chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st symptom was heart palpitations, followed by a few months of intestinal issues. Symptoms have deteriorated to include shortness of breath, at times brain fog, dizziness, and the arrhythmia has gotten worse. Recently diagnosed with myocarditis, diastolic dysfunction, and arrhythmia.
Patient was sitting down at a blood pressure machine and passed out. She hit her face on the edge of the machine when she passed out and had a small cut on her face. She was lain down on the floor and paramedics were called in. Patient had no difficulty breathing, or any signs or symptoms of anaphylaxis after passing out. She did feel dizzy and was sweating.
pt turned bright red, legs blotched purple/grey & pink, pt had shrill cry immed following vax;
lower back pain; NECK ACHING; ALL OVER BODY ACHE; EARS RINGING; INSOMNIA; BACK ACHING; ANXIOUS; SHARP PAIN IN LEFT CALF; WEAKNESS; FATIGUE; PAIN AT INJECTION SITE; FACE GOT PRETTY RED; FACE STARTED ITCHING; LEFT EAR ACHING; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included uterus removed, ovaries removed, surgery for internal bleeding, and gall bladder removed, and concurrent conditions included sulfa allergy, latex allergy, paper tape allergy, pollen allergy, high blood pressure (temporary), fibromyalgia, and sleep apnea, and other pre-existing medical conditions included patient had allergies with medication which used to put under.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: 13-JUN-2021) dose was not reported, administered on 28-MAR-2021 11:00 to left deltoid for prophylactic vaccination. Concomitant medications included cetirizine hydrochloride, cyanocobalamin, famotidine, probiotics nos, and propranolol. On 28-MAR-2021, the subject experienced face got pretty red. On 28-MAR-2021, the subject experienced face started itching. On 28-MAR-2021, the subject experienced left ear aching. On 28-MAR-2021, the subject experienced sharp pain in left calf. On 28-MAR-2021, the subject experienced weakness. On 28-MAR-2021, the subject experienced fatigue. On 28-MAR-2021, the subject experienced pain at injection site. On 29-MAR-2021, the subject experienced neck aching. On 29-MAR-2021, the subject experienced all over body ache. On 29-MAR-2021, the subject experienced ears ringing. On 29-MAR-2021, the subject experienced insomnia. On 29-MAR-2021, the subject experienced back aching. On 29-MAR-2021, the subject experienced anxious. On an unspecified date, the subject experienced lower back pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face started itching, and left ear aching on 28-MAR-2021, and sharp pain in left calf, weakness, and fatigue on 02-APR-2021, was recovering from face got pretty red, neck aching, all over body ache, ears ringing, insomnia, anxious, and pain at injection site, had not recovered from back aching, and the outcome of lower back pain was not reported. This report was non-serious.   The additional information received on 2-APR-2021 The following information was updated and incorporated into the case narrative: reporter address, patient details (age, birth date, sex, race, ethnic origin), medical history, events(lower back pain, weakness, fatigue, injection site pain) concomitant medication (famotidine, propranolol, Zyrtec, probiotics, vitamin), dose of drug used to treat AE.
Information has been received from a physician assistant concerning a male with hypertension, osteoarthritis and no drug allergies whose wife in December 2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck).  Concomitant therapy included PRILOSEC, DIOVAN, TIMOPTIC, vitamin D (unspecified), omega-3 vitamin and vitamin B complex.  On 02-FEB-2009 the male patient developed shingles.  He was seen in the office with blisters and post herpetic neuralgia pain on the right groin, right thigh and low back on the right side.  The area affected was dermatome L1.  The female who received the vaccine was not experiencing any symptoms or problems.  Follow-up information was received from the physician assistant concerning the 76 year old male with a history of chickenpox during childhood whose 74 year old wife on 29-DEC-2008 was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck) (lot #:  663198/1419X) into the right deltoid.  It was reported that the patient and his wife lived together.  On 09-Feb-2009, the male patient developed shingles.  He developed vesicular rash with extensive lesions on the right hip, groin and low back.  The area affected was dermatome L2.  The patient had grade 9 pain.  The maximum temperature was 99.  At the time of this report, the patient was recovered.  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician assistant concerning a male with hypertension, osteoarthritis and no drug allergies whose wife in December 2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck).  Concomitant therapy included PRILOSEC, DIOVAN, TIMOPTIC, vitamin D (unspecified), omega 3 vitamin) and vitamin B complex.  On 02-FEB-2009 the male patient developed shingles.  He was seen in the office with blisters and post herpetic neuralgia pain on the right groin, right thigh and low back on the right side.  The area affected was dermatome L1.  The female who received the vaccine was not experiencing any symptoms or problems.  Follow-up information was received from the physician assistant concerning the 76 year old male with a history of chickenpox during childhood whose 74 year old wife on 29-DEC-2008 was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck) (lot #: 663198/1419X) into the right deltoid.  It was reported that the patient and his wife lived together.  On 09-FEB-2009, the male patient developed shingles.  He developed vesicular rash with extensive lesions on the right hip, groin and low back.  The area affected was dermatome L2.  The patient had grade 9 pain.  The maximum temperature was 99.  At the time of this report, the patient was recovered.  Follow up information reported that the physician assistant was unable to provide further adverse event information.  No further information is available.
FELL FROM CHAIR IN OBSERVATION, WAS AWARE, HAD HEADACHE AND DIZZINESS, OBSERVED FOR 30 MINS AND RELEASE WITH NO ISSUES
Patient may have inadvertently received a higher dose of vaccination, technician  wasn't sure if she mixed the vial with 1.8 ml of diluent or 0.8 ml of diluent . Patient did receive 0.3 ml of of  vaccine.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021 at 11:53 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:53 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 61.74 for dose administered on 03-Apr-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a break through of varicella of less that 50 lesions. Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the physician who reported that he was not aware of any recent adverse reaction to VARIVAX (Merck). No further information is expected.
68 Y male with a h/o COVID+ on 9/23 (vaccinated in February), history of tobacco use (stopped smoking 1 m/ago), and HTN who presents with syncopal episode at home.   The patient experienced a syncopal episode on 9/29 overnight after going to the bathroom. No neurologic symptoms or seizing to suggest a neurologic etiology, and patient has no history of cardiac disease with no events noted on tele for 24 hours to suggest a cardiogenic etiology. Most likely orthostatic and vasovagal in etiology in the setting of poor PO intake for the past week. Patient was noted with improved appetite over the course of his admission eventually eating 100% of his meals with no destaurations or dizziness noted on road test. His initial pre-renal AKI improved to baseline with fluids.   Patient notably tested positive for COVID on 9/23 now s/p 5 day course of prednisone 40 mg daily starting 9/22 with symptom onset on 9/22. On arrival to the ED, patient was afebrile, hemodynamically stable, and non-hypoxic satting well on room air. On 9/30, patient's O2 desaturated to 92 and 90-92 on road test requiring 2L NC; he was then started on decadron/remdesivir. He was quickly weaned back to room air on 10/1 and discharged on 10/2 with 2 more days of decadron for a 5 day decadron regimen total.   Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  COVID pneumonia
My daughter seems to be having a reaction at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (My daughter seems to be having a reaction at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (My daughter seems to be having a reaction at the injection site). At the time of the report, VACCINATION SITE REACTION (My daughter seems to be having a reaction at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant drugs were reported. No Treatment medications were reported.   Reporter did not allow further contact
knot; bruise on her left leg; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (knot) and CONTUSION (bruise on her left leg) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MYALGIA (knot) and CONTUSION (bruise on her left leg). At the time of the report, MYALGIA (knot) and CONTUSION (bruise on her left leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
fever 100.0+, body aches, chills, racing heart (125+ BPM) headache, diarrhea, sore throat, stomach ache
pt recv 3 confirmed & 2 potential vax w/MMR in 1994 & pt was tested for measles & mumps titer & the results were negative;
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: rash on extremities
Patient states that evening after receiving FLUAD vaccine, she fell on floor and was unable to get up.
Information has been received from a 23 year old female with allergy to anything in the "cillin family" and a history of cesarean section and tuberculosis exposure, for the Pregnancy Registry for GARDASIL, who on 05-SEP-2008 was vaccinated with the first dose of GARDASIL. On 05-NOV-2008 the patient was vaccinated with the second dose of GARDASIL. On 16-MAR-2009 the patient was vaccinated with the third dose of GARDASIL. Home pregnancy test was done. The patient was pregnant now. Her LMP was 16-FEB-2009. On approximately 17-MAR-2009, "currently", she was experiencing sharp pains located "4 inches below her belly button and 4 inches to the left of her belly button". She stated the pain might be due to a previous cesarean section. Unspecified medical attention was sought by phone call. Follow-up information was received from the physician via a completed initial pregnancy questionnaire. It was reported that the patient had one previous pregnancy and one full term delivery. There were no birth defects or infant complications in the previous pregnancy. The patient's PPD tuberculin test was positive. The patient was taking isoniazid and vitamin B6 for the positive PPD concurrently. The lot number for the third dose of GARDASIL was provided as 661953/1130X. No other information provided at the this time. Additional information has been requested.
I had an uneasy feeling about the pharmacist because he was alone and running back and forth filling prescriptions and giving vaccines. He also seemed unsure of himself.  After three weeks I have a rapid anti-body test and then a blood drawn anti-body test. Both tests were negative. I am now going to get another vaccine (Pfizer). I am concerned that this might have been a bad batch of vaccine and others that were vaccinated think they are protected but are not!
1. FOCAL BILATERAL FOREARM URTICARIA; ERYTHEMA; TWO DAYS POST INJECTION 2. MULTIPLE PLAQUES BILATERL FOREARMS; TWO DAYS LATER 3. EXTENSIVE BILATERAL FOREARM ECZEMA AFTER CRYOTHERAPY OF PLAQUES; 4 WEEKS POST INJECTION 4. EXTENSIVE PLAQUE FORMATION, TRUNK, ARMS, LEGS BEGINNING WITH ECZEMA. 5. FAILED TOPICAL TREATMENT WITH TRIAMCINALONE 0.1% 6. DIAGNOSIS OF POST IMMUNIZATION PSORIASIS 11/03/2021
Rash/itching at site of injection and "hot" feeling systemically.  Rash on back, right arm.
This spontaneous report was received from a pharmacist refers to a 66 year old female patient with high blood pressure, high cholesterol and sulfa allergy. The patient's medical history included thyroid disorder (reported as thyroid). On 25-OCT-2013, the patient was vaccinated with a dose of PNEUMOVAX23) (lot # H021941, 11-JUL-2014) and FLUVIRIN intramuscularly in the right arm at different injection sites. Concomitant medications included unspecified medications. On 25-OCT-2013, the patient arm became red and swollen at the injection site (unable to discern if it was the site of the PNEUMOVAX-23 or the FLUVIRIN). Over the weekend approximately on 26-OCT-2013, the patient arm had gotten progressively worse, the redness had spread from the deltoid down past the elbow. No treatment was given. No laboratory tests were performed. Patient sought medical attention. The outcome of the events were reported as not recovered. Additional information has been requested.
PATIENT RECEIVED THE VACCINE AND APPROXIMATELY ONE MINUTE LATER SHE FELL TO THE FLOOR FROM THE EXAM TABLE.  PATIENT STATES SHE BEGAN TO FEEL DIZZY AND EVERYTHING WENT BLACK.  NEXT THING SHE REMEMBERS IS WAKING UP ON THE FLOOR.
@ inject site area of about 4" red, swollen, hard & warm to touch; arm was achy; took advil w/relief;
First dose received on 2February2021, second dose 1April2021.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 2February2021, second dose 1April2021.) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 2February2021, second dose 1April2021.). On 01-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose received on 2February2021, second dose 1April2021.) had resolved.            No concomitant medication information were provided. No treatment information were provided.
Woke up w/ raw sore throat , fever, stuffy head, deep cough in cheats, bad congestion. Felt like cotton in my lungs. Couldn?t lay down. Sounds like a harmonica when I breath. Still congested. Had another Covid19 test yesterday 10/12/2021@ Hospital offsite.
Pt recvd 1 dose of Engerix-B & 25JUN92 exp resp distress & bronchitis;
SEVERE HEADACHE AND BODY, JOINT PAIN. VOMITING, CHILLS PAIN IN ARMPIT AND DOWN SIDE OF TORSO ONE SIDE.
No adverse event; Patient received first booster dose as Moderna COVID-19 Monovalent on 24-Feb-2023; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received first booster dose as Moderna COVID-19 Monovalent on 24-Feb-2023) and NO ADVERSE EVENT (No adverse event) in a 7-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.   No Medical History information was reported.   On 24-Feb-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2023, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received first booster dose as Moderna COVID-19 Monovalent on 24-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received first booster dose as Moderna COVID-19 Monovalent on 24-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received first booster dose as Moderna COVID-19 Monovalent on 24-Feb-2023).    No concomitant medications were reported.  No treatment information was provided.
Patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. The patient received second booster dose. It was reported that the HCP mentioned because of miscommunication as a coworker told that there were some lot number whose expiration dates had been extended, patient received expired dose. Treatment information was not provided.
Fever came 6 days after MMR #1 and VARIVAX #1 - 104 degrees 1 week later after shots. 1" vesicular line with redness day after VARIVAX shot arm - (L) arm.
Significant swelling and pain in left armpit and breast lymph nodes after Pfizer full dose booster. The doctor recommended heat packing area, ibuprofen for inflammation, Tylenol for pain, and antihistamines. Swelling in the left armpit went down over two weeks, but still, some swelling in the lower outside of the left breast now at three weeks continues. The swollen area becomes painful with exercise.
This spontaneous report was received from a laboratory technician, concerning a 2 month-old patient of an unknown gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 19-MAY-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX 23 injection (strength, dose and frequency were not reported) lot # M036728 with expiration date of 20-MAY-2018, for prophylaxis; rather than receiving PREVNAR 13 due to a product confusion. No adverse effects were reported. Additional information has been requested.
Employee received 2nd vaccine yesterday and states vaccine was injected onto her shoulder joint.  C/o excruciating pain in her shoulder joint and going up to her neck.