chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trouble Breathing Blood Pressure spiked to 170/110 Lightheaded Confusion Slept from 6pm Friday after the shot till Monday morning @ 7am.  Awake for short period of time 2 or 3 hours intervals  Night sweats and bad dreams Left arm never hurt at all  Neck pain on left side Pain moved to my back Entire body aches and soreness Trouble seeing clearly   Today - Thursday April 15th I am feeling much better this afternoon  Blood Pressure back down to 134/78 All other symptoms have subsided
I felt tired/fatigue; I had increased heart rate/high pulse rate (about 120 the whole day); pain in my chest/I had chest pains around my heart; I had inflammation of my heart; Shortness of breath; my chest felt tight; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 17-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0176) via an unspecified route of administration, administered in arm left on 03May2021 14:00 (age at vaccination 17 years) as dose 2, single for COVID-19 immunization. Patient medical history included asthma (No longer a problem). Known allergies was reported as unknown. Family medical history relevant to adverse events was reported as mother A-fib, congestive heart failure. Other medications in two weeks was reported Non-Drowsy Allergy Relief 10 mg. The patient did not receive any other vaccine in four weeks. Covid prior vaccination was no and covid tested post vaccination was reported as no. Prior vaccinations was reported as none. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734) via an unspecified route of administration, administered in arm left on 12Apr2021 14:00 as dose 1, single for COVID-19 immunization. It was reported that on 04May2021 06:00 he had increased heart rate, pain in his chest, his chest felt tight and he felt tired. All of these happened regardless of if I was actively doing something or sitting down relaxing. Due to the recent reports he believed he had inflammation of his heart but it only lasted about 24 hours, he had chest pains around his heart, shortness of breath, high pulse rate (about 120 the whole day) and fatigue on 04May2021 06:00. The patient underwent lab tests and procedures which included heart rate/pulse rate: about 120 on an unspecified date in 2021 (increased heart rate/high pulse rate (about 120 the whole day)). Seriousness of the events was reported as non serious. The patient did not receive any treatment for the adverse events. Relevant tests was none. The outcome of the events was recovered on 05May2021.  Follow-up attempts are completed. No further information is expected.
As a volunteer at Gateway Med Research,I was tested 04/2004, 07/2004, 09/2004, 11/2004, 01/2005, for Hep C= all negative. After 3 dosages of Twinrix HAB265B6 on 03/10/05 lab tests for Hep C with Gateway were positive further testing as recommended with negative results.
some stiffness / soreness in the arm; some stiffness / soreness in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection; Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and her husband received the first dose of Pfizer COVID-19 vaccine and the patient experienced some stiffness/soreness in the arm on an unspecified date. The patient also reported that her husband was scheduled for cortisone shot in the knee on 19Mar2021 after the first dose. Their second dose is scheduled on 23Mar2021 and patient wanted to know if that would interact with the COVID-19 vaccine. The patient also wanted to know if she can take ibuprofen. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Initial medication error report received on 04 September 2013 from a pharmacist. A 9 years unknown patient whose gender, medical history and concomitant medications were not reported, received a dose of YF (lot number, route and site of vaccination was not reported) on an unspecified date. Patient received 2nd dose of YF within a month. Most patients do not experience any material increased in local or systemic adverse events, but some might. List of documents held by sender: none.
smallpox like scar on her chin; cold sore; throbbing, stinging pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 01Mar2021 16:30 (at the age of 68-year-old) (Lot Number: EN9266) as single dose for covid-19 immunisation. Medical history included Sjogrens, hypothyroidism, arthritis; known allergies: Augmentin, demerol, some sulfa drugs. Concomitant medications included Levothyroxine, simvastatin, Omeprazole, ibuprofen, vitamins B,C,D E, biotin, magnesium, zinc. The patient previously took the first dose of bnt162b2, via an unspecified route of administration, administered in Arm Left on 08Feb2021 16:30 (at the age of 68-year-old) (Lot: EN5318) as single dose for covid-19 immunisation. A few days after the second dose, she got what she thought was a cold sore starting on her chin. It got bigger each day until the 4th day, it was about 3/8" in diameter, and throbbing, stinging pain. She used Melaleuca oil on it, and it gradually subsided and went away, but left a smallpox like scar on her chin. The outcome of the event scar was not recovered, others was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Did the shot on left upper arm Immediately feeling numbness on left forearm after Around 2 hours after, right side of my face started having numbness too. I could still move my muscles to talk or smile, but the stiffness has been there whenever I move them
her arm was hurting; ear hurt; experience headache one side of head (1st dose); arm feverish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her arm was hurting), EAR PAIN (ear hurt), HEADACHE (experience headache one side of head (1st dose)) and PYREXIA (arm feverish) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9399D2) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (Patient has a lot of immune disorders and probably should not have gotten the vaccine). Concomitant products included THYROID and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.  On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her arm was hurting), EAR PAIN (ear hurt), HEADACHE (experience headache one side of head (1st dose)) and PYREXIA (arm feverish). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of every 4 hours. At the time of the report, PAIN IN EXTREMITY (her arm was hurting), EAR PAIN (ear hurt), HEADACHE (experience headache one side of head (1st dose)) and PYREXIA (arm feverish) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   This case was linked to MOD-2021-325358.
Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away .  Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar.  On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection.  On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications.  Action taken with the mRNA-1273 was not applicable.  The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal.  On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19
For about two weeks, I was having a headache which I don't normally get. I went to the emergency room on 01/21/2023 where they did a CT scan. They treated me for migraines and sent me home with some analgesia. I felt bit better for around 24 hours and then my symptoms progressively got worse. I returned to the emergency room where they did a CTA and an MRA which demonstrated a left internal carotid artery dissection at the level of the skull base. They escalated my anti platelets therapy and put me on Plavix, they also elevated my Aspirin dose.
This spontaneous report as received from a Registered Nurse referring a patient of unknown age who was vaccinated with dose 1 of GARDASIL (dose, route and lot # not reported) on 26-APR-2009 and on 26-JUL-2012 was vaccinated with a second dose of GARDASIL (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Pt got vaccine and she fainted about 5 minutes post dose. She immediately came too and was ok to go home after 15 minutes.
2 inch knot around injection site, warm to touch. Fever of 103. Favoring left leg and limping.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL0140), in left arm, on 09Feb2021 as dose 2, single (Lot number: EL3200), in left arm and on 16Aug2021 as dose 3 (booster), single (Lot number: EW0168) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Feb2022 as dose 4 (booster), single (Lot number: 013H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "past kidney cancer" (unspecified if ongoing); "nephrectomy" (unspecified if ongoing); "CKD" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "Dose:4 Moderna/  Dose: 1, 2 and 3 Pfizer" (unspecified if ongoing), notes: Dose:4 Moderna/  Dose: 1, 2 and 3 Pfizer. The patient's concomitant medications were not reported. Patient had no known allergies.   The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (May2022) positive, notes: Tested positive (rapid and PCR) and began Paxlovid on evening of day 3 of illness; (May2022) positive, notes: Tested positive (rapid and PCR) and began Paxlovid on evening of day 3 of illness, Symptoms subsided and rapid tests were negative on days 7 and 8 (last morning of Paxlovid use); (May2022) Negative, notes: rapid tests were negative on days 7 and 8 (last morning of Paxlovid use); (May2022) Negative, notes: rapid tests were negative on days 7 and 8 (last morning of Paxlovid use); (May2022) Negative, notes: Tested negative again with rapid tests on day 9 and morning of day 12; (May2022) Positive, notes: Late evening of day twelve symptoms returned and tested positive with rapid antigen. Patient was Still positive and symptomatic on day 15. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: No other medication in 2 weeks. Anti-viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date:18May2022, treatment stop date: 23May2022, indication: treatment of COVID-19. Adverse event: Rebound following Paxlovid: Tested positive (rapid and PCR) and began Paxlovid on evening of day 3 of illness. Symptoms subsided and rapid tests were negative on days 7 and 8 (last morning of Paxlovid use). Tested negative again with rapid tests on day 9 and morning of day 12. Late evening of day twelve symptoms returned and tested positive with rapid antigen. Still positive and symptomatic on day 15. Adverse event start date: 27May2022, no treatment and no known allergies. Device timestamp: 30May2022.
Site: Pain at Injection Site-Medium, Additional Details: patient states he has a lot of pain on his right arm. States he did go to the doctor for his annual visit and informed the doctor. He recommended him to apply some warm cloths
3 days post vaccine I began showing signs of shingles on the left side of my face, about 10:00 am-confirmed by Dr.  Began treatment of Valacyclovir HCL 1gram,  Methylprednisolone 4mg, & gabapentin 300mg
pt had varicella vax on 23SEP97 & 8 days later numerous papules  present to upper extremities;no fevers, no sz;no ER eval;no appetite change;
Severe Body Aches and Pain, Headache, Chills, Low Grade Fever, Exhausted, Labored Breathing, Nausea- Covid-19 Symptoms
7 days after vaccine administration, I noted a red area a couple of inches below the injection site that was itchy and warm to the touch. I kept an eye on it. When I awoke the following morning, the reddened area was larger, still warm to the touch, slightly swollen and itchy. On the 3 morning, the area was larger (roughly 10cm wide x 7-8cm tall), still reddened, swollen, warm to the touch and itching. Today is day 4 of the reaction. It seems to be about the same size or slightly larger than yesterday, and it is still reddened, swollen, warm to the touch and itching. I have applied topical diphenhydramine over the last couple of days as needed.
This case was reported by a consumer and described the occurrence of allergic reaction in a 29-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  The reporter is the subject.  A physician or other health care professional has not verified this report.  The subject reported that she had not relevant medical history.  The subject had previously received influenza immunizations with no adverse events.  The subject had no adverse events following receipt of any previous vaccinations.  Concurrent medications included Lexapro and bupropion hydrochloride (Wellbutrin).  On 1 November 2007 at 1:00 p.m., the subject received unspecified dose of Fluarix (unknown, left arm).  On the afternoon of 2 November 2007, 1 day after vaccination with Fluarix, the subject experienced an allergic reaction.  The subject described the allergic reaction as red, swollen and itchy hives over her body from the neck down.  The subject considered the events to be disabling and to be jeopardizing or requiring intervention.  On November 3, 2007 the subject was seen by a physician and was treated with diphenhydramine hydrochloride (Benadryl) injection, and Prednisone injection.  On November 4, 2007, the hives had spread to the face.  The subject returned to the physician's office and received 2 adrenaline (Epinephrine) injections plus Benadryl and Prednisone injections.  At time of initial reporting, 5 November 2007, the subject stated that the hives on her face had resolved but she still has the hives on her body.
I got very moody/angry/depressed 2 -3 days after my vaccination (felt like I was PMS'ing, but too early for PMS).   Around June 8, my depression/anger got even worse. On June 13, I actually had suicidal thoughts which is completely abnormal for me! I got my period 2 days early (on June 14). My period was heavier than normal. After I got my period, my emotions returned to normal. Since then, my periods have been normal and my moods have been normal.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported  Vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration
Pt vaccinated with Pneumovax 23 experienced a mild local reaction. No further details were provided.
Patient turned pale, felt foggy head, couldn't hear for a while. After laying down and drinking some water he felt better and gained back color.
This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown age and gender. Information on the concurrent condition, pertinent medical history and drug allergies of the patients were not reported. On an unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot# L019836, expiry date 24-MAR-2017) (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. This one of the reports from the same reporter. Additional information has been requested.
Vaccination failure/ rubella patient; Rubella patient/mild infection/viral symptoms as well as rashing, fatigue and a runny nose; This spontaneous report has been received via IQVIA from an unspecified reporter referring to a female patient of unknown age during social media monitoring. Information about medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was fully vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dosage detail, strength, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced rubella and vaccine failure. The patient experienced mind infection. She experienced viral symptoms as well as rashing, fatigue and a runny nose. The outcome of the events was unknown. Causality assessment was not provided.
generalized varicella like rash, 6 days p/vax 25-50 lesions & no tx other than DPH & APAP; lesions presently crusted;
Patient is a 43-year-old female experiencing an adverse event 15-minutes after receiving COVID-19 vaccine. Dizzy, lightheaded, and nausea. Diagnosed as a vasovagal episode resolved without the need for treatment or medication. Patient left the facility walking on her own and with no difficulty. In summary documented as a vasovagal episode.
Site: Redness at Injection Site-Mild, Additional Details: Delayed skin reaction began 2 weeks after vaccine, redness at injection site lasted 1-2 days, no itching, not bothersome
Administration error: A 39-year-old male patient receives his second booster without complying with the guidelines established by the CDC and the Department of Health.
1st Shot - Left deltoid:  Large raised welt the size of my fist, hot, and itchy.  The area was discolored for 3 weeks and sore.  The lymph nodes under the left arm were tender.  2nd Shot - Right deltoid:  Extreme fatigue for 2 days.  Excessive swelling of the right supraclavicular lymph nodes and right axillary lymph nodes.  Treated by physician with prednisone.
Bilateral loss of function and mobility of legs. Patient is still unable to walk. Guillain-Barré syndrome
Headache until current (no relief),; occasional random pulsatingsensation in left bicep muscle; Usual injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via unspecified route of administration in the left arm on 28Mar2021 at 10:30 (at the age of 45-years-old) as a single dose for Covid-19 immunisation. Medical history included rheumatoid arthritis. The patient did not have allergies to medication, food or other products. Concomitant medication included multivitamins (MANUFACTURER UNKNOWN), vitamin D nos (VITAMIN D), Isotretinoin (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 03:00, the patient experienced headache (continuing), occasional random pulsating sensation in left bicep muscle (abnormal sensation of limbs) and usual injection site soreness. The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event headache was not resolved. The clinical outcome of the events abnormal sensation of limbs and vaccination site pain was unknown.    No follow-up attempts are needed. No further information expected.
Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 17th December 2019, the patient received the 2nd dose of Shingrix. On 18th December 2019, 1 days after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The day bofore reporting, the patient received dose of Shingrix and now had lots of muscle pain. The patienty stated that, had no side effects from 1st dose of Shingrix.