chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loss of skin pigmentation at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site discoloration in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included estrogen nos (Oestrogens) and progesterone.   On 17th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced injection site discoloration. On an unknown date, the outcome of the injection site discoloration was not recovered/not resolved.   It was unknown if the reporter considered the injection site discoloration to be related to Shingrix.  Additional details were provided as follows: The patient had no known drug allergies. On an unknown date between 17th May 2020 to 19th May 2020, the patient developed a loss of pigmentation about the size of a quarter at the injection site. At the time of this report the event was reported not recovered. The reporter did not consent to follow up.
Patient vaccine administration record was not completed accurately and therefore the patient was given Bivalent Pfizer dose for 2nd Dose of Primary Covid 19 Series.  Will follow CDC guidelines and give  a Bivalent Pfizer Booster Dose in 60 days.  This error was discovered when logging the vaccine into the local Vax Webportal.
Muscle soreness in left arm, pain in left shoulder causing decreased range of motion; given near top of left shoulder. Pain x 4 weeks.
I broke out in Hives at the injection site originally and it spread all over my body. (Legs, behind my knees, thighs, breast, both sides of stomach, lower & upper back) I was prescribed Fexofenadine, Hydroxyzine, prednisone and Triamcinolone cream
Had vertigo on the right side then before rising, Igot up carefully, during the day when I put my head down and in the evening, tilted it up to put eyedrops looked to the left, vertigo on the left side. I had to hold on to something twice; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Mar2021 at 15:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included eye shingles from Aug2020, neuralgia, allergy to some nuts (mild), and allergy to grass and pollen. 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 received unspecified concomitant medications. The patient previously took ciprofloxacin (MANUFACTURER UNKNOWN), methylprednisolone (MANUFACTURER UNKNOWN), cobalt (MANUFACTURER UNKNOWN) and chromium (MANUFACTURER UNKNOWN); all for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19266) via an unspecified route of administration in the left arm on 16Feb2021 at 13:30 as a single dose for COVID-19 immunisation. On 11Mar2021, when the patient awoke at 17:00 had vertigo on the right side. Then before rising, the patient got up carefully. During the day when the patient put her head down and, in the evening, tilted it up to put eyedrops, looked to the left, vertigo on the left side. The patient had to hold on to something twice. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo on the right side and vertigo on the left side was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
I had really bad abdominal cramps to the point where I couldn?t walk. I took Acetaminophen tablets and it didn?t come back after they wore off
Narrative: had pfizer covid 19 vaccine 5/11/2021 and had a bad reaction-red rash around site on left arm and then to axilla, chest, and left side of face. all was on left side where the shot was given. was seen in er. shot was done at pharmacy. had steroids and benadryl in er. no sob, wheezing, or throat swelling; was told not to complete vaccine series; reaction started 2 days after vaccine given
Patient is a 30 yof who presented with 1 day of cough and positive COVID-19 test.  She states that there was an outbreak at a location she visited and thinks this is where she was exposed. She states she wore her mask the entire time she was at the location. She was feeling in her usual state of health until yesterday when she developed a cough. She was tested for COVID-19 yesterday and the result was positive today. She notes that "stuff tasted bad yesterday" but thought it was due to her usual sinus issues/sinus infection. She also says that she felt "foggy" and very fatigued this morning when she woke up. She denies fevers, saying she never runs a fever even with Strep, but does endorse cold chills. She also complains of feeling "sore" diffusely, especially in her back. She denies shortness of breath, N/V, diarrhea.   Patient was on room air and with stable vital signs. She was admitted for observation overnight at request of transplant nephrology and her home mycophenolate and lasix were held. Patient remained stable and on room air. She did have a slight increase in creatinine, possibly due to dehydration vs acute illness. She was counseled to hold her lasix for two days. Her potassium was replete and she received IV fluid. She will be discharged with a pulse oximeter for home monitoring and will follow-up in clinic.  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Having intermittent mild headaches since last shot. Headache worsened last night. I was a febrile this morning but have since become febrile, and we?ll as mildly  tachycardic, and fatigued
1st vaccine 10/15/21 few days after first vaccine palms developed tiny almost blisters mainly right hand burning intense itching sensation i notified occupational health and was still advised i had to receive second vaccine in order to be compliant 2nd vaccine 11/5/21 my hands continued with reaction to the point my skin started peeling off the intensity of pain became so unbearable i had a heartbeat in palm of hand unable to sleep called in to work at 12/20/21 to seek help went to dermatologist 12/20/21 he prescribed oral,topical steroids and steriod injection and was unfamiliar with covid vaccine side effects and thought perhaps it would subside with steroids or possibly psoriasis he wasnt sure of auto immune system response  with covid vaccination. at the same time my right knee swelled however no injury .fast forward another dermatologist stelera did not help or steroids currently skyrizi has not helped today my palm has never healed severe painful cracks it limits my daily functions had biopsy and is palmar psoriasis which is life long .i was referred to rheumatologist by orthopedic my large right knee effusion seen on MRI and x-ray  80ml of fluid was drained/collected rheumatologist stated i had psoriatic arthritis which is life long. I expressed my concerns for exemption prior to vaccine since I had two autoimmune diseases and Dr. our hospital physician deemed that I be vaccinated and even the second vaccine after expressing reaction concerns. Since this Vaccine my quality of life has dramatically changed pain, physical, emotional, not to mention this will never go away.
This case was reported by a consumer (GSK employee) and described the occurrence of influenza a in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In October 2012 the subject received a dose of FLUARIX (unknown details). On 14 December 2012, within months of vaccination with FLUARIX, the subject experienced influenza a, feeling miserable and vaccination failure ("lack of effect"). The subject stated that she had "just tested positive for A/flu (rapid test)" and that she feels "absolutely miserable." This case was assessed as medically serious by GSK. Relevant test results included influenza a virus test positive on 14 December 2012. At the time of reporting the outcome of the events were unspecified.
Nauseated within a few seconds of 1st dose; began vomiting 3-4 minutes later, continued dry heaving for ~20 minutes; face became cold, lips turned blue/purple, passed out. Several days of low-grade fever, aches/fatigue, "Covid arm" painful swelling and redness, altered body odor and metallic taste in mouth (more interesting than unpleasant). 2nd dose felt fine for the first 11.5 hours, then got up in the middle of the night, vomited for ~15 minutes, and passed out; several days of low-grade fever, aches/fatigue, "Covid arm" etc.
Left hand is completely paralyzed.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP 6955), via an unspecified route of administration at the age of 64-year-old administered in arm left on 18Mar2021 15:00 at single dose for covid-19 immunisation. Medical history included psoriasis and covid-19 (Prior vaccination patient had covid-19). The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left hand was completely paralyzed on 29Apr2021. The patient had MRI to rule out stroke. The event was serious for being disability. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. The patient underwent lab tests included magnetic resonance imaging (MRI): unknown results on unspecified date, nerve testing: unknown results on unspecified date. The patient received treatment included physical therapy. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
Vaccine adm 6-5-15 in afternoon. After 2 days inj site red. Over 1 wk area remained red, swelling occurred. 1 week after vaccine adm - went to ER, received shot for swelling and antibiotic for 10 days. then slept for 2 days. 6-16-15 presents at clinic to report event.
I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now; unexpected beneficiary effect/Herpes Simplex outbreaks disappeared; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now) and THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Antidepressant discontinuation syndrome, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, BOTULINUM TOXIN TYPE A (BOTOX) for Vocal cord dysfunction.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared). On 12-Jul-2021, the patient experienced HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now). On 13-Jul-2021, HERPES VIRUS INFECTION (I went 6 months herpes outbreak free but yesterday I had an out break I was so excited and now) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (unexpected beneficiary effect/Herpes Simplex outbreaks disappeared) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  She went 6 months herpes outbreak free but yesterday she had an out break she was so excited and now disappointed.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up information was received on 13-Jul-2021. New event Herpes NOS added.
9/21 - 2" x 4" area, red, warm, swollen, sore (BACTRIM) (no fever) given antibiotic by NP. 9/24 - same symptoms & sick from antibiotic dr said to stop antibiotic. 9/30 symptoms subsiding.
Patient fainted after his first Pfizer shot, he looked sweaty, hit his head when fainted, he said before he knew it, he was conscious again.  He did not make it to the chair to sit down for 15 minutes
Information has been received from a Licensed Visiting Nurse concerning a 21 year old female patient with hypothyroidism and no drug reactions or allergies, who on 14-APR-2010 was vaccinated intramuscularly with a dose of GARDASIL (LOT# 0040Z, Expiration Date: 03-NOV-2011). Concomitant therapy included SYNTHROID. On 14-APR-2010, the patient experienced rash down to the elbow. Subsequently, on 17-APR-2010, the patient recovered from rash down to the elbow. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Received booster dose from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received booster dose from an expired vial ) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received booster dose from an expired vial ). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received booster dose from an expired vial ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Expiration date of the vial was reported as 13 Dec 2021.  No concomitant medications were reported. No treatment medications were reported.
No additional adverse effects were reported in the patient; A patient received doses of vaccines following a temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies.     On 25-MAR-2020,  the patient was vaccinated with doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S036823, expiration date 31-MAR-2022 (dosage schedule, anatomical location and route of administration were not reported) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) by oral route, lot #S006053, with an expiration date of 07-DEC-2020 (dosage schedule and anatomical location were not reported), both administered as prophylaxis; following a temperature excursion (product storage error).  The vaccines involved were stored in a lowest temperature below 36 degrees Fahrenheit  (°F) / 2 degrees Celsius (°C) (25.2 °F) for 23 hours, as recorded by a data logger for a time frame of 23-hours. There was no previous temperature excursion. No adverse effects were reported. There was no product quality complaint (PQC) reported.  Lot numberS036823 has been verified to be a valid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB).
Ache; Tiredness; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's past medical history included patient had right shoulder surgery and concurrent conditions included patient had atherosclerosis, and non-smoker, and other pre-existing medical conditions included has sling shoulder and no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 12:30 for prophylactic vaccination at right deltoid. Concomitant medications included acetylsalicylic acid, and rosuvastatin. On 02-APR-2021, the subject experienced ache. On 02-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ache, and tiredness. This report was non-serious.
No adverse event; HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.; Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-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 15-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.). On 21-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.), POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.) and POOR QUALITY PRODUCT ADMINISTERED (HCP reported that patient received the vaccines on 21-Dec-2022 and then following that the vaccines were marked not to use.).    No concomitant information was reported. It was reported that first time excursion started on 15-Dec-2022. It was unknown that patient received any other vaccine in the 4 weeks prior to COVID-19 vaccine and also no reports of side effects had been reported to them. No treatment information was provided.
I started to get faint bit of tinnitus in my right ear late in the afternoon of the day I got the shot. I was hearing chime sounds. This phenomena started again late in the day on the day after the injection although its intensity was less. Now, exactly two days later, I am not hearing this.
Light headed, dizzy, briefly lost consciousness, bad headache, stomach ache, weakness, at site of injection and 4 inches below she had inflamed, red, hot skin that was hard.
Pt developed chickenpox but none within 24 hours. Progressive rash of papules, vesicles and ulcers, despite vaccination. Recovery is expected.
The week after vaccination I was admitted into the hospital for severe menstrual bleeding. My CBC result shows a platelet count of 17 10*3/uL, accompanied by low white blood cell and red blood cells count. I received multiple transfusions (2 units of whole blood and one unit of platelets), and was diagnosed with ITP.  I then received steroid treatment (Dexamethasone, 40mg/day,  4days), after which my blood counts are restored.
This spontaneous report as received from Sanofi pasteur refers to a child of unknown age. On an unknown date the patient was vaccinated with (merck) VARIVAX (lot # was not reported). On an unknown date the patient  experienced was disseminated zoster. The child was not very ill and was not immunosuppressed. The outcome of was disseminated zoster was unknown. Additional information is not expected.
Pt was seen for Viral upper respiratory infection, pharyngitis, right otitis media, and local redness to injection sites on 12/20/2010.  On 12/21/11, patient experienced an apparent witnessed "seizure," mom reports that she "fell backwards," had rigidity and alternating movements, seem to stop breathing, and her legs and arms looked "purple." She had a low-grade fever, but was not really markedly febrile, and hadn't seemed sick although she did have a significant local reaction where she received her injections in the thigh.
I was tested positive for COVID on April 18; I was tested positive for COVID on April 18; I also had pneumonia after; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i was tested positive for covid on april 18 on 18Apr2021, i also had pneumonia after, if she choose to get the second dose of the vaccine does she need to restart the vaccination series all over again on unspecified date in 2021. Patient stated that when could she receive the Pfizer COVID-19 vaccine after catching the COVID infection. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Apr2021. The seriousness of the i was tested positive for covid on april 18 on 18Apr2021, i also had pneumonia after was medically significant. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
06Oct97 & 20Oct97 Pt recv 1st & 2nd dose of vax. Lab eval revealed a lack of seroconversion.
Child began screaming a high pitched, top of his lungs scream w/i 4 hrs after receiving vax. He then never slept more than 15-40 mins at a time & never more than 4 hrs in a 24 hr period. He screamed 90% of his waking hrs & was unconsolable.