chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist concerning a 36 year old female with no significant medical history who on 06/29/2001 was vaccinated with a first dose of "thiomersal free" hep b vaccine recombinant in the left deltoid. There was no concomitant medications, additional vaccines nor any recent immunizations. The pt was not ill at the time of the vaccination. On 06/29/2001 at 1015H, approximately one hour after the vaccination, the pt developed nausea, dizziness, generalized itching, hives at the injection site, chest heaviness, rash on her arms, and headache. She was taken to the ER and treated in the ER with injectable Benadryl. She was also started on a course of prednisone and vistaril. The pt was not admitted to the hospital, but was kept in the ER for several hours for observation and discharged that same day. As of 07/02/2001, the pt recovered from her experiences. Upon internal review nausea, dizziness, generalized itching, hives at the injection site, chest heaviness, rash on the arms, and headache were determined to be other important medical events. No further info is available.
90y.o. male with multiple medical problems including CAD, dementia, paroxysmal atrial fibrillation, sick sinus syndrome status post permanent pacemaker who presented to ED on 10/7/2022 from a local hospital for cardiology consultation.  Patient was evaluated at the hospital after sustaining a fall/syncopal episode.  Per notes his wife heard a noise and found patient on the floor. He had a scalp laceration that was repaired at a facility. His PPM was interrogated and showed a 2-minute run of V. tach. Troponin was elevated (175, 378, 504, 663). He underwent cardiac cath on 10/9 which showed multivessel disease, successful PCI and stent placement. Family requested transfer to our facility as this is where he receives most of his care. Patient was placed on IV heparin drip. CT head/cervical spine negative, chest x-ray, pelvic x-ray negative. He is now S/P post pacemaker upgrade to ICD implant by Dr. on 10/11/22. Pts post-operative course was complicated by confusion, fevers due to COVID-19 infection. He is s/p remdesivir and dexamethasone and has since been removed from isolation.
This spontaneous report was received from a pharmacist concerning a 1 year old female patient with no pertinent medical history or drug reactions/allergies. On 08-SEP-2014 the patient was vaccinated with a dose of (Oka-Merck) PROQUAD (dose, dose number, lot number, expiration date and route were not reported). No co-suspect and concomitant therapies were used by the patient at the time of the report. The pharmacist reported the patient developed a severe diaper rash, with pustules, on 11-SEP-2014 (reported as 2-3 days) after administration of (Oka-Merck) PROQUAD. The parents of the patient called the unspecified physician and was prescribed NYSTATIN topical cream. The symptoms did not improve. On 15-SEP-2014, the patient developed redness at the injection site. On 18-SEP-2014, the patient developed a mouth ulcer. At the time of the report the outcome was reported as not recovered. Patient sought medical attention with an unspecified physician and went to the pharmacy. Patient received treatment with Nystatin. Patient did not performed lab diagnostics studies. Additional information has been requested.
Severe stomach pain, loss of appetite, infant screamed for 4 hours continously, and gasped for 6 hours while breathing.
This spontaneous report as received from a medical assistant refers to a 6 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 10-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868. US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
Patient developed shingles on 9/17/2021 after receiving COVID vaccine dose #3 on 9/2/2021.  Patient does not have a history of shingles prior.
severe allergic reaction; This is a spontaneous report from a contactable physician. A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 21Jan2021at a single dose as Covid vaccine. Medical history included BPH, Meniere's disease, and known allergies to sesame oil. The patient had unspecified concomitant medications (other medications in two weeks). He had no other vaccine in four weeks. The patient experienced severe allergic reaction on an unspecified date in which resulted to emergency room/department or urgent care. Unspecified medications was provided as treatment for the event. He had no Covid prior to vaccination. He has not had Covid tested post vaccination. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of severe allergic reaction. There is limited information provided in this report.    This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Reports continued arm pain since first covid vaccine, has improved since initial 48 hours but continuing, worse with movement. Advised to follow up with PCP if it continues
About 3 minutes after giving flu immunization, patient complained of being light-headed and fainted. Very diaphoretic and weak.  Ambulance called and sent to Hospital where he was diagnosed as a fainting spell and sent home.  Back to work the following day. Dr. did not feel it was an allergic reaction to the flu immunization.
She got her vaccine, hours after the vaccine she got a fever.  Her fever was 102.2, it went up that evening after 8:00 PM to 103.7 and it stayed that way until the next day to around 11:00 AM, and subsided.  She then had a runny  nose, was very tired, lethargic and she had a very bad headache.  The next day she was even more tired, loss her appetite and could not eat without nausea, and head hurting very bad until her vision was not correct.  The day after that 3/24/22 she really felt bad to the point that she felt uncoordinated, was shaking, still unable to eat, low grade temperature, chills and headache.  She threw up that night for the first time.  Then on 3/25/22 she woke up and had trouble balancing very badly, vision was blurred, her eyes were crossing, unable to eat still, no appetite.  After 3 hours she had uncontrollable sneezing, and rolled over to the right and could not control her balance.  She feels her head is airy and light, things are spinning and then started to have projectile vomiting every 15 minutes.  Her husband called 911, she was sweating profusely and unable to move, could not open her eyes, could barely speak.  The EMT's came quickly and was unresponsive and her temperature apparently was over 106, her BP was 170/94.  They took her to the local Medical Center, where she was still throwing up, heart rate still low and unresponsive.  When she became aware she was throwing up the lining of her stomach, bile and blood.  She was still unable to sit up, still was unable to talk, was slurring her speech.  They put in an IV, her heart was low in the 50s, and her BP was still high, she could not see the monitor herself, but could hear the alarms going off alerting it was too high.  They kept asking her questions about her health, and could not give then any answers as to what would have caused this.  They sent her home without being able to walk, her equilibrium is still off, her head is light and feels like something is making her topple over and her body is giving way to it throwing her down.  She is gradually able to sip and eat light foods which just started yesterday, 3/28/22, and cannot grab things or walk.  She is just uncoordinated right now.  She has  a diaper on due to incontinence and has think mucous and is sneezing, and the drainage in thick in the back of her throat.  Her sputum is think as well.  She still cannot see straight, but has not run a fever.  She has been monitoring her BP and her last reading was 157/87 2 hours ago, heart rate 62.  She is getting cold/hot flashes and is shaking at times.    They kept her in the hospital until Saturday and could not find anything wrong with her, and discharged her not able to walk.  She informed them that she had the vaccine, and had been having symptoms ever since, and did not give her many instructions.    She had a knee replacement on 12/23/21 and she was given instructions on what to do prior to getting the vaccine and took 7 weeks of aspirin, and then was OK to get the vaccine.  Had no reaction to the first vaccine at al.
Immunization was given on a Monday. Patient states that approx. 24-26 hours later, noticed site was getting red and sore. By the next day, it was hard, warm and red. Dr. saw patient, documented site at 5 cm diameter redness, 3 cm in duration, cellulitis.
Patient came into the clinic with parent for the 2nd PEDS Covid shot. Sight prepped and cleaned, shot injected into arm using z-track method and when pulling out the vanish point needle some of the vaccine was leaking down patient's arm. Full dose not given.  Patient rescheduled for 2nd PEDS dose 12/16/21.
1/1/2021 around 8 pm fatigue and weakness, arm soreness.  1/2/2021 around 8 am body ache, weakness, fatigue 1/2/2021 around 12 pm body ache, weakness, fatigue, headache, chills. Left work went home. 1/2/2021 around 9 pm body ache from head to toes, weakness, chills, fever 102 F. 1/2/2021 around midnight body ache, weakness, chills fever 102 F, dripping sweat. Condition gradually improved. 1/3/2021 Morning temperature normal,  Still weak.
1st dose 15Mar2021;  2nd dose 01Apr2021; diagnosed with Bells Palsy; On Wednesday, 14Apr I started experience numbness to the right side of my face; This is a spontaneous report from a contactable consumer (the patient).   A 62-year-old male patient received the second dose of bnt162b2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EP7534), via an unspecified route of administration, on 01Apr2021 at 16:30 (at the age of 62-years-old) as a single dose administered in the left arm for COVID-19 immunization.The patient's medical history was not reported. The patient has no known allergies.  Prior to vaccination,  the patient had not been diagnosed with COVID-19. Historical vaccinations included the first dose of  bnt162b2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205) in the left arm on 15Mar2021 at 16:30 (at the age of 62-years-old) for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not receive any other vaccinations within 4 weeks prior to the COVID vaccine. The patient stated that on Wednesday, 14Apr,  she started to experience numbness on the right side of her face. She went to the ER and was diagnosed with Bell's Palsy. The patient experienced diagnosed with Bell's Palsy on 14Apr2021 at 16:30 with outcome of recovering and "numbness to the right side of my face" on 14Apr2021 at 16:30 with outcome of recovering.  Therapeutic measures were taken as a result of  Bells Palsy and and hypoaesthesia and included the administration of prednisone (not further specified). It was also mentioned that since the vaccination,  the patient has not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of crying in a 2-month-old male patient who received HAVRIX pediatric (batch number AD9Y4, expiry date 7th October 2017). Concomitant products included medication unknown (vaccine). On 28th August 2015, the patient received the 1st dose of HAVRIX pediatric .5 ml. On 28th August 2015, several hours after receiving HAVRIX pediatric, the patient experienced crying, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the crying, wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the crying to be related to HAVRIX pediatric. Additional details were provided as follows: This case was previously reported to a doctor. Chief operating officer reported that a 2 months old patient inadvertently received HAVRIX instead of Hepatitis B for his vaccinations, which led to administration of wrong vaccine and inappropriate age at vaccination. The reporter was not able to provide all the specifics without the chart but noted it was given in a thigh and other vaccinations were given but names unknown. The reporter stated that a phone call was made Friday afternoon to check on the child and his mom reported that the patient was crying but he did not experience any fever or rash. At the time of reporting, the child was due for a return visit in morning at 10 AM for a follow up to the vaccination.
Information has been received from a nurse practitioner concerning a 15 year old female patient who on unspecified date was vaccinated with the first 0.5 ml dose of GARDASIL. The nurse reported that the patient received her first dose of GARDASIL and the patient was menstruating upon being vaccinated but for about a month after being vaccinated the patient was still menstruating. According to the nurse, GARDASIL was the only change. At the time of the report the patient was not recovered. The patient sought medical attention by a visit to the doctor's office. Additional information has been requested.
Patient reported pain on injection on the date of the shot. Called back to pharmacy within 5-7-days of shot complaining of soreness and pain at the site. After ~ 1 month, pain had become a neuropathy/tingling issues
HE RECIEVED THE VACCINE IN THE MID AFTERNOON.  WOKE OVERNIGHT AND PATIENT REPORTS " HIS LUNGS FELT HEAVY" AND HAD GENERAL MALAISE THAT LASTED THROUGH THE DAY.
This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced pain at the injection site, because of thicker suspension. Event took place after use of vaccine. The reporter did not wish to be contacted for follow-up.
Case number PHEH2014US018358 is an initial spontaneous report received from a physician on 11 Sep 2014. This case refers to an unknown age and gender patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported), on an unknown date. On an unknown date after vaccination, the patient experienced anaphylactic reaction. The outcome, seriousness and causality of the event were not reported.
Chills and extremely shivering, fever 100.1, body aches- legs,  slight nausea
Welts on trunk, generalized pruritus, tingling on lips. Trapsorted to ED. Contacted by allergy - declined consult.
States 2 days after receiving flu vaccine in (L) arm, developed burning shooting type discomfort (L) breast near axilla. Slight at first. Notified clinic on 11/15/13 that episodes were continuing and increasing in intensity states happening once or twice a week.
booster; splitting headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 immunization; Bnt162b2 (2nd Dose), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; HEADACHE (medically significant), outcome "unknown", described as "splitting headache". The event "splitting headache" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: normal, notes: they did a cat scan on my head and the doctor said everything was normal.  The lot number for bnt162b2 was not provided and will be requested during follow up.
administered an expired dose of Bexero yesterday; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (expiry date APR-2023) for prophylaxis.   On 30-MAY-2023, the patient received Bexsero. On 30-MAY-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Bexero yesterday). The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 31-MAY-2023 The expiration date was mid-April but reporter did not had not the exact date. The pharmacist could not provide patient's complete date of birth. The reporter consented to follow up. One day before reporting, the patient was inadvertently administered an expired dose of Bexsero, which led to expired vaccine used.
On June 2, I didn?t feel myself. I was having chest pain, so I went to the nurse, and I asked her to take my blood pressure the reading was 192/120. I don?t take any blood pressure medication because I don?t have issues with my blood pressure. The nurse told me to go to urgent care. The Urgent Care center where they took my blood pressure, and it was still high. The doctor in the clinic gave me nitroglycerine. They also did a EKG and it was abnormal too. I was then transported to the nearest ER. I was given more nitroglycerine in the ambulance. Then I was admitted into the hospital for 3 days. They did several EKGs, a stress test, bloodwork and an ultrasound of my heart with contrast. In the hospital they had me on medication. I am now on a baby aspirin, amlodipine besylate, metoprolol and I was instructed to take my blood pressure every day. I am currently waiting on one more test to come back before I go to see my cardiologist
Saturday following shot had severe h/a;APAP didn't help;lasted about 24hr;also arm was ore-had not been sore before that;pt fine since h/a stopped;
Pt states that on 11/27/02 he noticed rash with small bumps on posterior of both upper arms and both thighs (anterior). The rash was itchy. Over the next 24 hrs the bumps disappeared and the areas became a solid, raised, plaque-like area. The areas on the thighs are crescent-shaped. On 12/2/02 rash is diminished but still present. He is using Cortaid for the itching.
vasovagal syncope, sinus tachycardia, PVCs, inappropriate tachycardia, POTS, all since vaccination
5 days after vaccine developed a "lump" at injection site which is sore.  On 08/05/2003 nodule measures 2.5cm and tender not red, not hout-follow up 08/22/2003-not red or tender.  Smaller nodule still present.
Rxn started 12 hours after injection, redness, swelling and burning sensation to injection site.  Pain which was relieved by Tylenol.
Swelling and tenderness in L axilla that still remains, as well as L lateral deltoid soreness and whole body fatigue.
Reports rash: red, little bumps, spreading, not itchy, x 1 days and eye concern: red,has no discharge, x 1 day
This is a spontaneous report from a non contactable Nurse via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13 (Exp: May17. Lot. n. M51192) via an unspecified route of administration at single dose on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced diabetes on an unspecified date with outcome of unknown. No follow up attempts possible. No further information expected.
high fever (103), body aches, chills, exhaustion, headaches, loss of appetite, very sore arm
This report describes the occurrence of ankle swelling in a 33 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the subject, who is a pharmacist.  The subject submitted a report directly to VAERS.  The subject's medical history, concurrent conditions and concurrent medications were not reported.   The subject had no adverse experiences following previous injections of tetanus and diphtheria toxoids adsorbed.  On 04/08/03, the subject received her first injection of Engerix-B.  On the same date, she received an injection of tetanus and diphtheria toxoids (AP).  On 04/15/03, seven days post-immunization, she began to experience pain in her elbows, knees, hips and ankles.  On 04/20/03, the subject noticed swelling of the ankles.  On 04/21/03, the subject was seen by her physician.  Unspecified blood analyses were "negative for rheumatoid arthritis and lupus".  The physician prescribed rofecoxib (Vioxx).  By 04/26/03, the subject found that Vioxx was "not working for pain".  She obtained "slight relief" with ibuprofen.  The subject was seen by a different physician, who prescribed a rapidly-tapering course of methylprednisolone (Medrol Dosepak).  The Medrol Dosepak "helped with the swelling and pan by day one".  On 05/02/03, the subject finished the first Medrol Dosepak, and began experiencing pain and swelling again.  On 05/03/03, the subject began a second Medrol Dosepak.  She noticed improvement "immediately".  As of 05/05/03, the events persisted but had improved.
Diluent was administered; Diluent was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA581A, expiry date 31st January 2023) for prophylaxis.   On 20th January 2022, the patient received Menveo. On 20th January 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reported stated that, Menveo diluent was administered only to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No side effects reported. The reporter consented to follow up via email.
pt had one dose of vax 17JUL97& got another un-necessary varivax on 12JAN97;pt did not devel any side effect so far;