chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles on left upper leg; Nerve pain started on left upper leg and back; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the  left arm on 19Feb2021 at 10:30 (at the age of 67-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on unknown date 2021 as a single dose for COVID-19 immunisation. Medical history reported as none. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06May2021, the patient experienced nerve pain which started on left upper leg and back. Severe nerve pain was still going on at the time of this report. On 12May2021, the patient experienced shingles on left upper leg. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which included treatment with valacyclovir, gabapentin 100mg and hydrocodone from unknown date. The clinical outcome of the event nerve pain started on left upper leg and back and shingles on left upper leg was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
R. arm site very sore with redness + swelling by evening, Also, tiredness, muscle pain, poor sleep overnoc with shivering Symptoms lasted 24-36 hours - my instructions were to report any reactions.
This case was reported by a pharmacist via call center representative and described the occurrence of white blood cell count increased in a 60-year-old male patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 20th February 2018, the patient received 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2018, 2 days after receiving SHINGRIX, the patient experienced white blood cell count increased. On an unknown date, the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the white blood cell count increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 13:40 hours, the patient received SHINGRIX on left deltoid. The health care professional reported that 2 days after receiving  SHINGRIX, the patient experienced increase in white blood cell count (abnormal lab results) in their lab report. The patient had blood drawn 2 days after SHINGRIX dose. The health care professional was notified about lab results 6 days after blood was drawn.
Fever, Headache, Fatigue, and Stomach ache, Nausea, Muscular pain
Pt came into  clinic to get her second Covid 19 vaccine. Pt had her covid consent all filled out stating that she was wanting the Moderna and on her vaccine card it only had the lot number of the vaccine. I did not check to see if she had the Moderna for her first shot, I only checked to date to make sure enough time has passed. Pt had her first covid vaccine as the pfizer and the second was Moderna. I did reach out to patients PCP, the doctor and the CDC to get some recommendations and both of their recommendations were to not repeat the series and to report to Vaers
Suspected vaccination failure; Got the Shingles in February!; The blisters dried up; Nerve pain that's left; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, blister and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the blister was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. The patient received Shingles vaccine several years ago from the date of reporting and in February of an unknown year got shingles. The blisters dried up, but the nerve pain was left till the time of reporting. Additional Supportive Information: This case was reported via interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
chronic severe urticaria or hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA CHRONIC (chronic severe urticaria or hives) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA CHRONIC (chronic severe urticaria or hives). At the time of the report, URTICARIA CHRONIC (chronic severe urticaria or hives) outcome was unknown.            No concomitant medications were reported.  On 20-Oct-2022, the patient received the Moderna Bivalent Covid-19 booster vaccine at an unreported dose, route and frequency of administration for Covid-19. It was reported that since receiving the vaccine, the patient had experienced chronic severe urticaria or hives.  No treatment medications were provided.
Redness and swelling around administration site. Also warm sensation. Signs have been going on for 4 days after administration. Mobility of arm is completely fine.
I did get Shingles in my right eye.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. It was reported that "It just occurred to me that I should let Pfizer know that after my 2nd Covid 19 vaccination, I did get shingles in my right eye". The reporter gave consent to contact if additional information is required. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
patient was going through actually Covid symptoms; lost sense of taste and smell; lost sense of taste and smell; fatigue and tired; Diarrhea; This is a spontaneous report from a contactable consumer. A male patient (consumer's father) of an unspecified age (reported as patient age: 83; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 17Feb2021 (Batch/Lot number was unknown) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer reported that the patient was going through actually Covid symptoms, on an unspecified date in Feb2021, where the patient lost sense of taste and smell. He was fatigue and tired and was now having diarrhea. The patient was having it from past 6 days. The patient underwent lab tests and procedures on 26Feb2021 which included COVID test with unknown results. The consumer wanted to get advice about the events and ideas about what could be happening and what they could do. The patient did not recover from the events on the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
03/11/2021 vaccination. Late summer, I experienced hot flashes and losing weight without doing anything. That continued, annual physical in November. My thyroid levels were off. More testing done in Dec 2021 which were 'off'. I had COVID 01/26/2022. With COVID, I broke out in hives. A day or 2 later, had a hard time, winded, and HR increased. Took steroids, antihistamines. My lips and throat swelled. I was in the hospital on March 4 and discharged March 6th; local Hospital. I came back on Sunday, notified on Graves disease. Going to see allergist in a couple of weeks. My HR still goes up easily. *Monitored yearly for thyroid due to my mom having thyroid issues. My annual blood work had been fine until now. *Been on steroids since being in hospital. I just finished this past Friday.
Shingles diagnosis, 1000mg valacyclovir 3x daily for 7 days after symptoms appeared after dose 1, started improving after 3 days of treatment;  starting same regimen after symptoms appeared yesterday after dose 2
Pt. stated redness, swelling and red varicose and warm to touch from/at injection site. Pt. explained to take TYLENOL and Ice. Pt. came into clinic and they prescribed clindamycin and prednisone.
I started feeling heart palpations that woke me up in the middle of this night. I was having surges of palpations all through the day. I went to the doctor a week later. I was sent to get blood work which was clear. It took a month to get a Holter monitor that noted surges. I was told if it got worse would get a consult for a cardiologist. I didn't go due to health expenses. I now have a prescription for Propranolol 10mg that I can take 3 times a day prn but I usually take it once to twice a day.
I first had pain in my neck on the left side starting Friday. By Saturday the pain was more intense and I started to notice loss of function in the left side of my lips. Sunday night the entire left side of my face had lost function. Eye wouldn't close, eyebrow could not raise, no function in left side of lips, loss of movement in cheek, left half of my tongue lost taste and sensation. I made an appointment the next day and was seen Monday night. I was diagnosed with a classic case of Bell's Palsy and prescribed 10 days of oral steroids. Symptoms continued unchanged for five days before beginning to see some improvement. Final outcome is yet to be seen.
still feeling a little bit of symptoms from corona; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (still feeling a little bit of symptoms from corona) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (still feeling a little bit of symptoms from corona). The patient was treated with PARACETAMOL (TYLENOL) for Sinus headache, at a dose of 1 dosage form. At the time of the report, COVID-19 (still feeling a little bit of symptoms from corona) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (abnormal) covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant  medications included reflux pill everyday  Treatment details included Tylenol sinus and headache
Shingles; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 03:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer. The patient had known allergies to penicillin and bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021, at 15:45 the patient experienced the events shingles (reported as shiggles) and headaches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unknown medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shingles and headache were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (8 weeks since patient received first dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (8 weeks since patient received first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (8 weeks since patient received first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact.
Rapid heartbeat, dizziness, weakness, shaking (not chills), fainting, confusion
Left-sided facial paralysis diagnosed as Bell's palsy. Symptoms began on 4/6 as dry eye (due to the left eye not blinking properly) with facial paralysis evident on 4/7. This continued to get progressively worse until full left-sided facial paralysis and diagnosis of Bell's palsy on 4/8. Began a 7-day course of prednisone and valacyclovir on 4/8. The onset of symptoms was accompanied by neck pain for a few days prior. To date, there has been some improvement but not back to normal yet. No prior medical history of Bell's palsy or any other facial paralysis.
Small, red, itchy blotches on my face, about 3/8? in diameter.
chills; headache; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 9th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a day after receiving Shingrix, the patient experienced chills and headache. The patient was treated with naproxen (Aleve). On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the chills and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that had no side effects with the 1st dose but with the 2nd dose had chills all night and a headache. The patient asked what is the best way to treat the side effects.
I have PMR and after using the muscel I got the shot in it would pulse with pain.  This happened 2x on Mon 18th and Tues 19th.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 at 14:00 as dose 1, single (Lot number: EL9269), in left arm, on 04Mar2021 at 14:00 as dose 2, single (Lot number: EL6199), in left arm and on 24Sep2021 at 14:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12May2022 at 14:00 as dose 4 (booster), single (Lot number: 059M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "gerd" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; LIPITOR; DESCOVY; BENADRYL; PANTOPRAZOLE; SINGULAIR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (unspecified date) negative, notes: Had been negative each of prior 4 days; (31May2022) Positive, notes: Last positive antigen test was Tuesday 31May; (05Jun2022) Positive, notes: Positive rapid antigen test today (05Jun). Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 27May2022 to 31May2022.  Clinical course: Paxlovid/Covid rebound on 4th day after completing 5-day Paxlovid prescription. Symptoms returned on 04Jun2022. Positive rapid antigen test on 05Jun2022. Had been negative each of prior 4 days. Last positive antigen test was Tuesday 31May2022. Symptoms had resolved on 29May2022.  No follow-up attempts are possible. No further information is expected.
Tinnitus hearing loss and dizziness vertigo since March 15. Doctors visit heating screen pressure test in ear MRI of head. Meclizine Valium 12 day course of steroids Zofran. As of today April25 symptoms still persists.
Localized injection site reaction.  Softball sized slightly swollen and red injection site area in left arm in subcutaneous upper tricept area.  Received injection on 4-16-09. Reported to pharmacy on 4-21-09 with localized signs and symptoms.  Patient did not complain of shortness of breath or anaphylaxis during complete time span.  Patient had very mild flu-like symptoms lasting about 24 hours after injection during which time she developed the softball sized, slightly inflamed subcutaneous injection site reaction. There was also a smaller area inside the softball area that was raised and bumpy. I had advised her to use a cold pack and use the Claritin once daily that she takes for her hay allergy since she is very sensitive to benadryl.  I contacted the Collaborative Practice Physician and explained adverse event on 4-21-09 and agreed that the adverse event sounded localized, continue treatment as previously described, and have her contact her PCP if condition worsens.  I followed up with her on 4-24-09 and she stated that the area was only the size of a quarter now with a scab.  I told her to keep the scab clean and to use Aquaphor to help healing.  She stated that she did not need to see her PCP and she had no other complications.
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a healthcare provider at an elementary school for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequently to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at an urgent care unit for shingles. As a direct and and proximate result of the pt's of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event of shingles was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
fever of 105 persisting for 4 days despite APAP, chills, severe aches, h/a, n/v, stomach cramps, dizziness, raised itchy bump @ inj site for 8wk;