chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a full blown Herpes Infection in that eye; after the vaccine my right eye started feeling weird; This serious case was reported by a consumer and described the occurrence of herpes ophthalmic in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes ophthalmic (the patient had a prior medical history of a herpes right eye Infection which flared up approximately every 6 to 9 months when patient became either fatigue or extremely stressed), fatigue and stress. Previously administered products included Valtrex (the patient was taking Valtrex 500 to 1000 mg whenever had an infection). Additional patient notes included had no flare ups for almost a year and decided to get first Shingrix vaccine.   On 19-JAN-2023, the patient received the 1st dose of Shingrix. In JAN-2023, 1 week after receiving Shingrix, the patient experienced herpes ophthalmic (Verbatim: I developed a full blown Herpes Infection in that eye) (serious criteria GSK medically significant) and abnormal sensation in eye (Verbatim: after the vaccine my right eye started feeling weird). The outcome of the herpes ophthalmic and abnormal sensation in eye were not reported.   It was unknown if the reporter considered the herpes ophthalmic and abnormal sensation in eye to be related to Shingrix.     It was unknown if the company considered the herpes ophthalmic and abnormal sensation in eye to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAY-2023 The patient self reported this case. About a week after the vaccine the patient's right eye started feeling weird and developed a full blown Herpes Infection in that eye. The patient was wondering if they should take a chance of getting the second shot. The reporter asked if Valtrex could be administered before the second shot or immediately after the second shot. Even the doctor could not answer this question.
THE PATIENT WAS TO RECIEVE THE SECOND DOSE OF THE MONOVALENT COVID 19 TO COMPLETE THE INITIAL SERIES.  THE BIVALENT WAS ADMINISTERED INSTEAD.  THE PATIENT DID WAIT IN THE OFFICE FOR THE RECOMMENDED TIME OF 15 MINUTES AFTER ADMINISTRATION WITH NO PHYSICAL ADVERSE REACTION NOTED.
A few hours after receiving the first PFIZER vaccination patient experienced generalized muscle twitching that started on right side of body (vaccination administered in left deltoid). Twitching initially  happened in face, arm, leg, glute and calf on right side, The night of vaccine had jerk movement out of sleep and very vivid dreams. Low grade temp the night of with left collar bone and left arm soreness. Felt generally "off". The following day patient's twitching focused more on right calf and glute with calf cramping. Twitching resolved one and a half weeks later.
Rash about 1.5 in long and 1 inch wide on left arm near vaccine site
noticed that her chin was getting fatter and not reducing; This is a spontaneous report from a contactable pharmacist (patient).    A 56-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported),via intramuscular route of administration, administered in left Arm on 18Apr2021 at 15:00 as Dose 2,Single (at the age of 56-years-old) for COVID-19 immunization and deoxycholic acid (KYBELLA) taken for fat tissue increased, start and stop date were not reported. The patient previously received Shingrix to prevent shingles in Nov-2020 and first dose of bnt162b2 vaccine on an unspecified date in Mar-2021 (26th or 27th) administered via intramuscular route of administration in left arm as Dose 1, Single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced they remove fat from the chin/I am having an opposite effect where before I as showing a positive outcome and then along came the pfizer vaccine and noticed that her chin was getting fatter and not reducing. Reporter stated that she had both shots of our shots of Covid vaccine, she was undergoing Kybella treatment which is an injection to reduce chin fat. Wanted to know if they have had reports of problems with the vaccine with Kybella. Stated that she should have had chin reduction and is experiencing the direct opposite.  Both having negative outcomes and believes it is related to product.  A review of interim safety data from the clinical program did not identify adverse events specifically associated with Botox or cosmetic fillers. The outcome of the events is unknown at the time of this report.  Follow-up attempts needed. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reporter's Comments: Reporter causality: She thinks it is RELATED to the product.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100945497 Same reporter/drug/event, different patient
initial soreness in arm the next morning i had severe headache, muscle aches, joint pain, and fever. i slept all day and all that night. i was not able to work that day. The next day, i had joint pain and muscle aches, and sore left arm and left armpit.
had severe itching then hives started all over my body, 9 days later, still currently on steriods
Minimal soreness at injection site; headache; some lethargy; This is a spontaneous report from a contactable consumer reported that: A 68-years-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/Lot Number: EL3248; Batch/Lot Number: EK9231), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jan2021 as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included type 2 diabetes mellitus, patient is allergic to sulpha, tetracycline, shellfish, IV dye. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received concomitant medications from unspecified date at unspecified dose frequency and an unspecified indication included: sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]), hydrochlorothiazide (HYDROCHLOROTHIAZIDE) phytosterols nos (CHOLESTOFF ORIGINAL), colecalciferol (VITAMIN D [COLECALCIFEROL]), acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID; ASCORBIC ACID]). On 16Jan2021 08:PM, the patient experienced minimal soreness at injection site, headache, some lethargy. Outcome of the events were recovered.
shivering; nauseous; This case was reported by a consumer via interactive digital media and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 9th January 2021, the patient received the 2nd dose of Shingrix. On 10th January 2021, 1 days after receiving Shingrix, the patient experienced shivering and nausea. On an unknown date, the outcome of the shivering and nausea were unknown.   It was unknown if the reporter considered the shivering and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient him/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received 2nd dose of Shingrix and on the next day, the patient was shivering and nauseous. The patient wanted to know that do he/she needed to contact physician or wait it out and how long would these symptoms continue.
After I was administered the vaccine at the University, after spending a few minutes I began to feel a sensation in my throat as if it were swelling, scratching and when I swallowed I did not feel it. Every time the minutes passed I felt it more. After the 15 minutes passed, I notified him and a paramedic gave me all the vital signs which had an elevated blood pressure and an elevated pulse. They took me to the ambulance where I was under supervision. I continued with the sensation of throat and dizziness. I took the medicine that the doctor had prescribed: benadryl and prednisone in case of having an allergic reaction. I continued with the symptoms and my mother was watching me in case of having difficulty breathing and when I got home I got a little nauseous. Present tiredness and pain in the area that disappeared on Sunday. From Sunday until today I have presented insomnia since it is difficult for me to sleep and I manage to sleep a few hours.
This spontaneous report as received from a nurse refers to a 61 year old patient. Medical history and concurrent conditions were not reported. On 22-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Pt received ZOSTAVAX shot on 9-13-16. Reported sore red bump and 2 in red rash on 9-17-16 to RPh.
Info has been received from a physician concerning a 19 month old Asian female with no known medical history or allergies who on 5/18/05, in the PM, was vaccinated in the left arm with a 1st dose of varicella virus vaccine live (lot 649845/0767P). There was no illness at the time of vaccination. On 12/23/05, the pt developed breakthrough chickenpox. The pt had 18 lesions and they were all on her back. The pt's breakthrough was also described as vesicle/papules on a red base on lower back, 18 total. Unspecified medical attention was sought. No relevant diagnostic tests were performed. The pt's outcome was recovered. The pt did not experience adverse events following prior vaccinations. There was no product quality complaint involved. Additional info is not expected.
Macular papular rash; some hives to forehead; onset acute; noticed the rash shortly after midnight.
I had a slight fever and fatigue after receiving the vaccine. I was previously diagnosed with a bit of an irregular heart rhythm. On 03/16/2022, after wearing a heart monitor for a week, I was diagnosed with supraventricular tachycardia. As of today, I am having a lot of allergy and sinus issues.
Information has been received from a nurse concerning a female who on 13-Jun-2008 was vaccinated with the third dose of GARDASIL. On the same day, after receiving her third dose, the patient passed out in the office and experienced syncope. Subsequently, the patient recovered fully from syncope on the same day. The patient saw the nurse practitioner. This is one of several reports received from the same source. Additional information has been requested.
Patient is a 73 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15-minute waiting period after the injection, the patient began to experience lightheadedness and headache, flushed, left deltoid where vaccination given hot to touch, nausea.  She denied rash, difficulty breathing, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality, rapid progression of symptoms, respiratory distress and skin changes.     Patient with flushing, headache, left arm warm to touch, and nausea after first vaccine administration of Pfizer in the 15-minute waiting period.  Blood pressure elevated, SpO2 is 98-99% on room air, pulse 68.  Patient notes that she has reactions with medications and vaccines.  Water provided.  After sitting for a few minutes, patient reports that she is no longer lightheaded, headache is almost gone, nausea has resolved.   ALLERGY REVIEW OF SYSTEMS:   Waves of nausea:  Lightheaded with some dizziness, headache:     Previous Reactions: Adverse reactions to medications in the past.    Objective    Vitals Vitals:   02/09/21 1145 BP: (!) 179/63 Pulse: 68 SpO2: 98%            Physical Exam Constitutional:      Appearance: Normal appearance.  HENT:     Head: Normocephalic.     Mouth/Throat:     Mouth: Mucous membranes are moist.  Eyes:     Extraocular Movements: Extraocular movements intact.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Musculoskeletal:        General: No swelling.     Right lower leg: No edema.     Left lower leg: No edema.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water and patient took Tylenol before vaccine administration Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash)     Patient feeling back to normal.  BP 152/76 at 1203.  All symptoms have resolved.  Left deltoid without swelling, redness, rash.  Patient ambulating without difficulty.  She is cleared to drive home.  If she should have symptoms return or worsen, she is to call PCP or go to ER.
5 days after receiving vaccine (only have sore arm for two days) began to have pain all along collarbone on left side and enlarged lymph nodes, one the size of a grape. Tenderness to point that uncomfortable to wear seat belt or even undergarments cause pain. Occasional tylenol for pain and monitoring. At this time, still swollen and sore.
ON 9/16/2019, PT RETURNED TO PHARMACY AND TOLD US THAT ON THE DAY HE RECEIVED THE VACCINE HE HAD TO GO THE EMERGENCY ROOM DUE TO SEVERE PAIN IN LEFT DELTOID, AND SAID THAT HE THOUGHT HE WAS HAVING A HEART ATTACK, AFTER BEING ADMITTED ER DOCTOR TOLF HIM THAT WHAT HE WAS EXPERIENCING WAS A RESULT OF THE VACCINE HITTING A NERVE.
This spontaneous initial report was received from a nurse, referring to an unspecified age and gender patient. Patient's medical history, current conditions and concomitant medications were not reported. The Nurse informed that on an unspecified date the patient was vaccinated with an improperly stored ZOSTAVAX (strength, dose and route were not provided) Lot # M040146, expiration date 26-DEC-2017; reconstituted with properly stored sterile diluent (MERCK) Lot # L029308, expiration date 31-MAR-2018; indicated for prophylaxis. The storage temperature reported was -11 Celsius degrees with a time frame of 5 hours. No digital data logger was involved. Previous temperature excursion was not reported. No adverse event was reported.  .
every once in awhile during the day i get a racing heart...heart palpitations,  just when im sitting doing nothing
COVID-19 Positive Test Results; COVID-19 Positive Test Results; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EL9269, Expiry date: Unknown) via intramuscularly administered in Arm Left on 02Mar2021 (at the age of 58-years-old) as dose 2, single and patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EM9809, Expiry date: Unknown) intramuscularly administered in Arm Left arm on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 31Jul2021 the patient experienced COVID-19 positive test results. On 02Aug2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Rapid Antigen Test) as positive for nasal Swab. Patient did not receive other vaccine in four weeks. Patient has no covid prior vaccination, He tested for covid post vaccination. The events resulted in doctor or other healthcare professional office or clinic visit. No treatment received for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Morderna COVID-19 Vaccine given on 2/27/2021 after receipt of Pfizer COVID-19 vaccine on 2/15/2021.
Initial information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional and an additional information was received on 05-Dec-2018 from the same reporter. This case was linked with 2018SA336905 (same reporter). This case involves a 54 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (lot UJ046AB) in the shoulder nos. on an unknown date at 07:42 AM (reported as yesterday) that was exposed to 11 F. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to product storage error and deteriorated drug administered. It was not reported if the patient experienced any adverse event. 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. List of documents held by sender: none.
My left arm was swollen 3 times its normal size. I had swollen hands and my lymph node stopped working.
Extreme weakness; Fainted; Loud ringing in ears after regaining consciousness for 5 minutes.
Lymph node swollen on left side  of neck, temperature was 100.5, muscle ache, swollen & pain at injection and fatigue
feeling ill after receiving a flu vaccine; Initial information received on 24-Sep-2023 (processed as a non-case) and follow up information received on  24-Sep-2023 regarding an unsolicited valid non-serious case received from a patient via specialty pharmacy.   This case involves a 68 years old male patient who experienced feeling ill after receiving a flu vaccine (INFLUENZA VACCINE) and while treated with DUPILUMAB [DUPIXENT] via dupixent single dose pre-filled pen.  The patient's past medical history, medical treatment(s), concomitant disease, risk factor and family history were not provided.   On an unknown date, the patient started taking DUPILUMAB Solution for injection at a dose of 300 mg subcutaneously (strength: 300 mg/2mL, frequency: other, with an unknown batch number, indication and expiry date). On an unknown date, the patient received a dose of suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  Information on batch numbers was requested.  Patient reports missing one dose of Dupixent due to feeling ill after receiving a flu vaccine (malaise) (onset: 24-Sep-2023,  unknown latency)   It is unknown if there were lab data/results available.  Action taken with DUPILUMAB was drug withdrwn.   Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (feeling ill after receiving a flu vaccine).  At time of reporting, the outcome was Unknown for the event feeling ill after receiving a flu vaccine.  Additional information was received on 24-Sep-2023 from patient: Case was updated from non case to valid case. Text amended accordingly.
EMPLOYEE DESCRIBED "TASTING THE VACCINE" IMMEDIATELY AFTER ADMINISTRATION. AT 8 AM SHE DESCRIBED NUMBNESS AND TINGLING IN HER LEFT JAW DOWN LEFT SIDE TO KNEE LASTING 24 HOURS. CONTINUES IN L JAW TO DATE.