chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash all over their body; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's comment: The nurse reported that the patient received a dose of Shingrix and got a rash all over body. The reporter was unsure if either was reported so reporting since it was unknown. The reporter stated that he gave a lot of Shingrix and these were the only two times he had this reaction. The reporter did not agrees to follow up from GlaxoSmithKline. Additional Supportive Information: This case had been linked with US2022AMR159095, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR159095:Same reporter
dizzy headache 5am 10/4/11 called private doctor took tylenol and dramamine as ordered felt better that afternoon
Patient is a 73 y.o. female patient of MD with a history of PMR on chronic prednisone, paroxysmal atrial fibrillation on Eliquis, postmenopausal bleeding s/p surgical hysteroscopy, endometrial ablation/IUD insertion 8/17/23, T2DM, GERD, Urinary Incontinence who presented to Hospital 9/13/2023 with generalized weakness, and two weeks of URI symptoms. She was found to be positive for COVID (9/14/23). Was transferred to the ICU with impending respiratory failure, she was intubated on 9/17/23.Found to have GBS, neurology and PMR followed. IVIG treatment began. Palliative care followed and ultimately with further decline was transitioned to comfort care and compassionately extubated 9/26/23.  Acute Hypoxic Respiratory Failure -Suspected due to aggressive Guillain Barre progression  -Intubated 9/17 due to impending airway compromise -CTPA 9/17: No evidence of PE. Mild GGO, evidence of PAH, decreased Cardiac Output.  -Patient will likely require tracheostomy de to AIDP/GBS prognosis if aggressive care is desired -Methylprednisolone 40 mg x 10 days (EOT 9/27/23) for Covid hypoxemia -Acute change in mental status, not responding to pain. CT head on 9/24 with no acute intracranial process.  -Compassionately extubated 9/26/23 and passed.    Guillain Barre Syndrome -Suspected due to Covid, bloody diarrhea (Possible C. Jejuni) -Ganglioside Monosialic Antibody panel was lipemic. Second Panel still pending. -PMR completed NCS/EMG highly consistent with AIDP (Guillain-Barre Syndrome) concerned will need trach and LTAC placement when medically ready in addition to PEG.  -Neurology consulted for further evaluation, appreciate recommendations. Started IVIG, rate decreased due to suspected hypersensitivity reaction. No further need for LP. -Gabapentin 300 mg TID for neuropathic pain. Continue oxy Q4 with break through diluadid. -IVIG 0.4 gm/kg x 5 days. Premedicated with benadryl and tylenol, slowed rate and response well. -GOC per above.   Quadriparesis Respiratory Weakness -Suspect Secondary to GBS. With PRM, much less likely to be other etiology -Myasthenia Gravis panel pending, Myositits Myo Marker Panel pending  -MRI (9/14/23) and CT Head (9/14/23) Negative for acute infarct or acute intracranial process. Further imaging as above. -CK, ANA, DS-DNA, ENA, P-ANCA all WNL. -MRI Pan scan 9/18 primarily unremarkable -Management as above.   Takotsubo Cardiomyopathy HFrEF -Likely secondary to GBS. Possibly secondary to Covid 19. -TTE (9/18/23) showing apical hypokinesis and LVEF of 28%, no noted LVOT   Covid 19 Infection  -Positive PCR (9/14/23), reportedly experiencing upper respiratory illness for 2x weeks prior to admission -Urine Culture growing GBS (9/13/23) -CXR (9/17/23) with no active disease -Bcx, Sputum Culture NGTD -Isolation removed (9/20/23)    Sinus Tachycardia -Likely in the setting of cardiac arrhythmia's due to GBS, pain  -EKG (9/17/23) NSR, non acute. Patient prior to intubation with no chest pain. -ECHO as above. EKG (9/20/23) Non acute
On 2/9/22 I received the booster and immediately felt dizziness, nausea, and shortness of breath. I rested and developed a fever in the middle of the night. When I awoke on 2/10/22 I had a bright red welt on my body. As the day progressed I developed more. In the middle of the night I began having extreme itching and more spots developed. I went to my doctor on 2/11/22 and was put on steriods.
Case number PHEH2014US020799 is an initial spontaneous report received from a health care professional on 13 Oct 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1411501) intramuscularly at a dose of 0.5 ml on unspecified date. It was reported that the patient felt light headed. The outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. No additional details available.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). Certified medical assistant reported that both vaccines were exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reports. Follow-up received. Certified medical assistant stated other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 17 years old, female patient with no pertinent medical history reported. On 21-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 20-FEB-2013 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
wrong reconsttitution; Headache; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Rabies NVS (RabAvert) for prophylaxis.    On an unknown date, the patient received RabAvert at an unknown dose. On an unknown date, unknown after receiving RabAvert, the patient experienced drug administration error. On an unknown date, the outcome of the drug administration error was unknown.  Additional details were received as follows: The age at vaccination was not reported. Caller states he the patient received pre exposure vaccine and had been reactivated or not effective because it was not given immediately after reconstitution. He states it was given about 10 minutes after reconstitution. This led to drug administration error. He was referred to his physician. HCP not asked.  AE report filed after call ended, as caller concerned about reactivation of vaccine.   Follow up information received from consumer on 25st October 2019 as follows: On 19th October 2019, the patient received the 1st dose of RabAvert (intramuscular) 1 ml with batch number ARBA171A, expiry date 31st July 2022 in right arm.  In October 2019, less than a week after receiving RabAvert, the patient experienced headache and dizziness.  In October 2019, the outcome of the headache and dizziness were resolved.  It was unknown if the reporter considered the headache and dizziness to be related to RabAvert.
This initial spontaneous case, was received on 07-Dec-2017 from a pharmacist, concerns a female patient of unspecified age. On unspecified date, the patient administered with FLUCELVAX QIV (dose, anatomical location, route of administration, batch number, expiry date: not reported). On unspecified date, the breast-feeding patient might have received a flu vaccine. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious.
This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (Slept for 17 hours and felt fine), BACK PAIN (Lower body ache in his lower back.), VACCINATION SITE PAIN (Sore left arm) and CHILLS (Within 24 hours patient felt severe chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HYPERSOMNIA (Slept for 17 hours and felt fine), BACK PAIN (Lower body ache in his lower back.) and CHILLS (Within 24 hours patient felt severe chills). In February 2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). In February 2021, HYPERSOMNIA (Slept for 17 hours and felt fine), BACK PAIN (Lower body ache in his lower back.) and CHILLS (Within 24 hours patient felt severe chills) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company comment: This case concerns a 61-year-old male patient with no medical history provided who experienced non-serious unexpected events of Hypersomnia and Back pain and non-serious expected events of Chills and Vaccination site pain. The events Hypersomnia, Back pain and Chills occurred on the same day after the second dose of mRNA-1273. The precise temporal relationship for the event Vaccination site pain cannot be determined, having in mind that the exact start date of the reported event was not provided. At the time of the report, outcome of the event Vaccination site pain was unknown whereas all the other events resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-455204 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Non significant Follow-up received. Sender's Comments: This case concerns a 61-year-old male patient with no medical history provided who experienced non-serious unexpected events of Hypersomnia and Back pain and non-serious expected events of Chills and Vaccination site pain. The events Hypersomnia, Back pain and Chills occurred on the same day after the second dose of mRNA-1273. The precise temporal relationship for the event Vaccination site pain cannot be determined, having in mind that the exact start date of the reported event was not provided. At the time of the report, outcome of the event Vaccination site pain was unknown whereas all the other events resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The patient was set to receive the second dose on 1/26/21 and received it early on 1/20/21. The patient reported headaches, body aches, and fever off and on ranging from 100 to 102. These symptoms lasted for approximately 24 hours post-vaccination.
**Moderna was booster, previous had Pfizer for 2 previous vaccines. Severe supraclavicular node inflammed on left side.  smaller nodes very tender around L-shoulder and running to occipital nodes.  First day pretty much immobile and unable to move head sideways or neck.  Very uncomfortable.  Day two inflammed nodes remain but starting to be able to move neck slightly.  Pain running down back of neck off and on.
pt exp vomiting, a sl fever of 24 hrs duration, & a rash on body p/recvd dose 1 of Engerix-B; MD decided not to administered rest of doses; MD thinks it may be an allergic type med response;
Sore hard lump at the site of the injection lasting for 12 days after the injection.  Extreme/severe full body tremors -30 minutes, 3 times during that day, two and a half weeks after the injection.
03/15/2021 - dizziness and nausea for 60 hours.  The nausea subsided but not the dizziness Sent to ENT: no issue with ears -- Referred to Neurologist for vestibular issues.  Diagnosis:  Unilateral Peripheral Vestibular Hypofunction---- treatment is physical therapy.  I accomplished all the exercises but the dizzy sensation remains.  No further testing has been done.
the anxiety from the 1st dose; This case was reported by a consumer via call center representative and described the occurrence of anxiety in a 36-year-old male patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received the 1st dose of RabAvert. On an unknown date, less than a year after receiving RabAvert, the patient experienced anxiety. On an unknown date, the outcome of the anxiety was not recovered/not resolved.   It was unknown if the reporter considered the anxiety to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Rabavert for post-exposure prophylaxis. The patient experienced some anxiety prior to receiving the RabAvert vaccine and since the administration of it, the anxiety had become worse, which led to anxiety aggravated. The reporter consented to follow-up. For tolerance after 2nd dose, refer case US2020187878.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187878:2nd dose
took the shot still got shingles/suspected vaccination failure; Eternal shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shot still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Eternal shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAR-2023 The case was received from the patient via interactive digital media. The patient took the Shingles shot and still got the shingles 4 years later and he/she had eternal shingles now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Large rash around site of injection, appearing 7 days post-injunction.  Itches, and warm to touch.
My left leg started hurting from knee down, pressure and painful, I had problem walking. I went to the doctor because the situation progressed very rapidly, in a matter of weeks, it went worst. The doctor said I had to remove my leg vein on my left leg and they did that three weeks ago. One week later and doctor checked for any clots and said everything looks good that it takes time to heal.
12 hrs p/shot complete shaking, severe flexion spasm-t102, nausea, perspiration; went beyond severe shaking as result of chills; 2AM temp nl-presently has severe h/a, generalized aching-backache-fatigue;
Patient marked that she had never received a dose of Covid vaccine previously. Monovalent dose was given per protocol. Upon further investigation, patient had previously received the primary series of Moderna vaccine dating 2/16/2021 and 3/16/2021. We have gotten direction from our medical director that the patient had to wait a minimum of two weeks before coming back in and getting the bivalent booster that she needs.
later in day extreme headache leg pain nauseous throwing up bile was on couch for 3 days headaches lasted for 2 and a half days throwing up 3 days leg pain first day third day extreme stomach and back pain. still 5 days later still have nausea slight headache and stomach pain
On 11/27,  17 days after my Moderna booster, I developed acute urticaria and dermatographia. The urticaria was mild, migratory, and recurred daily and throughout the day (though worse at night).  By 12/13 symptoms were improving to one break out a day. Self treating with cetirizine. Still not completely resolved
Information has been received from a medical assistant(also reported as office manager) referring to a 13 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 25-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 07-MAR-2014, the patient was vaccinated with second dose of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Duplicate vaccine administered. Booster dose administered on 6/4/2022 and discovered after 4th dose administered on 9/13/2022
compression fracture; she had back injury; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient medical history was not reported. Concomitant medications were not reported.  On an unknown date, after taking the first dose, the patient experienced back injury and compression fracture. Therapeutic measures were taken as a result of the events and included cyclobenzaprine hydrochloride (FLEXERIL), a muscle relaxer. The patient was originally scheduled for the 2nd dose on 15Apr2021 but was rescheduled on 29Apr2021 because of the injury, and the patient asked if it is okay to take the vaccine when taking Flexeril. The clinical outcome of the events back injury and compression fracture was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
No additional AEs/no PQCs; HCP called in and reported that the improperly stored vaccine was administered on 09/12/2022.; 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, concomitant medications and previous drug reactions or allergies were not reported.   On 12-SEP-2022, the patient was vaccinated with a improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection (lot number W019624 was verified to be a valid number, expiration date reported and established as 19-DEC-2023) (dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis, that underwent a temperature excursion of -10 Celsius degrees up to 8 Celsius degrees (-4 Celsius) for 2 hours and 30 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported.
60 day follow up information states deafness - moderate, severe loss, and PDD. The annual follow up received on 12/5/03 states pt has a moderate/severe sensorineural hearing loss.