chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus began immediately following vaccine.  At nighttime when the surrounding noise is reduced and the quiet occurs, I now find it difficult to fall asleep because there is a continual loud buzzing/ringing noise running throughout my brain and extending through my ear canals.  I have never had Tinnitus and always pitied people that had the condition and never understood the issue, until now.  There should be a warning on these vaccines that they may cause Tinnitus.  In this instance, ignorance is not bliss because blissful sleep is no longer going to be allowed in a certain percentage of the population that receives these vaccines?  I intend to contact my doctor for testing. I am disappointed that no one in charge has brought this to the attention of the public.  We have the right to make factual decisions.  There are numerous people suffering from Tinnitus currently being ignored.  Given this condition, how can I take another vaccine knowing it could further exacerbate this problem.
This spontaneous report was received from a 63-year-old female patient, who was reporting on herself. The patient was also a nurse. Her concurrent conditions included high cholesterol. She did not have any drug reactions or allergies. No other information regarding the patient's pertinent medical history was provided. On 12-AUG-2016 (also reported as "when she was 52 years of age"), the patient was vaccinated with ZOSTAVAX injection, via subcutaneous route (dose, site of administration, lot number and expiration date were not reported) for prevention of shingles. Concomitant therapies included unspecified over-the-counter products and lisinopril (manufacturer unknown). On an unknown date, the patient developed granuloma annulare. The physician's assistant, who was the patient's primary doctor, knew of her condition. The patient was prescribed prednisolone (manufacturer unknown), a 4 mg solumed pack. There were no laboratory diagnostic studies performed and she was not given another dose of vaccine. There was no product quality complaint (PQC) involved. The outcome of granuloma annulare was not reported. The reporter considered granuloma annulare to be possibly linked to ZOSTAVAX. Additional information is not expected as no consent to contact the physician was granted.
Vomited up his breakfast and then continued to vomit all day long when any food or milk taken in.  The following day threw up first milk of the day but kept down the rest of the milk that day and was able to eat dinner (soup).  Third day kept down breakfast, threw up lunch, didn't have much of an appetite.  Today is finally back to normal.
Eyelids and lips swelling within 6 hrs of receiving vaccines. Seen at hospital, received 2 tsp of Benadryl and referred to return if problems.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored MMR II lot # L019989/expiration date 01-JUN-2017, lot # L028273/expiration date- 28-JUL-2017. No adverse event. Excursion temperature was 31 F and timeframe was 152 days (worst case). There was no prior temperature excursion. Call was because of the data logger. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
mom states child had area under eye which appeared to have been bumped on something which is where swelling began & encompassed entire face, w/redness & fever in the face but no elevated temp;given PO DPH & decadron in the ER;
nadvertently given expired product with no reported adverse event; nadvertently given expired product with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA419169(CLUSTER) and 2022SA420010(CLUSTER).  This case involves a 10 months old male patient who was inadvertently given expired product with no reported adverse event ,after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7378MA and expiration date: 30-Jun-2024) at a dose of 0.5ml once via intramuscular route in the vastus lateralis for immunization.  On 07-Oct-2022(latency: same day), the patient was inadvertently given expired product with no reported adverse event (expired product administered) (accidental exposure to product) following the administration.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
After 2nd dose of Moderna vaccine I had restlessness.  Unable to sleep from 1:00 a.m. - 6:30 a.m.
my sister went to the er on July 20th with what seem to be a illergic  reaction... she said she was itching all over and was swelling. They sister passed away on July 26th from myocarditis which is stated o. The cdc website a direct side effect of the moderna shot.
My friend, received both shots of the vaccine a few months back.  She know has COVID.; My friend, received both shots of the vaccine a few months back.  She know has COVID.; This is a spontaneous report from a contactable consumer. A 48-year-old non-pregnant female patient received first dose of BNT162B2(reported as "COVID vaccine", via an unspecified route of administration on an unspecified date, at 48-year-old, as single dose (Batch/Lot number was not reported)  and a second dose of BNT162B2(reported as "COVID vaccine", via an unspecified route of administration on an unspecified date, at 48-year-old, as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included compromised immune system. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines with 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient received both shots of the vaccine a few months back and she had COVID on 31Jul2021. The patient underwent lab tests included Covid-19 (with unknown test type): positive on 31Jul2021. It was unknown if the patient received any treatment. The outcome of events was recovering.  Pfizer is a marketing authorization holder of COVID vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID vaccine has submitted the same report to the regulatory authorities.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist refers to a 17 year old patient of unknown gender. The patient's pertinent medical history was not reported. On an unknown date the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (Dose Frequency: unspecified, Therapy Route: unspecified). Concomitant medications were not reported. On an unknown date the patient received second dose of (Oka/Merck) VARIVAX less than 4 weeks later and no adverse effect reported. No product quality complaint (PQC) was reported for VARIVAX. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. On a recent unspecified date, the patient was given a FLUARIX QUADRIVALENT injection as a requirement for her employment. After an unspecified period of time after the injection, the patient broken out in a rash. The patient did not consent to follow-up. The caller did not wish to participate in answering questions for an adverse drug event report.
Patient complained of dizziness after vaccine and put her head forward.  A Rapid Response was called and patient taken to observation area via wheelchair.  During transport patient has a near syncopal episode.  Moved to gurney.  Nurse Practitioner evaluated.  1528 BP 108/69, P 69, 02 98%.  Patient responsive and denies any other symptoms.  She states she has a prior history of syncopal episodes with a tongue piercing.  She responded well to reclining on gurney. Given water and crackers.  1533  BP114/79 P 72, 02 100%.  1558 patient discharged home with husband.  BP 106/73 P 66 02 98%. on discharge.  Patient advised to lie down when receiving second vaccine
administered Act-Hib with expired diluent/no AE; Initial information was received on 01-May-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 20 months old female patient who received 0.5 ml HIB (PRP/T) VACCINE [ACT-HIB] with expired diluent (expired product administered) via intramuscularly at the left thigh on 29-Apr-2020 for prophylactic vaccination [batch number and expiry date of diluent U6205AA and 22-APR-2020]. Batch number and expiry date of ACT-HIB and box was reported as UJ064AA , UJ064AAA and 04-OCT-2020, 22-APR-2020 respectively.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
muscle pain; Today, very short of breath; temp 102.5; uncontrollable chills; no appetite; no thirst; blistering; headache; weird bone; This is a spontaneous report from a contactable consumer reported for male (patient himself). A 53-years-old male patient received (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: ER8729), via an unspecified route, administered in Left Arm on 28Apr2021 at 04:45 PM (53-years-old at vaccination) as Dose 2, Single for Covid-19 immunization. Facility of the most recent COVID-19 vaccine was administered was reported as Other. The patient's medical history included asthma, hypertension, high T3 (triiodothyronine). The patient's concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and nebivolol hydrochloride (BYSTOLIC) within 2 weeks of vaccination. The patient past medications included terramycin, tetracycline and penicillin and the patient was allergic to all past drugs. 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. The patient previously took historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: EW0176), via an unspecified route, administered in Left Arm on 06Apr2021 at 03 :45 PM (53-year-old at vaccination) as Dose 1, Single for Covid-19 immunization. The patient had experienced BRVO (Branch Retinal Vein Occlusion) in the right eye approximately 1 week after first dose of injection. The patient received Shot in eyeball for 1st, nothing yet for the 2nd. On 28Apr2021 at 08:00 AM, the patient experienced muscle pain, very short of breath, temp 102.5, uncontrollable chills, no appetite, no thirst, blistering, headache, weird bone. Since the vaccination the patient had not been tested for COVID-19. These events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment medication for resulted events. Device date was reported as 28Apr2021. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information was expected.
5 minutes after shot shoulder pain then down to forearm.   10 minutes after shot, fast heartbeat and a little trouble breathing, headache, feel cold, stomach ache, belly ache, wanted to throw up,  muscles shaking, throat sore.   Drank vitamin C 1000mg.   After 15 minutes I felt better.   About every 15 minutes there would be another wave of the same pains.   Then I would feel better and then another wave.   There were five waves.   After 1 1/2 hours, it stopped and I went home.   Later that night, I was very thirty, couldn't sleep and my kidneys were sore.   Next morning, I could not raise my arm from the pain.  Every day since, I have had another wave of the same pains once in the morning and then again in the evening.   Each wave lasted 1 to 2 hours.   I would sleep and afterwards felt better.  Saturday March 20th, the wave at night was the worst one and it lasted 3 hours.   The wave today March 21st, the wave was smaller and then I could sleep.   Today my arm is better, I could move it normally.
This spontaneous report was received from a registered nurse via a company representative and refers to a child of unknown age and gender. On 05-JUN-2015, the patient was accidentally vaccinated with ZOSTAVAX (route of administration, dose, lot number and expiry date were not reported). The patient was prescribed VARIVAX (Merck). No adverse effect was reported. Additional information has been requested.
My fingers have reduced feeling and complete numbness all of the time.  Hands, forearm, bicep and shoulder are weak intermittently.  Weakness in hands and legs. Balance is off quite a bit. Buckling at the knees in both legs. Intermittently have intense pain and pressure in the joints of my fingers. Have much difficulty traveling up or down stairs. General fatigue.  Cannot follow my normal exercise regimen at all.  Saw primary care physician and was referred to a neurologist to follow up with the next day. Neurologist conducted several tests.  Latest blood work showed inflammation.  It has been 6 weeks and my symptoms have not yet improved.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of varicella zoster virus vaccine live. Subsequently the patient experienced localized swelling, redness and pain at the injection site. Unspecified medical attention was sought. The patient was given and antibiotic and it helped with the pain and swelling. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a physician concerning two female patients who were vaccinated with GARDASIL. The physician reported that the patients experienced abnormal pap smears after receiving all three doses of GARDASIL. The patient outcomes were not reported. Additional information is not expected.
Redness, swelling, pain left deltoid. Patient running fever. Doctor prescribed Keflex 500 TID x 10 days.
arm soreness; general fatigue for 2-3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 , MANUFACTURER UNKNOWN, ), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "general fatigue for 2-3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Urticaria rash started on 1/29/22 and since that time has developed dermatographism.on her upper back.
Site was hard red raised bump and she cried when it was touched even gently. Constant high fevers She is still scarred. Doctor prescribed tylenol.
chicken pox like rash from neck to toes; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th November 2019, 6 days after receiving Shingrix, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.  Additional details were provided as follows: The patient received 2 of Shingrix and developed a chicken pox like rash from neck to toes. The patient had been seen by an urgent care clinic. The reporter consented to follow-up. No other information available at the time of reporting.
I received the vaccine at 11:30 on the morning of Feb 26.  I noticed a rash on the inside crook of both of my elbows and across my chest on Sunday Feb 28 when I woke up.  It not itch or burn.  It was just red and splotchy.  Monday morning it was somewhat faded but down my forearms and the tops of my hands and fingers.  It continued to lightly appear and fade on and off for about a week.  I called my doctor and he said if it gets worse to come in but to go ahead and get the second dose.  I am scheduled to receive it at 11:30  tomorrow, Friday, March 26,  at Hospital.
Site: Pain at Injection Site-Mild, Additional Details: After getting first moderna shot, patient was at the monitoring area. I came and checked up on patient. She said she felling fatigue, cant walk, and experience some vision changes. I called 911 and gave patient some orange juice to drink. EMD came and checked her vitals bp was 104/81 and ekg seems normal. EMD took her took the car to do more further test.
Patient stated having numbness and weakness in arm that vaccine was given in. Also was achy - was better after sleeping thru the PM but worsened as used it on the following day - was increasing with use.
ProQuad was stored in the refrigerator for 6 days prior to administration.  No reaction or adverse event.  Will re-immunize in 4 weeks
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMh significant for tobacco use, hollenhorst plaque, vitamin d deficiency, glaucoma, CAD, malignant tumor or lung. parkinsonism, pneumonuia. per note on 4/16 "The patient is an 84-year-old with a past medical history significant for Parkinson's disease, lung cancer, peripheral vascular disease, orthostatic hypotension, chronic bronchitis, CAD status post pacer placement who presented to the emergency room with his wife secondary to generalized weakness. The patient reportedly fell 3 times on April 4 one fall resulted in his head striking a wall another fall resulted in a injured right hand/wrist. Since that time the wife is noted increasing weakness, inability to stand on his own and a loss of ambulatory capabilities. His wife also reports that the patient's been experiencing a cough with a green-colored sputum for approximately 4 weeks now. She also notes nonbloody diarrhea ?2 this morning and blood in his Foley bag. He's had no fevers chills nausea or vomiting. The patient also reports no headaches dyspnea or chest pain no abdominal pain or nausea or vomiting. Workup in the emergency room revealed an elevated white count and anemia lactic acid was normal as was his CMP. Chest x-ray revealed subtle opacities at the base left greater than right that may be related to pneumonia though much less suspicious that we'll was on previous study. There was also some irregular subcentimeter densities visualized in the lungs most suspicious in the upper right lung zone that may be the result of scarring although small pulmonary nodules could not be excluded. A CT of his head showed no acute abnormalities of the cervical spine with similar multilevel degenerative disc disease and facet arthritis throughout the cervical spine noted. His UA showed leukocyte esterase of 500 urine RBCs greater than 180. The patient was admitted. with a diagnosis of recurring pneumonia felt to be secondary to aspiration and a UTI. I been asked to see the patient to introduce his wife to hospice and palliative medicine and to evaluate for appropriateness for admission to facility. Initially the patient is wife stated that she was not interested in hospice. She reported no interest in both home hospice nor inpatient hospice. She reports that she had a home health nursing agency that she was pleased with and wanted to continue using this resource to help her care for her husband." Patient deceased 5/6
Vx mixed with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA675A, expiry date 31st March 2023) for prophylaxis.   On 23rd February 2023, the patient received Menveo. On 23rd February 2023, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 24-Feb-2022 Reporter's Comments:  Medical assistant reporting inappropriate reconstitution technique for Menveo.  Menveo mixed with sterile water and administered on 23rd February 2023. The reporter consented to follow up. AE contains all reported information. Additional Supportive Information: The patient received Menveo which was reconstituted with sterile water, which led to Wrong solution used in drug reconstitution.
Initial misuse report received from a nurse on 02 December 2013. The patient had received ACT HIB and was diluted with MMR diluent. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.