chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUN-2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This case was reported by a nurse and described the occurrence of hep A infection in a 41 yr old female pt who received hep A vaccine inactivated (Havrix). The reporting nurse stated that the pt received her first dose of Havrix at the health dept on 01Oct03. On the same date, the pt received adult tetanus and diphtheria toxoids adsorbed. Beginning on 01Nov03, the pt travelled for approx 3 weeks. Approx eight weeks after admin of Havrix, on 27Nov03, the pt presented to an urgent care facility with a variety of symptoms. Blood work indicated acute mononucleosis and acute hep A infection. The immunization series with Havrix was discontinued. The events resolved on 16Dec03. The nurse considered the events to be unrelated to vaccination with Havrix.
This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 51-year-old female patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 13th August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a week after receiving Shingrix, the patient experienced local swelling, induration and erythema. On an unknown date, the outcome of the local swelling, induration and erythema were unknown. It was unknown if the reporter considered the local swelling, induration and erythema to be related to Shingrix. Additional details were provided as follows: The patient presented to the pharmacy with a fist sized hard really red lump.
About 2 hrs after the vaccine became very tired, Sore injection site, no energy,  agitated state of mind, more pronounced TD symptoms throughout the rest of the day.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with an incorrect storage RECOMBIVAX HB lot # M044032, expiration date  03-JUL-2019 for prophylaxis. On an unknown date the patient experienced no adverse event. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA002800:Original Case : 1708USA002800
Throat felt tight and sticky, difficulty swallowing, anxious, tingling from waist up
Patient received vaccination on 8-27-13 came in on 9-18-13 to complain arm still hurts when she lifts it.
runny nose; Light Arthralgia, upper back/shoulders, progressing to arms, wrists, hands; Fatigue; unable to grip and hold things w/ hands; sleeping 10 h; All sxs (Symptoms) w/ worsening progression; This is a spontaneous report from a contactable Nurse. This 53-year-old female Nurse (patient) reported that.  A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 12:30 as dose 1, single for covid-19 immunisation. Medical history included ewing's sarcoma from an unknown date and unknown if ongoing as a teen. Concomitant medication included omeprazole 20 mg taken for an unspecified indication, start and stop date were not reported; amlodipine 2.5 mg taken for an unspecified indication, start and stop date were not reported. It was Unknown if patient had COVID prior vaccination. No COVID tested post vaccination. No other vaccine in four weeks. Patient was not pregnant at the time of vaccination. It was reported that patient experienced Day 1: constant runny nose. 3d after dose 1: 5pm: runny nose, Light Arthralgia, upper back/shoulders, progressing to arms, wrists, hands. Fatigue. All sxs (Symptoms) w/ worsening progression w/i 2h, unable to grip and hold things w/ hands, in bed by 7 pm and sleeping 10 h. This occurs daily at the same time (5p). Upon awakening the following am, I am back to my normal self / feeling well. It was reported that patient received treatment: Ibuprofen- No relief of sxs (Symptoms). The outcome of event all sxs (symptoms) w/ worsening progression was unknown and outcome of al other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US022041, is an initial spontaneous report received from healthcare professional on 26 Oct 2015. This report refers to a 53 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly on 26 Oct 2015. It was reported that vaccine was stored at room temperature for 8 hours prior administration. No adverse event was reported following this medication error.
Shoulder joint pain, limited movement, swollen hard muscle at approximate sight of injection, sometimes nerve pain extending from shoulder to hand and other times entire arm searing heat or cold sensation, and sometimes muscle ache. Unable to get into comfortable position to sleep. Difficulty sleeping.  Difficulty doing routine movements and avoid doing some things wearing clothes that require certain movements or drying hair, etc.
20 minutes after injection red all over upper border lips had small bumps. Face and top part of body really hot.
HOT FLUSHES IN THE FACE; A LITTLE DIZZINESS; A LITTLE KIDNEY PAIN ON HIS RIGHT  SIDE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included back fusion, rheumatoid arthritis, and mild high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 on left arm for prophylactic vaccination. Concomitant medications included etanercept for rheumatoid arthritis. On 06-MAR-2021, the subject experienced hot flushes in the face. On 06-MAR-2021, the subject experienced a little dizziness. On 06-MAR-2021, the subject experienced a little kidney pain on his right side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot flushes in the face, and a little dizziness on 06-MAR-2021, and a little kidney pain on his right side on 12-MAR-2021. This report was non-serious.
Please note that I have had Covid-19 2 months prior and have since tested negative.   Event:  Low grade fever 100.5, extreme fatigue, body aches, sore arm at injection site.
EXPIRED VACCINE ADMINISTERED 2 HOURS PAST EXPIRY TIME.; INJECTION SITE PAIN; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, for prophylactic vaccination (unspecified manufacturer) (dose series 1).  The patient received booster dose covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211B21A expiry: UNKNOWN) dose was not reported, administered 1 total, on 15-NOV-2021 for prophylactic vaccination in the left arm (dose series 2). No concomitant medications were reported.  On 15-NOV-2021,  the patient  experienced vaccine administered 2 hours past expiry time and injection site pain. It was reported that the vial had been punctured and was past the six hour expiration time (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and the outcome of expired vaccine administered 2 hours past expiry time  was unknown. This report was non-serious.
Too cold - can't get warm; Too hot; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events too cold - can't get warm/ feeling cold, too hot/ feeling hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the events too cold - can't get warm, too hot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, too cold - can't get warm, too hot was unknown.
pt recv vax; exp T 104; apap & tepid bath given;v x 1;low grade fever & dec appetite;
Heat at injection site immediately after administered, red face, "hot flash", heart flutter, arm tremors. Did not take any medications. Symptoms have improved.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-NOV-2014, the patient was vaccinated with a dose of VARIVAX, 0.5 ml, subcutaneous (lot number and expiration date were not reported) that underwent a supported temperature excursion. No adverse experience reported. This is one of several reports received from the same reporter. Additional information has been requested.
Accidently administered Tdap Vaccine after Moderna Covide-19 Vaccine within a week; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of IMMUNISATION (Accidently administered Tdap Vaccine after Moderna Covide-19 Vaccine within a week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced IMMUNISATION (Accidently administered Tdap Vaccine after Moderna Covide-19 Vaccine within a week). At the time of the report, IMMUNISATION (Accidently administered Tdap Vaccine after Moderna Covide-19 Vaccine within a week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I started getting super tired, fuzzy in the brain, listless. I took two home COVID-19 test. I thought the I had messed up the first one so I took a second one, both tests came back positive. I called my doctor, he prescribed the PAXLOVID. I think I was not taking the medication correctly. I kept getting work halfway through the medication. On February 20, 2023, I called the EMS to come take me to the emergency room. My heart rate was 180 upon arrival of the EMS. I cannot remember all tests that were run. I was hallucinating at one time during my stay in the hospital. I am on the road to recovery; I have a follow up appointment with my primary care physician and a heart doctor May.
Dizziness; drop in blood pressure; severe aches and pains in joints; low grade fever; migraine; nausea; throwing up; weakness
pt recv vax 1APR97 & exp hives & itching;to ER for intense itching treated w/unspecified IV med & DPH, pred & zantac;
2 minutes p/getting vax had fell out of chair, had a few (2-3) shakings of head & arms; p/5-10 sec got up & did not know what happened;
Received flu vaccine. Do not know any information about the manufacturer date or lot number. Nausea, light headed, fever.
Information has been received from a pharmacist referring a female patient of unknown age. Information about medical history, concurrent conditions and concomitant therapies were not provided. On 09-JUL-2015, the patient was administered first dose GARDASIL 9 (intramuscular, strength, dose, lot # and expiration date were not reported) for prophylaxis. On 23-MAR-2019, the patient was administered second dose GARDASIL 9. On 14-FEB-2019, the patient was administered third dose GARDASIL 9 (lot# N028092 expiration date 28-MAY-2020, dose 0.5 ml). (inappropriate schedule of product administration). No adverse effects reported after any dose.
Incorrect dosage administered. Patient received 0.25ml of Moderna blue cap booster dose instead of 0.5ml. Patient contacted and made aware of error. He denies any adverse effects and does not want to receive the other half of vaccine. Patient denies any other complaints.
Patient called pharmacy on 10-5-12 complaining of her left arm being red and swollen. Her bones and knees were hurting as well. The pharmacist suggests she take BENADRYL and call her doctor, patient states she is fine today, 10-9-12. Her doctor told her to wait until Sunday 10-7-12 for further directions. No directions necessary she also used cold compresses.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/16/2022 ACUTE RENAL FAILURE, UNSPECIFIED
The patient received Pfizer COVID vaccine (LOT: EN6203 EXP: 6/30/21) first dose on 3/3/21 and Pfizer COVID vaccine (LOT: EW0158 EXP: 7/31/21) second dose on 4/8/21 and was hospitalized with COVID pneumonia on 4/25/21
Large swollen raised and red area around shot location.  Size of an egg.  Very raised and red.
This case meets vaccine breakthrough criteria review.  SXS 1 WEEK OF COUGH, NAUSEA, DIARRHEA, BODY ACHES, CHILLS
Blurry vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: EP6955) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing). Concomitant medication(s) included: CITALOPRAM taken for anxiety; DIAZEPAM. The following information was reported: VISION BLURRED (non-serious) with onset 2021, outcome "recovered" (2021), described as "Blurry vision".  Additional information: He experienced a little bit of blurry vision. He provided her weight as 175-180lbs. He didn't have a prescribing doctor. He got the vaccine trying to be a proactive adult. The blurry vision started about an hour after both shots. The blurry vision is more with his distance vision, even with his glasses on. Which he guess is nearsighted. It was the distance that was effected both times even with glasses on. The blurriness has seemed the same both times. After the first vaccine the blurred vision lasted a week. So he will see what happens with this one. The concomitant medication Diazepam was taken for sleep by patient.  No follow-up attempts are possible. No further information is expected.
Hey guys, just a heads up if you know anyone with a CPAP machine who just received a second dose of the vaccine.   I received the shot on Friday.  No reaction all day.  No reaction all day Saturday.  Saturday/Sunday night I started vomiting into my CPAP mask/machine while still asleep. I wouldn?t have woken up unless my wife was there to hear me choking. She cleaned out my mask and had me lay on my side all night while monitoring me.  Scary stuff. Just thought you should make your friends with apnea aware. I still don?t remember the incident at all. I have a mild fever right now, 99.8. I used to tell my wife she saved my life, but now I don't mean it figuratively. UPDATE: I forgot to mention that I passed out Saturday night.  I was standing in the kitchen and the next thing I knew I was on the ground.
Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves approximately 35 years old female patient for whom receive ADACEL after receiving TENIVAC inadvertently was reported, while she received vaccines ADACEL and TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s), concomitant meidctaion and family history were not provided. On 08-Nov-2018, the patient received a 0.5 ml dose  of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot number not reported via intramuscular route in the right arm. On 08-Nov-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. The patient receive ADACEL after receiving TENIVAC inadvertently (extra dose administered) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Final diagnosis was receive ADACEL after receiving TENIVAC inadvertently. It was an actual medication error due to extra dose administered. It was not reported that if any adverse event occurred or not. Outcome of event was not applicable. 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. Documents held by sender: none.
Patient reports one week after vaccine administration he developed several papules and pustules on the lowere extremity with no clear cut etiology. He asked me to report it just in case it was a relevent reaction.
Patient developed rash around the sight, low grade temp, and muscle aches for about 48 hours.
12/31/14 pt. came to HD and reported to secretary that she had knots and pain in her (L) arm where she rec'd vaccines the previous week.
Medication Error. Moderna COVID Vaccine given to patient under age 18. Patient is currently 15 years old.
Approximately 12 hours after vaccination pain and slight stiffness was noticed in the right upper arm.  No after vaccination treatment was received according to report from client.  Shoulder stiffness progressed for the next 2  and 1/2 - 3 days after vaccination resulting in limited mobility, client unable to raise her arm.  Client called her physician who advised her to call the HD which she did 2/16/21 at 4:50pm.  Client reports having no other symptoms after vaccination and is applying (Icy Hot) patch to shoulder area which seems to be improving her mobility.  she is able to raise her right arm and the soreness is improving.  Client stated she would call her physician if she does not continue to improve and is agreeable to a call next week to see how she is progressing in her recovery.
Patient transferred from facility with  Exploratory laparotomy,  Lysis of adhesions,  Ileocecectomy with anastomosis,  Mid-jejunal small bowel resection with anastomosis, and  Ventral incisional hernia repair with biologic mesh related to chronic bowel obstructions
Suspected vaccination failure; I got the shingles shot and I broke out on my head; inching / inching bad; my whole head hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and headache. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and headache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and headache to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporting for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. After receiving Shingles vaccine, the patient broke out on his/her head. It was driving the patient crazy. The patient's head was hurt and itching bad. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Information has been received from a physician assistant concerning a 12 month old male who on 15-JAN-1999 was vaccinated with a dose of VARIVAX (Merck) injection. On 17-JAN-1999 the patient experienced a chickenpox like rash about 2 days after vaccination with VARIVAX (Merck). On an unspecified date, the patient recovered from a chickenpox like rash. Additional information has been requested.
Deltoid - 3cm diameter area of mild swelling, erythema, warmth, tenderness, cellulitis.
Presents to the ED for evaluation of fall. Tested positive for COVID on admission 10/16/2021
extreme neck pain associated with the infection; associated with the infection; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neck pain and infection. On an unknown date, the outcome of the neck pain and infection were unknown.   It was unknown if the reporter considered the neck pain and infection to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient took his/her first dose of the shingles injection.  The reporter wanted to know was it normal to had very extreme neck pain associated with the infection. The follow-up could not be possible as no contact details were available.
5 minutes after my body begin to feel warm and I begin to get light headed and my upper brow began to swell. I was laid down and my BP and BS wd elevated so I was take to the ED where I was given benedryl, pepcid and tylenol .  I was released with a Epi pen and while at home my tongue starting feeling a little furry and swole a little but I continued to take benedryl for that but I had a bad headache that lingered for the next 2 weeks after wards
fever 101, fatigue 24 hrs, weakness generalized for 24 hrs; vomiting 2 hrs p/vax; malaise;
This child had a swollen leg, right anterior thigh slightly warm, firm, erythema, edema (13cm x 13cm). Full range of motion, full weight bearing. Treatment: ice packs to the thigh, Benadryl next 24 - 48 hours for elevated erythema, decrease range of motion, or fever call doctors office or go to the ER. Emergency hours and # given to the mom.