chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myalgia, Fever, Rash,  lymphadenopathy  Narrative:  Received 1st dose at 0900 on 3/11/21. Noted increased arm pain that  evening and fever that night (up to 100F). Developed swelling in armpit and neck  and groin lymph node enlargement on opposite side of injection site. Lymph  swelling above clavicle persisted through 3/16/21, though improving. Noted fine  papular rash as well. Pt has had COVID infection 11/2020   Other Relevant History:
Site: Itching at Injection Site-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: feels like arm is "asleep" from injection site down
Patient was given expired dose of Pneumovax 23 expiration date 07/01/2022.  Patient was notified immediately . Pt denies any adverse reaction.
On 7/14/00 she developed a fever up to 102 degrees and became cranky.
Pt said 4 hours after her shot her legs felt weak + she felt tired, she said her heart started beating real fast-up to 100 beats per minute. Stayed increased until 8:00 AM on 6-22-19 when pt. took a Xanax + it slowed down. Heart rate went back up 6-23-19 late afternoon + stayed up until 8:00 AM 6-24-19. Also on 6-23-19 had chills + fever.
GAVE VAXCHORA TO A 66-YEAR-OLD CONSUMER; This spontaneous case report (PVX2019-2555) was received from a pharmacist on 11-Oct-2019. It described a 66-year-old female consumer whose pharmacist "gave Vaxchora to a 66-year-old consumer" (PT: Product use issue). The consumer was receiving Vaxchora for an unknown indication.  Case report: A 66-year-old female consumer took Vaxchora three days ago.  Action taken with Vaxchora with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "gave Vaxchora to a 66-year-old consumer" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "gave Vaxchora to a 66-year-old consumer" was considered as not applicable.
J96.00 ACUTE RESPIRATORY FAILURE 10/1/2021 METABOLIC ENCEPHALOPATHY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 METABOLIC ENCEPHALOPATHY J96.10 CHRONIC RESPIRATORY FAILURE 12/28/2021 METABOLIC ENCEPHALOPATHY J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/1/2021 METABOLIC ENCEPHALOPATHY J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 METABOLIC ENCEPHALOPATHY J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/28/2021 METABOLIC ENCEPHALOPATHY J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/12/2021 METABOLIC ENCEPHALOPATHY R09.02 HYPOXIA 12/27/2021 METABOLIC ENCEPHALOPATHY J96.00 ACUTE RESPIRATORY FAILURE 10/1/2021 DELIRIUM J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 DELIRIUM J96.10 CHRONIC RESPIRATORY FAILURE 12/28/2021 DELIRIUM J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/1/2021 DELIRIUM J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 DELIRIUM J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/28/2021 DELIRIUM J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/12/2021 DELIRIUM R09.02 HYPOXIA 12/27/2021 DELIRIUM J96.00 ACUTE RESPIRATORY FAILURE 10/1/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.10 CHRONIC RESPIRATORY FAILURE 12/28/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 10/1/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/28/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.22 ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 12/28/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/12/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE R09.02 HYPOXIA 12/27/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
This spontaneous report was received from a 26-year-old male pharmacy technician (also reported as healthcare worker and is also the patient) via a company representative. The patient had no pertinent medical history and drug reactions/allergies. On 15-AUG-2013 the patient was vaccinated with a dose 1, 0.5 milliliters (ml) GARDASIL (lot#, expiration date not reported) intramuscularly (reported 'route as directed'). Approximately on 17-AUG-2013 (reported as 2 days after receiving the vaccine) the patient became very sleepy and tired. The events resolved on an unspecified date in 2013. Treatment was not rendered for the events. No laboratory diagnostic studies were performed for the events. Medical attention was not sought by the patient. Causality was not reported. Additional information has been requested.
Swelling and redness on the lateral aspect of left arm about 4cm X 4.5cm. No tenderness with hard center.
Fourth day after vaccine started with excessive  eye blinking and then during day 10 presented fever & diarrhea.
legs will not move; had a horrible time it's just terrible; aching; running a fever; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (legs will not move), VACCINATION COMPLICATION (had a horrible time it's just terrible), PAIN (aching) and PYREXIA (running a fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021 at 2:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced MOBILITY DECREASED (legs will not move). 05-Aug-2021, the patient experienced VACCINATION COMPLICATION (had a horrible time it's just terrible), PAIN (aching) and PYREXIA (running a fever). At the time of the report, MOBILITY DECREASED (legs will not move), VACCINATION COMPLICATION (had a horrible time it's just terrible), PAIN (aching) and PYREXIA (running a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter. Patient was wondering if she can take any kind of ibuprofen or Advil or Tylenol.
I've had nerve damage; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (on an unknown date received 1st dose.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve damage (Verbatim: I've had nerve damage). The outcome of the nerve damage was not resolved.   It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the nerve damage to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 30-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 2nd round of shingles and he/she had the shot both times and also he/she had nerve damage that still never goes away.  The patient states that he/she feel like the shot only helps a bit. Follow up was not possible, as no contact details were available.
Patient describes upper arm pain starting early April. Was seen by physician 5/12/2021 for generalized muscle aches, weakness and pain. Patient was diagnosed with Polymayalgia Rheumatica based on elevated CRP/ESR and started on prednisone 15mg daily .
33 y/o male is seen in the ED for pneumonia approx five days after series of vaccinations. cough, dry start 9/9/06 end 9/15/06 started 2-3 days after vaccinations. fever start 9/11/06 end 9/15/06 up to 102-103F between 9/11 and 9/12. fatigue, malaise <60 days start 9/9/06 end 9/15/06, chest pain start 9/12/06 end 9/15/06, associated with inability to take a deep breath.
Day 7 post vaccine arm pain at injection site.  Sometimes a dull ache and sometimes sharp pain with movement.
red swelling rash about 2 inches below injection site/delayed rash, 10 days after first dose; red and tingling; red and tingling; This spontaneous case was reported by a consumer and describes the occurrence of RASH (red swelling rash about 2 inches below injection site/delayed rash, 10 days after first dose), RASH ERYTHEMATOUS (red and tingling) and PARAESTHESIA (red and tingling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced RASH (red swelling rash about 2 inches below injection site/delayed rash, 10 days after first dose), RASH ERYTHEMATOUS (red and tingling) and PARAESTHESIA (red and tingling). At the time of the report, RASH (red swelling rash about 2 inches below injection site/delayed rash, 10 days after first dose), RASH ERYTHEMATOUS (red and tingling) and PARAESTHESIA (red and tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The evening after receiving the shot I started having a headache. The next morning (Friday) I was feeling flu like and by the end of the day maintained a fever of 101.6, dizziness, taste and smell loss, muscle and joint pain. I remained like this till about Saturday afternoon.  Sunday I still had the headache but otherwise felt fine. I had sex with my fiance and as I felt I was going to climax my head started hurting very badly. I saw lights and it felt like an oncoming freighter hit me. I tried Tylenol and ibuprofen but nothing helped. I even used ice packs wrapped around my head. That night I had a hard time sleeping from pain and worrying if I would wake up, never felt anything like this before. It feels like something bad happened in my head.  Tuesday I couldn't take it anymore and called the health dept where I got my shot, they suggested I go to urgent care. I went there and was given a shot of torodol. The doc said go to the emergency room for a brain scan after a week and a half of it hadn't stopped, that a lot of people were coming in after the booster reporting severe headache, but all symptoms should go away by then. I was supposed to have a follow up with them but do not have insurance nor the money to go back.  I have not shaken the headache. It's a pressure in my head and mostly effects my left side. I have a constant high pitch noise in my head. Lights and loud noises can hurt. My brain literally feels damaged and I'm really scared and don't know what to do.
bi-lateral pneumonia; coughing blood; heart issue/Heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "bi-lateral pneumonia"; HAEMOPTYSIS (non-serious) with onset 2021, outcome "unknown", described as "coughing blood"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart issue/Heart inflammation". The events "bi-lateral pneumonia", "coughing blood" and "heart issue/heart inflammation" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: (2021) did not contract covid but heart was affected.  Clinical information: It was reported that it was also ruled out the possibility of having gene prone to a heart issue.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient states arm has red, splotchy areas below injection site that began today. Areas observed.  Red, splotchy areas noted to right arm. Patient to follow-up with regular MD.
Vertigo, BPPV  started during first night sleep and still ongoing Day 13 had routine mammogram and then ultrasound noted left axilla and left breast abnormality.  Rash on left upper arm appeared morning of day 14
Hypersensitivity reaction at the site (5-6cm asymmetric annual erythema with visible small bump from injection site)
Left thigh developed erythema and swelling but no tenderness beginning about 5 hours after the immunizations.
Swelling and redness at injection site, fever of 101.5, loss of appetite, aching muscles and joints, rash, better after two days but still have low grade fever of 99.5
elevated body temperature 101 deg, chills, body aches, upset stomach 5 hours symptoms and temp down w/800 mg Motrin
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Jan2021 as dose 1, single (Lot number: 029L20A), on 13Feb2021 as dose 2, single (Lot number: 030M20A), on 01Nov2021 as dose 3 (booster), single (Lot number: 032F21A) and on 02Jun2022 as dose 4 (booster), single (Lot number: 037A22B) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "HLD" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE oral; LEVOTHYROXINE oral; HYDROCHLOROTHIAZIDE oral; OLMESARTAN oral; ROSUVASTATIN oral. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: several negative tests. Therapeutic measures, Paxlovid from 06Dec2022 to 10Dec2022, were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
A vaccine dose was administered to a homebound patient. The dose was prepared and stored in a portable cooler with a data logger by the local Health Department. Paramedics administering the dose did not recognize the cooler temperature was below the temperature storage range of the vaccine. The vaccine was administered without adverse effects to the patient during the 30 minute period the patient was observed.
fire-engine red" rash at injection site; fire-engine red" rash at injection site; fire-engine red" rash at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site burning in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site burning, injection site erythema and injection site rash. On an unknown date, the outcome of the injection site burning, injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site burning, injection site erythema and injection site rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient reported fire-engine red rash at injection site after Shingrix administration. The patient informed that pharmacist advised them to pre medicate with ibuprofen before next Shingrix dose. The reporter consented to follow up.
Within 2 hours I experienced tenderness at injection site. At @4:00 am, 11 hours post injection, I experienced sore upper right arm, headache, and fatigue.
1st dose Sep2021, 2nd 06feb2023/LATE SECOND DOSE; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 73PP9, expiry date 30th May 2024) for prophylaxis.   Previously administered products included Shingrix (received the first dose in September 2021).   On 6th February 2023, the patient received the 2nd dose of Shingrix. On 6th February 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-Feb-2023 Reporter's Comments: The patient received the first dose but not at that pharmacy.  The patient lost insurance or something and visited to receive the second dose on the same day prior reporting. The reporter gave the permission to follow up. Additional Supportive Information: The patient had received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Shingles; Cannot find drug store/ doctor office who can supply second shot; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2019).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for 2nd dose.  The patient had Shingrix shot and cannot find drug store or doctor office who can supply second shot.
This spontaneous report was received from a pharmacist refers to a patient of unknown age (gender unspecified). On 01-OCT-2012, the patient was vaccinated with a dose of expired PNEUMOVAX 23 (lot #669579/0595AA, expiry 30-AUG-2012, route-not reported). No concomitant medications were reported. No adverse effect were reported. Additional information has been requested.
After adminstaration of vaccine, patient had sharp pain behind the eyes and patient claim to have swollen eyes lids. Paramedic came and took vitals signs and ekg.  Patient symptoms subsided. She state she was fine and she was release by the nurse.
Covid/flu symptoms within hours after vaccine and lasted 24 hours approx, seizure like episode Friday following, loss of feeling in right arm
Nurse placed a few drops of rotavirus vaccine in mouth and infant stopped breathing and became cyanotic - responded to stimulant with return of normal color & breathing. No further rotavirus vaccine given that day. Patient has history of prematurity (32 wk gestation).
Induration, erythema and wheal-8.5cm diameter centered on injection of DTaP site. (Actual induratio only approx. 5cm). Bandaid imprint visible in swelling so site confirmed. Not yet, but expected to recover.
lower back aches; pain radiates from her lower back down to her pelvis; pain radiates from her lower back down to her buttocks; feels like a needle is pricking her and her right deltoid area where she received the vaccine; body aches over her whole body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back aches), PELVIC PAIN (pain radiates from her lower back down to her pelvis), MUSCULOSKELETAL PAIN (pain radiates from her lower back down to her buttocks), VACCINATION SITE PARAESTHESIA (feels like a needle is pricking her and her right deltoid area where she received the vaccine) and MYALGIA (body aches over her whole body) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by reporter.  Concomitant products included VITAMINS NOS (MULTIPLE VITAMIN) for an unknown indication.   On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced BACK PAIN (lower back aches), PELVIC PAIN (pain radiates from her lower back down to her pelvis), MUSCULOSKELETAL PAIN (pain radiates from her lower back down to her buttocks), VACCINATION SITE PARAESTHESIA (feels like a needle is pricking her and her right deltoid area where she received the vaccine), MYALGIA (body aches over her whole body) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) on 05-Apr-2021 at an unspecified dose and frequency. At the time of the report, BACK PAIN (lower back aches) had not resolved and PELVIC PAIN (pain radiates from her lower back down to her pelvis), MUSCULOSKELETAL PAIN (pain radiates from her lower back down to her buttocks), VACCINATION SITE PARAESTHESIA (feels like a needle is pricking her and her right deltoid area where she received the vaccine), MYALGIA (body aches over her whole body) and PYREXIA (Fever) outcome was unknown.            Nature Made Women's Multivitamin Gummi was the concomitant medication reported by patient. Treatment information also included herbal tea only on 5-Apr-2021 Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-079229 (Patient Link).