chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client received 2nd dose of COVID-19 vaccine at 3:26pm. At 3:32pm RN was notified that client was not feeling well and had requested water. Check in with client who reported he was feeling dizzy and nauseous. Took client to cot by wheel chair. Check pulse (92bpm) and pulse ox (95 SpO2). Gave cold compress for neck and forehead. Client vomited small amount of yellow vomitous. Client grey/ashen in color when mask removed. LPN assesed for neck/back, jaw, and shoulder pain. Client became diaphoretic and he removed his vest. Client stated he had jaw pain and pain in back. Also reported arm pain and felling tired a few days before. EMS called. Interpreter used for interaction at cot.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster - related conditions. On or about 2012, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) to the patient. On or about JUNE 2017, the patient was treated by a family nurse practitioner at a medical office for shingles. The patent was diagnosed with shingles and /or other zoster related injuries after and despite being inoculated with the ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); and other losses and damages.  The outcome of the events was considered to be not recovered. Additional information has been requested.
12+ Pfizer COVID vaccine was given 6 days after the 10 week expiration in the fridge. The 10 week expiration out of the freezer was 7/19/23 and the vaccine was given on 7/25/23.
tenderness; redness; warmth; This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a 57-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 54T44, expiry date 30th June 2020) for prophylaxis.   On 8th October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 8th October 2019, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site tenderness, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site tenderness, injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site erythema and injection site warmth to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received FluLaval in the left deltoid and within 12 hours experienced tenderness, redness and warmth at the injection site. The issues resolved within 24 hours. This case is 1 of 2 cases, reported by same reporter.
No additional AE.; an improperly stored vaccine was administered to a patient.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 13-SEP-2022, the patient was vaccinated with an improperly stored (temperature: -11.8 Celsius [C] degrees, time frame: 1 hour, 45 minutes, 0 seconds) measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W019623 was found to be valid, expiration date: 19-DEC-2023 (strength, dose, route of administration and vaccination site were not reported) for prophylaxis (product storage error). No additional adverse events were reported.
she felt tingling in her facial area; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (she felt tingling in her facial area) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PARAESTHESIA (she felt tingling in her facial area).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
PERSON ADMITTED TO HOSPITAL ON 12/6/2021 WITH CONGESTION, BODY ACHES, EAR PAINS FOR A MONTH. FOUND UNRESPONSIVE AT HOME BY FAMILY.  FOUND HYPERTHERMIC, TACHYCARDIC, AND HYPOXIC ON ADMISSION.  HAD AN EPISODE OF BRADYCARDIA FOLLOWED BY ASYSTOLE, THEN INTUBATED. FAMILY CHANGED CODE STATUS TO DNR AND PERSON HAD AN ANOTHER EPISODE OF BRADYCARDIA FOLLOWED BY ASYSTOLE. PRONOUNCED DEAD ON 12/7/2021.
Wheezing,cough,sensation of throat constriction, sore throat, watery eyes, extremely stuffy nose, body aches
AFTER PATIENT RECEIVED FLUAD (FLUSHOT) SHE  HAD SITE OF INJECTION REACTION INCLUDING  REDNESS, HEAT AND SWELL, HOWEVER SHE RECEIVED THE SAME VACCINE IN LAST 4 YEARS WITH NO PROBLEM
Pt recv vax on 11/18/98; on same day pt exp muscle aches, cough, congestion, fever x 2 mon
Patient stated that he's had weakened legs since vax. Stated it's hard to work, stated that he had blood clots with numbness since vax.
COVID infection; COVID infection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 1, single (Batch/Lot number: unknown) and in Nov2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient's concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: COVID-19 PCR test (nasal swab) in May2021, which was positive. It was unknown if therapeutic measures were taken as a result of drug ineffective and COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5 min. after vaccination - uncontrollable crying, nasal congestion, watery eyes, & itching. 30 min. after vaccination whelps began on back & splotchy face. Child went to ER - O2 Sat 96% on room air on arrival VISTARIL IM given at ER about 1 hour after vaccination.
seen by MD on 7AUG96 described by office nurse as local rxn on lt deltoid which includes 55mm knot, red appearance to skin & skin hot to touch;nurse states MD is placing pt on ATB;
Vaccine was administered and about 12 hours after patient complained of pain/weakness in the arm that injection was given.
RPh on-duty on 09/30/2022 administered a BiValent booster to the patient, but it was only the 2nd dose in the series for the patient. Per current guidelines, they should've gotten 2nd dose in the initial series rather the BiValent Booster .
Approx 5 min p/t recvd vax devel rash on face & forehead & both legs were red; no rash anywhere else on body; rash lasted approx 15 min; no other problems; no resp distress; pt cried;
Lt arm red, warm to touch, swollen from mid upper arm to anticubital area. C/O discomfort when touch. Physician notified.
pt recv vax & awoke crying & having jerky body movements;pt taken to ER while there @ 4AM temp was noted to be 105 R;tx w/APAP & Ibuprofen & sent home;12noon temp 99 R;
Ears feels funny; Lips feels funny; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ears feels funny) and ORAL DISCOMFORT (Lips feels funny) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced EAR DISCOMFORT (Ears feels funny) and ORAL DISCOMFORT (Lips feels funny). At the time of the report, EAR DISCOMFORT (Ears feels funny) and ORAL DISCOMFORT (Lips feels funny) had not resolved.            Concomitant medications were not provided. Treatment information was not reported.
Pt claimed dose given today was his first dose of Pfizer, Actually was his second dose given at 11 days from his first.
Purpura rash has been inflamed; Purpura rash has been inflamed; This is a spontaneous report. A contactable consumer (patient) reported a 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection; Lot number: EN6205 and Expiration date: not reported) via an unspecified route of administration, administered on the right arm on 26Mar2021 08:15 (at the age of 58 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Henoch-Schonlein purpura (HSP/Iga). Concomitant medications were not reported. 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 vaccination. On 01Apr2021, the patient stated that the purpura rash has been inflamed. The patient did not receive any treatment for the event. The patient also stated that few people have noted the same. One lady hasn't had a flare-up in 30 years but after her injection did have a flare-up. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event purpura rash has been inflamed was not recovered.
Vials were frozen & underwent 4 temperature excursions; 7 doses given from 5 vials that underwent more than 1 temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were frozen & underwent 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials that underwent more than 1 temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were frozen & underwent 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials that underwent more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vials were frozen & underwent 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (7 doses given from 5 vials that underwent more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  On 13Jan2022 the freezer got to 5.4F for 15 minutes, then returned to the appropriate temperature range. On 20Jan2022 the freezer got to 6.1F for 15 minutes, then returned to the appropriate temperature range. On 11Feb2022 the freezer got to 10.8F for 10 hours and 15 minutes overnight into 12Feb2022, then returned to the appropriate temperature range. On 25Feb2022 the freezer got to 22.6F & was out of range for 20 hours total into 26Feb2022 then returned to the appropriate temperature range. Date vial moved from freezer to refrigerator was 1dose/vial on 25Jan2022. Number of vials/doses impacted was 7 doses/5 vials. 5 vials were eventually punctured & used after the 2nd excursion.  No treatment medications were reported.
Swollen and tender left neck lymph node; Swollen and tender left neck lymph node; Headache; Tiredness; This is a spontaneous report from a contactable other health professional (HCP). A 35-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), intramuscular on left arm, on 12Jan2021 at 09:15, at a single dose for COVID-19 immunization. Medical history included anxiety and migraine from an unknown date and unknown if ongoing. Concomitant medication included escitalopram. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm at 23Dec2020, 03:30 PM. The patient experienced swollen and tender left neck lymph node, headache and tiredness; all on 12Jan2021 at 17:30. There was no treatment given for the events. The outcome of the events was not recovered.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 02-MAR-2013 at 11:00 am, the patient was vaccinated with RECOMBOVAX HB (lot # H018689 and expiration date 07-NOV-2014) (dose, therapy route and anatomical location unspecified). The physician reported that on an unknown date, RECOMBIVAX HB was exposed to multiple low temperature excursions. The excursion time at -1 was 39.50 hours (also reported as 17 hours -1, then 4 admin (2)). The patient was not experiencing any known symptoms. This is one of several reports from the same source. Additional information has been requested.
pt said almost immediately after getting the vaccines she broke out in a rash on her lower back.  It spread from side to side and higher on her lower back.  It itches severely.  she went to a dermatologist and they did now know what the cause was but gave her a steroid shot and "medication" that did not seem to help.
I have post menopausal bleeding.; This is a spontaneous report from a non-contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8733, expiry date not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 as first dose, single for covid-19 immunisation. Medical history included patient had an adverse reaction to aloe many years ago and have not had her period in 2 years. The patient's concomitant medications were not reported. The first dose of was administered in a doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications the patient received within 2 weeks of vaccination. The patient had no covid prior to vaccination. Patient had post menopausal bleeding on 02May2021. Patient have not had her period in 2 years and have started a very heavy flow period. Patient have contacted her doctor and have a pelvic ultra sound scheduled. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received in response to the event. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of the vaccination and of the report. The event  post menopausal bleeding was not recovered.   No follow-up attempts are possible. No further information is expected.
intestinal cramping; gastro-intestinal discomfort; she was not feeling well; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the female patient of 59-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, on 20Mar2021 in between 12:30 to 13:00 in the afternoon (Batch/Lot Number: EP7536), (at the age of 59-years-old) on her right arm as single dose for covid-19 immunisation. The patient medical history included allergy to sulfa from unspecified date and was ongoing. The patient stated that she had her first reaction to sulfa in her 30 or 40 years of age (probably closer to 40) and does not take it anymore. The patient had no family medical history relevant to events. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, patient experienced intestinal cramping. The patient was not feeling well too and hence missed to take her second dose of Covid vaccine. The patient also reported that both herself and her husband were scheduled for their second dose on 11Apr2021 and were unable to take because she was not feeling well. The patient enquired about how to reschedule appointment and stated that the intestinal cramping had nothing to do with the reaction, that was 3 weeks ago. The patient enquired into appointment scheduling due to missing appointment for second dose of vaccine on 11Apr2021 due to not feeling well, caller clarified that it was gastrointestinal discomfort in 2021. The events did not require a visit to emergency room or physician office. The outcome of the event intestinal cramping was recovered on 11Apr2021 and other events was unknown.  No follow up attempts are possible. No further information is expected.
The subject is a 78 year old male who was admitted to the hospital due to respiratory failure, lower extremity weakness and died while enrolled in RSV11 study. The study received RSV vaccine or Placebo and influenza vaccine on 10/22/02. The subject developed lower extremity weakness with SOB 336 days post immunization and was admitted to the hospital on 9/23/03. He was found to have a large syrinx (syringomyelia) in the thoracic spinal cord probably secondary to chronic ischemia which had progressed to the point where there was compromise of his lower extremity innervation causing his weakness. Pneumonia was found on his chest x-ray which accounted for his respiratory failure; he was treated with antibiotics. He developed thrombocytopenia and leukopenia secondary to his immunosuppressive therapy and was treated with granulocyte colony-stimulation factor. His counts improved. He was maintained on hemodialysis. He developed further respiratory failure secondary to mucous plugging and required intubation for deep suctioning. He developed a subsequent left upper lobe infiltrate which was felt to be secondary to Aspergillus. Deep venous thrombosis was discovered and he was treated with Heparin. There was a long discussion undertaken with wife and the family requested comfort care only and to extubate the pt. Subject was extubated, given IV morphine for comfort and expired 15 days after admission on 10/8/03, 351 days post immunization. Discharge summary: 9/23/03-10/8/03. Admission diagnosis: respiratory failure, lower extremity weakness. Discharge diagnosis: Respiratory failure secondary to pneumonia exacerbating chronic obstructive pulmonary disease. Large thoracic spine syrinx probably ischemic in origin. neutropenia secondary to Cytoxan. ANCA positive vasculitis with secondary glomerulonephritis and end-stage renal disease, hemodialysis-dependent. Alveolar, ar hemorrhage syndrome secondary to ANCA positive vasculitis. Paroxysmal atrial fibrillation. Mucous plugging of the bronchial tubes with further respiratory failure. Deep venous thrombosis. Aspergillus pneumonia. The respiratory failure, large thoracic spine syrinx, neutropenia, ANCA positive vasculitis, alveolar hemorrhage, paroxysmal A. fib, mucous plugging on bronchial tubes, deep vein thrombosis, and Aspergillus pneumonia were reported by the investigator as not related to the study vaccine. The death certificate received on 1/2/04 states renal failure and vasculitis.
Initial information received on 19-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 4 years old male patient who experienced expired dose was administered to consumer, while he received vaccines HEPATITIS B VACCINE and PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Sep-2017, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot number not reported via unknown route in the deltoid NOS. On an unknown date, the patient received a dose of suspect HEPATITIS B VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. The patient developed a non-serious expired dose was administered to consumer following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE and following the administration of HEPATITIS B VACCINE. (Other relevant tests included No lab data). Final diagnosis was expired dose was administered to consumer. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for expired dose was administered to consumer. 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.
3 days p/vax pt devel sl fever;arm became quite swollen it was extremely hot & erythematous;skin appeared to have been severly sun-burned;lasted 2wk pt reports there is still a hard lump in the site but has no pain @ site;inflam to shoulder
Patient received Pfizer COVID vaccine on 2/15/2021 and 1/27/2021.  On 4/8/2021 developed fever, headache, loss of taste/smell, and sore throat.   Tested positive for COVID.
07/13/02 edema and redness to right arm deltoid region. Pt afebrile per ER written report. Received Cefthidon IV followed with one day course Keflex 250mg with 6 hours, Benadrl for itchy. Received IV Benadryl as well in ER. 07/14/02 pt has returned ER visit with vast improvement.
pt recvd vax & exp mild elevation of alkaline phosphatase & recvd 2 addtl doses of Engerix-B; still exp this mild elevation;