chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsions), DYSPNOEA (couldn't breathe) and OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache). On 12-Jun-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criteria medically significant and intervention required), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing) (seriousness criteria medically significant and intervention required), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted). On an unknown date, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant) and VACCINATION SITE REACTION (She is still having an injection site reaction.). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 07-Jun-2021, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) had resolved. At the time of the report, SEIZURE (Convulsions), DYSPNOEA (couldn't breathe), OROPHARYNGEAL DISCOMFORT (felt like her throat was closing), INSOMNIA (couldn't sleep), VACCINATION SITE SCAR (huge spot at injection site), NAUSEA (nausea) and VOMITING (vommitted) outcome was unknown and VACCINATION SITE REACTION (She is still having an injection site reaction.) had not resolved.        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.   No concomitant medications reported. The patient went to emergency room and they gave her Benadryl she had convulsions, and she never had an issue with Benadryl. They then gave her steroids that helped with her symptoms of throat closing and breathing. She was still having an injection site reaction.  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.
Pt received second dose of varicella virus vaccine live on 10/19/1998. ELISA testing on 07/16/1999 revealed negative seroconversion.
got the flu; Initial information received on 14-Sep-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional.  This case involves a female patient who got the flu (influenza), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's, past medical treatment, vaccination, concomitant medication and family history were not provided.  The patient mentioned that she had taken the Fluzone Trivalent in the past and had been immunocompromised due to cancer.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious flu (influenza) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  Other details: reporter wanted to know about availability of FLUZONE HIGH-DOSE TRIVALENT in the country this year, and asked whether FLUZONE HIGH-DOSE QUADRIVALENT is adjuvant-free. Reporter had been taking Fluzone high-dose trivalent since years.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  At the time of report outcome of the event was unknown.  Batch number has been requested for suspect product for this case.; Sender's Comments: A elderly female patient who presented with influenza following the vaccination with INFLUENZA VACCINE (unknown manufacturer). Time to onset is not clearly defined. Patient also had ongoing immunodeficiency and cancer, and information on concomitant medication, and lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.
I had myocarditis for about  4 months starting 2 weeks after my last vaccination.  It has subsided now. However, I have developed rhinorrhea that discharges 4-6 times a day with clear water-like discharge that started 2 weeks after my second dose and STILL has not gone away.  This fills my sinuses and then just literally 'streams' out of my nose -  1 to 3 ml per time.  Help?
the arm was quite sore; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date: Mar2021), via an unspecified route of administration on an unspecified date at single dose in arm for covid-19 immunization. The patient's medical history was and concomitant medications were not reported. The patient was a frontline healthcare worker, the patient said the arm was quite sore (far more than expected) after vaccination, but no problem after an hour or so. The outcome of the event was resolved.
achy; uncomfortable; red rash on lower side of arm/red dots; itchy rash; oozing rash; arm very uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), INJECTION SITE DISCOMFORT (uncomfortable), RASH ERYTHEMATOUS (red rash on lower side of arm/red dots), RASH PRURITIC (itchy rash) and RASH (oozing rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included BACITRACIN and HYDROCORTISONE (CORTIZONE 10).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (achy), INJECTION SITE DISCOMFORT (uncomfortable), RASH ERYTHEMATOUS (red rash on lower side of arm/red dots), RASH PRURITIC (itchy rash), RASH (oozing rash) and LIMB DISCOMFORT (arm very uncomfortable). On 05-Feb-2021, PAIN (achy) and INJECTION SITE DISCOMFORT (uncomfortable) had resolved. On 23-Feb-2021, RASH PRURITIC (itchy rash), RASH (oozing rash) and LIMB DISCOMFORT (arm very uncomfortable) had resolved. At the time of the report, RASH ERYTHEMATOUS (red rash on lower side of arm/red dots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.
fever x 4 days OCT30-2NOV97;watery eyes, runny nose;
HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.; Sender Comments:  US-009507513-2306USA011972:
expired Daptacel adminisetred to patient / no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 years old male patient who received 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5281AA (Expiry date 05-Oct-2019) via intramuscular route in the left thigh on 24-Oct-2019.  The patient's medical history and concomitant medications were not reported.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) ; and HEPATITIS A VACCINE (HEPATITIS A).  It was an actual medication error case due to Expired vaccine used.  At a time of reporting No adverse reaction 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.
Felt like a rolling headache in my brain. Mild but moved around my head for 15 days.  Had my vaccine at Pharmacy, told to go shop not sit for 15 min. Never given info to report side effects.
Dizziness, nausea, later had breathing "tightness", when arrived home found had bright red erythema over face, neck, upper trunk
Induration with tenderness to palpation of left anterior/lateral aspect of deltoid and axilla area near teres major. Decreased movement of left shoulder due to pain. Hydrocodone/acetaminophen prescribed for pain control.
My menstrual cycle has been off since I got my first vaccine; This is a spontaneous report from a contactable consumer reported for herself.   A 22-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 08:00 AM (at the age of 22-years-old), as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history, concomitant or other medications in two weeks, other vaccine in four weeks included none. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced her menstrual cycle had been off since she got first vaccine. It was stated that her menstrual cycle has been off since she got first vaccine, but she didn't really notice it until after her second. There were 50 days between her cycle in May and June, and then another 35 days between June and July. Her cycle has been notably worse as well, heavier bleeding and cramping as well as getting migraines frequently when on her period. Serious criteria included none and the event was not serious. No treatment received for the event. Clinical outcome of the event was not recovered.  Information on lot/batch number was not provided and would be requested during follow up.
Swelling of eyes, lips cheeks. Scratchy throat. Was told to take Benadryl every four hours for the next three days.
Chills, aches, fever, nausea 24 h after the injection AND AGAIN 2 weeks after the injection.  Lasted 48 hrs each time.  The purpose of this report is to note the delayed side effect of the second dose injection-- 2 weeks
I have received both shots. One in each arm. Week after second shot I?m having trouble with my arms by my shoulders. Severe pain wakes me up in mornings and last throughout the day. I have never had problems like this until I took the second dose and both arms hurt me now
Nephew in a wheelchair right now from one of these shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: WHEELCHAIR USER (disability), outcome "unknown", described as "Nephew in a wheelchair right now from one of these shots".  Clinical Course: Caller asked if there was anything harmful in the product. Caller elaborated he wanted to know the ingredients of the vaccine. Caller mentioned during the call he has a "nephew in a wheelchair right now from one of these shots". Caller also referenced that people have died or had adverse events from the vaccine. Caller asked about the recording when he first contacted Pfizer. Caller reported the recording was 15 minutes, said the recording explained things he didn't want to know about a COVID shot or about Pfizer, said he found it very disturbing and asked was the purpose to scare me. Caller reported that his heart was beating fast, but it is not related to any vaccine, it was related to the fact that he had to listen to the recording while waiting on the line for almost 15 minutes. The recording is almost 15 minutes long. You have to listen to the information about the vaccines. He was blown away. He has never heard an introduction that was that in detail in length. He is calling because he called a local# with a question and they said to call Pfizer about vaccines. When the caller was questioned about which vaccine he was calling about he said all of them. Caller said also the COVID-19 vaccine. Has questions and concerns about that. Calling about all of the vaccines. Wondering if Pfizer is getting a lot of reports from people who have had adverse events from the vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
complains she has had pain in her am ever since she had flu shot, she states the doctor said we may have hit a nerve.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 22-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Intense shaking, chills, intense, on-going fatigue and sleepiness, muscle pain, day-long headache, some nausea, loss of appetite, dehydration, two+ days of pain and soreness at the injection site and along upper left arm of injection site.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant product use was not provided by the reporter. It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use. No treatment information was provided. This case contains information for the 05th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
The shot was administered very high on my right arm, slightly dorsal. About 6 hours after the shot, my arm started to get very sore and became hard to use.  By 11 hours afterward, the pain and weakness of my arm/shoulder became extremely uncomfortable and I began alternating taking Tylenol (1000mg) and Ibuprophen (600mg) every three hours (6 hours between the same drug), around the clock.  The following 2-4 days, my shoulder felt dislocated--it was very painful to move in some ways, felt weak, and I had some tingling/numbness in some of my fingers (most noticeably my middle finger).  Sleeping was difficult due to the pain. I purchased a sling and continued to rest, ice, and manage the pain. Each day there was some improvement.  On day 3 I saw a doctor about it.  She was not overly concerned about long-term affects, but suggested adding heat to my therapy.   I am now on day 7 after the shot, and although I do not have full range/use of my arm and some pain and weakness persists, it is much better.  I hope in another couple of days, it will be good as new.  Apart from the bad reaction in my arm, on day 2, I experienced some aches, fatigue, and slight chills.
I got symptoms of Covid and tested positive; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number) via an unspecified route of administration on 13Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient had got first Pfizer shot on March 13th, Saturday and 1 week Later on March 20th I got symptoms of Covid and tested positive, two days later got an antibody infusion. My doctor says get the second shot 2 weeks after I feel 100% or close. The CDC guidelines say "If I got the shot and the antibodies, I should wait 90 Days". The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was reported as unknown  Follow-up activities has been raised. Information on the lot/batch number has been requested.
Pt recv vax on 9/25/97; post vax pt exp erythema, induration & burning at vax site; pt imp by 9/30/97
Right arm pain about 2 hours after injection that worsened over time. About 12 hours after injection chills, temp of 99.6. About 24 hours after injection extreme muscle and joint pain, nausea.  36 hours after injection arm is red swollen and still painful.
Tested positive for COVID-19 on 27Jun2022. Symptoms included headache, sore throat, and coughing and nasal congestion that began 24Jun2022.; Tested positive for COVID-19 on 27Jun2022. Symptoms included headache, sore throat, and coughing and nasal congestion that began 24Jun2022.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6205), in left arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in left arm, on 07Oct2021 as dose 3 (booster), single (Lot number: FF7588), in left arm and on 01Jun2022 as dose 4 (booster), single (Lot number: F54991) at the age of 62 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Jun2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on 27Jun2022. Symptoms included headache, sore throat, and coughing and nasal congestion that began 24Jun2022.". The events "tested positive for covid-19 on 27jun2022. symptoms included headache, sore throat, and coughing and nasal congestion that began 24jun2022." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive; (24Jun2022) Negative, notes: COVID test type post vaccination: Nasal Swab; (26Jun2022) Positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included no other vaccines within 4 weeks prior to the COVID vaccine. Amoxicillin, Mucinex, Tylenol, and Excedrin to treat symptoms; stopped after tested positive. patient was not diagnosed with COVID-19 prior to vaccination. Awareness Date: 26Jun2022. The case was reported as non serious. No follow-up attempts are possible. No further information is expected.
Pt recvd vax in MAY or JUN92 & exp a severe h/a; pt was treated w/ASA & APAP w/no relief of the sx;