chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash in her mouth; swollen lips; difficulty of breathing; intense itchiness of legs and feet; occasional weakness; occasional dizziness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet) and ASTHENIA (occasional weakness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet), ASTHENIA (occasional weakness) and DIZZINESS (occasional dizziness). At the time of the report, RASH (rash in her mouth), LIP SWELLING (swollen lips), DYSPNOEA (difficulty of breathing), PRURITUS (intense itchiness of legs and feet), ASTHENIA (occasional weakness) and DIZZINESS (occasional dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information were provided No treatment medication were provided
2 patients (2 doses) given that could have been doses greater then 30 days in refrigeration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients (2 doses) given that could have been doses greater then 30 days in refrigeration) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients (2 doses) given that could have been doses greater then 30 days in refrigeration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients (2 doses) given that could have been doses greater then 30 days in refrigeration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Developed diffuse maculopapular rash on torso, BUE, BLE a little over 48 hrs after receiving vaccine
Viral eye infection.  Ophthalmologist confirmed that was likely due to immune system reaction to COVID vaccine.  Took several office visits and various prescriptions to resolve.  Took more than one month to resolve.
red spot below the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spot below the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red spot below the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site). At the time of the report, RASH MACULAR (red spot below the injection site) and INJECTION SITE ERYTHEMA (redness at the injection site) outcome was unknown.            No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: no new information updated.
Information has been received from a Licensed Practical Nurse and a Registered Nurse referring to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history of the patients were not reported. On unspecified dates the patients were vaccinated with improperly stored dose of MMRII (lot # K009192, expiry date 27-JUN-2016, lot# K003822, expiry date 14-MAR-2016) (route and dose unspecified) orally. Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from same source. Additional information has been requested.
Became ill with COVID 7 days later, then developed a-fi b 8 days later
No adverse effects were reported; HCP calling in to report that VARIVAX was administered to a patient before recognizing that the vaccine was expired.; This spontaneous report was received from a pharmacist, regarding a 41-year-old female patient. Her medical history, concurrent condition, and concomitant therapies were not reported.   On 29-JUN-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (VARIVAX) 1 time dose (dosage regimen, anatomical location, and route of administration were not provided), valid lot# 010308, expiration date: 24-MAR-2022, administered as prophylaxis (expired product administered). It was reported that the patient was unaware of this situation.  The reported stated there were no know adverse reported (no adverse event).
p/vax pt c/o tingling/numbness rt arm; seen in ER; that night T104; redness & rash at inj site; spreading up around collarbone & neck;given ice pack & DPH
I had severe dry coughing and sometimes phlegm, running nose, fatigue, sneezing, congestion, brief period of nausea and headaches. I tested positive for COVID-19 with a home test. I spoke to a pharmacist, and he gave me over the counter medications for it.
irregular menstrual cycles - i will normally get a very light period or no period at all.  in the months since my vaccine, i?ve been bleeding or spotting every 2 weeks. in july i had my regular period for 5 days, and a week later started having light bleeding for 5 days. a few days later i started bleeding again for 5 more days and this repeated 1 more time.
Chills; aches; congestion; difficulty breathing; loss of smell and taste; loss of smell and taste; fever; weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Lot number: ER8731) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 06:15 PM), administration date: 2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 28Nov2021, outcome "recovering", described as "Chills"; PAIN (non-serious) with onset 28Nov2021, outcome "recovering", described as "aches"; NASAL CONGESTION (non-serious) with onset 28Nov2021, outcome "recovering", described as "congestion"; DYSPNOEA (non-serious) with onset 28Nov2021, outcome "recovering", described as "difficulty breathing"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 28Nov2021, outcome "recovering" and all described as "loss of smell and taste"; PYREXIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "fever"; ASTHENIA (non-serious) with onset 28Nov2021, outcome "recovering", described as "weak". The events "chills", "aches", "congestion", "difficulty breathing", "loss of smell and taste", "loss of smell and taste", "fever" and "weak" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pain, nasal congestion, dyspnoea, anosmia, ageusia, pyrexia, asthenia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Follow-up attempts completed. No further information expected.
I received the flu shot on the above date. I instantly noticed swellling of the area. The next morning a brusie was noted at the injection site. 2 days after I started having pain inside my shoulder. The pain was so uncomfortable i was unable to get comfortable at times. Anti inflammatory did help some. When the pain got intense i did notify my management. To this day. I do have some soreness but minimal. I have seen an improvement. My bruise is still present.
after receiving the Pfizer vaccine in 2020 I had many irregular and absent period due to the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "after receiving the Pfizer vaccine in 2020 I had many irregular and absent period due to the vaccine". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 15:34, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
On 1/12/2021 (6 days post COVID vaccine), developed redness, swelling, excessive itching on left arm, the site of the injection that was given on 1/6/21. Redness extended from left shoulder to just above left elbow. Hard area at injection site which slowly dissipated but increased swelling noted on the inner aspect of left arm after about 2 days. On 1/16/2021 (today as I am writing this), swelling, redness and itchiness have considerably subsided, however still slightly present. Under advise from my PCP who I had seen on 1/14/21, I have been taking benadryl and have "iced" the arm for 2-3 days. post initial symptoms.
Increase skin erythema, swelling, itchy induration formation 3cmx3cm on left deltoid.
This is a 70-year-old female  states it was sharp and associated with the nausea and vomiting.  The pain is nonradiating.  The ureteral stent was placed secondary to kidney stones.   She states she also had a trip and fall yesterday landing on her left flank region which exacerbated the pain.  She also admits to hematuria but no fever, chills or dysuria. Denies any head trauma or other injuries from the fall.   In the emergency room she had a CT of the abdomen that showed the following:  1. Stable left-sided hydronephrosis with a stent in good position. The previously noted stone in the left renal pelvis is once again noted measuring 8 mm. This previously measured 10 mm. Smaller stones are noted layering in the lower pole calyx of the left kidney. There is mild stranding of the perirenal fat on the left. Correlation with urinalysis and blood work is recommended. Possibility of pyelonephritis cannot be excluded.2. Moderate constipation-type pattern. No colitis or diverticulitis. No abscess or perforation. Mild hiatal hernia.  Patient has no further nausea or vomiting since admission in is resting comfortably prior to my assessment   Patient denies any fever, cough, chills, rhinorrhea, sore throat, chest pain, shortness of breath, palpitations, orthopnea, paroxysmal nocturnal dyspnea,diarrhea, constipation, dysuria, frequency, melena, hematochezia or focal neurological complaints      Surgical history: Appendectomy, carpal tunnel, cholecystectomy, D&C, hip surgery, knee surgery, shoulder surgery, ureteral stent   Social history:   No tobacco, alcohol or illicit drugs.  She is divorced   Family history:  Hypertension                   06/01/2021 tested positive 6/02/2021: patient discharged.
No adverse reports technically reported by patient. I am reporting to VAERS that an unindicated dose of Shingrix was given to the patient. The patient reported that he only received one dose of Shingrix, however, upon further investigation after the dose of Shingrix was administered, we discovered he actually completed the series on 08/02/2021
administered a dose of Boostrix on 18Jul2023 from lot number HF2YA, which had an expiration date of 15Jul2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 18-JUL-2023, the patient received Boostrix. On 18-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Boostrix on 18Jul2023 from lot number HF2YA, which had an expiration date of 15Jul2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 The reporter was a medical assistant. At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received Boostrix which was already expired, which led to expired vaccine used.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (dose and route were not reported, lot # K007828 with expiration date: 02-MAR-2017). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient has received a total of two Moderna vaccines with Public Health on 3/24/21 and 5/5/21.  no adverse reaction noted. Just given to many doses of COVID 19 Moderna
appendicitis 5 days after their second dose; This spontaneous case was reported by a patient and describes the occurrence of APPENDICITIS (appendicitis 5 days after their second dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus (diabetes 2), Blood pressure abnormal, Blood cholesterol abnormal and Kidney disorder. Concomitant products included ATORVASTATIN, METFORMIN and INSULIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced APPENDICITIS (appendicitis 5 days after their second dose) (seriousness criterion medically significant). At the time of the report, APPENDICITIS (appendicitis 5 days after their second dose) had resolved.            Concomitant medications reported included unspecified blood pressure medication, kidney treatment medication, cholesterol treatment medications, blood thinner medication and antidiabetic medication. No vaccines were given within 1 month, prior to Moderna COVID-19 vaccine. Patient was not allergic to medications, food and other products. Patient never had COVID + test or diagnosis. Patient stated that  they got appendicitis 5 days after their second dose of the Moderna COVID-19 vaccine. No treatment medications were reported.  Company comment  This is a spontaneous case concerning a 69 year old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI of Appendicitis (appendicitis 5 days after their second dose) 05 days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Concurrent medical condition Type II diabetes mellitus could be considered as a risk factor to the event. No details on labs, diagnostic tests, concomitant medications and treatment were provided. The event had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events´ seriousness assessed as per medical judgement.   This case was linked to MOD-2022-597351 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 69 year old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI of Appendicitis (appendicitis 5 days after their second dose) 05 days after receiving the 2 dose of mRNA-1273 vaccine in the covid 19 vaccination series. Concurrent medical condition Type II diabetes mellitus could be considered as a risk factor to the event. No details on labs, diagnostic tests, concomitant medications and treatment were provided. The event had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events´ seriousness assessed as per medical judgement.
Felt normal side effects for 24 hours . 3 days later started with weakness, diarrhea , slight fever. 5 days later having bouts of weakness, not able to think clearly an BP was elevated to 160/90. Now for 2&1/2 weeks symptoms continue  up till today when almost passed out, BP190/99. Feel terrible. Have apt next week with my Dr. Getting scary.
received a expired dose; was administered an additional dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a expired dose) and EXTRA DOSE ADMINISTERED (was administered an additional dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a expired dose) and EXTRA DOSE ADMINISTERED (was administered an additional dose). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (received a expired dose) and EXTRA DOSE ADMINISTERED (was administered an additional dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  A pharmacy had administered 3 doses of Moderna covid-19 vaccine to patient which had been punctured and stored at room temperature for between 18-24 hours. The vaccine had been punctured on 10MAY2021 and left on the counter overnight before 3 doses were administered the following day on 11MAY2021. All doses were administered from 1, 10 dose vial lot number 031B21A. The facility then determined that this vaccine had "expired" and administered an additional dose of vaccine. The dose had been stored within the recommended conditions, administered the same day, lot number 031B21A. The concerning dose of vaccine had not experienced any previous temperature excursions.   Patient had not experienced any known symptoms since receiving 3 doses of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Patient demographics and dates of dose updated.
Body aches starting around 9:00 pm. Severe chills starting at 11:00 pm lasting through night. Excessive urination starting at 12:00 am 12/29 every hour. Severe headache starting at 2:00 am (not able to control with Tylenol).
Sun 11-13-05 developed rash on chest. Mon 11-14-05 Rash spread to arms and upper thigh and itched in evening, T 99.1. Tues 11-15-05 Rash is "all over" body; itching body, headache, tired. 10:30 pm afebrile sore throat.
She reported itching and redness to the left arm at the injection site. It began as a quarter sized area and increased in size to cover about a 5 inch area. She took Benadryl and used hydrocortisone cream to lessen symptoms. The area was gone in about 2-5 days.
This case was reported by a physician, via a sales representative, and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Hepatitis B vaccine, (Unknown manufacturer) for prophylaxis. On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown manufacturer). At an unspecified time after vaccination with Hepatitis B vaccine series, the subject experienced not responding to therapy. Titers showed that the subject did not reach seroprotection level. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 11 January 2008 indicated that the subject was a male in his mid 30's. It was reported that he experienced elevated liver function tests. The onset of the event was not reported. The elevated liver function test were suggested to be related to alcohol use and his overweight condition. No outcome was provided.
3.5 cm x 5 cm slightly tender red swelling on the left thigh.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided. The expired vaccine was given as a booster dose to patients on the date last 20 Oct 2021 to 29 Nov 2021. The lot number of the vaccine was 026B21A(17 Sep 2021).The vaccines were stored in freezer, one to two vials were taken out  and placed in fridge each day as needed.
BRUISING ON RIGHT ARM, SWOLLEN ON ARM, RED/WARM. ITCHING. PATIENT FELT SICK HAD ACHES AND PAINS, GI UPSET, NAUSEA, HEADACHE. PATIENT FELT TIRED. PATIENT CAME IN ON 6/24/19 AND STILL HAD REDNESS, SORENESS, AND SWELLING BUT SAID THE NAUSEA/TIREDNESS HAS SUBSIDED. COUNSELED PATIENT SHE MAY WANT TO TALK TO HER DOCTOR AS INJECTION SITE LOOKED INFECTED.