chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shot and got the shingles/suspected vaccination failure; Shingles from top of head, down back, below bum; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 85-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles from top of head, down back, below bum). The patient was treated with ascorbic acid (Vitamin C), benadryl (nos) (Benadryl Oral) and caladryl (nos) (Caladryl). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient's children via interactive digital media. The patient got the shot and got the shingles 3 times. The reporter reported that every time from top of patient's head, down his back, to below his bum. The reporter was miserable off the chart. Not down with the shot. The patient got relief with megadose vitamin C (21 thousand mg per day) divided up with 3 low/no carb meals, benadryl oral and caladryl topical applied liberally.  Fortunately the patient was retired and did not had to be very physical, but the first round of them was very hard on his 85 year old body. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
It was reported that on 11/15/01, a 2 month old infant received injections of Infanrix, Engerix-B, Hib and IPOL. Within 5 minutes, post vax, the infant began crying, turned blue, appeared to either fall asleep or pass out and developed a rash on the face and body. The infant was observed in the physician's office for 2 hours. The rash lasted 1.5 hours. The other events had also resolved and the infant was sent home. The reporting physician considered the events to be related to Infanrix and Engerix-B administration. From addition correspondence received on 3/19/02, it was reported that the pt is currently healthy and medically stable. Additional pt information, lot numbers for the vaccines and the route/site where the vaccines were administered were also provided. This is considered to be an "Other Important Medical Event".
11/07/2021- Started having lower back pain and I did not think much about it. The next day I went to work out with my trainer, I was very tight, and we did a light workout. Tuesday I was too tight, so we just stretched. Wednesday through Friday I was in a lot of pain the muscles had been very tight. From my lower back, buttocks, the actual pain goes does from my legs to my feet. On my right side, I have the weakness and most of my pain. On my right thigh the muscle contracts, like spasms. In my right arm there has been weakness from my shoulder blades to my fingers. The pain starts from my tail bone, my back, all the way to my feet. the middle of my body is fine, then it is from my shoulder blades to my arms. Wednesday, I went to see my doctor, my feet and hand and tingling. Saturday and Sunday my joint felt lock and tight. It is just hard to bend my knees and arms. I feel stiff. I don't feel like I could move my knees and elbows in the same way. It just feels weird. The doctor prescribed methylprednisolone 4 mg dose pack. I started taking blood work on Thursday, 11/12/2021. And I have been taking Tylenol. Doctor diagnosed Piriformis Syndrome arthralgia fatigue. I have not stopped working; my brain feels fine. It is just my body. It is enough to affect my daily life, because I am not able to go to the gym and go on walks.
2 month old who screamed inconsolably for over an hour after given PREVENAR 13, hepatitis B right thigh and PENTACEL left thigh. Right leg turned neon red. Feet turned blue. Better after TYLENOL.
Increased temp of 99.2F oral, extreme fatigue, lethargy, episode of incontinence, hallucinations beginning in the morning and has continued through the day.
Loss of taste and smell; Loss of taste and smell; nausea; headache; This is a spontaneous report from a contactable nurse (patient himself). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscularly on the left arm on 25Jan2021, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number known but not reported) on an unspecified date for covid-19 immunization. The patient experienced loss of taste and smell, nausea, and headache - all on 26Jan2021. No treatment was received for the adverse events. At the time of the report, the patient had not recovered from the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient had a nasal swab for Covid-19 on 26Jan2021 with results of negative.  Information about the lot/batch number has been requested.
no adverse eveent; improperly stored doses of rotateq administered; This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. The medical assistant described on 17-OCT-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R035369 and expiry date 10-OCT-2020, (strength, dose, route were not reported) for prophylaxis (product storage error). No adverse effects reported and no product quality complaint. It was reported that the vaccine was stored 6 hours 48 minutes at temperature below 36 degree Fahrenheit (33.8 F), there was no previous temperature excursion. It was stated that call was placed because of data logger.
This spontaneous report as received from a Nurse Practitioner refers to an adult female patient of unknown age. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date in January 2015, when the patient was 26 years old, she was vaccinated with the first GARDASIL 9 (lot # K018149, expiry date and dosing details unknown) for prophylaxis. On an unknown date in July 2015, the patient developed low-grade squamous intraepithelial lesion (LGSIL) which may have been developing before vaccination (cervical dysplasia). The patient had an unknown human papilloma virus (HPV) status in July 2015. On an unknown date in late July 2017, at the age of 28 years old, the patient was vaccinated with the second dose of GARDASIL 9 (lot # N004799, expiry date and dosing details unknown) for prophylaxis (inappropriate schedule of drug administration). The third dose of the GARDASIL 9 was not administered. No treatment was provided for the event. The outcome of cervical dysplasia was unknown. Causality assessment was not provided by the reporter. Lot number K018149 is an invalid lot number for GARDASIL 9.
On April 27th as soon as I had my shot I couldn't get up from the chair. I felt like I couldn't walk. I sat for a couple of minutes and I just barely made it outside as I was having issues walking. I barely made it to the car. My speech was slurred. I experienced fatigue when I got home. Speech went back to normal. For 2 weeks I was walking very slowly and realized I could have had a mini stroke. I also experienced dizziness and vertigo. Ever since I received the 2nd dose, my walking speed has dramatically decreased.
This case was reported by a consumer (also the subject) and described the occurrence of nausea in a 59-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergies and anxiety. Concurrent medications included Antihistamine and Citalopram. On 29 October 2012 at 09:15 the subject received a dose of FLUARIX (unknown route, right arm). On 2 November 2012, 36 hours after vaccination with FLUARIX, the subject experienced nausea and in November 2012 within 2 weeks of vaccination with FLUARIX, the subject experienced headache, muscle pain, vertigo, eye sensitive to light, shortness of breath, chest pain, irregular heartbeat, rapid heartbeat, weakness, sweating, unable to function (also described "knocked her flat down") and decreased ability to perform daily activities (described as "had to call off work"). The subject explained that the nausea started after 36 hours and the other events "crept in and it took up to two weeks for the symptoms to appear". The subject noted that her symptoms were worse at the time of the report and she had "to call off work". She reported that the "extreme" muscle pain caused an "inability to function and knocked her flat down". The subject indicated that she "did try" to seek medical attention but "was unable to get into doctor". The subject reported that she received the FLUARIX as a requirement for her employment. At the time of reporting the events were worse. The subject reported that she experienced "side effects" from the Hepatitis B three dose series. She noted she had "same symptoms" with Hepatitis B vaccine which resolved, but according to the subject, the symptoms "came back with a vengeance" when she received FLUARIX. See A1002560B for details regarding "side effects" with Hepatitis B vaccine.
A week after receiving first vaccine, I awoke to the ring finger on both left and right hands locked in a "trigger" position. It was painful, yet I could move them into normal position. I had lung surgery scheduled for April 21, so waited until I recovered to schedule appointment with Dr. for hand surgery for the trigger finger on 11/5.  It was successful.
swelling after Shingrix shot; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was not recovered/not resolved.   It was unknown if the reporter considered the swelling 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 an adult per the vaccine indication. The patient asked to take ibuprofen for swelling after Shingrix shot.
This spontaneous report as received from the consumer (the patient's daughter) refers to a 82 year old female patient. The patient pertinent medical history included allergy to surgical tape. On an unspecified date in March 2013, the patient was vaccinated with the 1st dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) and a dose of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported). On an unspecified date in March 2013, three days after receiving ZOSTAVAX and PNEUMOVAX 23, the patient experienced shingles. The patient was treated with prednisone and an unspecified antiviral medication. The consumer also explained that, on an unknown date, the patient had short term and long term memory issues. On 17-OCT-2014, the patient experienced the patient received a second dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). No adverse effects had been reported after the 2nd dose of ZOSTAVAX. The outcome of shingles and memory issues was unknown. The relatedness between the events and ZOSTAVAX and PNEUMOVAX 23 was not provided. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with VAQTA that were stored improperly. No adverse effect reported. This is one of several report received from the same reporter. Follow up information was from the same registered nurse who stated that patient identifiers and dates of administered were unavailable at this time; however, lot numbers and expiration dates were available, VAQTA (Pediatric) lot number: J000366, expiration date: 27-AUG-2015. Additional information has been requested.
Information has been received from a physician concerning an 70 year old patient who on 12-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Merck). The patient presented to the physician office on 24-MAY-2011 with shingles. The patient was not treated. There was no hospitalization and the patient was taking no medication. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Product storage error; Revaccinated with Flucelvax Quadrivalent; Received Afluria expired; This spontaneous case initially received from other health professional (nurse) on 24-Oct-2018, concerns a 74-year-old, elderly female patient.  The patient's current illness was unknown and had not received any concomitant medications.  On 15-Oct-2018, the patient was administered an expired Afluria (TIV) Thiomersal [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid (arm), batch number: 14449221A, and expiry date: 30-Jun-2018] (explicitly coded as expired vaccine used) for influenza prophylaxis. The health authority preferred event included 'product storage error'.  It was reported that there was no adverse event after the vaccine administration, so on 30-Oct-2018, the patient was revaccinated with Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-cultured derived, batch number: 252660, expiry date: 31-May-2019, dose, anatomical location and route of administration: not reported] (explicitly coded as extra dose administered) for an unknown indication.   The patient did not experience any adverse events after vaccination.  The reporter assessed this case as non-serious.  Follow-up received from the other health professional on 26-Nov-2018: Added Flucelvax QIVc (co-suspect vaccine) in the product tab as the patient was revaccinated on 30-Oct-2018. Added new event  inappropriate schedule of vaccine administered in the event tab. The reporter confirmed that patient did not experienced any adverse events afterward.  Follow up retrieved from VAERS (VAERS ID: 799244) reported to VAERS by other health professional (nurse) on 02-Apr-2019: New event 'product storage error' was added in the event tab. The verbatim 'revaccinated with Flucelvax Quadrivalent' was changed from inappropriate schedule of vaccine administered to extra dose administered in the event tab. Arm was added as anatomical location for Afluria (TIV) Thiomersal in the narrative. The patient's current illness was unknown and had not received any concomitant medications. The VAERS ID (799244) was added in the product tab and additional information tab. The narrative and case comment were amended accordingly.; Reporter's Comments: A 74-year-old, female patient was administered expired Afluria (TIV) Thiomersal vaccine (expired vaccine used) and revaccinated with company co-suspect vaccine Flucelvax QIVc in the same season (extra dose administered). The health authority preferred event included 'product storage error'.  The company assessed the causality of the events as not related to the suspect vaccines considering the events expired vaccine used and extra dose administered as accidental in nature and of the event product storage error as incidental in nature.
Within 30 minutes of vaccination, patent began to experience profuse nasal drainage and significant nasal congestion.  Patent broke out in hives. Patent took Benidril and Pepsid, and symptoms subsequently disappeared within an hour.
Intussusception dx at Hospital ED. Air enema x3 to correct on 09/03/2022
Pt vaccinated with DT and developed 16 X 14.5 CM area of erythema, induration after 5 days.  Treated with Duracef 500 mg/Decadron 5/12 pack.
Patient states he felt feverish, with body aches, and head ache. Patient presented to clinic with petechial rash on upper arms, upper chest, upper back, anterior groin, and anterior upper thighs bilat.
Bells Palsy. Complete paralysis of the right side of my face. Inability to close my eyes, or hold Food and water in my mouth. Migraines, hypersensitivity to sound, emotional distress. CT,Xray,MRI, autoimmune labs, HSV titer, lymes titer, WBC count, inflammation marker, and any other lab work all came back normal.
When child woke up next morning after getting Tdap & HPV vaccines afternoon before she felt itching on her neck, both sides. Glands felt swollen per child. It itched on neck & top of shoulders for 3-4 days. Red spots on neck (over glands). Went away after 3-4 days.
My husband was holding her. She was acting tired which isn't normal for her even was she is tired.  While holding her, her eyes were barely open and she was laying across his arms. He changed her diaper on the changing table a few minutes later. During the diaper change, she had her eyes closed and was not fighting the activity. Once again, this is not normal for her not to fight a diaper change. While she was laying on the table, i gave her 2.5mL of tylenol and 1.25mL of ibuprofen. She normally loves taking her medications but turn her head away. I placed the syringe in the side of cheek and slowly dispense the medications. My husband finished her diaper change and brought her to the kitchen where I was located. He was holding her across his body. When I looked at her, her skin was pale and lips was very pale. I grabbed her from my husband and carried her to the living room. She was limp, her lips were blue when i placed her on the floor and her eyes were closed. I unzipped her PJ and started stimulating her chest. During this time, I was telling her to breath and saying her name. Quickly, her lips were pale again, then a few moments later she opened her eyes. She laid on the floor for approximately 2 minutes before she got back up and started behaving normally with normal skin and lip color. The entire incident approximately started at 9:55am to 10:05am(I had texted a friend who is a nurse to call me asap at 10:09).
Patient reports cold and flu symptoms starting 10/15/21. She reports loss of taste and smell. Patient was evaluated in the ED and found to be positive for COVID-19. The patient will be discharged.
Pt. a 19yo male, c/o dizziness approx. 5 min after receiving his initial vaccination. Pt. ambulated to the privacy tent and was laid supine on the couch. Initial vitals BP 106/64, P 62, SpO2 98% on room air. Pt was observed 20 min. Secondary vitals found to be improved and pt stated that he felt better. Pt refused any further treatment. Pt refused transport to the ER via ambulance. Pt left the observation are at 13:51.
Patient had right sided facial redness and itchiness about 20  to 30 minutes after injection, no swelling, no rash, that lasted about 10-12 hours, patient then had right periorbital swelling about 1-2 hours after injection, with slight scleral injection and itchiness of the eye, this lasted about 24 -36 hours then resolved completely Flu like symptoms ( body aches, fever, chills) within 24 hours that last about 36 hours post vaccine
administered a YF-Vax for which the diluent had expired with no reported adverse event; Initial information received  on 03-Jun-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient of an unknown age and gender patient who was administered a YF-Vax for which the diluent had expired with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE [YF-VAX].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect YELLOW FEVER VACCINE , ( lot : UJ386AA ; expiry date : 22-Aug-2022) and diluent (lot: U6627AB ; expiry date: 20-May-2022)  in unknown administration site for immunization.  On an unknown date the patient was administered a YF-Vax for which the diluent had expired with no reported adverse event (expired product administered) (unknown latency). The diluent expired in May  Action taken : not applicable.   Outcome: unknown   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 the 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 was hospitalized overnight from 5-9-21 through 5-10-21 for reasons not related to Covid-19, at Hospital; his lab reports show that he tested negative for Covid-19 at this time. He developed shortness of breath on 5-16-21 and was taken to Hospital. Patient was transferred Hospital on 5-17-21 where he was admitted and tested positive for Covid-19.  Patient was in the ICU during his hospital stay at hospital and required mechanical ventilation; he was discharged on 6-8-21 to Hospice.
This is a spontaneous report from a contactable other HCP (patient herself). A 32-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6203, Expiry date: unknown) via an unspecified route of administration in Arm Right on 04Mar2021 at 12:00 PM as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included shoulder surgery 2/25 from an unknown date and unknown if ongoing. No other vaccines administered within 4 weeks. There was no COVID-19 prior the vaccination. COVID-19 was tested post vaccination (broad qPCR test) on 23Feb2021 as negative. The patient previously received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EZ9266, Expiry date: Unknown) via an unspecified route of administration in left leg on 11Feb2021 at 01:00 PM as 1ST DOSE, SINGLE for COVID-19 immunization. Concomitant medications included acetaminophen and  ibuprofen taken for an unspecified indication, start and stop date were not reported. On 06Mar2021 at 04:00 AM, the patient experienced headache, dizziness and fever. Treatment was not received for the events. The patient underwent lab tests and procedures on 23Feb2021 which included nasal swab test and qPCR test was negative. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.