chrisvoncsefalvay/vaers-outcomes huggingface dataset:
metallic taste in mouth; feels like she is having stroke; neck still hurts; side of her face was numb; arm stiff; eyes were stiff; pressure behind head; pressure behind neck; pressure behind eyes; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in mouth), HEAD DISCOMFORT (pressure behind head), MUSCULOSKELETAL DISCOMFORT (pressure behind neck), OCULAR DISCOMFORT (pressure behind eyes) and CARDIAC DISCOMFORT (feels like she is having stroke) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Infection, Surgery (multiple surgeries) and Biliary stent placement.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced HEAD DISCOMFORT (pressure behind head) and MUSCULOSKELETAL DISCOMFORT (pressure behind neck). 30-Jul-2021, the patient experienced OCULAR DISCOMFORT (pressure behind eyes). On an unknown date, the patient experienced DYSGEUSIA (metallic taste in mouth), CARDIAC DISCOMFORT (feels like she is having stroke), NECK PAIN (neck still hurts), HYPOAESTHESIA (side of her face was numb), MUSCULOSKELETAL STIFFNESS (arm stiff) and OCULAR DISCOMFORT (eyes were stiff). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of She took it for 4-5 days and then stopped and PARACETAMOL (TYLENOL) for Adverse event, at a dose of She took it for 4-5 days and then stopped. At the time of the report, DYSGEUSIA (metallic taste in mouth), HEAD DISCOMFORT (pressure behind head), MUSCULOSKELETAL DISCOMFORT (pressure behind neck), OCULAR DISCOMFORT (pressure behind eyes), CARDIAC DISCOMFORT (feels like she is having stroke), NECK PAIN (neck still hurts), HYPOAESTHESIA (side of her face was numb), MUSCULOSKELETAL STIFFNESS (arm stiff) and OCULAR DISCOMFORT (eyes were stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  The pressure behind neck and head started within 10 minutes of getting the vaccine and got worse overnight. The adverse events were fast and differently at each time.
missed dose; No additional adverse events reported. No; This spontaneous report was received from a physician, referring to a 17-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On an unknown date in June of 2003, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose details, strength, route, lot# and expiration date were not provided) for prophylaxis. patient did not receive second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (product dose omission issue). No additional adverse events reported.
SORE ARM; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and had not recovered from sore arm. This report was non-serious.
Woke with a headache, dizzy and very foggy.  Continued with a fever all that day of up to 101.5  Periodic nausea.  Took Tylenol every 4 hours and went to bed that night at the 29th hour with 100 degree temp.  At 36 hours still had 100 temp and  nauseaus and tired . Lasted until about hour 50 and then was able to eat a small meal.  Third day still have 99.5 temp but feel fine today and mostly back to normal
A few days after receiving the vaccination, I woke up to my face feeling very hot and irritated. I had red, bumpy patches across my cheeks and mostly around the corners of my lips / chin and medial cheeks. For the first few days, the patches were very itchy. I also noticed a few patches pop up along my neck and on my hands, but those disappeared. However, the patches on my face remained.   In the past week (starting around 4/21), the patches lost their bumpiness and became scaly, flaky, and dry, while still being itchy. I started taking Benadryl on 4/26, which has helped with the itchiness, but the patches don't seem to be getting much better despite washing my face twice a day, exfoliating a few times a week, and moisturizing the patches with my normal moisturizer as well as applying Vaseline in the evening hours before bed. Since using Vaseline over the past few nights, the redness has gone down slightly but the flakiness is still prevalent, getting worse throughout the day. The patches look mostly like Seborrheic Dermatitis, a condition I've never had before on any part of my body.   I haven't had an opportunity to see a physician yet, but have ordered some Aveeno eczema creams to try and reduce the flakiness and itchiness. I'm hoping this reaction doesn't occur again with the second shot as it's been very uncomfortable. I also never developed a rash around the injection site.
Itchy; injection site was became red; Injection site was became swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (injection site was became red) and VACCINATION SITE SWELLING (Injection site was became swollen) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (injection site was became red) and VACCINATION SITE SWELLING (Injection site was became swollen). On 21-Jan-2021, VACCINATION SITE PRURITUS (Itchy) had resolved. On 24-Jan-2021, VACCINATION SITE SWELLING (Injection site was became swollen) was resolving. At the time of the report, VACCINATION SITE ERYTHEMA (injection site was became red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient used hot compress and took ibuprofen for treatment   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2021: No specific follow-up information recorded.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single, in left arm, on 18Mar2021 as dose 2, single, in left arm and on 05Oct2021 at 13:00 as dose 3 (booster), single, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood clot disorder many years ago." (unspecified if ongoing), notes: Other medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 01Jul2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), 2022 min after the suspect product(s) administration, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive, notes: Tested positive on 02Jul - one day after rebound symptoms began. Therapeutic measures were taken as a result of drug ineffective, covid-19.Clinical Course: Patient did not received other medication in 2weeks:.Treatment start date: 21Jun2022. Treatment stop date: 26Jun2022. Vaccine administration date: 05Oct2021. Vaccine administration time: 01:00 PM. reporter stated that Covid rebound after taking Paxlovid. Rebound symptoms occurred 5 days after finishing your medication and had continue for 5 days now. They were still ongoing. Tested positive on 02Jul2022 one day after rebound symptoms began. If treatment ae: No. patient did not had any known allergies.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: ~~~
As I said, I was hospitalized TWICE. I do not know the dates of that. I do not know if the hospitalization, I can't remember this is too much stuff. I'm just going to guess. I was dizzy, very dizzy, and ended up going to the ER via ambulance. I ended up being prescribed pravastatin and something for dizziness. I also was told to take a little baby aspirin every day. Then I  was hospitalized for a few days again and I had a CAT scan as well. I was in the hospital because I had rashes on my hands and my legs. The DR prescribed an antibiotic and a steroid cream as well. It healed up a bit but the rash is still there. At the Hospital they said that I had a slipped disc in my leg as well and that they think it was due to my scoliosis but they are not sure.
12 minutes after getting the shot my heart started to tighten, I got a burning sensation down my shoulders, chest, neck and head.  I felt like I was on fire.  It went away and then came back.  Went away and came back.  I got light headed and passed out.  I work up throwing up.  I was taken to the ER.  I was told I had a reaction to the vaccine.    I?m still having symptoms and have a burning sensation off an on.
Information has been received from a registered nurse concerning herself with a history of osteoporosis and borderline elevated LDL who on 04-AUG-2008 was vaccinated with ZOSTAVAX (Oka/Merck) S.Q. into her left arm.  Concomitant therapy included ALENDRONATE SODIUM (dose, duration and indication not reported) and LIPITOR.  On 01-SEP-2008 the patient had been experiencing tinnitus of her left ear.  The nurse had seen 2 family physicians and 2 specialists regarding her symptoms.  She had a constant hissing in her ear 24 hours a day.  There was a change in pitch from time to time and she had "clicking" in her ear from time to time.  The nurse had also experienced dizziness that had subsided.  The nurse continued to have hissing in her ear.  The nurse had been treated with decongestants, antihistamines and DRAMAMINE.  The nurse reported that it was not life threatening but it was "life spoiling".  A magnetic resonance imaging (MRI) of her ear did not reveal any abnormality of the ear but she saw that the report listed "ptosis" but she had no other information about that result.  The patient underwent an ENG (results not provided).  The nurse had visited physician's office for medical attention. Follow up was received from the retired registered nurse with a frontal maningioma that on 01-AUG-2000 (not 04-AUG-2000 as previously reported) she was vaccinated with her first dose of ZOSTAVAX S.Q: into her left arm. There was no illness at the time of vaccination. On 01-SEP-2000 at 08:00 AM the patient experienced sudden onset of tinnitus and hearing loss. Th ehearing loss of the patient's last ear was ongoing. The patient's ENG report on 19-FEB-2009 showed essentially normal ENG with evidence of very slight positional nystagmus, able to rule out vestibular nerve and/or end organ lesion, positional finding not significant at this time. On 16-JAN-2005 MRI images of the brain and internal auditorycanals were performed. THe results were benign left frontal dural-based extraaxial homogeneoualy enhancing mass, consistent with a coningioma, no evidence of a vestibular schwanoma seen, bilateral internal carotid arteries were normal as viewed, mild bilateral proptosis (previously reported as ptosis) seen and thyroid disease should be excluded. No further information is available.
SORE ARM; This spontaneous report received from a vaccine facility concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported.  On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L204 and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-287530 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up information contains patient initials
Initial and follow-up information has been received from a pharmacist concerning a 63 year old white female who in January 2008 was vaccinated with a dose of ZOSTAVAX (Merck) SQ.  Subsequently the patient had a mild case of shingles in August 2008, 7 months after the vaccine was given.  It was also reported that on 15-AUG-2008, the patient had pain on left back (trunk).  The pain was mild to moderate.  The patient was most concerned when couldn't determine what problem was.  The patient recovered from shingles.  The patient recovered from the pain on left back (trunk) on 15-SEP-2008.  In further follow-up, the patient reported that her pain on left back (trunk) had an onset date on 05-AUG-2008.  It was also reported that the patient was treated with famciclovir 500 mg and MOBIC "7.5" for pain.  The patient reported that on 05-AUG-2008 she also experienced a major itching on stomach.  The patient also reported that her rash didn't occur at the site of injection.  She assessed her pain as 4 (10 as the most painful).  The patient had a history of chickenpox in 1953 and had not been exposed recently to herpes zoster.  No additional information is expected.
Pruritis to body and arms, nausea, vomiting, headache, malaise.
sudden onset sever vertigo with severe nausea and vomiting, diagnosed by ENT doctor as vestibular neuronitis.  Treatment was physical therapy and symptoms 95% resolved in 5 weeks
I have continually had a headache since the vaccine! I don't normally get headaches. This is in the top of my head like a background headache.
March 29 to present (still occuring): back of neck tightness, stiff and soreness; contributing to ulnar nerve issues on right hand July 5-Aug 10: Left breast mass - intraductal papilloma & left breast - Fibrocystic change w/ductal epithelial hyperplasia usual type without stromal fibrsis and cyst formation Aug 31-Sept 2: Migraine headache;  Sept 3 to present (still occuring) : Vertigo;  Sept 12-17: left nose bleeds requiring nose cautery in 4 locations & nose packing Sept 27 to present (still occuring): nausea
SHAKING; CHILLS; FEVER; ABDOMINAL PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight was 130 pounds, and height was 65 inches. The patient's past medical history included mostly just injuries, and concurrent conditions included non alcoholic, cigarette smoker, and drug abuse-marijuana, and other pre-existing medical conditions included the patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced abdominal pain. On MAY-2021, the subject experienced back pain. On 25-MAY-2021, the subject experienced shaking. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, shaking, abdominal pain and back pain was not reported. This report was non-serious.
Hives right after the shot, dizziness and ringing in the ears started about 4 hours later.
Rash to right upper chest, axilla, upper arm, and back - vesicular rash.  Does not follow any dermatone and is non-painful.  Vaccine administered to left arm and site is healing well.
Shot on 3/8/21 & on 4/23/21 had pain in chest. MWH tested & NOT heart  UT LUNGS that a clot in each.
ARM TENDERNESS TO THE TOUCH; ARM TENDERNESS; .This spontaneous report received from a consumer concerned a female 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: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced arm tenderness. On an unspecified date, the subject experienced arm tenderness to the touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm tenderness, and had not recovered from arm tenderness to the touch. This report was non-serious.
crying non-stop for 3 hrs & fever @ 101 which did not respond w/APAP;
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in the refrigerator on 17-NOV-2021.Vial did not undergone any temperature excursion. No adverse event was reported. No treatment medications were reported.
The patient's weight was 135 kilograms, and height was 70 inches. The patient's past medical history included reported to only take "ADHD" medication at school" when needed, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 on 13:15 at left arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced not feeling well. On 02-APR-2021, the subject experienced achy. On 02-APR-2021, the subject experienced feel off. On 02-APR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, was recovering from achy, tired, and feverish, had not recovered from feel off, and the outcome of not feeling well was not reported. This report was non-serious.
swelling of both wrists; pain in my finger joints; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling of both wrists) and ARTHRALGIA (pain in my finger joints) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica (treated with prednisone in the past.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swelling of both wrists) and ARTHRALGIA (pain in my finger joints). At the time of the report, JOINT SWELLING (swelling of both wrists) and ARTHRALGIA (pain in my finger joints) outcome was unknown.            The concomitant history was not reported.   The treatment history was not provided.  Patient took second dose of moderna vaccine on 31-MAR-2021 (lot number-026B21A)   This case was linked to MOD-2021-294391 (Patient Link).
My last period was on April 10, 2021. I always have my cycle every 26 days. I was scheduled to have it on May 6/7 and I still haven't gotten it. 2 years ago after my second child, I had a tubal litigation. A few months ago my husband also had a vasectomy so there is no way I am pregnant. Also on November 1, 2020, I tested positive for COVID-19. During this time I was late a few days for my period. I am about 7 days late and I do not have any spotting or cramping.
expired Pentacel was administered, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (MI) (Reference number- 00884020) and transmitted to Sanofi on 03-Dec-2021.  This case involves an unknown age female patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.  On 03-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ390AA and expiry date: 12-Oct-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered).  It was reported "Caller wants to know if there will be any side effects, if they need to repeat the dose and if so, how long do they need to wait before re-administering. Caller stated she was told that the product is still viable for 6 months after the expiration date and wants us to confirm if that is true or not. She asks if there is a grace period past expiration? What are safety concerns? Can it be repeated immediately? This is inactivated vaccine, right? What is (vaccine adverse event reporting system) VAERS reporting"?  This case was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.