chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day of vaccine, Became very flushed within an hour, lasting til bedtime. Flushed face returned the next day also. Left arm became surprisingly sore and painful to move that first evening. During the night entire body became very sore and aching, lasting through second day. Was unable to sleep once the pain started. Second day still flushed, sore arm, achy body and very tired.
The patient experienced no symptoms; The patient was vaccinated with an improperly stored dose of GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered intramuscularly (dose and frequency were not reported) (lot number 9029515 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date was reported as 08-JUL-2020) for prophylaxis.  The improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced a temperature of 0.7 Celsius degrees for 3.048 hours (information captured by a data logger) without a previous temperature excursion. The patient did not experience symptoms.
On 6/12/07, the patient received a tetanus shot. It is not indicated in the chart where the patient received the vaccine and the lot #, expiration date, and manufacturer of the product are unknown. The patient came to the ER on 6/14/07 with an erythematous, warm, raised rash on the left arm around the injection site (size was 4 cm). The patient was observed and discharged home.
Patient presented to the clinic with symptoms of chickenpox on limbs only. Per mother patient has received varicella vaccine.
Lots of pain, can't lift arm, swollen, rash, itching very red all around the arm. Very hot to the touch and feels hot.
pt had a sore achy arm all of the way to his hand immediately after getting the vax.  Later that day he became fatigued, extremely nauseated, had body aches, chills, profuse sweating, and headache.  He took Tylenol 1000mg that night, the next morning and again twice the next day.  The next day his eyes hurt, had headache, loss of appetite, fatigued with body aches and pain.  On 4/3/2021 he still had a headache but the other symptoms were better and disappeared by the end of this day.
Pain in left calf leading to development of blood clot above left knee cap near inside of quad; Pain in left calf leading to development of blood clot above left knee cap near inside of quad; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included U/L fasciatomy in same leg with nerve damage, Blood transfusion, previous clot in femoral during recovery, Shellfish (allergy). The patient has not had COVID prior vaccination. The patient received first dose of BNT162B2 for COVID-19 immunization on an unspecified date (lot number: unknown) at 38-years-old. Concomitant medication included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported. On 04Mar2021 16:00, the patient experienced Pain in left calf leading to development of blood clot above left kneecap near inside of quad. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment for the events: Originally treated as cellulitis with doxy. The outcome of the events was recovering. The patient was not tested for COVID post vaccination.   Information about Lot/Batch number is requested.
Vomiting; Diarrhea; Nausea; Headache (within 24 hours of shot).; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 12:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and seasonal allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included mesalazine (LIALDA), loratadine (CLARITIN), phleum pratense (GRASSTEK) and mutivitamins; all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021, the patient experienced nausea and headache (within 24 hours of shot). nausea/vomiting/diarrhea (within 5 days of shot).The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, vomiting and diarrhea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
My arm is in terrible pain since getting the vaccine 3 months ago. There are times that I wake up in the morning that I am unable to lift or utilize my arm, it is beyond sore and painful. I shrugged it off month after month but after 3 months, I am growing concerned.
Patient reports that a week ago Friday he received his Covid shot (#1).  That evening approximately 10 PM began having abdominal cramping, periumbilical and lower abdomen, more on the right.  Seem to improve the next day but since has waxed and waned.  Upon awakening today had increased pain which is progressively worsened through the day.  Some nausea but no vomiting.  No fever or chills.  Reports normal bowel movement this a.m., approximately noon loose watery stool x1.  No blood in stools.  History of cholecystectomy.  Patient was started on Zosyn and CT found to have a distended appendix with a fecalith consistent with acute appendicitis without perforation.  Patient underwent a laparoscopic appendectomy the next day and was discharged home.
BONE PAIN; CHILLS; HEADACHE; FATIGUE; INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced injection site pain. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced bone pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fatigue, and fever on 10-APR-2021, and had not recovered from headache, bone pain, and injection site pain. This report was non-serious.
Tiredness began 5 hours after immunization. Nausea began 12 hours after immunization. High fever accompanied nausea and persisted for 48 hours.
5-day(s) hospitalization for IVIG - extreme weight loss. Tripping, falling, loss of muscle mass, inability to walk without assistance. Now is in a wheelchair of which pain up feet legs, thigh persist. All of symptoms like respiratory breathing problems began in December of 2008. Had several doctor visits. 6/9/09 MR received for DOS 3/11-15/09 with DX: Guillain-Barre Syndrome- Acute Inflammatory Demyelinating Polyradiculopathy. Pt initially presented to pcp in 12/2008 with c/o low back and buttock pain and progressive weakness.  Initially thought to be a neuropathy (pt with DM typeII) however with increasing LE weakness pt referred to neuro. Admitted for IVIG. Recent 50 lb wt loss-unintentional. PE (+) for 0-4/5 strength of LEs, UEs WNL. absent-diminished reflexes in LEs. Sensory loss in LEs as well. Ataxic gait with bilateral foot drop. Follow-up: Unable to walk without assistance, except for small baby steps w/ assistance. Cannot go up stairs at all. Bowels shows incontinence, she still has extreme nerve pain - and has to have prescription drugs for pain, has to constantly fight a cold, she is also very sensitive to regular temperatures  gets too cold easy. Cannot stand more than 30 minutes. Has nerve pain in fingers, hands, legs, diaphragm. The atty that we picked from the list we were given from federal courts, has not made any strides - is there any other compensation for my mother's loss of ability to work full time, or even drive her (inability to) own car?
Diarrhea; dizziness; vomits; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), DIZZINESS (dizziness), VOMITING (vomits) and FATIGUE (tiredness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and CETIRIZINE for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced DIARRHEA (Diarrhea), DIZZINESS (dizziness), VOMITING (vomits) and FATIGUE (tiredness). At the time of the report, DIARRHEA (Diarrhea), DIZZINESS (dizziness), VOMITING (vomits) and FATIGUE (tiredness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Pregnancy test: other (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided
Varicella storage at 8 deg for possibly > 24 deg, child to be revaccinated or titer drawn
Initial report received from a nurse on 12 Jan 2010. This patient below 4 years of age, received a 0.25 ml dose of Novartis H1N1 on 11 Jan 2010. No adverse event occurred. Following internal review on 13 Jan 2010 of the data received on 12 Jan 2010, the following correction was made: The product was recoded to S-OIV FLUVIRIN.
No adverse events were reported.; received one improperly stored dose of PNEUMOVAX 23 on an unspecified date.; This spontaneous report has been received from a pharmacist concerning to 1 of 19 patients, a 70-year-old female patient. The patients' historical condition, concomitant medications and drug reactions or allergies were not reported.   On 18-SEP-2019, the patient was vaccinated with an improperly stored dose (product storage error) of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route and frequency were not reported) lot # R018732, the expiration date: 27-FEB-2020 for prophylaxis.  The administered dose experienced a temperature excursion at lowest temperature below 36-degree Fahrenheit (32F) for 6 hours. Previous excursions were unknown by reporter. The temperature excursions were not detected by a data logger. No adverse events were reported.  This is one of several reports received from the same reporter. Marrs# 1909USA001561, 2003USA005393, 2003USA005394, 2003USA005395, 2003USA005396, 2003USA005397, 2003USA005398, 2003USA005399, 2003USA005400, 2003USA005401, 2003USA005402, 2003USA005403, 2003USA005404, 2003USA005405, 2003USA005406, 2003USA005407, 2003USA005408 and 2003USA005409. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: Unspecified; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R018732; expirationdate: 27-FEB-2020; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1909USA001561: US-009507513-2003USA005393: US-009507513-2003USA005394: US-009507513-2003USA005395: US-009507513-2003USA005396: US-009507513-2003USA005397: US-009507513-2003USA005398: US-009507513-2003USA005399: US-009507513-2003USA005400: US-009507513-2003USA005401: US-009507513-2003USA005402: US-009507513-2003USA005403: US-009507513-2003USA005404: US-009507513-2003USA005405: US-009507513-2003USA005406: US-009507513-2003USA005407: US-009507513-2003USA005408: US-009507513-2003USA005409:
Fever of 106, extreme swelling of arm at injection site, tinnitis, shortness of breath, tachycardia, headache.
Fever with shaking chills, mod to severe body aches, nausea X 18 hours. Controlled somewhat with Ibuprofen 800 mg Q6 and Tylenol gm 1 Q4. Same symptoms with first dose on 3/28/19.
Patient says very sore arm woke her from sleep 12 hours after her vaccine dose.  Pt says, 10 days after vaccine, she is still having significant arm pain from shoulder blade down.  She says arm has dull pain if she doesn't move it, but has severe "spear-like" pain if she moves the arm.  She says it has affected her daily function.
I have had constant tinnitus for almost two weeks which started very soon after my second Moderna shot. It varies in severity but never goes away completely.
"it hurt like heck"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ("it hurt like heck") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE PAIN ("it hurt like heck"). At the time of the report, VACCINATION SITE PAIN ("it hurt like heck") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-092573 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received: No significant information was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092573:Case for second dose
Redness and pain at injection site. Developed pain right arm, neck, back-scapula. Pain improved but still present.
Events- Thrombocytopenia;Symptoms - uncontrollable nose bleed, petechiae; Time - 2000/28Mar06;Treatment - Given platelets by ICU
I first felt like I had a buzzing feeling in my head for about 4 hours.. I went to bed and once I woke up I could not hear in my left ear.. I lost 80% of my hearing in my left ear for two days
Patient discovered deceased in his lounge chair by his wife upon her return after being out of house for 90 minutes.
Red welp developed at site of DTAP injection on evening after vaccine.  when seen at office on 05/14/04, red, warm, raised area 13x10cm on left anteolateral thigh at site with small hives around peripheral. No rash, no fever else where on body, no itching. Treatment: Cool compress, Zyrtec, Keflex.
Fever, raised and swollen around site that immunization was given. DTaP reaction measured 45mm on left deltoid and warm to touch.
SHINGLES- CIRCLE BY EYE; This case was reported by a nurse via sales rep and described the occurrence of ophthalmic herpes zoster in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's disease (chronic condition).   On 27th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was seen by the provider on 30th December 2019. The patient had shingles- circle by eye the size of a quarter. The patient wanted to know if she should receive second dose of Shingrix.
Information has been received from an 84 year old female consumer with high blood pressure and drug reactions/allergies reported as none who on 08-NOV-2006 was vaccinated with Pneumovax 23. Concomitant therapy included unspecified blood pressure medication. On 09-NOV-2006, the patient experienced a "severe reaction" of a low grade fever, a very red arm and swelled arm after being vaccinated with Pneumovax 23. The patient "heard of the batch being bad" and the office was not charging her for the vaccination. The physician treated the patient with acetaminophen and will see the physician for follow-up today. The patient stated that "this was a booster dose of Pneumovax 23". At the time of the report, the patient was feeling better. Additional information has been requested.
Tinnitus started on 10/6/21, the day after my booster vaccine.  So far have been treated with steroids, anxiety and sleep meds, tinnitus still present as of 11/18/21
vaccine in an right thigh; cellulitis; This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a 5-year-old patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 12th July 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site. In July 2021, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the cellulitis to be related to Kinrix and Kinrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pediatric patient received Kinrix in right thigh which led to vaccine administered at inappropriate site.  Less than a week after receiving Kinrix, the patient developed cellulitis.  The reporter consented to follow up. The reporter and healthcare professional gave permission to contact them for further information. No other information was shared. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR154891:Same reporter US-GLAXOSMITHKLINE-US2021153977:same reporter US-GLAXOSMITHKLINE-US2021AMR154890:same reporter
CHILD'S DOB LISTED ON CONSENT  BY FATHER.  VACCINE WAS ADMINISTERED. UPON ENTERING INFO INTO THE SYSTEM, THE CHILD'S DOB IS LISTED. FATHER INSISTS THAT THE YEAR OF BIRTH IN SYSTEM IS INCORRECT. CHILD WAS 11 Y.O. AT TIME OF COVID VACCINATION.
After first vaccine, patient developed a tightness in chest after about 5 hours. He said it didn't feel like acid reflex or have difficulty breathing. It was around his sternum (breastbone) area. He said he felt like he was about to the point when he needed medical help when it went away (about 3 hours later).
idiopathic thrombocytopenic purpura, treated with dexamethasone x 4 days
pt devel rash approx 4 days ago;started as red rash over arms-now whole body;over least 2 days areas over arms have devel blister;fever for approx 2-3 days resolved;10 days prior to rash had MMR;also started on ATB for OM;gen mac pap rash;
Got a black mark on the arm; This is a spontaneous case initially received from pharmacist on 30-Nov-2018, concerning a female patient of unspecified age.  On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for influenza prophylaxis.  On an unspecified date, after vaccination, the developed a black mark on the arm.  At the time of this report, the outcome of the event was not reported.  The reporter assessed this case as non-serious.; Reporter's Comments: A female patient of unspecified age developed black mark on the arm after administration of (INN Flu Vaccine Seasonal). The causality of the event was unassessable due to lack of onset latency with the suspect vaccine.
I went to urgent care to be vaccinated and they placed me in the back. Within 15 minutes of the vaccination I started to have severe chest pain on the left which is the same side as the vaccination. They monitored me for about 45 mins then sent me home. About 2-3 hours after I got home I started to get a tingling feeling in my face and mouth. Also, my neck got really stiff and I wasn't able to move my neck for about a week. I made an appointment with my doctor. He told me he thinks it is anxiety and sent me home. The numbness on face and mouth has continued. The chest pain lasted for about 1.5 weeks. Each incident would last between 5-20 mins at a time.
Blood clot in left arm on 2/28/2021 (2 weeks after 2nd dose of Moderna). Diagnosed at  Emergency Room.
the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event; the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2022SA379788(CLUSTER).  This case involves a 50 years old male patient to whom while administering INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] the product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Sep-2022, the patient received a 0.5 ml dose once of suspect INFLUENZA QUADRIVAL A-B VACCINE, unknown formulation (Exp: 30-Jun-2023, Lot  UT7680KA) not reported via intramuscular route in the left arm for Immunization and product leaked out from where the needle and syringe connect, and that patient's whole arm was covered in the product and some even leaked onto her pants with no reported adverse event (incorrect dose administered) (Accidental exposure to product) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.