chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has a mild fever; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable male consumer (patient, age unspecified) reported that he received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 10Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reported that patient was wondering if he had virus or if it's just side effects. On an unspecified date in Feb2021, the patient experienced has a mild fever. The outcome of event was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were administered doses of improperly stored ZOSTAVAX injection (Strength, dose, frequency, anatomical location, route, lot/batch # and expiration date were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute ZOSTAVAX injection, was stored properly. The vaccines were exposed to 6 to 14 Fahrenheit degree (F) for 1.5 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012415: US-009507513-1707USA012416: US-009507513-1707USA012417: US-009507513-1707USA012418:
Cold; Cough dried up; Snotty nose dried up; A spontaneous report was received from a 77-years-old  male patient concerning himelf who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cold disappeared, cough dried up and snotty nose dried up.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the events cold disappeared, cough dried up and snotty nose dried up.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, cold disappeared, cough dried up and snotty nose dried up was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX. Concurrent medical conditions included arthritis. Concomitant products included Oral Contraceptives. On 5th February 2018, the patient received SHINGRIX. On 5th February 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain was unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient had no medical history except for arthritis. The patient received oral contraceptives as concomitant medications. The patient experienced soreness in site of SHINGRIX administration shortly after receiving vaccine. No medical intervention had been taken except for ibuprofen at night. The pharmacist reported that this was definitely related to vaccine administration and that soreness was about the same since two days ago. No other reported medical history except for arthritis and only reported medication is oral contraceptives.
Started off as red irritated skin at and around the injection site with some crying and progressed to a swollen hard red lump below the injection site with uncontrollable crying due to pain.
Sore throat, itchy eyes, face tingling 10 minutes after injection. Treated at facility with Albuterol nebulizer, Solumedrol 125mg IM, Medrol dose pack; started on Allegra. 9:00pm - swelling in face, tingling went to ER - developed palpitations - short of breath - in atrial fibrillation with rapid ventricular response. Treated w/ Cardizem and converted to NSR. Admitted to hospital for overnight observation. No known history of atrial fibrillation. Started Cardizem 120mg; ASA 325mg. 11/26/07-records received for DOS 10/31-11/01/07-DC DX: New onset atrial fibrillation with rapid ventricular response. Possible brough on by stress of allergic reaction. Hypertension, controlled. Allergic reaction secondary to influenza vaccine. After receiving vaccine C/O throat sore, mouth felt swollen, tingling around lips. Palpitations shortness of breath.
PATIENT'S ARM WAS RED THAT NIGHT.  THEN IT BECAME HOT AND SWOLLEN.  SHE DID NOT HAVE A FEVER.  SHE WAS ADVISED TO SEE A DOCTOR.  DOCTOR STATES THAT SHE HAS A SKIN INFECTION AND WAS GIVEN AUGMENTIN ON 10/28/15.
7 days after 2nd vaccine, Patient passed out and seemed to have a seizure.  It lasted less than 10 seconds he woke up and felt nauseous.  He was driving a car by himself at the time.  He did not have an accident and woke up and drove home.  He continues to have these episodes now 4 times.  He has been to Neurologist and had EEG for 48 hours, MRI of brain w/ & w/o contrast, CT scans , all tests normal.  He has been to cardiologist and had EKG, Zio patch for 3 weeks, Echocardiogram, Tilt Test,  all test results were normal.  He  has been experiencing Anxiety ever since these episodes began.  No doctor has a definite diagnosis.
One day post vax, this pt experienced a "reddened area 5 cm x 3 cm at injection site. Also itching noted from left arm." The pt recovered.
About 6 hours after vaccine 100F fever and chills. Cleared in about 24 hours.
Bladder Infection; This case was reported by a pharmacist via call center representative and described the occurrence of bladder infection in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 19th November 2021) for prophylaxis.   On 12th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced bladder infection. The patient was treated with antibiotics nos. On an unknown date, the outcome of the bladder infection was unknown.   It was unknown if the reporter considered the bladder infection to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and couple of weeks ago from the date of reporting, developed bladder infection. The reported consented to follow up.
diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (age at vaccination:65 Years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that the product complaint was diarrhoea started after receiving the first dose which lasted for 3 weeks that continued after the second dose. Reporter had undergone some blood work and stools results found to be normal. The patient experienced diarrhoea on 10Mar2021 with outcome of not recovered.  Therapeutic measures were taken as a result of diarrhoea was Imodium. The outcome of the event diarrhoea was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 29-JAN-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-DEC-2015, the patient was treated by a Nurse Practitioner at a health clinic for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir, ibuprofen, acyclovir and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
63 year old male patient presents to ED 6/25/21 reporting 5 weeks of progressive cough, dyspnea and intolerance to exertion that has become steadily worse despite supportive therapies. He reportedly completed outpatient ABX from PCP within the past 2 weeks and suffers ongoing deterioration of his breathing accompanied by night-sweats, chills and fever. 1st Vaccine on 5/27/21, 2nd 6/17/21. hypoxemia secondary to large left sided pneumonia.large left sided effusion with compressive atelectasis and question of infectious vs malignant origin.acute hypoxemic respiratory failure requiring HFNC. Patient admitted to the ICU on our service for ongoing care.Hospital Course:Mildly elevated BNP and non-diagnostic EKG.Findings consistent with bilateral pneumonia, large left complex parapneumonic effusion versus empyema with compression of left lung and evidence of external impingement on LV. Systolic blood pressures ranging in the 80s to 90s with MAPs ranging from mid 60s to mid 80s with heart rates in the 90s, which may be attributed to diminished LV filling. Transferred  6/26/21.
patient reports"Breathing got shallow, Tongue swelling, lip swelling, face swelling, and nose ?dripping? got fatigued" states h/o anahylaxis and states that she had an anaphylactic reaction, but did not need to use an epipen. symptoms are now resolved.
Patient reports dizziness, nausea, flushed and visual changes.  Patient reports going running before vaccine and didn't eat or drink.  After patient spent some time lying down and drinking some water, patient reports symptoms resolved.
Post 1st Dose 07.15.09 Throbbing behind ear.  Post second dose 07.17.09 Hives all over body swollen hands & feet.
At 7 in the evening began having numbness, severe pain and swelling in arm.  Progressed through night and experienced nausea and vomiting, fever 101 F.  Elevated blood pressure.  At. 2 a.m. went to emergency room.  Received Benadryl and Dilaudid for pain.
given pneumovax 8OCT93 3PM & woke up 9OCT 3AM w/body aches; 6AM h/a, chills, t100; took APAP; 3AM 10OCT93 woke up disoriented; fell on floor, t104, deltoid hot & sore; went to ER BP 60/0, WBC 50,000;
immediately following vaccine patient developed chills and headache. Headache has continue to this date. 4/22/21 developed chest pain went to the emergency room and was diagnosed with a bilateral pulmonary embolism.
Left upper arm swollen. 4.5 inch red ring around the area, some nodules palpated. Left upper arm warm to touch almost to elbow. Treated with ice and warm compresses.
This spontaneous report was received from a registered nurse and refers to 1 year old female patient. The patient's concomitant medications included influenza virus vaccine (unspecified) given in the left leg, PREVNAR 13 given in the left leg and hepatitis A virus vaccine (unspecified) given in the right leg. The patient had no known allergies. On 01-NOV-2017, the patient was administered with the PROQUAD (lot # N015623 and expiry date: 15-NOV-2018) at a dose of 0.5 ml once subcutaneously in the right leg to vaccinate against measles, mumps, rubella and varicella viruses. On the same day, the patient was accidentally administered with M-M-R II (lot# M045391 and expiry date: 14-NOV-2018) at a dose of 0.5ml once subcutaneously in the left leg for prophylaxis (inappropriate schedule of drug administration). On 01-NOV-2017, the patient was accidentally given both the PROQUAD and M-M-R II vaccine, when she should have only received the PROQUAD vaccine (drug administration error). The patient's parents did not report any adverse events to the facility thus far. The patient's laboratory data was unknown. As of 01-NOV-2017, it was unknown, if the patient would receive the PROQUAD or M-M-R II vaccines in the future.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 18-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mLVls 10SDV, (lot number L035882, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 had a temperature excursion. The lowest temperature excursion was of 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
no additional adverse event; VAQTA dministered after a temperature excursion; This spontaneous report was received from a medical assistant concerning a 13-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W017343, expiration date: 13-DEC-2023, administered intramuscularly on the left thigh as prophylaxis (strength was not provided), after a temperature excursion on 01-DEC-2022 at a temperature of 47.9 Fahrenheit degrees for 47 minutes. No additional adverse events were reported (product storage error).   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:
Headache, sleeplessness.  Took 2 Advil.  Did not help headache, slept fitfully - not enough.
Severely painful skin and muscles from right shoulder up neck to head 2 days after vaccine.  Fever of 101 24 hours after vaccine with headaches, muscle weakness, diarrhea.  5 days after vaccine diarrhea,  and sever headache.
Initial report received from healthcare professional on 22 January 2013. A 43-year-old female patient had medical history of FLAGYL allergy and concomitant medications were not reported, had received an intradermal dose of FLUZONE ID (batch number-UT4470AA) in left arm (deltoid) on 12 January 2013. The patient denied illness at the time of vaccination. On 13 January 2013 the patient experienced mild to moderate facial swelling 48 hour post vaccination and on unspecified date the patient experienced headache and sinus congestion 72-96 hours post vaccination. It was reported that, as per physician the patient had an allergy to the flu vaccine however it was not confirmed. The patient took self-treatment as BENADRYL, TYLENOL and Ibuprofen and symptoms were resolving within 1-2 hours. On 17 January 2013, the patient was evaluated by physician and no medical treatment was prescribed. Laboratory investigations/relevant diagnostic tests were not reported. At the time of this report, the outcome of events was unknown. Documents held by sender: None.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a two months old male patient who received components of PENTACEL (first dose, batch number: C5463AA, expiration date: 26-Jul-2019, dose: 0.5 ml, via intramuscular route in the right thigh) separately on 10-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and ROTATEQ for Immunisation. It was an actual medication error due to inappropriate reconstitution technique and wrong technique in product usage process. It was reported that PENTACEL components were administered separately, reported DTaP+IPV liquid portion was administered and then the ACTHIB portion was administered separately and was reconstituted with sterile diluent but not 0.4% NaCl solution. Components of PENTACEL 0.5mL IM in two injections to his right thigh were administered. Patient was administered the liquid component of PENTACEL in one injection and then received the ACTHIB powder component in one injection, and the ACTHIB component was reconstituted with a sterile diluent made by Merck. It was unknown whether the patient had any adverse 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 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. List of documents held by sender: none.
Forgot her last dose of Vivotif; Spontaneous report received on 20FEB2020.  A female consumer reported that she "forgot her last dose of Vivotif" (PT: Product dose omission). She was receiving Vivotif capsule for immunisation. It was reported that the consumer had completed 3 doses but forgot to take her last dose of Vivotif which was due on 17FEB2020. She stated that she did not have the access to the capsule on that day but would be having access tonight. She will be on a trip to Africa on 05MAR2020. Action taken with Vivotif with respect to the reported event was not applicable. The clinical outcome of the reported event was unknown.  Company Comment: A consumer forgot to take her last dose of Vivotif (missed dose) as she did not have access to Vivotif on the scheduled date. Vivotif should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.; Sender's Comments: A consumer forgot to take her last dose of Vivotif (missed dose) as she did not have access to Vivotif on the scheduled date. Vivotif should be taken every other day. Considering the nature of the event, the causality of missed dose is assessed as not applicable to Vivotif.
He received the dose in the morning in the right arm and noted chills that evening. 3 days later, heartburn and constipation. He also noted swelling of the upper lip and around the right eye. He took Benadryl without immediate relief but the swelling resolved after 2 days. GI symptoms resolved after 5 days.
Within 1-2 minutes I experienced full body tingling; facial numbness; vision became distorted/blurry; vision became distorted/blurry; whole body was sweating; abdominal pain; lower extremity aching; nausea; experienced moderate to severe lower back spasms; sciatica; This is a spontaneous report from a contactable other health professional (patient). This 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# ELO739), via intramuscular on 04Feb2021 03:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history included medullary kidney disease, and allergies to iodized contrast and bees (both resulting in anaphylaxis). The patient did not received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 1-2 minutes (03:15) patient experienced full body tingling and facial numbness. A minute later his vision became distorted/blurry and he began getting warn. A minute later his whole body was sweating, he was experiencing abdominal pain, lower extremity aching, and nausea. These symptoms other than the sweating persisted for another 5 days. After the 5th day, patient experienced moderate to severe lower back spasms and sciatica that resulted in an urgent care visit and a prescription for muscle relaxers and a mild pain reliever. The muscle spasms have been present for a week now and is slowly getting better. Patient was seen by an orthopedic urgent care where they recommended physical therapy and limited walking/sitting for extended periods of time. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included diphenhydramine hydrochloride (BENADRYL) (day of vaccination) and muscle relaxers. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of whole body was sweating and sciatica was not recovered, outcome of moderate to severe lower back spasms was recovering, outcome of other events was recovered on an unspecified date in Feb2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on event-vaccine chronological association, a causal relationship between reported events and BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. 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.
Initial information regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional on 17-Oct-2020.   This case involves patient (unknown demographics) who got flu of some kind even with the shot (influenza), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concurrent condition, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site prophylactic vaccination.  On an unknown date, the patient got flu of some kind even with the shot and end up passing it around (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Received vaccine on 1-26-17. Two days later noticed left arm was beginning to get red with some swelling at site. Today, five days later, site is red with approx 5mm induration at site, but swelling and redness go down arm approx 2/3 of the way to the elbow.