chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash starting at scalp and proceeded to go all over body front and back with welts and lots of itching.  Benadryl 25mg administered every 4 to 6 hours for first 24 hours. Rash is continuing at this point but beginning to dissipate.
Rash on arm, 101.3 Temperature 04/27/2019,   Laryngitis 04/30/2019,  Sore throat, white sores and inflammation at back of throat, Tired, chronic cough 04/30/2019.  Symptoms lasted until 05/14/2019
Feeling tingling in fingers, toes and lips. I feel like I am catching a bug and just need to rest.
p/vax pt devel an inj site rxn characterized by redness, swelling & warmth;pt seen by MD tx symptomatically & recovered;
After the vaccine - arm sore, spot a rash red spot and raised lump on right breast and saw a doctor. Mammograms and went away a couple weeks and shot right.
Atopic dermatitis; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 11Feb2021 16:30 (lot number: EL9264) on the left arm, and second dose on 04Mar2021 16:30 (lot number: EN6199) on the right arm, both via unspecified route of administration as single dose for covid-19 immunisation. Medical history included fatty liver. The patient's concomitant medications were not reported. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other medications within two weeks of vaccination. The patient previously received second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) on 20Jan2021 for immunization. The patient also previously took ibuprofen and experienced allergy. On 17Feb2021 (also reported as on day 7-8), the patient was diagnosed with atopic dermatitis described as red blotchy rash over most of body, with moderate itching on back, hips, and one leg. The rash started after the first dose, took prednisone. Rash flared back after 2nd dose. The patient was seeing a doctor due to the event. Since the vaccination, the patient had not been tested for covid-19. The patient had not recovered from atopic dermatitis at the time of the report.   No follow-up attempts are needed. No further information is expected.
This case was reported by a nurse practitioner and described the occurrence of not responding to therapy in a 34 year old male subject who was vaccinated with Engerix-B for prophylaxis. The subject had no relevant medical history or concurrent medications. The subject received 1st dose and 2nd dose of Engerix (lot number AhBZB172AA) on 31 October 2005 and 08 December 2005, respectively. The subject also received 2nd dose of Havrix (lot number AHBZB229AA) on 08 May 2006. On an unspecified date in June 2006, five weeks after receiving 3rd dose of Engerix, the subject's hepatitis B antibody titer resulted in a negative result. It was considered that the subject did not respond to therapy. No additional information was reported.
Pain in left armpit; slight swelling and tender to touch. First started approximately one week from injection date; lasted four days. Has currently subsided.
Patient received vaccine afternoon and woke the next morning with decreased mobility and pain.  Unable to sleep due to pain.  Went to personal physicain who DX patient with tendonitis due to the flu shot.  Taking Aleve with good results.  Mobility improving and pain diminishing.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 17Dec2022 to 21Dec2022 for COVID-19 treatment. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient went home after vaccination, started with a headache first around 8 pm on 9/23/10 and symptoms started progressing with sore throat ("lump in her throat that it was hard to swallow) then body ache and diarrhea and kind of having instestinal spasm ("like charlie horses"). Because of the spasm patient was having hard time breathing. Patient didn't have any allergic symptoms. It was more like Flu like symptoms. Patient is getting better as per converstation (9/23/10 9:30 AM).
The night of the vaccine, I experienced achiness, weakness, and fever. The highest fever was 100.6. I also was nauseous but did not throw up. The back of my neck was hot and I had chills. I drank plenty of fluids the next day but did not eat. I also experienced double vision. I also had a bad muscle spasms in my legs and hands from yesterday and today. I feel very tired and moody. I took medications for my stomach and they seems to help.
Vaccine administered to age < EUA (vaccine given to < 18 year old).  No other adverse effects noted.
Exposed to a low temperature of 31.5 degrees Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number 5AR2D, expiry date 31-DEC-2025) for prophylaxis.   In JUN-2023, the patient received Bexsero. On 15-JUN-2023, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Exposed to a low temperature of 31.5 degrees Fahrenheit). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-AUG-2023 The reporter reported that on 15th June 2023 the Bexsero vaccines from the lot number 5AR2D was exposed to a low temperature of 31.5 Fahrenheit. The reporter stated that the vaccine was administered between 15th June 2023 to 21st June 2023. The reporter did not had specific date of vaccination for the patient. The reporter stated that at the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The Boostrix vaccine temperature was exposed to 31.5 degrees Fahrenheit, which led to incorrect storage of drug. The reporter did consent to follow up. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023105935:same reporter US-GSK-US2023105936:same reporter US-GSK-US2023105934:same reporter
Patient came in 4 days after vaccination to show me her arm. Her LEFT arm was visibly swollen, red, warm to the touch and apparently very painful. She also had several fluid filled blisters located approx. 6 inches away on the left side of her chest that she reported had popped up the night before. She also reported blisters in her mouth, inside of lip on the gum line and a sensation of itchy scalp since vaccination.
Patient reports her left arm and right eye were swollen approximately 5 1/2 hours after injection. Patient reports taking BENADRYL 25 mg that evening and the following evening for the swelling. Patient reports arm and eye are no longer swollen.
Patient given COVID-19 vaccination on 3/1/2022 at 8:45 am. When medical assistant input the vaccination, it was discovered the expiration date on the vial was 2/28/2022 and the BUD date on the bag: 2/28/2022. It was brought to the manager, and she called Pfizer regarding the vaccination error. The expiration date on the vial had been extended by Pfizer to 5/2022, thus making it still viable vaccination. As for the BUD date, Pfizer representative stated per the viability studies on vaccination excursions, the vaccination was good for 45 excursion days. March 1, 2022, would only count as 1 excursion day. Patient was notified about the incident by the provider, and reassured she received a viable vaccination.
I received a flu shot on oct 29th & I was fine at first, but later on at night I started getting chills, nausea, and excruciating muscle & joint pain. I've never had a reaction like this to the flu shot or any other vaccine before, and I don't *think* I was already sick because I had no symptoms prior to receiving the vaccine. It's now 1:52 am oct 31st and the symptoms have only continued to get worse. I have a fever that ranges from 102 to 103° F. I'm very weak and walking is significantly harder than usual, and much more painful. I'm more unstable than usual and unable to stand without some form of assistance. I started feeling short of breath about a few hours ago, it's not super severe but it is worrying uncomfortable. I have fibromyalgia already but this is much more severe than my usual chronic pain & probably twice as painful as the worst flareups I've ever had. I've been taking tylenol, but I'm unsure if it's helping at all.
10/25/2022: Constant dull pain base of neck, sharp intermittent pain back of head, ringing in ears, right side facial twitching, extreme fatigue, right leg pain. (10/20/22-10/23/2022: severe body aches and cause inability to sleep, nausea, fatigue)
Redness, swelling, pain of R upper arm. Fever of 102 x 3 days.
Subsequent to receiving the second dose of Engerix B, the pt experienced a rash at the injection site. The reporter noted that Engerix B was administered to six pts, all of whom developed a rash. In some cases the rash extended to include the arm only, the arm, face and trunk or the whole body. The most recent information received reports the outcome of the rash as resolved after one to two weeks.
swelling of lymph nodes; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in the left arm on 02Jun2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as 1st dose, single dose for COVID-19 immunisation. Patient got her 2nd dose of the Pfizer BioNTech Covid-19 Vaccine on 02Jun2021 and was experienced that swelling of lymph nodes up until today. The swollen lymph nodes were in the left arm just below her armpit, this was the same arm where she got the 1st and 2nd dose of the Pfizer BioNTech Covid-19 Vaccine. Patient wanted to know how long the swelling of the lymph nodes usually lasts. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 30 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EP6955), in left arm, on 15Apr2021 as dose 2, single (Lot number: EN6207), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 22Aug2023 to 27Aug2023 as treatment for the events.
The patient was given an expired dose of Tenivac, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 62 year old male patient who was given an expired dose of TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 03-Sep-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6021AA, expiry date: 27-Jul-2020) once via unknown route in the left arm for prophylactic vaccination.  No other medications or vaccinations were given during the visit.  It was a case of an actual medication error due to expired vaccine used (latency: same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Headache, chills, body aches, fever 100.4, nausea. Symptoms lasted 30 hours. Nausea and inability to eat lasted 3 days. Patient suffered similar effects after second dose. Third dose was a half dose but caused worse side effects.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 10Feb2022 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Garlic" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: 12Jul2022; MELOXICAM, start date: 12Jul2022; SENOKOT; TYLENOL; VITAMIN B 12 [CYANOCOBALAMIN]; VITAMINS C; VITAMINS D3.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT ROPORTED NEXT DAY SHE HAD SEVERE DIARRHEA - LOST A LOT OF FLUID AND DEHYDRATION. DID HAVE SOME SORENESS DUE TO INJECTION.
The evening after the shot I began to have soreness in my neck and throat and have a head ache. My left arm was sore. The next day I had vomiting, diahrea, and dizziness. My arm is sore and swollen and has read sploches.
Pt went to the ER with redness to her left arm and nausea that she said started the day after her immunizations. ER physician gave her a steroid shot, antibiotic and antinausea medicine.
This spontaneous report was received from an approximately 66 year old female patient with no pertinent medical history and no drug reactions/allergies. Approximately on 31-DEC-2012 (2 days ago), the patient was vaccinated with 0.65 milliliter (ml) (reported as normal) ZOSTAVAX (lot number and expiry date unspecified) subcutaneously in the arm (reported as normal). Concomitant medications included carvedilol and simvastatin. Approximately on 01-JAN-2013 (last night), the patient experienced an unusual type of headache that included heaviness at the top of her head and across her eyes. Her arm hurt within a couple of hours of receiving the ZOSTAVAX and continued to hurt Monday through previous day (yesterday). She was treated with ibuprofen. She did not seek any medical attention. No laboratory diagnostic tests were performed. At the time of the report, her arm hurt was feeling much better. The outcome of an unusual type of headache that includes heaviness at the top of her head and across her eyes was unknown. The relatedness for both the events was unknown for ZOSTAVAX. Additional information has been requested.
Presents for increasing SOB, dx with COVID x6 days PTA. Hypoxic on arrival. Admit for acute respiratory failure with hypoxia, COVID pneumonia. Tx: O2, abx, steroids, vitamins, remdesivir, baricitinib. DC home on O2.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. On 13-AUG-2014 the patient was vaccinated with one dose of GARDASISL (lot # J009788, expiration date 17-MAR-2016, dose was unknown, intramuscularly) which underwent an unsupported temperature excursion. No adverse effects reported. This is one of several reports received form same reporter. Additional information has been requested.
Information has been received from a pharmacist via a company representative concerning a male patient "in his 70s." It was reported that on an unspecified date in 2013, the patient received a dose of ZOSTAVAX 19400 PFU (lot number, dosage, and route of administration not provided), which was reconstituted with sterile diluent (MSD) as a routine vaccination. No information was provided regarding the patient's past medical history, concurrent conditions, or other concomitant medication. In approximately June 2017 (reported as "sometime last month"), the patient developed a shingles rash on his torso. The patient saw his primary care provider who prescribed him an unspecified antiviral treatment. The patient was not considered to be immunocompromised. The outcome of the shingles rash on his torso was reported as recovering. No additional information was reported. Additional information has been requested.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02C1A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (twice weekly) from 11-Feb-2010 to 11-Apr-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Sep-2020 to an unknown date for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Sep-2020 and the estimated date of delivery was 07-Jul-2021. On 02-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The vaginal delivery occurred on 09-Jul-2021.  On 02-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2020, Pregnancy test: positive (Positive) positive. On 03-Mar-2021, Ultrasound scan: (normal) Routine ultrasound was reported.. On 25-Mar-2021, Blood glucose: normal (normal) Normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  The patient had live full term birth.   This case was linked to MOD-2021-270945 (Parent-Child Link).   See case MOD-2021-270945 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: significant follow up appended: Pregnancy outcome were reported.
A few hours after the shot I began experiencing vision problems in my left eye and flashing lights that were diagnosed later in the week as a torn retina.
fever 101, headache, vomiting x 5, low grade fever, still weak, no vomiting, only ate 1 piece of toast;
Right ribcage and right upper back pain. Difficulty breathing  specially lying down on my left side and during inhalation. Feels like something is pressing on my chest. Went to ER on 12/30/20 after midnight. Was given Toradol IM on my right arm. Still feeling pain when I woke up today and difficulty breathing is still the same.
Got Shingrix shot on 7/22. That evening pain in arm and aches as well as chills. Tylenol helped. Next morning awoke feeling weak. Then arms and legs so weak, could not stand. Sat on bottom step of staircase on way up to bedroom. Next thing I knew I was lying on the floor. Awoke in sweat and with dry heaves. Wound up with bump on head and back black eye starting that afternoon. Stomach queasy all day.
Information has been received from a health professional concerning an approximately 7 year old patient who was vaccinated with a dose of VARIVAX (Merck) (lot #, route and site of administration not reported).  On approximately 27-MAY-2008 the patient developed 5-10 lesions.  At the time of the reporting, the patient's outcome was unknown.  This is one of several reports from the same source.  No further information is available.
headache, bodyaches, low back pain. He took advil this morning at 0600 with improvement. He has not sought emergency/PMD/UC treatment. Advised patient to take tylenol for bodyaches and we will call him to follow up.
my entire sense of taste and smell has completely changed and I can no longer enjoy having the food that I love; my entire sense of taste and smell has completely changed and I can no longer enjoy having the food that I love; This is a spontaneous report from a Pfizer a contactable consumer (Patient himself). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration in left arm on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization and experienced with No reaction on previous exposure to vaccine. On an unspecified date patient stated that "her entire sense of taste and smell has completely changed and she can no longer enjoy having the food that she love, there is nothing else that could have caused that and she haven't got sick. She hasn't done anything except taking the vaccine and it's ruining my life." Outcome of events was unknown.  The lot number for the vaccine, [Pfizer/BioNTech COVID-19 Vaccine], was not provided and will be requested during follow up.
I started to experience stiff joints and a swollen knee. I have arthritis on my left knee and right elbow and both were painful to use. I also started to get some pain in my right hand. I never experienced inflammation in my right hand until after the vaccine was administered. I rested for a couple of days and took my Humira a day early to get some relief.  The Humira helped calm down some of the symptoms, but I am still experiencing more inflammation than usual. My left knee is warmer and swollen compared to my right knee. I am also more cautious when using my right elbow to prevent discomfort.
Nausea/vomiting, swelling, redness, heat at site of vaccine. Headache. Fatigue.