chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of stomach pain in a 5-year-old male patient who received FLULAVAL QUADRIVALENT (batch number Y7985 ?, expiry date 30th June 2019. GSK note: the reported batch number did not match with any GSK batch number. Clarification has been requested) for prophylaxis. Previously administered products included FLUARIX, FLUZONE and FLUMIST. On 26th September 2018, the patient received FLULAVAL QUADRIVALENT. On 26th September 2018, several minutes after receiving FLULAVAL QUADRIVALENT, the patient experienced stomach pain, pale skin, sweating, vomiting, nausea and fatigue. The patient also experienced low blood pressure and hard to awaken. On an unknown date, the outcome of the stomach pain, pale skin, hard to awaken, sweating, vomiting, low blood pressure, nausea and fatigue were unknown. It was unknown if the reporter considered the stomach pain, pale skin, hard to awaken, sweating, vomiting, low blood pressure, nausea and fatigue to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT on left arm. The healthcare professional stated that the patient received FLULAVAL and minutes later experienced stomach pain, nausea, pale skin, fatigue, and severe sweating. The healthcare professional provided patient with soda water and after taking a sip patient vomited but was a foamy vomit. Less than a day, after receiving FLULAVAL QUADRIVALENT, the patient had a hard time staying awake and when they checked his blood pressure, it was lower than what it was when he first came for the appointment. The patient has received other flu vaccines (FLUARIX, FLUZONE, and FLUMIST) in the past but never had FLULAVAL before. The patient was taken to the hospital by ambulance but they are unsure if the adverse events were cause from the vaccine.
My mother received the vaccine on 4/17/21.  The following day she was bedridden.  Her condition did not improve over the next two days.  My wife and I were out of town and I was maintaining phone contact with her every few hours to monitor how she was feeling.  She expected she would feel bad for a few days...  On 4/21/21 she appeared to feel better in the morning when we spoke and she advised me she was going shopping with a friend.  Around 2pm on 4/21/21 I received a phone call from her friend advising she was taking my mother to the emergency room at the local hospital.  My mother was unable to answer basic questions and we believed she was suffering from a stroke.  The following day when I arrived back in the area I spoke to the neurologist on call who confirmed my mother did have a minor stroke but that it was in an area of her brain that should not effect cognitive functioning.  My mother was given a CT scan, brain MRI, spinal tap and an echocardiogram.  All of these tests came back "normal".    My mother is still in the hospital and has shown no improvement.  She is agitated and confused.  She asks the same questions over and over again.  The neurologist has advised that they have no explanation as to why she is experiencing these symptoms.  The only thing that changed was her receiving the covid vaccine.
Started within 1 hour of vaccine (pt. Has history of delayed anaphylactic reactions) with severe diarrhea, abdominal pain, nausea, tachycardia, tingling in back of throat and cough.  Called the on-call physician with the clinic where the vaccine was received. Was instructed to take an extra Zyrtec/take bedtime dose early. Progressed (aver an hour) to worsening cough, body itching, chest redness, SOB (83% O2 saturation?taken @ home), chest pain. Used EpiPen auto-injector and went to the ER. Due to ER being over capacity had to wait in the waiting room for a while. An EKG was obtained and results were abnormal. Was treated/observed in the ED and then discharged home.   Symptoms of chest pain, heart palpitations and SOB with exertion in addition to low-grade fever are still unresolved (as of 9/26/2021). Allergic reactions completely resolved over a period of 48 hours.
fever bone; fever bone; back pain; headache; general discomfort; body aching; cough; This is a spontaneous report from a contactable consumer (parent). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization (at the age of 13-year-old). The patient's medical history and concomitant medications were not reported. The patient was fine but on Monday on an unspecified date patient experienced fever bone, back pain, headache, general discomfort, body aching and on Tuesday started with cough. Caller wanted to know if these might be side effects of the vaccine. Patient received Tylenol, vitamins and fluids. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Husband called and reported that about 2-3 days after wife received 1st dose of Pfizer vaccine, he noticed that she was having trouble with his vision (seeing colors, shapes, etc.)
Following my first dose of the vaccine, I started having very heavy bleeding on my menstrual cycle each time. I used to only have light bleeding for 3-4 days, and now I bleed heavily for an entire week every time. I made no other dietary or medical changes and had the same light bleeding prior to the vaccination for my whole adult life whether on or off birth control, no matter which birth control I'm on. It's now painful and affects my ability to work out/go to work, etc. I've talked to other women my age who have experienced similar symptoms. I don't think the vaccine was worth this consequence at all. I'm worried that it impacted my fertility as well.
My first dose it was during my baby conception, I didn?t know that. The second dose I felt tired and very sick. After that I discovered that I was pregnant. During my pregnancy I had headache every day for almost 4 months and I also throwed up almost everyday.  Between my 3 to 4 months we discovered evidence of Down syndrome. On 14 to 15 weeks we had the confirmation.  I am afraid that the vaccine applied during the conception might be related to this event.
Sick for 2 days following 2nd vaccine-chills-fever-achy 4/23/21-Called for RX for cold sore-4/19-23/2021 flu like symptoms returned.May 1st Noticed tingly numbness in fingers & toes-Hot flashes & sharp pain in left big toe. May 7th-Vertigo while driving-Very Scary-never had vertigo ever before. Dizziness continued-went ER 6/07/2021 due to numbness & Unbalanced feeling.CT scan was clear but advised to see a neurologist! Had a physical with Dr. on 6/17/2021 & discussed issues -She also suggested for me to see a neurologist as symptoms seemed to be getting worse-Very difficult to feel confident driving. 06/25/2021 saw Dr. at the clinic-He suggested PT Had neck x-rays 06/30/2021 & PT 07/7-07/12/2021 Symptoms continued.07/14/2021 Had EMG & needle test at clinic-Continued with PT. 07/23/2021 had MRI of brain-Results normal.Symptoms continued.Had biopsy done & was diagnosed with small fiber neuropathy on 08/11/2021. Symptoms continue off & on to date.
Patient states she had a golf ball sized, slightly raised red area where injection was given. Lasted one week. Also C/O cough and fatigue. About pt also on Coumadin, states that since being on Coumadin, has not been able to tolerate eggs, usually gets diarrhea. Started Coumadin 1997. Received yrly flu shot since 2000.
tired more than normal/tired couple of days after each vaccination; sore arm-vaccination site; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm-vaccination site) and FATIGUE (tired more than normal/tired couple of days after each vaccination) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013220A) for COVID-19 vaccination.     No medical history was reported by the reporter.  The patient's past medical history included No adverse event. Concomitant products included DICLOFENAC and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm-vaccination site). On 17-Jan-2021, the patient experienced FATIGUE (tired more than normal/tired couple of days after each vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm-vaccination site) and FATIGUE (tired more than normal/tired couple of days after each vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090559 (Patient Link).
patient was given an expired Adacel; Initial information received on 26-Jun-2019 regarding an unsolicited valid non-serious case received from Other health care professional (pharmacist intern).   This case involves a 42 years old male patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history and family history were not provided.  The patients did not receive any concomitant medication.  On 26-Jun-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5563AA, expiry date 28-Feb-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to expired vaccine used.  It was reported that patient was given an expired Adacel.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Pt was due for Pfizer monovalent 2nd dose. I accidentally ended up administering Bivalent booster dose. No treatment, outcomes, or symptoms during the time of event.
05/13/2006 went to emergency room with high fever, dehydration.  Given fluids, random bumps on back.  Seen by medical doctor on 05/15/2006 a rash. Diagnosed with questionable reaction to vaccine versus viral.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned multiple (two) patients. 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 had suspected immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210551575 and 20210550960.; Sender's Comments: V0: 20210551477-Covid-19 vaccine ad26.cov2.s-Suspected immunological vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
vaccine was injected below the deltoid muscle, in the middle of the biceps and not on the deltoid muscle; A spontaneous report was received from a consumer concerning a 39 Year old male patient, of unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, vaccine was injected below the deltoid muscle(inappropriate route of vaccination).  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 27 Mar 2021 , prior to the onset of the events, the patient received his first of the two planned vaccine doses of mRNA-1273 (Lot number: 017B21A)  via intramuscular route into middle of his biceps for prophylaxis of COVID-19 infection .  On 27 Mar 2021, after receiving the first shot of Moderna vaccine at 8: 30 in the morning, the patient's wife was asking if patient needs to be revaccinated since the vaccine was injected in the middle of biceps and not on deltoid muscle.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event vaccine was injected in the middle of biceps and not on deltoid muscle was considered as resolved.; Reporter's Comments: This report refers to a case of Inappropriate route of Vaccination, for mRNA-1273, lot #:  017B21A, with no associated AEs.
GUILLAIN-BARRE SYNDROME; This spontaneous report was received from a consumer (bother-in-law of the patient) and concerned a male patient in his 60's of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's past medical history was not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration unknown, batch number unknown), dose, vaccination site, and vaccination date not reported, once in total, for prophylactic vaccination. Batch number was not reported. Company will conduct follow up to obtain batch number. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre syndrome. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of Guillain-Barre syndrome was not reported. This report was serious (other medically important condition).; Sender's Comments: V0: This spontaneous report received from the brother-in-law of the patient concerns a male in his 7th decade of life who experienced Guillain-Barre Syndrome an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, clinical symptoms, diagnostic testing, corrective treatment, and outcome were not reported. The relationship of the event to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested.
I was extremely fatigued. I could barely move throughout the house for about a week. It got better as the week progressed. I also had a headache and very little arm pain. I only felt the arm pain when I took a shower. I was so tired as well. When I went to the doctor they said I have an ear infection. My blood pressure has also been sporadic up and down. I have headaches all the time. I was prescribed Neomycin-Polymyxin-Hydrocortisone Otic 3.5 10,000-1 Sol Sand 2 drops into left ear 2xdaily. I still have shooting pain in my left ear.
Low grade fever & body aches & headache 1st day following vaccine, minor nerve (??) pain in L arm - elbow, wrist 1st and 2nd day following vaccine, significant muscle soreness in upper L arm where shot given 1st & 2nd day following vaccine, swelling & discomfort in shoulder/neck area L side of body w/enlarged lymph nodes 1st & 2nd day following vaccine, slight raised red rash-like area ~2 inches x 3 inches on upper L arm near injection site that is warm to touch 2nd day following vaccine
Information has been received from a health professional concerning a patient in the fourth grade who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. The patient was not hospitalized. There was no product quality complaint involved. Additional information has been requested.
hypoglycemia / blood sugar dropped; Husband tested positive /took Paxlovid; Husband tested positive /took Paxlovid; insulinoma; This is a spontaneous report received from contactable consumer (patient's wife). An 86-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6198), on 19Mar2021 as dose 2, single (Lot number: EP7534) and on 22Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 86 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 11May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: SIMVASTATIN. Patient's wife reported that in Mar2022 patient had surgery for an insulinoma which is a begin tumor on the pancreas that causes the pancreas to secrete too much insulin. Took that off and didn't take much of the pancreas. Everything was clear and the biopsy was good. Has been getting along fine since then. Currently, it's August and he had Covid last week (in Aug2022), took Paxlovid from 30Jul2022 to 03Aug2022, and yesterday (09Aug2022) his blood sugar dropped to 29 and had to be taken to the hospital. Timing seems rather interesting that the Covid, Paxlovid, and then blood sugar drop when there hadn't been any problems with his blood sugar since March until now. Patient's wife is wondering about the possibility of hypoglycemia as a result of the Covid or Paxlovid. She has read where it is a possible side effect of both Covid and Paxlovid. Patient tested positive and was given Paxlovid. Finished Paxlovid a week ago today, 03Aug2022 and his blood sugar dropped yesterday (09Aug2022) and he is in the hospital. Patient's wife is wondering if this is a valid situation. She knew that not a whole lot is known about covid. patient got the Pfizer vaccines. Patient's wife did as well. She has not had covid. Wondering about the timing of this blood sugar drop though. She also reported patient's blood sugar was better as of 10Aug2022. Still hospitalized while the doctors try to figure out why this happened. On an IV that was stabilizing his blood sugar. He's not diabetic. The patient underwent the following laboratory tests and procedures: Biopsy: (Mar2022) Everything was clear and the biopsy was good; Blood glucose: (09Aug2022) 29, notes: Unit Not Provided; (Aug2022) better; SARS-CoV-2 test: (Aug2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, hypoglycaemia, insulinoma. Outcome of hypoglycemia and insulinoma was recovering, outcome of other events was unknown.
GI Issues; diarrhea; nausea; This spontaneous case was reported by a patient and describes the occurrence of GASTROINTESTINAL DISORDER (GI Issues), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 025b21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021 at 2:57 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (GI Issues), DIARRHOEA (diarrhea) and NAUSEA (nausea). At the time of the report, GASTROINTESTINAL DISORDER (GI Issues), DIARRHOEA (diarrhea) and NAUSEA (nausea) outcome was unknown. Not Provided
Starting around 8pm I started with cold chills, rigors, and fever. I also had shooting pains down my left arm into my hand like nerve like pain. Extreme exhaustion into the next day. Decreased appetite,  odd taste when I attempted to eat. Left leg also was sore the next day. Over 24 hours after vaccine and I still feel foggy and  not 100% back to normal and sore arm and lymph node in armpit of left arm also enlarged.
PATIENT FAINTED ABOUT 2 TO 3 MINUTES AFTER GETTING HER FIRST DOSE OF COVID VACCINE. NO INJURIES REPORTED. MOM AND PHARMACIST ASSISTED THE PATIENT, PARAMEDICS ARRIVED AT SCENE FOR EVALUATION. AFTER GETTING SOME FLUIDS AND SUGAR, PATIENT FELT BETTER. MOTHER REFUSED TO GO TO HOSPITAL. AFTER LONG OBSERVATION, PATIENT DEPARTED PHARMACY WITH HER MOTHER.
Pt reports heart rate in 130s x 45 minutes-1 hour.  She reported shortness of breath and O2 sat 95%,. Symptoms resolved simultaneously after 45 minutes- 1 hour. She also reports weakness and fatigues that lasted x 1 day.
My granddaughter told me she tested positive last Thursday. I went to work, but on Monday my breathing wasn't right, I felt weak; I work on a place that I can't sit I couldn't stand straight, but I couldn't work anymore, I went to the bathroom for 10 minutes to rest, I had to do this three times; I took apple juice and energy drink. At 5:00PM I couldn't make it to the car to drive back home. Yesterday, when woke up I couldn't breathe, my eyes hurt, I had nausea, I had head and body ache, my joints hurt. I felt so sick I called to the doctor and took the COVID-19 test at the pharmacy (yesterday at 4:30PM) and it was positive. I have to quarantine for 5 days. I spoke to the doctor today and called the pharmacy for a prescription. I will start taking it today.
maculopapular rash over her whole body. appeared 12 days after vaccine was given.
Patient recieved a finger stick for a POC Cholesterol and then a Tdap and HPV shot, patient yelled immediately that his head hurt and proceeded to faint in almost a seizure like way. We got him on the table and he started to feel better, he was given juice and crackers and the MD came in and checked him and his heart and rate.
7/13/16 HAVRIX vaccine administered. 7/14/16 mom called Triage Nurse - Pt has hives, instructed to give BENADRYL and monitor for dr and us. 7/16/16 seen in office, hives progressing.
Pt had syncopal episode following dose #2 of GARDASIL. Took approx 5 mins to fully recover, was out for approx 15 seconds, feet elevated, cool rag to forehead. Vomited x 1. Email sent.
One week after developed hives and itchy rash lightly on upper arm and much more intense from the waist down. The first four days has the most intense itching and welts. By Tuesday the intensity lessened during the day but mainly my feet and ankles were itchy. As of today 2/11 the rash seems to have disappeared. I cannot find any other source- no changes in food, lotions, detergents, etc