chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While working, during night hours severe allergic reaction occurred. Rash and itch all over the body, red swollen eyes and neck. Received IV at infirmary by ships medical staff. 2 nights later re-occurred - same symptoms but heavier. Medical team inserted IV and added Adrenaline via IV as well. Upon return contacted medical doctor for interview on the 17th of January. Made appointment for allergy test - due to long waiting time earliest opportunity is July 15th. Note: have visited this ship before prior to Moderna vaccines without any allergic responses.  Report from virtual doctor appointment:  Chief Complaint: Allergic reaction   HPI: Pt is a 40 y.o. male who presents with allergic reaction.  Pt states that he is an auditor working on ships. Is flown to various ship ports around the world to provide auditing services. On Jan 10th he awoke with urticaria, and a swelling of his eye. Was treated with IV benadryl by hip doctor and symptoms improved. Pt states that on the night on Jan 12th, the urticaria returned, this time with swelling of the lips and the ship doctor noticed swelling of the oropharynx. Pt was treated with epi and IV benadryl and again symptoms abated. Was given a prescription for oral prednisone for 5 days which he has now used all of and recommended to take loratadine which he is currently taking. Pt states that he had asthma has a child but had grown out of it by adulthood. Pt states that he has an allergy to duck feathers in the past with asthmatic type symptoms as the  Pt denies any new foods, mediations or supplements. Pt states that he received Moderna booster on 12/28/2021. Previous two vaccinations were also Moderna. Pt likes in area but states that he is happy to drive to other area for care as he travels frequently.   Problem List: There are no problems to display for this patient.   Past Medical History: No past medical history on file.
Information has been received from a registered nurse concerning a pt who was vaccinated on an unspecified date with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). Subsequently the pt developed a rash. Medical attention was not sought. Additional info has been requested.
Case was hospitalized for 9 days in November 2021 for Covid treatment following vaccination in May 2021.   * Acute hypoxemic respiratory failure due to COVID-19  Assessment & Plan Presented unresponsive, had CPR by his wife at home prior to paramedic arrival, found to be in severe respiratory failure prompting BiPAP in the emergency room. Could not maintain his sats so intubated. Tested positive for Covid with imaging consistent with Covid pneumonia. I believe he was vaccinated. CRP 13.4 on admission, will repeat in a.m. Has been extubated a few days now with improving oxygenation -Supplemental oxygen -Finished remdesivir -10 days of dexamethasone done on 11/17  -On baricitinib   Hypothyroidism Assessment & Plan TSH on 11/16 was 35.6. Patient hesitant to start thyroid replacement as he says he did not have any symptoms before covid infection -Recheck TSH as an outpatient.    A-fib  Assessment & Plan Noted to have a few runs of afib in ICU. Completed amiodarone infusion a couple days ago. Monitor on tele for recurrence. Did not discuss AC with him, has not had an echo. Will check a TSH. Resting HRs low 60s in SR so held off on nodal blockers.    Elevated LFTs Assessment & Plan Moderate transaminase elevation noted. Likely COVID related. Monitor CMP. Improved while here (ALT/AST of 151/70 on day of discharge), recommend rechecking as an outpatient.    Bacterial pneumonia Assessment & Plan Bacterial pneumonia suspected by the ICU treating physicians. Procalcitonin around 20 on day of admission. Finished 7 days of rocephin. Culture data negative. Leukocytosis likely related to steroid use.    Acute kidney injury  Assessment & Plan Resolved. Cr normal. Cr 1.3 on admit so this was mild.
Patient requested Moderna Booster, stated she had adverse/allergic reaction to Johnson & Johnson.  Patient was placed on stretcher and given vaccination on left deltoid.  At 1613 Patient began to experience tingling on  lips, redness on chest, and complained of feeling hot.  Patient was given Benadryl 50mg IM to right deltoid.  VSS. Patient was monitored for 30 minutes, patient then stated she felt better and was able to drive herself home.
BODY ACHE; FEELING OF URGENCY; TIREDNESS / FATIGUE; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and  expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced feeling of urgency. On 08-APR-2021, the subject experienced tiredness/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, feeling of urgency, and tiredness/fatigue on 10-APR-2021. This report was non-serious.
Sore muscle at the injection site, inability to raise arm comfortably started the same day, continued into day 3. Day 2, while in shower in the morning experienced nausea, then passed out. Later in the day had a fever of 101.
broke out in hives all over. head to toe. with severe itching and fever. mom gave benadryl ( diphenhydramine) 2.5ml x 2 doses and tylenol (acetaminophen) 5ml x 1 dose
Sore arm began a few hours after shot with  a hard swollen area about 3-4 inches in diameter. The other symptoms began during that night about 2 a.m. and continued throughout most of the next day:  nausea and vomiting (early morning only), severe headache, severe body ache...all over. Second day after shot - arm soreness and swelling is still here but with reducing  intensity. All other symptoms seem to have subsided....thank heaven!  I took Goodies powders for headache and body ache after eating a piece of white toast. Took every 4 hours throughout the day which seemed to help but felt bad enough to continue taking until  end of day.
Information has been received from a nurse (patient's mother) concerning her daughter (age unspecified) with a history of asthma who was vaccinated intramuscularly with a first dose of Gardasil.  Concomitant therapy included "birth control pill" hormonal contraceptives (unspecified) and inhaler for asthma (therapy unspecified).  Subsequently, on an unknown date the patient had an asthma attack and also experienced flu like symptoms.  The patient had her inhaler with her and used it to stop the adverse event.  Subsequently, on an unknown date the patient recovered.  It was reported that the therapy was discontinued.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Convulsion; Syncope; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:15 (2:15 PM) (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no covid prior vaccination and not covid tested post vaccination. There were no other vaccines in four weeks. It was reported that the patient experienced Syncope and Convulsion on 08Apr2021 at 14:30 (2:30 PM). The outcome of the events was recovered in Apr2021. No treatment for the reported events. The event resulted in Emergency room/department or emergent treatment.
This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received BOOSTRIX. Co-suspect products included INFANRIX, KINRIX, PEDIARIX, ROTARIX, HAVRIX and ENGERIX B. On an unknown date, the patient received BOOSTRIX at an unknown dose, INFANRIX at an unknown dose, KINRIX at an unknown dose, PEDIARIX at an unknown dose, ROTARIX at an unknown dose, HAVRIX at an unknown dose and ENGERIX B at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, INFANRIX, KINRIX, PEDIARIX, ROTARIX, HAVRIX and ENGERIX B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: This office spoke with a pharmacist at GSK approximately two weeks ago regarding the stability of their vaccines. They stated that they may have administered vaccines that were stored outside of recommended temperatures but could not be certain. There are several GSK vaccines potentially involved including BOOSTRIX, INFANRIX, KINRIX, PEDIARIX, ROTARIX and possible HAVRIX and ENGERIX B.
The patient received Moderna monovalent 2nd booster dose on Wednesday, 8/31/2022
This spontaneous report was received from an immunization coordinator referring to a male patient of unknown age who on 10-NOV-2014, was inadvertently vaccinated with a dose of PROQUAD (Merck), 0.5 ml, subcutaneously (lot # K011311, expiration date 14-FEB-2016) instead of intended ZOSTAVAX dose. No adverse effects reported. This is one of two reports from the same reporter source (linked report 1411USA004810). Additional information has been requested.
Extreme fatigue, temperature dysregulation, headaches and pre-syncopal episodes 16 days after receiving the 2nd dose of the Covid vaccine - concerning for possible encephalopathy vs dysautonomia (POTS like reaction) .  Discussed with neuro - sent to ED.  r/o encephalopathy. Ending diagnosis - dysautonomia  EKG and cardiology consult - asymptomatic 1st degree heart block - monitored and no treatment needed. EKG findings will resolve. Labs ordered - CBC, CRP, diff, ESR, troponins, CK, covid - normal, Mono - pending  No echo done  Neuro and cards consult in ED - seen by neuro attending - f/u outpatient dysautonomia clinic and cardiology as outpatient
vaccine administered after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccine administered after temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine administered after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (vaccine administered after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter.
pt recvd vax & 12 hrs p/vax exp abdo cramps/pain which were treated w/Zantac & Carafate-lasted 1 wk; In addtl pt was found to be a nonresponder;
I woke up with a fever, I was very tired the entire day, took a nap. Overall felt like flu like symptoms but they were over with 24 hours. I felt normal the next day around 4 pm. I just took Tylenol for my fever.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 12-APR-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (dosing regimen unspecified) lot #K023537, expiry date 22-JUN-2016. No adverse effects were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. No further information was provided. Temperature: 34.1F. Time frame: 48 hours. Data Logger: no. Was it administered (AE): Yes. Previous temperature excursion: no. This is one of several reports from the same reporter. Additional information has been requested.
The next day after I had muscle ache a sore throat and chills but no fever so I went to Urgent Care  and had a strep test that was neg, but was prescribed 2 antibiotic and 2 steroids as a precaution.  2 Covid test were performed also which were both neg as well.  The groggy feeling lasted for about 5 days and all symptoms subsided.
This case was reported by a physician, via a GSK representative, and described the occurrence of muscle pain in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 12 October 2011 the subject received a dose of FLUARIX (.5 ml, unknown route). On 14 October 2011, 2 days after vaccination with FLUARIX, the subject experienced "severe" muscle pain and tiredness. The physician considered the events were disabling. The subject was unable to go to work. At the time of reporting the events were resolved. The physician considered the events were possibly related to vaccination with FLUARIX. The physician reported 2 subjects who experienced adverse events following vaccination with FLUARIX. This is case of 1 of 2. See case ID A0950526A for details of the other report.
Enlarged lymph node in left collar bone.  Appeared on March 30th; day after 2nd injection.  At it's largest it was the size of a grape.  Today, about 2 weeks later it is the size of a pea.  It hurt without touch but did not look red around the area.
Patient called and stated she had a rash from injection site in upper arm in deltoid that ran down  her arm to about 3 inches above her elbow. It was approximately 3 inches in width as well. The first injection of SHINGRIX on 5-22-18 did not cause this reaction. Patient was told to put BENADRYL CREAM on the rash. Patient came back in store on 7-26-18 and the rash was almost gone.
Swelling at site of injection, tenderness, pain, swelling, redness, warmth.
Mild, left sided lip and cheek numbness, left axillary swelling, left breast tenderness.  Onset 11/9/21.  All continue except left breast tenderness (that lasted 3 days) In addition to these, onset of fever of 101.1, body aches, headache and stomach pain on 11/9/21 and these lasted until 11/11/21.
stage 4 brain aneurysm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized from 04-Apr-2021 to 23-Apr-2021 due to INTRACRANIAL ANEURYSM. At the time of the report, INTRACRANIAL ANEURYSM (stage 4 brain aneurysm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and investigations done while patient was hospitalized were not reported.  Concomitant medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Mom contacted me 8/7 re: redness/warmth left leg when got shot last week. She sent me a picture which was very localized with 3-4 small blister like lesions visible. Not seeming to bother. Reviewed note and had received varicella only in that leg. Mom reached back out on 8/8 with mild erythema on ovoid area that width wise cover about 1/3 of anterior thigh. Blistering still present and at medial aspect of erythema. Still not bothering.  8/11/2020: 2cm redness blister at injection site scabbed over
within 5 minutes developed numbness/tingling in lips and tongue with swelling. received prolonged monitoring at the site with resolution of symptoms within 3 hours
Extreme pain at injection site for prolonged time 1 month sharp stabbing pain an undulation at site as well.
When I sat up to get up from bed, I felt extremely dizzy. I sat back down for a few moments and then got up again. I went into the kitchen and opened the refrigerator, but I fell on the floor. When I got up, I still felt really dizzy. I also had chills and a fever. I've been experiencing lightheadedness as well since taking that 3rd dose. I've been dealing with scalp issues and a strange headache too.
Monday 2/29 in the morning felt a little dizzy  Tuesday 2/30 in the morning felt something was not right. Felt a little more dizzy Wednesday morning had full blown vertigo. So bad I could hardly stand up. Never in my like had I ever had vertigo. At 3:00 pm Two Doctors adjusted the left ear twice to get the crystals right. No issues with the right ear. The left ear is the one I have ringing in. Had to use a neck brace for 2 days and slept in a chair for two night. No more dizziness. But for 4 weeks was not myself
States went directly home after vaccination at Health Department, felt nauseated and vomited upon arrival at home, which was approximately 1/2 hour after vaccine administration. States felt "very weak and extremely dizzy", felt heart palpitations and rapid heart rate, went to lay down and woke up approximately 12 hours later needing to void. Was unable to stand due to vertigo, had to lay back down and wait until morning. Was able to stand the next morning but "barely" could tolerate being upright and standing. Legs were extremely weak. States was still experiencing some vertigo but was able to make it to bathroom. Right arm injection site extremely edematous, red and warm, arm also extremely sore and difficult to move. States "feels like I'm getting pneumonia, there's stuff in my chest, I can feel it in there." Also states "I didn't feel like this before", states "I took some Mucinex and that seems to be helping loosen whatever's in there up".
Patient received Moderna 0.5 mL IM x 1. Patient's mother reported a cough and red eyes in the patient since that time.
Received shot 29th about 2 pm - my arm was really hurting and heavy, later in evening felt achy. Got up during night arm was really hurting and sweat pouring off me. Took shower. Decided to go to work and passed out on my way - Totaled vehicle.  2 fractures to back/arm - head injuries.
Daily morning queasiness with trembling, weakness, diarrhea and anxiety that disappeared by 10:30am. It lasted for 10 days and never re-occurred.
Symptoms began at 6pm. Fever, headache, runny nose, chills, pain in left arm, nausea. Took 1 Advil at 7pm. Advil is cutting the pain.
1/31/21 - 5 PM occasional heart racing.   Restless sleep that evening. 2/1/21 through 2/03/21- Headache  2/1/21 through 2/2/21 - Loose stool and some slight nausea from time to time. 2/1/21 started feeling a bit off balance and dizzy especially when first standing up.  This still happens occasionally as of 2/16/21. 2/7/21 felt pressure in chest and difficulty catching a deep breath. Feel like I'm not getting a comfortable amount of oxygen although I am able to breathe normally without wheezing or catching my breath. This is still the case today 2/16/21
pt recvd vax & devel a severe allergic rxn which resulted in permanent damage to the organs
sore arm; achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PAIN (achy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DORZOLAMIDE and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PAIN (achy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Jan-2021, PAIN IN EXTREMITY (sore arm) and PAIN (achy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-028013 (E2B Linked Report).; Sender's Comments:  MOD21-028013:Husband case
Mother noted large redness, swelling next day at each injection site. HIB was largest. Child had some fever. Large redness, swelling and warmth remained 4/3/02
Initial information regarding an unsolicited valid serious case from a consumer/non-health care professional via Medical Information (Reference number- 00574863) and transmitted to Sanofi on 23-Apr-2021  This case involves a 50-year-old female patient who experienced anaphylactic reaction, scratchy eyes, the throat feeling funny and throwing up in the afternoon, while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  Past vaccination(s) included INFLUENZA VACCINE in 2009 (she had the flu shot that contained H1N1 and she had no reaction).  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medications were not reported.  On 29-Nov-2010, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: unknown and expiration date: unknown) via unknown route in unknown administration site for vaccination.  On 29-Nov-2010 at 09:00, the patient developed a serious anaphylactic reaction, same day 45 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Seriousness criteria was assessed as medically significant as per important medical event (IME) list.  On 29-Nov-2010 at 09:00, the patient developed a non-serious scratchy eye, the throat feeling funny and throwing up in the afternoon, same day 45 minutes following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was also reported that should she get the COVID-19 vaccine? She did not seek treatment but gutted it out. She did call the clinic and was advised if the reaction gets worse to go to the Emergency Room; that she never had to go to get treatment; that all the information she has on the vaccine was that it was from Sanofi and the Fluzone Trivalent; that she has not had a flu vaccine since.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was resolved on an unknown date for the events.  There will be no information available regarding batch number in this case. Sender's Comments: This case concerns a 50-year-old female patient who presented with anaphylactic reaction, eye scratch, throat discomfort and vomiting same day 45 minutes after vaccination with FLUZONE QIV. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination, history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
A week after receiving the booster I tested positive for Covid. I found out on the day I tested positive that I was exposed 4 days earlier.
pt recvd vax; 19dec  seen in clinic; appetite dec, 1/3 of nl; watery stools x 24; inc flatus; pulling ears;
10 hours after receiving vaccine I experienced a fever of 101.3, weakness and dizziness. I went to sleep and the fever was gone 6 hours later.
for 10 days after vaccine all joints were achy, a lot of fatigue and headaches off and on with diarrhea.
Rec'd Menveo & HPV. Seemed fine  walked out of office, felt faint &  vomited. Came back inside.  Had eaten breakfast but no fluids