chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on her entire body with mild itching; Rash seems to have spread into an entire mass of red; This case was reported by a pharmacist via sales rep and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   The patient's past medical history included rash (experienced rash on an unknown date when she had a virus).   On 5th September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 6th September 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced itchy rash and generalized erythema. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the itchy rash and generalized erythema were recovering/resolving.   It was unknown if the reporter considered the itchy rash and generalized erythema to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 1st dose of Shingrix experienced rash on her entire body with mild itching. The patient on the same day received Flu vaccine and experienced injection site extremely red and rash. The patient took Benadryl and felt little better on the day of reporting. The patient did not experienced any trouble breathing. The reporter asked whether patient had a stronger reaction because she received the flu and shingles vaccines on the same day. The reporter asked whether patient should receive the 2nd dose if Shingrix in November or wait longer. The reporter thought that the patient might be little afraid to get the 2nd dose at all after the reactions.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included complement deficiency. The patient's concomitant medications were not reported. On an unspecified date, it was reported that the patient lapsed 2nd dose of a 3 dose series. The patient needed to be vaccinated prior to starting SOLIRIS. Within one month after receiving first dose, patient developed an infection which delayed second dose of product and unable to start on SOLIRIS at this time. The outcome of infection was unknown. Information on the batch number has been requested.
My eyes started swelling last night with discomfort behind my eyes, today I am getting discoloration on the lids of my eyes. My eyes are noticeably puffy.
He had significant pain with fever the afternoon and evening after the vaccine with warmth and tenderness of the thigh.  He awoke several times that evening with a low grade fever.  24 hours after the vaccine, his entire left thigh swelled with edema from thigh to the knee (see photo).  The fever resolved with less pain 24-48 hours after the vaccine, but then he has complained of mild itching at the vaccine site.  3-4 days later the swelling has improved slightly, with less pain but mild bruising of the thigh tissue where the erythema was previously.
Headache, Myalgia, Fever, chills Narrative:  myalgia resolved, but still complains of headache as of today 2/3/2021. Taken Ibuprofen for fever and headache
arm hurt with first dose; This is a spontaneous report from a contactable consumer (patient herself). A 49-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via intramuscular route of administration in the left arm on 29Dec2020 at a single dose because "a coworker came down with Covid." Medical history included migraine and headache. The patient's concomitant medications were not reported. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient reported that her arm hurt with first dose on an unspecified date. There were no relevant tests conducted. The outcome of the event was recovering.
Extended menstrual cycle length, increased menstrual bleeding length and amount. High fever/nausea/dizzyness/muscle soreness in week following vaccine. Dizzyness continued for several weeks. Headaches continued for several months.
Information has been received from a registered nurse concerning an 8 year old female with no pertinent medical history or allergies who on 16-AUG-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 657784/0645U). No concomitant medication use was reported. On approximately 16-AUG-2007, (within 24 hours of vaccination) the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information was received on 11-OCT-2007 from a registered nurse concerning an 8-year-old female with amoxicillin and Cefzil allergy who on 16-AUG-2007 was vaccinated subcutaneous in the right thigh with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 657107/03368U) (previously reported as lot # 657784/0645U). There were no illnesses at the time of vaccination. Concomitant vaccines administered on 16-AUG-2007 included a first intramuscular dose of Havrix administered in the left thigh (lot AHAVB186AA). On 17-AUG-2007, the patient developed a hard, raised swollen area the size of a half dollar; overall site reaction with edema and redness was approximately 6-8 inches in diameter. On an unspecified date the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
This may not be related to vaccination, but about 2 weeks after the vaccination I started to feel a bit sick, stiff neck and muscle pain.  The pain became more extreme over the next few weeks turning to very strong continuous chest pain.  I still have chest pain, shortness of breath, pain when breathing deeply or moving chest left to right.  Also ongoing pain across shoulders and slightly down arms.
On May 3, I started to have rashes on my body: legs, buttocks, back, arms, forehead, hands.  They are of difference sizes ranging from 1/4" to 1/2" in diameter, pink/dark pink in colors.  Very itchy.  Most are individuals. some in clusters of two/three.  Raised.  On the second day, those raised spots look lower and smaller but more red, and less itchy until touched when the itchiness would flare up again.  First I suspected it was bug bites but my partner had none of these sleeping in the same bed and living in the same household.  And the on the second day, May 4th, there were more new ones creeping up.
Left arm redness, swelling, warm to touch, tender treated with Medrol dose pak.
103 fever, vomiting, dry heaves, coughing, severely tired, loss of appetite, all symptoms lasted for 4 days
Headache, nausea, and emesis 3 days after the vaccine with sudden worsening the day prior to hospitalization. Subarachnoid hemorrhage and multifocal white matter changes.
Had to go to the ER. Woke with wheezing & difficulty breathing. Missed a week of school. Has been wheezing all week. 11/30/2009 ED record 11/15-11/16/2009,DC DX Rhinitis   patient with c/o's SOB, cough, and wheezing, rx's bronchodilator and Zyrtec. ICD-9 code 460.0
Mother stated that "last night my daughter had a lot of temperature, and now it is 101.5"  Denies N/V.  Advised to give fever reducing meds, increase H2O.
devel t105, abdominal pain, sore throat & urinary frequency w/large lcoal rxn (redness, warmth, edema) of rt deltoid (site of inject);
neck tingling; shingles rash; This spontaneous report was received from a physician and refers to an 88-year-old female patient. The patient's medical history included neuropathy peripheral. The patient's concurrent conditions and concomitant therapies were not reported.  On an unknown dates (reported as years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); and on an unspecified dates, with varicella zoster vaccine rge (cho) (SHINGRIX), administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided). The course with varicella zoster vaccine rge (cho) (SHINGRIX)was completed on an unspecified day in June 2022 (reported as 3 months ago).  On 23-AUG-2022, the patient developed shingles rash, and had to be started on valacyclovir. The patient also had neck tingling along with shingles rash,but the physician believed that was might be related to neuropathy. At the time of reporting, the outcome of the events shingles rash and neck tingling were not reported.   The causal relationship between the events and suspected therapies were not reported.
Multiple blood clot in both lungs; Having a hard time breathing / , breathing got more and more labor; Coughing blood; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Multiple blood clot in both lungs) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Multiple blood clot in both lungs) (seriousness criterion medically significant) and HAEMOPTYSIS (Coughing blood). an unknown date, the patient experienced DYSPNOEA (Having a hard time breathing / , breathing got more and more labor). The patient was treated with RIVAROXABAN (XARELTO) for Adverse reaction, at a dose of 20 mg twice a day and RIVAROXABAN (XARELTO) for Adverse reaction, at a dose of 15 mg twice a day. At the time of the report, THROMBOSIS (Multiple blood clot in both lungs), DYSPNOEA (Having a hard time breathing / , breathing got more and more labor) and HAEMOPTYSIS (Coughing blood) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Computerised tomogram: abnormal (abnormal) CT scan result indicated that patient had multiple blood clot in both.         Concomitant medication use information was not provided by reporter.  After 2nd dose patient had severe breathing difficulties, later started coughing blood. CT scan result found blood clots this clots are deep so patient had done echogram of heart and CT scan of leg because of showing legs problems and the results were unknown.  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.   This case was linked to MOD-2021-273692 (Patient Link).; 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 patient came into Walgreens pharmacy and requested a 1st dose of Pfizer vaccine so that she would get a $100 gift card from her medicaid insurance.  After the vaccine was given, it was uncovered that she received 2 Moderna doses already and 1 Pfizer dose in the same day on 10/28 at a different pharmacy.  She received two Pfizer first doses in the same day on 10/28/21.
Patient was very anxious while receiving the vaccine. Soon after receiving his COVID-19 booster shot, he turned pale and passed-out. Mom said he passed-out before with vaccinations. He woke up. I gave him juice. His mom insisted on taking him out to his car. She mentioned laying him down in the car is what works best for him. Once he was more awake, his dad took him to the car.
Feel really badly; Significant arm pain; Difficulty lifting arm; Fever; Fatigue; This non-serious case was reported by a consumer and described the occurrence of feeling bad in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Feel really badly), pain in arm (Verbatim: Significant arm pain), mobility decreased (Verbatim: Difficulty lifting arm), fever (Verbatim: Fever) and fatigue (Verbatim: Fatigue). The outcome of the feeling bad, pain in arm, mobility decreased, fever and fatigue were resolved (duration 1 day).   It was unknown if the reporter considered the feeling bad, pain in arm, mobility decreased, fever and fatigue to be related to Shingrix.     It was unknown if the company considered the feeling bad, pain in arm, mobility decreased, fever and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-MAY-2023 The patient received 2nd dose of Shingrix and had fever, fatigue, significant arm pain and difficulty lifting arm for a day or so but made her feel really badly. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from an an executive from the Department of Health Immunization Branch via a company representative refers to 14 patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On unknown dates, the patients were vaccinated with two doses each of M-M-R II injection (albumin status, dose, route of administration, lot number and expiry date were not provided). On unknown dates, the patients experienced mumps. The outcome of the event was not reported. Relatedness between the event and M-M-R II was not provided. Additional information has been requested.
The day after vaccination the patient noticed quarter sized red dots on the right side of back and down the right leg. The spots are somewhat itchy but are not painful.
Had the vaccine now have shingles / Suspected vaccination failure; now have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the vaccine 3 years before day of reporting and now had shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Approximately 20 minutes post vaccine client complained of itching all over was given Benadryl 50 mg @ 4:05 p.m ; post administration of Benadryl symptoms progressed to  complaint of nausea with mucous like secretions, coughing, wheezing, &  difficulty swallowing & breathing.  EpiPen administered at 4:15 p.m.; EMS called AT 4:17 p.m. which transported client to ER
Fever (102); body aches; Bruise at the injection; Tender at injection; Large tender lymph node of axilla area with swelling; Large tender lymph node of axilla area with swelling; flu like symptoms; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever (102)), PAIN (body aches), VACCINATION SITE BRUISING (Bruise at the injection), VACCINATION SITE PAIN (Tender at injection) and LYMPHADENOPATHY (Large tender lymph node of axilla area with swelling) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gadolinium deposition disease and Raynaud's phenomenon. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR  XR) and VITAMIN D NOS (VITAMIN D) for an unknown indication.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021 at 6:00 AM, the patient experienced PYREXIA (Fever (102)), PAIN (body aches), VACCINATION SITE BRUISING (Bruise at the injection), VACCINATION SITE PAIN (Tender at injection), LYMPHADENOPATHY (Large tender lymph node of axilla area with swelling), LYMPH NODE PAIN (Large tender lymph node of axilla area with swelling) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PYREXIA (Fever (102)), PAIN (body aches), VACCINATION SITE BRUISING (Bruise at the injection), VACCINATION SITE PAIN (Tender at injection), LYMPHADENOPATHY (Large tender lymph node of axilla area with swelling), LYMPH NODE PAIN (Large tender lymph node of axilla area with swelling) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pain in arm that began immediately following administration - has continued x5 wks with  ass. & in ROM due to pain.
Received pfizer vaccine end of March 2021 started having pancreatic issues not I recognized may 1 of 2021. Hospitalized in july for advanced clot in transplanted pancreas. No signs of organ rejection at this time and no clots in transplanted kidney, only the pancreas. Was faithful in taking antirejection medication and no reason except covid vaccine causing this clot. Had abd u/us 5-27-21, 6--3-21, CT abd 7-7-21 and final pancreas u/s 7-12-21 found the clot
Has hard, red swollen area at one injection site (believes to be varicella) running fever.  (Right arm site of injection).
Feb 28th, ringing in my right ear began and I noticed that I couldn't hear out of that ear. I made an appointment with a Dr., an ENT and he confirmed that I had hearing loss in my right ear. After an MRI and a series of lab work, everything was normal. I also took the standard prednisone dosage and the 3 shots of Decadron in my right ear with no improvement. As of today, I still have tinnitus and hearing loss and neither have improved.
not received 2 dose yet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 31st March 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2 dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-NOV-2023 The patient reported that he/she had first dose of Shingrix on March 31st and missed the 2 to 6 month booster window. The enquired do he/she need to start over or  get the booster on day of reporting after 7 and half months since first one. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
pt recvd vax & c/o burning/stinging sensation during & immed p/vax;
Parent consent form for school influenza clinic received at the beginning of the school year.  Child received a flu shot at a clinic appointment on 10/10/2022.
Patient experiencing numbness in fingertips at time of vaccine. She is still having numbness/tingling in shoulder/neck as well.
Developed fever on day of vaccination to 102 degrees-not responding to Tylenol or Motrin; decreased appetite. Drinks little. Family speaks Creole-some problems with communication.
facial paralysis; Fever; Chills; arm pain; tenderness; redness; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I called because on 8th March I got vaccination the first shot of Pfizer after 3-4 hours I did have side effects like normal Fever, Chills, arm pain, tenderness and redness but after one day and half to that I ended up facial paralysis half of the face that's why I called you." When paraphrased the concern, consumer stated, "Yes, on 12th March, so I did have the symptoms after the vaccination I had face paralysis and I also have fever chills and everything like the common one and then I did not know what happening, I realized it could be because of the vaccine. It was within 72 hours the doctor put me on the treatment and also I started the physiotherapy because I am had for 6 weeks this condition and condition is improved but still I want to know more information about this side effect and what can be done in this situation, what is the contraindication or if this one like second shot side effects. That moment I did not take the second dose and I was not allowed to take the second dose, so I called your company (Pfizer)." The outcome of events was unknown.  Information about lot/batch number has been requested.