chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mildly sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient inquired about Shingrix vaccine and Guillain-Barré Syndrome. The patient stated that he had the first dose of Shingrix with no side effects with the exception of a mildly sore arm. The reporter was referred to health care professional. The reporter consented to follow up.
10 minutes after dose I felt lightheaded and shaky. This feeling continued for a few hours after dose. That night I started with body aches, nausea, and chills. Overnight I had a fever of 100.5 F. Body aches, nausea, and chills continued for 36 hours. I also felt very fatigued. Starting on day 2 I had pain in my armpit in injection and "Covid arm". Redness and swelling around injection site.
Information has been received from a female who on 12-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot number reported as 658397/1820U). On 15-MAR-2008, the patient went to the Emergency Room and was diagnosed with BELL'S PALSY. It was unclear what prompted the ER visit and it was not further specified if the patient was admitted to the hospital. No other information was reported. Additional information has been requested.
Hip pain; This is a solicited report based on the information received by Pfizer (Manufacturer control number: 21K-163-4052045-00).  A contactable consumer (patient) reported that a 66-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via intramuscular on 05Mar2021 (Batch/Lot number was not reported) (at the age of 66-year-old) as single dose for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at 40 mg, Citrate Free for non-infectious intermediate, posterior and panuveitis moderate to severe rheumatoid arthritis. Medical history was not reported. The patient took the adalimumab (HUMIRA) subcutaneous from Jul2020 to an unknown date and in Oct2020, the patient experienced COVID-19 and brain fog. In Dec2020, the patient experienced right hip replacement. In Oct2020, the patient experienced exhaustion and nausea. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 12Feb2021 (at the age of 66-year-old) for Covid-19 Immunization. The patient's concomitant medications were not reported. On an unknown date, the patient experienced hip pain. BNT162b2 was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The case was reported as serious due to medically significant. The action taken in response to the event for adalimumab was dose not changed. The outcome of the event was unknown.  The reporter's causality for the events of right hip replacement, COVID-19, brain fog and hip pain was not provided. Company's opinion is that there is no reasonable possibility that the events of right hip replacement, COVID-19, brain fog and hip pain are related to HUMIRA.   The reporter's assessment of the causal relationship of the event with the suspect product BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event arthralgia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new infor-mation is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Miserable; Joint pain; Fatigue; Headache; Muscle pain; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Miserable), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea). On 09-Nov-2021, the patient experienced FEELING ABNORMAL (Miserable). At the time of the report, FEELING ABNORMAL (Miserable), ARTHRALGIA (Joint pain), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was not sure if he had fever. The patient received first dose of Moderna COVID19 Vaccine on 01-Mar-2021 and second dose on 29-Feb-2021.  No concomitant and treatment drugs were reported.; Sender's Comments: This case concerns a 72-year-old, male patient, with no disclosed medical history, who experienced the non-serious, unexpected event of feeling abnormal and non-serious expected events of  arthralgia, fatigue, headache, myalgia, chills, and nausea. The events occurred  one day after booster dose of mRNA 1273 vaccine. The rechallenge is not applicable as no additional dose is expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Pt with history of 3 Covid vaccine first and second dose Moderna on 02/03/2021 and 03/08/2021, third dose Pfizer on 01/07/2022. After second dose of Moderna Covid vaccine Pt had frequent UTIs admitted in the hospital for urosepsis with E Coli and epididymitis on 06/21/2021, 2 months later after Pfizer booster vaccine Pt had an episode of Bursitis of right shoulder, and 3 months after vaccination he had an episode of syncope fall with laceration on the left eyebrow and bruise on the left forehead and he was admitted at hospital for 2 days for observation for UTI/pyelonephritis r/o for sepsis and had acute on CKD, was on cefepime and vanco and d/c on cefdinir for 10 days course. the following month on 05/04 had bursitis of left hip with steroid shot, on May/23 had respiratory symptoms and resulted positive for Covid infection, had ESI on 7/2022 with some resolution of sciatica and leg pain then worsening of weakness with bilateral legs giving out 7/22/22 needing assistive device for ambulation and he was admitted at hospital on 7/25/2022 with worsening of his radicular pain and myelopathy, and he was admitted for NS eval: had L2-L4 laminectomy complicated by epidural hematoma requiring evac on POD#1, discharged after 8 days to rehab to continue with aggressive physical therapy, 1 week later He was readmitted to hospital due hypotension and found extensive bilateral DVT, and severe dysphagia requiring EGD showing esophagitis with pathology resulted mild chronic gastritic with reactive appearing changes, mild reflux changes and erosion with chronic inflammation, stayed for 8 days and he is currently in a rehab facility but cognitive status still impaired.
04Oct90 pt vax w/ hepta B; devel fatigue + nausea which persisted until 19Oct90. SGOT values elevated.
Pt was given the vaccine at age 13, vaccine is approved for ages 16 and up. Pt's mom was called 48 hours after vaccine and she reports that pt is doing well and did not have any side effects from vaccine. No adverse event, no treatment. Mom was advised that pt will be unable to get the second dose in the series based on CDC guidance for reporting vaccination errors.
Starting around 9:00pm with general malaise that developed into severe nausea and joint pain over next two hours. Pain was severe enough to bring tears. Began treating with Tylenol 650mg every 4-6hrs, which seemed to help initially. Starting around 11pm, I had severe chills with uncontrollable tremors lasting next 3-4hrs. Could not stop shaking, could not get warm. Intense joint pain continued. Was able to sleep intermittently from 2-3am, but awoke with return of severe nausea and vertigo/dizziness around 3am, accompanied by profuse sweating and hot flashes. I laid on cold tile floor with ice-pack on head/chest until it passed, about 30min, and nearly called for ambulance. Treated nausea by inhaling vapor from rubbing alcohol and taking a dose of zofran dissolving tab, which seemed to help. Able to sleep 4am-9am May 15th and return to normal diet. Malaise continued throughout 15th, but gradually subsided. Rashes in armpits and hot sweats night of 15th. I appear to be mostly normal as of today, May 17th.
Delay Skim reaction. I initially only had normal fatigue and achy ness for 24 hrs starting day of vaccine. 9 days later my hands became itchy, irritable, swollen and darker shade of red. It was so irritable I couldn?t sleep and antihistamines, and otc itch creams didn?t provide relief, so I went to a clinic. Prescribed oral and topical steroids. Initially it allowed for itch relief so thought it was great. But next day it comes and go?s in all different spots of my body. It will start itchy then turn red, and could form bubbles on my skin. I apply topical steroid and it will go away about 30 minutes later and show up in another spot. Alternating from hands, formarms, armpits, lower stomach, upper thighs, but can come one and disappear on its own. I?m on my 5th and final day of oral prednisone 50mg a day, and still experiencing this. No other causes could have caused this. Nothing new during this time frame.
1. Fever, fatigue - leg pain - 24 hours after vaccination (Fever 100.7).  2.  Small local reaction <1cm - red - no swelling.  3.  3 days after injection slight droopy right eyelid - no fever, no redness or swelling at injection site - no current leg pain.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had bad reaction by the evening of the, out cold, did not really wake up again until Friday), NASOPHARYNGITIS , HYPERSOMNIA, NAUSEA (extremely nauseated) and PAIN (right arm hurts) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Illegible and 030M20A) for COVID-19 vaccination.  The patient's past medical history included No adverse event. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION COMPLICATION, NASOPHARYNGITIS, HYPERSOMNIA, NAUSEA (extremely nauseated) and PAIN (right arm hurts). At the time of the report, VACCINATION COMPLICATION, HYPERSOMNIA (had bad reaction by the evening of the, out cold, did not really wake up again until Friday,), NAUSEA (extremely nauseated) and PAIN (right arm hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information  provided. No Treatment information  provided.
Info has been received from a physician concerning an 11 year old male who was vaccinated once with a 0.5ml, SC dose of varicella virus vaccine live. It was reported that the pt was covered with chickenpox, that started on 4/9/05, when he came into the office on 4/11/05. The pt had a fever of 102.2F. The doctor prescribed acyclovir, 800mg four times daily for 5 days and Keflex 500mg, three times daily for 1 day. The pt has since recovered. No product quality complaint was involved. Additional info has been requested.
2 weeks after flu shot my husband had headache, sore throat, hacking cough and phlegmy cough, stuffy and runny nose, tearing eyes, weakness all over, couldn't get out of bed.
-O2 needs increasing 8-- >10LPM, CT chest increasing consolidation, send resp panel, COVID-19, and sputum culture (of note wife visited when she was sick)
itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
I was not educated about the side effects, risks and benefits and was not given the vaccine information sheets nor did I sign a consent form. I did not even know that my son recieved a combination vaccine and I have the documentation to prove it. Vital signs were not obtained. This facility expected me to remember all of the information that I had received on 6-18-03 when my other son received his vaccines. My son received his vaccines on 8-26-04 around 2:30pm. My son received his 2 month old vaccinations Pediarix, Hib, and Prevnar only one nurse administered these shots.  He did not cry after receiving these painful IM injections.  I questioned the nurse about why he was not crying because I thought it was very unusual she was not concerned she just smiled and said "he whimpered a little bit". I gave him some Tylenol because I did not want him to have any pain at the injection site before we left the doctor's office this was one of the things I remembered from past vaccinations. The only thing I was aware concerning vaccines was that children may be cranky, may run a fever or have pain at the injection site. I was so unaware of the dangers of vaccinations.  No one educated me. He went into a deep sleep before we left the doctor's office parking lot.  He slept for prolonged periods and would not wake to sound or touch. He woke up a few times ate very little and went right back to sleep.  He was found dead on his back less than 20 hours from vaccinations. I know he was not allergic to Tylenol because he had taken it many times before it had to be the vaccines.  No one told us that an unusual behavior could indicate a possible reaction. 1/5/05 Autopsy report received which revealed COD as SIDS.  Patient found supine on couch w/blanket.  Autopsy also revealed recent URI and glomerulosclerosis.
had the vaccine and I still got shingles; Shingles; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 suspected vaccination failure (serious criteria GSK medically significant), shingles and shingles. The patient was treated with gabapentin. On an unknown date, the outcome of the suspected vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure, shingles and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had the vaccine and still got shingles but not very bad and then got it again a year later but not very bad. The patient further stated Gabapentin really did help. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. Follow-up could not be possible as no contact details were available.
Nausea, fever, headache, sore muscles for approximately 5 days with the first vaccine.  Same symptoms starting about 6 hours later for the second vaccination, but only lasted 1 day.  Same symptoms starting about 24 hours later, only lasted about 10 hours. 1st - Moderna 007M20A,  2nd - Moderna 002A21A on 3/3/21,  3rd Moderna 039021A on 10/30/21
Injection Site hive; The Injection area was a little itchy like a 1 out of 10; little Redness on the injection site; Muscle Pain; A spontaneous report was received from a consumer who was also a 63-years-old male patient who received Moderna's COVID-19 vaccine and experienced redness on the Injection Site, and Muscle Pain, hives began around the injection area looking like little bumps and pink color and the hives were more visible, little itchy. Patient's medical history was not provided, and concomitant medicines taken by the patient, Azithromycin 250mg from January 5th until January 10th (Prescribed by his Physician). 2 days before the vaccination. On 12 JAN 2021, approximately, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Jan 2021, the patient started to experience following redness on the Injection Site, and Muscle Pain, hives began around the injection area looking like little bumps and pink color and the hives were more visible, little itchy.  Treatment included Benadryl By mouth, Famotidine By Mouth, Hydrocortisone 1% Cream by topical route  63 years old male patient calling to report that he had the Moderna COVID-19 Vaccine on 12JAN2021 in the deltoid muscle of the left arm. The next day he had a little Redness on the Injection Site, and Muscle Pain. On 14JAN2021 the redness disappeared. On 15JAN2021 hives began around the injection area looking like little bumps and pink color and the hives were more visible on 16JAN2021. The Injection area was a little itchy like a 1 out of a scale of 1 to 10. Today 17JAN2021 The Injection Site hive is still going on but not as visible. He reported, "I took Benadryl, and acid reflux medicine Famotidine (heard it is good for hives). Applied Hydrocortisone 1% cream on it as per my pharmacist recommendation."  Action taken with mRNA-1273 was not reported. The outcome of the events, redness on the Injection Site, and Muscle Pain, hives began around the injection area looking like little bumps and pink color and the hives were more visible, little itchy, was considered not recovered/resolved
fatigue; body aches; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (BNT162B2, lot # ELO142), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension, diabetes and pacemaker. The patient's concomitant medications were not reported. The patient experienced fatigue and body aches on day of injection on 09Jan2021. The event outcome was unknown.
Received Covid Vaccine on 7/9/21 Experienced 102 degrees. muscle aches, cold chills for 2 days 7/12 Experience tingly sensation in left arm and numbness 7/13 Experienced tingly sensation in left arm and left left and numbness 7/14 Symptoms on my left arm and left leg above were getting worse 7/15 Feeling the same symptoms above and started to get a headchage 7/16 In the morning around 8:30am  the left side of my face was was numb and tingly as well as my left leg and arm; I had difficulty speaking. I went to the emergency room and they admitted me to the hospital that night. For the next couple days I stayed in the hospital; the numbness in my face wore off however my left arm and leg  I am still getting tingly feelings and difficulty walking on the left leg.  The hospital has given me an xray, mri (contrast of my neck and brain and one without contrast) and I also took a spinal  tap yesterday. I was sent home yesterday on the evening of 7/19 after being in the hospital since 7/16 and currently awaiting results from my test to follow up with the neurologist.  I need to say this: I am very very healthy, I wake up every morning and run 6-9 miles, go to the gym in the evenings 3-4 times a week, I eat healthy, I have never had any of these symptoms or issues ever in my past until I received the vaccine. We need to get this vaccine off the market because this is not right; I am still currently week and getting tingly feelings still on my left side and have been unable to work.
p/vax vomited large amount 5x through day;diarrhea by evening;no fever;10/23/99-10/25/99 diarrhea, no vomiting or fever;10/25/99- to MD T100.3, placed on clear liquid & ATB;up to 15 liquid stools/day;hosp;devel bright red rash like sunburn;
Tachycardia (112-120 bpm) palpitations, shortness of breath, feeling faint, slightly disoriented.
Raw, scratchy throat causing discomfort and hoarseness, extreme fatigue and heaviness, inflamed eyes, difficulty with sleep.   Health care provider ordered bloodwork and initially diagnosed mono because of EBV titer results.  These symptoms lasted 3 months.  I felt okay so I got the bivalent pfiser vaccine on 09/15/2022.  By 10/01/2022 I had the same symptoms again.  My Healthcare provider ordered the same bloodwork, including the EBV panel.  All blood work was again within normal range and the EBV titer results were the same.  Now a question about the mono diagnosis.  6 weeks later I was starting to feel normal and I got a virus that included congestion and a severe and persistent cough.  But along with that the same throat, fatigue and eye symptoms returned.  They subsided again by 12/26/2022  An immunologist, on 12/28/2022, reviewed my test results and told me he had no answer.  On 01/02/2023 the symptoms returned.  Depression is also becoming an issue.  I've exercised 5 times a week for 30 years.  I'm down to slow walking when I can muster the energy to do it.  NO DIAGNOSIS, NO TREATMENT, UNKNOWN OUTCOME,   I've never had symptoms like this before in my life.