chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At about 1 o?clock 14 hours after injections started feeling nauseous as day went on became very weak and light headed along with headache and a slight fever Just went to bed by 8 am felt better but not normal yet
Office form was completed by parent. He wrote child was 2 yrs old. Child is foreign born, DOB was recorded day/month/yr. - Language was a bit of a barrier. Nurse did not double check DOB. Against form prior to administering FLUMIST. Child was 3 mos. under minimum age for FLUMIST. (No adverse reactions reported).
at injection site emerged that is red,; at injection site hot; at injection site itchy; Injection site pain; small bump/large raised lump at injection site about the size of two fingers; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the right arm on 13Mar2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, psoriasis, hidradenitis suppurativa, osteoarthritis. The patient had a history of allergy to nickel, sulfas, wool, alcohol and Neosporin. The concomitant medications included multivitamin (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN) and ALEVE. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not tested positive for COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. On 13Mar2021, the patient had injection site pain and a small bump that lasted 3 days then went away. On 21Mar2021, a large, raised lump at injection site, about the size of 2 fingers, emerged that was red, hot and itchy. The patient did not receive any treatment for the reported events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for vaccination site pain, vaccination site warmth, vaccination erythema and vaccination site itchy was not resolved while that of vaccination site lump was resolved on 16Mar2021.   No follow-up attempts are needed. No further information is expected.
This case was reported by a consumer via Regulatory Authority and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 7th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling bad, pain, cough, chills, and headache. On an unknown date, the outcome of the feeling bad, pain, cough, chills, and headache were unknown. It was unknown if the reporter considered the feeling bad, pain, cough, chills, and headache to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient just took the second dose day before reporting date and he/she feel really bad, aching, coughing, chills and headache. The patient mentioned that it would worth it to keep from getting shingles. The follow up would not possible as no contact details available.
Medical assistant reported ROTATEQ was administered after temperature excursion. No additional AE. Names of vaccines involved ROTATEQ 1968393 05/24/2024/ Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/2023); Medical assistant reported ROTATEQ was administered after temperature excursion. No additional AE. Names of vaccines involved ROTATEQ 1968393 05/24/2024/ Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/2023); This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported.  On 14-AUG-2023, the patient was vaccinated with one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis after temperature excursion (lot# 1968393, expiration date: 24-MAY-2024; strength was not provided). The vaccine was improper stored at 8.9 degree Celsius for 12 hours 20 mins on the same date (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
This case was received from a foreign health authority on 01-AUG-2013. This case is not medically confirmed as it was reported by a consumer. An 1 year old female patient (weight: 11.5 kg) with no medical history reported, received an injection of measles, mumps and rubella vaccine (manufacturer unknown, batch number not reported), dose, route and site of administration not reported, on an unreported date. On 18-JUL-2013, the patient experienced rash all over with temperature and lack of appetite. At the time of reporting the patient was recovering. The health authority considered that case serious due to be medically significant.
It was reported that a 43 year old male pt received a Menomune vaccination, and Td vaccination on 7/17/03. Two days later at 8:00 am in the morning, the pt developed numbness and tingling in the left arm, weakness in the left hand, and bilateral kidney aching and discomfort. The recovery status of the pt was reported as unknown.
Bud date 04/07/2022 Vaccine administered 04/08/2022 .Pfizer advised product actual Bud 4/9/2022. Patient advised
Information has been received from a 79 year old female retired registered nurse with blood pressure high, muscle cramps, "four fractured lumbar spine disc under control", and allergies to penicillin, iodine, DEMEROL, codeine, quinine, BENADRYL and normal saline who on 18-OCT-2006 was vaccinated with Pneumovax 23 vaccine, intramuscularly. Concomitant therapy included Atenolol, trazodone HCl and TYLENOL. Subsequently, in the afternoon the patient experienced coldness and joints that ached. Four hours later the retired nurse experienced a temperature of 102 degrees F for 24 hours. The next morning the nurse broke out in a red, raised rash, that was stinging but not itchy. The retired nurse drank a lot of fluids to help with her reactions. The nurse recovered 4 to 5 days after she experienced these adverse reactions. Additional information has been requested.
I woke up about 4:00 am feeling dizzy and nauseous. I made my way to another BR, lay down for 20 minutes, took Tylenol (500 mg) and went back to sleep. Woke about 8:00 am, feeling ?unsteady?, took another Tylenol and went about my day. Next morning (10/31) I felt fine
accidental overdose in reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; this is 1 of 30 cases reported from this site; no adverse effects noted;
Tingling, numbing, electric sensation in all four extremities began two days after the vaccine. Then experienced Raynauds in right middle finger 1/9/21 with no past history of Raynauds prior to vaccine. Then developed shingles on left hip which was diagnosed on 3/20/21. Tingling/numbing/electric sensation in all four extremities continues and has not gotten any better
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Mar-2021 at 9:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 44.55 for dose administered on 20-Mar-2021. No concomitant medications were reported. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degree Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-Mar-2021 and beyond use date for the vial was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
DOSE INTERVAL WAS 13 DAYS, OUTSIDE OF THE 17-24 DAY INTERVAL.  THIS DEVIATION DID NOT RESULT IN ANY ADVERSE EVENTS REPORTED THUS FAR.
I began to feel symptoms roughly around October 25th, 2021, soreness, and tenderness, and muscle pain around chest. As the week progressed, I began to have more pain and soreness, becoming more and more intense. I could not lean back because it was extremely painful. Any type of arm movement; I would feel it. Tuesday Nov 2nd, 2021, blood pressure was extremely high 160/110; ER visit was prompted, and they recorded 168/123 for blood pressure. Continued to feel the pain; I was in a gurney in the hallway when the doctor came. I was describing the symptoms and said that it sounds like pericarditis. I am still taking 600 mg Ibuprofen and when I don't take it, I still get pain.
pain and swelling in below arm pit of arm shot was given; pain and swelling in below arm pit of arm shot was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 10:30 (Lot number: FF2587) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; PEPCID [FAMOTIDINE]; TRAZODONE; LIPITOR. Past drug history included: Morphine, reaction(s): "drug allergy"; Lisiniprol, reaction(s): "drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 05Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6201, Location of injection: Arm Right, Vaccine Administration Time: 02:30 PM), administration date: 12Feb2021, for Covid-19 immunization. The following information was reported: AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 02Oct2021 13:00, outcome "recovering" and all described as "pain and swelling in below arm pit of arm shot was given". Therapeutic measures were not taken as a result of axillary pain, swelling.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
patient received vaccine that was administered post temperature excursion with no reported adverse event; patient received vaccine that was administered post temperature excursion with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old female patient who received Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] vaccine that was administered post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Feb-2023, the patient received a dose 1 of 0.5 ml once of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection that was administered post temperature excursion with no reported adverse event (poor quality product administered) (latency: same day) (lot: U7450AA, expiry date: 10-Oct-2024) via intramuscular route in the right deltoid with unknown strength for immunization.  On an unknown date the patient received vaccine that was administered post temperature excursion with no reported adverse event (product storage error) (latency: unknown).  Action taken: not applicable.  Outcome: Unknown.  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 the guidelines. 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.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chills-Severe, Systemic: severe body aches-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Unable to Sleep-Severe, Additional Details: pt states that a few hours after the receiving the vaccine, she experienced severe body aches, severe
0.25ml Fluviron give. Rec >4yrs. Box marked but not actual vial. Pt had no Reaction.
Patient immediately complained of feeling light headed. Several minutes after receiving the vaccine, they fainted.   Resuscitation several minutes after fainting. EMT was called and took blood pressure, temperature and EKG readings.   All readings were normal and patient refused transport and hospitalization. Profuse sweating and dizzyness after resuscitation and patient recovered enough to drive himself home 90 minutes later and left the store. After arriving home, patient experienced flu symptoms (nausea, aches, shivering, tiredness) for 24 hours after shot was administered.
I developed a extremely itchy, red and hot to touch rash on my arm at the injection site 8 days after the shot.  My biological sister also had this same delayed reaction on the same day post vaccine and she received the Moderna vaccine on a different date and location than I did.  I have photos of my rash and she has photos of her rash.  I wanted to report this so that the scientists can determine if there is a genetic link given that my sister and I both had the reaction on the same day post vaccine but got our vaccines on different days and different locations.
Client was seen at the health department about 3:30 on 3/24/08.  Client left the building after receiving a Hepatitis B shot, dose 3, and became pale, dizzy, and weak, and lost vision in his right eye.  Mom took him to Hospital and was told it was not an allergic reaction when talked with staff in walk in clinic so she took him home.  He continued to be very weak and remained home from school the next day with headache and dizziness.
After receiving the vaccine, the patient began to feel right sided neck soreness and slight itching, no rash, swelling, or shortness of breath. Additional dizziness and slightly diminished right facial sensation. Prior to receiving the vaccine, she felt anxious. Monitored in the ED and discharged home feeling improved. She declined pepcid, benadryl, and solumedrol.
allergic reaction; Neurological reaction; Obsessive blinking; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced allergic reaction, neurologic reaction and excessive eye blinking. On an unknown date, the outcome of the allergic reaction, neurologic reaction and excessive eye blinking were unknown.   It was unknown if the reporter considered the allergic reaction, neurologic reaction and excessive eye blinking to be related to Influenza vaccine Quadrivalent 2017-2018 season.  Additional details were provided as follows: The case was reported by patient's mother. The age at vaccination was not reported. The patient received a flu vaccine manufactured by GlaxoSmithKline in 2017.   The patient had an allergic reaction to the flu vaccine.   The patient had a neurological reaction and obsessive blinking. The reporter inquiring about ingredients of the 2017 GlaxoSmithKline flu vaccines.   The package inserts were not available in resources . The reporter declined to provide any additional patient demographics or details. The reporter did not consent to follow-up.
Neck pain radiating to back and down spine; chills; a little trouble breathing and soreness at site on left arm. No obvious distress.
Vacinnated on Friday..following Sunday evening noticed bumps, blisters, hives on both of my hands in the pad areas of my hands. extended into the tips of index fingers and thumbs. very sensitive to the touch. I took some Benedril which helped with swelling. that was the most severe after effect. I'm pretty sure it was the vaccine because i had not been anywhere that weekend and had not  put my hands on anything unusual that i don't normally touch. It only happened to my hands. Other than that i had minor flu like symtoms from the shot,  achiness and slight fatigue feeling. I had an ER doctor look at my hands when i went in today to get help for my bronchitis, which i had some before the covid shot. It got worse on Monday. He perscribed prednisone which has pretty much taken the hand spots away..i was tested negative for covid today(1/19/21) by the way.
no adverse event; We gave 4 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (no adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine).    Concomitant products were not reported.  It was reported that monovalent 4 doses were administered. Vial size was reported as 5.5ml. The vial was initially stored in the refrigerator on 02-Nov-2022. The vial did not undergo any temperature excursions.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681659:Same reporter
Employee reports flu like symptoms; sweating, chills, fever, nausea, lightheadedness.  The employee reported side effects started after she got home and have not improved. No treatment was provided.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age with an unspecified race and ethnic origin. The patient's height, and weight were not reported. Concurrent conditions included: multiple sclerosis (MS) which was treated with unspecified immunosuppressants for 14 months.  The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, expiry: unknown), single dose, on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  On an unspecified date in JUL-2021, 4 months post-vaccination, a COVID-19 antibody test and showed no spike antibodies (b-cells) which met criteria for confirmed immunological vaccine failure. Her doctor instructed her to stay home due to her history of MS and immunosuppressants and recommended she received 2 dosed of Pfizer's mRNA vaccine. On an unspecified date in SEP-2021, 7 months post vaccination, a repeat COVID-19 antibody test was positive for antibodies. The patient recovered from confirmed immunological vaccine failure in SEP-2021. The patient underwent corneal surgery on an unspecified date and on 08-NOV-2021, 1.5 months post surgery, the patient received a booster dose of Pfizer's mRNA vaccine The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211118872-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt reports arm was immediately sore, then red and hot to touch, swollen and a rash on the arm turned purple.  Swelling in lymph nodes near neck and swelling continued to elbow.  Patient experienced ear pain. Joint pain in knees and legs after 4 days.
Chills and temperature of 101 within 4 hours. High temperature Continued through the next day rising to 104 (Saturday). We administered 1300 mg TYLENOL every 6 hours. He then had diarrhea which we treated with IMODIUM. He tried to drink as many fluids as possible and ate soup. Sunday his temperature dropped to normal and he was feeling better. He stood up to walk across the room and became covered in sweat, collapsed in a chair, lost consciousness, eyes rolled up in head and he vomited a small amount. I proceeded to call 911 to get help. I thought he might be having a heart attack. Medics came, examined him and transported him by ambulance to the hospital.
Thick, clear, vaginal discharge followed by breakthrough bleeding 15 months post menopause.
Breakthrough case admission after 2 vaccines Pfizer 5/18/21 lot# Ew0172;  Pfizer 6/16/21 Lot# Ew0172
Brought to the ER after developing an immediate reaction to the vaccine-stated she felt hot, flushed , throat and chest tightness and a cough.  BP 183/105 HR-105  RR-18 Pulse Ox 98% on Room Air.
Large red warm area without induration occurred 4/19 (2 days after vaccines given).