chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered Pentacel but was only given the liquid portion and not the HIB powder/ no adverse event; Initial information received on 15-May-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves 2 year old patient (gender not reported) who was vaccinated with a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Batch number: UJ1088A or UJ062A, expiry date: 24-Jul-2020, ActHIB lot-UJ062AAdose in series not reported) via intramuscular route in right leg on 14-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) ; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE); HEPATITIS A VACCINE (HEPATITIS A VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) on an unknown date.  It was a case of actual medication error due to inappropriate reconstitution technique. It was reported patient was administered Pentacel but was only given the liquid portion and not the HIB powder  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 and Module VI of the 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.   Documents held by the sender: none.
MILD LEFT ARM SORENESS STARTED DAY AFTER VACCINATION AND PERSISTS 6 WEEKS LATER. NOTICES IF PUTS ARM ABOVE HEAD.  POINT TENDERNESS AT  DELTOID INJECTION SITE.
Extreme sore throat, extreme headache, diarrhea, body aches, fevers, chills, extreme sinus pressure, tooth/jaw pain, swollen glands, ear pressure
Severe muscle contractions, tremors, high fever, dizziness, nausea, increased in severity over a period of about 2-3 hours, called 911, transported to emergency room.
Information was received on 06-MAR-2017 from a certified medical assistant regarding an unspecified number of patients. Medical history, concurrent conditions and concomitant medications were not reported. The unspecified number of patients received unspecified doses of PEDVAXHIB (lot number M027882, expiration date 14-APR-2019; lot number M006709, expiration date 06-DEC-2018; lot number M020101, expiration date 07-MAR-2019; and lot number M032147, expiration date 14-APR-2019), and M-M-R-II (lot number L015280, expiration date 30-APR-2017) that were improperly stored. PEDVAXHIB temperature 10.8 Celsius. Time frame: cumulative 3 hours and 51 minutes. Previous temperature excursion yes 12.8 Celsius, 4 hours and 30 minutes. Call was because of data logger. M-M-R-II temperature 12.8 Celsius. Time frame 4 hours and 30 minutes that occurred in Nov 16. Call was made  because of a data logger. Vaccinations may have occurred between 18-NOV-2016 and present, 06-MAR-2017. No adverse effects were reported. No further information was provided. Additional information has been requested.
Spondylitis ankylosing aggravated; Tendonitis; Tendon thickening; Fatigue; This is a solicited report from a contactable consumer (patient) based on information received by Pfizer from Facilitating Company (manufacturer control number: 21K-163-4080256-00). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration on 01Apr2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization; and adalimumab (HUMIRA; solution for injection in pre-filled pen), subcutaneously from an unspecified date (lot number was not reported) and ongoing at unspecified dose and frequency for ankylosing spondylitis. Medical history included spinal nerve stimulator implantation from Feb2021 and ongoing ankylosing spondylitis. The patient's concomitant medications were not reported. On 02Apr2021 (1 day after vaccination), the patient experienced fatigue. On an unspecified date, the patient experienced spondylitis ankylosing aggravated, tendonitis, and tendon thickening. The action taken in response to the events for adalimumab was dose not changed. The outcome of event fatigue was unknown while the outcome of the remaining events was not recovered.  The reporter's causality for adalimumab with the events spondylitis ankylosing aggravated, tendonitis, and tendon thickening was reasonable possibility, while for fatigue it was no reasonable possibility.  The reporter's assessment of the causal relationship of the events with the suspect product, BNT162B2, was not provided at the time of the report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  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
Patient received vaccine on 3/13/21 in the morning. Later that evening she stopped by and said she felt tired but was well. I saw her today and asked how she was doing. She stated that by 6pm that evening at home she had body aches, fatigue, fever, nausea and at 2am her fever was at 102.4. Sunday continued with fever, down to 100.8, body aches, and fatigue, nausea, and diarrhea. Her temperature this morning was 99 and was she was feeling much better. Treatment was not needed.
Numbness and Tingling sensation that started on the side injection was given.  Right shoulder into neck, tongue and head, eventually moved throughout entire body.  Also sensation of tremoring through body.
Pt states that he had some stomach pain as well as slight leg pain. I instructed him to call his doctor and let them know because it might be signs of a clot and out of caution the doctor might want to see him.
Started with itching on injection site arm, hives developed, face flushed, tightening on right side of throat.  Benadryl 25 mg given PO.
Minutes after receiving the vaccine, the patient broke out in a rash. The rash spread throughout her body. She did not have any other symptoms. Baseline vitals were taken, all normal except for elevated BP. Patient seemed normal cognitively. Patient stayed around for 30 minutes but did not progress symptomatically. She was escorted home by her husband.
On 7/31/05 patient experienced flat dark pink rash throughout body. Complained of itching; used Caladryl lotion. Lasted 5 days. On 8/2/05 patient complained of anxiety attack while at work, felt heart racing, lost focus, went home from work and stayed at home for 1 week. While at home, complained of overwhelmed feeling, could not sleep. Complained of not wanting to live; described it as Deep Depressive State.  She states she saw a counselor on 8/10/05 where she had another acute anxiety episode. Was taken to ER where blood tests and US were performed. Doesn't know results. On 8/11/05 patient was hospitalized for evaluation and treatment. She was released on 8/15/05 and is now on anti-depression meds Lexopril. She states that she was on other medication before the acute episodes.
Pt complained of right hip pain directly after receiving the vaccine. Pt was immunized on the 2nd floor of hospital, pain began as he ambulated downstairs and continued for 2 days. Pt has no Medical Hx of arthritis, walks everyday 3.5 miles. This pain was new, directly after vaccine, took Ibuprofen and subsided after 2 days.
Patient report headache, body aches and fatigue 2 hours post vaccine. Home remedies include Ibuprofen on 01/06/21 and two doses of Ibuprofen this morning 01/07/21.  Patient remains working. He reports no improvement in symptoms.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L048237, expiration date 18-MAY-2017 or lot #M003659, expiration date 08-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine with lot # L048237 experienced a temperature excursion of maximum 53 degrees Fahrenheit for 8 hours. Doses of vaccine with lot # M003659 experienced a temperature excursion of maximum 53 degrees Fahrenheit for 100 hours. Data logger was involved. Additional information has been requested.
chilblain like lesions on right large and second toe within one month of Pfizer booster (11/21) after having had an initial Johnson and Johnson vaccine in 4/21.
Chills, muscle aches. Sweats. Very sore arm cant move it liw grade fever
after 1st dose c/o chest and back pain (along scapula on left side of back).c/o pain with deep breath. no sob. Narrative:  after 1st dose c/o chest and back pain (along scapula on left side of back).c/o pain with deep breath. no SOB, N/V, dizziness. denied fever, chills or headache. Returned for 2nd dose on 1/21/2021.
Rash; Minor swelling at site of vaccine injection; Itching; This case was reported by a consumer via sales rep and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had shingles in the eye 15 years ago from the time of reporting) and post herpetic neuralgia (had severe post herpetic for many years).   On 9th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site rash, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site rash, injection site swelling and injection site itching were unknown.   It was unknown if the reporter considered the injection site rash, injection site swelling and injection site itching 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 per the vaccine indication. The patient stated that had the rash and minor swelling and itching. The patient asked about how long may the rash and minor swelling at the site of vaccine injection last and is treatment needed. The patient preferred to have anonymous. The patient was advised to speak with healthcare provider for the next steps. The patient had vaccination at local pharmacy and there were no warnings on information sheet or from pharmacist that history of shingles a concern.
pt got first covid shot on 3/20/21 then 2nd shot on 4/10/21.  Pt didn't have any side effects after the first shot.  For both shots pt got it in the left arm.  About 9 days after the 2nd shot of the vaccine pt intially had sore throat, cough and head ache but resolved, pt also had a rash on arm that resolved too.   Pt did have one bout of mild diarrhea before admission to hospital on 4/19/20.  Pt admitted to hospital on 4/19/20 for tachycardia and on and off fevers since getting the 2nd shot of the vaccine.  PCT 0.3 and 0.2 on 4/20, 4/21 respectively.  wbc= 23.69 and 16.6 on 4/19 ,4/21 respectively.  Working diagnosis at discharge per ID note is prolong side effect to covid vaccine.  Pt discharge from hospital on 4/21
Information has been received from a pharmacist concerning a patient who was vaccinated with PNEUMOVAX 23 (lot # not reported) on an unknown day. The patient experienced a rash. It was not reported if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
I received the shot of Trumemba on the morning of June 11th. I felt well in the evening so I went out playing tennis. When I came back, I developed body chills and high fever. My whole body was shaking and I couldn?t control it. I recovered the next day morning with a light headache.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's medical history, concomitant therapy and concurrent conditions provided. On unknown date in August 2014, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly (lot#, expiration date and site of vaccination were not provided). On 09-JUN-2015, the patient was vaccinated with the second dose of GARDASIL 0.5 ml, lot# K005083, expiration date 04-NOV-2016, intramuscular (site of vaccination was not provided). No adverse event was reported. Additional information has been requested.
This spontaneous report as received from a physician refers to a 15 year old female patient. On an unknown dates the patient was vaccinated with 1st, 2nd and 3rd dose of GARDASIL 9, intramuscular (lot # was not reported). On an unknown date, an additional dose of GARDASIL 9 (lot # was not reported) was intramuscularly administered to the patient after the series of three GARDASIL 9 vaccinations was already completed. The physician stated that there were no adverse effects or side effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 months old female patient who received an expired dose of 0.5 mL ACT-HIB (frequency once) lot UI805AA via intramuscular route in the right thigh on 26-Oct-2018. The patient's medical history and concomitant medications were not reported. Concomitant medications included MMR for Immunisation; and PREVNAR 13 for Immunisation. It was an actual medication error case due to expired vaccine used. It was reported that the patient had not any bad reaction and had no treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer BioNTech vaccine on 4/30/2021, 5/22/2021, and 12/02/2021. Presented w/SOB x3days. Hx of COVID-19 01/2021 c/b pulmonary disease requiring 3L NC of O2. SOB worsened; admitted to hospital; tx'd for CHF and PNA, d/c on 10L NC O2. ED 9/12, found to have acute on chronic hypoxic resp failure requiring Airvo support 2/2 progression of fibrotic lung disease from COVID-19. Severe 2-vessel CAD dx'd 9/15 plan to perform stage PCI. Cont'd to decompensate 2/2 resp status. Private was called; PCI cancelled 2/2 inability to tolerate procedure. Comfort care only, exp'd 10/05/22. Tx'd w/vanc, linezolid, zosyn, prednisone, levofloxacin,
States she has had left arm pain since her first does of the vaccine. she is able to lift arm however describes it as stiff.
Information has been received from a physician concerning a 15 month old male who on 01-MAY-2007 was vaccinated with a dose of Zostavax (656861/0329U). On 01-MAY-2007 the patient received Zostavax instead of varicella virus vaccine. No adverse events reported. No product quality complaint. This is one of several reports received from the same source. Follow-up information received from the medical assistant indicating that when she was getting the vaccination vials, she "saw the word vax and grabbed the wrong vial". She said that the office has labelled the boxes with "shingles" and "chickenpox" to avoid this in the future. She also stated that there were no adverse events reported. The patient's sibling also had a similar reaction after therapy with Zostavax (WAES0705USA00719). Additional information has been requested.
Information has been received from a physical therapist concerning her daughter with a history of meningitis at the age of 2 and seasonal allergies who on unspecified date was vaccinated with the first dose of Gardasil (lot # not reported). On 26-NOV-2007 the patient was vaccinated with a second 0.5 mL dose of Gardasil (lot # not reported). Concomitant therapy included WELLBUTRIN and other "unnamed medications." On 28-NOV-2007 the patient developed hives over her entire body (also reported as 26-NOV_2007). The patient contacted her gynecologist, who advised her to call her internist. The patient took 4 Benadryl 25 mg as directed. She was slightly better the following morning and called her physician who then started her on Medrol DosePack. On approximately 29-NOV-2007 the patient experienced horrific muscle pain, she blacked out for a short period, vomitted green bile, was dizzy and had a fever. The doctor discontinued the Medrol DosePack. Hives returned and she went to the ER on 01-DEC-2007. The patient was given intravenous fluids and was treated with Motrin and Benadryl which were ineffective. Blood test for Creatine Phosphokinase was normal. The patient then started on another unnamed medication for hives which was later discontinued. A few hours later, the patient was started on Prednisone. The patient was later released from the emergency room and is completing therapy with prednisone. The patient was reported as recovering. Hives over her entire body, horrific muscle pain, blacked out for a short period, vomitted green bile, dizziness and fever were considered to be other important medical events. Additional information has been requested.
Pt received both doses of COVID Pfizer vaccine., on 3/10/21 and 3/31/21.  Pt tested positive for COVID prior to a routine unrelated procedure on 6/2/21, but was asymptomatic.
Pruritic rash located on trunk and arms.  Pt referred to emergency room for anti-histamines and observation.
4x6 cm pink in color - mildly warm to (R) upper arm. Benadryl and if no improvement or increased S/S to start Keflex 250/5 1/2 tsp. BID for 7 days.
Pt came in today said on Friday developed red circle around vaccination site it is warm to touch no pain or itching.
Patient fainted after receiving vaccine. Patient also had a similar fainting reaction to a Tdap vaccine 4 years ago. Fainting episode was brief, patient was moved to a lying-down, legs-elevated position with cold compress applied to forehead, and quickly recovered.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 16-JAN-2012 at 7:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # 671141/1267AA) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 29-FEB-2012, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # 671141/1267AA, expiration date 05-NOV-2012) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports received from the same source. Additional information has been requested.
Dose Number 1: 25Apr2021/Dose Number 2: 09May2021; Achiness; Headache; Neck ache; Fatigue; Soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09May2021 14:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D NOS; VITRON C [ASCORBIC ACID;FERROUS FUMARATE]. Vaccination history included: Bnt162b2 (dose number=1, Batch/lot number  unknown, administration time 14:30, vaccine location Left arm), administration date: 25Apr2021, for COVID-19 immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09May2021 14:30, outcome "unknown", described as "Dose Number 1: 25Apr2021/Dose Number 2: 09May2021"; PAIN (non-serious) with onset 2021, outcome "recovering", described as "Achiness"; HEADACHE (non-serious) with onset 2021, outcome "recovering", described as "Headache"; NECK PAIN (non-serious) with onset 2021, outcome "recovering", described as "Neck ache"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovering", described as "Soreness at injection site". Therapeutic measures were not taken as a result of pain, headache, neck pain, fatigue, vaccination site pain.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
NEUROMYELITIS OPTICA 3/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS