chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose on 06Jan2023, 2nd on 10Jan2023; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 7TP53, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 10th January 2023, the patient received the 2nd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:13-JAN-2023 Reporter's Comment: The reporter was a nurse coordinator. The reporter reported that the 6 month old infant patient received Fluarix QIV dose on 06th January 2023 and instead of coming back in 28 days for second dose, the parents misunderstood and brought the patient back on 10th January 2023 and received second dose. The vaccine administration facility was the same as primary reporter The reporter did consent to follow up. Additional supportive information: The patient received 2nd dose of Fluarix Quadrivalent early than recommended time frame, which led to shortening of vaccinations schedule.
I received the shot at approximately 5 pm and my arm was almost instantly sore. About 3 hours later starting getting pain behind my left eye and left side of my face felt numb. I had a headache until Tues. and arm pain is pretty much gone today (wed). I was extremely fatigued on Tues but less so today. The numbness in my face is pretty much gone today too. I did let my doctor know at my physical on Monday.
patient with severe pain at injection site, shoulder pain, enlarged lymph nodes, locked shoulder; pain with rotation, abduction and adduction
Child Given vaccine that may have had temperatures excursion (Data Logger Failure) with stable Fridge temps Before & After. DOH determined the vaccine to Be At Risk & Advised Reporting & Revaccination. Child Had No ill Effects thus FAR.
Customer calling to check stability of PROQUAD. Per caller the product has been stored in the refrigerator since April 20, 2022. Date of excursion April 20 ,2022; This spontaneous report was received from a medical assistant referring to an unknown gender and age patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  It was reported that the product (measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) had been stored in the refrigerator experienced a temperature excursion (Temperature: 45 Fahrenheit (F)) (Product storage error) since 20-APR-2022.  On 25-APR-2022, after a time frame of 120 hours of storage of the product, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) (valid lot #W004694, expiration date: 08-AUG-2023) (strength, dose and route of administration were not provided) administered for prophylaxis.
Allergic reaction - Urticaria. Treating with short-course PO prednisone
fainted; severe headache; Chills; body aches; arm pain; This is a spontaneous report received from  from a contactable consumer (patient). A 34-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Mar2021 at 14:00 (Lot Number: EN6198) (at 34-year-old) at single dose in arm left for COVID-19 immunization. The patient's medical history was not reported. No allergy to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within 2 weeks of vaccination included testosterone cypionate, chorionic gonadotrophin (HCG), rosuvastatin, and tadalafil (CIALIS), all taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Feb2021 at 14:00 (Lot Number: EN6201) at single dose in arm left for COVID-19 immunization. He woke up in the middle of the night (4:00 am on 06Mar2021) after getting his second vaccine with severe headache, chills, body aches and arm pain. After getting up and using the bathroom, he went to take his temperature and fainted. The events were reported as non-serious, while resulted in emergency room/department or urgent care, treatment included intravenous (IV) fluids, paracetamol (TYLENOL). The outcomes of the events were resolved on an unspecified date in Mar2021.  Information on the expiration date of vaccine has been requested.
positive with covid; positive with covid; sinus strainagned at the back of the throat.; sinus strainagned at the back of the throat.; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on an unspecified date single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced positive with COVID on an unspecified date, sinus strainagned at the back of the throat on an unspecified date. The outcome of the events was unknown. Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between reported "positive with covid" and suspect BNT162B2 cannot be excluded.
pt recv vax 6SEP96 & 14SEP96 730AM 15SEP96 lips were blue;pt in crib having a sz, eyes were rolled in head & was having alot of mucus foam  coming form mouth;911 called & pt was taken to ER;
Within the 15 minutes, I was just not feeling right short of breath / chest tight/ heaviness, and my right arm feeling dead. The nurse brought me back to a room and then my head started swimming.  Nurses checked my pulse and oxygen and they were fine. Within  5 -10 minutes everything got fuzzy The doctor came in and when she came in my, speeches started becoming slurred, my face numb, things just were just like I was another stroke. They gave me an aspirin and called an ambulance,
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient without drug reactions/allergies. The patient did not have pertinent history. On 30-APR-2013 the patient was vaccinated with her first dose of GARDASIL. There was no concomitant medications. Later it was found that she was pregnancy. It was reported that the patient's last menstrual period (LMP) date was estimated to be between 03-MAR-2013 and 07-MAR-2013. The patient became pregnant with estimated date of conception (EDD) of 08-DEC-2013. Initial exposure to GARDASIL was at 8 weeks(s). No treatment was given for adverse event. Blood work was performed. Additional information has been requested.
Rash located on the lower left leg and thigh.  lesions and itching present.  Treatment with cortisone cream, keflex x7 days, ataraz.
Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0179) via an unspecified route of administration in the left arm on 07May2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. She previously took azithromycin (ZITHROMAX) on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17May2021 at 06:00, the patient experienced vertigo. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of vertigo was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Immunization on 6/3/03. On 6/6/03 running fevers, lethargic-but still eating/drinking. 6/9/03 fever 103 degrees ax at home, wheeze, seen x 2 that day in clinic. Chest x-ray and UA done. 6/10/03 no fever. 6/12/03 ER visit, fever, lethargy. 6/13/03 rash. 6/16-rash and diarrhea. Much improved 6/18/03 but not completely recovered.
Information has been received from a pt who in 2000 was vaccinated with Hep-B vaccine and subsequently, the pt experienced twitching in the legs. No further information is available.
The patient experienced no symptoms; patient was administered an expired dose of Pneumovax23; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 10-JUN-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) by intramuscular route as prophylaxis (concentration, number of dose and vaccination scheme frequency were not reported; reported lot number R033080 and expiration date 06-JUN-2020)0 (expired product administered). The patient did not experience symptoms (no adverse event). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R033080; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Erythema: 3-inch, round, itchy surrounding injection site. 2nd: 2-inch, irregular below injection site.
Initial report was received on 31 July 2013 from a health care professional. A 33-year-old male patient with a history of allergy to penicillin had received for post exposure series on 25 July 2013 an intramuscular injection of IMOVAX, lot number J1358 (site of administration not reported) and an intramuscular injection of IMOGAM (lot number and site of administration not reported) and "later that day" developed a rash and swelling over much of his body. According to the reporter, the patient had not informed the physician and received the second dose of IMOVAX and again had the same reaction. The patient was hospitalized. Outcome was not recovered. Documents held by sender: none.
Shortness of breath; Felt like a racing heart; Didn't feel normal; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PALPITATIONS (Felt like a racing heart) and FEELING ABNORMAL (Didn't feel normal) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), PALPITATIONS (Felt like a racing heart) and FEELING ABNORMAL (Didn't feel normal). At the time of the report, DYSPNOEA (Shortness of breath), PALPITATIONS (Felt like a racing heart) and FEELING ABNORMAL (Didn't feel normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Heart rate: 84 (High) Patient's usual heart rate is 74 bpm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Followup received on 22-JUL-2021 and updated details of second dose
Mild rash. Present to torso & neck, Presented over a 48 hour period, has not worsened. Sites may or may not itch at times, sites are 0.5 to 2 cm in diameter.
(L) thigh swollen - red and warm to touch. Area measured 19cm x 10 1/2 cm (at ER). ER visit 12/12/07. Vaccinated 12/10/2007 - Seen 12/17/07 in ECC.
She seems to be breathing a little bit heavily in her sleep; She seems to be breathing a little bit heavily in her sleep; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 83-year-old female patient received BNT162b2 (BNT162B2), on 17Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation; clopidogrel bisulfate (PLAVIX), (Batch/Lot number: unknown) for intracranial aneurysm. The patient's relevant medical history included: "Cerebral Aneurysm" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed. (Dose 1 & 2), Covid-19 vaccine manufacturer unknown.), for COVID-19 immunization. The following information was reported: HYPERVENTILATION (non-serious), SLEEP APNOEA SYNDROME (non-serious) all with onset 17Aug2022, outcome "unknown" and all described as "She seems to be breathing a little bit heavily in her sleep".  Additional information: Reporter stated, "my mother is 83 and she takes Plavix for a Cerebral Aneurysm on a very tiny vein and we got one of the Covid boosters today and I am not even sure which one it was, was it the (Pharmacy name)? And I was wondering if there is any risk of that because she seems to be breathing a little bit heavily in her sleep. I was wondering if I should be concerned?"   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient received 0.2ml of 12 and up pfizer on 2/8/20222 will f/u 2-9-2022 for patients status
Headache throbbing, dizziness, increased blood pressure for 6 days with whooshing in ears, and some shortness of breath subsiding when i lay down, and took extra blood pressure meds.
Complaining of shortness of breath and cough for the past few days.  diagnosed covid positive one day ago with sx starting 5 days ago.  Short course of remdesivir for 3 days.  Decadron 6 mg daily.  Azithromycin.
Systemic: Allergic: Difficulty Breathing-Medium, Error: Wrong Vaccine/Product Administered-, Additional Details: PATIENT WAS GIVEN THE BIVALENT BOOSTER DOSE INSTEAD OF THE PRIMARY SERIES AS A SECOND DOSE AND SHE STATES SHE HAS BEEN HAVING BREATHING ISSUES SINCE THEN AND HAD TO VISIT PULMNOLOGIST
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose number, dose, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that the pharmacist had been using a 31 gauge insulin needle to administer ZOSTAVAX. On an unknown date the patient experienced tenderness and redness at injection site. The patient had sought medical attention by contacting the pharmacist. There was no product quality complaint involved. The outcome of tenderness and redness at injection site was unknown. The causality was unknown. It was reported that the pharmacist could not provide any information on how many patients received ZOSTAVAX with insulin need of 31 gauge. This case is linked to the case # 1406USA008277 via the same reporter link. Additional information has been requested.
Modern a COVID-19 Vaccine . On 3/4/2021 my right arm became red and itchy.   red are was about the size of a baseball.  I used antihistamines and topical steroid cream. Also topical Benadryl cream for the itching.  The redness and itching cleared 3/14/2021.  I did not consult a physician regarding this
pt recv vax 18DEC98 & 20DEC98 pt devel a fever of 101 & inc salivation;pt was evaluated @ an urgent care clinic where a dx of upper resp infect was made;tx w/APAP & recovered;
pt recvd vax 11MAR93 & the evening exp an allerg react of topical & internal hives; exp required a visit to either an ER or MD; w/in 10 days pt recovered;
Pt vaccinated with DTP experienced screamed & inconsolable x 18 hrs severe local rxn in thigh
No known adverse effects; patient received an expired dose of PNEUMOVAX; This spontaneous report has been received from a registered pharmacist, concerning a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 18-FEB-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dosage form, lot number R011632, expiration date on 02-FEB-2020 (concentration, frequency, administration route, and anatomical location was not reported) as prophylaxis. No known adverse effects reported.
Menveo-Reconstitution with saline solution; Menveo-Reconstitution with saline solution; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA911A, expiry date 31-MAR-2024) for prophylaxis.   On 21-JUL-2023, the patient received Menveo. On 21-JUL-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo-Reconstitution with saline solution) and inappropriate dose of vaccine administered (Verbatim: Menveo-Reconstitution with saline solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-JUL-2023 The reporter was a medical coordinator. The healthcare professional asked how to proceed with this patient. The reporter consented to follow up. The reporter called to report that a patient received a Menveo dose that was reconstituted with saline solution instead of the liquid CYW-135 conjugate vaccine component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Tinnitus, headache, dizziness and nausea. On-going symptoms.  Waiting for Dr.'s return phone call.
Information has been received from a physician concerning an approximately 13 year old female patient who on approximately 16-DEC-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The physician reported that approximately six hours after receiving the pneumococcal 23v polysaccharide vaccine patient developed generalized swelling in the same arm that the vaccine was given. This swelling lasted for approximately 18 hours and then went away. It was reported that the "patient was currently undergoing testing by an allergist for titer." Unspecified medical attention was sought by the patient. No further information was provided regarding this. Additional information has been requested.
I started to notice a ringing in my ears in early November. The ringing would vary in intensity from barely noticeable up to a 4 to 5 on a 10 scale of intensity. On 12/19 or 20 I sought out my doctor. Doctor advised blood pressure was not the issue and believed it to be related to allergies and sinus pressure. Advised to use SUDAFED and a nose spray. This caused the ringing to subside though it is getting worse again. It is usually the left side but uncommonly both. Occasional peaks at 4-5, but peaks of 3 is typical. Follow up with doctor Jan 30.
Pain, redness, warmth to lesion on (L)L arm. 9x15cm circular area at 2c swelling of diameter of arm.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 03-MAR-2014, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, 2 ml, which had a lot # of H017721 and an expiration date of 01-APR-2014 (dose number was not reported). The vaccine had two temperature excursions, the first of 336 hours with the lowest recorded temperature reported as 33 Fahrenheit (F) (0.555555556 Celsius (C)) and second of 248 hours with the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
36 weeks pregnant with her first pregnancy and she received the first dose of the Pfizer Covid vaccine; Soreness of the arm; This is a spontaneous report from a contactable nurse (parent) via a Pfizer-sponsored program. A 29-year-old female patient (the patient was 36 weeks pregnant at the onset of the event) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the age of 29-year-old on an unspecified date (pregnant at time of vaccination) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The nurse stated her daughter was 36 weeks pregnant with her first pregnancy and she received the first dose of the Pfizer Covid vaccine. She just had soreness of the arm on an unknown date. Her doctor recommended she get the vaccine.  The events outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1st dose at 11:15 AM, immediately had R sided tongue swelling, then had throat closing sensation, given epi IM 0.3 mg at noon by vaccine clinic staff, EMS picked patient up and patient had initial improvement but had some more tongue swelling so was given diphenhydramine 50 mg IV as well with improvement and transported to emergency department. Given prednisone 40 mg in emergency department. Patient currently resolved, and now has no symptoms. Observed 4 hours after epi without issue, discharged.