chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my son received the Meningitis vaccine and the Meningococcal B vaccine, he all of the sudden started feeling very ill.  He had to run out of the restaurant, where we were having lunch, and vomited several times.  He then came back in and sat down and was on the verge of tears saying his head hurt terribly.  After several hours, it finally passed, but it was quit frightening.  That didn't happen with my daughter who received the Meningitis vaccine but didn't receive the Meningococcal B vaccine.  I wasn't sure if there have been other reactions to the Meningococcal B Vaccine since I understand it's fairly new.
About one week after the injection,  my arm developed a red  patch, about 3 inches long by 1-1/2 inches wide. The patch is itchy and feels slightly hard.  There are also several bumps or pimple- like spots.
Injection site is warm, reddish coloured and somewhat sore, ice packs are recommended, TYLENOL & BENADRYL too.
Rapid heartbeat; Dizziness; Injection site red, sore and swollen at injection site; Injection site red, sore and swollen at injection site; Injection site red, sore and swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Injection site red, sore and swollen at injection site), VACCINATION SITE PAIN (Injection site red, sore and swollen at injection site) and VACCINATION SITE SWELLING (Injection site red, sore and swollen at injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.  The patient's past medical history included Dizziness.  In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Injection site red, sore and swollen at injection site), VACCINATION SITE PAIN (Injection site red, sore and swollen at injection site) and VACCINATION SITE SWELLING (Injection site red, sore and swollen at injection site). At the time of the report, HEART RATE INCREASED (Rapid heartbeat), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Injection site red, sore and swollen at injection site), VACCINATION SITE PAIN (Injection site red, sore and swollen at injection site) and VACCINATION SITE SWELLING (Injection site red, sore and swollen at injection site) outcome was unknown.     Concomitant medication was not provided. Treatment medications were not provided.  Action taken with mRNA-1273 in response to the event was not applicable  Reporter did not allow further contact
Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 14 patients who was inadvertently vaccinated with a dose of expired FLUZONE QUADRIVALENT (Batch number: OI044621A, expiration date: 30-Jun-2018, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used (nurse inadvertently gave 14 adult patients expired Flu vaccine). It was unknown whether patient experienced any adverse event following vaccination. 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.
11/19 1/2 hour after injection pt felt dizzy, ate, went 8:30 home and laid down. At 3:30 am woke up with rash on abdomen and back - red pin point - now resolved.
covid test and it came back on 22Feb2021 as positive; What I understood is that if you had Covid, you are not supposed to be on the vaccine for 70 days. I cannot have it 90 days or something around that time after having a positive Covid test; This is a spontaneous report from a contactable consumer. A 46-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EM9809) via an unspecified route of administration on 12Feb2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested covid and it came back on 22feb2021 as positive. Patient thought that she is not supposed to be on the vaccine for 70 days. She cannot have it 90 days or something around that time after having a positive Covid test. The patient underwent lab tests and procedures which included Nasal swab test positive on 22Feb2021. Her second shot scheduled on 05Mar2021. The outcome of the events was unknown.
Pt vax 3 doses;  showed neg titer 3 months after 3rd dose.  4th dose was given 12Dec90.  Titer 2 months later was still neg.
Received H1N1 vaccine on 1/25/10 at school. Later had onset chest tightness & hoarse voice. Using albuterol & seen at hospital 1/26/10.
Mother reports child started running 104 fever night of injections and has run fever since injections and broke out in a rash on morning of 06/22/2010. Giving child Tylenol and Motrin along with tepid baths to bring down fever. Called health department and instructed to take child to MD for evaluation.
Soreness in area of shot, then down whole left arm. Within 12 hours I could not lift my arm or grasp anything without intense pain in my arm. The whole left side of my body ached. I applied heat and ice alternately to area of shot. (There was no redness or heat at site.)  Inability to lift my arm without intense pain lasted for three days, full range of motion did not return for 6 days.
About 6 hours post injection felt a couple incidents of tachycardia and notable arythmia.Had been symptom free for 8 months.within 3 weeks,resting pulse of 135 plus was the norm.Despite my history,it seemed that something triggered it.Covering my bases.
Ulcerative colitis flare up a week after COVID19 vaccine.  Was in remission for 10 years.
Have had shingles and the vaccine / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have had shingles and the vaccine / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the shingles was in the same virus family as chickenpox. The patient stated that shingles was still bothered him/her. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
experienced joint pain 2 weeks after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single and second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single both the doses for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The Physician said he experienced joint pain 2 weeks after receiving the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if that was normal and how long the side effects usually last and also wanted to know Pfizer's recommendations on how to treat these side effects. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
At 9PM on 9/30/21, Aprox. 4 hours after my 3rd dose, I got serious heart palpitations and shortness of breath, and elevated heart rate which I was put into the emergency room for. I was given a EKG, chest X-ray, blood tests, and continuous heart monitoring. Afterwards we ruled out other things like heart attack, and was sent home with a referral to get a heart monitor put on. I am currently wearing the monitor at the time of submitting this, but I am still having heart palpitations just not as frequent as the night of the vaccine.
Numbness and tingling in fingers and toes, sore neck, whole body aches. Suspicion for Guillain-Barre Syndrome.
red swollen hives on neck started on Sunday evening, October 10 and have continued into Monday morning October 11
pain at previous surgery sites (2 shoulder surgeries for torn bicep); cold; hot flashes; joint pain; headache; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), HOT FLUSH (hot flashes), ARTHRALGIA (joint pain), HEADACHE (headache) and ARTHRALGIA (pain at previous surgery sites (2 shoulder surgeries for torn bicep)) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 209F232A) for COVID-19 prophylaxis.     The patient's past medical history included Torn muscle (torn bicep) and Surgery (2 shoulder surgeries for torn bicep).    On 10-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 10-Nov-2023, the patient experienced NASOPHARYNGITIS (cold), HOT FLUSH (hot flashes), ARTHRALGIA (joint pain) and HEADACHE (headache). On an unknown date, the patient experienced ARTHRALGIA (pain at previous surgery sites (2 shoulder surgeries for torn bicep)). On 12-Nov-2023, NASOPHARYNGITIS (cold), HOT FLUSH (hot flashes), ARTHRALGIA (joint pain) and HEADACHE (headache) had resolved. At the time of the report, ARTHRALGIA (pain at previous surgery sites (2 shoulder surgeries for torn bicep)) outcome was unknown.      Concomitant and treatment medications were not reported.
(1) tiny bump noticed on 7/3/15-it scabbed on 7/5/15. More bumps developed on upper, then lower back on 7/4/15 and 2 more bumps on abdomen on 7/5/15 and one below nose on 7/6/15. Felt warm-on and off and has been sleeping more.
Right armpit discomfort (lymph node?) about 3 weeks after vaccine.  5/18/2021 - mammogram showed focal asymmetry in left breast
Information has been received from a registered nurse concerning a 6-year-old female with no pre-existing allergies, birth defects or medical conditions, who on 08-JUL-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 02-JUL-2007, the patient developed over 50 lesions and had a temperature of 99-100 degrees. The mom was treating with Tylenol. The mother called the office and stated that the "brother had chickenpox 2 weeks ago." No laboratory or diagnostic tests were performed. No medical attention was sought. On 09-JUL-2007 the patient recovered. The R.N. also reported that four of the patient's siblings developed chickenpox following varicella virus vaccine live (Oka/Merck) administration (WAES numbers: 0706USA04088, WAES0707USA01591, 0707USA01593, 0707USA01595). This is one of several reports from the same reporter.
Pt. presented 24 hours after vaccination with faint rash on face and back. Treated with hydroxyzine 10 mg/5ml - 1/2 tsp 98 hours PRN.
pt brought to ED via EMS for increasing SOB, weakness after being diagnosed with COVID t days earlier; hypoxic respiratory failure; O2 sats in ED 50%; placed on NRB and O2 sats went up to 70%; placed on Vapotherm 35L; given dexamethasone, remdesivir, vitamins C & D, zinc; pt's condition worsened requiring intubation; off sedation but still unresponsive; head CT showed right CVA and developing left CVA; DNR; comfort measures; pt experienced asystole and never recovered
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to an 8-months old female patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J004875, expiration date 17-OCT-2014) on 15-JAN-2014 in the afternoon. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The parents of the patient were going to consult with physician and declined to repeat the dose. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
PATIENT IS A 27 YEAR OLD, 35 WEEKS PREGNANT, FEMALE. PATIENT RECEIVED A MODERNA 0.5 ML VACCINE TO HER RIGHT DELTOID @ 11:55 A.M. WITHIN 5 MINUTES OF RECEIVING THIS INJECTION, PATIENT COMPLAINED OF NEW ONSET CHEST PAIN. PATIENT STATED SHE HAD NOT EATEN ANYTHING PRIOR TO RECEIVING THE VACCINE. PATIENT'S VITAL SIGNS WERE ALL NORMAL BP 130/72, PULSE 83, RR 16. PATIENT DENIED SOB. EMS WAS CALLED AND TRANSPORTED PATIENT TO ER. AT DISCHARGE, PATIENT WAS A&oX4, WALKING, TALKING, NO ISSUES.
within an hour after injection his head felt tingling then his wrist started itching ,as the day progressed he had welts develop and had severe itching over his body. this continued for 2 days when the itching and welts gradually faded
I did get a sore and swollen arm when I got the vaccine. I started getting symptoms of sore throat. The next day my throat was sore and scratchy. The third day I had headaches, low grade fever, soreness, tiredness, and nasal congestion. I had a COVID-19 test done on 4/27/2022 which was positive.  I did a telehealth visit and received a prescription for Paxlovid. After I started taking Paxlovid, I lost sense of taste except for a bitter taste. I now feel like I have shortness of breath, headache, and congestion. My headaches are worse in the evening time.
Patient saw the doctor on 7-12-20 and was given a steroid cream for rash covering his body from neck to legs
pt recv 3 doses of vax,was pos surface antigen core,Hep B E antibody & low pos for Hep B surface antibody at "about 2 wk p/ 3rd inject;still pos everywhere else x/ surface antibody;
Chills/Shivering/Shaking; Felt bad; nausea; Flu like symptoms; After the injection, it "knocked him for a loop"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (After the injection, it "knocked him for a loop"), CHILLS (Chills/Shivering/Shaking), NAUSEA (nausea) and MALAISE (Felt bad) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Benign prostatic hyperplasia and Food allergy. Concomitant products included ATENOLOL, FAMOTIDINE (PEPCID [FAMOTIDINE]), OLMESARTAN MEDOXOMIL (BENICAR), TAMSULOSIN, FINASTERIDE, MIRTAZAPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FISH OIL for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION COMPLICATION (After the injection, it "knocked him for a loop"). On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and NAUSEA (nausea). On 26-Feb-2021, the patient experienced CHILLS (Chills/Shivering/Shaking) and MALAISE (Felt bad). On 25-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (After the injection, it "knocked him for a loop") and NAUSEA (nausea) had resolved. At the time of the report, CHILLS (Chills/Shivering/Shaking) and MALAISE (Felt bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.   Reporter did not allow further contact
patient unsure of exact date of when symptoms started spot is still red, was able to reach out to PCP who adv warm wet compresses. Onset of symptoms was a few days post injection, reports no symptom relief and area just get progressively worse and worse. Has been using also hydrocortisone cream at home. Adv would be a good idea to have someone look at the area in person given progressive worsening of the area with no relief, want to r/o soft tissue infection and also generally make sure the area heals up properly. Can go to PCP, urgent care, or walk in clinic as desired. Call back if issues, S?, concerns. Will close.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 16-JUN-2016, the patient was vaccinated with improperly stored dose of M-M-R II 0.5 ml injection, lot # L026553, expiration date: 16-JUL-2017 (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by the boyfriend of a consumer and described the occurrence of upper respiratory symptoms in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In the late morning on 9 June 2010 the subject received 1st dose of TWINRIX at 1.0 ml. About 3 to 5 days after vaccination (around 12 June 2010) the subject experienced a bad upper respiratory infection with profuse nasal discharge and other symptoms typical of upper respiratory infection. Profuse rhinitis was also reported with onset of 13 June 2010. All symptoms reported to have cleared within 7 to 10 days. The subject received a 2nd dose of TWINRIX on 14 July 2010 and within 3 to 5 days (around 17 July 2010) experienced the exact same upper respiratory symptoms that followed the 1st dose including upper respiratory infection with profuse nasal discharge and other respiratory symptoms of upper respiratory infection. These events went away after 7 to 10 days. In late October 2010 and early November 2010, the subject caught a bad cold after a long plane ride. It was reported to be the subject's worst cold since childhood. At the time of reporting the outcome of the events was unspecified. Similar events occurred with the subject's boyfriend (the reporter) following administration of TWINRIX. For details regarding this case, refer to case number A0985300A.
PATIENT RECEIVED VACCINE, AFTER ABOUT 25MINUTES SHE STARTED DEVELOPING SYMPTOMS SUCH AS LEG CRAMPING, EYE SWELLING AND EYE ITCHING SIMILAR TO MAST CELL ACTIVATION FLARES SHE HAS HAD IN THE PAST.  SHE DENIED ANY LIP, TONGUE OR THROAT SWELLING AND DENIES ANY WHEEZING OR TROUBLE BREATHING, SHE ALSO DENIES ANY ABDOMINAL PAIN, VOMITING OR DIARRHEA.
She said her son is feeling very weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "She said her son is feeling very weak".  additional information: Consumer stated her 9-year-old son, and 5-year-old daughter received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine at 10 AM. She said her son was feeling very weak. She wants to know what she should give her child to treat the symptoms.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider(s) recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In SEPTEMBER 2012, a healthcare provider, at a clinic, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 19-APR-2013, the patient was treated by a healthcare provider at a clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
Pt. called back 3 days after receiving a flu shot stating a 1 1/2" x 2" red area surrounding injection area. Pt. unconcerned I suggested informing MD. She stated she would, MD told pt. to use BENADRYL. Called pt. back - BENADRYL solved problem.