chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 91 y.o. female patient of MD with history of hypertension, hyperlipidemia, ovarian cancer presented to Doctors Hospital with generalized body aches, chills, cough.   Covid-19 virus infection - Improved  Date of onset of symptoms: 11/06 Symptoms present on admission: Yes Date of covid positive test: 11/08 per patient at her Doctor's office.  Unable to view results. Vaccination status: vaccinated Imaging: CTPA: No evidence of PE.  Linear bibasilar opacities are most consistent with atelectasis.  Superimposed infection is not entirely excluded in the appropriate clinical setting. Cardiomegaly without pulmonary edema.  And age-indeterminate compression deformity of T8 5 vertebral body which is new in comparison to February 2019 CT. Oxygen requirements on admission: 2 L nasal cannula Current oxygen requirements: RA  Medical therapy: remdesivir and steroids Consultants following: None Anticipated special isolation end date: 11/18  antitussives, IS   Out of Special isolation    Back pain Compression fracture T5 Today, patient complains of both upper and lower back pain Received IV Toradol as patient does have multiple medication allergies Lidocaine patch added Added ultram  Continues to have pain  MRI thoracic spine Acute compression fracture at T5 with 75% loss of vertebral body height.  Vertebral body height loss at this level is worse than on the CT of the chest from 11/13/2022. mild retropulsion of the posterior aspect of T5 into the canal with mild effacement of the thecal sac.  No significant spinal stenosis.  No compression of the thoracic spinal cord. Neurosurgery consulted - recommended CTO brace and f/u outpatient in 2 weeks   Hyponatremia  Euvolemic 127-- >129-- >130->130-- >128 S/b Nephrology, suspected SIADH physiology  Recommended 1.5 L fluid restriction  Patient to have repeat BMP in 1 week with PCP  Hypertension Resume amlodipine as per home regimen. Low blood pressure this morning after receiving hydralazine.  Dropped blood pressure in the 70s received fluid boluses much improved Continue to monitor   Hyperlipidemia Resume statin    Hypokalemia K replaced Monitor   Elevated troponin Chest pain  Troponin 17-- >18 Patient denies any chest pain.  She has bilateral rib pain with coughing. EKG: Sinus rhythm with nonspecific ST-T changes. EKG shows Left anterior fasicular block seen on previous EKG  Troponin 22-- >21  Pain likely musculoskeletal    Elevated BNP NT proBNP 696 She appears euvolemic on exam Monitor   Constipation Continue MiraLAX and senna/docusate added home milk of mag Monitor
In the same evening after she received Td, she developed generalized skin itching. She was taken to the ER. She was given Benadryl PO and observed for 45 min. She took another Benadryl dose the next day. She was ok after that. There were no rash.
Pt received HPV on 1-20-15 at 6 pm RA. Pt c/o neck pain on (R) side of neck.
approximately 3-5 minutes after receiving dose, client states he felt a surge of warmth rush over him. Client loss consciousness and fell out of his chair. Client was laying prone with both arms down by his sides. Assume client hit his head when he fell. After approximately 10-20 seconds, client awoke, confused as to what happened, but oriented to person, place, and time. Client remains pale and diaphoretic. Client sat for 3-5 on the floor, recovering, then moved client to a wheelchair to escort him to the medical eval area. Upon transport to eval area, client stated he felt it happening again. He then fell unconscious again, with is head falling forward, client panic. Started to seize with body going stiff and sliding out of wheelchair. 4 staff assisted client safely to the floor, placing a blanket under his head. Approximately 10 seconds of so activity and client awoke again confused as to what happened, but oriented to person and place. Client had bladder inconvenience. 911 called at 1854. BP 130/84, stats 97%, HR 70 s, breathing non labored, 16-20 breaths per minute. Report given to EMTs. After 10 minutes client moved to chair. Vitals remain stable. After 20 minutes client stood up and walked around. Taking water and crackers. Color is better. Client refused ambulance to the ER. Called his friend, an RN, who will take him home. Client encouraged to stay with a friend if he chooses not to go to the ER. Also encouraged client to talk to his provider before receiving his 2nd dose.
p/MMR vax given pt put on coat & waited for mom then stated felt dizzy & fainted; Pt was laid on floor, jacket was removed & pt regained consciousness even a/jacket was completely removed;
very painful area that follows the nerve line from the centerline of the back to the right, over the upper part of the shoulder blade and today it started going down the fore arm; feeling bad; pain is severe; feel pretty awful; chills; nausea; This spontaneous case was reported by a physician and describes the occurrence of NEURALGIA (very painful area that follows the nerve line from the centerline of the back to the right, over the upper part of the shoulder blade and today it started going down the fore arm), FEELING ABNORMAL (feeling bad), PAIN (pain is severe), FEELING ABNORMAL (feel pretty awful) and CHILLS (chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myofascial pain syndrome.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced NEURALGIA (very painful area that follows the nerve line from the centerline of the back to the right, over the upper part of the shoulder blade and today it started going down the fore arm), FEELING ABNORMAL (feeling bad), PAIN (pain is severe), FEELING ABNORMAL (feel pretty awful), CHILLS (chills) and NAUSEA (nausea). At the time of the report, NEURALGIA (very painful area that follows the nerve line from the centerline of the back to the right, over the upper part of the shoulder blade and today it started going down the fore arm), FEELING ABNORMAL (feeling bad), PAIN (pain is severe), FEELING ABNORMAL (feel pretty awful), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
First of all my arm was black and blue. And my arm hurt for a good 2 week and I could barely lift it. My whole arm broke out in a rash and the rash spread across my chest and across my back. It last a couple weeks. My Dr. gave me some cream and told me I was allergic to the shot. I was also so tired. I slept 12 hours over a weekend.
Suspected vaccination failure; Respiratory syncytial virus infection; Upper respiratory symptom; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection) and upper respiratory symptom (Verbatim: Upper respiratory symptom). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection and upper respiratory symptom were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and upper respiratory symptom to be related to RSV vaccine.   It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection and upper respiratory symptom to be related to RSV vaccine.   Additional Information: GSK Receipt Date- 07-NOV-2023 The patient age was over 60. The reporter reported that the patient got a RSV vaccine, the brand of vaccine was unconfirmed.  The patient got adult RSV within a few days of reporting he got the RSV vaccine.  The patient was confirmed to had RSV (Respiratory syncytial virus infection) by PCR test.  The reporter reported that the patient had a upper respiratory symptoms but did not report lower respiratory symptoms. The reporter would inquire of the pharmacy where he was vaccinated which brand of RSV vaccine he received. This case was considered as suspected vaccination failure as details regarding time to onset confirming respiratory syncytial virus infection were unknown at the time of reporting. This case had been linked to US2023AMR155714, reported by the same reporter, for a different patient. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2023AMR155714:Patient 2
I woke up the day after receiving my booster with what I thought was pink eye and therefore tried to "let it run its course". My left eye was watery, pink, some pain, and very sensitive to light; so much so that it would give me a headache. The light sensitivity was not as severe after a few days but my eye was still pink. After a little over 2 weeks (19 days) and my eye was not getting better, I decided to go into urgent care. The PA at the Physicians Care Unit there diagnosed me with: 1. ocular pain, left eye and 2. unspecified acute and subacute iridocyclitis. He prescribed me with oral prednisone for 6 days and polytrim eye drops for 7 days. My eye did get better while on the treatment but my eye pain and light sensitivity returned shortly after finishing the treatment. I went in to Vision clinic and saw Dr. on 2/17/22 where he diagnosed me with primary iridocyclitis, left eye. He provided a script for 2 eye drops: Cyclopentolate Hydrochloride Ophthalmic Solution and Prednisolone Acetate Ophthalmic Suspension. I am still currently using the Prednisolone Acetate twice a day. My eye feels so much better but I still experience slight pain from time to time.
Patient received 1st dose on 9/24/21 and reported a sore arm afterward but then awoke 9/27 to AICD firing and fired multiple times enroute to ED and in the hospital. Found to have multiple electrolyte abnormalities (K 3.1, Mag < 0.5); placed on amiodarone and lidocaine drips, started mexilitine 200mg q12. Single chamber AICD upgraded to dual chamber AICD on 10/4/21. Recurrent VTach on 10/8/21 - multiple AICD defibs - paced out and started again on amiodarone and lidocaine. Continue issue - required intubation and sedation on 10/8 due to on-going runs of Vtach and AICD defibrillations. Note - hospital course has now been further complicated by new LLE DVT and B-PEs on 10/9. Unclear if also associated with vaccine or a product of hospitalization / arrhythmia.
Patient received flu and shingle shot. At injection site for shingles shot developed red hot spot. patient put ice on it. Today also has spot further down arm. Patient started developing rash on torso around waist moving to breast area.
Conceived within days of the vaccine and had a molar pregnancy. Prior to this I have had 5 normal, uncomplicated pregnancies.
14 days after receiving injection there is still a large circle of redness which is hot, swelling and itching.
itchy rash on neck, trunk, feet, thighs  appeared about 60 hours after covid vaccine
patient complained of a red, raised hard circular lump at injection site. she states her arm is sore from shoulder to elbow.  she went to doctor on 9/20/2021 and he said it was alright and to apply cool or warm compresses and it would heal over time.  she stopped into the pharmacy and showed her arm and the redness was gone at that time.  we will follow up with her thursday 9/23/2021
Received TRUMENBA 6/14/17 - welt around area on L upper arm on 6/15 - drew a circle around it then extended and 2 other red spots appeared. Became hot to touch, painful and pt had low grade temp.
pt admit to hospital w/ incidental finding of covid19.. tested positive 12/27/21 s/p 2 doses of Pfizer on 2/18/21 & 3/11/21
Information has been received from an RN concerning a 26 year old Caucasian female with no past medical history who "many years ago probably as a child" was vaccinated with a dose of MMRII. On 8/16/01, the pt had a negative rubella titer IgG AB. The pt sought unspecified medical attention. Follow-up information reported that the pt on 8/27/01, received a 3rd dose of MMR (638832/1874K) in the right arm. No further information is expected.
redness, after a min, around left shoulder to anterior axillary line pt seen in urgent care and then diagnosed
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable physician. A 26-month-old patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration, on 28Jan2019, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. One week after vaccination, in Feb2019, the patient experienced seizure like activities such as jerky movements and eye switching, diarrhea, swelling of the arm. Outcome of the events was unknown. Sender's Comments: Considering a plausible drug-event temporal association and the consistency of the event with the known safety profile of the suspect product, a reasonable possibility that seizure like activities such as jerky movements and eye switching are related to PREVNAR 13 administration cannot be excluded.
COVID Breakthrough Case  Pfizer Dose 1 1/18/21 (lot not listed in database) Pfizer Dose 2 2/8/21 (lot not listed in database) COVID Positive 9/12/21 (approximately)  9/19/21: Patient is a 83 year old elderly female from a facility who was brought to ED via EMS for a progressively worsening cough. She has a past medical history of asthma, atrial fibrillation not on anticoagulation, CKD stage 3, diastolic heart failure LVEF 67%, COPD, hypertension, hyperlipidemia, mitral regurgitation, pulmonary hypertension and dementia. Patient is a poor historian and history was obtained per chart review and from ER staff. Per chart review patient was diagnosed with Covid-19 approximately a week ago. She has had increased shortness of breath, cough, vomiting and diarrhea.  On arrival to ED patient was febrile 99.2, hypertensive 179/79 and saturating at 89% on room air. Supplemental oxygen was applied 2L NC with improvement in oxygen saturation to 94%.  Laboratory findings were significant for hyponatremia 126. CKD stage G3b.  Transaminitis ALT 189 and AST 218. ProBNP 4058. Troponin 0.06.  Anemia HGB 11.5. D-dimer 1.01.  CT chest negative for PE.  Ground-glass airspace disease in all 5 lobes likely representing multifocal pneumonia versus viral pneumonitis.  Rocephin and Zithromax initiated in ED.  DuoNeb treatment and Decadron given in ED.  Ativan given for agitation.  9/27/21: 83-year-old female was brought in due to persistent cough and shortness of breath, admitted for acute hypoxic respiratory failure secondary to bilateral community-acquired pneumonia secondary to COVID-19 pneumonia so she with COPD exacerbation, also had component of acute on chronic diastolic heart failure.  Pt received Actemra, completed remdesivir, finished IV antibiotics, started on some steroids, respiratory status significantly improved however remained on low-dose oxygen. Remained stable throughout hospitalization and was stable for discharge.
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M039318, expiration date: 20-SEP-2018, lot # M035142, expiration date: 03-AUG-2018, lot # M028546, expiration date: 07-JUN-2018, lot # M018436, expiration date: 13-APR-2018 or lot # L037559, expiration date: 29-SEP-2017, as prophylaxis (Strength, dose and route of administration were not reported), which experienced a temperature excursion between 6 and 14 Fahrenheit degrees for 2 days. There were no previous temperature excursions reported. Data logger was involved. No adverse reactions were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006914: US-009507513-1703USA009937.
felt dizzy; disoriented; fell of his bike for the first time; he still feels unwell; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 84-year-old male patient received first dose of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 13May2021 (age at the time of vaccination 84-year-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced felt dizzy, disoriented, fell of his bike for the first time, and he still feels unwell. Consumer stated, he is not going to take the 2nd dose anymore because he does not think it will help him. Consumer was informed about the Pfizer Medical Information Department and telephone number was shared. Consumer hung up the call abruptly, hence further probing could not be done. Limited information available over the call. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
After the second shot of covid vaccine i went to the ER for dizziness,a weird feeling on the chest,extreme shortness of breath,heart rate over 180 bpm,a near fainting feeling and fatigue.
Tiredness; fatigue; right eye itches/burning sensation; right eye itches/burning sensation,; right eye slightly blurred; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 26Apr2021 at 14:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ALLERGY RELIEF) for unspecified indication from unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the right arm on 05Apr2021 at 14:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 06:00, the patient experienced tiredness, fatigue, right eye itched/burning sensation and right eye slightly blurred. No therapeutic measures were taken as a result of these events. These events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events tiredness, fatigue, itchy eyes, burning sensation on eye and right eye slightly blurred was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Muscle pain in shoulder (L) from point of injection. After 1 week pain traveled to other shoulder to point couldn't lift arm. Constant pain since then.
Pt. became light headed immediately after receiving vaccine. Pt reports feeling medicine go through her and immediately becoming lightheaded for just a minute. Vitals reviewed and pt. reports feeling fine a minute later. Pt. dc 'd home after waiting 30 minutes with precautions given.
PATIENT PRESENTED URTICARIA RASH APROX 5 MINUTES AFTER SHOTS. LUNGS CLEAR AT EXAMINATION. GIVEN BENADRYL 25MG PO. BESIDES, RASH. PATIENT IN GOOD CONDITIONS.  GIVEN PRESCRIPTION FOR PREDNISONE PO.  WILL REFER TO ALLERGIST BEFORE NEXT DOSE OF SHOTS
Awoken in middle of night with feelings of vertigo, dizziness, feelings of passing out, sweating, clammy, shaking, headache, nausea, fatigue