chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When I got the first vaccine I was in my 36th week of pregnancy. I started to get a tingling sensation 06/3/2021 on my right pelvic area and extended up to my back. I developed a rash on 06/05/2021 and it felt like a burning sensation if I touched it. I went to the Urgent Care two days later because the rash was spreading. They took a swap and it was positive for Shingles. I had the Chicken Pox as a child and I had the Chicken Pox vaccine as well. I was given Acyclovir5Xdaily for 7 days. The rash dried up and it is starting to get better.  Due Date: 06/28/2021  Pregnancy: First
Headache, nausea, itching at injection site, raised and red around injection site.
Diffuse red papular rash all over body no large 2-3 cm realized indurated areas - 2 on back and 1 on leg. Also no fever.
Hives from head to ankles.  Itching. Reddness. Benadryl 25mg po.  No other signs or symptoms.  Resolving, may meed to administer a second dose or seek family doctor if unresolved.  Monitoring closely.
Pt recvd 3 Hep B vax 1AUG89, 31AUG89, & 23JAN90; following these titer=5; Pt was given a 4th dose of Engerix-B vax on 15AUG90; Pt seroconverted p/4th dose titer=80; 7AUG91 titer=12;
Recieved the vaccine 12-16-20.  12-17-20 Started experiencing body aches, headache, and cold/hot sweats.  Some swelling at injection site.  12-18-20 Only symptom is significant swelling, redness, and hot to touch.  12-19-20  Site swelling, redness, and hot to touch had spread.  Got Antibiotic Keflex 500mg QID.  12-23-20 significant reduction.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:19 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
16JUN97 abd discomfort;bad h/a x 2 1wk;
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 15:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing); "Type 2 sugar diabetes" (ongoing); "high blood pressure" (ongoing); "lower lumbar sciatica" (ongoing); "COVID-19", start date: 11Mar2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Apr2021, outcome "recovered" (05Apr2021), described as "sore arm".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that with the first Covid 19 vaccine, she just had a sore arm the day after she received it and it only lasted a day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving the vaccine, patient was standing in the line to pay for his purchases. He suddenly fall down on his back. He was unconscious, breathing normally, no swelling in lips or face, no hives, no sweating, no obvious injuries. 911 was called. He positioned on his back. His legs was raised above heart level until the ambulance arrived.
with adverse reaction to vaccine; This spontaneous report was received from a physician referring to a currently 76-year-old female. The patient's medical history included renal insufficiency, lung nodule, nephrolithiasis, appendicectomy, tubal ligation, prolapse repair, spinal laminectomy, hysterectomy, carpal tunnel decompression, spinal fusion, cholecystectomy, endoscopic retrograde cholangiopancreatography, intestinal obstruction, hand operation, cystoscopy, thumb Surgery, trigger finger release, arthroscopy, biopsy liver, magnetic resonance imaging of lumbar spine, and ultrasound abdomen. The patient's concurrent conditions andc therapies were not reported.  On 22-APR-2009, the patient started therapy with zoster vaccine live (ZOSTAVAX) subcutaneous injection (dose, strength, lot #, expiry date, and route of administration were not provided) administered for prophylaxis.  On an unknown date, the patient experienced adverse reaction to vaccine. The outcome of the event was not reported. The causal relationship between the event and zoster vaccine live (ZOSTAVAX) was related.; Sender's Comments:  US-009507513-2208USA008403: US-009507513-2208USA008360:
Patient was administered with vaccine past the BUD (17-Feb-2023); No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history or conditions, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis). The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with vaccine past the BUD (17-Feb-2023)).    No concomitant medications were provided. The vaccines were administered between 13-Mar-2023 to 05-Jun-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. No treatment medication was provided. This case contains information for the 8th of 20 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
States hr so after after shot just went to itching and burning. had to pick pet up so did not report til today 1:30 pm 9/11/09. Asked if she took anything for pain or ice cloth to area - Now worried about pet surgery, area red very warm.
Pt vaccinated at 6:15pm.  At 6:25 pm developed subjective sensation of tightness in throat. No SOB, no GI sx. Pt given 25 mg Benadryl at 6:30 pm; continued to note sensation of throat swelling with difficulty swallowing. MD onsite evaluated the patient and monitored her. PMH: prior allergic rxn to chemical exposure requiring epi-pen. no meds, NKDA. Tolerated 1st vaccine w/o effectsPE: p 80s, RR 18, BP not measured;Face/Neck, throat no visible swelling; Skin: no rash, no hives; lungs: clear; Cardiac regular. Pt given epipen at 6:35. Sx's improved. At 6:45 reported return of sensation of throat tightening and some difficulty swallowing. PE was unchanged, pt speaking in full sentences (see cont page)  Pt received 2nd dose of Pfizer COVID 19 vaccine at 6:15 5/6/21. At approx 6:25 pm developed subjective sensation of tightness in throat. No SOB, no GI sx. Pt given 25 mg Benadryl at 6:30 pm; continued to note sensation of throat swelling with difficulty swallowing.   PMH: premature menopause, previously allergic rxn to a chemical exposure requiring epi-pen.  no meds, NKDA. Tolerated 1st dose of vaccine w/o effects  on PE p 80s, RR 18, BP not measured  Face/Neck, throat no visible swelling  Skin: no rash, no hives lungs: clear Cardiac regular  Pt given one dose of epinephrine via epipen at 6:35. Noted improvement in sx. However, at approx 6:45 reported return of sensation of throat tightening and some difficulty swallowing. PE was unchanged, pt speaking in full sentences, no distress, pulse and respirations stable, no wheezing or facial/tongue/throat swelling noted.   Pt offered option of reporting to ER or urgent care for more prolonged observation, but declined. Rx for prednisone 50 mg daily x 5 days and epipen called into local pharmacy. Pt cautioned about need to call EMS if increased difficulty swallowing, SOB, dizziness, GI distress. Pt's 21 year old son lives with pt and is aware of precautions.  Pt was observed until 7:20 pm , reported improvement in sx prior to leaving vaccination site.     Addendum: Dr. (Name), MD contacted pt by phone on Friday May 7. Pt was confirmed to be at work at a restaurant; and "too busy to talk" The patient also returned a phone call on Wednesday, to Dr. (Name's) office and left a contact phone number. Therefore, it appears pt has recovered from the incident and is able to go to work
Case number PHEH2015US026923, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 21 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 06 Oct 2015 which was stored out of recommended temperature range (temperature excursion at 34 degrees). The nurse stated that, the reason for the refrigerator to be out of temperature range was unknown. There was not any further problem since the temperature excursion problem. No further information provided. No adverse event was reported following this medication errors (incorrect storage of drug). Follow up report received from nurse on 26 Jan 2016: Updated reporters comments.
My left arm was extremely soar where i could not raise it.  i went to an urgent care clinic on the day i stated feeling the pain.  they gave me a steroid shot and prescribed 5 days of prednisone.  the pain of movement didn't change drastically, but i noticed it was a little better.  Now i am in 3 weeks of this problem and the paid is in my deltoid muscle.  i got a heating pad and i use ibuphophen at night.  i am not able to sleep sell during the night and im normally a 6 or 7 hour sleeper straight.
Patient reported normal adverse reactions of pain, soreness, and fatique in the days following vaccination. What she was concerned with however is the redness at the injection site that has persisted now 5 days following vaccination. As noted earlier, she noticed the redness around the 3rd day, but is uncertain whether it was present prior to that. Upon contacting her family physician (via phone to my knowledge) today, he prescribed a MEDROL dose pack and I fruther advised that diphenhydramine may assist if due to an allergic reaction.
I've had worsening tinnitus since my second shot.  There were not spaces for multiple dates of shots, but my first two were at Facility and my booster at Pharmacy.  I had tinnitus prior (very minor), but it is chronic and heavy now in both ears, both as steady sound and wavering.
Suspected vaccination failure; I only got one shingle on my lower back; Was very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case The age at vaccination was not reported. A year after the patient got the shingles shot and the patient got shingles. The patient only got one shingles on his/her lower back.  The patient further stated that if patient had not got the shot, he/she would of have more shingles and that one was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Fluzone High-Dose administered that had undergone delayed shipping transit/No AE; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA307301, 2019SA307319, 2019SA307320 and 2019SA307322 (same reporter).  This case involves a 75 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] that had undergone delayed shipping transit.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Oct-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ290AB, expiry date- 09-JUN-2020 via intramuscular route in the right deltoid.  It was a case of actual medication error due to incorrect product storage.  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.
on March 4, 2021 I felt itching on my forehead.  It felt like poison ivy but I knew I had not been in contact with poison ivy.  On March 8,      I saw a dermatologist who confirmed it was shingles.  He prescribed  Valacyclovir.  It lasted for about 1 week.
Redness, swelling, warmth to site of infection 3x4cm in size.
Chest tightness, difficulty swallowing, short of breath during exertion and wheezing. Skin flushing. Epi 0.5mg and 50mg of Benadryl given.
By 3pm, my arm was so sore that I couldn't lift it. By 4:30pm I was starting to get throbbing pain in my arm as well as intense pain to any touching of my arm. My arm also swelled. It felt like someone was pulling on my arm muscles and trying to rip them out of my arm. I napped for 2 ours with a heating pad and it didn't help. Then I iced my arm for a few hours and the swelling started to go down. I also was nauseous all evening. All night long, if I moved my arm I would get waves of pain and throbbing. As of 5pm the next day, the swelling has gone down and I have some use of my arm, but it is still painful to touch my arm and the muscles are still incredibly sore. This is NOT normal swelling and soreness from a vaccine.
Hot and cold flashes, Headache, Nausea, Dizzy, Light headed, fatigue, soreness at injection site
The patient developed a rash/redness on arm and welts on chest and back 3 days after receiving vaccine.
10/17/14-Red blister about 1 inch to the left of injection site and swollen lymph node (golf ball sized) by L clavicular bone. 10/18/13 and 10/19/14 - severe muscle spasms to R upper back. 10/20/14-sore neck, no back spasms.
Dizziness and nausea began overnight on Feb 4-5, continuing throughout the day on Feb 5. Went to ER for treatment the evening of Feb. 5. IV fluids administered to treat mild dehydration. Symptoms eased temporarily, then increased on Feb 6. As of today (Feb 10), symptoms have steadily improved, but not yet fully recovered.
Swenllen area, fecer in area, itchy and little pain. Started to feel symptoms during afternoon.  My doctor prescribed predisone 20 mg one daily for 3 days.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. Date of Refrigeration  of Vaccine was 07/05/2021.
Fever, extremely high heart rate within 14 hours of dose, tender knot in Rt neck at collarbone, extreme muscular aches, weakness, stomach pain, fatigue
Seen at ED 12/6/09 for vomiting and diarrhea. Mom informed ED pt had had since night before, received IV fluids and ZOFRAN. Also amoxicillin for early PNA.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 4:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 4:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 44.59 years.  Concomitant products were not provided.  On 27-May-2021, the vaccine with batch number 008C21A was moved to fridge. On 22-Jun-2021, four vials were moved to the clinic. On the same day, at 08 AM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Jun-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.
Numbness down left arm, mouth felt numb. Started 15 minutes after vaccine, lasted 45 minutes.
Arthralgia & UrticariaPruritus Narrative:  At 21:00 on 12/28/20, employee developed severe itching all over her body. She took OTC diphenhydramine 50 mg + famotidine 10 mg at 07:00 on 12/29/20. Itching persisted for 14 hours, until she fell asleep. Upon waking, she complained of bilateral hip pain which lasted 24 hours.
Within 3 hours, rash of hives across my chest. The hives erupted with white puss. They re-erupted about one week later. 21 days later, redness is still present and the area is tender to the touch.  Within 2 hours, chills and fever of 100.0 which lasted about 6 hours.  Within 24 hours, stomach cramps accompanied diarrhea which lasted 4 days.
Initial information received on 07-Feb-2019 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 82 years old male patient who received a 0.5ml booster dose of TENIVAC batch number not reported via unknown route in unknown administration site on 17-Jan-2019. The patients past vaccination(s) included first dose of TENIVAC on 02-NOV-2009. The patients past medical history, medical treatment(s) and family history were not provided. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.