chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years 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 immunization; Covid-19 vaccine (Dose: 2; Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3; Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu symptoms".  Additional information: The caller received the 2nd booster shot of the Pfizer-BioNTech Covid 19 Vaccine and had flu symptoms due to the vaccine. His date of birth is (DOB withheld). However, (Name withheld) called on behalf his girlfriend who also received the 2nd booster dose of the Pfizer-BioNTech Covid 19 Vaccine and has a rash all over her body (both arms and her chest) ever since she received the vaccine. He stated that her girlfriend is in pain. His girlfriend's date of birth is (DOB withheld).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt had a BOOSTRIX on 9-21-09. 9-22-09 c/o throat feeling tight, swallowing seems different. (L) deltoid is really sore. Has had sore arm ever since vaccine given, conts. today.
I was 8-weeks pregnant when I received my first dose of the Pfizer COVID-19 vaccine. This first dose was administered on Friday January 29, 2021. Three days later on Monday February 1, 2021, I was told my baby did not have a heartbeat on the ultrasound in the clinic (confirmed by radiology that day as well) and that I was having a miscarriage.  I had no other signs or symptoms of miscarriage or illness.  Pregnancy history - I do not have any other children yet.
Diffuse papular/vesicular/pustular and scab lesions to body. Ulcers to oral mucosa.
Patient fainted after getting vaccination,  bumped the car in front of him.  Did not remember hitting the car.  He was diaphoretic, clammy, palor in color, VSS but low, patient stated that he vagals with all shots.  He was removed from his car and taken to the emergency tent.  laid on a cot with his legs elevated.  His vital signs were: 80/40, 49, 98%, 88/60, 56, 99%; 100/64, 78, 96%; 110/68, 64 98% Patient stated that he was feeling better, he runs a low blood pressure and frequently gets orthostatic hypotension.
3 to 4 hrs p/immun pt devel 102-103 fever w/emesis; The following day 27JJUL93 pt fever fell to under 100 w/some c/o of discomfort in shot site; no further emesis was reported;
Menveo adminsitered instead of Men-b; Received 2 doses previously of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date 28th February 2023) for prophylaxis.   Previously administered products included Menveo (Received 1st dose of Menveo on 20th February 2017) and Menveo (Received 2nd dose of Menveo on 17th June 2021).   On 6th February 2023, the patient received the 3rd dose of Menveo. On 6th February 2023, unknown after receiving Menveo, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter reported that patient received an accidental dose of the Menveo instead of Men-b.  The patient also received 2 doses of Menveo previously. No reactions were reported.  The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up via email.  Additional Supportive Information: The reporter reported that the patient received 2 doses of Menveo previously and now received an accidental dose of the Menveo instead of Men-b, which led to wrong vaccine administered and extra dose administered.
Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 9AT7A, expiry date 06-AUG-2024) for prophylaxis.   On 20-JUN-2023, the patient received the 1st dose of Shingrix. On 20-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jun-2023 Department supervisor reported that the patient was administered the liquid adjuvant portion only of Shingrix and it was not reconstituted with the lyophilized component.  At the time of reporting a repeat dose has not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. This is 2 of 3 linked patients, reported by same reporter. The patient received only liquid adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023090171:Same Reporter US-GSK-US2023090167:Same reporter
Itching, burning at site, followed by swelling, increased pulse, difficulty breathing. Seen in ER, given Epi x2 and BENADRYL.
Pt was given a second dose of Covid 19 from a syringel that expired on Friday 9/3/2021, the staff member thought because it was in the fridge it was ok to give, pt has not had any reaction at this point.  We will disgard  any vaccine that is left at the end of the day even if if expires in the evening as we close at 5 to assure there are no syringes in the fridge that expire the next day.
Can't move the right arm/Can't use the right arm because of pain; pain in the right arm/Can't use the right arm because of pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the right arm/Can't use the right arm because of pain) and VACCINATION SITE PAIN (pain in the right arm/Can't use the right arm because of pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the right arm/Can't use the right arm because of pain) and VACCINATION SITE PAIN (pain in the right arm/Can't use the right arm because of pain). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the right arm/Can't use the right arm because of pain) and VACCINATION SITE PAIN (pain in the right arm/Can't use the right arm because of pain) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided. for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment. action taken with mRNA-1273 (COVID 19 Vaccine Moderna)(intramuscular), was not applicable
dizziness; headaches; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; CHILLS (non-serious), outcome "unknown", described as "chills".  Additional information: The patient received two doses of the Pfizer COVID-19 vaccine and developed some side effects such as dizziness, headaches and chills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 14-JUL-2015 the patient was vaccinated with one dose of improperly stored PEDVAXHIB, lot# L002867 with expiration date of 11-NOV-2015 (strength, dosage, frequency and route unspecified)(incorrect product storage). No adverse effects were reported. This is one of 4 reports received from the same reporter. Following review, it was determined that the report did not meet criteria for a quality investigation. Incorrect product storage was not considered a true Adverse event and there were no reported adverse effects. Additional information has been requested.
Redness, swelling at injection site. Rash at injection site. Pain at injection site. Given 5-days of prednisone to use ice and MOTRIN.
36hr p/vax pt had fever 106 @ home;seen in ER w/negative PE other than fever 103.8 @ time;p/ibuprofen, CBC diff, blood cult;nontoxic, content, w/rash then & over next 5 days;rx fever control;
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. On an unknown date, the patient experienced redness at the injection site after administration of ZOSTAVAX. The outcome of redness at the injection site after administration of ZOSTAVAX was unknown. Additional information is not expected.
Pt. woke this A.M. with 3 large blisters to R thigh. Approximately 9" in length. Seen by PCP today who thinks it is unrelated. ? impetigo.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot number, dose and route not reported) on 28-JUN-2012. On 28-JUN-2012, the patient was vaccinated again with a dose of PNEUMOVAX 23 (Lot number, dose and route not reported). No symptoms were reported. Additional information has been requested.
rash that went up her neck and around to her back and then up the back of her neck and then to her hair; red, hard bump at the injection site; bump that turned into a bruise at the injection site; Initial information was received on 23-Jul-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (GMI Inquiry number: 00694400).  This case involves a 51-year-old female patient who experienced rash that went up her neck and around to her back and then up the back of her neck and then to her hair (rash), red, hard bump at the injection site (vaccination site mass) and bump that turned into a bruise at the injection site (vaccination site bruising) after she received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 15-Jul-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 15-Jul-2021 the patient developed a non-serious red, hard bump at the injection site (vaccination site mass) and bump that turned into a bruise at the injection site (vaccination site bruising) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  On 16-Jul-2021, the patient developed a non-serious rash that went up her neck and around to her back and then up the back of her neck and then to her hair (rash) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the patient was recovering from rash, and the event outcomes for vaccination site mass and vaccination site bruising were unknown.  There will be no information on batch number for this case.
Rt thigh and buttock swelling, redness, hot to touch. Pt had 101 fever acting okay.
Headache beginning at night (Wednesday). Headache increasing in strength throughout the night until it became very very painful throughout the following morning until mid afternoon (Thursday).. Dizziness and nausea beginning late morning day after shot (Thursday) for about 3 or 4 hours, making it difficult to stand up.  By 3:30 or 4:00 most severe symptoms seemed to lesson, or disappear.  Over the following  4 days have had slight headache and general fatigue.
sick; felt so tired/chronic fatigue; coming down with the flu; This is a spontaneous report from a contactable Other HCP. This 27-year-old female Other HCP reported for herself that.  A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Jan2021 (at the age of 27-years)  as Dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. It was reported that patient was tested positive for covid in December and got the first dose of the Pfizer covid vaccine on 23Jan2021. After that dose patient got really sick and felt so tired, like she was coming down with the flu. she had chronic fatigue. She had really concerned about getting the second dose of the vaccine and spoke with his doctor about it. From what she understands the side effects after the second dose are harder than after the first. She was asking question if they have any information about getting the second dose in this situation. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
sleepiness; Nausea; headache; chills; body aches; runny nose; fatigue; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 15Dec2021 11:30 (Lot number: FH8027) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sjogren's Syndrome" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "Allergies: Iodine-based dyes" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; MELOXICAM. Vaccination history included: Bnt162b2 (Dose 2, Dose product: COVID-19, Dose brand: Pfizer, Lot number: EP6955, Route of administration: Intramuscular), administration date: 08Apr2021, when the patient was 59 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, Dose product: COVID-19, Dose brand: Pfizer, Lot number: EP6955), administration date: 18Mar2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 11:30, outcome "unknown", described as "Dose number=3"; SOMNOLENCE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "sleepiness"; NAUSEA (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "Nausea"; HEADACHE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "headache"; CHILLS (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "body aches"; RHINORRHOEA (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "runny nose"; FATIGUE (non-serious) with onset 15Dec2021 17:00, outcome "recovering", described as "fatigue". Therapeutic measures were taken as a result of somnolence, nausea, headache, chills, pain, rhinorrhoea, fatigue.  Additional information: Patient was not received any other vaccines within 4  weeks. Patient was not diagnosed with covid prior vaccination and also not tested for covid-19 post vaccination. Treatment received for the adverse event was Tylenol.  No follow-up attempts are needed. No further information is expected.
Patient reported feeling very nauseated about 5 minutes after immunization. Patient was asked to sit and relax, while patient was given a cup of water to drink and some crackers by accompanying parent. Patient's body temperature was warm but not hot, and he was able to communicate the entire period whiles here at the facility. Emergency services was offered to patient but parents declined. About 30minutes after the immunization patient and his family left the pharmacy. Patient was able to walk without any complications. Further advice was given to patient's family to contact emergency services if needed.
PATIENT DESCRIBED AND IT WAS SEEN A RASH WHICH WAS RED FROM SITE TO ELBOW WHICH WAS SWOLLEN AND WARM. PATIENT SAID SHE ALSO HAD SEVERE MUSCLE ACHES ALL OVER BODY; THE ARM WAS SWOLLEN AND WARM MORE THAN HER OTHER ARM ... PATIENT WAS ADVISED TO SEEK MEDICAL ATTENTION AND REPORT BACK.
Headache; Sweating for approx 12-24 hours; This is a spontaneous report from a contactable healthcare professional (patient himself). A 28-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EH9899, expiry date: Mar2021), intramuscular in the left arm on 15Dec2020 14:45 at a single dose for COVID-19 immunization. The patient was vaccinated in a hospital facility. Medical history included Type II diabetic, irregular heartbeat (Sinus Arrhythmia), and gout. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included atenolol. The patient previously had allergy with lisinopril. On 05Jan2021 23:30, the patient experienced headache and sweating for approximately 12-24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received prednisone and Benadryl as treatment. The outcome of the events was recovering. The case was considered non-serious.  No follow-up attempts are possible. No further information is expected.
Patient had a large red patch of irritated skin from her shoulder to her elbow. It went away on its own after a few days. She told her primary care but did not seek any medical attention.
On the day of admission, she was seeing her PCP for a routine visit where hemoglobin was found to be 6.6.  She was otherwise feeling well with no change in her BMs (dark black from iron) and no other symptoms.  FOBT was positive.  She was admitted to our facility and received 2U PRBC.  Her hemoglobin has improved to 8.4.  An occult GI bleed is of concern for her ongoing iron-deficiency anemia.  She was seen by general surgery and recommended to have an outpatient colonoscopy and EGD next week.  She will continue her ASA 81 mg for now (given severe CAD and no brisk bleeding) and also her PO iron supplementation.  We have also arranged for a repeat Hb next week to assure ongoing stability.   PER ED CHART: Reason for Visit  Other  Diagnoses   Acute GI bleeding  Fatigue, unspecified type  Blood loss anemia     Follow-up Items Upon Discharge: -Continue PO ferrous sulfate and all other meds -EGD / Colonoscopy next week to evaluate for iron-deficiency anemia  -Repeat Hb on 10/20/21
Pt with COPD and on chronic home oxygen.  Pt requiring increasing oxygen at home and admitted with COVID and hypoxic respiratory failure.
R arm red, frim mass at inject site where DT boosterj given. Arm is still sore. Has full ROM upper arm.
Left arm felt heavy at first, then I felt light headed, when I sat down I looked straight ahead and my hearing started to get fuzzy and my vision slowly went black, and I felt the cold sweats. I closed my eyes and  lifted the bottom of my mask slightly to increase air, and then I was perfectly fine. This was this morning, I just feel sick now.
p/vax pt exp inj site soreness & bottom of feet were very warm & painful; tx: relafen
Information has been received from a medical assistant concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. Since 06-SEP-2017, the patients were vaccinated with PEDVAXHIB (lot # N000235 with expiration date 26-OCT-2019) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 1 hour and 20 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009338.
5 days after pt received his 2 month old vaccines. Pt out of a sudden became unresponsive in my mothers arms. My 15 year old brother witnessed pt feet, hands jerking and eyes rolled back. My mom gave pt mouth to mouth, by the time the ambulance arrived pt was responsive and pt was rushed to the hospital. Dr. did not know what had happened to him since he was responsive, an x-ray was taken but the Dr. could not read it because it was fuzzy. The hospital reports state pt  choked but that's not what the hospital said since they didn't know what happened to pt and its obvious when somebody chokes. its still unclear what happened to pt that day.