vomiting were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved. The reporter considered the sickness, wheezing, asthma aggravated and cough to be probably related to Influenza vaccine. It was unknown if the reporter considered the sleep loss, urination involuntary, fecal incontinence, headache, chest pain, vomiting and sleeplessness to be related to Influenza vaccine. Additional details were provided as follows: The patient was a nurse. The brand name of flu vaccine was unknown. The patient was sick since then, further described as asthma exacerbations. The patient also attributes these exacerbations to being immunocompromised and to discontinued oral steroids. Due to these exacerbations, the patient was wheezing and coughing. The patient's coughing causes her to throw up and to pee and poop on herself. Less than a month after receiving Influenza vaccine, the patient was not slept in three days. The coughing also causing her head to hurt and chest to hurt. The patient felt like she was coughing so hard or so much that she could cause a stroke (stated in reference to her head hurting). The patient felt like these events were life-threatening and was on the verge of going to the emergency room or hospital. The patient was calling regarding a question on NUCALA. NUCALA was prescribed, but not started. The patient's prescriber wants her to receive a flu vaccine and the shingles  vaccine prior to starting NUCALA.
pt felt shaky, said she had 'heavy breathing' and just felt weird. patient states she was anxious due to h/o reaction with covid vaccine. initial vitals were 144/95 pulse 98 O2 100%, after a few minutes she reported feeling better and wanted to leave. 2nd set of vitals were 113/77 P 95 O2 99%
Developed Herpes Zoster (on lower lip) a few days after receiving  booster shot
Pt. was given vaccine and felt lightheaded and dizzy shortly after while walking to waiting area.  She had a seat in the waiting area and was provided water.  Shortly after having a seat she passed out.  Respirations and Pulse were monitored and were normal.  Approximately 30 seconds after passing out, pt. returned to consciousness.  9-1-1 was called and patient was evaluated by fire dept. and ems.  Pt. was anxious about receiving the vaccine and ems confirmed that heightened anxiety may have contributed to her response.
Pt developed dizziness, lightheadedness, sob after receiving vaccine. Then reported mild chest pain, headache, neck pain, weakness in lower extremities. BP 220/112, HR 86, O2sat 99 RA. Pt escorted to ER via wheelchair.
expired Tenivac was given to a patient with no adverse event; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case received from a Nurse Practitioner via Agency (Reference number- 00495304).  This case involves a 55 years old male patient who received an expired dose of  DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] batch number: U6187AA, expiry date: 06-FEB-2021 via unknown route and administration site on 21-Feb-2021 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error due to expired vaccine used (latency same day).  Reporter causality: not reported. Reporter can be contacted by Sanofi: Yes. Potential product technical complaint (PTC): No. Description: Nurse Practitioner would like to know how to proceed. Does the patient need to be re-vaccinated and are there any health risks. Reviewed case and did not speak with the caller as the caller requested a response via email. Product used.  At the time of reporting 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 holders 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.
Patient saw blood run down his arm from vaccination and immediately felt faint. I helped to a chair, got him a cool, wet cloth and O.J. because he had nothing to eat that day also. Pt was very clammy and sweaty, but after juice and sitting for 15 mins., recovered and was alert, called pt 3 hrs later.
1 week after the injection, started getting severe hives under both armpits.  The hives created terrible itching and burning.  Sweating or wearing any (all natural) deodorant made it worse.  Symptoms have started to subside (as of 11/5/21) but still persist and will occasionally flare up.
This case was reported by a physician, via a GSK representative, and described the occurrence of injection site rash in a 6-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline) on an unspecified date the subject received unspecified dose of PEDIARIX (unknown route, right arm), and experienced vaccine administered at inappropriate site (arm rather than thigh as indicated). At an unspecified time after vaccination with PEDIARIX, the subject experienced "rash on right arm" (injection site rash). The event was reported as a local injection site reaction. At the time of reporting the outcome of the event was unspecified. The physician considered the event of injection site rash probably related to vaccination with PEDIARIX.
08/26/2002: DtaP, IPV given in left thigh, MMR in right thigh 08/27/2002; Fever to 102 degrees, increase redness and swelling at sight and surrounding thigh 08/28/2002; Fever low grade. Redness and swelling cont. but improved
Mild lightheadedness Immediately Following vaccination  3-4 hrs post vaccine    small welts over face, mild tingling and itching  of the throat     4 days post vaccine
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2016, the patients were vaccinated with VARIVAX (dose and route of administration were not provided, lot # M028798 with expiration date 18-AUG-2017), which were improperly stored (temperature excursion 6.8 F for 6 hours on 28-OCT-2016 and 6.44F for 4 hours and 30 minutes on unspecified date). No adverse experiences were reported. Data logger was involved. This is one of several reports received. Additional information has been requested. Sender's Comments: US-009507513-1611USA008845.
Information has been received from a pharmacist concerning a 67 year old white female consumer with no known allergies who on 14-FEB-2008 was vaccinated SQ in the left arm with 0.5mL of zoster vaccine live (Oka/Merck) (lot # 659324/1835U). There was no illness at time of vaccination. On 15-FEB-2008, the patient had "nerve irritation running down her left arm". On 19-APR-2008, medical attention was sought, the patient spoke with the pharmacist and stated that she had "nerve pain" at the injection site. There were no lab studies performed. The patient's sister is a physician (not sure what kind) and told the patient to take (BENADRYL). Subsquently, the patient recovered from the symptoms. Additional information is not expected.
Hurt arm; Tiredness for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced tiredness and pain in arm. On an unknown date, the outcome of the tiredness was recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the tiredness and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient reported after 1st dose of Shingrix in August 2019, experienced tiredness for a couple of days and arm hurt. The reporter did not consented to follow up.
Patient feeling "Rush ", dizzy, heart racing.  Reaction stopped and then another wave of the same symptoms restarted, symptoms resolved quickly.  VS were taken initially: BP 122/89, HR 117, O2 Sat 100%.  VS re-check BP 119/76, HR 81, O2 Sat 100% on RA. Pt currently asymptomatic, no interventions at this time, was monitored for 2 hours post-vaccine.
soreness in arm where vaccine was injected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 14:30 (Lot number: 3248) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No COVID prior to vaccination. No other vaccine in four weeks. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer, lot number=EL3248, vaccine location=Left arm), administration date: 03Mar2021, for COVID-19 IMMUNISATION. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 23Mar2021 22:00, outcome "recovered" (2021), described as "soreness in arm where vaccine was injected". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: Facility type vaccine was at a workplace clinic. COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
light headed; heart palpitations; chest pains; heart still feels slight tightness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number and expiry date: unknown) (age at the time of vaccination was 60 years old and patient was non-pregnant at the time of vaccination) via an unspecified route of administration, administered in arm left on 18Aug2021 17:15 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included high blood pressure, high cholesterol, mild valve regurgitation and arthritis and known allergies to Penicillin, Sulfas and Pistachio nuts. Concomitant medications included/list of any other medications the patient received within 2 weeks of vaccination Lisinopril, Metoprolol, Rosuvastatin and Celebres. She did not take any other vaccine in four weeks prior COVID -19 vaccine. She was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Aug2021 17:15, the patient became lightheaded within two or three minutes, but that subsided quickly. After thirty minutes later, the patient started having palpitations and chest pains that lasted the rest of that night and most of the next day. The patient felt still feels slight tight. The patient did not receive any treatment for the events. The outcome of the events light headed was recovered/resolved in 2021 and unknown for other events.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow up. Follow-up attempts are completed. No further information was expected.