chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Period after being menopausal for 1 year.; This spontaneous case was reported by a consumer and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Period after being menopausal for 1 year.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Menopause since 2020.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Period after being menopausal for 1 year.) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Period after being menopausal for 1 year.) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant product information was provided.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a female of unknown age who experience serious unexpected  postmenopausal heamorrahage after being menopausal for one year after being vaccinated with spikevax. Time to onset and dose number is unknown. The event was upgraded to serious as per IME list. The benefit-risk relationship of Spikevax in not affected by this report It was reported that patient got her period after being menopausal for one year.; Sender's Comments: This spontaneous case concerns a female of unknown age who experience serious unexpected  postmenopausal heamorrahage after being menopausal for one year after being vaccinated with spikevax. Time to onset and dose number is unknown. The event was upgraded to serious as per IME list. The benefit-risk relationship of Spikevax in not affected by this report
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-JAN-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 480 hours with the lowest recorded temperature 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Approximately 3 days after anthrax #2, developed approx 5 cm rash in local area; itch requiring benadryl.
Nausea vomiting couldn't hardly walk hip pain legs ache n head pounding puking dehydration wheezing
Hospitalized; Covid positive; Fully vaccinated with booster. Discharge Provider:  Primary Care Provider: Admission Date: 4/28/2022 Discharge Date: May 1, 2022  HOSPITAL COURSE: 80-year-old female with a past medical history significant for systolic heart failure with last known EF of 45% with severe tricuspid regurg as well as atrial fibrillation and chronic kidney disease stage 4 presents to complaints of shortness of breath with nonproductive cough.   Patient recently tested positive for COVID-19 on 04/24/2024 at her residence.  She was later found to be hypoxic and was sent in to the local emergency department.   In the emergency department the patient was found to be in the mid 80% range on room air and required 2 L of oxygen to maintain an adequate oxygen saturation.  Chest x-ray was obtained which showed some interstitial thickening and pleural effusions.  Labs remarkable for an elevated NT proBNP at 10,000. COVID-19 PCR testing was obtained and this came back positive.  Patient was given dexamethasone, furosemide, and admitted to the medicine service   # Acute Hypoxic Respiratory Insufficiency Etiology was felt secondary to COVID-19 with acute on chronic combined CHF. Patient was able to wean off supplemental oxygen prior to discharge and was able to ambulate without any dyspnea.    # Acute on Chronic Combined CHF Echocardiogram was obtained which was notable for LVEF of 40%. She was treated with IV Lasix with clinical improvement in dyspnea and oxygen requirements. Her weight close to discharge was 44.4 kg and she was transitioned back to her home Lasix prior to discharge. She was continued on her cardiac remodeling agents (Entresto, beta-blocker and Imdur). Hydralazine was not added to her regimen as felt her BP would not tolerate. Discharge instruction included fluid restriction and monitoring daily weights with recommendations to increase Lasix if weight noted to increase.   # COVID-19 Patient was noted to have been vaccinated and completed booster (10/28/21). She was treated with Dexamethasone while hospitalized but not discharged on such as she was not hypoxic and felt symptoms primarily related to above.    Patient was discharged back to facility in stable and improved condition, with discharge instructions provided.
Given Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given Expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given Expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.
Lose of use in left arm Rash since the injection  Severe neck pain Loss of sleep
Started to feel weakened after about 6 hours.  Woke up about 12 hours later with very sore muscles, headache, and significant cold shivering.  Was unable to go back to sleep.
A report was received from a health care professional on 11/19/03 concerning a 27 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up  pending.
This spontaneous report was received from a registered nurse referring to an unspecified number of adult patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unspecified dates, the patients were vaccinated with a dose of PROQUAD for prophylaxis (dose, route of administration, lot number and expiration date were not reported), reconstituted with water sterile diluent (lot number and expiration date were not reported). No adverse effects were reported for any patients. This is one of the two reports received from the same reporter. As of 09-JUL-2018, all telephone attempts to obtain follow-up information have been unsuccessful. This case was previously considered non-valid, but per current process it was determined to be valid as age group of the patients was provided. Sender's Comments: US-009507513-1710USA016158.
immed p/vax pt felt hot & began to perspire;pt then exp dizziness, blurred vision, & nausea;pt was placed in a supine position & was given an ammonia ampule & oral fluids;pt recovered w/in 30min;
Headache; Chills; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm on 10Mar2021 at 17:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient has no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 11Mar2021 at 18:00, the patient experienced headache, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 09Mar2021, the patient underwent SARS-CoV-2 test and the result was negative. The clinical outcome of the events headache, chills and fatigue was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received HPV #2 at 1315 on 3/09/07. Did become faint immed after but ok after rest and P liquids. Came to clinic on 3/11/07 eve and reports multiple symptoms: fatigue, fever, aches, stomach pain and nausea; returned again on 3/12/07. She believes these s/s were due to HPV vacc. TX: CL's and rest. Refused RX. Labs WNL with Bands Sl increased.
polyarthritis similar to rhuematoid arthritis; no other systemic sx; cont to exhibit arthritis sx as of 12JUN92; 2nd dose 20JAN, 3rd on 3FEB;
Fever; 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 PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
sore back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "sore back".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No adverse reaction.  Expiration format different and expired vaccine given to patient.  When error discovered (9/14/2022) system notified and advised corrective action to take. Parent notified on 9/15/2022 and will bring patient back to office to get recommended repeat vaccine. Documentation in patients' chart and staff educated on format of expiration dates
This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced muscle pain, tiredness and chills. On an unknown date, the outcome of the muscle pain, tiredness and chills were recovered/resolved. It was unknown if the reporter considered the muscle pain, tiredness and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist had to end call due to time constraints, no further details were known.
Patient has a sore, warm, red rash that she reported to her doctor. The patient was prescribed Cephalexin when a week passed and the rash was still there. Patient reported the prescriber had thought she may possibly have a bacterial infection from the vaccine, and according to the patient, the doctor also said they had seen a couple similar cases of the same vaccine.
Breakthrough case admission after 3 vaccines Pfizer 3/18/21 Lot# EN6207;  Pfizer 4/8/21 Lot# ER8732;  Pfizer 11/19/21 Lot# 320308D
began having episodes of weakness a few days after first injection--now diagnosed as paroxysmal atrial fibrillation
GUILLAN BARRE SYNDROME. PATIENT FELL, LOST FEELING IN LEGS,  STAYED IN HOSPITAL FOR 4 DAYS, BECAME INCONTINENT,  LOST FEELING IN CHEST AND HE WAS COUGHING AND SPITTING UP PHLEGM, STARTED LOSING FEELING IN MUSCLES OF NECK,  INTUBATED. DIAGNOSES WITH GUILLAN BARRE.
2   ischemic strokes (simultaneous) one of left pons , ;  second in corona radiata right side
Painful rash on left arm & left arm hurts, wheal-like spot on lower left arm. Bruising & inflammation at injection.
Started feeling lethargic and weak at 6:30pm 2/28/21.  Stomach bloating, eyes burning, no appetite, then burping that tasted and smelled sulfur-like. Around 4am 3/1/21 woke up to nausea and diarrhea. Did not go to work. Slept on and off . Drank water and ate crackers. Took Immodium  and it helped for a few hours. As on 7:30pm 3/1/21, I am still nauseated and have diarrhea . No energy to do any daily activities. Been laying down the entire day. Exhausted and out of breath going up the stairs to bedroom.
hot to touch; itching in injection arm; swelling in injection arm; redness in injection arm; mild soreness in her injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (itching in injection arm), VACCINATION SITE PAIN (mild soreness in her injection arm), VACCINATION SITE SWELLING (swelling in injection arm) and VACCINATION SITE ERYTHEMA (redness in injection arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Sensitive skin (had to use hypoallergenic products on her skin).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (mild soreness in her injection arm). On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (itching in injection arm), VACCINATION SITE SWELLING (swelling in injection arm) and VACCINATION SITE ERYTHEMA (redness in injection arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; HYDROCORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (EQUATE ANTI ITCH) at a dose of continuous spray. On 21-Jan-2021, VACCINATION SITE PAIN (mild soreness in her injection arm) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to touch), VACCINATION SITE PRURITUS (itching in injection arm), VACCINATION SITE SWELLING (swelling in injection arm) and VACCINATION SITE ERYTHEMA (redness in injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
red, hot , swollen mark at the injection site , in the right arm.; red, hot , swollen mark at the injection site , in the right arm.; red, hot , swollen mark at the injection site , in the right arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red, hot , swollen mark at the injection site , in the right arm.), VACCINATION SITE SWELLING (red, hot , swollen mark at the injection site , in the right arm.) and VACCINATION SITE ERYTHEMA (red, hot , swollen mark at the injection site , in the right arm.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (red, hot , swollen mark at the injection site , in the right arm.), VACCINATION SITE SWELLING (red, hot , swollen mark at the injection site , in the right arm.) and VACCINATION SITE ERYTHEMA (red, hot , swollen mark at the injection site , in the right arm.). At the time of the report, VACCINATION SITE WARMTH (red, hot , swollen mark at the injection site , in the right arm.), VACCINATION SITE SWELLING (red, hot , swollen mark at the injection site , in the right arm.) and VACCINATION SITE ERYTHEMA (red, hot , swollen mark at the injection site , in the right arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Information has been received from a registered nurse concerning an older female (approximately 50 years old) refugee who in order to obtain a Green Card was vaccinated with varicella virus vaccine live (date of immunization nor provided). The pt had no history of chickenpox. The following day, the patient developed herpes zosters on her face, including her eyes. It was reported that the pt had "quite a case" of herpes. Medical attention was sought. The pt subsequently recovered from the event. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: 6J5342) at the age of 23 years 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: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2023) Negative, notes: Negative test 2 days after finishing Paxlovid; (11Feb2023) Positive, notes: positive test 4 days after finishing Paxlovid; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Patient received anti viral treatment for COVID-19 from 03Feb2023 to 07Feb2023.
Pt fainted on mother's arm after a few minutes of receiving vaccine. She fainted approximately 30 seconds - 1 minute. When she woke up, she was pale and weak. BP was taken, and it was below normal. She drank water and ate skittles to boost her sugar and get BP back up. She was informed to sit for another 30 mins with her mother to make sure she was okay. She also had a fan blowing cool air on her to help her feel better. After waiting over 30 mins and retaking her BP, pt felt better enough to leave with her mother. Mother was advised to watch her daughter for the remainder of the day, and for the pt to eat a hearty meal before returning for her second covid imz.
1-2 cm erythema with vesicles left ant chest and posterior left upper arm, maculopapular rash left inner upper and outer arm, Herpes zoster, Onset 4/10/06 am. Started Acyclovir 200 QID x 5 days.
the morning following the vaccine at 10 am i noticed a constant ringing in the ears (both)as the day went on the sounds grew louder and then at times the ringing would be extremely high pitched lasting 5-10 seconds abd then slowly reduce but still present. then by noon i noticed my BP was elevated at 148/107 and my HR was very fast 110 bpm and was irregular at times.  my BP remained elevated until the next morning and my heart rat slowed down to 72 BPM by the next morning but the tinnitus(ringing ) continued. i still have mild/moderate ringing. i haven't had the high pitched episodes in about 12 hours.  BP back to normal
The next day, just a sore arm. A headache for 16 straight days. I started having a lot of anxiety. I had to get medication for it. I did an online visit and then I went to NOW clinic  to get my blood pressure system checked. My blood pressure was fine.  Medicine I was prescribed: Alprazolam. I recovered from my headache just before the second dose of vaccine which was 2/8/2021.
Itchy red rash from neck to knees; Itchy red rash from neck to knees; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL8982), via an unspecified route of administration in Arm Left on 26Jan2021 at 10:45 (at the age of 68-year-old) as single dose for covid-19 immunization. Medical history included Peripheral neuropathy, essential tremor, high BP and cholesterol high. Concomitant medication(s) included pregabalin (LYRICA); topiramate (TOPAMAX); rivaroxaban (XARELTO); atorvastatin (LIPITOR); spironolactone (ALDACTONE); LASIX (FUROSEMIDE), all are taken for an unspecified indication, start and stop date were not reported. The patient previously took flagyl (metronidazole benzoate) and experienced allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: 6L0140), via an unspecified route of administration in Arm Left on 07Jan2021 at 11:30 (at the age of 68-year-old) as single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 at 14:00 patient experienced itchy red rash from neck to knees, occurring 10 days after second vaccine. She ate a bowl of new cereal and had never eaten before on this same day, also had a mammogram 3hrs prior to starting to itch. Events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. On 04Feb2021, the patient underwent lab tests and procedures which included mammogram with unknown results. Patient received treatment for reported events with Decradron inj, prednisone, benedryl, zyrtex. The outcome of reported events was not recovered.  Follow-up attempts completed. No further information expected.
Local reaction. Rash on LVL where vaccine was administered, 30mm in diameter, no treatment per MD needed.
Dizziness and vertigo since the day after the vaccine and no relief as of today - 3 weeks later.