chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was very sore; Pain goes from the top of her shoulder and into/ all around the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore) and PAIN (Pain goes from the top of her shoulder and into/ all around the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore) and PAIN (Pain goes from the top of her shoulder and into/ all around the arm). At the time of the report, PAIN IN EXTREMITY (Arm was very sore) and PAIN (Pain goes from the top of her shoulder and into/ all around the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
patient reports having left axillary pain and swelling.  also with pain in left arm in area of injection.  unsure if left axillary pain and swelling was occurring prior to covid booster, or if symptoms happened after booster.  reports may have also experienced lymph node swelling after 1st or 2nd dose of covid vaccine -- but that swelling eventually resolved.
Severe dizziness resulted bedbound for 4 weeks, when able to ambulate, saw primary MD and get anti-dizziness med, got better slowly but still have mild to mod dizziness from time to time. Also, easily get tired
Starting on 3rd day after the first vaccine shot, I felt sharp pain on my left chest and left back, two days later, rashes appeared, diagnosed as Shingles. Treated with antiviral medication. As today, rashes almost gone, but part of my chest is still sensitive to touch, temperature. The injection site of my left arm still feel mild pain and weak.
COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4232546-00.  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported:DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive; (09Jan2022) positive. The action taken for adalimumab was unknown. Clinical course: Causality for Humira(Adalimumab) The reporter's causality for the event(s) of COVID-19 with Humira(Adalimumab) was no reasonable possibility. Causality 1) COVID-19 (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): No reasonable possibility  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a causal association between reported events drug ineffective, covid-19 with suspect BNT162B2 is possible.
Broke out into hives, had trouble breathing, was pale.  Went down to Urgent Care in my building and had to get a breathing treatment, decadron shot and benadryl.  Was given a prescription for Medrol Dose Pack, The next day had to go back to Urgent carea for another shot of decadron because was still having trouble breathing. Gave my a differect prescription for predisone, Hydroxzine and Zantac.
About 1 week after my Covid booster; I noticed my T had spiked to an uncomfortable level; vaccine received same date: Flu; vaccine received same date: Flu; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 (Lot number: 30145BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 14Oct2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing), notes: Tinnitus. I have tinnitus but very low with generally no issue. ; "shingles" (unspecified if ongoing), notes: I had shingles about 3 years ago and has never gone away. Concomitant medication(s) included: LATANOPROST; CALCIUM; MAGNESIUM. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL 9269), administration date: 11Feb2021, when the patient was 65 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9262), administration date: 24Jan2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Oct2021, outcome "unknown" and all described as "vaccine received same date: Flu"; IMMUNISATION (non-serious) with onset 23Oct2021, outcome "unknown", described as "About 1 week after my Covid booster"; TINNITUS (non-serious) with onset 23Oct2021, outcome "not recovered", described as "I noticed my T had spiked to an uncomfortable level". The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of immunisation, tinnitus.  Additional information: Facility where the most recent COVID-19 vaccine was administered as Withheld. Relevant past drug history mentioned as No. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient stated about 1 week after her Covid booster, patient noticed her T had spiked to an uncomfortable level. Patient did not think of any relation to the booster. Patient  thought it was maybe just a spike but after 3 weeks of continual noise, patient asked a relative who experienced T along with some other symptoms. Since the vaccination, the patient has not been tested for COVID-19. Device Date mentioned as 15Nov2021.   Follow-up attempts are completed. No further information is expected.
Sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepiness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure high. Concomitant products included THYROID for Thyroid disorder NOS, LOSARTAN, PROPRANOLOL HYDROCHLORIDE (INDERAL), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PANTOPRAZOLE, CALCIUM, VITAMIN D NOS and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced SOMNOLENCE (Sleepiness). At the time of the report, SOMNOLENCE (Sleepiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Patient is also taking high blood pressure medications concomitantly.
feels like he had the flu; does not have appetite; yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am; is very tired; is with lots of pain in the arm where he got the injection; had chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), CHILLS (had chills) and FATIGUE (is very tired) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (had chills). On an unknown date, the patient experienced INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), FATIGUE (is very tired) and VACCINATION SITE PAIN (is with lots of pain in the arm where he got the injection). On 10-Aug-2021, CHILLS (had chills) had resolved. At the time of the report, INFLUENZA (feels like he had the flu), DECREASED APPETITE (does not have appetite), SOMNOLENCE (yesterday went to bed at 7 in the afternoon and today did not woke up until 10 am), FATIGUE (is very tired) and VACCINATION SITE PAIN (is with lots of pain in the arm where he got the injection) outcome was unknown.            Treatment information was not reported.
Pt sates, "Went to take a pt test this morning and when it came time to running the mile and a half, about 10 seconds after starting it felt like my whole body was telling me to stop. I had trouble keep my breathing under control and pain in my chest. I pushed myself to finish, but the entire time I could keep control of my breathing and the pain continued".
Approximately 2 hours after receiving vaccine, I developed severe fever, chills, headache, and nausea that lasted for about 48 hours. When the symptoms began to resolve, I noticed the toe next to my pinky-toe on my right foot was discolored, swollen and there was a red streak going from the toe up my foot. The next day the foot and toe were swollen, warm, red, and painful so I went to the urgent care. I was given antibiotics for cellulitis.  As the swelling began to subside, I noticed the toe was discolored (purple) and the skin began peeling off.  The toe continued to be purple/blue and is slowly returning to a more typical color.
3rd COVID vaccine received 9/17/2021. Patient COVID + 09/06/2022, died 10/19/2022 from complications.
pt devel a pea sized lump @ inj site of tetramune;lump turned into a dimpled indentation which persists;
pt recv vax 5JUL96 & next day lymphocytosis noted;ATB therapy had been initiated w/assumption that an infectious process existed;bradycardia & apnea inc p/vax;It was felt that abn WBC count & differential were viral, rather than bacterial;
Redness, swollen, painful, hurts to left arm. Dx: Local peri-vaccination site viral cellulitis with axillary lymphadenitis
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 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "IBD" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing); "sensitive to penicillan" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Jul2022) Positive; (08Aug2022) Negative; (10Aug2022) Positive, notes: I went to Urgent Care and tested positive with a PCR test for COVID-19 again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient  tested positive for Covid on 26Jul and started Paxlovid the evening of 27Jul2022 finishing it the morning of 01Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My left arm was swollen and painful for 10 days.  I have a hematoma that is the size of a half dollar and still painful.  My hands have been swollen and I have been dizzy.
All died within the 5 weeks after first shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for six patients. This is the fourth of six reports.   An elderly patient of an unknown gender and age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date of 2021, as single dose for COVID-19 immunization. The patient' s medical history and concomitant medications were not reported. On unknown date, in 2021, the patient died within the 5 weeks after the first vaccination. It was not reported if an autopsy was performed.  The patient was in a residential home with 5 other elderly residents. He/she died in sleep.  The information on the lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter/SD/AE, different  patients; Reported Cause(s) of Death: All died within the 5 weeks after first shot
Patient came to vaccine clinic requesting the flu shot, VIS form given and injection to right deltoid with 25g 1" needle.  No symptoms, no reaction, no further treatment.  documented vaccines given in computer and noted the patient already received this season's flu shot in September 2021.  pt called to notify of second flu shot for season was given.
started w/itching & swelling to rt deltoid area 7/3/99;taken to ER 7/3/99;Augmentin prescribed;f/u visit to office 7/6/99-swelling to arms less;
In the evening of the 4th I started feeling like I had a head cold kinda thing with congestion, nasal drip, and headache. Woke up the next morning and was still feeling bad and we were supposed to go out of town that day and I decided to do a home COVID-19 test and it was positive and I called a telehealth for a visit and the RNP prescribed PAXLOVID and I started taking it that immediately that evening. That evening I started experiencing fatigue and feeling worse and the symptoms started feeling minor and on the 11th I was still feeling fatigue and on the 12th I was normal and on the 13th I started feeling the rebound symptoms with fatigue, cough, congestion. I also ran fever and a funny taste in my mouth and it was odd there for awhile. It finally started to trail off over awhile and I would say that about the 25th I started feeling like doing anything. I monitored my blood oxygen level and blood pressure and still have a lingering cough.
Received augmented dose of flu vaccine, Developed severe shoulder pain that has persisted for 5 weeks; Next day, onset of a rash in arm below vaccination, later diagnosed by primary physician  as shingles.
can't hear out of left ear; Ringing in both ears; Ringing in  the other ear that did not last long; Ringing in one ear that didn't last long; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (can't hear out of left ear) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TINNITUS (Ringing in one ear that didn't last long). On 16-Apr-2021, the patient experienced TINNITUS (Ringing in  the other ear that did not last long). On 18-Apr-2021, the patient experienced TINNITUS (Ringing in both ears). On 20-Apr-2021, the patient experienced DEAFNESS UNILATERAL (can't hear out of left ear) (seriousness criterion medically significant). On 15-Apr-2021, TINNITUS (Ringing in one ear that didn't last long) had resolved. On 16-Apr-2021, TINNITUS (Ringing in  the other ear that did not last long) had resolved. At the time of the report, DEAFNESS UNILATERAL (can't hear out of left ear) and TINNITUS (Ringing in both ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No 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 events, a causal relationship cannot be excluded.; 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 spontaneous report has been received from a 64-year-old female consumer reporting on herself. The patient's historical conditions were not reported and her concurrent conditions included clotting disorders (unspecified) and autoimmune diseases (unspecified). The patient's concomitant therapies included warfarin sodium (COUMADIN), fosinopril sodium, alprazolam, atorvastatin, and carvedilol. She did not have any reactions/allergies. On 21-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date and dose were not reported; route of administration was reported as injection and frequency as one injection) for the prevention of shingles which was reconstituted with a sterile water diluent (manufacturer unknown) (lot number and expiration date was not reported). On 18-MAR-2017, the patient experienced a body rash and a yeast infection. She then sought medical attention on an unspecified date and was treated with prednisone (manufacturer unknown) and hydroxyzine hydrochloride (manufacturer unknown), there were no laboratory diagnostic tests performed. At the time of this report, the patient had not recovered from her rash and fungal infection. The causality assessment between rash and fungal infection with ZOSTAVAX was unknown. Additional information has been requested.
Started vomiting several times a day starting 8/24/2016-12/2016. Received 2nd dose GARDASIL 9/1/16. Continued ER visit 9/11/16 with severe abdominal pain. Returned to emergency department 9/14/2016. Admitted to hospital 9/15/2016 with pancreatitis, abdominal pain, constipation, and post-viral Ileus. Released from hospital 9/22/16. Continued vomiting, abdominal pain, and gastrointestinal distress. Started seeing GI specialist 9/26/16-1/16/17. Started contracting Strep Throat 11/2016. Developed walking Pneumonia after Strep Throat 11/2016. February 2017-Strep Throat, Urgent Care. June 2017-Strep Throat, Urgent Care. October 2017-Strep Throat, Urgent Care, Developed Walking Pneumonia. January 2018-Strep Throat, Urgent Care. October 4, 2016-Seeing GI specialist for Post Viral Gastroparesis and Visceral Hyperalgesia. January 5, 2017- 3rd dose GARDASIL 9. January 2018-Started seeing a pulmonologist for Reactive Airway Disease. October 13, 2016-ER visit for distended abdomen, extreme constipation. November 2016- ER visit for difficulty breathing and cough. October 21, 2017-ER visit for persistent difficulty breathing. November 17, 2017-Left arm pain (mimicking heart attack)-Thoracic Outlet Syndrome. January 23, 2018-Continued treatment for Thoracic Outlet Syndrome. September 7, 2017-Diagnosed Chronic Regional Pain Syndrome. March 2018-Amenorrhea. September 2018-Suspected Premature Ovarian Failure. January 2019-Confirmed Diagnosis Premature Ovarian Failure, treatment is estrogen therapy. Given antibiotics for Strep Throat. Given an Albuterol and steroid inhalers for Walking Pneumonia.
Information has been received from a nurse practitioner concerning a 4 year old female who on 03-AUG-2007 was vaccinated with a second single subcutaneous dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (Lot # 658133/0773U) in her leg.  Concomitant vaccine administered on the same day included DTaP.  Within 24 hours post-vaccination, on approximately 04-AUG-2007, the patient developed a large hive at the site of injection.  The next day, the patient was covered with hives all over her body.  The patient was treated with a long acting antihistamine at the office visit on 06-AUG-2007.  The office has not heard from the patient's mother and is unaware of the patient's present status.  No further information was provided.  Additional information has been requested.
34 weeks pregnant at time of vaccination. Start of preterm labor the evening after receiving the flu vaccination on 09/27/2017. I had just had my OBGYN appointment that morning and everything checked out fine. Received the flu vaccine at the end of the appointment. Went to hospital on 09/27/2017 for bleeding at 34 weeks gestation. Admitted for preterm labor. Preterm labor continued on and off for the next few days. Was in the hospital until 10/02/2017 and was sent home on bedrest. Preterm rupture of membranes occurred at home on 10/03/2017. Baby was born at 35 weeks gestation on weighing 5lbs 6oz. Baby kept in hospital for 12 more days. Due date was 11/05/2017.
Patient reports that she received second Pfizer Covid vaccination "on the back of her arm". This could have possibly resulted in inappropriate subcutaneous administration (instead of intramuscular). She experienced local redness and induration, but this was painless.
within 4 hours of the injection, the arm was very sore and hard to lift. I developed a headache. By 12 hours post-injection, I had severe chills and a migraine. The migraine type headache lasted 3 days. The arm remained sore. On the third day, I developed a baseball-sized rash at the injection site, and then a rash across my chest and abdomen (front only). These rashes lasted about 3 hours, with tiny red bumps (like a heat rash). On day 8 (a week and a day after the injection), I developed very bad hives across my neck, torso (front and back side), upper arms, and lower arm on the left (where the injection had been). The hives continued down to my hip flexors on the front side. They were large welts and extremely itchy. I took Benadryl and used calendula cream to calm them down. However, the hives kept returning for a week. After that, they finally went away, although they would return when I would engage in cardiovascular exercise -- for another 2 weeks.