chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortness of breath; experiencing heart propagation and raising heart beat; This is a spontaneous report from a contactable consumer or other non hcp. A 29-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) as single dose via an unspecified route of administration on 2021 as DOSE 3 (BOOSTER) for covid-19 immunisation. The concomitant medications and medical history was not reported. The patient received his two Pfizer about ten months ago and than he had COVID and than last since two week after he had COVID they gave him a booster and he was experiencing heart propagation and raising heart beat and shortness of breath and many other different things like this. he did not received treatment after vaccine. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist refers to a 16 months old female patient with vaccination. The patient's medical history included kingella infection. The patient was vaccinated with VARIVAX (merck) on 13-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-NOV-2012 the patient experienced injection site reaction, 9 days after onset of therapy, injection site swollen, warm swollen area at injection site and low grade fever. No treatment information was reported. The outcome of injection site reaction, injection site swollen, warm swollen area at injection site and low grade fever was reported as not recovered/not resolved. The relatedness for injection site reaction, injection site swollen, warm swollen area at injection site and low grade fever is unknown for VARIVAX (Merck). Drug Reactions/Allergies: Ceftriaxone. No further information is available. Additional information has been requested.
Pt had feeling of throat tightness and difficultly swallowing. No rash or hive. No wheezing or stridor. She was given 0.3 Epi via epipen IM to the right thigh. Symptoms subsided in 2-3 minutes. Monitored patient for 1:15 minutes total without return of symptoms. She was released to home with script for epipen and directions to call 911 for EMS if symptoms returned.
Pt had 3 dose series of Hepatitis B vaccine, last dose given 03/29/03.  Later diagnosed with M.S. (04/23/04). Study being done of possible relationship. Summer 2003-intolerance to heat, stomach upset. 04/22/04: Numbness arms, hands and wrist down. Medicine: Avonex.
Covid arm bright red getting larger, itchier and spreading each day although I?m taking antihistamine and using lotion
Became very weak; lost muscle mass; lost 8 lbs; when he moves it hurts; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Became very weak), WEIGHT DECREASED (lost muscle mass), WEIGHT DECREASED (lost 8 lbs) and MYALGIA (when he moves it hurts) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 ASTHENIA (Became very weak), WEIGHT DECREASED (lost muscle mass), WEIGHT DECREASED (lost 8 lbs) and MYALGIA (when he moves it hurts). The patient was treated with CELECOXIB (CELEBREX) at a dose of UNK dosage form and CYCLOBENZAPRINUM at a dose of UNK dosage form. At the time of the report, ASTHENIA (Became very weak), WEIGHT DECREASED (lost muscle mass), WEIGHT DECREASED (lost 8 lbs) and MYALGIA (when he moves it hurts) outcome was unknown.            Concomitant medications were not provided.   This case was linked to MOD-2021-200648 (Patient Link).
pt recv vax 9JUL97 & 3SEP97 to MD office w/a rash that dx as shingles;
Has not had menses since her 1st dose of the vaccine.  she is not pregnant and has not been pregnant.
1100 Patient noticed tingling in right jaw 5 mins after receiving vaccine. Upon assessment patient vital signs were BP: 146/98, O2: 97%, HR 81. Tingling in jaw doesn't radiate anywhere in his face.  After assessment and sitting for a few minutes, tingling in face started to subside.  Patient feels he is going to be ok. Doesn't need any other further supervision. Patient waited remainder of 15 mins and left with no further issues.
I want to start by saying I?m not sure if this is an adverse event due to the vaccines. I got the booster in November and my health condition started in May. I was diagnosed with shingles, which is odd for my age and because I am not immune compromised. It could of well been triggered by stress and anxiety however I figured I?d report it just in case. Again, I?m not sure if this was something the booster triggered since I was boosted in November 2021 and I was diagnosed with shingles May 2022.  Currently my shingles rash is drying up and I am not as itchy as when it began.  The pain is almost non existent unless I work out or walk too much that day. The week I was diagnosed I was very itchy and had some pain.  I have shingles rash on my right side of my stomach, lower abdomen, and lower back.  I used calamine lotion for the itch and that helped.
Information has been received from a physician through the Pregnancy Registry concerning a 30 year old white female with no medical history or allergies who on 21-MAR-2007, was vaccinated IM with a first 0.5ml dose of Gardasil (lot# 657006/0188U).  Concomitant therapy included prenatal vitamins.  On 21-MAR-2007, the patient was inadvertently administered the vaccine.  It was reported that the patient's last menstrual period was (LMP) 21-JAN-2007.  A urine pregnancy test and an ultrasound was performed.  The patient was reported to be 8 weeks and 3 days pregnant.  Her reported estimated delivery date was 28-OCT-2007.  The result of the ultrasound was normal.  On 19-APR2007, an ultrasound was performed to screen for chromosomal abnormalities.  It was reported to be normal.  On 21-MAY-2007 and 06-JUN-2007 both ultrasounds were also reported as normal.  On 31-AUG-2007, the patient was prescribed Nystatin (topical) twice a day for the treatment of candida.  On 05-OCT2007, the patient was prescribed VISTARIL 25mg PRN for the treatment of insomnia.  On 19-OCT-2007, an ultrasound was performed and the results were reported to be small for dates but normal.  On an unknown date in 2007 the patient was prescribed ZANTAC 150mg twice a day for the treatment of gastrooesophageal reflux disease (GERD).  There were no previous pregnancies, no spontaneous abortions (miscarriages) and no live births reported.  On 06-NOV-2007, the patient gave birth to a live born infant weighing 4175 grams and 19 3/4 inches.  She was 41 weeks from her LMP.  The infant was reported to be normal and there were no congenital anomalies.  There were no complications during the pregnancy or labor and delivery except, it was reported that the patient had failure to dilate.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information is not expected.
Just a couple mins after being given the shot my chest becan to burn HOT my lips became really numb. My provider gave me a shot of steroid in my hip ro counteract the reaction (from my understanding) this seemed to work almost instantly.  I could still swallow and breathe fine my lips were still numb for awhile and my left side of my throat was a little swollen but nothing that impeded my breathing or swallowing and it slowly receded. She continued to monitor me for the next couple hours to make sure I didnt need to go to the hospital for further treatment. I wanted to avoid going to the hospital if possible due to risk of being exposed to covid while there. After she observed me and was assured my husband would leave work to watch me and take me to ER if I had any firther problems she allowed me to go home. I was instructed to continue taking benadryl for the rest of the day and given a RX for Prednazone ro take another pill that evening. On and off for about 9 days I would wake up itching from head to toe. My lips or tongue would become tingly or numb. I would just take some benedryl and it would seem better. I didnt change anything about my daily life ,foods or any thing. I have had erratic bp and blood sugar readings either high or low. Over the top fatigue and daily migrains flashes of light in my vision and unbelievable amounts of exaustion
Presented with weakness/SOB x3 days; CXR: "low lung volumes with central congestion"; no inflammation lab values drawn;  placed on supplemental oxygen, zinc and steroids. He was initiated on remdesivir by Dr. He tolerated this very well and was able to wean quickly to room air
Metallic taste; Headache; metal is sticking to my arm and serval lot of side effects; metal is sticking to my arm and serval lot of side effects; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 05Sep2021 (Lot number: FC3182) at the age of 41 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Systemic lupus" (unspecified if ongoing), notes: Verbatim: Systemic lupus. The patient's concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 2021, outcome "unknown", described as "Metallic taste"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), ADVERSE DRUG REACTION (non-serious) all with onset 2021, outcome "unknown" and all described as "metal is sticking to my arm and serval lot of side effects". Therapeutic measures were not taken as a result of dysgeusia, headache, feeling abnormal, adverse drug reaction.  Additional information: Patient reported, she went out for vaccine two days ago on Sunday 05Sep2021 and the first shot and a metal was sticking to her arm, she had metallic taste and then an imbibing' headache and serval lot of side effects and went to the pharmacy and they wanted her to call you and she had already contacted her doctor.  No follow-up attempts are possible. No further information is expected.
Hospitalized 10/8/2021; COVID-19 positive 10/8/2021; fully vaccinated  Discharge Summary(Physician) ? ? General Medicine BRIEF OVERVIEW: Admission Date: 10/8/2021 Discharge Date: Oct 13, 2021     DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] COVID-19 virus infection [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is an 82-year-old male with a past medical history of cardiomyopathy, systolic CHF, aortic stenosis status post bioprosthetic aortic valve, dementia, CKD, hypertension and prostate cancer who presented secondary to a chief complaint of weakness.  The patient developed a cough 3 days prior to admission which was nonproductive.  He became weak during this time.  Blood home the night prior to admission he slid out of his chair and required family to assist him to the floor.  He did not lose consciousness.  To decreased oral intake.  He fell again and EMS was called.  In the emergency department, he had a temperature of 39.0°.  CMP and complete blood count were unremarkable.  Procalcitonin was 0.1.  UA was positive for ketones and protein.  No signs of infection.  COVID PCR was positive.  Chest x-ray was negative for acute process.  Tylenol was given in the emergency department as well as a 500 mL bolus.  The patient was admitted for COVID infection with generalized weakness.  He was seen by PT/OT who recommended subacute rehab, but family opted for home with home care.  The patient did not require oxygen.  He was afebrile.  He was discharged home on 10/13/2021 with home care.
Metallic taste in mouth;  cotton/dry mouth while trying to swallow;  flush/tingling sensation throughout body but especially extremities.  Occurred within the 5-15 min observation period.  I did not speak up about it as I was trying to analyze it myself and rationalize the symptoms.  It did not cause tachycardia or SOB or intervention but it makes me a little hesitant for the 2nd dose due to my shellfish allergy/sensitivity.   The sensation reminded me of the systemic response when receiving a contrast IV dye.   I did leave a message at the VAERS 800# to ask if I should submit this form but did not want to delay any longer in case this information is helpful with the feedback/data for others.  I understand it is not a true "adverse or sentinel" event but I wanted to report my reaction especially with the shellfish allergy (which I wasn't aware of to be a risk factor until I read more articles about it).
It started with achy ness the first couple of weeks. By April, I could not walk at all. I could not turn over in bed. This went on for months. I went to the ER on the end of April at the clinic. The gave me a huge dose of a steroid and that helped me about 8 hours. I went to the ER about three times till June. I am on prednisone and I can not come off. Then vaccine has stopped my RA medicine from working disease. The was a numbness in the left hand it lasted three months and went away about January 2022. I was just numb, the whole time since August I had termers in the left hand and fingers. I am seeing a neurologist because they believe the vaccine has caused me Parkinson's disease. It has also messed up my knees. Once able to stand I have trouble walking. I feel as if I have no strength in  my knees the hyperextend and feel like they are going to break. I have never had this issue before. The have measure a rise in my inflammation factors since being vaccinated.
This spontaneous report was received from registered nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with improperly stored RECOMBIVAX HB, lot # R012001 (expiry date: 06-NOV-2020) for prophylaxis (strength, route and dosage were not reported) (incorrect product storage). The temperature excursion of the vaccine was 47 degree Fahrenheit to 77 degree Fahrenheit for a time frame of 2 hours. There was no previous temperature excursion. A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved.
Information has been received from a nurse practitioner (N.P.) concerning a current 29 year old female patient who "5 years ago" when she was approximately 24 year old was given GARDASIL series to treat the patient for genital warts. Nurse practitioner reported that genital warts had returned in approximately June 2010 "a couple of weeks ago". The patient sought unspecified medical attention. Pap smear was performed with no results provided. At the time of the report, the patient had not recovered from genital warts. Additional information has been requested.
I have a knee replacement which was affected at 5:30 am in that I awoke with excrutiating pain. When I bend my knee and straighten my leg the pain is crippling.  This was post-booster.
The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-2023; No adverse event; Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 016H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 21-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered with Moderna COVID-19 Vaccine beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 12-Mar-2023 and was administered to patient on 21-Apr-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the reporter was not aware if patient experienced any adverse events. Treatment medications were not provided.  This case was reported for patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-721680 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721680:1st patient case (Master case)
acute vesiculobullous eczema appeared on both hands and left foot; headache; allergy reactions appeared on both of my thighs and legs; This is a spontaneous report from a contactable consumer. This 32-year-old female consumer (patient) reported for herself that.  A 32-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 12:45 as (At the age of 32-years) dose 2, single for covid-19 immunisation. Medical history included, Known allergies: quinolone antibiotic (probably). There were no concomitant medications. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No Other medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 11:00 Am as (At the age of 32-years) dose 1, single for covid-19 immunisation. The patient experienced acute vesiculobullous eczema appeared on both hands and left foot, headache, and allergy reactions appeared on both of my thighs and legs on 20Apr2021 10:00. It was reported that patient had headache until 48hours after she got his 2nd dose. After 72hours, allergy reactions appeared on both of his thighs and legs. Also, acute vesiculobullous eczema appeared on both hands and left foot. It has been 3 days and is not getting better. Patient did not receive any treatment for events. The outcome of event was not recovered at the time of report.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I went to the medical facility for a covid vaccine today. I received the Pfizer vaccine. I started to have a reaction to it and was instructed by the physician on site to use my epi pen. Symptoms resolved within 5-10 minutes of using my epi pen. The on site MD called EMS and I was transported to ED for obs. I was discharged shortly thereafter. I have a hx of anaphylaxis both idiopathic and to iron dextran and basil.
PATIENT RECEIVED EXPIRED DOSE THAT WAS LAST DRAWN ABOUT 70 HOURS AGO. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. REPORTED TO PFIZER DATA SAFETY TEAM FOR CLINICAL INFORMATION ON SAFETY AND INFO ON RE-DOING 2ND DOSE. PFIZER REP STATED SAFETY LESS OF CONCERN THAN EFFICACY. REVIEWING PROCEDURES ON READMINISTRATION AND PATIENT WILL BE INFORMED. SCHEDULED A FOLLOW-UP WITH PATIENT NEXT DAY TO DETERMINE IF STILL NOT EXPERIENCING ANY SE/AE
This spontaneous report has been received from the medical assistant refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK) used to reconstitute the VARIVAX was properly stored. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of VARIVAX (dose, units and frequency not reported) (lot# N035937 and expiration date: 18-DEC-2019), subcutaneously. The doses of VARIVAX were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter.
Redness, swelling, pain and itching at site, tingling in  right hand.  All starting the evening after vaccination. Patient was seen by provider on 9/21/2023 who verified that the patient was experiencing a localized reaction and that the vaccine was given lower on the arm than it should have been.
Per Emergency room report. Patient started itching in the left upper extremity where Menactra vaccine was administered upon leaving clinic. Later patient started to complain of itching sensation in the throat and Mom noticed some swelling in the face. Mom gave him 25mg of Benadryl and took him in to Emergency room for further evaluation. IV was placed, Benadryl given and blood work was completed. Monitored for several hours with complete resolution of symptoms.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent or historical condition was not provided. On 27-JUN-2016 the patient received improperly stored GARDASIL (strength, dose, frequency and route unknown). Reporter reported GARDASIL with Lot # L024993 and expired 17-AUG-2017 which was not valid for GARDASIL. However, Lot # L024993 was valid for GARDASIL 9. Concomitant therapy was not provided. The vaccine was stored under 30F for 15 minutes. There was no previous temperature excursion. Digital logger was not involved. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
5 x 4 cm erythematous area; headache and fever per history, 2d ago. Erythema at this time resolving and patient asymptomatic.
Right thigh area, red raised hot to touch x 2 days. Bumps on chest.
pt recv vax 3NOV95 & 6NOV95 testing revealed that the pt was HBsAg positive;it was noted that the pt's mom was not HBsAg positive;
Symptoms leading to Congestive Heart Failure: Breathing and digestive issues Fluid backing up into body (around lungs, stomach, and groin areas, and legs)
Shivering/chills started first,  in the middle of the night, then I woke up feeling like I had a moderate case of the flu: joint/muscle aches, headache, fever (100 to101 throughout the day ) and intermittent mild nausea. Symptoms were relieved  by acetaminophen , and were resolved by 9:00 PM  the evening of 09/06/2020, approx 28 hours post-injection.
3/30/2021 - Woke up with a headache, chills and fever (Temperature reaching 101) 3/31/2021 - Headache, chills and fever persists until about 6:00pm 4/1/2021 - Slight lingering headache in the morning. No fever, no chills.