chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 8/29/2022 Discharge Date: 9/9/2022  PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE:    90-year-old female with a history of paroxysmal atrial fibrillation on Coumadin, stage 2 chronic kidney disease, iron deficiency anemia, frequent falls of recent.  Patient states she has fallen multiple times in the last week, she attributes this to unsteady gait.  No loss of consciousness.  She presented to the emergency room today for evaluation after hitting her head.  On arrival she was mildly hypertensive, otherwise hemodynamically stable on room air oxygen.  Patient had a workup which included normal electrolytes with a BUN and creatinine of 24/1.1, white blood cell count normal at 7.85 hemoglobin 12.7.  Urinalysis showed greater than 180 white blood cells with positive leukocyte esterase and many bacteria.  She was also COVID-19 PCR positive.  Patient denies any respiratory complaints.  She denies any urinary complaints.  She states she has been eating and drinking okay, maybe not as much as usual.   Patient did have a CT cervical spine which demonstrated acute fractures of the inferior endplate of C6 and also nondisplaced fracture of C7.  The case was discussed with Trauma surgery/Orthopedic surgery and per ER they stated a Miami J collar is indicated, no recent to transfer downtown.   Patient patient also had a CT lumbar spine which showed no fracture but did demonstrate a new moderate right hydronephrosis and hydroureter, as well as a stable left hydronephrosis and hydroureter.   Patient currently has some mild discomfort in her neck at the fracture site per her report, she has however wearing a Miami J collar, and I did not removed for exam   When writer to cover case care management was looking for a rehab facility for patient and her husband was also admitted given that they are COVID positive.  During patient's admission she did well.  She did develop hematuria and required bladder irrigation which resolved.  Writer had several conversations with patient and her daughter regarding goals of care.  They did meet with palliative Care and will continue discussion as an outpatient.  We did discuss Coumadin and risk and benefits of stopping Coumadin and they were agreeable to stop Coumadin given patient's multiple falls resulting in significant injury as well as hematuria and anemia.  Patient was out of isolation and PT OT recommended home with home health.  On the day of discharge patient was stable and discharged in good condition.
24 hours following the booster dose of Moderna, I began to experience an urticarial rash that began over the medial aspect of proximal bilateral lower extremities. This was proceeded by petechial rash over the right lower extremity in the pattern of self-inflicted excoriations as the rash was quite pruritic. There have been daily occurrences of this rash over bilateral upper extremities, torso, and lower extremities since receiving the booster dose of the vaccine. The rash improves approximately 2 hrs. after taking 10 mg Cetirizine, but will return after 24 hrs. in various locations.
Two hours after receiving vaccine heavy vaginal bleeding occurred for several days.; heavy, unscheduled and severely prolonged periods; heavy, unscheduled and severely prolonged periods; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jun2021 (Lot number: EW0187) at the age of 28 years as dose 1, single and administered in arm left, administration date 19Jul2021 (Lot number: EW0187) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 28Jun2021, outcome "not recovered", described as "Two hours after receiving vaccine heavy vaginal bleeding occurred for several days."; HEAVY MENSTRUAL BLEEDING (medically significant), POLYMENORRHOEA (medically significant) all with onset 28Jun2021, outcome "not recovered" and all described as "heavy, unscheduled and severely prolonged periods". The events "two hours after receiving vaccine heavy vaginal bleeding occurred for several days.", "heavy, unscheduled and severely prolonged periods" and "heavy, unscheduled and severely prolonged periods" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of vaginal haemorrhage, heavy menstrual bleeding, polymenorrhoea. Clinical course: First dose of Pfizer vaccine lot #EW0187 on 28Jun2021. Two hours after receiving vaccine heavy vaginal bleeding occurred for several days. Her normal and scheduled menstrual cycle had already ended for the month on 13Jun2021. Since this first vaccine, she had heavy, unscheduled, and severely prolonged periods. Lasting up to 3 weeks at a time every single month since being vaccinated. Her physician has advised to monitor due to the vaccine being new and not all is known about what to expect long term in adverse reactions to the body.
When I received the vaccine I had only a mild response, a bit of soreness only, that went away in 24 hours. Then on day 7 post immunization I developed a reaction at the injection site.  There was a large (3 inch by 2 inch) raised reddish/pink area that was hard to the touch and warm.  It itched slightly.  It lasted 3 days and now it is starting to resolve.
her arm started to itch; arm started to itch was bright red; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (her arm started to itch), PYREXIA (low grade fever) and ERYTHEMA (arm started to itch was bright red) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043120A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (her arm started to itch), PYREXIA (low grade fever) and ERYTHEMA (arm started to itch was bright red). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (her arm started to itch), PYREXIA (low grade fever) and ERYTHEMA (arm started to itch was bright red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported by the reporter.
COVID-19; Dyspnoea; Hypoxia; This case was received via regulatory Authority (Reference number: 1490338) on 03-Aug-2021 and was forwarded to the company on 03-Aug-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), DYSPNOEA (Dyspnoea) and HYPOXIA (Hypoxia) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-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) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization) and HYPOXIA (Hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 19-Jul-2021 due to DYSPNOEA and HYPOXIA. At the time of the report, COVID-19 (COVID-19), DYSPNOEA (Dyspnoea) and HYPOXIA (Hypoxia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  The patient tested positive for COVID on 15-07-2021 after being exposed to family member(s) that were also positive. Patient went to the hospital on 19-07-2021 with symptoms of shortness of breath, hypoxia, and dyspnea.  Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable Company Comment  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events dyspnoea and hypoxia, a causal relationship cannot be excluded.  However, COVID-19 could be a contributory factor these events.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events dyspnoea and hypoxia, a causal relationship cannot be excluded.  However, COVID-19 could be a contributory factor these events.
HYPOTENSION 1/23/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a registered nurse concerning a 24 year old patient who on 11-NOV-2009 was vaccinated with the first dose of GARDASIL (LOT#0981Y). The registered nurse reported that on 13-NOV-2009, the patient had hives after the vaccination with GARDASIL. The patient sought medical attention by contacting with the office. It was unspecified if lab tests were performed. On an unspecified date, the patient had recovered. Follow up information has been received from the registered nurse regarding the 24 year old female patient with no known drug allergies who on 11-NOV-2009 was intramuscularly vaccinated in the right deltoid with the first dose of GARDASIL (LOT#0981Y) at 10:30 a.m. The registered nurse reported that two day after the vaccination with GARDAIL, on 13-NOV-2009, the patient developed hives. Oral steroid treatment was given to the patient and she was send to her primary care physician. At the time of the report, the patient's outcome was reported as unknown (previously reported as recovered). Additional information is not expected.
Redness noted on his right upper arm, warm to touch and measures 8cm (W) x 3cm (L). Skin is intact. No blistering, fluctuance. C/w location where PCV 13 was given in (R) deltoid. Afebrile, normal vital signs. Slight pain noted day 1 when reaction noted, none on day 2.
A non-serious spontaneous report of administration of FluMist to an 11-month old was received from a pharmacist. Relevant medical history and concomitant medications were not reported. On 27-Oct-2009, the patient received FluMist. There was no adverse event associated with this medication error, therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
Case received from a healthcare professional on 13 and 14-Sep-05 (MIS/VIS reference numbers # 05-0448 and 05-0452).  A 78-year-old female patient, with history of hypertension, polymyalgia and gastroesophageal reflux disease, had received an injection of DECAVAC (lot # U1586BA, on right gluteal region) on 24-Aug-05 and 2 days later, she presented with rash on whole body, uncontrolled itching and injection site tenderness.  She was seen in emergency room.  There was no fever.  It was reported that the vaccine was given with a 23 ga - 1" needle.  The patient did not recover.  Follow up information received on 17/Nov/2005.  As per responsible physician there is no additional information for this case.
pt was given dose of APAP & mom stated pt was going straight to daycare; daycare called mom stating pt crying persistently since dropped off-3 hrs of crying; temp reached 101;
On 8th I had a headache, it felt like a stabbing pain in my head. My eye was irritated and running on that side. My nose was runny and congested. This lasted about two hours and it stopped today and I was able to sleep. Doctor prescribe Sumatriptan nasal spray. I still haven't picked it up. I'm still taking the Amitriptyline at 20mgs daily from what was prescribed from dose 2.
PATIENT EXPERINCED IMMEDIATE SWELLING UNDER ARMPIT PATIENT REQUESTED IMMUNIZER TO FEEL FOR SWOLLEN NODULE AND IT WAS CONFIRMED. IMMUNIZER OFFERED TO TAKE PATIENT TO ER FOR TREATMENT HOWEVER PATIENT STATED SHE HAS EXPERICED THIS BEFORE AFTER A VACCINE AND WILL CONTACT HER PRIMARY PHYSCIAN FOR STERIODS.
her entire neck and ears are swollen after taking the covid-19 vaccine; her entire neck and ears are swollen after taking the covid-19 vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SWELLING (non-serious), EAR SWELLING (non-serious), outcome "unknown" and all described as "her entire neck and ears are swollen after taking the covid-19 vaccine".  Additional information: reporter said that she was advised to call to report if she experienced any side effects. Reporter mentioned that her entire neck and ears are swollen after taking the covid-19 vaccine.  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 registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent or historical condition was not provided. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L043620 with expiration date 02-NOV-2017, L049532 with expiration date 08-DEC-2017, M004329 with expiration date 26-JAN-2018, M009765 with expiration date 23-FEB-2018, L040421 with expiration date 15-OCT-2017, L045954 with expiration date 17-NOV-2017, M004328 with expiration date 26-JAN-2018, dose and route unknown). Concomitant therapy was not provided. There was no previous temperature excursion. The vaccine was stored under -12 celsius degree for 107 hours and 10 minutes. Data logger was not involved. No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery  due to rupturing.; Ruptured aneurysm with in 12 days of vaccine with no previous symptoms and patient deceased due to brain dead after the surgery  due to rupturing.; This is a spontaneous report from a contactable reporter consumer wife reporting on behalf of her 35-year-old husband (patient) received the second dose of BNT162B2 (lot number: ER 8731) at single dose for COVID-19 immunisation on 14Apr2021 at 05:15 PM. Relevant history included was unknown. Relevant concomitant drug was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   The patient previously received the first dose of BNT162B2 (lot number: ER 8727) at single dose for COVID-19 immunisation on 22Mar2021 at 04:45 PM.  The patient experienced ruptured aneurysm on 26Apr2021 at 09:00 PM, within 12 days of vaccine with no previous symptoms and patient deceased due to braindead after the surgery due to rupturing.  The event was assessed as serious due to Hospitalization (7 days), Life threatening illness (immediate risk of death from the event), Patient died on 30Apr2021 due to brian anuerysm. No autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Reported Cause(s) of Death: brain dead; Brian Anuerysm
The vaccine was given o 09/02/2022 @0900am.  An email was sent on 09/02/2022 @ 1016am advising staff that the monovalent vaccine should not be given per CDC guidelines as of 09/01/2022.  Patient made aware and will come back in 2 months for the bivalent vaccine. Provider is also aware and agreeable with the update
Gastrointestinal bleeding; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program COVAX US Support reported reporter's sister. A female patient of an unspecified age (reported as 77) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced gastrointestinal bleeding on 04Feb2021 with outcome of recovering.  The patient was hospitalized for gastrointestinal bleeding from 04Feb2021 to 09Feb2021. The patient received the 1st dose of the vaccine and is due for the 2nd dose on 18Feb2021. The patient was admitted in the hospital on 04Feb2021 for Gastrointestinal bleeding, was discharged on 09Feb2021 but was back in the ER on 10Feb2021. The patient was nearing recovery. The reporter denied that this was a side effect of the vaccine. The reporter was asking if it would be okay for her sister to take the 2nd dose as scheduled.   Information on the lot/ batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. There is no evidence or argument to suggest a causal relationship between the suspect vaccine BNT162B2 and the event gastrointestinal bleeding. The event is likely due to an underlying medical condition.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates, the patients were administered improperly stored dose of PNEUMOVAX 23 (lot # K020795, exp. 19-MAR-2015, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L023870 and expiration date 20-APR-2017, lot # L039141 and expiration date 16-AUG-2017, lot # M004883 and expiration date 02-OCT-2017, lot # M019707 and expiration date 25-OCT-2017, orally; exact doses were not reported). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Sore left shoulder (2 days), Headache (2 days), Nausea (Yesterday), Fever (2 days), Rash around neck and around site of vaccination (Today), Congestion (2 days). I have taken ibuprofen the past 2 days in order to help reduce shoulder pain, and fever.
Pain in arm at injection site for probably 2 weeks, post vax. Chest pain after booster injection and some joint pains.
not sure which covid vax mfg or lot number, but it was given on 10/27/2021, number 3
mildly pruritic, multi-focal to coalescing erythemic papules, arising intermittently on arms, chest, back, legs,  that started approxmiately 1 week after vaccine. There has not been an anaphylatic reactions have occured, no other enviromental changes have occured, other resident in house (who also received vaccine) has shown no symptoms
5 days after vaccination- loss of smell and taste, shortness of breath, sneezing, coughing, ear infections, fatigue, and headache.
nausea, diarrhea, rash, swelling at site, elevated temperature, headache, all after the first 8 hours of administration. At 48 hours, all have resolved except the rash.
Severe right shoulder pain with any abduction of the right arm. Treated with IM TORADOL and has started.
Patient had seizure like activity- Has seizure disorder meds were stopped 1-6-2021
Erythema, pruritis, induration approx 8" x 8" about 2-3 days p/TD inject;
Felt "funny" on the way home, lightheadedness, "red-velvety" rash over the entire body, eyes swollen, nares swollen, low-grade fever.
Malaise/fatigue, palpitations, nausea, low blood pressure, low temperature (35.6 C), shortness of breath, lightheadedness, leg pains, and numbness.
Information has been received from an 18 year old female consumer, for GARDASIL, a Pregnancy Registry product, who in 2009, was vaccinated IM with 0.5 ml the first dose of GARDASIL (Lot#: not reported). The consumer stated that approximately on 09-AUG-2010 "two weeks ago", she got the third dose of GARDASIL (Lot#: not reported), and approximately on 16-AUG-2010 "a week ago", she found out she was pregnant. Last menstrual period (LMP): approximately on 19-JUL-2010 "5 weeks ago". Estimated Date of Delivery (EDD): 25-APR-2011. On an unspecified date, the patient had performed a pregnancy test and the result was positive. Follow up information has been received indicating that in the beginning of October (on approximately 01-OCT-2010), the patient had a miscarriage. Upon internal review miscarriage was considered to be an other important medical event. No further information is available.