chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Gotten sick for about a day and a half starting about 5 hours after the dose) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Patient had never tested positive for Covid.  Concurrent medical conditions included Depression. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Antidepressant therapy. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Gotten sick for about a day and a half starting about 5 hours after the dose). In February 2021, ILLNESS (Gotten sick for about a day and a half starting about 5 hours after the dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. It was reported that patient had never been in a psyche ward. No treatment information was reported. This case was linked to MOD-2022-633800, MOD-2022-633801 (Patient Link).
Unstable blood pressure and rapid pulse. Unstable pulse and unstable blood pressure continues, following 1st and 2nd Covid-19 2019 injection.
Very sleepy at 8:30 p.m. Woke up at unknown time to my teeth chattering, very cold, too cold to get up for another blanket. Woke up at 7:30 a.m. and fell to the floor on the way to the bathroom. No balance or maybe dizzy. Spent Wednesday, Thursday, and Friday in bed. 99F temperature. Slept most of the time.
05:02 through 06.30: ? Shortness of breath ? Fluctuating blood pressure. ? Severe chest pain. ? Pain in joints. ? Muscle pain. ? Petechiae ? Purpura ? Diziness ? Headaches ? Asthamtic-like phlegm  ? Nerve pain in hands ? Numbness in hands
Right after shot pt arm got itchy and hives started. Pt given 25mg of bendryl po. and waited half hour and side effects subsided
Patient reports intemittent dizziness, changes in visual acuity intermittently and headaches.
Moderna COVID-19 Vaccine EUA-   3/30: - headache started around 2 pm,  ibuprofen taken at 5:30, nausea started around 7 pm  3/31: -woke up with a headache, felt fatigued all day, diarrhea around 5 pm, minimal appetite, nausea in the evening, brain fog on and off all day. No meds taken.   4/1: Woke up with headache, fatigued all day, nausea started around 4 pm, headache around 6 pm. No meds taken.
Lose of urine and bowel.  Pins/needle and numbness down legs and feet.  Lots of pressure on feet.  Difficulty walking.
Recvd vax @ 1145AM on 14MAY92 onset 230PM same day screaming, shaking legs & chin; no strength in arms; swelling lt ant thigh;
Large widespread hives, many over 12"in diameter. Even with Benadryl, lasted days.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with RECOMBIVAX (dose, lot number, expiration date were not reported) that were stored improperly. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 45-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) 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), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as COVID 19 treatment from 28Aug2023 to 02Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
administering a dose of BOOSTRIX via prefilled syringe using a BD safety glide (25 gauge) needle/ Product quality complaint ruled out because Luer Lok needle was not used; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in device usage process in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 5th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process. The action taken with Boostrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the wrong technique in device usage process 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 details were provided as follows: The age at vaccination was not reported. The reporter was administering to the patient a dose of Boostrix via prefilled syringe using a BD safety glide (25 gauge) needle which led to wrong technique in device usage process.  She attempted to inject into an unspecified arm, but the plunger would not push.  She did not think the patient received any medication during the attempted administration, so she prepared another dose using a new syringe from the same box and a new needle and was able to successfully administer a complete dose in the opposite arm.   Product quality complaint was ruled out because Luer Lok needle was not used. The reporter failed to obtain patient's gender and date of birth. The vaccine administration facility was the same as primary reporter. This case had been linked with case US2021167025, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167025:Same reporter
patient had swollen, knot at injection site and scaly skin, no redness, no temperature, shivering, nausea, dry heaving, very tired, stomach ache, not colon pain.
A consumer report had been received concerning a 12 year old female patient. The relevant history and concomitant disease of the patient was not reported. The concomitant medications of the patient were not provided. The patient was receiving nasal FLUMIST Quadrivalent started on an unknown date. Reporter stated that my daughter received FLUMIST Quadrivalent on Thursday late afternoon and on Saturday, she had a runny nose, on Sunday developed a sore throat, on Monday she had a fever of 100.7. This morning patient was tested positive for the flu at the doctor's office. At the time of reporting, the events of sore throat, fever (100.7) and runny nose was improving and the outcome of the event of tested positive for flu was unknown. The reporter considered the seriousness of the events of sore throat, fever (100.7), runny nose as non-serious. The event of tested positive for flu was captured and assessed as non-serious by company physician.
LOCAL REACTION TO LT THIGH 2X1, SLIGHTLY RAISED, RED.  PAINFUL TO TOUCH.
pt recv vax 25FEB98 & c/o nausea & pain in upper arm, shoulder, neck & back pain;taking APAP for discomfort;
Information has been received from a pharmacist (PharmD) concerning a female (age unknown) patient who on 26-MAR-2007 was vaccinated with a dose of Gardasil which was thought by the reporter to be her initial dose. Subsequently, on an unspecified date, the patient experienced generalized abdominal pain and was hospitalized on 29-MAR-2007 to rule out appendicitis. The pharmacist stated that all of the patient's test have come back normal but could not identify specifically what tests or labs were performed. It was noted that the patient was treated with IV fluids and pain medication as needed. At the time of this report, the patient had not recovered. No product quality complaint was involved. The reporter considered generalized abdominal pain to be an other important medical event. Additional information has been requested.
No adverse event; Dose administered after manufacturer date of expiry; Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.   No Medical History information was reported.    On 14-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-Mar-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administration of vaccine on 14-Mar-2023).    No concomitant medications were reported.  It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was 5.5 mL. Vial did not undergo any temperature excursions.  No treatment information was provided.
Information has been received from a medical assistant concerning her 13 year old daughter with no previous medical history reported who on 17-DEC-2008 was vaccinated with a first dose of GARDASIL and concomitantly at the same time with a dose of MMR . On 17-DEC-2008, the patient fainted after receiving her first and only dose of GARDASIL. The patient did not have any breakfast prior to vaccination. On 17-DEC-2008, the patient recovered within 10 minutes. The patient sought medial attention, the physician saw the patient. Additional information has been requested.
joints burning, skin burning, chills, fatigue, escalated heart rate, headache, nausea
pt recv vax approx 40 days prior to 29MAY98;pt became pregnant (LMP 20APR98) & exp a miscarriage 4wk later;
warm to touch / Injection site at Right deltoid warm to touch; expired drug given; This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number M17056, expiry date 31st March 2019) for prophylaxis.   On 11th December 2019, the patient received Menveo. On 11th December 2019, less than a day after receiving Menveo, the patient experienced injection site warmth and expired vaccine used. On an unknown date, the outcome of the injection site warmth and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site warmth to be related to Menveo.  Additional case details were reported as follows: The patient received vaccine in right deltoid. On 11th December 2019, the patient inadvertently administered an expired dose of Menveo. The injection site at right arm was warm to the touch. The reporter consented to follow up.
pt recv vax 17DEC96 & 20AUG97 pt devel chickenpox;
43 year old healthy female, approx 5'2" 125 lbs with no underlying medical conditions other than allergies tested positive for Covid today; 43 year old healthy female, approx 5'2" 125 lbs with no underlying medical conditions other than allergies tested positive for Covid today; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 23Aug2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "43 year old healthy female, approx 5'2" 125 lbs with no underlying medical conditions other than allergies tested positive for Covid today". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2022) Positive, notes: tested positive for Covid today.  Clinical course: Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported swelling and warmth at injection site of Menveo and swelling at injection site of Tdap the next day after receiving the injections. Cold compress to area was recommended and to call back pcp if any further problems.
Pt experienced painful swollen wrists and ankles in 12/99.  By the end of 01/00, all joints involved except hip joints.  Pt is under continuing medical supervision and treatment.
Patient was given his Pfizer booster dose 9 days before eligibility. Patient had no adverse side effects.
Shot didn't work / suspected vaccination failure; Had them five times; nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comments: This case was reported by a patient via interactive digital media. The reporter stated that, he/she had shingles five times and shot did not work for him/her. The reporter mentioned, nerve pain socks everyday and doctors still working to find him/her a vaccine suppressor to help with flare ups. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
My daughter and I attended a Community Flu Shot Clinic on the evening of November 11, 2020. I do not know which manaufacturer or variety of flu shot they used at that clinic.  I have gotten flu shots many times before without incident. I did remark to my daughter that it stung more than I remembered -- kind of a burning sensation during the injection and for for the whole ride home. I didn't have a noticeable reaction beyond that at first.  The next morning,  my arm ached. It felt similar to how a tentanus shot feels and there was a small red area tha looked like a mosquito bite at the injection site. I applied ice and took some bendryl and ibroprofen, per the instruction sheet I was given at the flu clinic.  By Saturday morning , I had a red patch on my upper left arm approximately three inches long and two inches wide. It was painful, itchy, and hot to the touch, with a hard lump under the skin about the size of a grape. My whole upper arm ached and it hurt to lift things or make a fist.  I called the Insurance advice nurse who suggested that I go to urgent care to rule out infection. I went to Facility and was told that it did indeed look infected. I was prescribed cephalexin - 500mg, every six hours for five days.   I am now on day two of antibiotics. The area is still red, hot and itchy but the pain has lessened and the lump seems to be shrinking in size. Ice helps.  :)
Mom specifies that girl has rash around mouth after the administration of the vaccine. Left foot swollen.
Information has been received from a physician concerning a 14 month old male who  on approx 17Aug04 was vaccinated with a dose of varicella virus vaccine live. On 28Sep04 the pt presented with shingles. The physician reported that the child was not exposed to anyone with natural chickenpox and believes this case of shingles was from the vaccine.  Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
mom c/o pt not wanting to walk on leg for 2 days; twitching in sleep; fever 102 R x 3 days; relieved by APAP; vomiting x 2 noc of vax; 28JAN94 pt exp diarrhea, viral syn;
PATIENT FAINTED ABOUT 20 MIN FOLLOWING VACCINATION. BLOOD PRESSURE WAS NORMAL, PATIENT STATED HE WAS VERY SCARED PRIOR TO THE VACCINE. AFTER FEW MIN HE WAS FINE
I received the second Pfizer shot on 4/13/21 in my left arm. The lymph node in my left arm pit was so swollen I had to ice it for days and could not put my arm down completed for a week! My primary care told me to come in if it was still sore after one week.
on 10/12 starting having a rapid heart beat, shortness of breath and light headed. After numerous testing and doctors was diagnosed with Atrial Fibrillation
black diarrhea; Stomach pain on left side under ribs, felt a lot of pressure; vomiting with blood; general malaise; fever; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (vomiting with blood) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031A21R) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (general malaise), PYREXIA (fever) and NAUSEA (nausea). On 15-Mar-2021, the patient experienced HAEMATEMESIS (vomiting with blood) (seriousness criterion medically significant), DIARRHOEA (black diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain on left side under ribs, felt a lot of pressure). At the time of the report, HAEMATEMESIS (vomiting with blood), MALAISE (general malaise), DIARRHOEA (black diarrhea), ABDOMINAL PAIN UPPER (Stomach pain on left side under ribs, felt a lot of pressure), PYREXIA (fever) and NAUSEA (nausea) had not resolved.  mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.  Concomitant product use was not provided by the reporter. Treatment medications included Nexium and ondansetron.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Started as small spots Sunday May 5th on his face, spread to his trunk arms and legs by Monday May 6th accompanied by 103 fever and severe itching.
R09.02 HYPOXIA 4/25/2023 CHF EXACERBATION, UNSPECIFIED
Information has been received from a registered nurse concerning an approximately 54-year-old patient who on 25-JAN-2006 (Lot # 651494/0504R), 22-FEB-2006 (Lot # 651494/0504R), and 26-JUL-2006 (Lot # 650889/0143R) was vaccinated with the first, second, and third dose of RECOMBIVAX HB. Titers conducted one year later in approximately 2007 (exact date not provided) were found to be negative. No additional information to report. There was no product quality complaint involved. It was noted that the reporter "would like a trace for the lot numbers provided". A standard lot check investigation was performed for Lot # 651494/0504R and Lot # 650889/0143R. All in-process quality checks for the lot numbers in question were satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released. Additional information has been requested.
LOW GRADE FEVER 100.1 DF, HEADACHE, BODY ACHE
A report has been received from a health professional and a consumer concerning a 10 years old female patient. No medical history and concurrent diseases provided. Concomitant medications were not reported. On 26-Sep-2012 the patient was vaccinated with FLUMIST. She was administered the full dose of FLUMIST in just one nostril. It rolled out of her nose all the way to her chin. The outcome of the event of administration of full dose in one nostril was unknown. The report was considered to be non-serious by the reporter. Corrected report on 08-Nov-2012: First reporter is HCP, case is now medically confirmed. Corrected report on 14-Dec-2012: Coding of administration of full dose in one nostril was changed from circumstance or information capable of leading to medication error to drug administration error. The patient had no symptoms. Corrected report on 22-Apr-2014: Manufacturer, received last season and reporter details added. The case has been updated with full data due to term additional for FLUMIST / Q/Laiv.
Continual pain at sight of injection (upper arm).  Worse at night.  Still have some pain.  Used Advil and topical  linament .  Reported to my chiropractor  in case it was a pinched nerve.  Was not and he suspected pain came from injection.
Numbness started after the second covid vaccine numbness throughout her body started in late April and early May, felt like facial droop and squeezing her left eye then saw neurologist. Has been treated with topirimate and mostly improved but still with facial numbness. Also  reports new dx atypical Migraines reports they started prior to getting vaccine.