chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body achy; arm is killing me; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles twice mild cases).   On 15th September 2021, the patient received the 1st dose of Shingles vaccine. On 15th September 2021, less than a day after receiving Shingles vaccine, the patient experienced general body pain. In September 2021, the patient experienced pain in arm. On an unknown date, the outcome of the general body pain was unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine 4 days ago and his/her arm was still killing, body achy the first night. The patient cannot wait for the second shot. The follow up would not be possible as no contact details were available.
Patient called the next day 3/18 stating the injection site was red, swollen and warm. She was told to take TYLENOL for any pain and to ice the area. She came in on 3/21 and said it was getting better.
Reporting administration error as per Agency.  We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised that the expiration dates were deemed viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to obtained expiration dates directly from them.  No adverse reactions were reported from the patient at the time of vaccination. No adverse reactions were reported since the administration of vaccination.
This solicited report was received from a physician referring to a 65 years old female patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2010, the patient was vaccinated with her first dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in May 2016, the patient went down with "mild case" of shingles that last approximately 3 days after receiving ZOSTAVAX . The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 66 years old male patient with chronic lymphocytic leukaemia. He received 2 courses of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with rituximab.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 19. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 6. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Sender's Comments:  US-009507513-2103USA003406:
High blood pressure, lots of shaking, sugars dropping drastically, tingling and numbness in arms and legs, headaches, exhaustion. Went to hospital 2 times but they didn't give anything and told me to see my doctor. I'm scheduled to see my doctor on July 1.
Moderate unilateral throat pain on side vaccinations recieved. Appeared with 24 hours of injection, resolved within 7 days. Treated with ibuprofen with minimal relief
Swelling, redness, itching, tender to the touch- used Benadryl cream
Only administered the diluent portion; Only administered the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 4C493, expiry date 20th March 2023) for prophylaxis.   On 2nd September 2021, the patient received Shingrix. On 2nd September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: Medical Assistant reported that female patient was vaccinated with the Shingrix vaccine but they only administered the diluent portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Health care professional (HCP) declined Medical Information when offered, as HCP reported they had already revaccinated the patient and they just want to get a replacement for the vial. The reporter consented to follow up.
Pt to ED 5/3 for cough and shortness of breath since yesterday, also fever and chills. COVID+ upon arrival 5/3, Bebtelovimab infusion ordered, started on dexamethasone and breathing treatments. No c/o any pain or shortness of breath.  O2 in place via nc at 4L. 5/4 pt is AxOx4, very pleasant. Denies SOB or any discomfort, no new complaints noted; stable; no acute cardiac issues noted. 5/5 no apparent distress noted, Orders to administer one time dose of hydralazine. Pt discharged 5/5.
On June 2, 1999 the pt experienced a varicella rash with 8-10 spots on the stomach and chest, 4-5 spots on the arms, and 2-4 on the legs. The spots appeared like bites. There were also two spots near the injection site.
June 30, 2021 hospitalized with elevated troponin, life-flighted to HCF, diagnosed with myocarditis on July 7, 2021.   Was seen in the emergency room in March for the same symptoms as she was hospitalized for in June. At that time, the ED provider thought she just had a terrible case of gastroenteritis and did not run any heart-related labs. Based on the symptoms, we suspect it may have been an undiagnosed case of myocarditis.  Latest cardiac MRI on Oct 11, 2021 shows improvement in myocarditis but not yet complete resolution. Also shows late gadolinium enhancement which may indicate an irregular heart rhythm.  Orders placed for a stress test.  I am Pts mom. I am not a provider, but I am an executive for a HCF. I am reporting on the advice of our medical director because of the continued problems with her heart. That may be an indicator that the March event was also a heart event.
This case was reported by a consumer and described the occurrence of supraventricular tachycardia in a 64-year-old female subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history included allergy to ibuprofen, allergy to vicodin, aspirin allergy, asthma, chronic obstructive pulmonary disease and sulf allergy. Concurrent medications included Salbutamol sulphate (Albuterol), Fluticasone propionate+salmeterol xinafoate (Advair) and Tiotropium (Spiriva). On 13 October 2007 at 13:15 the subject received 1st dose of Fluarix (.5 ml, left arm). On 13 October 2007, less than one day after vaccination with Fluarix, the subject experienced shivering, chills, body aches and muscle aches. On 14 October 2007, the subject experienced nausea. On 16 October 2007, the subject experienced supraventricular tachycardia and wheezing. The subject presented to the emergency room on 16 October 2007, 17October 2007 and 18October 2007. She was taken by ambulance to the hospital on 19 October 2007 and hospitalized in the intensive care unit. Treatment was not specified. She was discharged home on 24 October 2007. The subject considered that the events were jeopardizing or required intervention to prevent a serious outcome. At the time of reporting the outcome of the wheezing, supraventricular tachycardia, shivering and chills had resolved. The outcome of the other events were unspecified.
Daughter became very dizzy and clammy about 10 minutes after taking Gardasil Shot.  Felt nauseous and had to lie down.
pale red/pink raised rash that started in shape of C around the injection site (still noticeable due to bruise still healing) and small spot below site red that started to itch after about 2 hours.  rash has spread somewhat as well down arm today with another spot also itching and some small hives - rash has just begun today is 2nd day  used hydrocortisone cream yesterday and due to spreading  w second area took Benadryl today w hydrocortisone cream continued.
POSITIVE FOR COVID-19; This spontaneous report received from a patient via a company representative concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 03-JAN-2022, the patient experienced positive for covid-19. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of positive for covid-19 was not reported. This report was non-serious.  The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria, due to no PQC identified) based on the PQC evaluation/investigation performed.
Patient complaining of itchiness on immunization starting the same evening as vaccine administered. On 4/24/2019 patient had large urticaria on left arm.
Fever of 102°F; This is a spontaneous report from a contactable consumer (parent). A 15-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. After taking 2nd dose of vaccine, the patient experienced fever of 102°F in 2021. The patient underwent lab tests included body temperature: 102°F in 2021. The outcome of event was unknown.  Information on the lot/ batch number has been requested.
I did not have an adverse reaction to the vaccine. I had a holiday with my family and friends without any problems. After a camping trip with my family in July 2022, I tested positive for COVID-19 on 07/30/2022. I contacted my doctor's office in an email and in database. I had difficulty breathing and congestion. I did not receive a prescription, but I took over the counter medication.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with expired ROTATEQ (lot # 668825/0525AA, expiration date 09-JUL-2012) on 19-JUL-2012 (as the first dose). No adverse event reported. It was unspecified whether the patient had sought medical attention. Additional information has been requested.
Local site reactions: Pain-discomfort, itching, General symptoms: chills, fever, headaches, joint pains. Narrative:
Pain in his right testicles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 16:00 (Lot number: FE3592) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergies to trees and dust mites" (unspecified if ongoing); "Allergies to trees and dust mites" (unspecified if ongoing); "Lyme disease" (ongoing), notes: Has ongoing issues with Lyme disease. There were no concomitant medications. Vaccination history included: Bnt162b2 (His first dose was on 28Aug2021, with lot number FC3182, in his Left arm.), administration date: 28Aug2021, when the patient was 51 years old, for covid-19 immunization. The following information was reported: TESTICULAR PAIN (non-serious) with onset 19Sep2021 23:00, outcome "not recovered", described as "Pain in his right testicles".  Additional information: Caller just had the second Pfizer COVID Comirnaty shot yesterday around 4 pm. Since then he has had a lot of pain in his right testicle. He did not have a prescribing doctor. He just got it at pharmacy. He got his second shot yesterday at 4 o'clock. He has not went to the doctor or ER. He called the doctor's office and talked to the nurse. The doctor is supposed to contact him tomorrow. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No relevant tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI).  No follow-up attempts are possible. No further information is expected.
Patient received pneumococcal vaccine, lot# 0877R, right deltoid in clinic 12/20/05. Called office 12/22/05 to report right deltoid pain, itching, redness, swelling at injection site, et syncope on 12/20/05. Advised to go to ER. 12/23/05 notified patient at ER with fever 103, severe body myalgias, HA, suspects meningitis. Work up for meningitis was negative. WBC 20,000. Patient was discharged 12/27/05.
Description: concerned with left arm swelling within 24 hrs post AVA #3 on 11 Jul 07. With AVA #1 in Dec 05 he reported the normal burning, felt light headed for 14 hrs, denied swelling or redness. With AVA #2 on 22 Jun 07 he reported joint pain in wrist and elbow for 10 days without swelling and all symptoms fully resolved before AVA #3. With his third shot he reported that the area was itchy and warm. He stated that his wrist, elbow and shoulder joints of his left arm were stiff, and that his biceps felt tight. He stated that the swelling did spread below elbow but improved after a couple of days. He denied fever and headache and did not seek medical attention.
Day after my first shot, my arm was sore. My arm hurt for days after with intensity; I had a significant headache where I took migraine over the counter medicine the day after. The headache was gone the second day after; This is a spontaneous report from a contactable other hcp. A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Dec2020 19:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included covid-19. The patient's concomitant medications were not reported.  After my first shot, my arm was sore. I had a significant headache where I took migraine over the counter medicine the day after. The headache was gone the second day after. My arm hurt for days after with intensity decreasing. I did not have any effects after the second shot. Outcome of events was recovered. Case was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Patient hospitalized for COVID-19 pneumonia after COVID-19 vaccination. Received remdesivir and steroids and discharged to home medically stable.
I will describe all my symptoms in order, but the one that concerns me that is making my file this reports is chest pain.  Received vaccine Thursday am, had normal expected reactions Friday - tired, sore arm, muscle ache, dizzy.  Saturday I woke up and my heart hurt.  Latterly feels like it was sore and tight.  Most of my other symptoms' resolved except still dizzy and my stomach started to ache.  Sunday my chest felt better, but stomach still ached so bad it affected my appetite.  Mon and Tues I was miserable with a headache, nausea and dizziness.  Wed these symptoms resolved except for dizziness, but my heart hurt badly again.  Went to the doctor.  had a normal EKG and bloodwork.  Doc discussed endocarditis with me as possibility, but hard to diagnose without further tests. Further tests would not change treatment and were expensive, so did not pursue them.  My heart has not felt normal since - hurts, beats harder than it usually does with exercise.  Has resolved some over last few days.  Stil have bouts of dizziness  My first covid vaccines were Pfizer.  Booster that caused this episode was Moderna.
Patient said that she required hospitalization after receiving the shingles shot.  She began experiencing fever, a-fib, and trouble walking and went to the ER and was hospitalized.
Aching body joints and muscles starting about 12-15 hours after injection. 2nd day following injection presented swelling and tenderness of lymph node in left armpit (vaccinated arm.)
Redness at Injection site; Swelling at injection site, big and more pronounced than usual; injection site hot to touch; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 6-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 9249L, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. In September 2022, less than a week after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   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: 28-SEP-2022 Reporter's comment: GlaxoSmithKline field representative called GlaxoSmithKline to report an adverse event from an HCP office. HCP reported there was redness and swelling at the injection site. HCP reported the area was big and more pronounced than usual. HCP reported the injection site was hot to touch. Consented to follow up.
Pt had a firm swelling/bump at injection site. At this time there is no erythema, flu chance or pain. Pt in no apparent distress.
redness; pain; This is a spontaneous report from a contactable nurse via Pfizer-sponsored program. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced redness and pain after getting the vaccine and asking if they can use Benadryl. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
MMR used (off label) intralesional to respiratory papilloma (in larynx). The patient had been on Dapsone for years bid not disclose this until he developed haemolytic anaemia.  The Patient is a 66 year old man with a long history of dermatitis herpetiformis (DH). He has used Dapsone for 52 years with not problems. About 3.5 weeks ago he received injections with "vials of MMR vaccine". He then noted increasing fatigue, Shortness of breath, joint pains and generalized weakness. He turned yellow and went to the Ed where a significant drop in Hgb was noted (Baseline 15-16>6) Dapsone was discontinued and he was transfused with 2U PRBC (one on each of 6/7 and 6/08/06). Prednisone 80 mg daily was started for DH flare and he was advised to pursue a gluten free diet. Multiple radiographic studies and an MRI only revealed a distended bladder. There was no blood in his stool. Follow up Hgb from 06/13/06 was 11.5. Patient resumed Dapsone with 100 mg on 06/13/06 and 50 mg on 06/14/06 with rapid relief of DH symptoms. He decreased the prednisone to 40 mg with the intent to continue a rapid taper. He will follow-up with serial CBC's with is hematologist and was advised to pursue upper GI endoscopy and biopsy. This even seems unlikely to be secondary to Dapsone. Re-introduction of Dapsone is ongoing. The possibility of MMR related serum-sickness should be considered.
Expired booster dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired booster dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Reporter stated that the vial was initially stored in the refrigerator on 23-Mar-2022. And the vial did not undergo any temperature excursions. No treatment information was provided.
difficulty breathing chest pain-unable to comfortably lie down swelling of my face and throat fast heartbeat red face bloodshot and swollen left eye-felt something irritating in left eye insomnia-that night only injection site pain tiredness  headache chills and hot flashes joint pain nausea dizzy mental confusion After about 20 hours post shot and one I took some allergy medication I started to improve, it took a full week to feel normal.