chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose I had head to toe itching; This is a spontaneous report from a contactable Other HCP (herself). A 43-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number/Expiration date: UNKNOWN) via an unspecified route of administration, in the left Arm on 17Dec2020 14:00 as single dose for covid-19 immunisation. Medical history included covid-19 (COVID prior vaccination) and concomitant medication included duloxetine (DULOXETINE)(MANUFACTURER UNKNOWN); hydroxyzine hydrochloride (HYDROXIZINE) (MANUFACTURER UNKNOWN); bupropion hydrochloride (WELLBUTRIN) )(MANUFACTURER UNKNOWN). On an unknown date the patient had head to toe itching. Patient reported that all progress she made with taste and smell, was disappeared after the vaccine.The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Employee Immunization Clinic, Employees card was tagged for an MMR and employee had 2 records with one MMR on each record. MMR administered instead of Varicella. We notified the employee and she received on the same day the needed 2nd dose of the Varicella to comply with Employee immunization policy. There were no adverse reactions noted from the MMR vaccine. So Employee received an additional MMR that was not needed, in addition to the varicella that was needed to stay current.
Client's mother stated child was itching and proceeded to break out in rash over his entire body after taking the second pill in the oral typhoid series. The mother gave the child a dose of Benadryl and the child's symptoms resolved by the next morning.
Muscle Aches; Rash; This case was reported by a physician via sales rep and described the occurrence of muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced muscle pain and rash. On an unknown date, the outcome of the muscle pain and rash were unknown.   It was unknown if the reporter considered the muscle pain and rash to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient called the next day of vaccination to report muscle aches and a rash. It was unknown how long adverse reactions lasted. The reporter was a field representative and was at physician's office on day of reporting and notified of adverse event. The field representative had very limited information (i.e. vaccinated arm).  The physician office okay with receiving follow-up for additional details. The reporter consented to follow up.
This is a 61-year-old male with PMH of HTN HLD presents to the ED for evaluation of syncopal episode. For past 2 days patient complains he has been feeling generally weak and fatigued. Yesterday patient reports he received covid vaccine J&J. Today patient got out of bed to go to the kitchen downstairs while he was walking down states he complained of lightheaded and nauseous. At the bottom of the steps patient reports passed out for a brief moment and laid down on the stairs. Patient denies any falling, or any injuries. As per ED record wife claims that the patient was out for approximately 5 minutes and during that time patient appeared pale and sweaty. Patient denies any urinary or bladder incontinence. Patient denies biting of the tongue. Patient reports he went to work on Wednesday and possibly was exposed to COVID-19 at work. Patient reports very mild congestion and weakness as of now. Patient denies any loss of taste, loss of smell, nausea vomiting diarrhea. In the ED patient patient was administered 2 L of normal saline bolus and IV fluid was started at 125 mL/hour. Chest x-ray was unremarkable.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 03Jan2022 (Lot number: FJ1611) at the age of 40 years as dose 3 (booster), single, administration date 25Mar2021 (Lot number: EK5730) as dose 2, single and administration date 04Mar2021 (Lot number: EJ1685) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Feb2022 08:00, outcome "recovering" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Feb2022) negative, notes: Nasal Swab, iHealth Covid-19 Antigen Rapid Test; (09Feb2022) positive, notes: Nasal Swab, iHealth Covid-19 Antigen Rapid Test. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course was reported as, Facility type vaccine was Pharmacy or Drug Store. Patient not received any other vaccine in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and has been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
9X9 cm care of erythema mild warmth and mild TTP to left upper deltoid.
Received Hepatitis A and GARDASIL vaccines on 08/03/12. 13 days later developed painful legs (muscle and skin), perineal pain, lower back pain, abnormal cold sensation, no URI no fever. Diagnosed with transverse myelitis by specialist.
Dizziness; This is a spontaneous report from a contactable nurse (patient). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot number and expiry date were unknown), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination. The patient did not receive other vaccines in the last four weeks. Concomitant medications included omeprazole (PRILOSEC), metoprolol, levothyroxine sodium (SYNTHROID), aciclovir sodium (ACYCLOVIR VIAL), and meloxicam (MOBIC). The patient previously had allergies with morphine. On 28Dec2020, the patient experienced dizziness 12 hours after injection with outcome of recovering. The patient did not receive treatment for the reported adverse event. The report was considered non-serious.  Information on the batch/lot number has been requested.
A report has been received from a Health Professional concerning a 14 year old female patient with a history of seizure disorder controlled on medications. On 28-Oct-2013 the patient received nasal FLUMIST Quadrivalent (intranasal). On 01-Nov-2013 the patient had a positive test for influenza b. The reporter also stated that the patient had symptoms of fever (103f), headache, and fatigue and had seizure. The outcome of the seizure, positive test for influenza b, fever (103f), headache, and fatigue were unknown. According to the reporter the seizure was serious as an important medical event. All other events were considered to be non-serious.
This spontaneous report as received from a 64 year old female patient refers to herself. On 18-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX in the left arm. On 18-MAR-2014 the consumer developed a "large pink circle" at the injection site of her left arm "right away" after receiving ZOSTAVAX and that "later that day" on 19-MAR-2014 she developed an unspecified rash on her unspecified arm. "A week after" receiving ZOSTAVAX on approximately 25-MAR-2014 she developed pain "where her legs meet her pelvis". The patient had been limping since 31-MAR-2014 and developed an unspecified rash on both of her legs "last Wednesday" on 02-APR-2014 but stated that her physician said that the rash was not shingles. The consumer was seen by the physician on 03-APR-2014 and the physician told the consumer to take ibuprofen every 6 hours. On 05-APR-2014 the pain she had "where her legs met her pelvis" moved to just the left side of her pelvis and left leg. The unspecified rash on an unspecified arm and both legs was "healing". The patient had gotten "slightly better" but was still difficult to walk upstairs. Additional information has been requested.
Nurse 1 was pulling out needle from vial after dilution for pediatric Pfizer COVID 19 Vaccine (5-11 y/o) and Nurse 2 noticed the syringe that Nurse 1 used to dilute was a 5 cc syringe not a 3 cc syringe. Therefore, the vaccine was diluted with 1.6 mL NS not 1.3 mL. One vial had previously been diluted with the same syringe in the morning session and 10 vaccines were given. Parents of the children who received the vaccine in AM session will be called and notified. Provider, Supervisor and Nurse Manager were notified. Pfizer and COVID Call Centers were called/consulted; both gave the CDC resources/instructions (COVID-19 Vaccine-Administration Errors and Deviations) that states, for this diluent error/deviations ?do not repeat the 1st dose? and they recommended that children receive their second dose as scheduled. Second vial was wasted with 10 doses.
Fever or Chills  Cough  Muscle or body aches  Headache
Influenza vaccine info above surmised from military MEDPROS; which listed "Influenza, INJ, QUADRIVALENT PRES FREE; CSL Biotherapies as Manufacturer... - Patient received IM influenza vaccination (only vaccination that day) in R deltoid on 12Oct2016 at off-site ?vaccination clinic?. Initial vaccination was unremarkable. She initially sought care for continued pain and limitation in ability to abduct R arm due to pain on 1Nov2016. At that encounter; it was noted that she also experienced pain with any arm movement (not at rest) and did not note anything unusual initially after vaccination (e.g. no swelling, bruising). At subsequent visit with reporting Provider on 6April2017, she also noted that she experienced normal pain with vaccination at time of vaccination, that just persisted.  Physician who saw patient on 1Nov2016 suspected impingement (based on history and PE, noting impingement tests were positive), and patient noted that vaccination spot may have been high on the shoulder, near the acromion. Patient followed up with reporting Provider on 31Jan2017, and complained to screening medic of feeling pain in shoulder a couple days after being given influenza vaccine, and noted continued pain that was provoked when doing activities and when lifting arm. Patient had TTP over R deltoid. Full ROM was present, but she noted pain in R deltoid region with R arm abduction. SIRVA was suspected at that time. Imaging studies were ordered. X-ray on 15 Mar 2017 was unremarkable. MRI on 15Mar2017 noted normal deltoid, with no evidence to suggest myositis. A Partial-thickness, interstitial tear of the distal infraspinatus tendon, extending from the footplate to the myotendinous junction, with associated subchondral cystic change in the humeral head was noted. There was no evidence of full-thickness tear, or other abnormality. Patient was seen on 6 April by reporting Provider. She noted improving, but still present deltoid region pain with should abducting activities. No infraspinatus weakness or pain with infraspinatus movement was appreciated at that encounter. Patient saw Physical Therapy and Orthopedic Service on 17April2017.  Per, Ortho note: Continued pain was noted, especially with overhead lifting motions. PE notable as follows: ROM testing was normal. Impingement testing was positive. Diagnosed with ?impingement vs. tendonitis?  No surgical indication was found at that time.  Reporting Provider talked to patient on 30July2017.  She says overall pain picture is improving. She still has slight pain with R arm abduction. It is unknown at this time whether the clinic will/has awarded disability for R shoulder. She is still waiting for a determination on that.
pt recv vax 8MAY96 & 16OCT96 pt devel a significant papular patch in the area of rt facial nerve;pt to ER;trigeminal distribution on rt forehead, rt eye & upper cheek area;clinical ophthalmic dx of shingles made;tx w/med
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and intramuscular, administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications (reported as multivitamins). Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Nov2021, outcome "recovered" and all described as "positive COVID-19 test with symptoms". The event "positive covid-19 test with symptoms" and "positive covid-19 test with symptoms" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) positive, notes: Nasal Swab. It was also reported that patient tested positive for COVID: body aches, fever, bad headache, sore throat, chills, fatigue, vomiting.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Client rec'd vaccine on 03/15/2017. States she left the country on 04/07/2017.  After she returned she complains of onset of rash and facial swelling on 4/17/2017. Reports the second and third day she had difficulty breathing.  States she has seen her doctor and been to urgent care.  States she was notified by MD to notify the health district of possible reaction from vaccine.
Took 3 unrefrigerated doses; Spontaneous report received on 10FEB2020.  A pharmacist reported that a 49-year-old adult female consumer "took 3 unrefrigerated doses" (PT: Product storage error) while being on Vivotif (lot number: 3003307; expiry date: Nov 2020; 1 capsule alternate day) for immunisation. She took her first and second dose of Vivotif on 02FEB2020 and 04FEB2020 respectively and then took her next two doses on alternative days. The last three doses were not refrigerated and were kept at room temperature. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.   Concurrent condition included hypothyroidism.  Concomitant medications medication included Nature throid (thyroid; 65 mg) for hypothyroidism.  Company Comment: A consumer took three unrefrigerated doses of Vivotif (Product storage error). The last three doses of Vivotif were kept at room temperature and were unrefrigerated. Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took three unrefrigerated doses of Vivotif (Product storage error). The last three doses of Vivotif were kept at room temperature and were unrefrigerated. Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Broke out in hives 10 days after and they continue to persist. I can write on my skin - it will break out and then fade after 15 - 20 minutes.
patient recived expired dose of vaccine with no reported adverse event; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a pharmacist via (Medical Information- 00798747).  This case involves 63 years 10 months -old female patient who was vaccinated with expired dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 04-Oct-2021, the patient received a 0.5ml dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot number R1F78 and expiry date 30-Sep-2021 was reported) via intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Event outcome was 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 guidelines. 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.
After the shot patient was doing okay as soon as they got out of immunization area family member notices that patient was pale and getting dizzy. We had the patient sit down again. Gave him water and ensure to drink. Patient mention that he did not eat breakfast and had hard day of work previously. Family member gave food also and waited about 25 minutes before going home.
This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6199 and expiry date: 31May2021), via an unspecified route of administration, on an unspecified date (reported as yesterday), as dose 1, 0.3ml single, for COVID-19 immunisation. Patient had no medical history. There were no concomitant medications. It was reported that, the patient received the first dose of the COVID-19 Vaccine and was itchy from head to toe, even the eyes were itchy. The patient does not have rash. The patient was wondering if she should get the second vaccine. Patient received no treatment due to the events. The outcome for the events was not recovered. No follow-up attempts are needed. No further information is expected.
(14 April 2021) I started experiencing stomach discomfort which resulted in diarrhea .  It has been constant for the past 24 hours. (15 Apr 2021) I contacted my healthcare provider at 8:10 am and selected the call-back option.  The healthcare provider called me back at 8:17 am. The healthcare provider will start case file contact patient before the day is over.  I took Imodium at 8:50 am.  Got a call from the doctor's office (10:19 am) with instructions: Take fiber and plenty of liquids.  I informed them I took an Imodium, directions changed to drink plenty of liquids and let it run its course. There is nothing they can do because the vaccine was already administered.
Pt recvd 1st dose of vax 18JUN92 & 20 minutes following the vax exp a dry, raw throat; tight chest; h/a w/pressure behnid eyes; dizziness; flushing; hot sensation; nervousness; sl rash & nausea;
sore arm; This is a spontaneous report from a Non-contactable consumer (Patient) reported for herself. A 49 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Apr2021 00:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got shot on Wednesday 14Apr2021, experienced sore arm for 1st dose. Outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Localize reaction at injection site. Patient did not have SOB or other systemic symptoms. Localized reaction was redness and itching.
Post vax, the pt experienced shortness of breath and chest pain. An ER visit was required.
Developed Shingles, rash on midriff to back, nerve pain over a week after receiving vaccinations. Went to ER diagnosed by rash and symptoms. Perscriptions given: HYDROcodone-acetaminophen 5 mg-325 1 tab evert 6 hours as needed for pain for 3 days. PredniSONE 20 mg 3 tabs PO for 2 days, 2 tabs for2 days, 1 tab for 2 days
12/23/2020 0200 Severe Tremors and Chills. Nausea, dizziness, & near syncope. Headache. 0700 Softball size lump(edema), 6"x6" area erythema, hot to touch, and pain at injection site. Difficulty raising arm due to pain. Fatigue. 12/25/2020 0100 Awakened hot and sweating which lasted approximately 6 hours, fatigue. Arm issues continued. 12/26-27/2020 Arm slowly improving but fatigued and headache continued. 12/28/2020-Improved but headache continues.
No adverse effects, pt was given Pfizer monovalent. Newest schedule calls for bivalent instead of monovalent for 3 doses
At the end of July 2022, I ended up getting COVID-19.  My symptoms were fatigue, cough and slight slight nasal congestion.  I did not go to the doctor for the infection, I went because I was sick in December 2022 after Christmas.  I had extreme fatigue, slight nasal congestion and a cough.  The cough was slightly productive.
Suspected vaccination failure; Shingles on scalp; Was awful worse thing ever; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on scalp) and feels awful (Verbatim: Was awful worse thing ever). The outcome of the vaccination failure was unknown and the outcome of the shingles and feels awful were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and feels awful to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-MAR-2023 The case was received from the patient interactive digital media. The patient stated that no unfortunately he/she had mine too and he/she got shingles about 3 months ago. The patient got them on my scalp worse thing ever he/she just was wishing the worst for me to happen it was awful so even though you got that shot you could still get them. The patient was sorry to tell you that he/she had the vaccination and still got them worse than ever. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
I had inflammation in my joints. I became cramped up to where it was hard to sit and lay down. The inflammation in my hips makes it hard to move. It started to get difficult to walk. I am still struggling with the inflammation now I'm just not in as much pain. I have a lack in range of motion and movement. It feels like my body creates this contracting feeling. I didn't go to the doctor at all because I never thought nothing of it because it just progressed over time. I took more Advil and I have been going to physical therapy since July 2021. The pain that I had generated from my hip and only in my hips and also in my shoulders. I feel less pain now. I do feel better, but it still hurts.