chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old male patient who received Shingrix for prophylaxis. On 14th September 2018, the patient received the 1st dose of Shingrix. On 18th September 2018, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. Additional details were provided as follows: The pharmacist stated that the patient received a dose of Shingrix on Friday and came back to the pharmacy on the reporting date. The pharmacist thought that the patient might have the shingles rash. The patient said the shingles rash just started on the reporting date. The pharmacist stated that patient read online that, the shingles vaccine could cause shingles. The pharmacist referred the patient to see their physician to confirm the diagnosis of shingles.
hives; she had an achy left arm (injection arm); fatigue; This is a spontaneous report from a contactable nurse (patient). A 67-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number was not provided, unspecified route on 17Dec2020 (at the age of 67-years-old) as a single dose in the left arm for COVID-19 vaccination.  Medical history and concomitant medication were not reported. On unspecified date in Dec2020, the patient experienced she had an achy left arm (injection arm) and fatigue which she states that she expected. On 22Dec2020, the patient experienced hives. She woke up and had hives. Outcome of the event fatigue was recovered in Dec2020. Outcome of the events hives and she had an achy left arm (injection arm) were unknown.
I haven?t had any menstration (monthly periods) from April (since 2nd dose vaccination) to last week of August. After almost 5 months, I got periods on last week of August. That was extremely painful and heavy. The pain and the heavy flow lasted for 5 days.  I had to take over the counter medications for all these 5 days so I can stand up. After 5 days, the pain is decreased but normal flow lasted for another 5 more days. Still I get spots.    Immediately after vaccination (April 6th; second dose)  I had severe pain on the arm, fever and badly ache. This lasted for 2 days.
Received a tetanus shot on 6/29/15, for a puncture wound (R) arm; the next day my (L) arm developed a hematoma/infected area (L) upper arm-ecchymosis from injection site to elbow.
Patient presented on 10/21/12 complaining of swelling in right hand, itching and swelling on right forearm, and itching, swelling and redness of the left torso area in the shape of a line.  Patient had no other systemic symptoms.
Information has been received from a medical assistant concerning a male patient who in April 2006, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  In April 2006, the patient experienced a painful, lump at the injection site (2 on his shoulder and 1 on his arm pit).  Unspecified medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
This patient received the first dose of the Moderna vaccine on 1/28/2021 and the second dose on 2/25/2021. He also received the Jansen vaccine on 3/24/2021 approximately 3:00pm as well.
unspecified amount of patients died after GARDASIL 9 treatments; This spontaneous report was received from a consumer, who read on internet on a website regarding to unspecified number of female patients of unknown age. The patients' medical history, history of drug reactions/ allergies, concurrent conditions and concomitant medications were unknown to the reporter. On an unknown date, the unspecified number of patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, after an unspecified amount of doses the patients died (death) for an unspecified reason. It was unknown if an autopsy was performed. It was unknown to reporter whether the patients received any treatment, also unknown if they sought medical attention and there was any hospitalization or prolonged hospitalization. No product quality compliant (PQC) was reported. The causality assessment was not provided by the reporter.   Upon internal review, the event death was determined to be medically significant.; Reported Cause(s) of Death: died after GARDASIL 9 treatments for an unspecified reason
A report was received from a health professional on 10/11/02, concerning a 38 year old male vaccinee who experienced an injection site reaction approximately 30 minutes after receiving Fluvirin on 07/10/02. He experienced a red, hot, itchy injection site swelling. There was insufficient information to determine the reporter's causality assessment. 5 other vaccinees vaccinated at the same time with the same batch, had the same reaction. See PJP200200497, PJP200200500, PJP200200502, PJP200200503, and PJP200200504. Update (1) 12/10/02: A report was received from a health care professional, the injection site reaction had resolved at the time of the report.
Pt rec'd PPV instead of PCV at 4 mo. Well child check no adverse symptoms noted.
significant local reaction = erythema, elevation, warm to touch = 6cm x 6 cm
no additional AEs were reported; Medical assistant is reporting that a PROQUAD was given to a 17 year old patient.; This spontaneous report was received from a medical assistant and refers to a 17 years old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 07-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 1 dose, (lot # T030760, expiration date: 08-MAR-2022, albumin status:rHa) for prophylaxis (exact dose, dose number, route of administration and anatomical location were not reported). The vaccine was administered to patient in inappropriate age. No additional adverse events were reported. The outcome was unknown.
Patient confirmed they had never had severe reactions after vaccines. Patient left the pharmacy after receiving the vaccine to do some shopping and approximately 10 minutes later, patient returned stating she felt faint and collapsed in one of the aisles. She said staff had been responsive, came to her aid, and gave her a granola bar and Pedialyte. She stated she felt much better after eating the granola bar&Pedialyte and had said she skipped breakfast and lunch which may have contributed to feeling faint. Pharmacy offered for her to sit down but patient said she felt better and walked out of the store on her own.
Information has been received from a consumer concerning her female daughter with no known drug allergies who on an unspecified date was vaccinated with MUMPS virus vaccine live (Jeryl Lynn). Subsequently, on an unspecified date, the patient developed high fever. At the time of the report, the patient's status was unknown. It was reported that the patient also developed high fever every time she was vaccinated with MEASLES virus vaccine live (Enders-Edmonston) (MSD) (WAES number 0906USA05610) and RUBELLA virus vaccine live (Wistar RA 27/3) (MSD) approximately 30 to 40 days apart. No further information is available.
Started having excruciating, painful headaches.  On about 4/6/21, headache awoke me from sleep.  Pain was through my left eye towards the back of my head down to my neck. Lasted for awhile.  Took Tylenol and was able to get rest about an hour later.  Woke up that morning pain was still there but it was bearable.  Two days later it happened again.  Awaken with excruciating pain.  Didn't think it was related to shot because it had been almost 3 weeks since I had shot.  On 04/15/21, it happened again.  Never had any issues with headaches.  Not only have I been having headaches, I've been having pain in my legs, feeling lethargic, etc.
Patient developed symptoms of MISC on 6/13/22; fevers began on 6/13/22 with a Tmax of 38.7 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, sinus tachycardia, cough, vomiting, and mucocutaneous lesions/conjunctivitis. Abnormal labs included elevated fibrinogen, elevated CRP, elevated ferritin, elevated troponin, elevated BNP, elevated NT-ProBNP, elevated D-dimer, elevated AST, and elevated ALT. ECHO studies showed coronary artery dilatation, left ventricular dysfunction, mitral regurgitation, tricuspid regurgitation, dilated left atrium, and pulmonary valve regurgitation. Patient was admitted to the hospital on 6/19/22 and treated with IVIG, infliximab, and aspirin; he was discharged on 6/22/22. He was in the ICU from 6/19/22 to 6/20/22.
Patient reported local injection site reaction in the right deltoid, which began approximately 1.5 hours after receiving the vaccination. The area was red swollen, and painful. She also reported headache and nausea and tachycardia. She went to ER, received MOTRIN for her symptoms, and was discharged home. The next day, she was recovered.
Information has been received from a medical assistant referring to a 10 year old male patient with no pertinent medical history or drug allergies. The patient was vaccinated with the first dose of GARDASIL (dose and route not reported; lot# reported as K0004204, expiration date 12-JAN-2017) on 20-AUG-2014, 23-OCT-2014 and 26-FEB-2015. The third dose was administered in the left deltoid. On 26-FEB-2015, the patient fainted at home. The patient's mother sought medical attention by calling the physician's office on the same day. No treatment was given for the event and there were no lab diagnostics studies performed. The outcome of the event was reported as recovered on an unknown date in 2015. This is one of several reporters received from the same reporter. Additional information has been requested.
GBS;pt admitted to hosp;Annual follow-up dated 09/28/00 states the pt is 80% recovered.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Oka/Merck VARIVAX (lot # N017700, expiry date: 09-JUN-2019) intramuscularly instead of subcutaneously for prophylaxis (incorrect route of drug administration). No adverse effects reported. Other suspect therapies included sterile diluent. No product quality complaint was involved.
Approx one month later?pulmonary embolism, pleural effusion, concern of heart. IV heparin in hospital, oral blood thinners once released.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 05-APR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
ADACEL was exposed to temperature of 134.70F for 6 minutes and administered to patient with no reported adverse event; ADACEL was exposed to temperature of 134.70F for 6 minutes and administered to patient with no reported adverse event; Initial information received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was exposed to temperature of 134.70F for 6 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Mar-2023, the patient received 0.5 ml (Suspension for injection) dose1 of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U7549AA , expiry date: 04-NOV-2024) via intramuscular route in the deltoid NOS (Not otherwise specified) for Immunization.  On 28-MAR-2023, DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE was exposed to temperature of 134.70F for 6 minutes with no reported adverse event (product storage error), (poor quality product administered) (Latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.    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.
Patient presented with spontaneous IVH of small vessel origin with essentially no past medical history. She then acutely developed mesenteric ischemia. Died due to all dead small bowel which also appeared to be small vessel disease and not embolic/thrombotic. This process started one week after
Fever and chills. Pleuritic chest pain. Hospitalizaed 10 days after smallpox vaccination. ST elevation. Echo normal. CKMB 6.6. Troponin I 1.25. CBC, BMP, coagulation all normal.
It started almost immediately. Pain radiating up and down my arm. Some days I can barely use that arm. It makes my neck ache and wearing a seat belt is painful. I reported to moderna. They acted like I'm the only one this has happened to.
I am still experiencing some numbness and pain in my left arm, where I received the vaccination; I am still experiencing some numbness and pain in my left arm, where I received the vaccination; pain in the armpit; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit). At the time of the report, INJECTION SITE HYPOAESTHESIA (I am still experiencing some numbness and pain in my left arm, where I received the vaccination), INJECTION SITE PAIN (I am still experiencing some numbness and pain in my left arm, where I received the vaccination) and AXILLARY PAIN (pain in the armpit) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy breast: two biopsies recently in the left breast and left armpit (lymph node) - both benign.. On an unknown date, Biopsy lymph gland: two biopsies recently in the left breast and left armpit (lymph node) - both benign..     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2023: Significant Live follow-up received on 05-Nov-23: Reference numbers added
Red and purple bumps scabs covering both legs and arms; Red and purple bumps scabs covering both legs and arms; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 22Jan2021 at 15:45 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history, allergies to medications, food or other products, and was not diagnosed with COVID-19 prior to vaccination. The patient had no concomitant medications and had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that on 26Jan2021 at 16:00 she had red and purple bumps scabs covering both legs and arms; further reporting they looked like flea bites. She reported that they checked everywhere and there were no fleas and no bed bugs. The events were reported as non-serious and did not require hospitalization. The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was provided for the events in the form of oil on her body. The clinical outcomes of red and purple bumps scabs covering both legs and arms were not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
FEVER (100.2), CHILLS, HEADACHE, BODY ACHES LASTED UNITL 1/31/2021 AFTER TREATED WITH TYLENOL.
Within a few hours of the injection - tiredness and sore arm. Within 12 hours - fever, chills, fatigue, sore arm, limited arm mobility, injection site swelling and redness 24-36 hours after - fever and chills gone, still fatigued, sore arm with swelling, redness, and now itchiness By 48 hours after - only the arm symptoms remained, with the mobility mostly returned and it just being more localized, pain, swelling, and redness. About 5-6 days after - no noticeable redness, itchiness, swelling, or pain. Today (10 days and about 12 hours post-injection) - swelling in a defined oval/oblong shape, a little reddish or dark (kind of like a big mosquito bite or light bruise). The skin is itchy and it feels a little pain (like a bruise) when I touch it.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 28-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
child was placed prone to sleep in early morning hours of 7/15/99;child found dead a few hours later;
pt recvd vax & appeared pale, gray, almost unconscious w/shallow grunting resp 2-2 1/2 hrs p/vax; resp to pinching; color OK; t101.5; to hosp over noc for observation;
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored oral, ROTATEQ (lot # K019372 with an expiry date of 16-JUL-2016, lot# K009181 with an expiry date of 24-APR-2016). No adverse effects were reported. Additional information has been requested.
Bad diarrhea; Fast heartbeat; wobly; flushed; Shaking inside body; dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and HEART RATE INCREASED (Fast heartbeat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DILTIAZEM, ALPRAZOLAM, HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE), LOSARTAN, DULOXETINE and ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) mRNA-1273. On 25-Feb-2021, the patient experienced FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and TREMOR (wobly). On 26-Feb-2021, the patient experienced HEART RATE INCREASED (Fast heartbeat). On 27-Feb-2021, the patient experienced DIARRHOEA (Bad diarrhea). On 01-Mar-2021, FLUSHING (flushed), NERVOUSNESS (Shaking inside body), DIZZINESS (dizziness), HEADACHE (Headache) and DIARRHOEA (Bad diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided. Tylenol was provided as a corrective treatment for the symptoms No treatment medication were provided. Symptoms subsided on day 5 and she felt fine. Consent obtained for safety follow up   Reporter did not allow further contact
Within 15-minutes of vaccination, the patient reported a mildly swollen tongue. EMS managed the patient's care on-site.
Information has been received from a nurse and a woman in a physician's office concerning a 66 year old white male, a minister with neuronitis, gout and drug allergies to IVP dye, PCN and aspirin, and past medical history of elevated uric acid, and renal calculi (kidney stones), who on 06/17/03 was vaccinated in the right arm (also reported as right deltoid) with a first dose of pneumococcal vaccine 23 polyvalent (Lot # 645853/0256N). Concomitant medications included probenecid (manufacturer unknown) 500mg every day, colchicine 0.6mg every day, meclizine 12.5mg every 8 hours as needed, Nizoral shampoo 00.2%, hydrocortisone cream 0.2%, and Triamcinolone cream 0.1%. The physician indicated that on approximately 06/19/03 (also reported as 06/18/03 AM) the pt developed redness and swelling of the right arm below the deltoid, reported as "in area close to pneumococcal vaccine 23 polyvalent injection site", but not specifically at the injection site. The physician "thinks the nurse (temporary staff, not his regular nurse), administered the vaccine at an incorrect site, and doctor was unable to confirm exactly how given". The physician recommended ice and other therapies for the pt. No lab tests or diagnostic studies were performed. It was noted that there were no acute illness at the time of vaccination, and the pt had no known events following prior vaccination. Follow up information reported the pt recovered.  There was no product quality complaint. Unspecified medical attention was sought.  No additional information is expected.
A few hours after administration of immunization, Patient experienced arm swelling and pain. He was seen in hospital the following day for routine transfusion (secondary to Hgb SS), where an ultrasound was performed that showed no evidence of DVT, but evidence of subcutaneous edema without drainable collection. He received a dose of BENADRYL, and swelling and pain improved during the roughly 24 hours between ultrasound and office visit for re-evaluation. He had no redness or warmth, and felt the swelling and pain were both improving.