chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Back pain have been severely bad after she took both doses; Arthritis have been severely bad after she took both doses; Drug Rash; Diagnosed with DVT; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Diagnosed with DVT) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 11020A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis, Migraine and Back pain. Concomitant products included GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for Migraine.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced DEEP VEIN THROMBOSIS (Diagnosed with DVT) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (Back pain have been severely bad after she took both doses), ARTHRITIS (Arthritis have been severely bad after she took both doses) and DRUG ERUPTION (Drug Rash). At the time of the report, DEEP VEIN THROMBOSIS (Diagnosed with DVT), BACK PAIN (Back pain have been severely bad after she took both doses), ARTHRITIS (Arthritis have been severely bad after she took both doses) and DRUG ERUPTION (Drug Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After getting the first shot on 16 Jan2021, she was diagnosed with DVT on 18 Jan 2021 and has been on blood thinner ever since then. She also takes Emgality, a migraine injection every month. She states that ever since she received the vaccine and has been put on blood thinner, she gets rash every month when she take Emgality injection. She also reported that her underlying conditions like back pain and arthritis have been severely bad after she took both doses of the vaccine. Patient is going to speak with her doctor first thing in the morning tomorrow.  Company comment: 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.
After eating lunch, I laid down for a nap. When I woke up around 05:25PM, I was sweating and shaking. I also had some head confusion. I pulled out my glucose meter to check my blood sugar. It was 50. I ate 2 spoonful of sunflower butter and a big spoonful of yogurt. My son made me drink milk. I felt like I was going to throw up, so I stopped eating. I checked my blood sugar again. It was 55. My son called the emergency number because I couldn't put my words together. EMS took me to the hospital. My blood sugar was 97 at that point. I sat in the waiting room for about six hours. I finally just went home. I have an appointment with my doctor tomorrow.
Red bump that?s about two inches wide, hot to the touch, and it has been over a week. The location is the same spot vaccine has been injected in.
This spontaneous report as received from a licensed vocational nurse refers to a 6 month old patient of unknown gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 18-SEP-2015, the patient was inadvertently, subcutaneously vaccinated with the initial 0.5 ml dose of PROQUAD (Merck) lot # L005297, expiry date 17-AUG-2016. No adverse effects were reported. Additional information has been requested.
Patient had a first time seizure and she has no other risk factors for seizure.  Of note, the patient had COVID-19 infection three months ago and received her first dose of the Moderna vaccine three weeks ago
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE DRUG INDUCED POLYNEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 7/8/2022,  11/1/2022,  2/21/2023  --  RECURRENCE OF SAME SYMPTOMS
Probably viral exanthema (grouped nodules over flexor surface of both hands and elbows
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "APS" (unspecified if ongoing). Concomitant medication(s) included: HEPARIN, start date: 26Jun2022, stop date: 26Jun2022. The following information was reported: Drug ineffective (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following lab tests and procedures: SARS-CoV-2 test: Unknown results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Treatment included Paxlovid (Lot: GC2897) started on 27Jun2022. Other medication details: Other medication: start date: 26Jun2022, stop date: 26Jun2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
yearly vaccinations of pneumonia vaccine; adverse reactions or side effects experienced: none; This spontaneous report as received from a consumer referring to herself, a female patient of unknown age. The patient's concurrent conditions included hypothyroidism. The patient's historical conditions included chicken pox. The patient was a non-tobacco user.   Since an unspecified date 2010, the patient has been vaccinated with pneumococcal vaccine (manufacturer unknown) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis on a yearly basis (inappropriate schedule of product administration) without experiencing any adverse reactions or side effects.  On 11-OCT-2016, the pt experienced vaccination failure, herpes zoster and rash vesicular and on 30-NOV-2016, the pt experienced another episode of herpes zoster (captured in MARRS# 1811USA012180).; Sender's Comments:  US-009507513-1811USA012180:
The donor was vaccinated with Anthrax(P6) in the Nursing office ,after  with a full donation . Injection time was 11:00 am and five minutes after be vaccinated when the donor was still in the nursing office ,  the donor passing out  . The LOC was less than 40 seconds a the donor recovered with in 10 minutes . Other symptoms was visual disturbances  . Cold compress was applied, legs elevated and vitals signs were taken . Oral electrolytes was given to the donor (GATORADE)  The donor improved and left the Center in a very good condition . Two hours later the donor was called to follow up and the donor stated that was feeling fine.
PATIENT FELT NAUSEATED AND COMPLAINED OF THROBBING PAIN IN HER BACK.  BREATHING IS NORMAL.  SHE STATED THAT SHE FELT WEAK.
Syncope; Pulmonary embolism; This serious case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced syncope (Verbatim: Syncope) (serious criteria GSK medically significant) and pulmonary embolism (Verbatim: Pulmonary embolism) (serious criteria GSK medically significant). The outcome of the syncope and pulmonary embolism were not reported.   It was unknown if the reporter considered the syncope and pulmonary embolism to be related to Shingrix.     It was unknown if the company considered the syncope and pulmonary embolism to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAY-2023 The physician mentioned she had seen a patient who recently received a 2nd dose of Shingrix and the next day the patient experienced syncope and subsequently had a pulmonary embolism. The reporter did not agree to follow up from GlaxoSmithKline.
Had Covid after first shot; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Had Covid after first shot) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had Covid after first shot). At the time of the report, COVID-19 (Had Covid after first shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Coronavirus test: positive (Inconclusive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported.
face swelled up three times since the first dose; he received the second dose of the Moderna Covid-19 vaccine on 06Aug2021.and first dose 12-Jun-2021; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swelled up three times since the first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the second dose of the Moderna Covid-19 vaccine on 06Aug2021.and first dose 12-Jun-2021) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the second dose of the Moderna Covid-19 vaccine on 06Aug2021.and first dose 12-Jun-2021). On 26-Aug-2021, the patient experienced SWELLING FACE (face swelled up three times since the first dose). On 06-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (he received the second dose of the Moderna Covid-19 vaccine on 06Aug2021.and first dose 12-Jun-2021) had resolved. At the time of the report, SWELLING FACE (face swelled up three times since the first dose) outcome was unknown.      No Concomitant drugs were reported.  No Treatment information  were reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-220883 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Reporter contact information upated
Arrythmia, Rapid Heart Rate, Excessive Sweating, Shortness of breath. Dehydration. Had to go to hospital and have my baby montored as I was pregnant. I was told I was dehydrated per the excessive sweating. Also was at the cardiologist numerous times after vaccination. Was diagnosed with arrythmia am still being treated for it. This all happened 4 days after vaccination.
I had an expected immune response, low grade fever, headache and body aches, all the resolved within 10 hours. I only feel the need to report them as they coincided with my first injection rather than my second injection. I am curious if that is because I had COVID 19 in 4/2020 and therefore my immune system was already primed to respond.  If it turns out to be a pattern, I think it would be helpful for others who have already had the disease to be given a heads up before their first injection. Thanks for all the work you do!
Mother reports that patient became crabby, and she noticed a softball sized welt in the child's right gluteal, she said he described it as a bruise but it was not bruised. Patient felt feverish but did not have a fever. Patient went to physicians office and was told to take benadryl daily and with in 2-3 days it was resolved.
woke up the next morning with a slight headache; arm was really, really sore; heart was doing some weird things; a couple of weeks before getting second shot, it was hard to take deep breaths; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (heart was doing some weird things), DYSPNOEA (a couple of weeks before getting second shot, it was hard to take deep breaths), HEADACHE (woke up the next morning with a slight headache) and VACCINATION SITE PAIN (arm was really, really sore) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included HYDROCODONE for Back pain.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (woke up the next morning with a slight headache) and VACCINATION SITE PAIN (arm was really, really sore). In March 2021, the patient experienced CARDIAC DISCOMFORT (heart was doing some weird things) and DYSPNOEA (a couple of weeks before getting second shot, it was hard to take deep breaths). At the time of the report, CARDIAC DISCOMFORT (heart was doing some weird things), DYSPNOEA (a couple of weeks before getting second shot, it was hard to take deep breaths), HEADACHE (woke up the next morning with a slight headache) and VACCINATION SITE PAIN (arm was really, really sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Allergy test: results not provided Results not provided.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported as before getting second shot it was hard to take deep breaths, and her heart was doing some weird things because of that she thought it could be allergies and got allergy testing. Treatment information was not provided by the reporter.   This case was linked to MOD-2022-439863 (Patient Link).
no adverse event, It keeps reoccurring in one spot after vaccinated; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: no adverse event, It keeps reoccurring in one spot after vaccinated). The outcome of the nerve pain was not reported.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported via consumer interactive digital media. The reporter reported that, the why patient had nerve pain, the vaccine, patient was the 3rd person reporter had heard this from and one was reporter friend, it keeps reoccurring in one spot after vaccinated. The reporter had it because of medication side effects and never got it since. Follow up was not possible, as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter US-GSK-US2023AMR057506:Same reporter US-GSK-US2023AMR057511:Same reporter
Vaccine stored outside of manufacturer guidelines, product stability is unknown. Potential expired product used for immunization. No adverse events reported from vaccine.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. 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: Positive, notes: COVID 19 Treatment, Rebound covid. 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.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
This case was reported by a physician and described the occurrence of limb swelling in a child female subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unknown) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date on or before 13 July 2006, the subject received the 4th dose of Dtpa (unknown manufacturer and lot number). Site of injection was the left arm. Concurrent vaccination included measles, mumps, and rubella vaccine (MMR, unknown manufacturer, dose number and lot number). On 13 July 2006, at an unspecified time after vaccination with Dtpa, the subject experienced limb swelling. At the time of reporting the event was unresolved. The physician considered the event was possibly related to vaccination with Dtpa.
Site: Swelling at Injection Site-Mild, Error: Wrong Route (SC, IM, etc.)
This spontaneous report was received from a pharmacist and refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (exact dose, route, lot # and expiration date were not reported). No adverse symptoms were reported. Additional information has been requested.
4pm that same day- left side of face began to get numb, by 5:30pm severe whole body pain, by 6pm rigors. Took Tylenol and Motrin around the clock- nothing stopped the rigors and the pain increased.  5am on 1/23 fever taken 103. by 8:30am woke in a pool of sweat and aches decreased.  But by 11am full rigors and intense pain body pain began. at noon took Benadryl 25 mg and one Pepcid chewable. Stayed in bed with rigors and pain until noon on Wednesday when everything started to ease. Headache in left eye socket all day Wednesday, face numbness disappeared- MISSED 2 days of work as a nurse!!!
Developed 2 inch round rash that was very itchy with raised red bumps on left lateral thigh on 01/06/21. I treated with Benadryl and cortisone 10 over the counter meds with minimal benefit. I had  Itching moderate all over my thighs, back, arms. This morning on 01/19/21 I woke up with the same raised bumps, itching, redness on both forearms. Still itching all over my body. So I went to an urgent care center today at 12:30 pm. Nurse practitioner gave me a steroid injection, methylated oral steroid pack, anti itch pill hydroxyzine 25 mg, and triamcinolone acetone de cream for rash.
No adverse effects reported; One improperly stored dose of VAQTA was administered to on patient on 3/24/2020; This spontaneous report was received from a medical assistant referring to a 13-month-old patient. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.       On 24-MAR-2020, the patient was vaccinated with an improperly stored dose (product storage error) of hepatitis a vaccine, inactivated (VAQTA) lot # S025993, expiration date on 17-OCT-2020 as prophylaxis (formulation, strength, dose, frequency, route of administration, and anatomical location were not reported).  No additional adverse effects were reported.    The previous temperature excursion was 46.1 (units not reported) for 7 minutes. The temperature was 68.58 Fahrenheit degrees, for a time frame of 9 hours and 41 minutes. No data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from 2 nurses concerning a 6 year old boy, 66 pounds weight and 47 inches height, with seasonal allergies who on 26-MAR-2003 was vaccinated with varicella vaccine("OMNI") (manufacturer unknown) as stated by his medical documentation. The vaccine was administered by previous provider's office and there is no indication, lot number, dose, route of administration, or administration site. There was no concomitant medication. On 29-APR-2008, the patient was diagnosed with chickenpox by the reporting nurse practitioner with symptoms of itching with a chickenpox rash to the abdomen, arms, and face; itching scattered papules; and small crusted face and neck. The nurse practitioner ordered a urine analysis and blood work (results not reported). No other symptoms were reported. The patient was treated with BENADRYL and AVEENO. The patient sought medical attention with a physician office visit and was considered to be recovered. Additional information is not expected.
On approximately 2/28/99, the pt developed an abscess on the arm of the injection characterized by redness, swelling and induration. (parents thought to be a bug bite). A visit to the MD was required and the physician felt there was an association between Hep B vaccine and the adverse events. According to the MD, the episode occurred on the location of the injection. At the time of this report, the symptoms persisted.  No further information is available.
1:00 am, July 13 2022 to 6:00 pm July 14 2022: severe body aches, fever and nausea. 1:00 am, July 13 2022 thru today, July 16, 2022: severe nausea.
Pt presented to observation @725  @740 pt began to c/o vertigo and drowsiness Pt vitals taken 139/88 pulse 96 oxygen 100 Denies c/o throat /swallowing difficulties, itchiness Able to follow commands and speak complete sentences.  Drank water, apple juice, and graham crackers offered and pt declined. Pt then c/o bilateral arm chills/cold c/o down to bilateral thighs. Advised to wait additional 15 minutes for observation. @755 pt reports she is feeling less cold but s/s of cold/chills remain and dizziness/vertigo better. Pt ok for d/c per Dr  Pt left w/husband independently.