chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On May 8th my son received Moderna COVID vaccine, first dose. On May 22nd, my son went to work as per usual; after beginning work, his arms became numb, became nauseated, head started hurting, he then was unable to walk without assistance; he states his legs felt like they were weighted. He told his supervisor and they called ambulance. He states he had tunnel vision, but no loss of consciousness and he had difficulty speaking and holding head erect. He was taken to hospital and admitted with possible stroke. Multiple test were ran....CT head, MRI/MRA head, EKG, EEG, ECHO; labs were drawn....CBC, CK, CK MB, TROP, UA, UA DRUG SCREEN, D DIMER, SED, CRP, TROP....all of which were negative. He had another weak episode, tremors while in the hospital when he was up to take shower; of which nurse came in and assisted him. He stayed nauseated and had a severe headache during the hospital stay and for days after. He was diagnosed with paresthesia, complex migraine, and near syncope. He received his 2nd Moderna COVID vaccine on June 5th; On June 8th, he had another episode similar to first... severe headache, nausea, limb weakness, extreme exhaustion. He called his PMD and spoke with nurse; received a new prescription for antinausea medication and was instructed to continue with other meds for headache. On August 25th, he had another episode of headache, nausea (but not as severe), and tremors from head to toe. This lasted over 2 hours; He was able to get in with his PMD, who witnessed this episode. His PMD contacted the Neurologist to inform him of extreme tremors. He has been hospitalized, been back and forth to doctors, and no one can tell him what is going on. He had to resign from original job because doctors would not release him to go back. He works with heavy equipment. He is now working as a receptionist for a Veterinary clinic. He is now 22 years old with no pertinent medical history; he took no medications; he was married 6 months prior to this.
Spondylitis ankylosing aggravated; Device issue; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis aggravated.    The patient's past medical history included Ankylosing spondylitis and Rheumatoid arthritis.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant), DEVICE ISSUE (Device issue) and SWELLING (Swelling). At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) had not resolved and DEVICE ISSUE (Device issue) and SWELLING (Swelling) outcome was unknown.            Tried licked it because patient did not want to lose it and needle of pen never came out.   No concomitant medications were reported.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 46-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) events of ankylosing spondylitis  an unknown time after the first and second dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 08-Mar-2022: Follow up document contain suspect drug information and narrative description were reported.; Sender's Comments: This spontaneous case concerns a 46-year-old female patient with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) events of ankylosing spondylitisan unknown time after the first and second dose of mRNA-1273. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck), lot # L0045650, expiry date 11-FEB-2017; K010440, expiry date 22-JUL-2016; K021485 expiry date 03-NOV-2016, (number of doses unspecified). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
developed a sore red spot with  a burning sensation in the administration site of the vaccine; she developed a sore red spot with  a burning sensation in the administration site of the vaccine; This is a spontaneous report from a non-contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient was concomitantly taking  valsartan (manufacturer unknown) for the management of her blood pressure, ibandronate sodium (BONIVA) for her bones, levothyroxine sodium (SYNTHROID) for an unspecified indication and gabapentin (manufacturer unknown) for neuropathy.  The patient was also taking dietary supplements (unspecified) to improve her immune system. The patient reported that she developed a sore red spot with a burning sensation in the administration site of the vaccine on an unspecified date. The patient reported that this sore spot does not compromise the movement or her normal activities. The patient expressed her satisfaction with vaccine because it is a grace to have a vaccine that is saving the world. She also wanted to know if it would be appropriate to take Tylenol and if it would be appropriate to attend her therapy of the neck appointment. The patient also wanted information if the  COVID-19 vaccine would interact with her medications. The outcome of the events was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
BRAIN FOG; MIGRAINE; TIRED; NAUSEA; TINGLING IN HANDS; NUMBNESS IN HANDS; ARM HURT; VERY SHARP STABBING PAIN IN RIGHT SHOULDER; FEVER >103; This spontaneous report received from a patient concerned a 41 year old female. 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the subject experienced tingling in hands. On 25-MAR-2021, the subject experienced numbness in hands. On 25-MAR-2021, the subject experienced arm hurt. On 25-MAR-2021, the subject experienced very sharp stabbing pain in right shoulder. On 25-MAR-2021, the subject experienced fever >103. On 25-MAR-2021, the subject experienced nausea. On 26-MAR-2021, the subject experienced migraine. On 26-MAR-2021, the subject experienced brain fog. On 26-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and nausea on 25-MAR-2021, and fever >103 on 28-MAR-2021, and was recovering from numbness in hands, migraine, brain fog, tired, very sharp stabbing pain in right shoulder, and tingling in hands. This report was non-serious. This case is associated with PQC number: 90000175693.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Patient received his first Pfizer COVID vaccine on 3/3/21. Patient was conscious with no apparent issues after administration. Patient was asked to sit down for 15-minute observation afterwards. A few minutes later patient was swaying back and forth in his chair and saying he was feeling faint. I repeatedly addressed patient by his first name and asked if he could hear me and repeatedly asked if he was okay. Patient began slumping down in his chair but was still conscious. Patient was not responsive but made eye contact with me. Patient requested water. After giving patient water and observing him drink he began looking nauseous and threw up. Patient then passed out in his chair. I supported the patient upright in his chair and made sure he did not fall down or injure his head. I then immediately tapped him on both shoulders and repeatedly called his name. Patient then became responsive and 911 was called. While waiting patient said he was starting to feel better and was able to support himself in his chair. I did not observe any injuries due to fainting. When the ambulance came patient agreed to be taken to the hospital.
Left arm was painful around the injection site, pain was peaked during night, until next day, and start to subdue after 2 days.
10JAN92 noticed @ 5PM RAT: "peach-sized", swelling, rash across thigh anterior-lateral aspect circumscribed, tiny, red, t103 R;
She was given the bivalent booster but because she is immunocompromised she should have received a 3rd primary dose of Moderna monovalent.
Extreme fatigue , poor appetite, and muscle soreness for two days. Resolved after two days
Vaccine stored in refrigerator on 10/26/21, expired product 10/13/2021, administered date on 10/28/21; 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) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/26/21, expired product 10/13/2021, administered date on 10/28/21) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/26/21, expired product 10/13/2021, administered date on 10/28/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 10/26/21, expired product 10/13/2021, administered date on 10/28/21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vaccine was stored in refrigerator on 26-Oct-2021, there was no temperature excursion, and the patient did not experience any adverse event.  No treatment medications were provided.
Client noticed difficulty talking on 071208.  She also had difficulty closing her eye and she could not smile.  She then went to the med center where they diagnosed her with Bells Palsy and started her on Prednisone and Valtrex.  8/5/08 Reviewed ER medical records of 7/12/2008. FINAL DX: Bell's palsy Records reveal patient experienced abrupt onset left facial droop, unable to close left eye, mouth stiffness x 1 day. Tx w/antiviral & steroids.  D/C to home w/PCP f/u.
After recieving 2nd dose of Shingrix site of inj  developed hard bump & large red circular spot.  pt followed up on 1/13/21 + injection  site was slightly red, bump much smaller
She reports some fatigue, loss of appetite and dizziness, and went to bed early on the night of her 2nd vaccination. On Feb 12th, she reports receiving Botox and Juvaderm facial fillers. She reports she felt fine until Feb 11th or 14th, when reports feeling fatigue which gradually worsened in the following weeks. She reports around this time going to MD Now Urgent Care.  Around Feb 13th to the 17th, she developed N/V and loss of appetite, which also gradually worsened in the following weeks. She reports she stopped eating around this time due to the symptoms. She drank alcohol daily until February 18th. Between Feb 18th to 25th, she noticed that a hematoma developed on the site of injection and bruises on other places.  She reports onset of productive cough with white sputum and yellow diarrhea which occurred (several times daily). Both of these symptoms also gradually worsened in the following weeks. On Feb 27, she couldn't tolerate oral intake. She was admitted to Hospital on  Feb 28
The next morning after the vaccine I woke up with a fever of about 101.4 and severe chills. I took Ibuprofen and stayed in bed for about 20hrs and was better. My muscles ached also.
Client received vaccinations @ approximately 2 PM 5/7/09 fussy @ 5 PM 8-9 Developed fever 104.0 F even with TYLENOL every  4 hrs @ 1 am fa got Ibuprofen & gave had front fan & cool wet towels under arm pits.  Child was fussy but no high pitch persistent cry.  Grunty noise this am has rattley respiration child has reactive airway disease referred to local physician low grade temp 5/8/09 Also seen by local physician who felt it was a normal reaction.
Firmness, redness, hot to the touch area on arm about three inches in diameter in an area about two inches below injection site There is also itching and the area is painful to the touch Appeared one week after injection. Was fine until then.
Extreme fatigue, fever, nauseousness, and body aches among waking up first morning after vaccine administration. Cloudy/out of sorts feel throughout the day into the evening and then felt quite a bit better but still lethargic. Nauseous feeling continued through day 2 and now day 3 post vaccine, with vomiting on the evening of 7/21
Pt reported to me on 6/17/14 that at an unknown time after the vaccination her arm had significant bruising and experienced significant pain. The patient also reported significant swelling of the arm down to her hand. She is currently working with her doctor to get treatment. When I observed her on 6/17, I could see visible swelling of the left hand in comparison to the other.
Received DTAP, HIB, Hep B, PCV 7, approximately 10:00AM.  Fussy during day but normal from receiving injections to bed at 9:30, woke up at 10:00, crying, like screaming, trying to catch her breath, felt warm, was jerking arms and legs, became limp, looked exhausted, to ER, no treatment necessary.
7 cm round area of erythema and warmth on left upper arm/deltoid. No significant tenderness, no fluctuance.
Patient was vaccinated with DTaP on 05/24/2005 his arm becoming more and more red, swollen, hard and hot.  He complained that the arm was itchy.  The swelling was severe - his arm was hard and hot from swelling.  We went back to teh doctor because of the swelling. Within one week the redness and swelling extended almost to the elbow.  The arm did not hurt him when squeezed.  The swelling and redness began to go away and the color of the arm in certain places, though not swollen, became purple/brownish.  This area reduced in size to large patch which patient complain hurt when anything touched this area.  Our pediatrician referred us to dermatologist who recommended Benadryl before bed and Claritin in the morining in addition to Locoid ointment to the area.  After 1 week noticed some improvement in the brown patch -- the area became less raised.  The area is now more flat and improving
decreased nerve sensitivity of the skin all over her body; Almost constant tingling pins & needles feeling throughout arms, legs, and face & head; night sweating; hot flashes; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm at age of 29-years, on 24Apr2021 14:15 (Lot Number: ER8735) as single dose for COVID-19 immunisation. Medical history included allergies to an unknown sushi ingredient; she had asthma and Raynaud's. The patient was not pregnant at time of vaccination. Concomitant medications included Montellukast, Advair Inhaler and ProAir Inhaler (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took nifedipine and experienced allergies. The patient experienced almost constant tingling pins & needles feeling throughout arms, legs, and face & head; constant decreased nerve sensitivity of the skin all over her body (her skin was not as sensitive to pain as she used to be before the vaccine, especially her upper bod. She even accidentally cut her finger kind of badly and she didn't feel anything); night sweating; hot flashes. She experienced many other side effects from the vaccine, but the symptoms listed above were the ones that all started the night she received the vaccine and had not improved since, even after 9 days at the time she was submitting this form. Adverse events started at 02:00 on 25Apr2021. There was no treatment. The patient did not diagnose with COVID-19 prior to vaccination and not test it post vaccination. Events outcome was not recovered.
Red hard area a couple of inches below the site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (Red hard area a couple of inches below the site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Red hard area a couple of inches below the site). At the time of the report, VACCINATION SITE INDURATION (Red hard area a couple of inches below the site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time
Within a few days of vaccine, developed shooting pains and intense tingling in lower extremities, shooting up to level of hips initially, and after a few days, shooting up to level of knees. Also developed tingling, less intensely, in fingers and hands, without same shooting pains.  Onset about 5 days after  vaccine, becoming steadily worse. Severe enough to disrupt sleep and all usual activities. Symptoms worse with light pressure on the affected areas, such as snug socks or shoes, walking, heels resting on bed, but temporarily alleviated with firm pressure on these areas, but then rebound worsening when firm pressure is released.  Similar symptoms occurred in this patient, but less severe, after her 2nd dose of Moderna covid vaccine 7 months ago.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first and second dose of GARDASIL (lot number not provided) intramuscularly on 17-SEP-2012 and 15-OCT-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Fever, staring convuls & staring type sz w/blue color & upper resp infect such as red throat uncontrolable high fever w/red throat sx; Learning disorder, developmental handicapped slow learner;
Pt states starting on evening of 10/30 he had a sharp pain in ear area. On 10/31 had developed Bell's Palsy. Has been to 3 different physicians & incident has not resolved. Had MRI & Lyme came back negative, started Prednisone, Acyclovir & Doxycycline.
pt devel leukopenia (WBC 2.8) & fever of 104 10 hr p/vax;CBC @ the time of incident indicated leukopenia, blood cult were negative;CBC in 10 days was nl;
after patient received vaccine she stood up and stated that she felt ill. She fell onto left side and hit head on the floor. She felt nausea, burning sensation in head, weak, pale face and dizzy.
Could not sleep; Effected upper part of my body, my arms, my neck, my shoulders, It's been very severe/ /severe muscle condition; I had tiny bit of shingles on my side; I did not have memory of anything that happened/Do not remember all of it, I was out of my mind; This is a spontaneous report from a contactable consumer (patient). An 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, Expiration Date: unknown), dose 2 via an unspecified route of administration on 17Feb2021 as single dose for COVID-19 immunization. Medical history included blood pressure and cholesterol. Concomitant medications included hydrochlorothiazide taken for blood pressure and rosuvastatin taken for cholesterol. On 20Feb2021, the patient experienced could not sleep. In Feb2021, the patient experienced effected upper part of body, arms, neck, shoulders, it's been very severe/severe muscle condition, had tiny bit of shingles on my side, did not have memory of anything that happened/do not remember all of it, was out of my mind. The patient reported that she had some very severe muscle condition. She could not sleep. It was horrible. The patient understood that they put it in the muscle so that is why she was feeling that. It's been very severe, she was ok now and she think it is going to be better now. She have been taking treatment Tylenol 500 mg, two of them every 6 hours and the doctor gave a medication for tiny bit of shingles on my side to keep it from growing any further. The patient did not remember all of it, she was out of her mind. They took her to the hospital and then the patient underwent MRI to see if her brain was okay and they come up with a conclusion that is what it was and she did not have memory of anything that happened. The outcome of the events was recovering.   No follow-up attempts are possible; No information is required.
pt recv vax 25NOV96 & 3DEC96 pt exp bronchitis & was treated w/amoxicillin & brompheniramine maleate-phyenylpropanolamine HCL (dimetapp);pt devel raised chickenpox rash over hairline, chin, diaper area, & ankle (total of about 15 papules);
Vaccine (vaccinia vaccine against smallpox) administered to husband of patient. Skin lesions developed approximately 8/6/04. Husband's arm covered with band aid/shirt sleeve. Single pustular lesion developed in groin of patient.
On March 1, 2023, I was feeling pain in my shoulder. I went to the doctor who performed an exam, I was given meloxicam and cyclobenzaprine. This did not help to alleviate my pain. I went to an osteo doctor to help get the root of the problem. He took an x-ray. The x-ray showed, I had no problems with my bones, no fractures. I had a pinched nerve. He prescribed prednisone and diclofenac to help with the anthric pain and pinched nerve pain. I feel that I am healing, I ache and tingle where before I hurt more than anything.