chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt started c/o blurred vision of L eye while @ sch. Mon 12/7/09 (wears glasses). Seen @ ED that evening and referred to ophthalmologist. Had vision change when examined on 12/8 - referred to PCP on 12/9/09. Due to family H/O diabetes fasting labs done 12/10 Vision has improved since 12/11/09. Has f.u. appoint with doctor on 12/18/09 - will f.u. gradually improved.
Pt received Trihibit and IPV IM in right deltoid 9/17/03. Mom noted redness of right upper arm 24 hours later. Area also warm to touch and started weeping clear d/c followed by formation of multiple small blisters. Area of redness about 4" x 4". Diameter of upper arm (right) about 1 1/2" > left. Tx: cool compress. Called 9/24/03, swelling, redness resolved.
Nausea; fever; aches; chills; headache; This is a spontaneous report received from a non-contactable consumer (patient).  A 43-years-old non-pregnant female patient received unknown dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, it was unknown if patient has been tested for covid-19.On an unspecified date, the patient experienced nausea, fever, aches, chills and headache. Outcome of the events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-FEB-2019, the patient was inadvertently vaccinated with expired dose of M-M-R II lot # N005774, expiration date 17-FEB-2019 for prophylaxis (dose and route of administration were not reported). No adverse effects were reported.
Guillian Barre; sensory weakness; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a adult male patient who received DTPa (Reduced antigen) (Boostrix) (batch number H54EX, expiry date 14th June 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and sensory disturbance. On an unknown date, the outcome of the guillain barre syndrome and sensory disturbance were unknown.   It was unknown if the reporter considered the guillain barre syndrome and sensory disturbance to be related to Boostrix.  Additional details were reported as follows: The patient received Boostrix and had sensory weakness. The patient was sent to emergency room. The patient was diagnosed with Guillain Barre syndrome. The reporter consented for follow up.
Weakness in legs and arms, pain at injection site, hot, clammy, wheezy, shaky, sneezy, eyes watering, fever, nauseous.
Fever - 100.8 deg F Nausea - Throwing up Pain - muscles of entire body hurt
Severe SOB requiring ER visit, oxygen level 87%, inability to walk very short distances, and hospitalized for 6 days. Treatment with oxygen (4 days), prednisone, DUONEB for a nebulizer, and LEVAQUIN. Sent home with same medications, and symptoms gradually improved.
Discharge Provider: DO Primary Care Provider at Discharge: MD  Admission Date: 9/12/2022 Discharge Date: 9/15/2022  PRESENTING PROBLEM: Rhabdomyolysis [M62.82] Weakness [R53.1] Elevated CPK [R74.8] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 80 year old male who presented to the emergency department following a fall and weakness on 9/12/22. The previous night he had fallen while trying to get out of the bed and was lying on the floor until he was able to have neighbors help him back into bed. The morning of the 12th he still felt weak and couldn't get out of bed so he called 911 to bring him to the emergency department. Patient tested positive for COVID upon arrival. His SPO2 dropped down to 89 and patient was placed on 2L nasal cannula. Patient's labs indicated a CK of 3,033, BUN 21, Glucose 111 and urinalysis showed large amount of blood but no bacteria. Chest x-ray showed mild bibasilar lung atelectasis. X-ray of left hip and pelvis showed no fracture from fall. Due to history and elevated CK levels, rhabdomyolysis was suspected. Patient given IV 0.9% normal saline in the emergency department and was admitted to the hospital.   During his admittance, patient was started on DVT prophylaxis of Lovenox and SCDs along with an Albuterol inhaler PRN. He experienced off and on shortness and breath during his stay and alternated between 2L NC and room air due to dropping SPO2. On 9/13/22 Decadron 6mg PO daily and a one time dose of Remdesivir 200 mg IV followed by 2 doses of Remdesivir at 100 mg daily was ordered due to patient's shortness of breath and COVID. He has maintained his SPO2 on room air since 9/14/22. PT/OT evaluation and treatment was set up due to patient's new generalized weakness and hip pain from his fall. Patient also continued recieving 0.9% normal saline IV fluids throughout his stay. Continually checked CK levels, which have decreased from 3,033 to 1,655 down to 917 upon day of discharge.    Patient will be discharged to Facility on 9/15/22. The patient agrees with this plan of care and all questions and concerns were addressed to his satisfaction.  The patient had no significant complaints at the time of discharge and he was discharged in stable condition.
ITCHING OFF AND ON TO ARM; A LITTLE REDNESS TO ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-JUN-2021, the subject experienced itching off and on to arm. On 01-JUN-2021, the subject experienced a little redness to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching off and on to arm, and a little redness to arm. This report was non-serious.
began screaming 230PM wouldn't stop, wouldn't eat, fever 99.9, rt leg red & swollen-rest of body pale; adm to hosp;
Unexpected beneficial therapeutic response; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Obesity, Autism since an unknown date, Psoriasis and Stomach ulcer. Concomitant products included SECUKINUMAB (COSENTYX) for Psoriasis, TRAZODONE for Sleep disorder, SUCRALFATE for Stomach ulcer, Flintstones vitamin for Vitamin supplementation, NALTREXONE for Weight loss, PANTOPRAZOLE for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, 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 experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response) outcome was unknown. Not Provided          The patient 'is kind of coming out from autism and psoriasis and stomach ulcers have calmed down to nothing.
? Headache     BASE OF SKULL PAIN ? Nasal Congestion ? Back Pain     back ache ? Dry Mouth Loss of taste Body Aches Cough  over-the-counter supportive care measures including Coricidin HBP
PT STATES LOCALIZED PAIN AT INJECTION SITE AT TIME OF ADMINISTRATION. WHEN DISCOMFORT DID NOT RESOLVE IN 6 WEEKS, SHE REPORTED TO EMPLOYEE HEALTH ON 12/21/11.  DIAGNOSIS-PROLONGED INFLAMMATORY LOCAL REACTION TO FLU INJECTION WITHOUT ANY BRACHIAL PLEXUS INVOLVEMENT.  X-RAY = NO FOREIGN BODY, NO CALCIFICATION. NAPROSYN GIVEN WITH RELIEF.
Muscle pain; Tiredness; Pain in my left arm where vaccinated; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 14:45 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient has allergy to pollen, mould, avocado, nuts and few others food products. Concomitant medications include cetirizine hydrochloride (ZYRTEC) for unspecified indication from an unknown date and unknown if ongoing.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 the patient experienced muscle pain, tiredness and pain in my left arm where vaccinated. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle pain, tiredness and pain in my left arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
devel adverse rxn;became fussy & lethargic during 1st 24 hr post vax;no fever,mom noticed about 2 brief episodes of abnormal eye movements few days p/vax & episodes  of jerky movements x2 occasions;rxn disappeared right away per PAR;
kind of drowsy; broke out in hives; coughing; feeling dizzy on one side of the body when wake up; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown and expiration date was not reported), via an unspecified route of administration on 24Mar2021 as dose 1, single for COVID-19 immunization. Medical history included medical illness. The patient's concomitant medications were not reported. The patient experienced kind of drowsy on 24Mar2021, broke out in hives, coughing and feeling dizzy on one side of the body when wake up on an unspecified date in Mar2021. It was reported that patient was kind prepared but he/she does not have any COVID symptom before prior to the shot when had the shot, patient was kind of drowsy but had someone in the car with him/her, but it wasn't to that sick where patient could not drive but now patient started to feel dizzy. Patient was wondering, the question was for lymphedema patient a person who have had a radical cut and swelling in the part of their body with because the Covid symptom because prior to the shot, patient did not feel anything, patient was broke out in hives, coughing and at the time of this report, patient was feeling dizzy on one side of the body when wake up this form of is that normal, patient was trying to figure while he/she have these symptoms and if so how long. Outcome of event kind of drowsy was unknown; outcome of remaining events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I got my COVID-19 shot on March 30th, 2021 and had some fatigue, joint pain and muscle pain. On 04/05/2021 I started running a low grade temperature 100.9. This morning 04/07/2021 my arm was itching and I reached up to scratch my arm and where the vaccine was given is a 2x3 whelp and it itches.
Vaccine remained in the freezer past the recommended guidelines (14 days). Once discovered, Pfizer was contacted but did not have stability data to support acceptability of the product greater than 31 days in the freezer. All patients that were administered vaccine past 31 days were contacted and given an option to be re-vaccinated based on their doctor'S recommendation or advisory guidance.
Pt recvd MMR vax on 22JUN91 following the vax pt devel a low grade (99) cyclical type fever & leg pain @ the shins;
Patient was Covid +  on 11/01/2021.  Patient received Janssen on 03/19/2021.  Per H & P:  History of Present Illness  Patient is a 64-year-old male status post multiple surgical intervention secondary to pneumoperitoneum with evisceration.  The patient returns today with drainage from the incision wound.  Patient had a recent CT that showed a seroma but has continued to have increasing follow odor and discharge from the incision site.  He denies any documented fevers.  The patient's has not had any nausea vomiting constipation or diarrhea.  The patient rates pain is about a 5 out of 10 with no exacerbating or mitigating factors
Skin tender & painful where the shot is given. Can not lift arm (left) lots of pain on hand and neck.
COVID infection 2/2021. Resolution of symptoms. dyspnea on exertion since 1st COVID vaccination that started a few hours after the vaccination and has continued since that time.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to dialysis session two days after vaccination reporting right lower extremity pain and redness for one week. Admitted for management of cellulitis, received antimicrobials, and discharged to home improved and medically stable.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist at the store gave a Moderna vaccine to a patient outside of the 12 hour puncture time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist at the store gave a Moderna vaccine to a patient outside of the 12 hour puncture time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist at the store gave a Moderna vaccine to a patient outside of the 12 hour puncture time) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were reported.
Information was received from a pharmacist regarding one adult patient, age and gender unknown, who on 18-MAR-2014, may have received PROQUAD (Merck) (SDV, MDV or additive) in error, subcutaneously. Lot number J007205, expiration date of 02-DEC-2014. No known adverse effects. This is one of two reports from the same source (other case number 1404USA002356). Additional information is not expected.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient had not none drug reaction and allergies. Medical history were not reported. On 20-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml in the right arm, lot # J005067, expiry date 17-JAN-2015, (route was not reported0. Other suspect therapies included FLUZONE on the right arm (dose, route, lot number and expiry date were not reported). On 20-OCT-2014, the patient received PNEUMOVAX 23 and FLUZONE HIGH DOSE in the same arm, and the injections were given "close together" on the right arm. The reporter stated that the dose was administered by another pharmacist. It was also reported that the patient called the pharmacy and reported that the injection site area was "Bright red" and severely swollen, the patient stated that the swelling was "6 inches in diameter". The patient sought medical attention calling the pharmacy, did not received treatment and none lab diagnostics studies were performed. The outcome of the events were reported as not recovered. Additional information has been requested.
4-6 weeks, eyes swelled up, itched, fluid buildup bottom of eyes/check bones, felt like I was hit with a hard ball.   eye doctor determined eyes were clear, no infection 20/20 vision. Maybe allergies, tried allergy treatment route. It helped a little,  but not much. Still took 4-6 weeks to completely clear up. Took Zyrtec (24 hour), Refresh PF eye drops daily as needed and cold compress 203x a day. After same situation with 2nd dose  it was determined to not be allergies, but the treatment helped a little. I even stopped using products on or around my face to see if I had an allergic reaction, but even after stopping product use for 5 months, still had the same problem with both doses in same exact manner, exactly 4 days after vaccination. It was an odd reaction to the Shingles vaccination.
After normally expected side effects subsided (sore arm, body aches) I experienced 3 episodes of extreme vertigo between 2 AM - 6 AM.  This included when rolling over in bed and when standing up and sitting down.  At this point (8:16 AM) the vertigo seems to be gone although I remain light headed.
She started having the following symptoms about 30 minutes after the vaccine administration: Anxiety, shortness of breath, nausea. Her blood pressure was at 118/70 and pulse of 74 bpm. Her FSBS was at 375. The vitals were taken by Fire department EMTs who came on site. They recommended her to go to the hospital and she agreed.  Her symptoms had subsided by the time they were leaving the facility. We have no further information from her status at this time.
Arm is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is a little sore) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Arm is a little sore). At the time of the report, PAIN IN EXTREMITY (Arm is a little sore) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
No adverse effect; A patient was administered 2 doses of MMR II or 2 doses of VARIVAX; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On 11-JUL-2019, the patient was vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) or varicella virus vaccine live (oka/merck)(VARIVAX) (strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported.
10 minutes after administration, patient reported feeling "woozy." She then lost consciousness and urinated while unconscious. She then regained consciousness after 5 minutes. No other symptoms except increased sweating. Blood pressure was taken by paramedics and would not go above 70/50.
Influenza vaccine given 9-21-16. About 20 minutes later c/o throat itching and hard to breathe - has allergy to eggs but is able to eat eggs and has taken vaccine before. Placed in room given DEPO-MEDROL 80mg IM, BENADRYL 25mg IM and 25mg P.O. Cannot take Epinephrine. O2 per NC at 4 liters. After 60 minutes felt better and returned to work with OK from physician. About 45 minutes to an hour later patient experienced a second episode where her tongue started swelling and again-felt like she couldn't breathe as well as she had. Dr. was notified and patient received KENALOG 80mg IM and 50mg of BENADRYL IM and was observed for an hour and felt like her tongue was no longer swelling and patient was able to have someone drive her home. Patient stated that during the night she felt like her tongue was swelling again and took another 50mg of BENADRYL by mouth. Patient returned to work the next day.
Unsure if patients received partial doses; wrong technique in drug  usage process; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 5yr3p, expiry date 17th June 2024) for prophylaxis.   On 13th February 2023, the patient received the 1st dose of Shingrix. On 13th February 2023, unknown after receiving Shingrix, the patient experienced underdose and wrong technique in drug usage process. On an unknown date, the outcome of the underdose and wrong technique in drug usage process were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter who stated that patient received their dose of Shingrix from the same reconstituted vial.  She stated that she was unsure if one patient got a full dose and the other received no dose or if both patient received partial doses. The reporter reported about a patient who potentially received Shingrix underdose. The reporter consented to follow up. Additional Supportive Information:The reporter reported about a patient who potentially received Shingrix underdose, which led to underdose and wrong technique in drug usage process. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026657:Same reporter
chills; nausea; aches; shortness of breath; weakness; swelling at the injection site; This spontaneous report was received from a nurse referring to herself, a 80 years old female patient. Concomitant therapies included pravastatin, digoxin, ibuprofen and furosemide (LASIX). The patient was allergic to hydromorphone hydrochloride (DILAUDID), cefaclor (CECLOR) and codeine. There was no pertinent medical history.  On 06-NOV-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (left arm; lot number: S018405; expiration date reported as 28-MAR-2021, but upon internal validation established as 23-MAR-2021; strength and dose were not provided), intramuscularly for vaccination. On the same date, after the administration of the vaccine, the patient experienced chills, nausea, aches, shortness of breath, weakness and swelling at the injection site on the left arm. The patient received ibuprofen 200mg to treat the events. There was no lab diagnostics or studies performed. The patient spoke to the physician to seek medical attention. At the time of the report, the outcome of the events was recovering. The causality assessment between the aforementioned events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Pt developed nausea/vomiting w/in 24 hrs of being given vaccination. No other signs or symptoms.