chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Trouble urinating, not able to empty bladder all the way; Developed a urinary tract infection; Trouble urinating; not able to empty her bladder all the way and had to go often because of that; This case was reported by a consumer via call center representative and described the occurrence of urinary retention in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced urinary retention (serious criteria GSK medically significant), urinary tract infection, urination difficulty and increased urinary frequency. On an unknown date, the outcome of the urinary retention, urination difficulty and increased urinary frequency were recovering/resolving and the outcome of the urinary tract infection was recovered/resolved.   It was unknown if the reporter considered the urinary retention, urinary tract infection, urination difficulty and increased urinary frequency to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-MAY-2022 Reporter's Comment: The patient got Shingrix vaccine about 3 months ago in the left arm and shortly after the vaccine, she started having trouble urinating.   She reported that she was not able to empty her bladder all the way and had to go often because of that.   The patient also developed a urinary tract infection and her symptoms with difficulty urinating had improved and her urinary tract infection had cleared up.   The patient did not have any further information in regards to the lot or expiration date of the vaccine. The reporter did not consent to follow-up.
Fever/chills, extreme fatigue, body aches in all large joints (especially L hip), pain in thoracic spine/ribs that resulted in difficulty taking a deep breath. All symptoms subsided after 36 hours with the exception of the extreme fatigue.
Information has been received from a physician concerning a 76 year old white male with no pertinent medical history, and an allergy to aspirin who on 10 OCT 2006, was vaccinated intramuscularly into the left arm with a first dose of varicella virus vaccine live (Oka/Merck) rather than zoster vaccine live (Oka/Merck) (646536/0550R), instead of zoster vaccine live (Oka/Merck), "which is what the patient wanted". There was no illness at the time of vaccination. No adverse symptoms were reported. There was no product quality complaint. Additional information is not expected.
pt recv vax 10NOV98 pt did very good w/shot;mom called office 11NOV98 stating rt arm to elbow very swollen & very sore;no temp
Customer had dizziness, hot, sweaty, nervous, pass out, call 911 EMT took him to the hospital all his vital signs are fine, he called to let us know that he is at home and is feeling well.
Had body aches all day the day after the shot.  Took 9 ibuprofen in 10 hours. could hardly lift my left arm up over my head. I felt pretty bad. Felt fine the following day.
Shortly after red itchy bumps appeared all over my body, they lasted about 4 days causing me to go see my PCP who prescribed the 1st round of prednisone which didnt work so she prescribed another round which cleared it up a little but soon after the bumps came back just as bad and its going on 5 weeks now and I am no longer taking anything but the bumps and itchiness are still present.
I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I had a seizure before, I got down and head hit on the wall.; I have neuropathy in my head so bad. It's very hard for me to write.; I can barely walk.; I am suffering so bad; This is a spontaneous report from a contactable consumer (patient). A 90-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 02Aug2021 (at the age of 90 years old) as dose 1, single for COVID-19 immunization. Medical history included menstrual seizure, iritis. Concomitant medication included "lot of medications" as reported by the patient. No other vaccine was administered prior to COVID vaccine. The patient experienced "i had a seizure before, i got down and head hit on the wall" on 06Aug2021, "i have neuropathy in my head so bad, it's very hard for me to write, i am suffering so bad, i can barely walk" on an unspecified date on Aug2021. Patient have lot of medical problems, and lot of health issues but well. Patient wouldn't feeling that bad, just the few weeks before, patient was diagnosed with iritis and have history of having menstrual seizures. Patient took the vaccination this past Monday (02Aug2021) and patient was going on well. This Friday (06Aug2021) after patient took it, When patient was walked into the room that, patient go to wait. Patient had a seizure before, patient got down and head hit on the wall. Patient took the first one on Monday and due to take second which the 23rd of this month. What to do. Patient was suffering so bad. Patient don't feel up to, have neuropathy in head so bad It's very hard for patient to write. Outcome of all the events were unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
My father received the 3 shot series of the Moderna Vaccine in Feb-Sept 0f 2021, with no major side effects.   He was completely healthy until July of 2023, when after receiving the Pfizer/Bio Booster (in late June), he started developing significant neurological problems.  After seeing multiple Neurologist, he was given the diagnosis of ALS + FrontoTemporal Dementia; possible "Prion-Like" Disease!!!
pt found by parents this morning p/vax apneic & cyanotic; paramedics & ER MD unable to resuscitate;
the strep test came back positive; his tonsils were very, very swollen; This is a spontaneous report from a contactable consumer (parent). An 18-year-old male patient received the first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 09Apr2021 (Lot Number: ER8737) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The consumer was reporting for their son. Their son is 18-years-old and received the Pfizer vaccine on 09Apr2021. On the next day (Confirmed as 10Apr2021), his tonsils were very, very swollen and by that evening. At about 2000H, it was so badly swollen, they took him to emergency care, and they did a strep test on him and the strep test came back positive. So, they prescribed him amoxicillin and finished the course of amoxicillin. Then on 07May2021, his tonsil was swollen again then he goes back to the doctor and they did another strep test but did not find strep and they gave him Methylprednisolone and Azithromycin. So, he just finished his last course yesterday (12May2021). He had his second Pfizer vaccine on 07May2021 and tonight he came home, his tonsils are swollen again, very swollen, almost touching, is this a reaction to the vaccine." Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Patient was feeling faint and dizzy and complained of  tingling. He was give benadryl 25mg and monitored for 38 minutes. Symptoms were resolved before he left.
05/06/21 PATIENT RECEIVED 2ND DOSE OF MODERNA COVID 19 VACCINE AT JOBSITE CLINIC . PATIENT  FELT FINE AFTER THE CLINIC BUT LATER AT HOME STARTED FEELING SICK.  PATIENT WAITED UNTIL SUNDAY 5/9/21 TO SEEK MEDICAL ATTENTION AT THE HOSPITAL AND WAS ADMITTED FOR STROKE. PATIENT REPORTED LOSS OF VISION IN ONE EYE. THE HOSPITAL NEUROLOGIST TOLD PATIENT THAT IT WAS DUE TO CLOTS IN HIS EYE.  PATIENT IS WATING TO SEE AN OPTHALMALOGIST  ABOUT THE EYE CLOTS. PATIENT HAS NOT BEEN BACK TO WORK SINCE FEELING SICK. EMPLOYER STATES HAS NOT RECEIVED ANY NOTICE  FROM DOCTOR STATING ANY CAUSE OR RELATION TO VACCINE
Shingles / Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9X374, expiry date 10th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacist called to report that the patient experienced Shingles.  The patient experienced Shingles rash on legs. The reporter consented to follow up.
male patient received Bexsero on 9/7/2023 instead of HPV vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 07-SEP-2023, the patient received Bexsero. On 07-SEP-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: male patient received Bexsero on 9/7/2023 instead of HPV vaccine).  The outcome of the wrong vaccine administered 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 Information: GSK receipt date: 3-Oct-2023 The medical assistant reported that treating physician is not aware yet or the patient's parent.  According to reporter she will notify parents and PCP.  Reporter stated patient was doing fine. The reporter consented to follow-up. The patient received Bexsero instead of HPV vaccine, which led wrong vaccine administered.
tingling throughout arm; rash on left buttocks; constant pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling throughout arm), RASH (rash on left buttocks) and VACCINATION SITE PAIN (constant pain in arm of injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 11-May-2021, the patient experienced PARAESTHESIA (tingling throughout arm), RASH (rash on left buttocks) and VACCINATION SITE PAIN (constant pain in arm of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling throughout arm), RASH (rash on left buttocks) and VACCINATION SITE PAIN (constant pain in arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Generalized big maculo-papular rash & fever 2 wks p/MMR vax;
severe body aches (myalgias); severe body aches (myalgias); joint pain throughout back/spine; joint pain throughout back/spine; joint pain throughout back/spine; after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements).; after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements).; This is a spontaneous report from a contactable physician (patient) reported for herself. A 36-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: FC3184), via intramuscular route o administration in left arm on 01Sep2021 (at the age of 36-years-old) as dose 2, single for COVID-19 immunisation at pharmacy or drug store. The patient's medical history included known allergy to PCN (Penicillin) and seasonal allergy, otherwise healthy. Concomitant medication was not reported. No other vaccine in four weeks. Other medications in two weeks were reported as none. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: EU0168), via intramuscular route of administration in left arm on an unknown date in Aug2021 (at the age of 36-years-old) as historical vaccine dose 1, single for COVID-19 immunisation and experienced COVID test name post vaccination=Binax Now Antigen Card/Covid test result=Positive. On 01Sep2021, after the second dose, est 10 hrs later, severe body aches (myalgias), joint pain throughout back/spine, after 24 hrs left axillary lymphadenopathy developed (size of a golf ball, warm, tender to touch, and painful with movements). Yes, COVID tested prior vaccination and post vaccination. In Aug2021, COVID test post vaccination (BinaxNow Antigen Card) was resulted positive by nasal swab. On 28Aug2021, COVID test post vaccination (BinaxNow Antigen Card) was resulted negative by nasal swab. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
A third dose of the Shingrix was administered to this patient. Patient and wife came into the pharmacy to receive the 2nd dose of Shingrix per provider instructions. However, patient had already received his 2nd dose and a 3rd dose was administered.   Patient did not have an adverse response to the vaccination and is tolerating well thus far.
Vaccination burned slightly, some arm soreness, but no other immediate reactions. Eight  days after vaccination I developed skin tenderness on L forearm. Days 9-13 have resulted in rash in several areas on forearm and additional tenderness on upper arm. At regularly scheduled dermatologist appt they advised it was shingles and prescribed an anti-viral medication (Valcyte HCL 1000mg).
This spontaneous report as received from a registered nurse refers to an unspecified patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored PROQUAD (lot # L024122 and expiry date: 30-DEC-2016) and VARIVAX (lot # L005301 and expiry date: 17-FEB-2017; lot M012991 and expiry date 14-MAR-2018; lot # L04865 and expiry date: 02-DEC-2017; lot #M014908 and expiry date; 25-MAR-2018). The vaccines were exposed to 10.8 Fahrenheit (F) for 6 hours, back in the range and data logger was reported as yes. No adverse effects were reported. No product quality complaint was reported for the vaccine. Additional information has been requested.
Vasovagal event with hypotension and dizziness after vaccine (patient stated did not eat that morning)
fatigue many days; sleep disturbance; light vomit; This case was received via an unknown source (no reference has been entered for a Regulatory Authority) on 23-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (light vomit), FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced VOMITING (light vomit). On an unknown date, the patient experienced FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance). At the time of the report, VOMITING (light vomit), FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
(0940) pt had 2nd SHINGRIX on 11-15-18 called clinic 11-16-18 at 0940 states "started having chills and body aches and joint pain at 12 mdn. Taken Ibuprofen with any results pain was at 10 now at 940 rates at 4-5'. Recommended TYLENOL 1,000 mg and will call pt back (1230) called pt back chills gone pain at 4 will call at 4 again. (1600) called back rates pain at 2. 11-19-18 0940 pt denies pain. Returned to her ADL's no discomfort.
No symptoms, patient did not report any side effect. But she did receive an expired vaccine. It expired 4/2023 and was given in 5/2023. Another HPV vaccine given on 5/22/23
Mild fever (38 celsius); i'm experiencing a heavy metallic taste smell since March 11th; i'm experiencing a heavy metallic taste smell since March 11th; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), unspecified dose number, administered on right arm on 08Mar2021 at 07:15 (Lot number: EM6199) as unknown dose, single dose (at the age of 33 years old) for COVID-19 immunization. The patient's medical history included having COVID-19 (mild case) on Mar2020. The patient is not currently infected. The patient's concomitant medications were not reported. On 11Mar2021 at 13:00, the patient experienced mild fever (38 Celsius). On 13Mar2021, the patient also reported that she experienced a heavy metallic taste smell since 11Mar2021. On 12Mar2021, the patient had taken a PCR test (nasal swab) and resulted negative. The patient also reported of no known allergies. The patient also reported that he had a checkup two weeks ago and all exams were normal. The patient received no treatment for the events. The outcome of the events was not recovered.          No follow-up attempts are possible. No further information is expected.
She reports about 20 hours after getting the shot, she noticed that she had a big red bump.  No fever or chills.  She reports that she felt okay and went to school - school nurse circled the spot and then it was noticed to be twice the size today.
Pt vaccinated with OPV 5-6 hrs after immunization child cried intermittently for period up to 3-5 hrs, inconsolably. Also had fever 101-102F.
pt stated within 30 minutes after taking the vax she had leg pain starting in the calf and moved all the way up to the thigh.  This pain last for 2 days.   On 2/12/2021 she woke up she was dizzy and nauseated.   Pt has not contacted her PCP regarding her symptoms at this time.
Hives/body rash on left side of body, neck, and face. Hives/rash also under right arm and groin area.
Unable to raise arm, very painful (hadn't hurt at time of injection), decreased ROM--deltoid muscle. Symptoms gradually improved over one week's time.
A 69 year old woman was treated with OncoTICE. Four hours after her first instillation of Oncotice she presented with chills and nausea. After the second instillation she experienced chills and nausea again and also vomited. The symptoms subsided without treatment and OncoTICE will be continued.
Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021
Tingling in toes,muscle weakness in legs, can't walk, hard to breathe, trouble walking, sneezing, coughing, retaining urine, can't push out bowels, whole body weak, left side very weak.
Site of injection turned red on date of vaccination. A rash was noticable the next morning. The rash spread across and under the left arm, all the way across the left breast by 1pm the day after the vaccination. The rash lasted @ 10 days.
At time of vaccine administration, patient did meet minimum age requirements for Moderna vaccine. Patient only 17 years of age. In observation for 15 minutes, no effects/reactions noted.
Developed a high fever.  Day one by 6:00 pm had 100.4 9:30 pm had 101.9 took 2 Advil 3:30 am 101.9 took 2 Advil Second day 7:30 am 100.4 started major chills 10:30 am102.6  took 2 Advil 1:00 pm 101.9  3:00 pm 102.7 body aches took 2 Advil 6:00 pm 101.5 10:00 pm 101.9 slight headache took 2 Advil 3:30 am 101.8 sore 2 Advil Sweated extensively until 9:00 am temp was then 97.6 by 10 started feeling better    9:30 pm that night and the next morning it went up to 102.6 around 10:30 am
Patient was given flu shot on 10-10-11. Patient called pharmacy on 10-17-11 to complain of redness, soreness, black, blue and yellowing of injection site. Patient stated that she was concerned so she went to physician office. Patient thought injection site was infected PA stated that injection was not infected per patient but that the injection was given incorrectly and hit a vein.
3days p/vax devel abd distention & vomiting; dx w/intussusception which was reduced by air contrast enema same day;
Initial and follow-up information has been received from an RN and a PA concerning a 67 year old (DOB reported as 8/1/34 and 8/8/34) Caucasian female pt who on 10/23/01 at 12:00 was vaccinated IM in the right deltoid with the 2nd dose (lot 637263/1448K) of pneumococcal vaccine 23 polyvalent (Dose 1 in 1996, with no known reaction). Concomitant therapy on 10/17/01 at 13:10, included a dose (lot E04861KA) IM in the left deltoid of influenza virus vaccine (Fluvirin) (number of previous doses uncertain). On 10/23/01, within a few hours, post vax, the pt experienced erythema and warmth at the injection site. The pt presented to the physician's office on 10/24/01 at 11:00 for the reaction. It was noted that the area was 7" X 11" with induration that was raised. Erythema of the right arm was present from the injection site around to the center of the inner bicep. The reaction was characterized as having a "welt" or hive appearance consistent with "a reaction seen with preservative in injectable medication". It was noted that the pt did not experience shortness of breath or chest pains, but that minor pruritus was present (reported that "none were serious"). The pt was subsequently hospitalized for 3 days and treated with IV antibiotics (not specified), diphenhydramine hydrochloride (Benadryl) (50mg as directed) and warm and moist compresses (20 minutes on and off). It was noted that the pt refused all tests and follow-up treatment. The pt "was concerned that this was Anthrax". Subsequently, the pt recovered from the experience. No further information is available.
Began at 3 pm day of vaccine w a burning stinging sensation in the left nipple (chest). Symptoms gradually occurring from that time on such as: chills followed by sweating profusely; aching all over body; left arm pain w pain still in elbow today & loss of strength in left arm; deep sleep for hours;   By the third day, tongue was coated w a waxy like taste. So I called my pcp. Was told that I needed to b seen. Diagnosed w a yeast infection in my mouth & was prescribed a prescription mouthwash   Started to feel normal on 6 th day
Itching all over, baseball size redness, with warmth and itching at injection side, onset of difficulty in breathing, face, tongue, mouth throat tingling, hives, feeling dizzy, feeling warm, voice changes, felt like throat closing up.
Patient is fully vaccinated and boosted 10/22/2021.  COVID + 1/13/2022 on admission to hospital.78-year-old female with past medical history of diabetes type 2, hypertension, dyslipidemia, presented to the hospital with a substernal chest pain.  The patient denied any previous history of coronary artery disease.  EKG, no sign for ischemia.  Elevated troponin COVID-19 was positive.  Chest x-ray, mild congestion changes. Seen and evaluated by Infectious Disease who reported that the patient is not a candidate for Decadron or baricitinib and to continue with supportive treatment. Discharged, stable.