chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss; Shingles; Information had been received on 11-NOV-2019 from a lawyer and the patient (pt), regarding a case in litigation referring a male pt of unknown age. Concurrent conditions and medical history were not provided.  In or around October 2017, the pt was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dose, route, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose of the prevention of shingles (herpes zoster).  Shortly after vaccination the pt suffered of shingles and hearing loss. Pt sustained severe and permanent personal injuries. Further, as tragic consequence of companies' wrongful conduct, pt suffered serious, progressive, and permanent incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The causality between Zoster Vaccine Live (ZOSTAVAX) and the events was related. The reporters considered shingles and hearing loss to be disabling. Upon internal review hearing loss was considered as medically significant event
red; itchy; It is going up the arm now: 3 in length wise; 1.5 in diameter rash around the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (1.5 in diameter rash around the injection site), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (It is going up the arm now: 3 in length wise) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TRAZODONE for Sleep difficult.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (1.5 in diameter rash around the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (It is going up the arm now: 3 in length wise). At the time of the report, VACCINATION SITE RASH (1.5 in diameter rash around the injection site), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE RASH (It is going up the arm now: 3 in length wise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
pt recv vax;pt exp fluid retention during pregnancy;at 39 weeks gestation,pt underwent a C-section due to two-legged breech position of the baby;delivered a healthy 7 lb male baby;
11/02/22 presents to EC ED for "shortness of breath". PMHx of "asthma, DM 2, OSA, hypertension, CHF, DVT/PE on Eliquis"
Pt had always had a small dry patch on the arm, pt came in one week after booster dose and showed pharmacist the spot. It had became inflamed, red, and reportedly itchy. Pt said she showed her dermatologist that spot previously, which he said wasn't eczema just dry skin. She has had that spot for about a year prior, but the booster has made it inflamed and itchy.
Initial information received on 02-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA003119 (FLUZONE QIV, same patient). This case involves a female patient (age not reported) who experienced left Shoulder pain, while she received vaccine INFLUENZA VACCINE. The patient's past medical treatment(s) and family history were not provided. At the time of the event, the patient's concurrent condition included Tobacco user. On 18-Oct-2018, the patient received dose of suspect INFLUENZA VACCINE (lot number, expiry date, route, was not reported) in her bursa of her left arm. On an unknown date, the patient developed a non serious Left Shoulder pain following the administration of INFLUENZA VACCINE. On an unknown date, the patient performed MRI. Final diagnosis was barely Left Shoulder pain. The outcome of the event was not reported.
PATIENT'S SON CAME IN 3 DAYS AFTER THE VACCINE WAS GIVEN AND STATED THAT ARM WAS RED AND SORE. HE ALSO STATED THAT MOTHER WAS EXPERIENCING FLU-LIKE SYMPTOMS. ARM WAS SWOLLEN AND ITCHY. WE RECOMMENDED IBUPROFEN FOR SWELLING AND LORATIDINE FOR ITCHINESS.  ALSO RECOMMENDED PT FOLLOW UP WITH MD IF STILL CONCERNED. WE DISCUSSED THAT REDNESS, SWELLING AND FLU LIKE SYMPTOMS ARE ALL COMMON SIDE EFFECTS.
Extreme body aches, chills, fever of 102, severe migraine. Lasted for 20 hours.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry. The vials did not undergo any temperature excursions. Treatment details were not reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information.
hot flashes, below the arm right side of the body, hot sensation on and off comes frequently; right hip pain; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient) reported that a 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 (past Friday night) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24Jan2021 (Sunday), patient experienced hot flashes, below the arm right side of the body, hot sensation on and off comes frequently. She also had right hip pain. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
swollen 2 to 3 inches around inj site-red, w/big knot-hurts to move arm-all the way down to elbow;
That was 14 and now 42 years old I have had my period like clockwork same flow same amount of days So when I realized I'm not there too after I got my second dose that I have not had one period since getting that second vaccine I am very concerned is now November so that is 8 months of no period when I was like clockwork I definitely 100% think it's related to the vaccine additionally my sister who also like clockwork has always had her period is 37 years old in the exact same thing happen to her
24hrs p/vax or 12 hrs later broke out in fine rash from chest back, arms & legs-measls like rash that itched; rash from neck on down;mostly on torso lasting about 4 days treated w/hydroxyzine HCL relieved itching
Information has been received from a pharmacist concerning a 67 year old female patient with penicillin allergy and sulfonamide allergy who on 20-JUL-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 664670/0151Z, exp 28-MAR-2011) SC in left upper arm. On 22-JUL-2010 the patient woke up with swelling and redness below the injection site on her left upper arm. The patient sought unknown medical attention. At the time of report the patient's status was not recovered. Additional information has been requested.
BEFORE THE VACCINE I HAD ISSUES WITH STRESS PAIN LIKE ON MY SHOULDERS AND NECK AREAS. AFTER MY VACCINES MAYBE LATE MARCH 2021 I STARTED NOTICING ACHES AND PAIN MOVING AROUND ESPECIALLY IN BED WHEN I AM TRYING TO TURN ON MY SIDES. ALMOST LIKE I HAVE ARTHRITIS. I STARTED ALSO HAVING JOINT PAIN THAT I NEVER USE TO HAVE. I AM IN CHRONIC PAIN DAILY. SOME DAYS IT'S MORE ACHIER THAN OTHER DAYS. IT'S NOT AS BAD DURING THE DAY WHEN I AM MOVING AROUND BUT WHEN I AM IN BED AND TRY TO TURN OR MOVE I FEEL MY ENTIRE BODY REALLY ACHIE. I HAVE NEVER HAD THESE SYMPTOMS BEFORE. I AM TRYING TO SEE A CHIROPRACTOR AND MASSAGE THERAPIST NOW AND SEE IF THIS WILL HELP BUT SOMEITMES THE ACHE IS UNBAREABLE. ADVIL WLL JUST TAKE THE EDGE OFF BUT IT NEVER GOES AWAY. IT WEIGHS HEAVY ON MY MIND DAILY. ALSO MY MENSTRUAL CYCLE IS OUT OF WACK. I USED TO BE REGULAR ON MY CYCLE BUT AFTER THE VACCINE I DID NOT HAVE MY PERIOD UNTIL APRIL FOR ABOUT 3 DAYS. I MISSED MAY'S PERIOD. MY SISTER ACTUALLY HAD COVID AND SHE IS NOT VACCINATED BUT SHE IS GOING THRU THE SAME THING. HER PERIOD IS OUT OF WACK AS WELL
This spontaneous report received from a pharmacist concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The pharmacist reported that on an unspecified date, the patient experienced passed out after receiving the Janssen covid-19 vaccine, Patient had been drinking heavily the night prior and did not have much food, which may have played a factor in the event The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210902863- COVID-19 VACCINE AD26.COV2.S -Passed out. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
p/both immunizations approx 3-4 hrs later had piercing screaming episode that lasted 5 hrs-unconsolable;
Today it feels a gritty; Pharmacist reports that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product.; Pharmacist reports that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product.; her eye was burning for about 30 minutes/Today it feels a grittyand irritated.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in eye in a 50-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 16-OCT-2023, the patient received Arexvy. On 16-OCT-2023, less than a day after receiving Arexvy, the patient experienced burning sensation in eye (Verbatim: her eye was burning for about 30 minutes/Today it feels a grittyand irritated.), occupational exposure while preparing product for administration (Verbatim: Pharmacist reports that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product.) and exposure via eye contact (Verbatim: Pharmacist reports that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product.). On 17-OCT-2023, the patient experienced gritty eyes (Verbatim: Today it feels a gritty). The outcome of the burning sensation in eye and gritty eyes were not resolved and the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   It was unknown if the reporter considered the burning sensation in eye and gritty eyes to be related to Arexvy.     It was unknown if the company considered the burning sensation in eye and gritty eyes to be related to Arexvy.   Additional Information: GSK receipt date 17 Oct 2023: The pharmacist reported that a small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product. She stated it was not a product quality issue, and that she had too much pressure in the syringe. She reported that her eye was burning for about 30 minutes before she went to the emergency room. After ER evaluation, she was told everything was fine in her eye - no abrasions or lesions visualized by the attending physician.  Today it felt a gritty and irritated. The patient stated that small amount of AREXVY squirted out of the syringe/needle when preparing for administration of product which led to occupational exposure while preparing product for administration and exposure via eye contact.
Initial report was received on 04 June 2014 from a healthcare professional. This is a cluster of two unidentified patients who had received on 29 May 2014 and 02 June 2014 an intramuscular injection of ADACEL, lot number U4875AA and an unspecified amount of time later, developed cellulitis at the injection site. The patient's required and ER/doctor visit. No further information was provided at the time of the event. Outcomes were unknown. Documents held by sender: none.
The evening after I had my vaccination, the lymph nodes in my armpits swelled up quite a bit; the following day, the nodes behind my knees and in my neck also became swollen.  This swelling lasted two weeks.  I also began experiencing really debilitating head pains the following day that would come and go every day for two weeks.  I was extremely fatigued for a few weeks and found it hard to work.  Additionally, my hair started falling out in handfuls after vaccination and this is still an issue.  I also had a rash starting in my armpits and going down my arms and sides.  My menstrual cycle was interrupted (I stopped ovulating and had bleeding every day) and this is just now getting back to normal three months later.  Six weeks after vaccination, my head pains returned and were very extreme.  I went to the ER where I was diagnosed with a colloid cyst in my brain.  I had urgent surgery the following week to remove as it was preventing spinal fluid from exiting my brain; my endocrinologist believes the incident could be related to the inflammation caused when I was vaccinated.
Spot (resembling chickenpox) on face, legs, hands and arms, decreased appetite, diarrhea, increased fussiness, fever.
The morning after my vaccination, I woke up with a migraine and I started noticing my heart beating out of my chest randomly. This went on throughout the first day. It made me nervous, but I dealt with it. I felt better the second day following the vaccination and the symptoms subsided.
Rash, pain, swelling, redness - size of tennis ball - given SQ in rt arm flu shot given in rt arm deltoid.
Conductive deafness; Ear discomfort; Paranasal sinus discomfort; Ear congestion; Hypoacusis; sensorineural hearing loss; This spontaneous case was reported by a health care professional and describes the occurrence of CONDUCTIVE DEAFNESS (Conductive deafness) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LEVOTHYROXINE SODIUM (SYNTHROID), ESTRADIOL (ESTRACE VAGINAL), PROGESTERONE, DEXLANSOPRAZOLE (DEXILANT) and ESTRADIOL (MENOSTAR) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-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 CONDUCTIVE DEAFNESS (Conductive deafness) (seriousness criterion medically significant), EAR DISCOMFORT (Ear discomfort), PARANASAL SINUS DISCOMFORT (Paranasal sinus discomfort), EAR CONGESTION (Ear congestion), HYPOACUSIS (Hypoacusis) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) (seriousness criterion medically significant). The patient was treated with NEOMYCIN at an unspecified dose and frequency; POLYMYXIN on 25-May-2021 at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) (nasal) at an unspecified dose and frequency and PREDNISONE on 20-May-2021 at an unspecified dose and frequency. At the time of the report, CONDUCTIVE DEAFNESS (Conductive deafness), EAR DISCOMFORT (Ear discomfort), PARANASAL SINUS DISCOMFORT (Paranasal sinus discomfort), EAR CONGESTION (Ear congestion), HYPOACUSIS (Hypoacusis) and DEAFNESS NEUROSENSORY (sensorineural hearing loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: mixed sensory neuro/conductive hearing loss (abnormal) mixed sensory neuro/conductive hearing loss.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with the drug in response to events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Symptoms were still ongoing and present at the time of this report; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: En6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: Ep7534), in right arm, on 27Sep2021 as dose 3 (booster), single (Lot number: Ew0164), in right arm and on 13Apr2022 as dose 4 (booster), single (Lot number: Fm0698) at the age of 62 years, in left arm for Covid-19 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "slight high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 11May2022, stop date: 28May2022. Past drug history included: Aleve, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: home test said I was positive for the virus. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: Patient received Paxlovid as each packet exactly 12 hours apart (7 a.m. and 7 p.m.) for five days until gone. Four days later, Covid symptoms returned and a home test reported as positive for the virus. Symptoms were mild.  Follow-up attempts are completed. No further information is expected.
10/9/2022 new onset of intermittent left-sided chest and shoulder pain.  Cramping/stabbing intermittent pain not associated or relieved by movement.  Some lightheaded feeling.  Has persisted with infrequent occurrence for 3 days now.  Elevated Blood pressure with Diastolic readings as high as 100.
This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. A 42 year-old male patient received bnt162b2 (COMIRNATY), administration date 03Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: CHEST PAIN (non-serious), VACCINATION SITE PAIN (non-serious) all with onset Dec2021, outcome "unknown" and all described as "Chest pain on their right side together with injection site"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "Pain in extremities"; JOINT SWELLING (non-serious) with onset Dec2021, outcome "not recovered", described as "Swelling on right knee both posterior and anterior/knee swelling is getting worse"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Both the patient's knees are swollen and painful". The events "chest pain on their right side together with injection site", "pain in extremities", "swelling on right knee both posterior and anterior/knee swelling is getting worse", "both the patient's knees are swollen and painful" and "chest pain on their right side together with injection site" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: It was reported that the patient had continuing side effect after getting the Pfizer Covid-19 vaccine as booster dose. The patient experienced those side effects 12 hours after the booster dose administration, and complained that the swelling was worse at that time wherein both the patient's knees were swollen and painful. The patient had lab tests, kidneys were normal, rheumatoid arthritis also normal and all tests were normal but the knee swelling was getting worse. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sudden onset of fever accompanied with febrile seizures approxmitatly 9 days after vaccinations were recieved. visited ER after first seizure on 3/19/09 and follow up visit with pediatriction on 3/20/09 and at approx 4pm on 3/20/09 was taken back to local ER with high fever and  2 small seizures . Upon arrival to ER he had another seizure and was hospitalized overnight. several tests were run to determine the origin of fever and the only thing that was found was a very slight ear inflamation and the ER physican said that there was a possibility that it could be an adverse reaction to his vaccinations received 9 days prior to this event.  3/27/09 Received hospital medical records of 3/19-3/20/2009. FINAL DX: febrile seizures, resolved; middle ear effusions Records reveal patient experienced several episodes of febrile seizure w/generalized shaking of arms & legs, eyes rolled back in head.  Seen in ER & dx w/acute otitis media & started on oral antibiotics.  Seen by PCP who concurred w/dx.  Recurrent febrile seizures & admitted.  Temp max in hospital 102.2.  No further seizure activity & d/c to home on continued oral antibiotics.
-pain at injection site that began as soreness and progressed to 7/10 pain and radiated to same side shoulder, neck and back that lasted for first 48 hours -pain near injection site continued past first 48 hours and still continues 12 days after injection with moderate pain to touch and pain when lifting arm and lying on affected side