chrisvoncsefalvay/vaers-outcomes huggingface dataset:
throwing up; fever; body aches; her whole intestines hurt; it was horrible; thought she had contracted COVID-19; thought she had contracted COVID-19; tired; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration on left arm on 17Dec2020 at 19:15, at a single dose for vaccination.  Medical history included ongoing ulcerative colitis, onset date was unknown, but when she was about 25 years of age.  Concomitant medication included ongoing azathioprine for ulcerative colitis, started probably 5-10 years ago and taken daily since. In the past, she took different products for ulcerative colitis off and on when she had an episode. This patient reported she was administered her first Pfizer COVID-19 Vaccine injection on 17Dec2020 and was just kind of tired on 17Dec2020; but she had onset of serious reactions to the COVID-19 Vaccine starting 18Dec2020 for 2 days straight and then as suddenly as the events started they suddenly stopped after 2 days with no lasting effects. She called to ask if there is any data about if the second dose of the COVID-19 Vaccine will be just like the first shot or if the events are just hit or miss; she is really hoping not to be that sick again with the second dose. Serious reactions to the COVID-19 Vaccine further described as sick for like 2 days straight. Afternoon of 18Dec2020 she was throwing up; had fever; body aches; thought she had contracted COVID-19 in between injection and onset of symptoms; she had no lung issues; her whole body hurt; she could not stop throwing up; her whole intestines hurt; it was horrible; she could not hold anything down for like 2 straight days and then just left on 20Dec2020. Scheduled date for second dose was on 06Jan2021, she has no plan to change dose schedule. The outcome of the event of tired recovered in Dec2020, while other events recovered on 20Dec2020.
I started getting raised itchy bumps that started on my left arm near my wrist and they finally went away, others appeared on various areas of my body. (I have pictures) They are still flaring up now, in August, 2021. The doctor prescribed Prednisone, Hydroxyzine for itching, Famotidine and Allegra. None of them stopped the flare ups. Hydroxyzine helps with the itch. Calamine lotion helps some, but not for long. My doctor has referred me to Dermatologist (NP).
Boostrix + Administration of expired dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4N2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 06-JUN-2023, the patient received Boostrix. On 06-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix + Administration of expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Jun-2023 The nurse asked that the dose was valid. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received an expired dose of Boostrix, which led to expired vaccine used. The case was linked with case US2023080436, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023080436:same reporter, different patient
This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of GARDASIL (Lot # K016966 Expiration date: 10-MAY-2017), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experience has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Nausea, stomach cramping, vomiting, light headedness, diarrhea
FATIGUE, SORENESS AND ANXIETY AFTER 3RD ANTHRAX SHOT MARCH 2003.
This case described the occurrence of joint pain in a 53 year old female pt who received hepatitis A and hepatitis B. The report was initially received from the pt and partially confirmed by a physician. The pt's medical history was notable for codeine allergy and liver failure. The reporting physician stated that a "liver biopsy failed to disclose an etiology, but there was a suggestion that there could be some association with alcohol". Medical history also included the onset of menopause on an unspecified date in 2004, tonsillectomy and tinnitus. The pt is a nonsmoker. Concurrent medications included Synthroid for an unspecified medical condition and Valium for sleep. On an unspecified date, the pt "tested negative for Hep A, B, and C". The pt stated that she was "a candidate for a liver transplant and was placed on an accelerated dosing schedule for hepatitis A and B vaccination. On 6/21/04, the pt received "two doses" of hepatitis A in her left arm. On 6/21/04, the pt also received 2 doses of hepatitis B in her right arm. Approximately 1 day, post/vax of hepatitis A and B vaccine, on 6/22/04, the pt experienced joint pain throughout her body. She was seen at a physician's office. The joint pain persisted. On 7/21/04, the pt received a dose of Twinrix as the 3rd dose in the hepatitis A and B immunization series. The joint pain persisted. At an unspecified date, post/vax of Twinrix, the pt "found out through subsequent testing, that her liver is functioning normally again"., The pt was seen on 11/2/04 by the reporting physician. He reported that the pt's joint pains were "quite diffuse, including the jaws, elbows, fingers, pelvis, knees and ankles. There were no objective signs of inflammation in any joint, no substantial morning stiffness, no rash and no vasculitis problems". The joint pain was ongoing at the time of follow-up, 11/2/04. The reporting physician considered the joint pain to be "a possible reaction to hepatitis B vaccine.
injection site hot; injection site discoloured; injection site  red; injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (injection site hot), VACCINATION SITE DISCOLOURATION (injection site discoloured), INJECTION SITE ERYTHEMA (injection site  red) and VACCINATION SITE PAIN (injection site sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE WARMTH (injection site hot), VACCINATION SITE DISCOLOURATION (injection site discoloured), INJECTION SITE ERYTHEMA (injection site  red) and VACCINATION SITE PAIN (injection site sore). At the time of the report, INJECTION SITE WARMTH (injection site hot), VACCINATION SITE DISCOLOURATION (injection site discoloured), INJECTION SITE ERYTHEMA (injection site  red) and VACCINATION SITE PAIN (injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up received on 10-JUL-2021 and contains non significant information
10/7- received first pfizer covid vaccination dose 10/15- woke up with chest tightness, substernal pain radiating to left, shortness of breath on exertion 10/25- increasing chest tightness and tachycardia elevated Ddimer and SVT, chest pain
Stomach pain (burning) a day after the second shot, lasting 4 days so far.; This is a spontaneous report from a contactable consumer reported for himself. A 82-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 25Feb2021 11:15 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medication were not reported. Patient had allergies of Keflex. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot number: unknown) via an unspecified route of administration in Arm Left on 04Feb2021 15:15 as SINGLE DOSE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 27Feb2021 at 20:00 patient experienced stomach pain (burning) a day after the second shot, lasting 4 days so far. Patient didn't received treatment for the event. Outcome of the event stomach pain was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pain and swelling in my arm where the needle went in, fever, sore muscles and joints, tiredness, headaches, felt like vomiting and still feel nauseous(I have a doctors appointment to be referred to digestive since I still fell nauseous and I cant eat), pain in my neck and knees , not sleeping well, it was red and itchy (I got a reaction), fast heartbeat I almost faint 3 times, had blurred vision and chest pain.
Icy, cold feet. This started gradually in November, shortly after vaccine. I'm a hiker and work out at the gym, never had this problem before. This is an every day occurrence and now have to use a hot pack on my feet through out the day for relief. I finally had to be checked by my Dr on 1/27/2022.
Swelling, redness, mild itching at injection site. "Vaccine arm," apparently. Started a few days after vaccination, still ongoing. Only mildly irritating, does not interfere with daily life.
Mom advises that son developed fever 2 days ago. He developed a rash yesterday which has spread from stomach, legs to face. He also has an ear infection was treated with Amoxicillin. Mom took him to ER yesterday, Amoxicillin discontinued. Given Benadryl.
A week after the injection my left arm, at the injection site started to get red and swollen, it was round shape about the size of a tennis ball, it is now 12 days since the injection, the swelling has enlarged and has taken the whole upper arm front side of the upper arm and wrapping into my  body. It is warm to the touch and my whole arm to my shoulder aches and sore, and beginning of to be very painful regardless of touching it or not. its starting to feel like I?m losing strength and hard to lift things.  Getting a little concerned and not sure what to do.
In the about 12 hr - severe joints pain, esp. large joints; chills, fatigue, generalized itching. On the third day - dry cough, sore throat, tracheolaryngitis.  On the fifth day (today, Monday) missed work due to feeling sick and noticed rash.
PAIN IN ARM, UNABLE TO MAKE A FIST, LEFT SIDE SORENESS, LEFT ANKLE SORE, DIFFICULT TO MOVE LEFT SIDE OF BODY
Fatigue, Unspecified speech issue  Narrative:  Tired for a few days after injection. Report says "Speech affected in beginning, memory good", but no details.
Chills, myalgias, redness @site of injection, pain + difficulty abducting her arm.
ADVERSE EVENT NOS; 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, start therapy date were not reported 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 an unspecified date, the subject experienced adverse event nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from adverse event nos. This report was non-serious.
that evening devel redness & warmth;It was slowly progressed & is painful;where is a wide band of indurated, erythematous skin that goes from should down inside upper arm & around elbow & over the trapezius;hyperpigmented coloration;
This spontaneous report as received from a 73 years old female patient with asthma and allergic to pain medicine that begins with letter k refers to herself. The patient was vaccinated with ZOSTAVAX (lot number, dose and route were not reported) in the arm on 29-SEP-2012. No other co-suspects were reported. Concomitant medications included budesonide, SYMBICORT, PROAIR, hydrochloride, amlodipine, vitamins, omega-3 marine triglycerides, potassium, magnesium, MUCINEX and raspberry ketone. On 07-OCT-2012 the patient began to experience symptoms that included redness, swelling, rash and a hard, warm, swollen lump. The rash started as a four-inch rectangle area near the injection site and "now has moved to include more of her arm". Her whole arm felt funny and hurts and her fingers were numb. There was no treatment information given for adverse events and no laboratory diagnosed study performed. The adverse events were improved on therapy. The patient was not recovered at the time of report. The patient had sought unspecified medical attention, and she saw her pulmonologist on Monday but had not seen her primary physician yet for this experience. Additional information has been requested.
Event:  10 days after 1st dose, I suffered a celiac artery dissection and common hepatic artery dissection. Symptoms: Horrific abdominal pain!!!! Extremely high blood pressure. Treatment:  Lisinopril
He started to feel bad that afternoon and began having problems breathing that night, very short and rapid breaths, he also developed a rapid heart rate and had to vomit 4 times between midnight and 5:00 AM. 12/17/09 ER record for DOS 10/30/2009. DX: Pneumonia Presented with complaint of trouble breathing, vomiting, did not sleep well and generalized body aches. Received H1N1 vaccination yesterday and last night experienced symptoms. On examination noted: Rhonchi with SOB, patient's face flushed. Treated Albuterol/Atrovent, Proventil, IV Rocephin and oxygen. At time of discharge, respirations unlabored, SAT 98%. Given prescriptions.   01/05/2010 Clinic medical record for DOS 05/30/2008-12/14/2009. 12/14/09 note "Feels well".
Patient was given adult dose of Pfizer covid vaccine. Provider was notified and patient parent was informed
she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms; she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms; This is a spontaneous report from a contactable physician (patient) via the sponsored program. A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), on 12Mar2021 2:00 PM (received at the age of 69-years-old) for COVID-19 immunization. Medical history included osteoporosis, benign head tremor, ongoing lumbar radiculopathy and lives with pain and tingling every day of her life. The patient explained that her history is due to an injury years ago. She had Lumbar radiculopathy in the right leg that involved tingling, occasional pain going on every day for a number of years. She also has osteoporosis and was on Prolia every 6 months and the only other thing she has is benign head tremor She had a head concussion number of years ago but other than that she stated that she is in pretty good shape. Concomitant medications included denosumab (PROLIA) for osteoporosis. The patient reported that she received the first Pfizer covid 19 vaccine on Friday 12Mar2021. She stated that through the night she experienced tingling in the face, nose, cheek, chin and tingling in her arm. The tingling in her right leg intensified on Saturday 13Mar2021. Also, along with that, she had some tingling in her face that came in length in her nose and her chin on the left side that kind of comes and goes. She stated that she is getting better at the time of the report 15Mar2021. She further stated that she had right lumbar radiculopathy and lives with pain and tingling every day of her life, she thinks the vaccine caused a flare up of her symptoms. She reported that she has been experiencing she has the pain and tingling in her legs, she had this before, but the vaccine has increased her symptoms, so she is having more flare up and more pain. She was also experiencing the pain down both of her legs and pain and tingling in her face. She stated that she did not see this in the contraindications. She is concerned about taking the second dose. She wanted to know do these symptoms go away and should she get the second dose. At the time of report, it was getting a little better, but she wanted to report this because she thinks Pfizer needs to know this. She said she did not read this in any other side effects of this particular vaccine. Outcome of the events was recovering.  Information on batch number has been requested.
Information has been received from a physician and a nurse concerning a 25 year old female who on 06 Nov 2006 was vaccinated intramuscularly with the first single dose vial of Gardasil. On 06 Nov 2006, that evening, the patient developed itching all over her body, but no rash was associated with it. The physician and nurse reported that the patient also developed nausea. Unspecified medical attention was sought. The nurse told the patient to try some over the counter Benadryl to treat the itching as was recommended by the physician. There was no lot number provided. At the time of this report, the outcome of the events were unknown. Additional information has been requested.
Began experiencing chills and had difficulty breathing.  Pulse oximeter  was between 90 to 95%.  Pulse as high as 106.  Could not breath adequately laying down until after 4:00 am.  So I had to sit up or dtand that time.  Due to chills needed to have blanket wrapped around me.
Patient reported immediate soreness at injection site and swelling that evening.  Swelling worsened and she was evaluated at urgent care 5 days later.  Patient reports her arm was 2x the size of normal, here was a hard spot at injection site, a ring around the site, and white dots.  States she was diagnosed with a lymph infection and was given a compression bandage and prednisone.  Swelling started to decrease 7 days after injection.  Patient states the vaccine was given in her dominant arm, lower than in the past.  She has always received the vaccine in her non-dominant arm.  Reached out to urgent care for more information but the center was not able to locate her in the system after multiple attempts.  She was given the preservative free Fluarix QIV PFS, which she had never received in the past.
This spontaneous prospective pregnancy report as received a physician and from an office administrator refers to a 26 year old female patient with no pertinent medical history. On 06-SEP-2013 the patient was inadvertently vaccinated with her first dose of GARDASIL (lot # J002641, expiration date 10-DEC-2015, 0.5ml, intramuscularly). There was no concomitant medication. The patient became pregnant with LMP of 11-JAN-2013 and EDD of 18-OCT-2013. Initial exposure to GARDASIL was at 34 week(s). No lab diagnostics studies performed. The patient did not seek medical attention. The pregnancy outcome was outcome pending. Additional information has been requested.
This is in follow-up to report(s) previously submitted on 8/14/2008. Initial and follow-up information has been received from a physician concerning a 24 year old female with needle phobic and mitral valve prolapse and no known drug allergy, who on 21-JUL-2008 was vaccinated with a first 0.5 ml dose of GARDASIL (lot number 659055/1522U) intramuscularly in the left deltoid. On 21-JUL-2008, approximate 1 minute after the vaccination, the patient became pale and nearly experienced syncope.  The physician reported that the patient experienced symptoms of syncope but did not lose consciousness.  The physician gave the patient some cold water and drink. The patient rested for approximate 10 minutes. Subsequently, the patient recovered from symptoms of syncope.  Additional information is not expected.
Not sure of exact time. Continuing pain in shoulder/arm, along with flu-like symptoms (which I never had before). Pain has continued since November.
LCV/small vessel vasculitis; severe rash 3-4 days after 3rd Pfizer shot; he had palpable purpura including torso, all extremities; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "hx HTN" (unspecified if ongoing); "stroke" (unspecified if ongoing); "prostate CA" (unspecified if ongoing), notes: prostate CA. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, product: COVID 19, brand name unknown: COVID19 Vaccine), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 1, product: COVID 19, brand name unknown: COVID19 Vaccine), for COVID-19 Immunization. The following information was reported: CUTANEOUS VASCULITIS (medically significant) with onset 22Apr2022, outcome "recovering", described as "LCV/small vessel vasculitis"; PALPABLE PURPURA (non-serious) with onset 22Apr2022, outcome "recovering", described as "he had palpable purpura including torso, all extremities"; RASH (non-serious) with onset 22Apr2022, outcome "recovering", described as "severe rash 3-4 days after 3rd Pfizer shot". The events "lcv/small vessel vasculitis", "severe rash 3-4 days after 3rd pfizer shot" and "he had palpable purpura including torso, all extremities" required physician office visit. The patient underwent the following laboratory tests and procedures: Biopsy skin: LCV/small vessel vasculitis. Therapeutic measures were taken as a result of cutaneous vasculitis, rash, palpable purpura.  Additional information: Adverse event: patient developed severe rash 3-4 days after 3rd Pfizer shot. He had palpable purpura including torso, all extremities. Skin biopsy with dermatologist showed LCV/small vessel vasculitis  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. 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.