chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weeks later he developed shingles/Suspected Vaccination Failure; weeks later he developed shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: weeks later he developed shingles/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: weeks later he developed shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient got the shingles jab on a recommendation from his doctor and weeks later he developed shingles.  The reporter certainly would not be getting this shingles jab either. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
approx 1mo p/vax pt began vomiting & vomited throughout the day; hosp; lab tests nl, tx w/IV's; cont'd to vomit, pale, passed bloody stool, underwent surgery; dx intussusception.
Left sided facial weakness, numbness and tingling in face, cheek, tongue, jaw, and neck.  Diagnosed with Bells Palsy on 01/04/2021
Information has been received from a consumer concerning his son, a caesarean baby with penicillin allergy who "within 2 or 3 days of being born" on approximately 02-JAN-2003 was vaccinated with MMR II SQ.  On an unspecified date the patient had "sensory perception disorder".  The patient had "problems" with loud noise and rough textures."  The consumer reported that his son "was a little bit late with walking and talking, but started walking before crawling." "When the patient was 2 or 3 he had asthma attacks."  The patient had sought unspecified medical attention.  At the time of reporting the patient's "sensory perception disorder" and "problems with loud noise and rough textures" and "asthma attacks" persisted.  Additional information has been requested.
Patient with history of throat constriction, lip tingling, headache, fecal urgency and chills/tremulousness about 15-20 mins after Pfizer COVID-19 vaccination.
pt recv vax 28OCT95&c/o scapula tingling,dizziness,numbness in elbow&severe h/a lasting approx 24hr;sx lessened by the next day&the pt recovered;
Chills and above symptoms for 3 days. Tested positive for COVID 11/2020 Narrative:
Pains; vertigo; Arm hurt tremendously (sore); Chills; Aches; Fever - 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains), VERTIGO (vertigo), ARTHRALGIA (Arm hurt tremendously (sore)), CHILLS (Chills) and MYALGIA (Aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Pains), VERTIGO (vertigo), ARTHRALGIA (Arm hurt tremendously (sore)), CHILLS (Chills), MYALGIA (Aches) and PYREXIA (Fever - 102 degrees). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN (Pains), VERTIGO (vertigo), ARTHRALGIA (Arm hurt tremendously (sore)), CHILLS (Chills), MYALGIA (Aches) and PYREXIA (Fever - 102 degrees) outcome was unknown.            The patient stated that it took a while to get in touch with the doctor who gave her prescription for 1 pill of vertigo and it was a common generic medication. The doctor had advised her to take 1 pill before 2nd vaccine dose as well along with acetaminophen. The patient stated that she took 1 pill of acetaminophen and stated that she is not sure if it did anything.  The patient reported that she is on blood pressure medication along with Synthroid but was unable to provide the name of the blood pressure medication.       Reporter did not allow further contact
got real real sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (005570). The reporter is the parent.  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: ILLNESS (non-serious), outcome "unknown", described as "got real real sick". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 15-SEP-2016, the patient received improperly stored doses of PROQUAD lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; (dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Since the second immunization patient complains that she has had episodes of tachycardia..  These have been worked up by primary care, pulmonology, and cardiology.  LVH was found.  Holter was not revealing.  Heart rate up to 160 per the patient.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.       Moderna booster vaccines were administered to patient around 490 to 500 people on the date last Oct 20.2021 to Nov 29, 2021, with lot numbers 006C21A (10-10-2021), 026B21A (09-17-2021),031B21A (9-22-2021).
Blood pressure varies, High Cholesterol, Cramps leg, Sleep insomnia, nervousness, libido decrease, aches in joints, muscles, mood irritable, bursitis, shrunken testicles.  12/4/06 Received medical records from VAMC which reveal patient experienced: HTN, dyslipidemia uncontrolled, shoulder pain secondary to DJD, glucose intolerance, impotency, ETOH abuse & BPH.  Occasional insomnia.  Bout of otitis media. Quit smoking 10 years ago.     Ortho consult done 9/04 for right shoulder pain revealed dx: early AC joint DJD.  Metabolic consult for decreased libido & impotency done 3/04.
Hours after vaccination he beccame stuffy, by the next morning he was completely congested, wheezy, decreased appetite, gagging, projectile, spitting up, trouble breathing, respiration (68) coughing, blocked duct, stuffed nose, clearly sick. Took him to the dr today 2/6/10 because there has been no improvements and he has r.s.v and bronchiolitis which he was put on steroids and a nebulizer to treat. Seeing how he had just had a physical prior to hb shot and was determined to be "beautifully healthy" im convinced it was a reaction to the shot.
NOTICE PINCHING PAIN IN LEFT SHOULDER AREA [NOT INJECTION SITE], FEELS LIKE A PULLED MUSCLE THAT MIGHT ERUPT IN PAIN, BECAME SHOCKING, STABBING, TAKE YOUR BREATHE AWAY PAIN THAT INVOLVES SHOULDER OVER TOP OF SCAPULA, RADIATES OVER CLAVICLE OVER TO ROTATOR CUFF..THE WHOLE AREA ERUPTS IN PAIN.  CAN BARELY BEATHE.  THIS HAS CONTINUED TP PRESENT, THOUGH THE PAIN LEVEL NOT ALWAYS 10/10.  ALSO HAVE DISCOMFORT AT INJECTION SITE THAT I DESCRIBE AS DEEP ACHING AT SITE, DOWN OVER ELBOW AND DOWN OVER THE MUSCLE ON TOP OF FOREARM.  THIS HAS BEEN A CONTINUOUS LEVEL 4-5/10 EVERY DAY SINCE I FIRST NOTICED IT ON 10/1/14. I SENSE A MUSCLE WEAKNESS THAT WAS NOT PRESENT BEFORE.
Redness, soreness, stiffness, kinda felt like blood was clotting in shot area. Left bruise days later
fever 101; body aches; vomitting x 3; sore throat; 36-48 hrs induration 1-2 days p/vax
Mother reported, swelling, redness and pain a few hours after injection on 4/24/2017. Pt. then started with fever on 4/25/2017. Pt's affected arm that was injected/swollen x2 size of the arm with severe tenderness. Pt was hospitalized for management.
HORRIBLE TASTE IN MOUTH, TONGUE AND LIPS; BREATHING ISSUE R/T ASTHMA; DIARRHEA; SICK; ARM HURTS AT INJECTION SITE; MUSCLE ACHES; 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 concurrent conditions included asthma. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced breathing issue r/t asthma. On 11-MAY-2021, the subject experienced diarrhea. On 11-MAY-2021, the subject experienced sick. On 11-MAY-2021, the subject experienced arm hurts at injection site. On 11-MAY-2021, the subject experienced muscle aches. On an unspecified date, the subject experienced horrible taste in mouth, tongue and lips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from horrible taste in mouth, tongue and lips, and the outcome of muscle aches, breathing issue r/t asthma, arm hurts at injection site, diarrhea and sick was not reported. This report was non-serious.
large red spot at site of injection, hot to the touch, some pain; lasted about a week or so  (Sorry, I just found the sheet with the info to report this!)
At 3:00 am I woke up with chest pain that would not resolve despite repositioning or taking NSAIDS. I felt like every time my heart would squeeze, I would feel a burning and sharp pain in my chest. After 1 week it subsided and got better.
also have neck & shoulder pain; h/a p/2nd dose in post exposure treatment; has persisted for 14 days; bitten by feral cat; wounds became infected & pt taken to OR for debridment, infection treated;
The pain around the injection site progress to full body ache, head stuffed ness breathing though mouth and slight fever 100.1 took Ibuprofen. The next day sore all over, hard to walk and took Ibuprofen for 6 hrs. On 12/16 lost taste/smell, diarrhea, nausea .Then 12/17 continued aches and fever pt went to get a Covid test was results positive. This morning exp body aches and slightly gaining taste .Pt has been not able to work for 10 days since testing positive.
Stomach upset; This is a spontaneous report from a contactable pharmacist.  A 47-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3246), intramuscular in the left arm on 10Jan2021 (at the age of 47-year-old) as a single dose for COVID-19 immunization. Medical history included hypertension. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. . The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL0140), intramuscular, left arm  on 20Dec2020 for COVID-19 immunization. On 10Jan2021, the patient experienced stomach upset. The patient took Compazine for the stomach upset. The clinical outcome of the event stomach upset was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
C/O dizziness after nasal spray. Temp taken 100.2. (Mom said child had fever off and on for few weeks but not sure if fever due to spray or prior).
lower leg,ankle,and foot were swollen. Painful hives on ankle, and on top of foot. smaller hives across lower back,on back of neck,and top of head.the muscles in my foot and leg were in a tight cramp,the big toe was to painful to even lay on the bed. it is still extremly painful when I try to sleep at night.  the muscles in my leg are still tight and painfull that also makes it hard for me to get sleep.   my back started hurting so bad it was hard to walk.   I guess that may have been because of no sleep.     I did not go to the Doctor because I was in to much pain to even move around my house and when I called the clinic to see if there was something I could do the nurse acted like I was crazy,she said I could,t have hives unless they were all over my body,well I still have the marks from them, they were like burns on my skin.    It seemes like what ever gave me the bad reaction just went after the arthritis in my body.
Information has been received from a Registered Nurse (R.N.) concerning a 16 year old male patient with allergic reaction to antibiotics (amoxicillin, "mycins" and sulfonamide) and lupus erythematosus who on 26-DEC-2002 was vaccinated into left deltoid with a dose of 0.5 mL of PNEUMOVAX 23, lot # 644217/1026M.  Concomitant therapy included PLAQUENIL, lisinopril (manufacturer unknown), aspirin and unspecified therapies. The reporting nurse reported that the patient developed "pneumococcal problem" and was in the hospital at this time. No other information to report at this time. The outcome was unknown. Additional information has been requested.
patient received second dose in gardasil 9 series after it was determined she was pregnant; This spontaneous prospective pregnancy report was received from a nurse practitioner refers to a 24-year-old female (currently 25-year-old) patient. The patient had no medical history and concurrent conditions.  On 30-JAN-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R023607, expiry: 06-MAY-2021, 0.5 milliliter, intramuscular for HPV prevention.  The patient became pregnant with Last Menstrual Period (LMP) of 06-MAR-2019 and Estimated Date of Delivery (EDD) of 11-DEC-2019.  After the patient was determined pregnant, on 06-JUN-2019, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiry: 23-JUN-2021, 0.5 milliliter, intramuscular for HPV prevention (maternal exposure during pregnancy).  Concomitant therapies included prenatal vitamins.  The pregnancy outcome was outcome pending. The outcome of maternal exposure during pregnancy is unknown.  Product quality complaints was not involved.
Heard code blue and patient was found going from sitting position attempting to get into chair, per front desk patient fell. Was found responsive at time of code who reports child fell. He was then assisted back down to a lying position and legs were then elevated. BP 122/74-78. No acute respiratory distress, no dizziness or HA. Alert and denies having had a meal for day. Was monitored for 10 additional minutes and felt better. Before discharge BP 118/70-82  O2 sat 99%, respirations even unlabored .
Initially, lips tingled, throat tightened, tongue swelled; this lasted about 2 hours.  Next I experienced headache, fatigue, nausea, muscle and joint aches, fever to the point I had to stay in bed.  This started about 4 hours after the injection, and at this point ( 50 hours later) am only mildly better.
Right cheek swelled for about an hour after they had left the pharmacy for the waiting period of 30 minutes. The swelling stayed for about an hour and then went down, no medication was needed and the patient is well.
This spontaneous report as received from a Registered Nurse refers to an unknown number of patients who were vaccinated with nonviable VARIVAX (Merck) (injection) (lot #, dose and route not reported) due to cold chain failure. The failure date was unknown. The provider needed to revaccinate the patients. Additional information has been requested.
Immediate onset of dizziness (she felt like she almost fainted), forehead was sweaty and body felt cold, difficult to see (bright), ringing in the ears, throat felt "funny" (although she was able to breath normally and drink water). This was her second Covid booster after the initial set of two shots (she had received her last booster in Oct 2022).
Tooth ache - unplacatable - later diagnosed as abscess with dead nerve - course of amoxycillin helped. This tooth was not 100% healthy before. Subsequently had root canal with good outcome so far. 2nd vaccine dose on 2/3/21, lot 042L20A.
1/2 hour later woke up with swollen tongue, ear, aches, stinging scalp. (All on right side of head and face). Sharp pain in ear. Saw Dr.-diagnosis-shingles 3/18 scabs beginning to fade off-ones on scalp have not formed scabs yet. Prescription used-Famvir. Further recovery will take time. Still sharp pain in right ear; occasionally.
Hot, reddened, painful injection site (right upper arm). Severe arm pain (continues at present). Severely limited arm movement (continues at present). Fatigue, bouts of crying, chills (continues at present). Irritability. Hot soaks applied and heating pad as TX. Some SX's persist at present.
Nausea and vomiting following administration approx. 30 mins after the administration S/SX started. Lasted approx 2 hrs. During the first 30 mins she also c/o difficulty breathing. No action taken by Mom for this.
p/vax pt exp hot flashes; sweaty palms & runny nose lasting 7 hr; woke every 24h w/nasal congestion & sweats x1 night
dizziness; Atrial fibrillation; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included atrial fibrillation (long history of atrial fibrillation, after stent placement in multiple vessels in Oct 2022 the atrial fibrillation ceased). Concurrent medical conditions included heart disease, unspecified, stroke, diabetes, spinal stenosis, intervertebral disc disorder, vascular disorder and post-traumatic stress disorder. Concomitant products included apixaban (Eliquis), metoprolol, clopidogrel bisulfate (Plavix), glipizide, tramadol, atorvastatin calcium (Lipitor) and prazosin hydrochloride (Minipress).   On 02-MAY-2023, the patient received the 2nd dose of Shingrix. On 09-AUG-2023, 99 days after receiving Shingrix, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant). On an unknown date, the patient experienced dizziness (Verbatim: dizziness). The outcome of the atrial fibrillation was not resolved and the outcome of the dizziness was unknown.   It was unknown if the reporter considered the atrial fibrillation and dizziness to be related to Shingrix.     It was unknown if the company considered the atrial fibrillation and dizziness to be related to Shingrix.   Additional Information: GSK receipt date: 13-Aug-2023 This report was submitted via the online direct entry reporting system. After second shot of Shingrix atrial fibrillation returned with dizziness.  The atrial fibrillation symptoms were not treated. The reporter consented to follow-up.
Myalgia fatigue, sore throat Narrative: Myalgia, fatigue, sore throat.
tiny red dots on her legs, from her thigh down to her ankles; was injected with 14 vials in the buttocks; was injected with 14 vials in the buttocks; This is a spontaneous report from a contactable other hcp. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Jun2021 (at the age of 45-years-old) as single dose for covid-19 immunization. The patient has no medical history and no known drug allergies and no concomitant medications. The patient has received fillers in the past and previously took Juvederm voluma on 05May2021. On 04Jun2021, the patient was injected with 14 vials in the buttocks and on 06Jun2021, the patient experienced tiny red dots on her legs from her thigh down to her ankles. The patient took a Claritin. Therapeutic measures were taken as a result of tiny red dots on her legs, from her thigh down to her ankles. The outcome of all the events was not recovered.  Information on lot/batch number has been requested.
Numbness and tingling in the opposite of arm of injection site. left arm begin to feel heavy after injection
Patient was sitting down and influenza and HPV (GARDASIL) vaccines were given.  Mother and Grandmother were in the room and reported that patient immediately looked pale and began to stiffen his arms and then appeared to lose consciousness.  Mother called for help and patient was moved to lie down on exam table.  He was reportedly unconscious for a few seconds.  The nurse practitioners were called into the room immediately after this occurred and the patient was awake and talking but appeared pale.  The pulse ox, blood pressure, respiratory rate and heart rate were taken and all within normal limits.  EMS was called and patient was taken to closest emergency department.
Friday 3/7/03 fatigue, head, neck warm, Saturday 3/8/03 AM- redness to shoulders upper arms, back of head slight SOB, Saturday 3/8/03 PM- hives developed on head. Benadryl taken. Sunday 3/9/03 AM hives resolving skin remains red until midday 3/13/03. Tuesday, Wednesday and Thursday- night sweats, Friday 3/14/03 all symptoms resolved.
Redness & swelling at injection site; tenderness at injection site that persists 3d later. Child still limping and erythema & swelling persist. No signs of infection.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 07-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.