chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right), EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck), INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear) and VACCINATION SITE PAIN (sore left arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Diabetes.Concomitant products included MELOXICAM for Arthritis, METFORMIN for Diabetes. On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck), VACCINATION SITE PAIN (sore left arm) and HEADACHE (headache). On 28-Jan-2022, the patient experienced MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right) and INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear). On 15-Jan-2022, HEADACHE (headache) had resolved. On 20-Jan-2022, VACCINATION SITE PAIN (sore left arm) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (now she can barely turn her head to the right), EAR PAIN (pain under her right ear), NECK PAIN (pain at the top of the right side of the neck) and INSOMNIA (cannot sleep because of a lot of pain still on her neck and under the right ear) had not resolved. The pain started first just during morning and night, but it was getting worse.No treatment had been given for her symptoms.This case was linked to MOD-2022-465200, MOD-2022-465201 (Patient Link).
BODY ACHES; CHILLS; RASH; HIVES; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 36 year old male. 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, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced body aches, chills, rash, hives, headache, nausea.  Treatment medications (dates unspecified) included: epinephrine, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, and nausea on 02-APR-2021, and had not recovered from hives, headache, and rash. This report was non-serious.
17 hours after 2nd dose I began feeling all the flulike symptoms. Fever as high as 102 sweats aches pain blurry vision. Could not hardly move. Injection site itched. Sore throat headache breathing difficult. It is 5 days after the shot and I am still running a low grade fever chest heavy blurry vision and abdominal pain
Shingles on face. Was prescribed Valtrex 1 gm for treatment for 10+5 days.
Fever of 102, body aches, chills, pounding headache, fatigue, loss of appetite, muscle pain
My period started almost a week early, and it had been incredibly regular starting on the 5th of the month for almost a year, lasting no longer than 7 days. It started on the 29th sfter I had already had it earlier in the month. It lasted for nearly two weeks, 12 days to be exact, and has been consistently going about 2-3 weeks between periods and lasting for aptoximately 2 weeks every time. My flow has also increased volume wise and cramping has increased. This is still ongoing. I am replacing my 5 year old paragard with a Mirena to try to help this situation.
Nausea; had strong joint pain when lifting weight; she was not able to go to work; headache; body aches; chills; fever during the day and night; tiredness; muscle pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took piroxicam and experienced drug allergy. The patient presented the following side effects on January 5th (05Jan2021): headache, body aches, chills, fever during the day and night, tiredness. The next day on 06Jan2021 she had strong joint pain when lifting weight, she was not able to go to work. On Thursday of that week on 07Jan2021 she still had a headache and fever sensation but she stopped having body aches, she still had strong nausea with headache and muscle pain on unknown date in Jan2021, on Friday 08Jan2021 she felt nausea and headache and on Saturday she felt better. The outcome of events nausea and headache was recovering. The outcome of event general body pain was recovered in Jan2021. The outcome of rest events was unknown.  Information on the lot/batch number has been requested.
Extreme fatigue began approximately 1-3 days after vaccine. Never improved; doctors thought was mononucleosis. Within next several months, all of the chronic fatigue, fibromyalgia, and neuro-mediated hypotension sympotms appeared and still has all of them 3.5 years later. Can't go to work or school; applied for disability. Medical Records received on 1/7/2005 states pt experienced confusion, memory loss, difficulty sleeping, fainting and headache. Follow up 01/18/05:Patient has still not recovered from the adverse event. Still experiencing chronic fatigue Immune dificiency syndrome, fibromyalgia, nurally mediated hypotension. I only heard bout VAERS last year and report this then, which was 6 months past the 3 year deadline to claim any money for my daughter. She sure could have used it since she has been unable to attend school, drive or work for 4 years now. Every time I asked any of her doctors if the vaccine could have caused this, they said she became ill iwth all of her symptoms 1-2 days after her 3rd Hep vaccine and has only gotten worse for 4 years.
Extreme chills started at +/- 8:30 pm.  Patient went to bed - fell asleep at about 8:45.  Woke up periodically during the night drenched with sweat.  Got up the following morning at about 8:00 am.  Arm was sore but tolerable.  Temperature was 98 F.
Telederm: The Patient has the following medical/social history Hyperlipidemia, Hypertension, osteoarthritis. Meds include atorvastatin,metoprolol,diclofenac gel, asa, omeprazole. This skin condition been present for 6 days- started 1 day after receiving pneumovax 23 vaccine. The rash has been treated with loratadine. The skin condition had the following response to treatment no change. HPI with Clinical question 65 yow with R flank, bilate LE macules-papules coalescing into patches both inner,outer thighs up R leg into flank. Is itchy and rough to touch. The patient does not have the following no HIV, no hepatitis. Will hold aspiring starting 9/21/19.
I believe this saved me from the hospital when I came down with covid; I believe this saved me from the hospital when I came down with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "I believe this saved me from the hospital when I came down with covid". Therapeutic measures were taken as a result of covid-19. Patient reported that "Paxlovid did its job in curing me". It was reported that the patient received your vaccines in Feb2021 and the booster in Nov2021 and believed this saved the patient from the hospital when came down with Covid. Paxlovid did its job in curing the patient.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pt in Hospice facility; on O2 supplementation; transitioning in dying process; pt passed away in the facility; COD on death certificate states:  Idiopathic Pulmonary Fibrosis and COVID 19 infection; hospice records do not show when pt had a positive COVID test
I went to the doctor on April 5 for my shoulder and said my hip was killing me as well. He sent me to a pain doctor 4/29/2021 who sent me for x-rays & gave me prescription for physical therapy. Nothing was broken. They told me to work on hip and core (more left hip). Started going to PT twice a week since May. Went to two different places at the time for back and hip, and another for shoulder. 6/21, went to my rheumatologist and brought up the pain at my regular check-up. Saw my internist 6/28/2021. Went for an MRI of pelvis on 7/15, went for MRI on hip 7/23 ? both showed inflammation, but no fractures. But showed inflammation on L4/L5 to the left, mild degenerative disc disease & slight bulging. Then I went to the hip doctor 8/11 where he retook more x-rays, steroid shot into left hip ? diagnosis was bilateral bursitis (left worse than right) and said to continue physical therapy. was sent to a different pain doctor for an SI pain joint injection after the follow up with original hip doctor on 9/22. Nothing has been helping.   Still in pain from adverse event
Very tired, severe muscle aches, pains, chills, fever, diarrhea, mouth sores and temporary gingivitis. My dentist and ENT doctor said it looked like an auto-immune disorder/response (lichen planus). But never actually was able to diagnose this with certainty.
Initial misuse report received from a healthcare professional on 21 November 2013 and on 21 March 2014. A patient of unknown age and gender who already had flu vaccine this season received FLUZONE on an unknown date. The patient received diluent. No adverse event was reported. The list of documents held by sender: None.
Breakthrough case admission after 4 vaccines Moderna 2/25/21 lot# 031M20A;  Moderna 3/25/21 lot# 045A21A;  Moderna 12/7/21 lot# 045J21A;  Moderna 5/17/22 lot# 056M21A
Pt states her tongue was tingling, brought to medical evaluation. Redness at neck, blotchy skin noted both arms 09:40 BP 194/78 pulse ox 98 Denies SOB 09:42 BP 191/83 pulse ox 96 HR 75 lungs clear to auscultation 09:48 BP 164/71 Pulse ox 95 HR 71 10:00 BP 174/73 Pulse ox 99 HR 66 C/o throat swelling 10:07 BP 170/78 Pulse ox 97 HR 64 10 :11 ell Epi pen 0.3 mg given L thigh 10:14 BP 180/80 pulse ox 97 HR 66 10:18 throat feels better , tongue still "a little numb" BP 179/76 Pulse ox 97 HR 74 Daughter to bedside 10:22 EMS arrrived BP 139/67 Pulse ox 97 HR 68 10:27 50 mg Benadryl given IM by EMS 10:30 via ambulance in stable condition
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and allergies were not reported. Since unspecified dates in September 2014, the patients were vaccinated with doses of RECOMBIVAX HB (lot # K010535, expiration date: 27-AUG-2016), (strength, dose, frequency, route and anatomical location were not reported), which were improperly stored. The excursion details indicated that the temperature was at 54.7 Fahrenheit (F), maximum for 838 hours, 59 minutes cumulatively and 19 F minimum for 838 hours, 59 minutes cumulatively. No adverse events were reported and product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Awoke during the night with sweats, chills, feverish (did not have access to thermometer).  In morning very weak, fatiqued, sweaty and occasional rash.  Resolved around 4:00 PM
pt recv vax 8FEB99 & pt was given DPH 35min p/vax (pt stayed in clinic) started itching chest & neck DPH given w/relief of sx;
Anaphylaxis after Hep A vaccine. Four hrs after received the vaccine child began wheezing, swollen lips and developed generalized urticaria. Received epinephrine and Benadryl in the ER (wheezing had subsided before ER visit). Mother states urticaria resolved within 2-3 ds and received Benadryl during that time.
The patient presented to the emergency department with altered mental status, dry heaving, and body aches. She was found to have a partially occluding thrombus of the right cephalic vein consistent with venous thrombosis, as well as findings of thrombosis in the anterior segment branch of the right portal vein. She had a d-dimer of 25.77 increased to 35.2, and was thrombocytopenic with a platelet count of 92, which dropped to 36 the following morning. Platelets to present were: 92-36-32-23-19-28. The patient received the Johnson & Johnson COVID-19 vaccination two weeks prior to presentation.
Vaccine administered on 9/21/09 to left deltoid. Symptoms began early morning on 9/22/09 with numbness, tingling, and itching to left hand radiating up left forearm. It comes and goes. Feels similiar to a bee sting with itching and throbbing feeling. Seems to move up and down arm.
elevated TSI confirmed the diagnosis of Graves' disease; This is a literature report for the following literature source(s):   A 14-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), 1 month after the suspect product(s) administration, outcome "unknown", described as "elevated TSI confirmed the diagnosis of Graves' disease". The event "elevated tsi confirmed the diagnosis of graves' disease" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood potassium: 1.6 mmol/L, notes: consistent with the diagnosis of hypokalemic periodic paralysis; Blood thyroid stimulating hormone: 0.007 uiU/L, notes: suppressed; Thyroid stimulating immunoglobulin: elevated, notes: confirmed the diagnosis of Graves disease; Thyroxine free: 3.74 ng/dL, notes: elevated; Vital signs measurement: were notable for tachycardia and hypertension. Therapeutic measures were taken as a result of basedow's disease. Clinical course:  Patient was presented to the emergency department with acute onset of severe lower extremity weakness. He had received his first and second Pfizer BioNTech COVID-19 vaccines one month and two days before presentation, respectively. Vital signs were notable for tachycardia and hypertension. Bloodwork revealed low potassium (1.6 mmol/L) consistent with the diagnosis of hypokalemic periodic paralysis; the paralysis resolved with potassium repletion. He was also found to have a suppressed TSH (0.007 uIU/L) and elevated free T4 (3.74 ng/dL). An elevated TSI confirmed the diagnosis of Grave's disease and he was started on Methimazole; this was switched to PTU after an allergic reaction. He has continued on PTU and had no further episodes of paralysis. This case series is the first to demonstrate Grave's disease after COVID-19 vaccination in the pediatric population. Given this possibility, pediatricians need to be watchful for symptoms of Grave's disease post-vaccination to prevent treatment delays.; Sender's Comments: Based on the available information in the case, an association between the reported events and The suspected drug cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product 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.,Linked Report(s) : US-PFIZER INC-PV202200096728 Same article/drug/event different patient;
Gave vaccines at 1:20 had him sit in waiting room where he slumped in chair and was not responding at 1:26. Assist of 3 to have him lie on floor with feet up and head cushioned. Got fan and wet cloth for forehead. Hands clammy. After 2 minutes, he was spontaneously opening and closing eyes but not talking. After another 3-4 minutes was able to talk some. Gave him water and had him sit up at 1:40. Dad wanted to take him to Dr. so left agency at 1:45 to go to Dr. Was awake, talking and walking without problems. Blood pressures 120's/90's 3 different times took it.
No additional AE; patient who was administered a PROQUAD vaccine which expired 03/02/2021 on 03/11/2021; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-MAR-2021, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) lot # S027460, expiration date: 02-MAR-2021 (formulation, strength, dose, frequency, route of administration were not reported) reconstituted in sterile diluent, for prophylaxis. No additional adverse event was reported.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.            No concomitant drug were reported. No treatment medications were reported.  The reporter's causality for the event of COVID with Humira (ADALIMUMAB) was no reasonable possibility.  Co-suspect product ADALIMUMAB (HUMIRA) action taken was withdrawn.  Company Comment:    This is an spontaneous case concerning an unknown-years-old female patient with medical history of Co-suspect product included non-company product ADALIMUMAB who experienced the unexpected AESI of COVID-19  unknown days after the 3rd. dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatment received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment:    This is an spontaneous case concerning an unknown-years-old female patient with medical history of Co-suspect product included non-company product ADALIMUMAB who experienced the unexpected AESI of COVID-19  unknown days after the 3rd. dose of mRNA-1273 vaccine. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatment received. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I now have internal shingles; Lump on neck and clavicle; Burning lump; Itching lump; has not had dose 2 yet.; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Shingrix at an unknown dose. In December 2019, less than 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced nodule, burning sensation, pruritus and incomplete course of vaccination. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles, nodule, burning sensation, pruritus and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, nodule, burning sensation and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Shingrix, the patient had internal shingles. The patient reported that, 7 days ago from the date of reporting, the patient had burning and itching lump on her neck and clavicle. The day before reporting, the patient had CT scan with results pending. The patient stated that, till the time of reporting, did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
A few days after receiving immunization, the patient reported continued pain at the in the area around the injection site and stated that her arm was hard to move at times.  I checked on her a couple of days later and she stated the she felt like she was improving.  I found out today (12/28) that she has continued to have issues and reported to her doctor.  She is now receiving medications for symptomatic relief as well as physical therapy.  The doctor told her the pain should resolve after several weeks.
I received my 5th dose on 09/16/2022. I tested positive with a home test on 11/22/2022 and I also took a lab test on 11/23/2022. The result came back on 11/24/2022. In the morning around on 11/22/2022 around 8:00AM. I had brain fog, congestions, headaches, runny nose, slight fever, loss of taste and smell. On 11/22/2022 I did a telehealth with a PA from my doctor's office. On 11/24/2022 I started taking DAYQUIL and NYQUIL before they prescribed me with medications. I only took it for 1 day. According to my symptoms the PA prescribed PAXLOVID for 5 days.
I woke up in the morning and noticed I had a cough, it felt like a burning in my chest. I felt a little bit tighter; I wasn't running a fever. I took a COVID-19 test that came up negative. I thought it was the respiratory infection that I get every year. The next morning, I went to urgent are and I was feeling a little worse. I still wasn't running a temperature. I didn't lose my taste or anything like that. They wanted me to do an RSV, COVID-19 and flu swab. They did the swab, and it came back positive for COVID-19 and negative for the other the two. The doctor prescribed me benzonatate and prednisone. I didn't want to take Paxlovid because of rebound. I spoke with my sister about it and she told me that I should get the Paxlovid and at that point I called the urgent care and got it prescribed and did that regimen. I did have a little bit of a rebound about a week or two after. I had a day or two of feeling run down, congested.
3 x 4cm area of erythema at site of DTaP injection L arm 8/27/02 (occurred 48 hrs later). No fever.
I received the 4th dose on 06/21/2022. My COVID-19 symptoms started on 11/09/2022 in the morning around 08:00AM. I had a severe cough and thick mucus. I had no fever, and no body aches. I couldn't sleep at night due to my cough. I did a PCR test on 08/23/2022. I received my result after 1 week which showed that I was positive for COVID-19 infection. I also tested positive for COVID-19 on 09/2022. I didn't get care from my doctor. I self isolated for 7 days and took over the counter cough medications. Due to my sinus infection I still cough once in a while but I am testing negative for COVID-19 infection.