chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was vaccinated against COVID-19 in March2021 with the Johnson & Johnson vaccine; I was vaccinated against COVID-19 in March 2021 with the Johnson & Johnson vaccine; Within 3 weeks the hair on my head started to fall out/I had significant hair loss; received my booster shot , by Pfizer on 20Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 57 year-old patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (I had zero side effects.), administration date: Mar2021, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "received my booster shot , by Pfizer on 20Dec2021"; OFF LABEL USE (non-serious), outcome "unknown", described as "was vaccinated against COVID-19 in March2021 with the Johnson & Johnson vaccine"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "I was vaccinated against COVID-19 in March 2021 with the Johnson & Johnson vaccine"; ALOPECIA (non-serious), outcome "not recovered", described as "Within 3 weeks the hair on my head started to fall out/I had significant hair loss".  Additional information: Patient was vaccinated against COVID-19 in Mar2021 with the Johnson & Johnson vaccine and had zero side effects. Patient received booster shot , by Pfizer on 20Dec2021. Within 3 weeks the hair on head started to fall out. Upon showering , patient had significant hair loss, and hair loss still continues to this day 09Jan2022. Patient have always had a full & healthy head of hair, whole life, and believes this hair loss is a direct result of the PFIZER booster.  The lot number for bnt162b2 was not provided and will be requested during follow up
Stroke - CVA (cerebral vascular accident) (HCC) on 05/21/2021; 6:00am 10 day Hospital stay, ongoing Rehabilitation / Physical and Occupational Therapy
Vaccine given to 14 year old. Manufacturer approval is for 18 years and over.
Pt recv vax on 3/1/99; on 3/2/99 pt exp fatigue, malaise, sore arm, sweats & vomiting
Information had been received on 19-APR-2017 regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was vaccinated with ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) at a pharmacy on or about 26-JAN-2012 as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. It was reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAY-2014, the patient was treated by her physician at a medical center for a painful rash that was diagnosed as shingles. While shingles is an incurable condition, the patient has been prescribed valacyclovir (VALTREX) to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009595: US-009507513-1704USA009664: US-009507513-1704USA009812:
suspected vaccination failure; contracted Shingles; still hurts of the nerve line it traveled.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   The reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's friend. The age at vaccination was not reported. The reporter got shingles twice, not as bad last time but it was close to one eye. The reporter did not trust Shingles vaccine after the patient contracted shingles from Shingles vaccine. After many years till the time of reporting, it still hurt of the nerve line it travelled. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pt received flu shot at work by Maxim health care nurses in flu shot clinic, no previous h/o problems or reactions to flu shot. Pt notes receives every year, no allergies to eggs.  40 min post injection, started with puritis and urticaria.  Treated in my office.
SkinRash, UrticariaPruritus, Itching to back, legs and abdomen
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, those patients were administered doses of improperly stored doses of GARDASIL 9 lot # M041990, expiration date: 28-JUN-2019 (dosage and route were not reported). No adverse events were reported. Vaccines were stored in the temperature of 47 to 77 degrees Fahrenheit for 18 hours. On 16-AUG-2017 a call was placed to the reporter. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA005591:Original Case : 1707USA005591
Patient reported that she had a hypertensive event a few days following the vaccine. She did not say if the doctors thought it was vaccine related, but reported it happened within a few days of receiving the vaccine.
Sore shoulder for three days-no treatment Bodyaches- for three day-Tylenol, rest, water Headaches- for three day-Tylenol, rest, water Slept all Saturday following, most of Sunday, Some of Monday Insomnia Sunday night about four hours, Monday about two hours. Internal external mouth sores.  Still healing from outside sores Brain Fog.   Took about three weeks for brain fog to go away from first to second shot.  Still have brain fog from second shot which what I am reporting on here.
ASYMPTOMATIC COVID-19; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced asymptomatic covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20210424495.
Information has been received from an approximately 79 year old female consumer with "allergies to a lot of medications" and no pertinent medical history who at the "end of November 2007" was vaccinated with .5ml of zoster vaccine live (Oka/Merck). Concomitant therapy included ZYRTEC and LIDEX cream. It was noted that "almost immediately" after vaccination the patient developed a rash on her arm that was very hot and painful. The rash healed within a few weeks of taking ZYRETEC and using a cream. There were however, 2 other breakouts about 2 months after she recovered, for a total of 3 breakouts. It was also noted that the breakouts had spread all over the patient's body and that the patient had become very nauseous. Unspecified medical attention was sought. The patient had "lab, blood work" and a biopsy performed (results not reported). At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
My heart feels like it is going to blow up for a period of 2+3 minute, started about a few months ago. Once or twice a month now. Feeling tired about 4 times a week although I exercise regularly and never get sick. Have had Covid now twice and now its been about 14 days of fever 4 times, achy joints, nazel cavities extremely clear an burn sometimes. Cannot smell or taste now.  Exhausted when getting up for 20 minutes or more. Joints sore. Feel like crap!
About 5 hours after vaccine, the main side effect was a very severe headache, and it is worse than the COVID-19 headache I had when I had the virus. It is like a ring of fire around the top of my head. It's still ongoing. Today is the first day it hasn't been a severe headache. I have a follow up with PCP tomorrow on 11/05/2021.
Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in a 57-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The HCP stated that 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022.  The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April.  The vial did not undergo any temperature excursions.  Treatment information was not provided.
This is a spontaneous report from a physician/pt, on an unspecified date, received a dose of Lymerix and subsequently, he experienced considerable pain in the shoulder. The most recent information, received on 9/20/99, reports the condition of the pt is unknown.
Saturday after I went to bed, the pain in my arm woke me up, followed by bouts of the chills.  When I got out of bed Sunday morning I didnt notice the swelling right away, just the pain.  Got up to shower around 11am to help with the pain and that's when I noticed the swelling in right armpit, size bigger then a golf ball, pain and discomfort 6/10.  Went to the walk-in immediately as this has never happened to me before.
Patient experienced itching the night of the vaccine and noticed spots of hives on her arms the next morning around 10am. It then proceeded to cause trouble breathing (short breaths) a few hours later. She did not have a fever. She called her primary care doctor who instructed her to take a breathing treatment (nebulized ipratropium/albuterol) and call the doctor if she didn't feel better in a few hours. Condition has since resolved except there are a few spots on her elbow where she scratched.
Received vaccine L upper arm. 2 hours later, experienced pain in left shoulder, radiating to back. Numbness and tingling and weakness of extremity. Numbness and tingling cleared up after 24 hours. Patient still reports discomfort L shoulder and back on day 11.
Patient stated the day she received vax she developed flu like symptoms. Including extreme fatigue, chills, fever-like symptoms. She also stated she had extreme pain in her arm at the injection site. She also had a red, bumpy, very itchy rash. All of these symptoms developed the day of vax and resolved within 3 - 5 days.
Approximately 10 minutes after receiving Hib vaccine, his skin looked mottled and blotchy and he spit up formula 3 times (he never spits up normally).  Approximately 1 1/2 hours later, his breathing sounded like "snorting", he spit up most of a 4 oz. bottle, and his eyes were watery and red, with redness on the skin around the eyes.  He was seen in the Emergency Room approximately 2 hours after vaccination.  he was thoroughly examined and bloodwork was done - all testing was negative.
Admitted with,Acute SARS-CoV-2 Infection with Multifocal Pneumonia and Acute Hypoxemic Respiratory Distress, Adverse Drug Reaction to Regeneron(outpatient  received prior to hosipital admission),IV Solu-Medrol,remdesivir,tocilizumab, supplemental O2
Information has been received from a registered nurse concerning a 19 week old infant who was vaccinated on 19-DEC-2006 with an oral dose of Rotavirus. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
She got her vaccine, her vision is already blurred really bad, and she has to eat several things, cannot eat carbs, eats protein, fruits and vegetables.  She was loosing the light in her eyes which is what happens when she eats breads, crackers, etc.  The darkness started coming in and she was bit confused with this and felt slightly dizzy.  She was thinking about what she ate, and could not figure out what happened and a candy bar will do this, but she did not eat anything.  Then she started having itching in her skin like she was on fire.  She got into a tub of cool water to help her soothe herself.  She did not have any rash, itching in her private areas, her head, her entire body and also in her mouth and lips.  Her eyes were itching, her nose was itching, her ears.  She had some calamine lotion that she put on, and that did nothing.  When she tried herself off from the cool bath she was still itching, and had no sleep for 2 days.  She did not call her doctor and cannot take Benadryl, and had to suffer itself out and deal with it.  She also put hot towels across her skin and also cold ones.  It has eventually subsided and it took about 3-4 days for these symptoms to subside.  She has an appointment to see her PCP tomorrow as she already had an appointment scheduled.  She will never get another one of these vaccines.  She did not have any issues with itching prior to the vaccine.   She does still have some itching, but has improved greatly.
Patient received 3 shots of vaccines.  Boostrix in the left arm, Fluzone Quad and Engerix-B in the right arm.  After the boostrix, patient started to pass out. I checked her pulse.  She was breathing normally and conscious. She was responsive but not fully.  I gave her 10 ml of benadryl (25mg). Patient stayed in the imz booth with a technician for 15 minutes.  Patient relative came and picked her up because she did not fill comfortable to drive home.  Called patient 4 hours later to check on her.  She said she took a nap and was perfectly fine now.
Headache; "Day 1-6 was mildly tired"/ "I was hit with extreme exhaustion"; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the leg left on 30Mar2021 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to food, medications or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), pyridoxine hydrochloride, tocopherol, folic acid, thiamine, nicotinic acid, riboflavin, calcium, selenium, cimicifuga racemose extract, magnolia officinalis, vitamin b12 nos, boron, glycine max extract (ESTROVEN) and linoleic acid (CLA); all from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, "day 1-6, the patient was mildly tired". She was hit with extreme exhaustion and headache started 7 days to day 17 post injection (as reported). She missed work and could not function for half the day. It was an exhaustion she had never experienced before and could not "push" through and overcome. The patient did not receive any treatment for the events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 08Apr2021, the patient underwent lab tests and procedures which included nasal swab test and the result was negative. The clinical outcome of the event "Day 1-6 was mildly tired"/ "I was hit with extreme exhaustion and headache was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected
A non serious spontaneous report of 12 months old receiving H1N1 LAIV was received from a registered nurse/health professional concerning a 12-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 30-Nov-2009, the patient received H1N1, Intranasal, for an unknown indication. 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.
At the time of second Hep A/Hep B vaccine (TWINRIX) pt. had instant heat down her arm that resolved quickly. Then one week later had pain with abduction and warmth x 2 weeks, no erythema, edema, or ecchymosis.
Jun 4 2022: sore throat chest congestion fever June6 2022: tested positive for COVID- symptoms like above plus headache dizziness feeling faint mouth sores and extreme fatigue Began Plaxid on June 7, 2022 Fever gone by June 9 Took three weeks before tested negative and symptoms came and went . Fatigue lingered fever never returned
Breakthrough COVID-19 case requiring hospitalization:  Patient is a 73-year-old male presents with shortness of breath, fevers and chills and myalgias.  Diagnosed with Covid on 11/29, underwent ab infusion outpatient.  Still progressing and came to the emergency department with hypoxia.  Patient was vaccinated in February 2021 but did not get his booster.  He was found to have Covid pneumonia as well as possible concurrent bacterial pneumonia as well as significant hypoxia.  Patient started on supportive care, IV antibiotics, steroids and remdesivir.  He completed a course of antibiotics as well as remdesivir.  He had slow improvement of his oxygen status and was requiring 2 L at time of discharge.  He will discharge on 2 L home oxygen as well as complete a course of steroids.  He is given follow-up for pulmonology.
2/4 booster 2/6 ED: L leg weakness, facial droop (TIA) 2/10 ED: headache/blurred vision (HTN emergency) 2/12 ED: L sided weakness/numbness (TIA) 2/13 ED: L numbness/weakness (Hem stroke) (DEATH)
Dose was given after vial was opened for greater than 12 hours. Was not realized until after dose was administered. Vial was refrigerated.
Body aches, headache, fatigue, chills.  Still present 24-hours after onset.
Information has been received from a registered pharmacist reporting on a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 08-JUN-2017, the patient was scheduled to receive a dose of M-M-R II. However, the patient was administered inadvertently an unspecified dose of VARIVAX lot # M003440, expiration date 20-JAN-2018 (route of administration was not reported) which was reconstitued with diluent MRK (lot # L005461, expiration date 28-OCT-2017). No adverse effects reported. It was unknown if the patient sought medical attention. No product quality complaint was involved.
Leg tremors/spasms for several seconds during sleep followed by extreme leg stiffness. Baby was jittery during sleep & very restless night of vaccine and next two nights. The leg tremors took place following 2 nights following vaccine and then a week later. He had tense muscles during day, with jerking reactions and unusual fussiness. Hypertonia in legs throughout the day for next couple weeks.
Received vaccine at 10:30am 12/17/10. At 4:00pm mom called reporting child did not nap. Was extra fussy, concerned about vaccine reaction. At 6:26pm spoke to on call MD. Reporting fussy, s/p fall w/head trauma. Went to ER at 10pm.
pt states woke up on 11AUG92 & face on rt side won't work; denies any pain, numbness or tingling; visited ER 11AUG92; dx bell's palsy; ER MD unsure of cause; could or could not be related to vax; refered for f/u w/neurologist;
Patient received vaccine and was asked to remain seated in lobby for 15 minutes. He asked if he could go buy a drink and we requested he sit in lobby first. After about 5 minute patient stated he felt dizzy. He was asked to remain seated and yell at staff if he needed help. Pharmacy staff visually monitored him and he spoke up saying he felt faint and dizzy. Pharmacist stood in front of him in his seat incase he fainted so he wouldn't fall down. Store manager called 911. Paramedics arrived about 5 minutes later and took over assessing patient. Patient never lost consciousness or needed CPR. Paramedics took his blood pressure and monitored him for a little while and patient went home.
Patient is 17.5 years old and received the Moderna Vaccine by outside RN staff during drive up clinic. Mother was contact and followed up.
Given MMR dose at 0827 at 0832 pt c/o of lightheadedness/dizziness. Pt hx of Autoimmune anaphylaxis.
Pfizer COVID-19 vaccine EUA on 05/21/2021 and tested positive via nasal swab PCR on 05/29/2021
02/13/23 presents to EC ED for "fatigue" "congestion, sore throat, cough". PMHx of "HTN, renal transplant 7/13/2022"
a 65 years old female patient received a 0.5 ml dose of Fluzone High Dose on 03oct2019 which was already expired on 05Jun2019/No AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (Office Staff).  This case involves a 66 years old female patient received a 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] on 03-Oct-2019 which was already expired on 05-Jun-2019 lot UJ051AB via intramuscular route in the left deltoid.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of report 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.