chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles, causes severe pain and a blistered rash on right side of my back and front ab.. Got  prescription Acyclovir (ZOVIRAX) 800 mg Oral Tab and traMADoL (ULTRAM) 50 mg Oral Tab from my doctor.
Immediate recurrence of GBS post vaccination.  This time around on Tuesday pt got a COVID vaccine and 6 hours after pt started feeling nauseous and 3 days after the vaccine had numbness in his feet b/l at first. Numbness travelled upwards up to the knees. Next the weakness started extending upwards to his mid thigh. Pt will not put any weight on his legs because he knows he is very unsteady.  Today he has numbness in his hands b/l. Pt had no symptoms before Tuesday. He lives at home (independent senior facility) and is coming from there. Pt woke up this morning and went from his bed to his chair and since then pt was not able to get up from the chair.
got the flu twice; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.   This case involves male patient (age unspecified) who got the flu twice (influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the flu twice (influenza) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
SHAKING; COLDNESS; TEMPERATURE OF 91.7; SORENESS AT THE INJECTION SITE; WEAKNESS ALL OVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 13-MAR-2021 11:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced shaking. On 13-MAR-2021, the subject experienced coldness. On 13-MAR-2021, the subject experienced temperature of 91.7. On 13-MAR-2021, the subject experienced soreness at the injection site. On 13-MAR-2021, the subject experienced weakness all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, coldness, temperature of 91.7, soreness at the injection site, and weakness all over. This report was non-serious.
Patient came to the emergency room with COVID-19 and progressive shortness of breath.  He states that he started to have difficulty breathing approximately 1-1/2 hours prior to coming to the ER.  He states is worse when he exerts himself or attempts lie flat.  He has had COVID for the last 12 days has been doing relatively well until today.  Patient had no respiratory symptoms of breathing difficulty and till this evening.  He does not use oxygen at home and he is on an inhaler only if he needs it.  Patient has not been on steroids.  In the emergency room his O2 sat was 76% on arrival.  His pH is 7.3, pCO2 50, PaO2 340 and bicarb 28 after being placed on BiPAP.  WBCs are 7.2, hemoglobin 14, hematocrit 49, platelets 290.  MCV is 88.  Sodium 139, potassium 4.4, chloride 103, bicarb 28, glucose 128, BUN 19 and CREAT 1.09.  Alkaline phosphatase is 152, AST 52 and ALT 61.  Lactic acid is 1.1.  A chest x-ray has not been resulted yet.  Patient has had COVID vaccines and booster    In the emergency room he was given 40 mg of IV Lasix and started on a nitro drip.  He was also placed on BiPAP   Patient denies any fever, cough, chills, rhinorrhea, sore throat, chest pain, palpitations, orthopnea, paroxysmal nocturnal dyspnea, nausea, vomiting, diarrhea, constipation, hematuria, dysuria, frequency, melena, hematochezia or focal neurological complaints   Patient discharged 1/22/22.  Pt previously vaccinated 3/3/21 & 3/31/21 with Moderna.  Pt tested Positive for COVID 19 on 1/5/22.
Swelling, rash, and pruritis of multiple fingers of bilateral hands.  Blisters on hands an feet, persistent now for 5 days.   Using oral and topical benadryl and using topical corticosteroid with mild temporarily relief but subsequent reoccurrence of symptoms
He got his shots very early in the morning. By night he was having seizures. Went to ER. They called it an "abnormal movement" and charged me 30 grand in brain scans and sent us home.
Patient received typhoid vaccine on 09/03/14. Lot # K1200-1 Exp=04/15/16 Manufacturer=Sanofi Pasteur. On 09/05/14 she called stating her arm was sore from the shoulder down and she couldn't raise her arm. If the pain isn't better to follow up with doctor on Monday and if the pain is worse to go to the emergency room.
Dose administered to patient was expired. No adverse effects reported by patient. Manufacturer contacted for recommendations on revaccination, they were unable to provide recommendations.
that the patient was blind [could not see]./he office stating the patient went blind.; This case was reported by a physician via sales rep and described the occurrence of blind in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date unknown) for prophylaxis.   On 29th July 2020 14:30, the patient received the 2nd dose of Bexsero (intramuscular). On 29th July 2020, less than an hour after receiving Bexsero, the patient experienced blind (serious criteria GSK medically significant). On an unknown date, the outcome of the blind was unknown.   It was unknown if the reporter considered the blind to be related to Bexsero.  Additional details were provided as follows: The patient received dose of Bexsero on 29th July 2020 at approximately 14:30 and the patient's father called at approximately 15:30 to the office starting that the patient was blind. The patient was taken to the emergency room and administering physician was consulting with neurologist. The patient was not administered other medication at the time of visit.
Erythematous raised patch 3X5 inches with firmness and tenderness to palpation on left arm.
The spontaneous case, initially received from pharmacist on 15-Nov-2017, concerning 61-year-old, adult, female patient. On 29-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195240A and expiry date: 30-Jun-2018). On the same day of vaccination, soon after receiving the vaccination, the patient experienced severe pain in shoulder and could not move her arm. She also complained that she could not lift anything. Furthermore, she experienced pain in the arm, could not sleep and the pain radiated up to neck and down the arm causing migraine. No treatment medications were given to the patient. The outcome of the events shoulder pain and mobility decreased, was not reported. The patient was not recovered from the events activities of daily living impaired, pain in arm, sleep difficult, radiating pain, migraine was not recovered. The reporter assessed the case as non-serious. Non-significant follow up received on 07-Dec-2017: It was reported that, no treatment medications were given to the patient. The narrative was amended accordingly. Significant follow up received on 09-Jan-2018: Suspect vaccine was changed from FLUCELVAX TIV to FLUCELVAX QIV, indication of the suspect vaccine was changed from annual influenza vaccine to influenza prophylaxis, batch number and expiry date were added in the product tab. Events (arm pain, cannot sleep, pain radiates up neck and down arm and migraines) were added. Verbatim 'not being able to lift anything' was added to the LLT 'activities of daily living impaired' and treatment received was changed from unknown to 'no' for the event 'loss of personal independence in daily activities' in events tab. Narrative amended accordingly.
Itchy toe woke me at 2 am, ~18 hours after my COVID-19 booster Found one large fluid filled blister in between toes, it popped. The loose remaining torn skin is very thick, indicative of a deep blister Site has remained red, itchy, and sore as it heals, no more blisters noted 5 days later. The blister was so large and itchy/uncomfortable when I found it at 2 am, I am confident it was not there when I went to sleep
A couple days to about a week after receiving these vaccines, my son developed a cough and trouble breathing. I notified his doctor and we came in for a check-up. She said there wasn?t anything to be concerned about and to monitor the cough to make sure it didn?t last longer than a month and to come back if he had any fevers or other symptoms associated with it.   My son never developed any other symptoms besides this persistent cough. He coughs especially in the morning when he wakes up and it has been 3 months since the cough developed following the vaccinations. The cough is the same, with labored breathing, and no other symptoms.   We relocated to another area and my son was checked by another doctor, with whom I brought up my concern for this cough. She told me she would check his lungs but instead gave him a coronavirus test and sent us home. He does not, nor did he ever have coronavirus and his cough/labored breathing is still persistent.
This spontaneous report as received from parents via a consumer who read on epilepsy website refers to about 50 female patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (dose, route, lot # not reported). On an unknown date the patients started to experience seizures after receiving GARDASIL. The outcome of seizures was unknown. Relatedness between the event and GARDASIL was not specified. Upon internal review the event of seizures was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested.
mom reported the following on 30DEC93: took pt to hosp because of react to vax: facial swelling, temp, problems breathing; was informed that pt had lt sided facial swelling; temp of 100 & having apnic spells;
I had received the vaccine on April 12, 2021 at 11:30am.  I felt a warm sensation go down my arm when I received the vaccine. No ill effects however.  Around 2:30am the following morning (April 13, 2021) I started feeling ill. I had flu-like symptoms including: body aches, chills, fatigue, etc. I did not take my temperature, however, I believe I was feverish. I took 400mg of Ibuprofen around 11:30am (24 hours after receiving the vaccine). After sleeping for 2 hours, I began feeling better.
Narrative: COVID infection following COVID vaccine series 06/01 Janssen, dose #1 08/16 COVID swab, result: detected 08/17 pt cc: No symptoms exposure: unknown
Shingles, symptoms started approximately 2.5 weeks following vaccination (Pain started ~April 30-- diagnosed as pinched nerve in neck on May 6, shingles rash appeared May 7, Diagnosed May 8th. Shingles symptoms lasted over 1 month (with ongoing post-herpetic neuralgia/itching)
Fever, muscle aches, extremely sleepy. Symptoms lasted for about 48 hours.
Client was in observation area after receiving Janssen COVID vaccine. Medics reported client c/o nausea and vomiting. Medics started IV, administered Zofran 4mg IV, and transported client to OSU emergency room for further assessment.
Rise in blood sugar levels/Sugar went up like crazy; Rise in hemoglobin A1c; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Rise in blood sugar levels/Sugar went up like crazy) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    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 BLOOD GLUCOSE INCREASED (Rise in blood sugar levels/Sugar went up like crazy) (seriousness criterion hospitalization) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c) (seriousness criterion hospitalization). At the time of the report, BLOOD GLUCOSE INCREASED (Rise in blood sugar levels/Sugar went up like crazy) and GLYCOSYLATED HAEMOGLOBIN INCREASED (Rise in hemoglobin A1c) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: increased (High) Rise in blood sugar levels. On an unknown date, Glycosylated haemoglobin increased: increased (High) Rise in hemoglobin A1c.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given. Treatment medication was mentioned as patient medicines were changed and prescribed with a new pill.  Company Comment: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Diarrhea injection site is red, warm to touch and swollen about the size of a nickel. Narrative:
Report 2001007581-1 describes night sweats in a pt who rec'd Lyme disease vaccine (Lymerix) for the prevention of Lyme disease. Reportedly the pt had no known drug allergies or medical history. He took no concomitant medications. In November 2000, the pt rec'd his 1st dose in L deltoid of Lymerix without adverse event. In December 2000, the pt rec'd his 2nd dose L deltoid of Lymerix. In January 2001 he became to experience night sweats and fatigue. These adverse events resolved after 3-4 months. As of 6/8/01 the adverse events had resolved.
Continuous chest and heart pain. Irregular heartbeat (only a few times) and heart burn (only once).
Pneumococcal vaccine in right arm: red, very sore, rash, weak, muscle aches, very tired. Took TYLENOL.
Date of 2nd SHINGRIX injection 12/8/2018. 1st dose: pain at injection site with swelling, skin very warm to touch. Flu-like symptoms (headache, muscle ache, joint pain, feverish). Duration 4 days. 2nd dose: lesser pain at injection site, little to no swelling, skin mildly warm to touch. Flu-like symptoms as above. Duration 36 hours. Mild headache for 2 days.
Post vax, later that day, pt had temperature of 102F for 8 hours. He was a little fussy on 4/10/01. On 4/11/01, at 01:00 his temperature was 102F-103F and vomiting. Mother states right leg was swollen on 4/11/01. She took infant to MD on 4/11/01 and he was started on antibiotic and will see MD on 4/13/01 for follow-up.
Pt came to ER with SOB, no endurane, nausea.  Recieved first dose of covid vaccine 2/10 unsure of manufacturer.
Faintness; Eyes are yellow; Stomach cramps; Diarrhea; Can't sleep; Feeling unwell; Dizzy; Chills; Light headache; Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faintness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Faintness) (seriousness criterion medically significant), OCULAR ICTERUS (Eyes are yellow), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), SLEEP DISORDER (Can't sleep), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Light headache), NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, SYNCOPE (Faintness), OCULAR ICTERUS (Eyes are yellow), ABDOMINAL PAIN UPPER (Stomach cramps), DIARRHOEA (Diarrhea), SLEEP DISORDER (Can't sleep), MALAISE (Feeling unwell), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Light headache), NAUSEA (Nausea) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
vaccination site tenderness; Very Sore Injection Site; Big Red Circle Injection Site; Itchy Injection Site; Sore Arm Injection Site (A Little); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)), VACCINATION SITE PAIN (vaccination site tenderness), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)). On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (vaccination site tenderness), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On 18-Mar-2021, VACCINATION SITE PAIN (Sore Arm Injection Site (A Little)) had resolved. At the time of the report, VACCINATION SITE PAIN (vaccination site tenderness), VACCINATION SITE PAIN (Very Sore Injection Site), VACCINATION SITE ERYTHEMA (Big Red Circle Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided by reporter.
On 05/19/2021 around 0200 patient awoke from sleep, felt warm, appeared flushed and jittery. Temperature taken resulted 100.0 F.  At 0213 patient?s heart rate was 223 sustained 220?s for 10 min. Patient remained tachycardia 190?s for about 8 min.
shingles; pain; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (receiving Zostavax on an unknown date in August 2017).   On 15th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 4th July 2019, 50 days after receiving Shingrix, the patient experienced shingles and pain. The patient was treated with gabapentin and opioids {nos} (Opioid). On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional information received were as follows: The age at the vaccination was not reported. The patient received Shingrix on left deltoid. The patient experienced shingles and was prescribed by his healthcare provider gabapentin and unspecified opioid as treatment for pain associated with shingles.
Nausea, light-headed, short of breath. Laid down, removed mask, gave water. Patient had not eaten since breakfast and had nausea prior to vaccine. Symptoms resolved very quickly, within 3 minutes.
CHIEF COMPLAINT/REASON FOR VISIT Weakness - Generalized     HISTORY OF PRESENT ILLNESS  This is a 74-year-old male who was diagnosed with COVID-19 back on September 10th.  He presents the emergency department because of progressive dyspnea with minimal exertion.  The patient reports that he has had a dry cough as well.  He denies any frank chest pain however.  Patient did receive a Johnson and Johnson vaccine several months ago.  He denies any new peripheral edema, but does have chronic lower extremity edema.  He denies any high fevers or chills.  He denies a headache, nausea vomiting, abdominal pain, or diarrhea.
Nausea, loss of appetite, muscle aches and fatigue beginning on 1/21. Diarrhea beginning on 1/22.
Vaccinated on Mar 1 & 29, 2021; Boosted on Oct 29, 2021 & Apr 26, 2022; On May 24, 2022 I had a cough, head congestion and a slight fever.
Ongoing pain in the right armpit/lymph nodes and right breast and ongoing swelling in the lymph nodes of the right armpit. This lasted 6 weeks before I sought medical attention at my OBGYN to check for breast cancer.
This spontaneous report was received from a physician refers to a 84 year old patient of an unknown gender. Medical history and concurrent conditions were not reported. On 13-AUG-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, dose number, route, lot number and expiration date were not reported). Co-suspect and concomitant therapies were not reported. The physician stated that an adult patient received VARIVAX (Merck) on 13-AUG-2014, and should have received ZOSTAVAX. No adverse effect reported. Additional information has been requested.
I have developed muscle twitches all over my body.  It started with my left index finger and thumb and that is still the most noticeable and alarming site of twitching, but I have small fasciculations all over my body every day.
4 month old patient was given Fluzone Quadrivalent, no advesre event; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old female patient who was vaccinated with a 0.5 ml  first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot U6648CA and Exp. Date 30-Jun-2020) via intramuscular route in the left thigh on 24-Sep-2019.  The patient's medical history not reported and no concomitant medications received.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  The patient did not received any treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Began having intermittent chest pain approximately 5 days after covid 19 vaccine. Also chest pain with deep breath. Slight fatigue. No other symptoms. Resolved after 4-5 days. Was seen by Pediatrician on 05/25. Vitals and assessment normal. Chest pain had resolved at that time.
Employee was given the MMR vaccine in L arm, 30 minutes later employee called the clinic stating that she was developing a rash in the area where she was given the vaccine. The next day she did develop a fever that lasted for 2 days.
Information has been received from a physician concerning a 19 month old pt who on 3/30/99 was vaccinated with MMR and subsequently, the pt developed non-typical rash on the back, trunk, waist and chest. Follow-up information received on 9/30/99 from the physician stated that "this pt was not under my care when vaccine was given. I do not have details nor see rash." No additional information is expected.
Pt received vaccine for negative rubella titre on 3/2/00.  On 3/15/00 the pt developed pink macular rash over trunk, arms, anterior neck and severe arthralgias of hands with swelling, elbows, knees, hips.