chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose: 15-JAN-2022; 2nd dose: 21-APR-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th January 2022).   On 21-APR-2023, the patient received the 2nd dose of Shingrix. On 21-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose: 15-JAN-2022; 2nd dose: 21-APR-2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 27-APR-2023 The reporter did not consent to follow up. For 1st dose of Shingrix, details were reported. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
After recreational activity in the morning and showering, I came home and around 130PM started to feel a bit light headed. This progressed to feeling dizzy, with mild nausea and headache. After about 15 minutes, I decided to lay down in my bed and I slept for about 2 hours.  I got up, but these feelings persisted. My pulse was normal with no fever, but my blood pressure was elevated.  (My normal BP is 120/70) These feeling persisted, with BP reading in the 140-150/85-90 range over the next few days. The associated feelings seemed to diminish over the course of 4 days, and the BP seemed to be dropping as well. I the medical doctor at the clinic (May 10th) just to make sure everything was OK, and my pressure there was 125/75 when tested. I subsequently felt better each day and by the 12th was pretty much back to normal.  There has been no subsequent sequela to this event.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013133: US-009507513-1701USA013134: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA010177: US-009507513-1701USA013138: US-009507513-1701USA013132: US-009507513-1701USA013135:
Watery, loose diarrhea 7-8 times per day, unexplained low grade fever.
Severe pain in right arm started about 2.5 hours after injection and lasted  approx. 28 hours.  I could not sleep.  (After shot#1, I had some minor shoulder soreness for 24 hours) Low fever (99.5) began approx. 18 hours after injection and lasted approx. 12 hours. Extremely tired day after shot.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fell out of chair #7 in pharmacy. This author caught patient and brought to floor. EMS called at 12:44. Nurse on site took patients BP 108/66. Could not get HR. EMS arrived at 12:52. EMS evaluated patient. Gave patient cold water. Patient declined hospital transfer. Patient was over 18 and EMS gave her paper that stated she declined hospital care. EMS left 12:57.
Swelling in arm at location of injection; red raised 8 inches x 5 inches swelling; painful in back of left arm in area where varicella vaccine was administered; experienced 'asthma' cough; throat was itchy; used inhaler to reduce symptoms, no interference with daily activities.
Pt lightheaded after receiving MENACTRA R D and GARDASIL L Deltoid. Pt became flushed and developed red flat blotches on face and neck which resolved approximately 15 minutes about 2 x 4 inch raised erythematous area developed at site of MENACTRA injection (R deltoid). BENADRYL given and BP's monitored. No difficulty with breathing. T=99.7 Rechecked=99.0 BP 104/50 (71).
Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine; Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine; abd pain; pancreatitis; pancreatic head mass; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 63 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 12Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "DM" (unspecified if ongoing); "h pylori active infection" (ongoing). The patient took concomitant medications (unspecified diabetes medication). Vaccination history included: Astra zeneca covid-19 vaccine (Dose 1), administration date: Aug2021, for COVID-19 immunization. It was unknown if prior to vaccination whether patient was diagnosed with COVID-19 and unknown if since the vaccination whether the patient been tested for COVID-19.   The following information was reported: OFF LABEL USE (hospitalization), INTERCHANGE OF VACCINE PRODUCTS (hospitalization) all with onset 12Sep2021, outcome "unknown" and all described as "Astra Zeneca covid vaccine in Aug2021; and on 12Sep2021 had the pfizer covid vaccine"; ABDOMINAL PAIN (hospitalization) with onset 12Sep2021, outcome "recovering", described as "abd pain"; PANCREATITIS (hospitalization) with onset 12Sep2021, outcome "recovering", described as "pancreatitis"; PANCREATIC MASS (hospitalization) with onset 12Sep2021, outcome "recovering", described as "pancreatic head mass". The events "abd pain", "pancreatitis" and "pancreatic head mass" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: biopsy stomach: h pylori; computerised tomogram: pancreatitis with pancreatic head mass 3.6 x 3.6; decrease in size; magnetic resonance imaging: pancreatitis with pancreatic head mass 3.6 x 3.6; decrease in size. Therapeutic measures were taken as a result of pancreatitis. The physician reported that on 12Sep2021, patient had the Pfizer covid vaccine. The next day developed abd pain, was admitted to the hospital and found to have pancreatitis with a pancreatic head mass 3.6 x 3.6 cm on CT/MRI; follow-up (f/u) CT/MRI showed a decrease in size. An esophagogastroduodenoscopy (EGD) endoscopic ultrasound (EUS) was performed with fine needle biopsy of pancreatic mass, results were consistent with pancreatitis. Also found to have H. pylori on gastirc biopsy (bx).  The lot number for vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient, unrelated to BNT162B2.
patient came 9/19 to report symptoms after receiving 3rd dose of Pfizer. Symptoms: aching joints, chills, fever 101 for 3 days, low grade fever 2 days (99),  Per pt, after symptoms gone (5 days), cant breathe without coughing and acting lungs.
Pt. called - pain, redness, & swelling used ice & rested it. Better when called to followup - 10/30/11.
Vet states left shoulder swollen twice the normal size and warm to touch. 5 y/o male veteran into clinic reports recieved a Pneumonia shot yesterday in right upper arm has pain, redness and swelling start last night w/i 2-3 hours after shot, which has progressively worsened. Used ice last night and took a Tylenol PM prior to bed time which helped. Denies SOB, swelling of tongue.
Patient developed a generalized maculopapular rash starting on the trunk spreading to the face and arms with itching noted. No respiratory involvement noted. Patient did not appear ill. Good activity level and appetite.
Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Severe, Additional Details: Patient experienced seizure. Called 911 and paramedics treated. Patient advised to see primary dr for seizures. she states she had hx of seizures w/o treatment at this time.
Information was received from a medical assistant and an office manager, referring to an unspecified number of patients of unknown age and gender. The patients' current condition, concomitant medication and medical history were not provided. On unspecified dates between 23-JAN-2017 and 21-FEB-2017, the patients received unspecified doses of improperly stored VARIVAX (concentration, frequency and route were unknown; lot # M035142 with expiration date 03-AUG-2018 and lot# M039317 with expiration date 20-SEP-2018, respectively) for prophylaxis. No adverse effects were reported. VARIVAX was stored between 5 Fahrenheit degree (F) and 14 F for 18 hour 40 minutes, and between 14 F and 46 F for 4 hour 30 minutes. There was no previous temperature excursion, and the data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1702USA012230:
Patient was responsive for the first six minutes of 15 minute waiting period. Patient became unresponsive and tremoring. She did not respond to stimulation.  EMS was called promptly. Blood pressure was taken every 5 minutes and was elevated as well us pulse.
Blisters on ankles,treated at hospital.emergency room for cellulitis,then numbness in legs which travelled up my body including face and lips,nausea and lack of balance,bladder problems and eyesight deterioration.
Received the 2nd dose of the Pfizer vaccine; Pain in the arm of the injection ( right arm); chills that night; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the 2nd dose of the Pfizer vaccine), MYALGIA (Pain in the arm of the injection ( right arm)) and CHILLS (chills that night) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced MYALGIA (Pain in the arm of the injection ( right arm)) and CHILLS (chills that night). On 16-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received the 2nd dose of the Pfizer vaccine). On 19-Mar-2021, MYALGIA (Pain in the arm of the injection ( right arm)) and CHILLS (chills that night) outcome was unknown. At the time of the report, WRONG PRODUCT ADMINISTERED (Received the 2nd dose of the Pfizer vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment information not provided. THERE IS NO LAB DATA PROVIDED Events :his blood pressure levels Action taken with mRNA-1273 in response to the events was not applicable.
pt recv vax; mom stated pt was acting strange, was pale & shaky; fever of 101.2;pt looks ok now;
Breakthrough case admission after three vaccines Moderna 1/20/21 Lot# 80777027399;  Moderna 2/18/21 Lot# 011M20A;  Moderna 11/22/21 Lot# 012H21B
Left arm was red, itching after 7 days   around injection site. ( lasted 4 days.)   After 11 days top and bottom lips on inside of lips got fiver blisters. fiver blisters were still there after 3 weeks.
p/vax pt became feb to 102;48 hr p/receiving vax arm began w/swelling & redness from wrist to neck;swelling was marked;
Patient had a seizure 3 minutes after having the Flu -mist. We were still in the doctors office.
A non-serious spontaneous report of temperature, fatigue, cough and runny nose has been received from a consumer concerning a 22-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Sep-2011. On 29-Sep-2011, the patient experienced temperature, fatigue, cough and runny nose, where coughing went to chest. Rest of the family also have similar symptoms. The outcome of events of temperature, fatigue, cough and runny nose was resolved.
Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, after received the GARDASIL, the patient fainted, fell and broke her jaw. It was unspecified if the patient sought medical attention and if lab tests were performed. At the time of the report, the patient's outcome was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several cases reported by the same source. Additional information has been requested.
Information has been received from a physician concerning an 8 month old previously healthy female without medical history or concurrent conditions who in approximately June 2002 was vaccinated with the second dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant. It was reported that the pt received the first dose of vaccine in approximately April 2002, respectively. In August 2002, the pt was vaccinated with a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. In October 2002, the pt developed HIB type 1 meningitis and was hospitalized. The physician reported that the pt had also developed syndrome of inappropriate ADH (STADH), and was being treated (unspecified) for that, as well as a 10 day course of antibiotics (unspecified). At the time of this report, CSF specimens were being analyzed, and the pt's HIB type 1 meningitis and SIADH persisted. The reporter considered the pt's HIB type 1 meningitis to be a disabling event. Upon internal review, it has been determined that the pt's SIADH was considered to be an other important medical event. Additional info has been requested.
One day after patient had this vaccine, he got a red bump on his right cheek. Weeks later he started getting skin rashes.
Moderna COVID-19 VaccineEUA Jan 17: 24 hrs after injection, symptoms included: slight headache, nausea, slight chest tightness.   Jan 18:  Chest tightness remains and needed inhaler Jan 19 :  chest tightness worse and needed nebulizer with Albuterol Sulfate. Jan. 20:  same symptoms.  Airways feel inflamed. I have intermittent flare up of ?reactive airways,? with the last one October 2020.
Mom reports that she thinks child was running low grade fever later on that night on the same day as shots but she is unsure because never took temp but reports child felt warm to touch. Mom reports the morning after childs shot at 08:30 AM she noticied a spot on childs leg then noticed them starting to spread all over her body.  Reports that they were hives. Reports she gave Benadryl. Reports it was worse on arms and legs but was also on childs back, stomach, and face. Reports it took about 45 mins for them to spread. Mom reports that they were completely gone about a hour later. Mom didn't take child to be seen anywhere and reports that she is fine now. Mom just reported this information to me today.
COVID-19; Dose 2 30-APR-2021,  booster dose 01-AUG-2021; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 30-APR-2021,  booster dose 01-AUG-2021) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 30-APR-2021,  booster dose 01-AUG-2021). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 30-APR-2021,  booster dose 01-AUG-2021) outcome was unknown.            Concomitant product use was not provided by the reporter.  The third dose received on 01-Aug-2021 was reported as booster dose.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a 30-year-old female patient with no relevant medical reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred on an unknown date after the third dose of mRNA-1273 in covid-19 vaccination series. Inappropriate schedule of product administration is also noted in this case. No further details on clinical course, other lab test results and treatment received were reported. The outcome of event COVID-19 was reported as resolving. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 30-year-old female patient with no relevant medical reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred on an unknown date after the third dose of mRNA-1273 in covid-19 vaccination series. Inappropriate schedule of product administration is also noted in this case. No further details on clinical course, other lab test results and treatment received were reported. The outcome of event COVID-19 was reported as resolving. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
he had flu like symptoms; Sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 62-year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "renal cell cancer" (unspecified if ongoing), notes: Taking Sutent From 21Aug2020 to current; "covid-19 pneumonia", start date: 07Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "he had flu like symptoms"; PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Sore arm".  Additional information: Patient continues to be on previously reported therapy hold since 07Dec2020 due to having Covid pneumonia. Patient states he is doing better but MD told him to not restart sutent (Pfizer) 50 mg once a day by mouth until a week after he got vaccinated for covid. Patient was taking sutent from 21Aug2020 to current for renal cell cancer. Patient states he got his first vaccine on 08Mar2021 and said he had flu like symptoms and sore arm afterwards. Unknown if MD is aware. No adverse effects from therapy hold reported. Patient states that the last time he was on sutent he had sensitive tongue. Unknown if MD is aware. No other information provided by reporter. Patient cycle is 4 weeks on and 2 weeks off.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Piercing headaches; swollen gums; rash on roof of mouth; aching pain behind ears.
received Kinrix prior to 4 years of age.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th December 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th December 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The reporter stated that, the patient received Kinrix prior to the recommended 4 years of age, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This case is linked with US2022027794 and US2022004256, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022027794:Same reporter US-GLAXOSMITHKLINE-US2022004256:Same reporter
patient called a month later to complain that her arm was still sore and she could hardly lift it.  no treatment has been sought as of yet.
more sore this time compared to that after the 1st dose; body aches all over which lasted for 24 hours; Fever; her arm swelled (injection site)/her arm is still swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (more sore this time compared to that after the 1st dose), MYALGIA (body aches all over which lasted for 24 hours), PYREXIA (Fever) and VACCINATION SITE SWELLING (her arm swelled (injection site)/her arm is still swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 056A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (more sore this time compared to that after the 1st dose), MYALGIA (body aches all over which lasted for 24 hours), PYREXIA (Fever) and VACCINATION SITE SWELLING (her arm swelled (injection site)/her arm is still swollen). On 20-Mar-2021, MYALGIA (body aches all over which lasted for 24 hours) and PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (more sore this time compared to that after the 1st dose) outcome was unknown and VACCINATION SITE SWELLING (her arm swelled (injection site)/her arm is still swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 100.8 (High) Fever of 100.8 F.         No concomitant medications were provided. Treatment information included the application of mixture of baking soda with water.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-significant follow-up