chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; 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 HEADACHE (Headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided by reporter. Treatment information was unknown.
After receiving the first dose of Covid vaccine patient became hypotensive and diaphoretic. She was in and out of consciousness. She complained of chest pain. Medical emergency response team called and came to evaluate patient. Vitals taken, water given. Patient refused to go to ED. Symptoms resolved.
Pt fainted following immunization.  Pt was sitting in chair during administration & fainted following 4th vaccine.  Pt was still in chair when he fainted.  Pt was unconscious for approx. 30 seconds.  Pt. rec'd all vaccines in full before fainting.  Pt. stayed for 25 minutes a walking out to car with mom.
This spontaneous report was received from a male patient of unknown age who was reporting on himself. On approximately 04-JAN-2015, reported as last Sunday, the patient was vaccinated with ZOSTAVAX (injection dose, route of administration, lot number and expiration date were not reported) (reported as shingles). On approximately 04-JAN-2015, last Sunday (also reported: the following day), the patient experienced pins and needles feeling throughout his entire body. The outcome of pins and needles feeling throughout his entire body was not reported. The relatedness between ZOSTAVAX and the event was not reported. Additional information is not expected, because there is no patient's and physician's contact information.
5/25/22 - 5/26/22:  Headache, fever, and chills, treated on 5/26/22 with acetaminophen 1000 mg at 2:45am and 10:50am, fever resolved later in day. Headache remained intermittent through 5/26/22. 5/25/22:  Right shoulder pain. Treated on 5/26/22 with lidoderm patch. Improved. 5/25/22 - 5/26/22:  Right eye and right side facial pain. Resolved 5/27/22 5/26/22 - Current:  Right ear pain and frontal aspect of right ear. Unresolved 5/26/22:  Chest tightness. EKG result was sinus rhythm via Fitness Watch. Resolved on 5/27/22 5/26/22:  Right scapula pain. Resolved on 5/27/22 5/25/22 - current:  Sore right upper arm. Treated with warm water. Unresolved. 5/26/22 - current:  Swollen lower, right axilla (between right, lower axilla and upper right side of right breast). Swollen and spongy feel when touched. Unresolved.
Recurring itchy skin rash on both arms; Hives on both arms; This is a spontaneous report from a contactable consumer. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via intramuscular route of administration in the left arm on 29Mar2021 at 11:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included leaky heart valve, underactive thyroid and allergy to shellfish. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and alprazolam (MANUFACTURER UNKNOWN); all started from an unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via intramuscular route of administration in the left arm on 06Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. On 05Apr2021, the patient experienced recurring itchy skin rash/hives on both the arms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events recurring itchy skin rash/hives on both the arms was not recovered at the time of this report.
UNEXPECTED BENEFICIAL EFFECT - REMISSION OF RHEUMATOID ARTHRITIS; LETHARGY; TIRED; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight was 116 kilograms, and height was 60 inches. The patient's concurrent conditions included rheumatoid arthritis, Sjogren's disease, soreness, alcohol consumption, and smoker, and other pre-existing medical conditions included the patient had allergic to humira (drug-induced lupus-like reactions), remicade (total body rash), enbrel - others. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for rheumatoid arthritis. On 07-APR-2021, the subject experienced lethargy. On 07-APR-2021, the subject experienced tired. On 14-APR-2021, the subject experienced unexpected beneficial effect - remission of rheumatoid arthritis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and tired on 08-APR-2021, and was recovering from unexpected beneficial effect - remission of rheumatoid arthritis. This report was non-serious.
feeling terrible; severe headache; body aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (feeling terrible), HEADACHE (severe headache) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 15-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (feeling terrible), HEADACHE (severe headache) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (feeling terrible), HEADACHE (severe headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Very red, swollen right upper arm from shoulder to elbow. Hot to touch, itchy. Child says it hurts. Minimal temperature. Mom giving Tylenol. Child up and about playing.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02May2022 at 08:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left 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: "Asthma" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ALENDRONATE, start date: 01Nov2020; VITAFUSION WOMEN'S; LEVOTHYROXINE; ACETAMINOPHEN; GABAPENTIN; VIACTIV CALCIUM PLUS VITAMIN D & K; OXYBUTYNIN; SLOW RELEASE IRON; HYALURONIC ACID; ZAFIRLUKAST; PANTOPRAZOLE; FLAXSEED; FISH OIL; SUPER B COMPLEX [VITAMIN B COMPLEX]; ZINC; ARNUITY ELLIPTA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course : Patient received treatment for COVID-19 from 22Jul2022 to 25Jul2022 with Lot 1910754A.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
G47.33 OBSTRUCTIVE SLEEP APNEA 3/7/2023 CHRONIC DVT, UNSPECIFIED VEIN
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The Patient receives vaccine and the patient receive other medications in two weeks of vaccinations and she has no known allergies ,Patient Received (Paxlovid) From 27Jul2022 Treatment stop date- 30Jul2022 For the Treatment of COVID-19. .  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information , there is reasonable possibility of causal association between the events Vaccination failure and COVID-19  and the suspect drug BNT162b2 .
On the evening of 10/2/03 started getting sharp pains on left side of head that got more severe and by morning traveled to right side and into my neck and shoulders. Worsened through weekend; called urgent care and ER. Saw doctor on 10/6, took Naproxen all week. Also had bleeding gums, swollen face, pain in knees and lymph nodes under the arms felt very large. had brain scan on 10/13/03.
Pt had an anaphylactic reaction -- no previous history of allergies, asthma, food allergies.  About 5 minutes after administration of both vaccines, the patient started to complain of full body itching, especially his throat and ears.  At that time, we checked vital signs which were all normal, and administered 25mg of Benadryl by mouth.  15 minutes later, Pt was wheezing on exam (inspiratory and expiratory).  Normal oxygenation.  Pt was given 1 albuterol nebulizer treatment at that time.  Halfway through the treatment, the patient was no longer wheezing, and felt much better.  I reassessed the patient intermittently over an hour, and the patient did not have any further itching or wheezing.  During that time, I also gave him 60mg of prednisone.  I also sent the family home with prednisone for 5 days (30mg twice daily), benadryl prn, and albuterol 2 puffs with spacer every 4 hrs for 24 hrs, and then prn afterwards.
DEATH; This spontaneous report received from a consumer via a company representative concerned a 35 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, batch number: Unknown and expiry: Unknown) dose, 1 total, start therapy date were 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 an unspecified date, the consumer's lawyer's husband got the johnson and johnson shot and died days later. On 2021, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211033764- Covid-19 vaccine ad26.cov2.s-Death. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Nausea, leaned by in chair, head went back & hit banister on wall and patient appeared to be seizing to <40 seconds.  Eyes rolled back. Placed patient on floor by express care nurse. B/P 107/73 HR 71.  After a few minutes patient was stable and escorted to FMC in wheelchair of injections of Benadryl 25mg & DepoMedrol 40 mg.  Vitals taken again 112/82 HR 76.  Patient laid in exam room so we could observe her and Mom was by her side.  Patient left @ noon after one hr of observing. Prior to D/C vitals 118/80 HR 84.  D/C home with Mom.
COVID-19 TEST POSITIVE; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 72 year old male. Initial information was processed with additional information received on 06-APR-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, reflux, high blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no medical history of immunosuppressive disease processes. Patient had no known allergies. Patient had no drug abuse or illicit drug usage. The patient was previously treated with atorvastatin calcium, lisinopril, amlodipine, anti-reflux medications and ranolazine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: unknown) dose was not reported, frequency once total, administered on 06-MAR-2021 at left arm for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for prophylaxis.  On 23-MAR-2021, the patient had normally scheduled blood work performed including an antibody test for COVID-19 vaccine response. The results of the blood work showed a non-responsive result to vaccination (coded as suspected immunological vaccine failure) and the patient also had a positive COVID-19 test. All other results were normal. At the time of the report, the patient was scheduled for a second antibody test on 07-APR-2021 and he is scheduled for another Covid-19 vaccination of an unknown manufacturer on 12-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected immunological vaccine failure, and the outcome of covid-19 test positive was not reported. This report was serious (Other Medically Important Condition). This report is associated with Product quality complaint Number: 90000175289. The suspected product quality complaint has been confirmed to be void. confirmed no PQC was identified within the reported complaint reported based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210408983- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Suspected Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Within hours, post vax, back of neck got very swollen and could not turn head. Had a headache, fever and sensitive to light and sound, followed by years of migraine headaches.
Broken out in a rash, felt extremely tired and fatigued, and brain fog; Broken out in a rash, felt extremely tired and fatigued, and brain fog; Broken out in a rash, felt extremely tired and fatigued, and brain fog; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0178), via an unspecified route of administration on 27May2021 as 1st dose, single dose for COVID-19 immunization. Patient's medical history included osteoporosis, lung disease but it is very mild. It was reported that, a few months ago, on 28Mar2021, patient had a series of shingle shot and with the second shingle shot, patient also broke out in the same type of rash but this time, the first time with the shingle, patient had a rash on arms, legs, and chest but that cleared up. Patient waited longer than they told me to before getting the COVID-19 vaccine, the rash got cleared up, patient waited probably two to three more weeks, then patient got COVID-19 vaccine. Concomitant medications included prolia taken for osteoporosis from 14May2021, protonix (pantoprazole) and Valtrex. The patient experienced broken out in a rash, felt extremely tired and fatigued, and brain fog on 31May2021. The patient mentioned that she started noticing it 4 days after getting the first dose. The rash was still present, not getting any better; seem to be getting worse and was now being treated with cortisone. So, now the rashes are back, and patient just have a concern about getting second dose and asked what to do about that. Patient looking for some assistance and some support or advice. Patient shared that, would be travelling to the state of (withheld) and is required to have a COVID-19 Test just a few days after getting the COVID-19 vaccine. Patient mentioned the test is scheduled on 17Jun2021, and flight would be on 21Jun2021. The patient was not recovered from rash and the outcome of the events felt extremely tired and fatigued and brain fog was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
About 10 days after receiving the COVID-19 vaccine. I started experiencing rashes that appeared bilaterally on my extremities. They were on my thighs, feet, palms of hand, and forearms. It would itch first, and then as I would scratch it bumps would form. They were not like hives but similar to it. It would happen typically at night either before or after my bedtime. It had gotten worse to where I was scratching myself to the point of bleeding. I saw my PCP about 2 weeks after this at the end of November 2021. She diagnosed it as eczema and prescribed me with a hydrocortisone cream for it. I also had started taking OTC Benadryl called diphenhydramine of two 25mg twice a day. That medication keeps it in reasonable control. My extremities aren't affected as much anymore, but now it has moved to my scalp. I have tried other medications for the eczema but nothing else has worked. I did switch to Zyrtec for a while but it didn't work as well so I switched back to taking the Benadryl.
developed abdominal pain; shoulder pain; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN (developed abdominal pain), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included LITHIUM and DIPHENHYDRAMINE for an unknown indication.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced ABDOMINAL PAIN (developed abdominal pain), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain). At the time of the report, ABDOMINAL PAIN (developed abdominal pain), ARTHRALGIA (shoulder pain) and MYALGIA (muscle pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Patient reported to Emergency Room on 11/3/2013.  Left upper arm was red, swollen and warm to the touch. Emergency room provider ntoed an 11 x 11cm at the largest diameter area of erythema and warmth.  No pustular drainage, no fluctuants, no streaking and no axillary adenopathy.  Felt indurated. Clinical thinking was either a large local reaction versus cellulitis. Patient was discharged same day with empirical treatment of Keflex and to follow up with primary care provider in 2 days or return to Emergency room if symptoms were to worsen.  Patient did not report to clinic as instructed.  Follow up call made to family on 11/18/13 and they advised all symptoms had resolved.
Severe swelling of right lymph node on right jaw, fever, chills, anorexia, abdominal pain, rash, suspecting serum sickness like syndrome. Ultrasound was performed, showed kidney stones.
Pt was checking out after check-up appointment and fell to the floor, white and pale. After 5 minutes, pt's color is good and pt is A and O. Pt's vs normal- referred to ER for follow-up.
The patient suffered an outbreak of shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for it intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered on outbreak of shingles (herpes zoster). As a result of these symptoms, the pt was seen and treated by medical providers and at the reporting time, she was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. In addition, the pt sustained severe and permanent personal injuries; and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the time of this report, the pt was not recovered from herpes zoster. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered a disabling event by the reporter.