chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sicker than a dog; really bad headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (sicker than a dog) and HEADACHE (really bad headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sicker than a dog) and HEADACHE (really bad headache). At the time of the report, ILLNESS (sicker than a dog) and HEADACHE (really bad headache) outcome was unknown.            No concomitant medication and treatment medication information provided.The afternoon after receiving the second dose the patient experienced a really bad headache and  felt "sicker than a dog." The reporter did not know when or if these symptoms have resolved.
Fever, Chills, Vomiting, Aches in bones, Muscle pain, severe headache, swelling of injection site
All events took place:  Following first dose, minor rash on left arm; following second dose, first developed severe rash on arm and belly, extreme fatigue, severe hiccups and inability to swallow without choking; ultimately developed liver and kidney failure, was diagnosed with DRESS syndrome resulting from reaction to vaccine, was administered high-dose corticosteroids and antibiotics but continued to decline, developed hemorrhage in lungs and died due to multi-organ failure.  PDF Continuation field did not permit entering text, see attached Continuation Page.
Body aches, no fever, feels flu-like symptoms, no symptoms of an allergic reaction.
unable to use my arm as it is still swollen; unable to use my arm as it is still swollen and painful; This is a spontaneous report from a contactable consumer (patient). This 57-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 12:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 in Jan2021; the patient stated she probably had COVID at New Year but was not tested and she spent a few days in bed and was exhausted for all of Jan2021. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received some antibiotics from unknown dates for unknown indications and experienced allergies; the second dose of shingles vaccine on 09Feb2021 in the left arm (at 57-years-old) for immunisation and experienced a bad reaction; and the first dose of BNT162B2 (lot number unknown) in the right arm on 13Mar2021 at 12:15 (at 57-years-old) for COVID-19 immunisation and experienced very painful and swelled up. The patient reported that since getting the second shot in her left arm on 03Apr2021 she had been unable to use her arm as it was still swollen and painful. Her doctor put her on a week of steroids, anti-inflammatory medications and muscle relaxers to try and reduce the swelling. The patient reported having had a shingles shot in that arm in early Feb2021 with a bad reaction that went away after a week; which was why she had the first shot of BNT162B2 in her right arm , which swelled up immediately and was very painful but started feeling better the next day. The events were reported as non-serious and did not require hospitalization; the event resulted in a physician office visit. The clinical outcomes of unable to use her arm as it was still swollen and painful were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Vaccine-Induced Thrombotic Thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Vaccine-Induced Thrombotic Thrombocytopenia) in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Vaccine-Induced Thrombotic Thrombocytopenia) (seriousness criterion medically significant). At the time of the report, THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Vaccine-Induced Thrombotic Thrombocytopenia) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Vaccine-Induced Thrombotic Thrombocytopenia) to be related.    Concomitant medication information wasn't reported.  The patient was managed conservatively with steroids. Steroids and intravenous immune globulin therapy have been reported in the literature. This report highlights that VITT should be considered in the differential diagnosis for patient presenting with increased bruising in the setting of recent COVID-19 vaccine administration.  Company comment-This is a literature case concerning a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (Medically Significant), AESI event of Thrombosis with thrombocytopenia syndrome at an unknown interval after first and second dose of mRNA-1273 vaccine administration. It was reported that patient presented with easy bruising and thrombocytopenia following completion of the two-dose Moderna COVID-19 vaccine, suspicious for a diagnosis of VITT. The patient was managed conservatively with steroids, The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 34-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious (Medically Significant), AESI event of Thrombosis with thrombocytopenia syndrome at an unknown interval after first and second dose of mRNA-1273 vaccine administration. It was reported that patient presented with easy bruising and thrombocytopenia following completion of the two-dose Moderna COVID-19 vaccine, suspicious for a diagnosis of VITT. The patient was managed conservatively with steroids, The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
acute nontraumatic left eg pain and extensive soft tissue bleed in leg/bruise with precipitous anemia.noted in ER on 3/10 2/10/21 H&H HGB  13.1  HCT, AUTO 41.2 --at ER  3/10 RBC 3.06 M/mm3 LOW HGB 9.9 gm/dL  HCT 29.3 % LOW PLT 382--medrol pack started AFTER condition commenced taken 3/8-13.
Headache; Pain; Could not raise arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Could not raise arm), HEADACHE (Headache) and PAIN (Pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025620A and 072A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Could not raise arm). On an unknown date, the patient experienced HEADACHE (Headache) and PAIN (Pain). At the time of the report, MUSCULAR WEAKNESS (Could not raise arm), HEADACHE (Headache) and PAIN (Pain) outcome was unknown.            No Concomitant medicine were reported. No treatment information reported.
About 2 hrs after the injection my right deltoid became very hot swollen.painful..itchy.....then the redness and swelling,which was like massive hives ,eventually went all around my upper arm from my shoulder to my elbow,that nightI vomited,had diarrhea,a fever,extreme weakness..I started taking 100 mgm.of benedryl every 6 hours..the next day which was sat.,I was weak,had a fever,my atlrm a mess nauseated, then on Sunday my sinusez started bleeding and I knew that I now,has a sinus infection and bronchitis..I saw my family Doctor on mon...my arm was a bit less inflamed,I showed him pictures of  how it was ,,oooh and my face brokevout in a butterfly rash that took 2 weeks to heal.. I prayed that the Lupus wasn't rearing its ugly head..Dr.  put me on antibiotics for the resp .infections..Thankfully I was recovered in about a week..
Severe headache - Tylenol 7AM & 11AM, ibuprofen 3PM
This spontaneous report was received from registered nurse concerning an increased number of patients with unspecified age, gender, pertinent medical history or drug reaction / allergies. On an unspecified date, the patients were vaccinated with a subcutaneous 0.5 ml dose of PNEUMOVAX23 (lot number not reported). No other co-suspects or concomitant medications were reported. The patients in the practice experienced severe injection site reactions after subcutaneous administration of a dose of PNEUMOVAX23 (dates not reported). The reaction included redness (disability), pain (disability), tenderness (disability), with extensive swelling of the arm from shoulder to elbow (disability). The nurse also added that the pain and tenderness was so severe that "clothing could not touch the skin in the area of the reaction". The patients recovered on unspecified dates. There were not lab diagnostic tests. Treatment was not reported. Additional information has been requested.
Immediate - dizzy, itchy. All night - dizzy, itchy, nausea.
This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patients were vaccinated with VARIVAX lot # M028553 for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Additional information has been requested.
Initial report received from another company on 11/2/2005. It was initially reported by a physician that a health care professional (no individual patient identification provided) received a dose of influenza vaccine in the deltoid on an unspecified date. The lot numbers was not reported, but the manufacturer was reported. An unspecified amount of time later, the patient experienced an anaphylactic reaction. No other information was provided. The reporter of this case is the same as for non serious case 200502307.
Pt has red swelling with heat to left thigh which is being treated with Keflex and Benadryl.  Provider reports cellulitis of left thigh.
very tired and fatigue; Very sleepy; This is a spontaneous report from a contactable consumer (Patient) or other non health care professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced very tired and fatigue, very sleepy Just needing to sleep more in 2021. Patient was enquiring about a lot of people or any people calling saying that they have been having this kind of symptoms. The outcome of the events was unknown.  Information about Lot/Batch number has been requested.
I decided to get vaccinated for HPV at age 52; This spontaneous report was received from a physician refers herself a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of the Company unidentified HPV vaccine, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   It was reported that the patient received her first dose of vaccine, when she was 52 years old (product administered to patient of inappropriate age).
Vaccine was placed in the fridge to that from freezer and expired on 10/11/2021 and was given on 10/12/2021
Developed terrible headache, mild migraine. Took Tylenol, it helped. Felt general malaise. WORST PROBLEM IS PAIN, EXCRUCIATING PAIN AT SIGHT OF INJECTION. PAIN KEPT ME UP ALL NIGHT !!  STILL EXCRUCIATING PAIN.  I put ice on my arm right after I got the injection, and iced it every few hours thru the night - still the pain is unbearable.
joint pain - felt like an increase in the arthritis pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain - felt like an increase in the arthritis pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (joint pain - felt like an increase in the arthritis pain). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain - felt like an increase in the arthritis pain) outcome was unknown.            No concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080095 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080095:Wife case
About 18 hours after receiving the second dose of the vaccine, started to experience severe body aches from my neck to my knees. The body aches continued until about 48 hours after vaccination.; Redness at the injection site in left arm; Developed a swollen lymph node lump at the base of left armpit.; About 24 hours after receiving the second dose of the vaccine, began to experience chills. Was unable to control the body temperature even by taking hot showers and wearing multiple layers of clothing underneath blankets in bed.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 at 13:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa-based medications (sulfonamide allergy) and penicillin-based medications (penicillin allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9269) via an unspecified route of administration in the left arm on 06Feb2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021 at 07:30, about 18 hours after receiving the second dose of the vaccine, the patient started to experience severe body aches from neck to knees. The body aches continued until about 48 hours after vaccination. On 28Feb2021, about 24 hours after receiving the second dose of the vaccine, the patient began to experience chills. The worst of the chills came at about 30 hours posts vaccination. The patient was unable to control body temperature even by taking hot showers and wearing multiple layers of clothing underneath blankets in bed. Throughout this time on 28Feb2021 at 07:30, the patient also experienced redness at the injection site in left arm, and developed a swollen lymph node lump at the base of left armpit. That swelling still had not dissipated after 72 hours since vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe body aches from neck to knees was resolved on 01Mar2021 48 hours after vaccination; while that of the events chills, redness at the injection site in left arm and swollen lymph node lump at the base of left armpit was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
rash on her legs which is measles like; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash on her legs which is measles like on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Myalgia FATIGUE,eyelids and forehead, itching. At injection site sore,swelling,reddness and itching. Also going from hot feeling to cold.
Extreme pain, numbness and tingling extending down into hands and fingers.  Has now persisted for about 5 weeks with no relief.  Still has limited range of motion, weakness in arm, numbness, tingling and pain.  Have seen doctor and received steroid pack which helped for the timeframe she was on the pack.  After it ended all symptoms returned.  She now has been referred to a physical therapist as well.
Information has been received from a nurse concerning an 18 year old female patient who on 02-MAR-2010 was vaccinated with the first 0.5ml dose of GARADSIL (lot#662304/1013Y). On 02-MAR-2010, "right after getting the vaccine", the patient developed bruise at the injection site. It was reported that in the first week after she had a bruise at the injection site. The bruise was gone however the patient was still experiencing pain in the arm where the vaccine was given. Unspecified medical attention was sought. The physician told the patient to take MOTRIN and it worked, however as soon as MOTRIN wore off she experienced pain again. There were no laboratory diagnostics studies performed. Follow up information has been received from the registered nurse concerning the 18 year old female student with no pre-existing allergies and no other relevant medical histories who on 02-MAR-2010 was vaccinated with the first 0.5ml dose of GARDASIL (lot#662304/1013Y) into the left deltoid. On 02-MAR-2010, the patient was reported to have continued soreness at site (left deltoid) since vaccination on 02-MAR-2010. The patient had bruising for a week after vaccine was given. At the time of this report, the patient had recovered. Additional information is not expected.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 29Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; magnesium oxide heavy, sodium bicarbonate (ANTACID C), from 16May2022 (Batch/Lot number: unknown) to 25May2022. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (unspecified date) Negative, notes: three home rapid tests on 25May and 26May; (25May2022) Negative, notes: three home rapid tests on 25May and 26May; (26May2022) Negative, notes: three home rapid tests on 25May and 26May; (27May2022) Positive, notes: tested positive again on two home rapid antigen tests on 27May; (27May2022) Positive, notes: tested positive again on two home rapid antigen tests on 27May. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dose #1: 8/11/21; lot#FA7484 Dose#2: 9/1/21; lot #FC3184  After dose #1 started to have diarrhea. After Dose #2 diarrhea worsen - daily and watery with abdominal cramping and occasional bleeding, also nausea. Required ER visit for IVF on 09/12/21.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 12/03/2022. I checked my provider website, and it was recommended to wait before seeking treatment. I went to my doctor due to extreme fatigue and they are checking my thyroid levels.
cold in the hands and in the feet for about 15 hours; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (cold in the hands and in the feet for about 15 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL SUCCINATE, QUINAPRIL, ATORVASTATIN, DULAGLUTIDE (TRULICITY) and REPAGLINIDE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (cold in the hands and in the feet for about 15 hours). At the time of the report, PERIPHERAL COLDNESS (cold in the hands and in the feet for about 15 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: unknown (normal) couldn't get warm, took the temperature and was very normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she couldn't get warm, took the temperature and was very normal.  Treatment information was not provided.   Reporter did not allow further contact
Initial information received on 05 August 2009 from a health care professional.  A cluster of four adult male and female patients received ADACEL (lot number C3248AA) in July.  Post vaccination (date not specified), the patients complained of rash, fever, diarrhea and one patient complained of cellulitis.  The patients were not recovered at the time of the report.  List of Documents held by Sender: none.
Arm swelling, redness, and pain - 4 days Headache - 72 hours No appetite - 72 hours Extreme fatigue - 72 hours  Extreme all over body pain  - 48  hours Weakness in legs - 48 hours Fever - 18 hours Nausea - 18 hours (on and off) Chills - 6 hours (on and off) Cold Sweat - 6 hours (on and off)