chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIZZY; This spontaneous report received from a patient and concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose not reported, once a total administered, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the patient experienced dizzy. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of dizzy was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-DEC-2015 at 22:28, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 6.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
veins n skin are turning purple; veins n skin are turning purple; having a reaction; I'm dying/you just killed me; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me). At the time of the report, VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
Headache - started just after midnight ~8 hours after injection Muscle Aches - severe on left side  Joint pain - severe on left side/elbow Fever - 102 degrees at 4am Took 2 extra strength Tylenol Headache, aches, pains continued not quite as bad  Nausea started around 9 am Vomiting & diarrhea about 10 am Nausea continued most of day until 8 pm or so but no more vomiting. Aches, pains, headache continued all day and into the evening. Fever fluctuated between 98.4 and 102.5.  Stayed in bed all day with no appetite, kept eyes mostly closed, but couldn?t sleep more than ~30 minutes at a time. 9pm finally able to eat a little apple and took 2 more extra strength Tylenol. Still headache, Fever, aches, pains when I went to sleep for night but was was able to sleep 2-4 hour increments. 4/4/21 morning ~8 am (about 40 hours post injection)  muscle aches and pain improved a lot. Left arm & joint still a little sore.  Fever and headache improved.  Very weak and tired and no appetite after a day in bed with yesterday?s symptoms.
He received his ADACEL, HPV and meningococcal conjugate vaccine. Very early on Saturday morning, he was covered in hives. BENADRYL given. By 4 PM, he was so covered in hives that it was on his face, neck, ears, and over 80% of his body. Urgent care told us to use BENADRYL every 4-6 hours. I have been giving him BENADRYL every 4 hours because if it goes to 5 hours, he breaks out in a horrible, itchy rash. We are still giving BENADRYL every 4 hours and it has been 3 days.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 63-year-old male patient who received HAV (Havrix adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 24th October 2022, the patient received Havrix adult. On 24th October 2022, unknown after receiving Havrix adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-OCT-2022 Reporter's comment : The reporter reported administering expired Havrix to patient today (on the day of reporting). The reporter had consented to follow up. Additional supportive information: The patient had received an expired dose of Havrix adult, which had led to expired vaccine used. This case was linked with US2022153062 which was reported by same reporter.; Sender's Comments:  US-GSK-US2022153062:same reporter
pt recvd vax; 1 hr p/ dose 2, exp maculopapular rash; not subsided;
I had palpitations after the COVID-19 vaccines and my heart rate went up to 172. Its higher than it's ever been. My physician, put on a Holter monitor. They wanted to see if I had an arrhythmia. I schedule it around my 2nd vaccine. It continued for 3 days after the vaccine, and there was an increase. It took about a week or two to go back to baseline. I had no energy 2 days later and the following day I had more energy than I could possibly experience. After following that next day, I was fine after that.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "Generalized anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Oct2022 at 12:00, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
minor pain on left shoulder; severe pain in wrist,shoulders and left clavicle.; there is severe arthritis throughout his body; he is experiencing lethargic feelings; he wants to sleep all day; constantly tired; he lost a few pounds; He has low appetite; This is a spontaneous report received from a contactable consumer. This 73-year-old male consumer received 2nd dose of Pfizer COVID vaccine (Batch/Lot Number: EN9581),intramuscular on 18Feb2021,at the age of 73 years old,as Dose 2,single for covid-19 immunization.Medical history included prostate cancer from an unknown date and unknown if ongoing He had Prostate cancer for many years and is being treated by hormone therapy.That is consisting of an injection of a hormonal drug called Lupron and arthritis from an unknown date and unknown if ongoing The Tylenol for Arthritis is 650 mg. He took 2. Lot SJ8033, expiration Jul2023. Count size 24 caplets.It was sealed.He had arthritis before with just minor back pain.Concomitant medication(s) included leuprorelin acetate (LUPRON) taken for prostate cancer from 11Apr2016 to an unspecified stop date.The patient previously took lupron for prostate cancer and experienced therapeutic response shortened, bnt162b2 for covid-19 immunisation and experienced pain in extremity.The patient experienced severe pain in wrist,shoulders and left clavicle there is severe arthritis throughout his body,he is experiencing lethargic feelings, he wants to sleep all day,constantly tired on Feb2021, he lost a few pounds, he has low appetite on Feb2021 and minor pain on left shoulder on 28Feb2021.The patient underwent lab tests and procedures which included bone densitometry: unknown results on 02Mar2021 She said the good news, is the  cancer did not spread to any part of his body. It did not go to his bones and his PSA dropped  tremendously. Bad news is that there is severe arthritis throughout his body,bone scan: unknown results on a bone mineral density,computerised tomogram: unknown results on 10Mar2021 She said the good news, is the cancer did not spread to any part of his body.It did not go to his bones and his PSA dropped  tremendously. Bad news is that there is severe arthritis throughout his body, prostatic specific antigen: 5.07 on 16Dec2020. Therapeutic measures were taken as a result of there is severe arthritis throughout his body.Patient asked the doctor if the vaccine injection could cause a flare up of his arthritis.The doctor could not tell him if there were a reports because the studies were not conclusive yet.The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Rapid Heart Rate.  Client did not take her medication in the morning.  Also, she did not eat anything at breakfast.
I was exposed to COVID at an art gallery opening on 6/10/2022; I am certain of this, as the person with whom I came into direct contact tested positive on 6/12/2022. There were three couples in our group; out of those six, four people tested positive. We were all also fully vaccinated. I tested positive for COVID on 6/14/2022 when I took an at-home test. My symptoms began on 6/13/2022. I had a severely sore throat, an almost complete loss of my voice, low-grade fever, and constant coughing. As soon as I tested positive, I called my doctor's office and spoke with the NP or PA through teleconference. I was put on PAXLOVID. From 6/13/2022 to 6/16/2022, I was down and had all the symptoms. On 6/17/2022, I began to feel better and had a little bit more energy. I felt even better on 6/18/2022. On 6/19/2022 and 6/20/2022, I actually felt okay. At the time of this writing, I still feel better, though I still get tired and have a scratchy voice. On 6/20/2022, I was able to go to the mall and walked for 50 minutes. I feel that the PAXLOVID probably shortened my illness and helped keep it from becoming more severe.
First dose / over a year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional detils were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The information was copied and pasted from the chat transcript (as reported). No more information is available. The patient did not consent to follow up.
Headache, dizziness AP 89 reg R-20 BP 104/64. Rested flat recovered after 15 minutes.
Patient was administered the shingles vaccine and returned to the pharmacy to report developing a rash.  Patient was advised to see his doctor who diagnosed him with the shingles.
Narrative:  12/17/2020 COVID swab, result: not detected COVID infection following COVID vaccine series 02/26, Pfizer, dose #1 03/19, Pfizer, dose #2 08/07 pt cc: cough, fatigue, headache, myalgias, rhinorrhea, fever exposure: unknown 08/08 -  08/16 pt symptoms continue 08/10 COVID swab result: detected 08/17 clinically resolved
Initial case was received on 08 March 2010 from a healthcare professional who was also the patient. This is a case of misuse i.e. accidental exposure from broken syringe. The 28 year old female patient sustained a laceration on her right index finger on 18 February 2010, when the prefilled syringe "broke" of 2009 Monovalent Vaccine - No Preservative (lot number UT045BA expired 15 Feb 2010). The laceration was described as small. She could not provide dimensions, since it was healed. The patient had an allergy to penicillin ("PCN"), no other pre-existing medical conditions and no concomitant medications. She had no illnesses at the time of the laceration. No adverse event was reported. Documents held by sender: None.
Reports that she had headache, sore throat, diarrhea for 4-5 days, bleeding of left ear and numbness, tingling and weakness of upper extremities. This started within 24 hours of vaccine
swollen lips, blurry vision, shaky, tingling. Evaluated by EMS- Transported to Emergency room/department or urgent care.
Within 1st 15 minutes, felt stinging sensation in skin which progressed within 30 minutes to overall erythema.  Pt felt nauseated, and within an hour felt disoriented, had vertigo, difficulty walking.  15 minutes later chest felt tight and she felt weak and short of breath.  Was in clinic, got 02 and benadryl, then was transported to Emergency Room.  In ER was treated with steroids and vistaril, discharged on medrol dose pack and atarax, benadryl PRN.  Next day has diffuse myalgias, nausea, bone pain, severe abdominal pain, headache, no appetite.  migratory stabbing pains.
Headache, Diarrhea, NauseaVomiting,  RIGHT LOWER JAW PAIN, SEVERE TOOTH PAIN  Narrative:  PATIENT SAW DENTIST AND DISCOVERED  CAVITY. NO TOOTH PAIN PRIOR TO VACCINATION   Other Relevant History:
Pt noticed cough beginning 3 pm, arm redness, pain at injection site 6 pm - felt uncomfortable during night - obvious fever on awakening - Temp 102.2, P 128, B/P 122/82 - after TYLENOL 1 gm po x1 temp decreased 99.6, P 110 and by 6 pm 12/18/09 a febrile.
pain at the injection site; angioedema; hives all over the body; face swelling; lips swelling; generalized itching; This case was reported by a physician via call center representative and described the occurrence of angioedema in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   In September 2020, the patient received the 2nd dose of Shingrix. In September 2020, 3 days after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), hives, facial swelling, lip swelling and generalized pruritus. On an unknown date, the patient experienced injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the angioedema, hives, facial swelling, lip swelling, generalized pruritus and injection site pain were recovered/resolved.   It was unknown if the reporter considered the angioedema, hives, facial swelling, lip swelling, generalized pruritus and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient was also a physician and reported the events for himself. The age at vaccination was not reported, however it could be 77 years. The patient received 2nd dose in September 2020 on a Thursday and experienced angioedema, hives all over the body, face swelling, lips swelling and generalized itching and these all were resolved by the following week on Friday. Less than 2 months after vaccination, the patient experienced pain at the injection site that was resolved at the time of reporting. The patient was seen at the clinic for these events. The patient did not have vaccines lot number or expiration date information. The patient did not give consent to follow up with health care professional.
Patient did not reprt adverse reaction to pharmacy until 6/11/2019.  Patient states he left pharmacy and walked to front of store. He experienced chest pain and lower back pain. He met paramedics entering the store and they did an assessment.  He states all vitals were normal and then he felt fine momentarily.
Received 1st GARDASIL 8/13/09; mom reports 8/15/09 c/o headache lasting 2 days & vomiting. Had fluids & rest, no ER or follow-up visit. Family history of migraines.
Fever to 100.8F, body aches, nausea, fatigue. Large local reaction at shot site- red that spread over my entire upper arm, mildly swollen, painful
patient experienced Fever 102.6; chills; malaise; sore throat; headache; diarrhea; nausea; fever blisters; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9264) dose 1 via an unspecified route of administration in left arm on 06Feb2021 12:00 PM (at the age of 68-year-old) as single dose for COVID-19 Immunization at military base. Medical history included type 2 diabetes, hypertension, breast cancer from 2015. No known allergies. Concomitant medications included metformin, irbesartan (AVAPRO), metoprolol succinate (TOPROL XL), glipizide, methenamine hippurate (UREX), all received in two weeks. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 02:00 PM the patient experienced fever 102.6, chills, malaise, sore throat, headache, diarrhea, nausea, fever blisters. No treatment received for AE. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
On 1/6/2020 my arm  began to itch and I developed a baseball size red, swollen circle on my arm at the site of injection.  It was warm to the touch.
Mom states patient stopped talking and using sign language after he received his vaccines. Referred to speech therapy.
First dose March 24, second dose April 14. About a week later developed facial swelling. Was seen by her primary MD and given antibiotics for presumed facial cellulitis (clindamycin and cephalexin). The facial swelling improved but then her right eye became red with worsened vision (3 days prior to presenting to ophthalmology). Exam found new onset of inflammation of the conjunctiva and all internal structures (panophthalmitis). She is a long-time patient at the eye clinic since 1993 and has never had inflammation in either eye prior to this episode. There is no other explanation for the sudden presentation of an acute inflammatory condition.
I only received 2 shots out of the 3 as I am afraid the third would have killed me. My medical records indicate I received the GARDASIL vaccination with the FLU vaccine on the same date and ever since I have had multiple ailments that have yet to be alievated or resolved (all triggered by an autoimmune response). I live in chronic pain daily and as a former athlete I am astonished at how fast I have gone down hill with little to no help in managing my pain. I first developed back spasms and an arthritic like ache up and down my spine and in my hips which I saw an orthopedic immediatley for. I received multiple injections in my lower back and after a year and a half he told me to seek a second opinion because he did not know what was wrong with me. I tested HLA B 27 + and was then referred to a rheumatologist who confirmed ankylosing spondylitis and started me on humira. Humira helped initially but has helped less over the years. Since going on Humira in 2013 I have continued to decline physically and mentally from the amount of pain I am in. I can not sit or stand for more than a few minutes and constantly have to change positions to alleviate some of the agony.
t105 5APR92 generalized rash over body begining PM 5APR92 excessive drooling & irritability; Seen by MD 6APR92 was told it was a rxn from MMR;
Fibromyalgia; sensitive to pain; stomach aches; back aches; feelings of not being able to breath; low energy; not able to stand for long periods of time; hypermetabolic; atrophy of the muscles; stiff neck; pain along right arm; This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of influenza like illness (1st dose received in 8th October 2020 refer case US2021AMR177042).   On 9th November 2020, the patient received the 2nd dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 9th November 2020, less than an hour after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced stiff neck and pain in arm. On 9th July 2021, the patient experienced fibromyalgia, pain, stomach pain, back pain, difficulty breathing, energy decreased, difficulty in standing, hypermetabolism and muscle atrophy. On 16th November 2020, the outcome of the stiff neck and pain in arm were recovered/resolved. On an unknown date, the outcome of the fibromyalgia, pain, stomach pain, back pain, difficulty breathing, energy decreased, difficulty in standing, hypermetabolism and muscle atrophy were not recovered/not resolved.   It was unknown if the reporter considered the stiff neck, pain in arm, fibromyalgia, pain, stomach pain, back pain, difficulty breathing, energy decreased, difficulty in standing, hypermetabolism and muscle atrophy to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional case details were reported as follows: The case was reported by patient's mother. The patient received 2nd dose of Bexsero vaccine in the right deltoid.  Within the hour after receiving the Bexsero vaccine her daughter developed a stiff neck and she had pain along on her right arm, which both resolved in 7 days. The patient was diagnosed with Fibromyalgia in July 2021. Since being diagnosed with Fibromyalgia, the patient continued to be sensitive to pain, stomach aches, back aches, feelings of not being able to breath, low energy, not able to stand for long periods of time, hyper metabolic and atrophy of the muscles. The health care professional had decided not to treat her for Fibromyalgia at this time because the patient was so young.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR177042:Same reporter,1st dose