chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus- ringing in left hear; Gas pains; Slight constipation; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EW0151), via an unspecified route of administration in the right arm on 10Apr2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number:  EP7534), via an unspecified route of administration in the left arm on 18Mar2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 12:00, the patient experienced tinnitus- ringing in left hear, gas pains and slight constipation. The patient did not receive any treatment for the events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tinnitus- ringing in left hear, gas pains and slight constipation was resolving.  No follow-up attempts are needed. No further information is expected.
pt recv vax & approx 5 mins later pt sitting in car & noted some visual changes, rt visual field cut;nausea & feeling dizzy & some dysequilibrium;devel a h/a;referred to ER by MD;pt reported feels nauseous & lightheaded w/severe h/a;
Fatigue, rash, fever, short of breathe, sinus bradycardia,
10 minutes after vaccine administration, physician noticed right eye lid edema and erythema. Patient sent to ED via ambulance for observation
Information has been received from a health professional concerning a 76 year old female who on 14-DEC-2007 was vaccinated with Zostavax (Oka/Merck) (Lot # 658863/1414U), and subsequently developed localized rash. No treatment was required. There was no concomitant medication. At the time of reporting the patient was recovered. It was noted by the reporter that on 20 DEC 2007 "the patient was seen again today". This is one of several reports received from the same source. Additional information has been requested.
heaviness in legs; affecting her balance; can barely walk; blurry eyes/had difficulting seeing; id not feel right driving on the 2rd and 4th day; fingers were swollen really bad/can not fit wedding ring; lips swollen; possible whole face swollen; first three days in sever pain everywhere/exacerbated the pain worst than a normal person; heachache for about a week - it still has not gone away; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (heaviness in legs), BALANCE DISORDER (affecting her balance), GAIT DISTURBANCE (can barely walk), VISION BLURRED (blurry eyes/had difficulting seeing) and IMPAIRED DRIVING ABILITY (id not feel right driving on the 2rd and 4th day) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (heaviness in legs), BALANCE DISORDER (affecting her balance), GAIT DISTURBANCE (can barely walk), VISION BLURRED (blurry eyes/had difficulting seeing), IMPAIRED DRIVING ABILITY (id not feel right driving on the 2rd and 4th day), PERIPHERAL SWELLING (fingers were swollen really bad/can not fit wedding ring), LIP SWELLING (lips swollen), SWELLING FACE (possible whole face swollen), MYALGIA (first three days in sever pain everywhere/exacerbated the pain worst than a normal person) and HEADACHE (heachache for about a week - it still has not gone away). The patient was treated with LIDOCAINE ongoing since an unknown date for Adverse event, at a dose of 1 dosage form every two weeks. At the time of the report, LIMB DISCOMFORT (heaviness in legs), BALANCE DISORDER (affecting her balance), GAIT DISTURBANCE (can barely walk), VISION BLURRED (blurry eyes/had difficulting seeing), IMPAIRED DRIVING ABILITY (id not feel right driving on the 2rd and 4th day), PERIPHERAL SWELLING (fingers were swollen really bad/can not fit wedding ring), LIP SWELLING (lips swollen), SWELLING FACE (possible whole face swollen), MYALGIA (first three days in sever pain everywhere/exacerbated the pain worst than a normal person) and HEADACHE (heachache for about a week - it still has not gone away) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  The patient reported that for the first three days after receiving the second vaccine dose they experienced extreme difficulty walking and seeing, and intense swelling in the face and hands.  The patient continues to experience a headache as of 27-Apr-2021.
Arm felt like he had been punched; Injection site pain worsened; This is a spontaneous report from a non-contactable pharmacist. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. 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 vaccination. Concomitant medications were not reported. On 19Mar2021 hours later, the patient's arm felt like he had been punched. The injection site pain worsened the next day but subsided in the evening. The non-serious event had resolved. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events arm felt like he had been punched was recovered on an unknown date in Mar2021 and injection site pain was recovered on 20Mar2021.   No follow-up attempts are possible. No further information is expected.
Patient reported, upon injection, she experienced severe pain. Noted it was more painful than standard flu vaccine. Patient stated from the point of injection until today (6/24/2018) injection site was hot to touch, and was very hard underneath and surrounding. Patient showed me injection site, it was red in color, with scarring that resembled aftermath of a tetanus vaccine or ringworm within a 10-12 cm circle which was hardened underneath skin. Patient reported pain 10 on pain scale of 1-10. She reported this to me and my findings were observed when she returned to the pharmacy to pick up medication for treatment of cellulitis due to the vaccination.
This spontaneous report was received from the administrator and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 12-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot#, expiration date, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660:
On 9/04/2021 around 2:30PM I received an injection of Fluzone High-Dose Quad 2021-22. The vaccine was injected into my right arm by the pharmacist. I felt discomfort during the injection as the vaccine entered my arm. Within two hours post injection I felt substantial soreness in the area around the injection site. Several hours later as I attempted to change my clothing I experienced extreme pain in my upper right arm area, not soreness, while raising my right arm. My range of motion was restricted. I began taking 200 mgs of Motrin and 500 mgs of Tylenol for the pain. Within 24 hours post injection the initial injection site soreness went away as did the nausea, chills/fever; however, the  movement pain and restricted range of motion remained. I continued to take Motrin and Tylenol for several days without any pain relief or increase in range of motion. Deeply concerned I scheduled an appointment with Dr. at Orthopedic Clinic for 09/29/2021 to discuss the pain and range of motion issues that limit my ability to perform routine daily living activities. I explained I have never had any issues with my right arm/shoulder and that these problems began within hours of the vaccine injection. He diagnosed adhesive capsulitis, injected cortisone into my right shoulder area, prescribed physical therapy and a folllow-up appointment was scheduled for 11/03/2021 with (Dr. assistant). I began physical therapy on 10/07/2021. Immediately following the physical therapy my pain intensified and further restricted range of motion. Previously the pain was limited to my right upper arm. Now I also experience discomfort in my back on the right side that radiates out from the shoulder blade area after several minutes using the computer, using my iPhone, driving, etc. There has been no relief from the cortisone injection nor continued physical therapy 10/12/2021 and 10/19/2021. I requested an earlier follow-up appointment with Dr. and was seen on 10/15/2021 ordered an MRI and provided a prescription for Naproxen 500 mgs to replace the Motrin and Tylenol for pain. About one hour after taking one-half (250mgs) of the Naproxen prescribed dose I began experiencing dizziness and jitteriness in my hands that continued for several hours; I have not taken any more Naproxen and returned to Motrin and Tylenol for pain management. The MRI was completed on 10/20/21 and appointment with Dr. to discuss results is scheduled for 10/22/2021.
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second booster to early) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 016J21-2A, 006B21A and 031M20A) for COVID-19 vaccination. It was unknown if patient had allergies (medications, food and other products) or had acute and chronic illnesses at the time of vaccination. It was unknown if patient had ever had COVID positive test or diagnosis. It was unknown if any  other COVID-19 vaccines given prior to Moderna vaccine. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second booster to early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Three patient that received the second booster to early) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. It was unknown if patient had sought medical care (office visit, Urgent care, ER, hospitalized). No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow up contains contain No new information
I had severe muscle spasms  that took my breath away and lasted about 5 min each attack (felt like Charlie Horses). They started 12 hours after the shot was given. They affected muscles all over my body including my neck and back and legs and arms. They were severe and happened about every 30 minutes for the first three days, but they continued daily for a total of 8 days. I also had muscle soreness at the injection site for 3 days, but it was just at a discomfort level.
Vaccine given x's 2 Patient had URI at time Patient was aware of vaccine given and immunization form completed and signed by patient Patient mentioned vaccine had been given to him at work in October. Not documented through database or in patient's chart.
Developed chronic urticaria about 10weeks after 2nd vaccine.   Started using triamcinoline cream and Claritin.   Hives got worse.  Was given 5 days of steroids and taking 4 Claritin or Zyrtec daily and SingulAir at night.  Still getting hives but just a couple daily controlled with the triamcinolone cream.
18 MINUTES AFTER SHOT WAS GIVEN  PATIENT FACE BECAME RED AND HOT. SHE ALSO STARTED TO SHAKE AND CRY. SHE COMPLAINED OF PAIN ALL OVER
Patient did not have any adverse reaction, however our office vaccines were deemed unviable due to the lack of our office keep a correct temp log for the months of October and November 2018.
extremely painful menstrual cycle with fatigue for one week began on 3/20/21 on 3/23/21 hands began to have pins and needles, difficulty with coordination when standing and walking and limited endurance. Moved to cramping in hands and feet. Needed a wheelchair to see neurologist. No peripheral nerve damage.  Pt used tricycle to get around the school where she is employed.  Pt continues to have limited endurance, poor balance and numbness in feet.   Treatment has been limited to pycnogenol (natural blood thinner), she has been referred to a second neurological specialist.  Finally able to get her in for an MRI next week.
It was reported that patient died on 3/14/2021. This may have had nothing to do with the vaccine.
A report has been received from a Health Professional concerning a 50 year old, Female subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on an unknown date. The reporter stated that inadvertently administered FLUMIST to a 50 year old patient which started on 29-Oct-2013. The outcome of the event of inadvertently administered FLUMIST to a 50 year old patient is unknown. The report was considered to be non-serious by the reporter.
Developed fever of 103.7 at 3am on 7/31/18- seen in clinic that afternoon; given Tylenol at home by mother.
Fever, Vomiting, Weakness, Headache and Body ache for 3 or more days
I started having chills, a headache and was very achy around 1:30am on Thursday.  I took Advil every 6 hours, drank Pedialyte and rested.  I was fine by 3:30am on Friday.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown demographics. On unknown date, those patients were vaccinated with the improperly stored doses of ZOSTAVAX injection (strength, dose, route and site of administration were unspecified). No concomitant medications were reported. No adverse event were reported. This is one of several reports from the same source. Additional information is not expected as the reporter refused any further contact.
No adverse event; Dose of Moderna Bivalent administered after more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Bivalent administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 55-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     The patient's past medical history included Cataract bilateral NOS and Hepatitis C. Previously administered products included for Flu vaccination: Influenza vaccine on 29-Sep-2022. Past adverse reactions to the above products included No adverse event with Influenza vaccine. Concurrent medical conditions included Drug allergy (Hydromorphone), Penicillin allergy, Allergic reaction to antibiotics (Levaquin), Renal disease, HIV disease, Hypertension, Hyperlipidemia, Anemia, Aortic arteriosclerosis, Chronic hepatitis B, Secondary hypothyroidism and Prediabetes. Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]), ATORVASTATIN, VITAMINS NOS, FLUTICASONE PROPIONATE, COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA (MIRCERA), NIFEDIPINE, PANTOPRAZOLE, OLOPATADINE HYDROCHLORIDE (PATADAY), DARUNAVIR ETHANOLATE (PREZISTA) and SUCROFERRIC OXYHYDROXIDE (VELPHORO) for an unknown indication.    On 05-Oct-2022 at 3:29 AM, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 05-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Bivalent administered after more than 12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Bivalent administered after more than 12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose of Moderna Bivalent administered after more than 12 hours post puncture).    Patient did not have provided information about COVID positive test.  Date the vial was initially stored in the refrigerator was 23-Sep-2022.  The vial was first punctured on 04-Oct-2022 at 10:13 am.  On 05-Oct-2022, the patient received Moderna bivalent booster dose after more than 12 hours post puncture.  The vial did not undergone any temperature excursions.  Treatment information was not provided.
After being misdiagnosed at Urgent Care  with an eye infection my ophthalmologist discovered I have developed ocular herpes. I have been under treatment for 7 months and have now been referred to a corneal Specialist. Still under regular treatment.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age. Current conditions and medical history was not reported. Between 22-OCT-2014 and 29-OCT-2014, the patients were vaccinated with VARIVAX (Merck), 0.5 milliliter, subcutaneously once for an unknown indication. Concomitant medications were not reported. On an unknown date the patients received VARIVAX (Merck) that was improperly stored. VARIVAX (Merck) exposed to -10Celsius for 3 hours. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left leg started with redness and rash day after the shot, the second day patient would not walk on leg and seemed worse, went to emergency department and put on BENADRYL and antibiotic. Came to see pediatrician 3 days after event, no fever, walking fine, Mom says still was the same. Nurse practitioner states rash was "impressive" itchy and painful. Mom and grandmother state pt had vaccines Friday, redness/swelling small area on L lateral thigh near injection site yesterday, worse today. No fever some nasal congestion no diff breathing. Unsure which vaccine pt got in LLE but had on R that looked okay. No allergies known. In with mom, pt seen 3 days ago, with 4yr shots. Seemed fine. That dad was C/O about leg hurting. Mom said started with redness and rash just on one leg. Was not walking on it yesterday and seemed worse. Mom took patient to ED and put on BENADRYL and antibiotic. Mom says pharmacy was closed so has not started yet. No fever. Does seem to be walking fine today. Mom says looks about the same, today.
I began to feel numb around my mouth and nose.  It spread to most of my face, then chest, then arms, mainly left arm and leg, then to both legs.  General weird feeling / numbness, no pain.  I had trouble with limb control, not bad, but enough to notice. Mainly left side, but noticeable  on both sides.  From the onset on face numbness to the chest leg spread was just a matter of a few, maybe 5 minutes.  I looked at my face in the car mirror, and appeared to have facial control.  I was driving to a relatives house, and it worried me. On the way, I also noticed a lump in my right neck, about the size of a pea.  When I got to my relatives house I told them I thought I had a small stroke, but wasn't sure. The numbness lasted until the next day, then slowly went away.  It took about 2 days before the numb twitchy feeling went away from my left eye/upper cheek area.  The lump in my neck also went away.  rubbing on it actually made the numbness slightly go away. I did not go to a hospital, or seek any treatment.  I think I should have.   I do believe that l had a small stroke / blood clot, and that it should be reported.  I think I am OK now,
I got my shot and started experiencing symptoms 24 hours later and started experiencing body aches and feeling tired. I took 2 Aleve and went to sleep. I had a burning sensation in my lungs and felt out of breath doing things that I don't normally feel out of breath. Like going up the stairs and pushing a cart at the store with my kids.  At 2am I woke up and felt out of breath and then started feeling really "panicy". But I don't have any history of anxiety. From 2am on until the afternoon I was having panic attacks. I went to ER in the morning to deal with the breathing problems. They did x-rays and they said my lungs were clear and fine.  Somehow in my panic state I felt I was going to give my dad covid and he was going to die. When I got my second shot I started having the same symptoms. Everything was really similar, I woke up and had that anxiety feeling again. I felt restless and couldn't stop moving. I also had the out of breath sensation again. It went away after a couple of days.
Instantly after the vaccine was injected, injection site swelled up. There was blood that came out after injection but stopped bout 5 seconds later. The swollen area was hard to touch. It looked like a hard boil formed that has a diameter of a quarter. After about 15 minutes, the injection site was not hard anymore. A day after injection, patient reported that the injection site is still not hard and is red.
7-17-09 - Sleep & H/A  7-19-09 - H/A & hallucination (while awake) -> was taking food from ref. & thought it was falling on her.  About 2 PM (took med on am)
Sore upper right jaw 3 teeth day one, sore bottom right jaw one tooth days  2, 3, 4 and counting
Pt. got 2 yr vaccinations. About 2 - 3 hrs later started with hives all over the body with difficulty in breathing. Went to ER. Got DECADRON & ALBUTEROL after which recovered. Also had fever of 103.
After about 6 or 7 days of the injection, it appears rash on my upper left arm around the injection spot.  About 2" X 2" round area, and it's itchy and read, still there by now ( 9th day after the injection.)
Varicella rash on trunk with itching. Rx: symptomatic Tylenol and Benadryl.