chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt uncomfortable; Felt / miserable; First Shingrix shot several months ago; Horrible aching and soreness at injection site / pain level of 8 on a 1-10 scale; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, feeling unwell, feeling miserable and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the feeling unwell, feeling miserable and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site pain, feeling unwell and feeling miserable to be related to Shingrix.  Additional details were provided as follows: The patient was health care professional and reported for himself. The age at vaccination was not reported. The patient got his first Shingrix shot several months ago of reporting date and he had horrible aching and soreness at the site of injection. The patient also felt miserable and uncomfortable. The pain at injection site lasted for 4 weeks. The pain level was 8 out of 1 to 10 pain scale. The patient did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. No additional information provided. The patient did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244447:Same reporter. FU1 (deleted)
Lot number, dose in series not definite; pt has memory issues, spouse is POA & states patient had two boosters before the Bivalent Covid Pfizer immunization; rec'd flu shot concurrently. Spouse reported severe diarrhea (liquid stools x5 starting 2-3 hours after injections with generalized weakness). Spouse administered Pepto-Bismol then Immodium w eventual control of sx; Today patient is w/o symptoms, spouse reports no further diarrhea, physical exam unremarkable. Pt taking food/ fluids w/o difficulty; will f/u w PCP  within a week.
Day after chest pain and short of breath. 3 days after increased shortness of breath2/17/2021 Acute pancreatitis.  hospitalization Followed by Gastroenterology. 3/8/2021 Chest CAT scan 3/19/2021 MRI of pancreas 7/30/2021 CAT scan pancreas and chest 8/9/2021 Son passed unexpectedly from probable widow maker. 8/10/2021 Difficulty urinating. Prostatitis. Urology, Improved. Bactrim BID X 6 weeks. 8/11/2021 Consult with Pulmonologist for lung nodules. Has had numerous scans for several years to keep watch on these nodules which come and go. He feels this is infectious/inflammatory process. Started on Amoxicillin 500 mg-potassium clavulanate 125 mg tablet BID X 10 days. After several days on the antibiotic had a productive cough at times and seemed more SOB. Stomach upset and constant nausea while on the med. 8/19/2021 Sciatica/neuropathy like symptoms with both leg involvement. Hip pain after several days and leg pain continues. PT, Chiropractor, Ibuprofen, ice packs. Pain greatly increases at night. Unable to sleep since 8/19 due to the severe pain. Hand tremors increasing. Started on Gabapentin 300mg on 8/26/2021 at primary care appointment. 8/25/2021 PET scan. Doctor is not concerned? with this PET scan results. Will repeat CAT scan 3-6 months. Will  get referral for ENT. 8/26/2021 Food getting stuck while eating again. Dysphagia treated in 2013 and an EGD scheduled with Gastroenterology in Dec 3, 2021 8/28/2021 Dizzy. Fell once. ? from around the clock ibuprofen or Gabapentin *Most recent PET is showing uptake in R parotid gland. Recommend MRI follow up. This appears the same as previous PET in December 2020 Chest Medicine will send a referral to ENT. 8/31/2021 PCP appointment. Bloodwork done for autoimmune disorders. Gabapentin now BID. Platelet count high.~~Alpha 1 and Alpha 2 Globulin High                          9/1/2021 Chest pain, left arm tingling SOB. To hospital via rescue. Afib. Discharged same day. To follow up with Doctor and referral to cariologist. Medications Table PCP and need referral to cardiologist. 9/9/2021 TSH 0.26  ?subclinical hyperthyroid. Increased SOB and heartrate doubles when just walking  on flat surface. The increased pulse, afib, weight loss, hand tremors. Increased platelets and anxiety all symptoms of hyperthyroid.  9/16/2021 Thyroiditis. IgG showing acute inflammation.
Day following immunizations, the patient woke up with left foot pain so severe he was unable to walk. The foot pain lasted for a day and resolved in teh evening. The following day, 2 days after immunization, the patient woke up with right thigh pain which resolved without intervention.
Nonstop ringing in ears, jaw locking and ?popping? almost every day, joint pain especially from elbow to fingers.
Patient states that her arm was itchy after vaccination.  Area looked red and inflamed.  Removed bandage and applied ice to area and swelling subsided.
Woke morning after first (and only) Pfizer covid vacc. with prominent left ear ringing. 3x more volume  than normal level. Still ringing loudly two days before  appointment to get second dose of Pfizer with some occasional right ear ringing also (which I never had before at any volume). So felt I had to cancel the second dose. Now going on 26 days of constant life changing tinnitus. Obviously hoping it subsides.
Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 7-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 1, single (Batch/Lot number: unknown) and on 11Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 7 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 01Jun2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Breakthrough COVID infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
PT EXPERIENCED EXTREME BRUISING AND SWELLING IN ARM. SHE ICED IT.
Felt abnormal heart rhythms and shortness of breath with fatigue. Symptoms would come and go through the day.
test positive for COVID-19/fever, chills, body aches, joint pain; test positive for COVID-19/fever, chills, body aches, joint pain; This is a spontaneous report from a contactable other HCP. A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5703), via an unspecified route of administration in left arm on 15Dec2020 17:30 at a single dose for covid-19 immunization. Administration was done in the hospital. Medical history included seronegative rheumatoid arthritis and allergies to latex and actemra. Concomitant medication included tofacitinib citrate (XELJANZ), and ibuprofen. Eight days after vaccination, on 23Dec2020 at 13:30, the patient came down with fever, chills, body aches, joint pain. The patient was initially tested negative for COVID (nasal swab) and influenza on 27Dec2020 but did test positive for COVID-19 on 29Dec2020 (nasal swab). The patient stated that she knew that the vaccine did not cause COVID however as she was on immunosuppressants (Xeljanz), she wanted to record this information. There was no treatment included for the events. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
This infant was born to a mother who is Hep B positive. The RN gave the infant both the HBIG and the Hep B vaccination in the same leg (both given in Right thigh), which is an error. The Hep B vaccine needs to be given in the opposite leg of the HBIG as the HBIG can make the Hep B vaccine not as effective.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. From 20-Nov-2011 to 02-Dec-2011, 13 patients inadvertently received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Pt. contacted pharmacy on 11/21/11 stating her arm was still sore from vaccination given on 10/30/11. No redness, swelling, or fever. Her arm is getting progressively more sore when she moves a particular way. It isn't always sore - just when she moves it a particular way. Advised patient to call MD. Never heard back from patient.
Shingles; rash; This case was reported by a physician via call center representative and described the occurrence of shingles in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th October 2019, the patient received the 1st dose of Shingrix. On 11th October 2019, 6 days after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The rash was on the face, which was believed to be shingles. The patient was seen by the physician this week and emergency room visit was required. This case had been linked to the case US2019188976, reported by the same reporter.
Pt received shot in the morning. Then during the night had feeling of being in a daze. She went to bed and next morning had similar feeling but more intense than before. Also she felt as if she couldn't catch her breath. She took a BENADRYL, then next day she felt better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received paxlovid as COVID 19 Treatment.  Clinical Course: The patient did not received any other medications within 2 weeks of starting COVID-19. The patient previously received a COVID-19 Vaccine  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) cannot be ruled out.
Diagnosed with Shingles on 08/11/21. Symptoms started on 08/07/21. Also muscle pain in right arm and fatigue for first 48 hours.
Pt developed tingling in toes and fingers that have progressed to numbness and climbed up extremities to now include above the wrist down, and patient is now unable to ambulate.  Progression has been over three days.  Providers have diagnosed Guillain-Barre.  Patient received Pfizer Covid vaccine on 5/6/21 and 5/27/21.  Additionally, patient has underwent lumbar laminectomy in June 2021.  Pt also complained of trouble swallowing and headache on admission.   Pt received first dose of IVIG last night, is due to receive second dose tonight.  Pt was transferred to ICU level of care over night.  He is currently still admitted, there is discussion of transfer to another hospital with higher level neurology services at this time.  If he remains stable he will stay here.
Pericarditis occurred end of February and was seen by a doctor early March and was diagnosed. Still ongoing side effect and taking colchicine for the inflammation of the pericardium. Ongoing chest pain and pressure is present with pain radiating to the left side of my shoulder blade. There is also neck pain present. These symptoms are ongoing and still being treated for.
Fatigue, felt feverish (no documented fever), headache, nasal congestion, sinus pain and cough.
patient presents with redness and swelling of vaccine site. Treatment: Cephalexin 500 mg one QIDx7d
Patient is menopausal and experienced vaginal bleeding lasting about 2 days.  Heavy enough bleeding that required a pad, but it did not saturate the pad.
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 10-SEP-2015, the patient received an unspecified dose in immunization series for (Oka-Merck) PROQUAD (dose and route of administration were not reported) that was improperly stored. While lot # for administered dose was not specified by reporter, lot # may include: lot # L023113 with expiration date 24-DEC-2016, lot # L008355 with expiration date 11-SEP-2016, lot # L019995 with expiration date 02-DEC-2016 or lot # L019994 with expiration date 02-DEC-2016. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
patient received the DTap-IPV portion of PENTACEL only without reconstituting with the Hib component, with no reported adverse event; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case from a nurse and consumer/ non-healthcare professional via Media Information (under reference 00796883).  This case involves a patient (unknown age and gender) who received the dtap-ipv portion of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL (VERO)] only without reconstituting with the hib component (product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 04-Oct-2021, the patient received a 0.5 mL dose of suspect [PENTACEL (VERO)] (Total, lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique (same day latency).  It was reported "Caller states that she is the vaccine coordinator/nurse at her practice and that she is currently working from home. Caller states that she was contacted by a nurse at her practice and told that a patient received the DTap-IPV portion of PENTACEL only without reconstituting with the Hib component on 04OCT2021. Caller asked if she can use a standalone ACTHIB vaccine to count as the Hib portion that was not administered. Caller states that the nurse should know this and doesn't understand why she is asking. Caller states that she will call the nurse back and let her know how to proceed. Caller asked for the name of the organization used in the standard regarding PENTACEL reconstitution. Caller states that she does not have any information available on the patient or lot numbers for products because she is working from home."  At time of reporting, no adverse event reported.  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 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.  There will be no information available on the batch number for this case.
Severe itching, intense pain, redness, and swelling of left thigh after 2 stings from a wasp, which has lasted more than 1 week (and just now starting to completely resolve ~ 2 weeks post-sting). Skin discoloration continues and redness in an unusually large area around the sting sites. Symptoms continued despite use of ice / gel packs, cortisone cream, Anthisan (mepyramine maleate 2% w/w) antihistamine 2-3 times a day, and Benadryl.  The large area (4" x 6") and long duration of irritation reflected an unusual reaction to the stings, which would usually be 1" to 2" and clear in a few hours, or a day or two, at most (rather than ~ 2 weeks).
Patient experienced pain at the site of injection. The morning following the administration of the vaccine, patient felt nauseated. She fainted and fell from her chair. No symptoms since this event (1 week ago).
One week after initial shot, allergic reaction. Injection site has 2? red, dry, itchy spot, with a hard raised bump underneath about 4? in diameter. Spot is hot to the touch.
Case number PHEH2014US022299. is an initial spontaneous report from a pharmacist received on 04 Nov 2014. This report refers to a 16-year-old male patient. Medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 011021A) intramusularly at a dose of 0.5 ml on 01 Nov 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Per patient, broke out in a ?measles like rash?, morbilliform rash from head to toe 4 days after 2nd dose. After several days the rash resolved and pt now presents with pruritus and urticaria like rash. Currently managing topically with steroids
LIGHT-HEADED; This spontaneous report received from a consumer concerned a 21 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced light-headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light-headed was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566.
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/12/2006. Information has been receive from a registered nurse concerning an elementary school-aged child who on 20-JUN-2000 was vaccinated with a dose of VARIVAX (Merck). On 04-MAR-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Rash on arms and back and slightly pruritic, presented to E room for symptoms. Given BENDARYL 25 mg QID x 3 days on 6-19-2010. Told to return if no improvement.
About 3 hrs after injection I started to itch. In about 10 hrs I had a fast heart rate and hives all over my trunk-front and back. I took 2 BENADRYL at 10AM and 2PM. After 24 hrs the hives went away and my heart was at a normal rate. I had an influenza vaccine but I don't know which one it was on your list of flu vaccines.
Fever, chills, sweating beginning 7 hours after vaccination and lasting >24 hours.  Tenderness at injection site.
Received Vx after temp excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 1-day-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In January 2023, the patient received Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. In January 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 : 20 Jan 2023 Reporters comment: The physician reported that 5 patients received Engerix B after a temperature excursion of too cold. All patients were one day old. Two patients were boys, and three were girls. Reporter consented to follow up. Additional supportive information: As patient received Engerix B after a temperature excursion of too cold, which led to incorrect storage of drug. This is 1 of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR009387:Same reporter US-GSK-US2023AMR009449:same reporter - female patient US-GSK-US2023AMR009450:same reporter -  female patient US-GSK-US2023008733:same reporter -  female patient
Localized reddened area, about the size of a quarter accompanied by itching, swelling, pain at site,  and warm to touch. Employee applied ice and continued to monitor site. No additional rashes noted and rash didn't spread any.
24 hours after vaccine had onset of bilateral calf and thigh cramping lasting 3.5 weeks. Severe pain and cramping as well as bilateral knee/joint pain. treatment heat and occasional Motrin. I've had influenza vaccines yearly since 1983 never had a reaction.
Information has been received from a medical assistant referring to a 4 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Reported by Dr. office that patient had 17 x 15 cm raised area on left upper arm. Stated child did not have a temperature or other symptoms. Child was not seen by me with symptoms.
I had a fairly intense period of chills about 12 hours after the injection.  Later in the night, I touched my forehead and clearly had a fever.  By morning, I felt okay - just the slight suggestion of a headache, which cleared after an hour or two.