chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash/hives appear randomly over various parts of body, primarily around waist on either or both sides, have had on inner thighs, front of thigh, buttocks, stomach, right ear, right big toe, left labia?-all start out as small areas, approximately the size of a quarter and then in hours will increase to up to a full palm size, red and tender to touch, extremely itchy,  after initial treatment of steroid shot, Methylpred 4mg 21pack,  doxycycline hyclate 100 mg and  , itching lessened and subsequently went away. By 4/20 rash reappeared. Went to another clinic and received a steroid shot and Prednisone 20 mg , hives went away. Then reappeared  around 5/20-5/21 2021. Was treated with another steroid shot. Symptoms improved, returned on 6/5
Moderna 2/9/21, 3/24/21. Positive on 2/2/22
Pt called call center on 5/8/21 . Pt got pfizer vaccine on  5/5/21. Pt complains of fever 102F onset 5/6/21 and took tylenol and fever is gone as of today. Left arm has swelling on 5/7/21 and on 5/8/21 left arm at the injection site started a rash with redness at the site.  Pt spoke with external pcp. advised pt to follow-up with PCP. Ed precautions provided to patient.
Nerve pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: Nerve pain). The outcome of the nerve pain was not reported.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-JUN-2023 This case was reported by patient via interactive digital media. The reporter reported that the patient received 1st dose of Shingles vaccine it took him out for 2 days and experienced nerve pain.  The reporter stated that the 2nd shot was on 2 months and the nerve pain was worse and also states these vaccines are brutal too. Follow up was not possible, as no contact details were available.
Person receiving vaccine is also a staff member. While here during a vaccination event 2/10/2021 he voiced concern that during his 2nd dose he felt the needle was withdrawn too soon which caused liquid/vaccine from the syringe to splash on him. He felt that it was a decent enough amount to have him believe that he didn't receive a full dose. We spoke with our Chief Medical Officer who recommended that he be vaccinated that same day (2/10/21).
Influenza vaccine given 01/14/05 without immediate symptoms. 5 days later, on 01/19/05 client started having symptoms. 01/19/05 and 01/20/05, had slight sore throat, headache and slight nasal congestion. No chest congestion or fever. This AM 1/21/05, client experienced nausea and vomiting, without fever.
severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) in a 71-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious. Further information has been requested   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious. Further information has been requested
Large area of redness and swelling at injection site,  on day 5  symptoms continue but improving
Day of injection: Slight fatigue,  fever and headache began about 6-7 hours after injection.  Next day; extreme fatigue, slept three hours in the middle of the day, no fever immediately (slight in the evening) but increased headache, tightness feeling in head all day, joint pain.   Next day; fatigue worse, no headache nor fever, joint pain increased. At this point, I considered seeing a doctor but did not. Today; slight headache, no fever, fatigue seems to be getting better.
afeb lt focal sz x 1hr 9 days p/vax;tx w/Valium IV & dilantin IV-now on oral DIlantin;papular rash on chest & abd;
INTENSE HEADACHE; FATIGUE; SENSATION LIKE PINS AND NEEDS RUNNING FROM THE SHOULDER TO THE FINGER TIPS; SORE ARM; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, chronic obstructive pulmonary disease, asthma, bone degeneration, cigarette smoker, and alcohol user, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sensation like pins and needs running from the shoulder to the finger tips. On 06-APR-2021, the subject experienced sore arm. On 06-APR-2021, the subject experienced fatigue. Treatment medications included: paracetamol. On 07-APR-2021, the subject experienced intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, intense headache, and fatigue, and had not recovered from sensation like pins and needs running from the shoulder to the finger tips. This report was non-serious.
This spontaneous report was received from a medical assistant referring to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date,  the patient was vaccinated with one of the improperly stored doses of VAQTA lot # M047658, expiration date 28-OCT-2017 (strength, dose number, route and anatomical location was not provided) for prophylaxis or RECOMBIVAX HB lot # M037248, expiration date on 21-FEB-2019 (strength, dose number, route and anatomical location was not provided) for prophylaxis. The doses of VAQTA and RECOMBIVAX HB were in temperature of 50.7 °F (Fahrenheit ) degree for 45 minutes. There was no previous temperature excursion available. No adverse effect was reported and digital data logger was involved. Additional information has been requested.
Feverish (temperature normal), fatigue and headache the second day from injection and lasted for one day. About a week after the second dose, I started to  have hot flashes. This is not likely due to menopause for I had that for a few months two years ago. Now it is 4 months after the COVID vaccines and I still have it more than a dozen times a day.
Hard lump under skin 3cm medial from injection site.   3.6 cm x 4.1 cm Red, itchy, painful to touch, warm to touch
Patient returned to office less than 5 minutes after receiving a flu vaccine with diffuse urticaria and SOB and wheezing and diaphoresis. Chest exam with decreased O2 and wheezing. Given EPIPEN in office and 1 dose of CLARITIN with immediate improvement in symptoms. Taken to ER for observation and further eval.
Started a few hours later with Diarrhea. Then next morning just a slight sore arm (typical of flu vaccines) but then the unbelievable fatigue and muscle soreness took over and restless night sleep. When to ED and had PCR done to make sure I didn't have Covid - it was negative. Cough came and went, mostly at night. I'm 3 days in and just now getting back to normal but the muscle pain and fatigue are still there. No fever. No headache.
very sore arm 4-16 hours; fevers and chills 12-36 hours (max temp = 101.9); fevers and chills 12-36 hours (max temp = 101.9); headache starting approx 19 hrs; insomnia 12-24 hrs; significant fatigue 24-48 hours and more mild fatigue 48-72 hours (the mild fatigue being more than my baseline constant fatigue); migraine; This is a spontaneous report from a contactable patient. A 43-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular, administered in Arm Left on 21Jan2021 at 08:00 (Batch/Lot Number: EL3246) as 2nd dose, single dose for covid-19 immunization. Medical history included obese (BMI approx 30), seasonal allergies and breastfeeding.Concomitant medications included prenatal vitamins ,fexofenadine hydrochloride (ALLEGRA) and probiotics (PROBIOTICS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks of the vaccination. Post vaccination, the patient had not been tested for COVID. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular, administered in Arm Left on 22Dec2020 at 13:00 (Batch/Lot Number: EH9899) as 1 st dose, single dose for covid-19 immunization and experienced mild-mod sore arm. In Jan2021, after the second dose, the patient had very sore arm 4-16 hours (reported this because more sore than other vaccines she had received, over all she was not concerned about sore arm though), fevers and chills 12-36 hours (max temp was equal to 101.9), headache started approx. 19 hours, insomnia 12-24 hours(unsure from vaccine or fevers/rigors themselves), significant fatigue 24-48 hours and more mild fatigue 48-72 hours (the mild fatigue being more than baseline constant fatigue) and intermittent headache (tension vs mild migraine) for 1week. It was unclear if was vaccine related vs normal fatigue/stress/weather. The patient underwent lab tests which included BMI: approx 30 and temperature: 101.9. The event fever and headache was treated with ibuprofen. The outcome of events was resolved in 2021.  Follow-up attempts are completed. No further information is expected.
BAD REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the patient experienced bad reaction to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction to the vaccine was not reported. This report was non-serious.
Seen at Medical Center on 3/25/2011. Mother stated pt. had hives on face and a large knot/welt on legs. (1 inch below injection site). Pt. was given BENADRYL and Prednisone. Pt. doing much better today.
that her husband is allergic to an ingredient in Pneumonia vaccine called pneumovax, her husband had an allergic reaction many years ago due to the vaccine; This spontaneous report was received from a patient's wife and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On an unknown date, reported as many years ago, the patient had an allergic reaction due to the vaccine. He was allergic to an ingredient in Pneumonia vaccine called Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The outcome of allergy to vaccine was unknown.  The reporter considered the event of allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
The patient had swelling and redness in the left thigh, along with maculopapular rash all over her body, expecially her face. The patient was treated with Benadryl.
Pt recvd 1st,2nd,& 3rd vax 16MAY89,28JUN89 & 07DEC89, resp. 08DEC89 pt exp soreness w/ redness & heat @ inject site & felt tired. pt exp nausea,vomiting & butterfly rash of purpuric spots on nose,cheeks w/ red patches under eyes
Around 10:30 pm on 2/5/21, almost 6 hours after my first dose of the Moderna Covid-19 vaccine, I started feeling fatigued, soreness in my arm and a metallic taste in my mouth developed. I took 2 Advil (400mg) around 12:30am.  By 1am, my left side was weak, mildly numb and the left side of my head and left foot were prickly. By 3am, my tongue and throat felt mildly numb and all the other symptoms continued.  My husband, who is an internist, gave me a Benadryl tablet at that time. On 2/6/21, I woke up fatigued and weak on my left side. The prickly feeling in my head and foot has gone away and replaced with a headache on the left side. I still feel weak and slightly numb on the left side and my tongue and mouth still feel a little numb as well. No breathing difficulties. I have never had a reaction to any vaccine and I don't have any food allergies. I am only allergic to cats and occasionally have seasonal allergies in the fall.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 13Feb2021 at 14:00 as dose 2, single (Batch/Lot number: unknown), in right arm, on 29Sep2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 12Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: TRIAMTERENE/HYDROCHLOROTHIAZIDE, start date: 01Jan2000; EZETIMIBE, start date: 01Jan2020. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: The patient was started with antiviral treatment Paxlovid (Lot 2815223) on 30Jul2022. The patient had adverse event of headache, sore throat, fever, stuffy nose and cough on 30Jul2022 01:00 AM which were resolved on 04Aug2022. The treatment of Paxlovid was stopped on 04Aug2022. Other medication in 2weeks includes:Triamterene/Hydrochlorothiazide and Ezetimibe  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient complained of feeling lightheaded and wanted to laydown after vaccine. Patient was hypotensive and had involuntary muscle spasms and had chest tightness. He was take to the ED
Information has been received from a RN concerning a 17 month old female pt with no relevant medical history who in December 2002 was vaccinated SC with a dose of varicella virus vaccine live "0.5 ml/once". There was no concomitant medication. On 15Jul2003, "as of today", the pt  broke out with several vesicles on her chest and back. There was no relevant diagnostic laboratory data. It was noted that the child has several siblings and "so far none of them have contracted the chickenpox". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
He started having high grade fever on 3/12, reaching up to 102.9.  I asked him to go to his primary care physician who thought he had ear infection and prescribed Levofloxacin.  He called me on 3/16/13 complaining of severe shortness of breath and choking sensation in the neck.  He deteriorated over the next few days with worsening shortness of breath, persistent fever, renal and respiratory failure requiring hemodialysis and ventilator support.  He also underwent a single course of plasmapharesis with presumed diagnosis of Guillain Barre Syndrome but did not respond.  He had upper GI bleed and subsequent CT scan showed free air in the abdomen.  He underwent emergency surgery that showed gastric gangrene and perforation.  Total gastrectomy was performed.  He had increasing abdominal distention post-surgically and passed away approximately 5 am on 3/21/2013.
At injections site rash, pain, swelling (arm and under armpit) and redness.  Narrative:
Worried about getting blood clot; Tremor; Low temperature; Unable to lift her arm; Not feeling well; Swollen left arm; High temperature (Fever); This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm) and MALAISE (Not feeling well) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm), MALAISE (Not feeling well), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (High temperature (Fever)). At the time of the report, ANXIETY (Worried about getting blood clot), TREMOR (Tremor), BODY TEMPERATURE DECREASED (Low temperature), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift her arm), MALAISE (Not feeling well), VACCINATION SITE SWELLING (Swollen left arm) and PYREXIA (High temperature (Fever)) outcome was unknown.            No concomitant medication details was reported. No treatment medication was provided.
Left arm with reaction of 3" X 3" red warm area, slightly swollen - no fever, no SOB.
RN administered Pfizer (EL9261, exp 5/31/21) to employee. Patient should have received Moderna. Patient's first dose was Moderna (025L20A, exp 6/25/21) on 1/6/21.
The patient stated they had a seizure 3 days after the second COVID vaccine. He was taken by ambulance to the hospital for treatment.
Continuous headache; Sinus infection; A spontaneous report was received from a 66 year old , female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  continuous headache and sinus infection/sinusitis.  The patient's medical history was not provided. Concomitant product use was not reported.   On unknown date, prior to the onset of the events ,the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) continuous headache, sinus infection.Treatment details included antibiotic for sinus infection.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event(s), continuous headache, sinus infection were considered to be unknown at the time of the report.; 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.
This is a spontaneous report received from a contactable reporter (Other Healthcare Professional). The reporter is the patient. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 20Jan2021 09:00 (Lot number: EK9231) at the age of 39 years as dose 1, single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore left arm". Additional Information: The patient experienced sore left arms for 24 hours. The patient did not receive any vaccines prior vaccination within 4 weeks. No relevant test was done. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2021145143 same patient/drug, different dose/AE.
Pt states developed a red, swollen area near the injection site, warm to the touch. Pt was instructed to take BENADRYL 25-50mg every 6 hours as needed. Use cool compress to area.