chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the site of the injection) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the site of the injection). At the time of the report, VACCINATION SITE PAIN (Soreness at the site of the injection) had resolved.            No concomitant medications were reported.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021 contains events updated from unknown to recovered
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high cholesterol" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". After testing positive on 03Feb2023, the patient was started on PAXLOVID on the same day.Minor symptoms, some fatigue and depressive thoughts. Clear headed again by 07Feb2023. The patient took last dose of PAXLOVID on 08Feb2023. The patient tested negative (rapid antigen) on 10Feb2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One day Expired vaccine administered; Small Rash on the Injection Site on the Left Arm; A spontaneous report was received from a consumer, concerning a 35-year old male patient, who received Moderna's COVID-19 vaccine and experienced Injection site rash (vaccination site rash), Expired vaccine used. The patient's medical history was not provided.   Concomitant product use was not provided by the patient.  On 25 Mar 2021, prior to the onset of events, the patient received his first of the two planned vaccine doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis and stated that the vaccine was pre-drawn in a syringe and the paper label on the syringe indicated that it expired the previous day and experiencing small rash on the Injection Site on the left Arm .  Reporter was notified that an answer will be provided to the Nurse manager whom previously called, and she will communicate with the patient. MA Escalation is not necessary as Excursion team is already working on this case.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of Injection site rash was unknown and expired vaccine used, was considered to be recovered at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, Vaccination site rash, a causal relationship cannot be excluded.  This report also refers to a case of Expired product administered, for mRNA-1273, lot # unknown.
Arm was itching at site of injection and formed a 2 inch by 3 inch red rash.
12 year old received 1st dose of Moderna, not Pfizer.  No adverse reactions noted.  Error was noticed by data entry team.
After administration, during the patient's required observation period, the patient started to feel lightheaded and dizzy. He went to stand up and then blacked out, falling to the floor. He did not injure himself or experience any trauma in the fall. He did not lose consciousness. I believe he was experiencing increased anxiety from the event as the patient mentioned several times that he did not like needles/injections. The patient remained sitting upright for an additional 15 minutes, drinking water, and his mother escorted him out of the store and drove him home.
Per health department: Regarding the VSIR for  Health on the following COVID Vaccine Moderna. Please see the following determination; Doses Administered from 4.6.2021 to 5.21.2021:Based on the information you have provided and the lack of temperature data, we are not able to conduct an analysis or guarantee the doses administered between 4/6/2021 and 5/21/2021 provided the necessary protection against a COVID-19 infection. Please continue with the original plan of action on revaccination and completing Agency Reports on all clients you have identified.
81-year-old gentleman sent in from Health and Rehab facility for shortness of breath.  Patient has a known covid-19 positive from a week ago.  Patient having increasing shortness of breath throughout the night patient with cough chills congestion.  No nausea vomiting.  Patient initially was sat in the 80s on room air.  Patient is now on a non-rebreather.  Course of symptoms constant degree at onset severe degree of present moderate.  No known alleviating factors symptoms worse with any activity.  Patient evaluated emergency department chest x-ray shows bilateral pneumonia patient covid-19 positive.  Patient found significantly elevated inflammatory markers significant elevated troponin.  Patient is a DNR patient will be admitted with IV antibiotics IV steroids and remdesivir
Patient received the flu shot 8/19/20 and ended up sitting down on the ground because she was not feeling well. She tried to get up and instantly felt dizzy and went down to the ground. During this moment, we put her legs up and put her on her back. We provided her ice packs and also provided her some water to cool her down. She eventually felt better and we walked her to her car. My other pharmacist also called to check up on her 1 hour post leaving the store.
Initial swelling below injection site was size of golf ball, red, and hot. Pt describes tingling and soreness in arm. 48 hrs after injection swelling had increased to larger than a grapefruit, redness and heat had decreased and tingling was gone, but arm was still sore. Pt used ice pack on swollen site.
tingling in all of his extremities; abdominal cramping; This is a spontaneous report from a contactable other hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling in all of his extremities, abdominal cramping. The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
9/23/22 Adverse Event: Vaccination Timing Error. History of Event: 6 year old male given Pfizer 5-11 years monovalent booster 2.5 months early.  Series finished 6/12/2022.  There should have been a 5-month interval.  Treatment: Mistake identified and mother aware.  Charge Nurse and Pharmacy consulted immediately. Pharmacy advised there should be no adverse effects as a result.  Client watched for 15 minutes and felt fine. Regional Manager and were also informed.  Dr advised no further Covid vaccinations for at least 5 months starting today (9/23/22) and only if CDC recommends additional boosters.   After the client left, the nurse involved we discussed door screener using chart to verify correct timing for pediatric age group vaccination timing and doublechecking throughout the process  Final Plan: Dr called back after our initial discussion and wanted us to review CDC recommendations in October to determine future vaccination schedule. Person Reporting: RN Charge Nurse
Itching from head, neck, arms, hands 25 minutes after administration Given patient's own dye-free benadryl 25 mg po at 1500 at 1507, she was having continued itching and flushed at 1515, itching reduced, flushing improving at 1518, itching to hands, neck improved Face still flushed and sweating
Bone pain; This non-serious case was reported by a physician and described the occurrence of bone pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced bone pain (Verbatim: Bone pain).  The outcome of the bone pain was resolved.   It was unknown if the reporter considered the bone pain to be related to Shingrix.     It was unknown if the company considered the bone pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 It was reported that patient started feeling bone pain after the shot. The time until the bone pain started and stopped was unknown.
Patient received covid 19 pfizer vaccine on 5/22/21 and 6/12/21. Patient had a cardiology visit on 9/15/21 with intermittent chest pain for 2 years. Patient had recurrence of chest pain in Jan, Mar, Apr, and June of 2021 and was diagnosed with scapular dyskinesia by rheumatology and orthopedics. Patient was seen in cardiology clinic in summer when he had a fever of 103 and echocardiogram showing a large circumferential pericardial effusion.   Below is the cardiac mri imaging on 9/24/21: IMPRESSIONS: 1. The left ventricular size is normal. The left ventricular ejection fraction is 65 % by Simpson's method. Global left ventricular function is normal. There are no regional wall motion abnormalities of the left ventricular wall. The left ventricular mass is normal.   2. There is no myocardial late gadolinium enhancement to suggest prior infarct, inflammation, or infiltration. There is no evidence of myocardial edema by T2 weighted imaging.   3. The right ventricular size is normal. Global right ventricular function is normal. There are no regional wall motion abnormalities of the right ventricular wall.   4. Left atrial size is normal. Right atrial size is normal.   5. The pericardium thickness is normal. There is circumferential pericardial late gadolinium enhancement. There is no evidence of pericardial edema on T2-weighted imaging.
Right lower back and Right leg shingles developed 9/13/2000. He also appeared to have a transient knee sterile synovitis.
Chills, weakness , nausea day 1.  Rested all day.  Day 2, a little nausea and weakness.
He is having severe seizure and they put drip in him; they gave him the covid shot and flu shot and shingles shot all at once; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), (Batch/Lot number: unknown) for immunisation; varicella zoster vaccine (VARICELLA ZOSTER VACCINE), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series complete but unknown manufacturer.), for COVID-19 immunization. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening), outcome "unknown", described as "He is having severe seizure and they put drip in him"; OFF LABEL USE (non-serious), outcome "unknown", described as "they gave him the covid shot and flu shot and shingles shot all at once".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented next day with complaint of pain where shot was administered. Doctor quickly saw the patient and gave diagnosis of possible cellulitis.
Here for Pfizer bivalent booster dose 5-11y/o.  but received the monovalent, primary series vaccine formulation instead.  no side effects reported. Parent/patient made aware of the error. Parent spoke with vaccination site physician. MD advised for pt to be revaccinated in 2 months.
Shortness of breath; Weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness). At the time of the report, DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness) outcome was unknown.            no concomitant medication were reported no treatment information was provided   Reporter did not allow further contact
Arm numbness; Pins and needles; Very sore arm; Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy (Pineapple allergy). Concomitant medication was not reported. 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 4 weeks prior to the COVID vaccine. On 10Apr2021, the patient experienced arm numbness, pins and needles, very sore arm and joint pain. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events arm numbness, pins and needles, very sore arm and joint pain were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever of 100 degrees Fahrenheit; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever of 100 degrees Fahrenheit) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (Fever of 100 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 100 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 100 (High) 100 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported.
This was my second dose of the Pfizer/BioNTech COVID-19 vaccine. I took some notes during my waiting time following my injection similar to my first dose. Information from my last report can be found using Temporary VAERS E-Report No: 334845. Of note, I did prepare for my second dose by taking Benadryl 50 mg and Airborne Immune-Boost supplements the night before my second dose, so my symptoms were not as severe as last time.  6 minutes: Mild tingling around tongue. This time all around the edges of my tongue, but a lot less bothersome than the first dose. 8 minutes: Weird. Slight itchiness under left half of tongue. Still very mild but less concerning than first dose itchiness on the left and right sides of my tongue. 18 minutes: Itchy on right side slightly, only side noticeable. 20 minutes: Mild warm feeling on left side of top of my throat. Less bothersome than time. 26 minutes: Left throat warm ness resolved, but transitioned to right side of top of my throat. 31 minute: Throat warmness overall resolved, but slightly itchy on edge of right side of my tongue. 37 minutes: Top of throat on right feels weird but not itchy. Warm maybe? 39 minutes: Weird feeling on right side of throat resolved.  Symptoms more or less resolved the rest of the day, especially after second dose of Flonase @ 9:00 am.  14 hours later: About to go to bed. Feeling fatigued, similar to my first dose after working out. Took airborne and two Benadryl (25 mg each) before sleeping.  24 hours later: 03/27/2021, feeling more fatigued, groggy, mild headache (mostly at back of my head), and muscle aches around my body.  25 hours later: Groggy feeling and fatigue resolved. Possibly due to Benadryl or vaccine?  32 hours later: Majority of muscle aches resolved. Headache also resolved. Feeling mostly soreness at this point.  Drank Airborne @ 10:00 am and 4:00 pm. In between drank plenty of fluids (water, cranberry juice, apple juice, milk). No fever or chills.
I was fine the day of the injection. The following morning I woke up with a headache and fever. As the day progressed, I became nauseated, dizzy, sore, and fatigued. This is the third day and I feel significantly better.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 03Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm, on 24Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, in left arm and on 20Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "NAFLD" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: LISINOPRIL, start date: 01Jul2016; HYDROCHLOROTHIAZIDE, start date: 01Jul2016; ROSUVASTATIN; SERTRALINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID-19 is treated with Paxlovis, treatment start date=12May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be excluded.
Patient received a TWINRIX, typhoid and yellow fever on 7/3/08.  On 7/5/08 at 2:30pm began to feel numbness in L side of face.  Unable to blink left eye, feel teeth, tongue, lips and cheek on L side of face.  Went to emergency room, diagnosed with Bell's palsy and told it was probably due to the yellow fever vaccine.  Placed on VALTREX and prednisone.  Going out of the country in Oct 08.  7/15/08 Reviewed ER medical records of 7/5/2008. FINAL DX: Bell's palsy Records reveal patient experienced left facial numbness & weakness 3 days s/p vaccines w/gradual onset.  Difficulty smiling, watering left eye, difficulty eating/drinking.  Neuro consult done in ER.  Tx w/antivirals & tapering steroids.
About 24hrs after receiving the vaccine. I had body aches, shaking fever and headaches.
I got extreme Vertigo- vomited and was dizzy for 7 hours. I was dizzy for 3 days after and now have some dizziness. I went to the doctor after 4 days- had very high blood pressure (not normal for me), had an EKG (normal), and am waiting for blood work to come back.
10/4/2022  My bones ached several days after my vaccination which aggravated my hip , which was already bad, but this exacerbated my hip.  On 3/15/23 I had a hip replacement.
possible symptoms related to mononucleosis; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced possible symptoms related to mononucleosis on an unspecified date in 2021. Therapeutic measures were taken as a result of mononucleosis. The outcome of possible symptoms related to mononucleosis was unknown  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Employee, Medical assistant took Moderna from freezer and without waiting the 2.5 hours, he drew vaccine and injected into patients arm.  I  I have spoke with the patient today after she left to make sure she was not feeling any unusual side effects.  I am not sure of what the proper protocol is for this error is. I called the Moderna hotline and they really could not assist me in this matter.
Swollen stiff painful arm, stiff neck side of face inflammation, lower eyelid lg inflammation migraine complex eye very red, migraine really bad,
Patient received a Pfizer 2nd dose on 8/13/2021 after receiving a Moderna 1st dose on  7/16/2021. The mistake was due to miscommunication among the clinical team.
Besides the body ache, headache, and sore muscles, I had bad earaches and hives. the hives have gotten worse on the second day and keep spreading around. i've tried to take an antihistamine, but I'm not sure if it's working. I am waiting another day or two before heading to the doctors but I wanted to report the EARACHES and HIVES.