chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic reaction; Swelling in her left arm at the injection site; Itching in her left arm at the injection site; This spontaneous case was received on 30-Apr-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-01263) and concerned a 39-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2013, the patient was vaccinated with Fluvirin (inactivated influenza virus surface antigen (subunit), egg-derived, influenza vaccine; anatomical location: left arm, dose and route of administration: not reported) for influenza prophylaxis. The batch number reported was 13394P and expiration date: Mar-2014.  On an unspecified date, an unknown amount of time after receiving Fluvirin, the patient experienced an allergic reaction, swelling and itching in her left arm at the injection site. She was treated with Benadryl (diphenhydramine hydrochloride), at dose of 15 mg.   On an unspecified date, 24 hours after the onset, the patient recovered from all events.   The reporter did not provide a causality assessment.  Company comment: All events are assessed as related to Fluvirin.; Sender's Comments: All events are assessed as related to Fluvirin.
Hives - wrists, elbows, ankles, knees, waistband, hands - swelling, redness, itch approximately 24-72 hours after vaccine.  Swelling and numbness of lips, tongue, cheeks approximately 24-48 hours after vaccine.
Information has been received from a pediatrician's office concerning a 6-year-old female with no previous medical history and no illness at the time of vaccination who on 10-AUG-2000 was vaccinated subcutaneously in the right arm with her first dose of varicella virus vaccine live (Oka/Merck) (Lot 3 634502/0538K). On 10-MAR-2007, the patient experienced chickenpox evidenced by an erythematous papular rash scattered in the back, chest and arm with some areas of scabbing. There was no fever. Approximately 50 lesions were noted with excoriation. Subsequently, the patient recovered from chickenpox. No additional information to report. Additional information has been requested.
Pt experienced a syncopal episode during observation period after receiving Janssen vaccine. Pt did not sustain any falls while sitting in chair. Pt was given water, sugary snack, and had leg raised. Pt reported "feels fine" and was able to walk out of the vaccination site after approximately 20 minutes.
shingles; On or about February 3, 2016 and on April 19, 2016, pt was inoculated with ZOSTAVAX; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   On 03-FEB-2016 and on 19-APR-2016, the patient was vaccinated with two doses of the zoster vaccine live (ZOSTAVAX) (lot number, expiration date, anatomical location and administration route were not reported) at a clinic, for the long-term prevention of shingles and/or zoster-related conditions (extra dose administered) at a pharmacy. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX inoculation, patient was treated by a healthcare provider at emergency department for shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization (on an unknown date), physician care, monitoring, treatment, medications, and supplies. By the time of the report, the patient did not recover from shingles. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
After receiving the flu vaccine, client started to fall over to one side. Nurse helped child back to an upright position and used an ammonia ampule to arouse her. Client regained consciousness and seemed to be alright after a couple minutes. Child was also given water to drink. Childs' mom stated that the child had not eaten all day.
Puffiness over the left lower eyelid.  Pt was given Benadryl (2.5ml) in office and was observed for 30minutes.
Initially tingling all over extremities and very high blood pressure, dizziness and ringing in ears.  Ringing in ears never went away, and blood pressure has remained elevated, now 3.5 months later.   Previously had covid 2 months prior to vaccine.
Wrong dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (wrong dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. wrong dose was given to adults mistakenly and were reported to VAERS and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 08-Jan-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.  This case contains information for the patient 85 out of 104 patients described by the reporter.
Right arm vaccine site became red and swollen where varicella was administered, and persists 2 days after vaccine was received.
BODY ACHES AND FEVER WITH EXTREME WEAKNESS BEGAN.  SWELLING AND REDNESS AT INJECTION SITE. TREATED WITH IBUPROFEN 800 MG EVERY 4 HOURS. BY 3:00 PM HIGH FEVER WITH SEVERE CHILLS AND SHIVERING, NAUSEA, INCREASED REDNESS AND SWELLING IN INJECTION SITE. CONTINUED TREATMENT WITH IBUPROFEN THROUGHOUT 1/10/13. CONTINUED 102 FEVER, NAUSEA, EXTREME WEAKNESS, BODY ACHES. WENT TO URGENT CARE AT 6:00 PM.  RECEIVED TYLENOL, RX FOR PHENERGAN WITH CODEINE AND PREDNISONE. BY 1/11/13, DECREASED FEVER, CONTINUED WEAKNESS, LESSENED BODY ACHES. BY 1/13/13 MOST SYMPTOMS CLEARED, SLIGHT BODY ACHES.
Purpura right hand and penis, arm pain, fatigue, fever, pallor, bilateral stomatitis, chest pain, scapula pain, neck pain, left shoulder pain, left arm pain, shortness of breath, palpitations, new-onset angioedema in May 2021, and acute, severely prolapsed mitral valve with severe mitral valve regurgitation, requiring robotically-assisted mitral valve repair by Dr. at hospital on 7/27/2021
Thursday  I ran a low -grade fever and had a headache all day.  I was better by yesterday, the following day. Last evening my arm looked a little pink and today it is a deeper pink and a little itchy. The area is the size   of a small grapefruit. I had no reaction to the first dose and had it in the same arm.
MOC c/o increased rash/redness on body trunk & extremities since yesterday afternoon.
Myalgias, Chills, hyperesthesia, Headaches, neck pains, fatigue, weakness. The day after the second dose.
Information has been received from a medical assistant concerning a 7 year old patient with no pertinent medical history and an allergy to penicillin who was vaccinated SQ with 0.5 mL of the second dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 06-SEP-2007, the patient experienced varicella, with about 20 lesions. No lab diagnostic tests were performed. There was no product quality complaint. Medical attention was sought at an office visit. As of 07-SEP-2007, the patient was recovering from varicella. This is one of thirteen reports received from the same source. No further information is available.
Cough, Chills, Body aches, Nausea, Swollen eyes, Eyes mattered up.
Janssen COVID-19 Vaccine EUA: patient presents to emergency department (ED) reporting vertigo for four days starting soon after vaccination. At the time of vaccination patient administered multiple doses of epinephrine for suspected allergic reaction to vaccination and transported to ED for persistent nausea, vomiting, and tachycardia. Those symptoms resolved and patient was discharged to home stable. Since that event patient has experienced persistent vertigo. Vital signs within normal ranges except blood pressure 143/106 mmHg. Exam documents no focal neurologic defects. Diagnosed with vestibular inflammation, prescribed prednisone, and discharged to home stable.
No additional AE/PQC; patient was inadvertently administered  an expired dose of MMR II.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 02-AUG-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II), 0.5 milliliter, lot #U022983, expiration date: 22-JUL-2023 (strength, dosage regimen, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.
This spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 25-FEB-2014 was vaccinated with a dose of PROQUAD (Merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with HPV vaccine (yeast). Subsequently, following vaccination, the patient fainted.  The patient fully recovered.  No further details were provided.  Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 2/14/2007. No further information is available.
Tingling in hands and arms, numbness in right middle finger and index finger, muscle spasms in right arm, chills and hot flashes, slurring of speech and numbness of tongue, headache and neck pain.  All symptoms exhibited the afternoon of 8/24/2010 through 8/26/2010. Went to the Hospital Emergency Room for treatment.
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 18-MAR-2015, the patient was received improperly stored VARIVAX (Merck) (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue(PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received BEXSERO for prophylaxis. Previously administered products included BEXSERO with an associated reaction of injection site pain (1st dose received few years before the date of reporting, for tolerance refer case US2018GSK207716). On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a day after receiving BEXSERO, the patient experienced injection site pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were reported as follows: This case was reported by a nurse who gave the injection. The age at vaccination was not reported. The nurse reported that the patient stated this BEXSERO injection was 10 times as painful as the first dose of BEXSERO. The patient took Advil on the 2nd day and the pain resolved by the 3rd day. The nurse gave consent to follow up.
Vaccine administered 1/24/06 and developed rash several weeks afterward which appeared to be an erythematous patch rash on knees, fingers, legs, upper back and neck.
development of new onset sz, eye deviation, salaam spells w/EEG consistent w/hypsarrhythmia;Annual follow-up received on 10/04/2000 states that the seizures and developmental delay are ongoing.
coughing; congestions; headache; not feeling very good; he tested positive for covid infection last Friday; he tested positive for covid infection last Friday; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BNT162B2" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 06May2022, outcome "unknown", described as "fever"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 06May2022, outcome "unknown" and all described as "he tested positive for covid infection last Friday"; MALAISE (non-serious) with onset 06May2022, outcome "unknown", described as "not feeling very good"; COUGH (non-serious), outcome "unknown", described as "coughing"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestions"; HEADACHE (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive. Clinical Course: Caller, 38-year-old male, said he and his wife (30+ y/o) already received 3 shots of Pfizer covid vaccine, then he tested positive for covid infection last Friday, while his wife has been testing positive for over a week now. Caller stated that they are having a medium flu-like symptom; fever, coughing, congestions, headache. Caller said they do not feel the need of being hospitalized as he described the symptoms to be just mild, he is just wondering why the vaccine shots didn't work. Caller states he received the Pfizer Covid Vaccine 3 times and he is 38 years old and he has had the worst weekend ever after testing positive for Covid last Friday. Caller states he has a fever and he is not feeling very good. Caller states the vaccine is not working well, he has got it in his system, but it is not doing anything for him. Caller states the reason he is calling is because he is wondering why it is not working? Caller states they advertised everyone needs to get the shots, its been tested and it works but he doesn't know why it didn't work for him. Caller states he got the Omicron Variant and he is not seeing that the vaccine is working.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & devel an inj site rxn characterized by impressive redness & soreness;pt also had a lot of arm pain;rxn has lasted 5-7days;this is one of 3pts from this sit who exp above rxn;
Narrative: Timing error 2nd dose - Moderna vaccine given 22 days after 1st dose
About 10 hours after 2 nd shot- I  woke to use bathroom  and blacked out,  hit ceramic floor and was unresponsive. I had no muscle aches, fever or sense of lightheadedness prior to episode.. I woke unaware on floor- bumps, black eye., bruised.  I felt out of it - unclear, unfocused after this.
received the first dose of Shingrix 2 years ago and would like the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th April 2019, 2 years prior to reporting, batch number-X5XY4 and expiration date-2nd July 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The pharmacist called in on guidance of a Shingrix second dose.  The pharmacist stated  that the patient received the first dose of Shingrix 2 years ago and would like the second dose. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The healthcare professional (HCP) did not confirm a second dose being administered. The HCP wanted guidance on how to proceed with second dose. The reporter did not consent to follow-up.
Monday 10/31/2011 - received vaccine - felt bad next day then felt a little better - began having weakness on Thursday - Friday drenching sweats at night, severe HA at base of skull and feeling of something in his throat and nausea - these symptoms have prevailed since then (11/08/2011).
First bowel movement 17 hours after the vaccine-heavy rectal bleeding.  This have never happened to me before.  Assume it is related to the vaccine.  I don't know if this will be a one-time thing, but it is certainly the first time I have bled from the rectal area.
Patient received gray top pfizer booster thatw as inadvertently diluted with 1.8 ml sodium chloride.
I started getting symptoms of COVID on 4/7/2022. My symptoms were scratchy throat and thirsty. My symptoms progressed to stuffy nose, coughing, headache, sneezing, and felt feverish but never had a fever. I did an at home COVID-19 test that indicated positive. My symptoms lasted for 7 days. I called my doctor and was told if I got worse to call back or go to ER.
Red, swollen, painful, warm to touch. Patient diagnosed with cellulitis of upper, left arm.
Localized reaction - Swelling size of quarter and redness in area - Reaction disappeared after cold compress applied for 5 minutes.
Hives on chest ,severe neck pain for weeks ,1st dose notified doctor Claritin, pepcid recommended for 2nd dose ,symptoms lasted 2 weeks missed work due to side effects sweats hot flashes parasethsta around mouth fingers period late then severe clotts when it came ,fatigue severe neck pain to side of injection on going
13 days after receiving 1st vaccine in right arm, severe deep bone pain in arm.  8/10 - 10/10 pain x 5 days.  Pain still there - 2/10 - 3/10.
Fever 100.5 - 102.00 4/16, 4/17, 4/18, Fatigue, body pain, nausea, headache 4/16, 4/17,4/18.  Fatigue, body pain, nausea, facial / eye swelling, pain when walking in lower back and hamstrings 4/19, 4/20
On 3/22/21 I experienced several bouts of diarrhea coupled with clammyness/sweating/heart rate of 102. On 3/22/21 and continue to have swelling in my left armpit (Lymph node area), spasms in my left shoulder blade and surrounding soft tissue adjacent to my left armpit and neck area.  I have experienced soreness in that arm/shoulder but not at the injection site - overall bicep and clavicle area. I have been able to alleviate symptoms to a degree by taking a tylenol once or twice a day but the pain is limiting some of my daily activities to a degree.
Client became hot took temp. Baby shaking having seizure like activity. Called 911 paramedics took to hospital. Temp 104 degrees kept overnight for observation.
Herpes Zoster, R side breast (under) to approx T10. Acyclovir 800mg with 4hrs x 10 days.
SERIOUS FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced serious fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from serious fever, and headache. This report was non-serious.
Information has been received from a registered nurse concerning a patient who was vaccinated with their second dose of varicella virus vaccine live (Oka/Merck) (lot # 657758/0642U). On an unspecified date the patient experienced cellulitis. There were six cases of cellulitis with the same lot number. 2 cases were bad enough that the needed antibiotics. It was unknown whether medical attention was sought. The patient's outcome was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
ER - 14Nov2021  -  Leg - I had a scratch on my leg - the wound did not heal and went to ER because of this . There I got tested and also tested positive. 8-10 symptoms  started. tested positive , fever, chills and threw up after 2-3 days I was over and had a simple head cold and fatique and slept on and off for a couple days . Still no taste and smell.