chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ITCH ON THE ARM; CHILLS; FEVER; FATIGUE; MUSCLES IN BOTH LEGS HURT; HEADACHE; LUMP (ABOUT ONE INCH NOT CIRCULAR BUT ELONGATED AND IT EXTENDS TO LEFT AND TO RIGHT) ON THE RIGHT ARM AT THE SITE OF THE INJECTION; DIZZINESS; REDNESS ON THE ARM; PAIN ON THE ARM; SWELLING ON THE ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, penicillin allergy, alcohol user, smoker, and mold allergy, and other pre-existing medical conditions included: The patient did not had any drug abuse/illicit drug use. The patient was previously treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included hydrochlorothiazide/lisinopril for high blood pressure. On MAR-2021, the patient experienced redness on the arm. On MAR-2021, the patient experienced pain on the arm. On MAR-2021, the patient experienced swelling on the arm. On 25-MAR-2021, the patient experienced lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection. On 25-MAR-2021, the patient experienced dizziness. On 25-MAR-2021, the patient experienced chills. On 25-MAR-2021, the patient experienced fever. On 25-MAR-2021, the patient experienced fatigue. On 25-MAR-2021, the patient experienced muscles in both legs hurt. On 25-MAR-2021, the patient experienced headache. On 01-APR-2021, the patient experienced itch on the arm. Treatment medications (dates unspecified) included: cortisone, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, chills, fever, muscles in both legs hurt, and headache on 28-MAR-2021, itch on the arm on APR-2021, and fatigue on 29-MAR-2021, had not recovered from lump (about one inch not circular but elongated and it extends to left and to right) on the right arm at the site of the injection, and the outcome of redness on the arm, pain on the arm and swelling on the arm was not reported. This report was non-serious.
Pt recvd pneumococcal vax on 29OCT91 & pt devel hives; presented to MD placed on therapy w/Atarax;
This spontaneous report was received from a Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number M040267, expiration date 14-MAY-2018 (dose was not reported) for prophylaxis. The temperature reported was 33 grades Fahrenheit for 22 hours. It was not prior temperature excursion, and a data logger was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA002363: Original Case: 1706USA002271.
I got a red itchy rash below the vaccination site on my upper arm 3 days after the vaccine. It started about 2 inches in diameter and is now 3inches by 4 inches one week later, today March 12.  Last night I started taking an antihistamine, Claritin 10mg/day (loratadine).
After vaccination the pt reported feeling light headed. Pt was evaluated by Prospect EMS paramedic. BP 140/100, HR 59. Pt reports allergies to Vicodin, Percocet, Dilaudid, Benzoyl Peroxide, Dramamine, Iodine, silk tape, and lanolin. Pt declined transport to the ED. Pt ate a snack and drank some water, she then reported feeling better.
About 10-12 hours after both vaccines I had Grand Mal seizures and several clonic seizures throughout Sunday night/ Monday morning
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates the patients were vaccinated with GARDASIL (lot#, expiration date, dose, route not reported), which were improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
5/21/2021 - 2nd dose administered. 6 hours later was exhausted, slept for 24 hours, slight fever, right arm sore and tender to the touch.  5/23/2021 - oh mama! axillary lymph nodes swelled to I don't know how many times the size. Kids, this was a noticeable difference, like mini side boob difference, I should have taken a pic. injection sight was hot to the touch, I couldn't rotate my arm at the shoulder, anything above shoulder height really hurt.  5/24/2021 - Swelling in my nodes has gone down considerably, regained most of my mobility, injection site tender but not painful.  5/25/2021 - no more swelling, regained full movement in arm, no tenderness at injection site.   hope this helps, it was a wild ride and I'm glad I'm done with that. Thanks for the vaccine!
Had covid after the second dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19. At the time of the report, COVID-19 outcome was unknown.            No concomitants and treatment were provided.   This case was linked to MOD-2021-377147, MOD-2021-377137 (Patient Link). This is a spontaneous case concerning a male patient of an unknown age with no relevant medical history reported, who experienced non serious, AESI, unexpected event of COVID-19. The event occurred unknown days after the second dose of mRNA-1273 vaccine.   No information about the first dose was disclosed. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Client report receiving first COVID vaccine on 06/28/2021, time not known but adverse reaction began a couple hours after vaccination.  Adverse reaction of feeling warm began between 3 and 4 pm.  Client also had pain at the injection site and began to feel tired and sleepy.  On 06/29/2021 client had temperature of 101.2, continued to have pain at site that shot up to the left side her of neck, left arm pit and left side of breast.  Denies redness at site, numbness, nausea, diarrhea, and SOB.  Client went to ED on the night of 06/29/2021.  Client was given Tylenol while there and told to take as needed every 6 hours for pain and fever.  Client report pain is still present today and temperature is 99.3.
sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 68-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of vaccination failure (refer case US2021AMR222494). Concurrent medical conditions included diabetes (Family History) (patient's mother's brother was 4 years old when he died of diabetes), thyroid disorder, blood cholesterol increased, post-traumatic stress disorder and stress.   On 5th September 2021, the patient received the 2nd dose of Influenza vaccine Quadrivalent 2021-2022 season. On an unknown date, less than 2 months after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: The case was reported by the patient. Relevant tests include blood sugar on July 2021 result: 400. The patient got the flu shot this year on the year of reporting and she had a sore arm onset age 68  This case was 1 of 3 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR221277:same reporter US-GLAXOSMITHKLINE-US2021AMR222494:same reporter
This spontaneous report as received from a physician assistant via a company representative refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. The physician assistant stated the patient was vaccinated with a dose of GARDASIL 120 Y injection (strength, dose, route of administration, indication, lot# and expiry date unspecified) on 24-SEP-2014 and then on 10-OCT-2014. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Loss of taste; Tasted sugar or chocolate, it tested like chemicals; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), AGEUSIA (Loss of taste), DYSGEUSIA (Tasted sugar or chocolate, it tested like chemicals) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy. Concomitant products included VITAMIN D NOS, ZINC and CEFALEXIN MONOHYDRATE (LEXIPRON) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 18-Feb-2021, the patient experienced HEADACHE (headache). On 19-Feb-2021, the patient experienced AGEUSIA (Loss of taste) and DYSGEUSIA (Tasted sugar or chocolate, it tested like chemicals). At the time of the report, PAIN IN EXTREMITY (sore arm), AGEUSIA (Loss of taste) and HEADACHE (headache) outcome was unknown and DYSGEUSIA (Tasted sugar or chocolate, it tested like chemicals) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment medication was provided.  Patient reported that she took second dose at about 5 and half week after the first dose, and she did not had any adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Email was added, Outcome of the event Dysgeusia was updated to recovered.
DIZZY; DO NOT FEEL GOOD; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-OCT-2021, the patient experienced dizzy. On 27-OCT-2021, the patient experienced do not feel good. On 27-OCT-2021, the patient experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, weakness, and do not feel good. This report was non-serious.
REDNESS AND SWELLING TO LEFT UPPER ARM ,WARM TO TOUCH MOM APPLIED COOL COMPRESS
I developed on my hand and my second toe on my right foot bumps that were similar to hand foot and mouth disease. They were rather painful. I did get a ESR blood work done and came back with nothing stating it was a reaction and I did not have hand food and mouth.  This lasted for about a week.  I also had some general body ache, fatigue, muscle ache the first two days after the vaccine.
I received my 5th Bivalent Moderna on 09/22/2022. My COVID-19 symptoms started on 11/08/2022 in the morning around 08:00AM. I had nasal congestions, sore throat, back pain, fever, cough, headaches, fatigue, and appetite change. I went on 11/09/2022 in an urgent care where they did few tests. My COVID-19 test was positive. They gave me PAXLOVID but I didn't take it because my symptoms were mild. I took TYLENOL for a day. I only felt bad for 24 hours.
Thyroiditis was diagnosed; This spontaneous case was received on 14-Dec-2020  from a physician via agency (reference number: SEQW20-05764) with an additional document received on the same day from a physician via agency (reference number: SEQW20-05762) (being processed together) and concerned a male patient of unknown age.  The patient had no relevant medical history. The patient's concomitant medications included unspecified vitamin D for an unreported indication.  On 06-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prevention. The batch number was not reported and expiry date was 30-Jun-2021.   On 11-Nov-2020, five days after receiving Flucelvax Quadrivalent, the patient started feeling palpitation, severe muscle pain and severe headache.   On 21-Nov-2020, the patient was tested for COVID and was negative.  On 23-Nov-2020, the patient was diagnosed with thyroiditis. No other infections or signs were reported.   On an unspecifed date in 2020, the patient started treatment with Inderal (propranolol hydrochloride) at a dose of 40 mg, three times a day, for thyroiditis.   The outcome of the event thyroiditis was not reported.  The reporter reporter assessed the event as related to Flucelvax Quadrivalent. The reporter considered the event was a vaccine side effect.   The reporter assessed the event of thyroiditis as non-serious.  Company comment: A male patient experienced sympthoms of thyroiditis 5 days after administration of Flucelvax Quadrivalent. Thyroiditis was diagnosed 17 days post vaccination. The patient had no relevant medical history, while concomitant medications included unspecified vitamin D for an unreported indication. The patient was tested for COVID and was negative. Causality is assessed as possibly related due to lack of other confounding factors.; Reporter's Comments: The reporter considered the event was a vaccine side effect.; Sender's Comments: A male patient experienced sympthoms of thyroiditis 5 days after administration of Flucelvax Quadrivalent. Thyroiditis was diagnosed 17 days post vaccination. The patient had no relevant medical history, while concomitant medications included unspecified vitamin D for an unreported indication. The patient was tested for COVID and was negative. Causality is assessed as possibly related due to lack of other confounding factors.
Dizziness started 5:30pm 10/29/03 to 11pm 10/30/03 weakness started 5:30pom 10/29/03 to midnight 10/30/03. Irritability started 5:30pm 10/29/03 to midnight 10/30/03, nausea started 2:30pm 10/29/03 to midnight 10/30/03.
A report was received from a health care professional via the U.S. pharmacopeia Medication errors reporting program on 16 January 2004, concerning a child of unknown sex who experienced a seizure which was considered to be medically significant an unspecified length of time after receiving influenza vaccine (brand unspecified) on an unspecified date.  On a unspecified date, the vaccine experienced a seizure. It was not specified if the vaccine had recovered at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  This report may be a duplicate of PJP-2004-00004 (#56258), but this could be verified within reporting timelines.  Follow-up pending  See ref: PJP-2004-00092.
Each time I have had the vaccine and the booster, I have had a period of time from 3 to 4 week after the vaccine that I have felt, depressed - like a black fog, extremely lethargic and occasional suicidal thoughts. You must know that I am a PhD Mental Health Counselor and I have never had these feelings before...and after it happening this 4th time, I decided to report it. I initially reported feeling very sick after the first vaccine for a week and I continue to have a reaction but with LOTS of fluids, bed rest and a combination of Advil and Tylenol - it runs it's course in 5 to 6 days.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: the patient experienced swelling 7 to 10 days after injection. then on 7-4-22 she got a rash and then rash on mid section. Rash went away on 7-15-22. on 7/21/22 she got her second shot and has the redness at the site only.
had anaphylactic reaction, went to ER; This case was reported by a other health professional via sales rep and described the occurrence of anaphylactic reaction in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PROQUAD for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device and PROQUAD. On an unknown date, less than a year after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced anaphylactic reaction (serious criteria medically significant). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved.   It was unknown if the reporter considered the anaphylactic reaction to be related to Kinrix and Kinrix Pre-Filled Syringe Device.This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was an Epidemiologist. The patient had anaphylactic reaction less than a year after receiving Kinrix and ProQuad at 4-year-old visit, the patient went to emergency room to be treated and recovered. It was unknown if the reporter considered the anaphylactic reaction to be related to ProQuad. The reporter agreed to follow up from GlaxoSmithKline.
Red, itchy area at injection site, size of a softball - used BENADRYL cream on area. 4 day later says size has decreased & no longer itchy.
stroke (left facial droop, left side of body weakness, slurred speach, confusion, inability to express self)
muscle and joint aches; muscle and joint aches; headache; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 10Dec2021 11:00 (Lot number: FF2589) as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "birth control pill" (unspecified if ongoing). Concomitant medication(s) included: TDAP, administration date 15Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Vaccine Administration Time: 02:15 PM, Route of Administration: Intramuscular), administration date: 01Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 11:00, outcome "unknown", described as "Booster"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 10Dec2021 20:00, outcome "recovered" (2021) and all described as "muscle and joint aches"; HEADACHE (non-serious) with onset 10Dec2021 20:00, outcome "recovered" (2021), described as "headache". Therapeutic measures were taken as a result of myalgia, arthralgia, headache.   Additional information: AE treatment - Ibuprofen. If covid prior vaccination - No. If covid tested post vaccination - No. known allergies -no. Other medications in two weeks - birth control pill.  No follow-up attempts are possible. No further information is expected.
bp decreased; lightheadedness; facial swelling; lip swelling; tongue swelling; This is a spontaneous report from a non-contactable other HCP. A 52-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6207) via an unspecified route of administration on 18Mar2021 as dose 2, single (at the age of 52-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 18Mar2021, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, After rest and water, her bp decreased, still not normotensive. She felt like her dizziness was subsiding until we stood her up. Blood pressure increased. She sat back down, given more water, pb and cracker and lozenge. The reported seriousness of the adverse events was non-serious. At 11:21 she reported lightheadedness was mild. She was ambulated around bay but reports increased lightheadedness/dizziness. No sob, cp was reported. Patient feels well overall otherwise. Dizziness, facial swelling, lip swelling and tongue swelling were to be observed. On an unspecified date in Mar2021, the outcome of the event blood decreased was resolved while that of the other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A causal association between BNT162B2 and the reported blood pressure decreased cannot be completely excluded based on information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This report describes the occurrence of seizures in a 2 month old female who was vaccinated with Infanrix. This report was received from the subject's mother and has not been verified by a physician or other health care professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. Reportedly, on 12/18/02, the subject received an injection of Infanrix (576A2). It was not known if the subject had received previous injections of Infanrix. The mother stated that four hours post-immunization, her daughter began to experience seizures. Reportedly, her daughter "has been having seizures since." Her daughter is now three months old and reportedly "is still getting worked up for the seizures." Seizures are considered medically serious (OMIC).
Information has been received from a physician concerning a 6 yr old female who on 10Jun99 was vaccinated with a dose of varicella virus vaccine live. On 13Jun05 the pt experienced a case of breakthrough. It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.