chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Nurse refers to an 11 years old female patient with vaccination. The patient was vaccinated with, .5 ml GARDASIL on 01-DEC-2012. No other co-suspects were reported. Concomitant medications included: BENADRYL. On 01-DEC-2012 the patient experienced urticaria, 1 day after onset of therapy. The patient was treated with BENADRYL was reported. The outcome of urticaria was reported as recovered/resolved. The relatedness for urticaria is unknown for GARDASIL. No further information is available.
her arm was sore and hurting; This is a spontaneous report from a contactable consumer reporting for herself. A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL1284 /expiration date: not provided), via intramuscular route of administration, on 29Dec2020 10:15 AM (at the age of 51 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was none. Concomitant medication was not provided. On an unknown date, the patient experienced her arm was sore and hurting. The outcome of the event her arm was sore and hurting was unknown.
(1) Immediately after rapid heart rate and labored breathing; (2) 12/1 Emergency Room - severe allergic reaction to shrimp; (3) 03/03 Emergency Room - TIA mini stroke (4) 03/06 - Emergency Room - full stroke
A non-serious report of "unable to sleep" has been received from a consumer, patient's mother, concerning a two-year-old female subsequent to H1N1 2009 MONOVALENT vaccine. The patient's medical history and concomitant medications were not reported. The patient received H1N1 MONOVALENT VACCINE before the onset of the event given on 15-Oct-2009. On 15-Oct-2009, the patient was unable to sleep or take naps for four days. On 19-Oct-2009, the event was resolved. On 21-Oct-2009, follow-up information was received: it was clarified whether the reporter is health professional or not and also confirmed that currently, the patient is healthy and sleeping well.
12hrs p/vax pt became feverish, lethargic, stomach pains, nausea, almost delirious, lips swollen; also congestion, shallow breathing; per mom went to school that morning;
Patient has been having cognitive issues and went to see her PCP. Patient states concussion like symptoms and cannot concentrate.
started to develop subacute  sensorineural hearing loss 3 weeks after second dose of lymerix, unexplained by any other etiology, being treated with steroids and low dose methotrexate
The pt complained of left upper arm redness, inflammation, hard area, tender to the touch, itchy, hard knot area within red area. No other symptoms.
Arm pain - unable to use. No complaints from 1st dose given 07/07/16.
Some blood in the stool; Stomach cramps; Diarrhea; A spontaneous report was received from a consumer, concerning herself, a 68-years-old, Female patient, who received Moderna's COVID-19 vaccine and experienced Stomach cramps/ Abdominal pain upper, Some blood in the stool/ Haematochezia, diarrhea.  The patient's medical history was not provided. Concomitant medication includes Blood Thinners.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) intramuscular route for COVID-19 infection prophylaxis.   On an unspecified date, Patient experienced Stomach cramps, Blood in stool and diarrhea. She thinks it was either related to vaccine or new fruit she was eating. Treatment information was not Provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, Stomach cramps, Blood in stool and diarrhea were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
doses given after temperature excursion; Product storage error; This spontaneous case was reported by a respiratory therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
I was diagnosed Guillain-Barre and admitted to Medical center on 03/Nov/2019. I presented weakness in arms and legs with no other health issues.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On 20-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot # R006220 and expiration date reported as 29-FEB-2020 (dose, strength, frequency and route of administration were unknown. No adverse effects were reported. It was reported that the vaccine had a temperature excursion of -9°C to 8°C during 9 hours and 32 minutes. No previous temperature excursions were reported. Data logger was involved.
It is NOT adverse event. When pharmacist was administering the 2nd dose of shingrix to customer, during injecting the vaccine into the skin, some leak out of the syringe (not sure amount)- had some drops on gloves.
over 42 days  apart 1st dose 04/26/21, 2nd dose 06/22/2021
He immediately developed a headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 22Feb2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 22Feb2021, outcome "not recovered", described as "He immediately developed a headache". Additional information: The patient received the vaccine 10 days ago. It has been 10 days and he still has not gotten rid of the headache. The patient wants to know what he should do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dose of MENQUADFI after the second excursion the temperature reach 0.5 C for 32 minutes/ vaccines were given after the first 3 excursion, with no reported adverse event; Initial information received on 08-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2023SA276685.  This case involves a 11-years-old female patient who was administered dose of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] after the second excursion (the temperature reached 0.5 c for 32 minutes) and after the first 3 excursion, with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Aug-2023, the patient received 0.5 mL dose of suspect meningococcal A-C-Y-W135 (T conj) vaccine, solution for injection (batch number: U7673AB; expiry date: 29-Jun-2025) via intramuscular route in the left deltoid for Immunization after the second excursion the temperature reach 0.5 c for 32 minutes and after the first 3 excursion, with no reported adverse event (poor quality product administered) (same day latency).   Reportedly, Temperature excursion details were on 28Aug2023 for 3 hours 31 minutes at 2.1 C to 10.7 C; On 29Aug2023 for 32 minutes at 0.5 C to 6.5 C On 30Aug2023 for 2 hours 1 minutes at 1.0 C to 5.3 C On 31Aug2023 for 3 hours 32 minutes at -0.4 C to 6.0 C; Reason: the refrigerator malfunctioned; Human error: No.  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.
TINGLING SENSATION BEHIND THE LEFT KNEE (LIKE PINS AND NEEDLES WHEN FOOT FALLS ASLEEP, BUT NOT PAINFUL); This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no change in lifestyle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: 07-MAR-2022) dose was not reported, administered on 06-OCT-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced tingling sensation behind the left knee (like pins and needles when foot falls asleep, but not painful). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling sensation behind the left knee (like pins and needles when foot falls asleep, but not painful). This report was non-serious.
Almost 22 hours after receiving the shot, I started to get a sore throat. 4 hours after the sore throat I was hit with strong fatigue. An hour later I had a high fever (100.8 degrees). Took alkaselzer which only cured the runny nose and sore throat. Muscle aches and fever persisted. 48 hours after the shot, fever subsided but congestion and headache on right side of head continued. Took alkaselzer when headache was too much to sleep. This is day three, woke up with migraine, congestion and runny nose. Everything I've read said symptoms only last 1-2 days.
patient states given four vaccines (Tdap HepA pneumonia and menigitis) all in same arm right deltoid at Pharmacy on 4/5/19
Started as a runny nose then progressed to swelling of the nose and eyes. A rash started on the face and then by morning had progressed to a full body itchy rash. We went to the hospital er and they sent us to the pediatric ICU for the night. They ran many test and by the time we were released they told us it was something "viral". There was a slight rash left over. We were referred to an allergist and he said it looked viral from the pictures i showed him. We scheduled for allergy testing but then the pandemic hit.
2 month old pt was administered Fluarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N, expiry date 30th June 2023) for prophylaxis.   On 27th September 2022, the patient received Fluarix Quadrivalent 2022-2023 season. On 27th September 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 27-Sept-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up but declined to provide her last name. Additional supportive information: The patient received Fluarix QIV at inappropriate age, which led to inappropriate age at vaccine administration.
Severe tingling everywhere especially in feet; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm on 24Apr2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced severe tingling everywhere especially in feet. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of severe tingling everywhere especially in feet and included treatment with gabapentin (MANUFACTURER UNKNOWN). The clinical outcome of the event severe tingling everywhere especially in feet was unknown at the time of this report.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient stated she had received 2 doses of the Moderna COVID-19 vaccine and 2 boosters. No treatment medications were reported.
Syncope (drop in blood pressure) Passed out...Occurred while driving resulting in car accident
WENT TACHYCARDIC, DIZZY AND ALMOST FAINTED, WHICH PRODUCED AND ANXIETY ATTACH. HR 180 BPM, WAS GIVEN 6 ML PUSH ENDOCARD, DID NOT WORK.  THEN WAS GIVEN 12 ML PUSH ENDOCARD WHICH SLIGHTLY HELPED HEARTRATE STABALIZE.  WAS BROUGHT TO ER FOR EKG BLOODWORK AND FURTHER OBSERVATION.  MR received revealing ER visit for anxiety attack and SVT on same day as flu shot. PE WNL except tachycardia and anxiety. Treated with Adenosine in ambulance which converted pt. from SVT to Sinus Tach. In ER given Ativan, Zofran, and KCl. Discharged after several hours. Impression: Anxiety attack, tachycardia, nausea, hypokalemia.
Hospitalized (10.14.21 - 10.21.21);  COVID-19 positive (10.14.21);  Fully Vaccinated  Admission Date: 10/14/2021 Discharge Date: Oct 21, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Transaminitis  Hypoxia Generalized weakness AMS (altered mental status) COVID-19 virus infection COVID-19 HOSPITAL COURSE: Patient is an 87-year-old male with past medical history of hypothyroidism, type 2 diabetes, chronic systolic heart failure status post pacemaker, history of CVA with residual left-sided weakness, wheelchair bound who presented to the hospital with COVID-19 infection.  Patient was fully vaccinated.  Patient was admitted to the hospital due to altered mental status and generalized weakness in the setting of a scope infection.  Patient was not hypoxic but for a brief moment during admission.  The patient was globally weak and had progressive difficulty ambulating at home until the 20th brought into the ER.  In the ER he was found to have elevated LFTs, general weakness.  Neurology was consulted who recommended CT of the head which was unremarkable aside from chronic changes.  Chest x-ray was done which showed no cardiopulmonary disease.  due to his LFT elevation of the liver ultrasound was performed which showed no evidence of portal vein thrombosis.  Patient was a candidate for monoclonal antibody therapy which he received and tolerated well.  For about 20 the patient had an aspiration event, became more confused, and had 1 fever.  Chest x-ray showed aspiration pneumonitis, white blood cell count was normal, procalcitonin was normal.  Patient recovered quickly, never required oxygen.  Short of breath was consulted who recommended NPO while the patient was confused, this resolved and the patient was able to advance back to a general diet prior to discharge.  patient was evaluated by Physical therapy and Occupational therapy who recommended subacute rehab given the patient's profound weakness in the setting of his recent infection.  Patient was unable to stand without significant assistance.  The patient's wife and daughter were insistent that the patient would do better at home and wanted to set up home health nursing and were adamant that they can't care for the patient better at home than at rehab.  Patient's daughter was heavily involved in the patient's care, she was very concerned about specifically his thyroid medication and felt that missing a few doses of his thyroid medication contributed significantly to his acute decompensation in the hospital.  Given has improvement in mental status, improvement in his vitals, he was afebrile, he was tolerating a general diet, and received adequate therapy for his COVID-19 infection the patient was considered stable for discharge home with home health care with the family support.  I discussed with the daughter that the patient be brought back if caring for him at home becomes unsafe, overwhelming, or cumbersome for the patient and her family.  Patient and family were in agreement this plan discharge home in stable condition
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included splenectomy. Concurrent medical conditions included thyroid disorder, diabetes, cirrhosis of liver without mention of alcohol and idiopathic thrombocytopenic purpura. Concomitant products included thyroxine sodium (Levothyroxine). In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, 3 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site pain. On an unknown date, the patient experienced fatigue and daytime sleepiness. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving and the outcome of the injection site erythema and injection site warmth were recovered/resolved and the outcome of the fatigue and daytime sleepiness were unknown and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fatigue, injection site pain and daytime sleepiness to be related to SHINGRIX. Additional details were provided as follows: About 3 days after receiving the vaccine the site around the injection site was swollen, red and hot covering area of 7 inches by 7 inches. The events red and hot were not anymore, but the area was still little bit swollen. The patient tried putting ice and taken aspirin to help with the pain. The patient did not know the full form of ITP. Accidentally hit one when they asked patient how much time it took to get it. The patient called yesterday and was put on a list and they will been going to call her back and the phone probably was dead, but she waited they know, she did not know, three or four minutes and then went on the call list. Today, when the patient talked to a representative, she was surprised that they called her or answered the phone, (inaudible) on the other end, that was excellent. As far as referring people to their company, it was depending on what the doctor prescribes for her and she trust on her doctor. However, the patient had a reaction and still in a lot of pain in her left arm, it was being almost a month and they can read the report where it was swollen. But as far as the representative, they were great, courteous, and just, you know, directed patient through, so she could not had asked for a better person to do that No further details were provided at time of reporting.
severe rash and blisters on his back and his and legs; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.  On or about 23-AUG-2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) in a pharmacy (exact dose, site and route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: severe rash and blisters on the pt's back and his legs.  The outcome of the event was unknown. The relatedness between severe rash and blisters on the pt's back and his legs and zoster vaccine live (ZOSTAVAX) was reported related.
Had Varivax at health dept 3/14/06. Was seen in my office by me 4/6/06 complaining of several days of insect bites, on exam pt had lesions consistent with Varicella < or = to 10 lesions.
bilateral PE; This is a spontaneous report received from non-contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received tofacitinib citrate (XELJANZ), for rheumatoid arthritis; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "unknown", described as "bilateral PE". The action taken for tofacitinib citrate was unknown.  Additional information: Description of Event: Patient has rheumatoid arthritis and is receiving Xeljanz and is in remission. She received her COVID vaccine and then developed a bilateral PE.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 and tofacitinib citrate to event bilateral PE cannot be excluded based on temporal association and available information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Narrative: Patient reported colored horizontal line of lateral peripheral vision both eyes on 4/16/21 in afternoon (lasted about 10 min) then blurry vision for approximately 10 min (resolved by the time seen in ER 4/16/21 approx. 2:30am - per RN note from hospital). After blurry vision global headache reported. Pt with history of migraine headache, wears glasses, denied nausea and vomiting. CBC w/ diff, Ct, MRI, MRV unremarkable. Pt discharged from ER within 24 hours. Received ibuprofen 600mg.