chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She started feeling little light headed some time after receiving 2nd dose; Once in a while she loses her balance, She still has that issue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She started feeling little light headed some time after receiving 2nd dose) and BALANCE DISORDER (Once in a while she loses her balance, She still has that issue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LISINOPRIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BALANCE DISORDER (Once in a while she loses her balance, She still has that issue). On 23-Feb-2021, the patient experienced DIZZINESS (She started feeling little light headed some time after receiving 2nd dose). At the time of the report, DIZZINESS (She started feeling little light headed some time after receiving 2nd dose) and BALANCE DISORDER (Once in a while she loses her balance, She still has that issue) had not resolved.            Treatment medication was not provided.  Patient started feeling little lightheaded sometime after receiving 2nd dose and it was not constant however every once in a while, patient loses balance and still has that issue.
Patient came into get a Pfizer Covid-19 vaccine. After administration we processed the claim and discovered that he patient had received a vaccine before.
Higher cholesterol in blood tests after getting the vaccine; A spontaneous report was received from a 69-years-old female consumer, who received Moderna's COVID-9 vaccine (mRNA-1273) and experienced high blood cholesterol levels.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 11-FEB-2021, the patient experienced elevated blood cholesterol level after getting the vaccine.  On 11-FEB-2021, a blood test was done and the cholesterol level was elevated.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was unknown.
No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as there were no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 12-year-old female patient. On 29-FEB-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  This is one of five reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002623:
2 days following vaccines (FLUVIRIN, PNEUMOVAX, ZOSTAVAX) developed cellulitis of vaccinated arm - all 3 vaccines in left arm per request. Seen in ER 10/4/14 - Rx's for antibiotics/anti nausea/pain given - also received IV fluids due to nausea/dehydration.
mom stated that on day pt recvd vax came home, took nap on awakening from nap pt could not move legs & when attempted to walk, legs would give way; rt leg was weaker than lt; taken to MD;
redness (around injection site); bumpiness (at injection site); hot to the touch (at injection site); rash (at injection site); itchy all around injection site, 2-3inches in width; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (redness (around injection site)), VACCINATION SITE MASS (bumpiness (at injection site)), VACCINATION SITE WARMTH (hot to the touch (at injection site)) and VACCINATION SITE RASH (rash (at injection site)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness (around injection site)), VACCINATION SITE MASS (bumpiness (at injection site)), VACCINATION SITE WARMTH (hot to the touch (at injection site)), VACCINATION SITE RASH (rash (at injection site)) and VACCINATION SITE PRURITUS (itchy all around injection site, 2-3inches in width). At the time of the report, VACCINATION SITE PAIN (soreness at injection site), VACCINATION SITE ERYTHEMA (redness (around injection site)), VACCINATION SITE MASS (bumpiness (at injection site)), VACCINATION SITE WARMTH (hot to the touch (at injection site)), VACCINATION SITE RASH (rash (at injection site)) and VACCINATION SITE PRURITUS (itchy all around injection site, 2-3inches in width) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported.  The treatment medication was not reported.
Indurate, erythematous, tender and itchy 3-4 cm surrounding injection site.
Day of 1st injection: Within 60 seconds of receiving the shot, I felt light-headed, dizzy, and claustrophobic. I began having cold sweats. I thought I was going to vomit. After walking around and sitting for the next 20 minutes, I felt better and the personel allowed me to leave.   Day 1 after injection: I woke up feeling mild but persistent chest pains. I also felt mild fatigue.   Day 2 after injection: The chest pains subsided, but my heart continued to race. I also felt fatigued and brain fog for the entirety of the day.   Day 4 after injection: I continued to feel my heart racing throughout the week. When I got home from work, I felt light-headed and thought I was going to pass out. I also began to feel claustrophobic again.  I went to the ER where they measured my blood pressure at 195/109. They ran a CT scan and prescribed me blood pressure medicine.
Pt presented to my clinic 48 hours after receiving DTaP Lot # with a large (7cm x 5cm) erythematous, raised, warm lesion around injection site R thigh and one small R inguinal node.
SHE NOTICED EARLY IN THE MORNING HER ARM WAS TENDER. IT WAS SWOLLEN AND HOT, AND WAS ITCHY. SHE DID NOT HAVE A FEVER, BUT FELT A LITTLE SLUGGISH ALL DAY. SHE WENT TO SEE A NURSE IN OUR ER THAT DREW A LINE AROUND THE REACTION AREA. IT WAS ABOUT 5 INCHES IN DIAMETER. WHEN SHE REPORTED THE REACTION TO ME TODAY IT IS NOW ABOUT 7 INCHES IN DIAMETER. WITH WHITE DIFFUSE EDGES, A  RED CIRCLE RADIATING OUT FROM THE INJECTION SPOT ABOUT 2 TO 2 1/2 INCHES .
This spontaneous report received from a patient, concerned a female of unspecified age. The patient's concomitant medications, height and weight not reported. The patient's medical conditions included difficulty swallowing pills. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose: not reported, administered May 13, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On May 13, 2021, patient felt a little achy. Treatment medications (dates unspecified) included: paracetamol. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from felt little achy on May 13, 2021.
Rash, burning, spot about 2 inches by 2 inches red raised hot to touch.
Patient stated 12 hours after receiving vaccine upper arm became red and painful with a red raised rash covering whole upper arm. Got worse over weekend to point where it was too painful to move the arm. Seen in office 3 days later and treated with MEDROL dose pack and ZYRTEC.
pain at injection site, red lump below injection that is raised and hot to the touch, sore throat, headache, body aches, head ache, chills, low grade fever
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no adverse evevnt; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA054981 and 2023SA057733.   This case involves child patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c (clesius) and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine, Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Pt did not have any reactions. this report is to notify the CDC that a Pfizer bivalent 5-11 year old was given as the first dose in the primary series for this 5 year old. pts mother and PCP were both notified after CDC advised to continue with the 2nd dose (pfizer monovalent 5-11y/o orange cap) at the recommended and then 3rd dose is the bivalent booster 2 moths after the 2nd dose.
Inappropriate Schedule of Product Administered; Initial Report Received on 2-Jun-2023   A medical assistant reported that a 56-year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received a late second dose of HEPLISAV-B.  No relevant medical history was reported. No allergies or previous reactions to other vaccines were reported.  No relevant concomitant medications were reported.    On an 18-Apr-2023, the patient received the first dose of HEPLISAV-B (Lot #941587, expiration date of 31-Aug-2025, and NDC #43528-003-05) from a provider in the left deltoid with route of administration not provided.   On 01-Jun-2023, 44 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #941592, expiration date of 31-Aug-2025, and NDC #43528-003-05) from a provider in the right deltoid with route of administration not provided. The patient did not experience any adverse effects.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
diarrhea commencing 03/13/2021 and ongoing this date 04/06/2021
sore arm; This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE PAIN (sore arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Panuveitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   NO CONCOMITANT AND TREATMENT DRUGS WERE GIVEN. CO-SUSPECT DRUG HUMIRA IS GIVEN   This case was linked to MOD-2021-165802 (Patient Link).
This is a spontaneous report from a contactable nurse. This nurse reported for a 50 year-old female patient who received the first dose of TRUMENBA, (lot number N16808, expiration date 31Jul2017) at 0.5 ml single intramuscular in the left deltoid on 24Aug2016 at 10:30 am for immunization. Medical history included seasonal allergies for which she was receiving ZYRTEC 10 mg once daily orally as concomitant medication. On 13Jul2016, the patient received pneumococcal vaccine (PNEUMOVAX 23, Merck, Lot 431459, expiration date: 30Apr2017) in the left upper arm intramuscular for immunization with no reaction. Ten days after vaccination, on 04Sep2016, the patient had redness, swelling, soreness and itchiness at the injection site and local injection site reaction (probably about 8 cm by 8 cm area). The patient was evaluated in the reporter's office due to the events and treatment including cool compresses was given. No tests were needed. The patient recovered on 09Sep2016. The reporter stated that it would be basically a delayed local reaction, not like cellulitis or anything like that. She considered there was a reasonable possibility that the events were related to meningococcal group b rlp2086. Follow-up (27Sep2016): New information reported from the same contactable nurse includes: suspect vaccine details (dose number, updated time of administration), reaction data (updated events outcome), updated lot number and company trade name of the past vaccine, details on visit by nurse practitioner due to the events, absence of tests, causality assessment. Follow-up attempts are completed. No further information is expected.
Pt recvd vax 31JUL91 & devel fever of 102 w/severe crying spell which lasted a couple of hrs in duration;
Patient received his first shot of GARDASIL 9 at 9:15am. Patient was scheduled to have bloodwork drawn after having this shot. After about 5 minutes of waiting in the room, I went back into the room to check on patient, and Mom said that the patient became nauseous, sweaty, and feeling ill. The patient did have a pale pallor. Patient was laying down when I went in. At this time I measured the patient's blood pressure, and received 122/76 manually in his left arm sitting. Fingerstick blood sugar was 93, fasting. Patient stated he had not eaten any breakfast this morning. Dr. instructed patient to hold off having bloodwork done until next week. Mom and patient verbalized understanding. Patient was given peanut butter crackers and a can of coca cola in office. At 9:40am the patient stated he was feeling better. Mom asked if the patient should be kept home from school today, informed that was up to her. Mom and patient decided to stay home from school today. Advised them to get a note for school from the front desk. Mom and patient verbalized understanding.
Student in school clinic 2/10/2006 reported itching and red bumps 2 at vaccine site for 1 week before student came into clinic. Denies fever nor rash nor itching at other site on body. Recommended ice, Benadryl for itching and Tylenol for fever. 2/13/2006 student returned to clinic improved. Used Benadryl ointment.
Patients father had pre-warned that the patient does become light headed and may faint with vaccination. Patient has severe anxiety over needles and gets light headed and faints when vaccinated. Patients father stated it happens with anything related to needles and has talked to doctors and specialists and is fine and normal. I had patient sit in her chair and the father cradled her head just incase patient did faint. I administered the vaccine and patient did get light headed and fainted. This did look like a vasovagal syncope response as she did get flush, light headed and fainted. Pt remained seated until she was back to normal and could move without incident. Pt was fine and father left with pt.
My symptoms first began as a tingling, itching, and pins and needles sensation in my hands. It later progressed to my feet and all other random areas of my body. The itching sensation I felt was spontaneous and random. It didn?t appear to be caused from something I was repeatedly touching. I noticed it most frequently on areas of my body where my clothing was touching, or after doing some thing with my hands. I did not begin to experience a rash from itching until Sunday, 11/27. The itching began to turn into a rash, that was consistent with the pattern of my scratches. The more I itched, the more irritated my skin would become. The rashes eventually were accompanied with hives. My symptoms have been manageable with Benadryl, however I need to keep repeatedly taking Benadryl every four hours to keep the itching, burning sensation in my skin from returning. After doing extensive research online to try and figure out what the cause of this could be, it appears to be an allergic reaction. This condition is called dermatographia urticaria, also known as skin writing disease. I am concerned this is a potential delayed side effect to the vaccine. My fiancé and I both experienced the same symptoms on the same day as each other. We haven?t been able to pinpoint the cause of what is causing this allergic reaction as we have not changed any of the products we have been using recently. We do not currently have any other known allergies. And we would like to know if this is a potential side effect of the Moderna booster that has been reported. We have lived with this spontaneous, chronic condition now for about a week.
Passed out x2. A&O x3 after laying down. HR- 92, O2 96%.
PT was given 2 month Imms swp? for 4 hrs after getting IMMS. Woke up and cried for 4-5 hrs.
patient stated feeling dizzy, nausea, stomach pain. Patient was given ice pack and felt better after 25 mins
2 hours later of my vaccine I started feeling tired & soreness on vaccine site. Later on that night I had chills, low grade fever & body aches. The next day my blood pressure dropped I had to contact my doctor. The doctor recommended for me to stop taking my blood pressure medication & to drink a lot of Pedialyte. The symptoms lasted for 3 days.
Swollen lymph nodes in left armpit. Causing pain and tenderness in that area.
Temp 99-100, fatigue, headache, myalgia, injection site pain, left axilla swelling and pain. All symptoms have resolved except left axilla swelling and pain. No palpable lymph nodes. Only generalized swelling.
Patient reports residual muscle pain and slight swelling. Says this unusual from years past. Advised to use OTC TYLENOL, to call MD if unbearable. Will call in 24 hours.