chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt had all of his immunizations done on 1/29. On 1/30 in the morning he woke up with symptoms of pre-syncope (saw black, felt lightheaded). He also felt excessively thirsty even after drinking 7 canteens over 24 hours. He also had some hypotension during examination. He was given acetaminophen.
Itching, rash, facial redness and swelling around eyes and audible wheezing within 15 minutes after vaccine was given
Feel like I want to throw up/ nausea; Feeling kind of dizzy/ dizziness; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in right arm on 15Apr2021 (around 08:00 or 09:00) (Lot Number: EW0162) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure (he was diagnosed with high blood pressure 2 years ago, or maybe 3 years); ongoing diabetes mellitus (type 2 diabetes, maybe 3-4 years ago, his father was diabetic); heart problems (he has had 17 strokes and 10 heart attacks so far, his father passed away of a heart attack), ongoing polycythaemia (diagnosed a few years ago, maybe 10 years, or 10-12 years, or maybe 15 years, he was in his late or early 40's when he was first diagnosed with polycythemia and the diagnosing physician said it was kind of odd that the patient had polycythemia because it's usually older people that get polycythemia); pain; heart burn. Patient mother had arthritis really bad. Concomitant medications included eicosapentaenoic acid ethyl ester (VASCEPA) for pain from awhile ago, maybe a year or two; metformin for blood pressure for at least 2-3 years; lisinopril for diabetes for a few years, maybe 3-4; omeprazole for heart burn for a few years, maybe 3-4; lovastatin from a few years ago, all ongoing. Patient had no prior vaccinations (within 4 weeks). The patient experienced felt like he wanted to throw up/ nausea on 15Apr2021, feeling kind of dizzy/ dizziness on 15Apr2021. Patient reported that his weight is between 170 and 180, and that the last time he weighed himself he weighed 176 pounds. Clinical course: Patient reported that he got the first dose of the Pfizer Covid-19 vaccine a couple of hours ago, 2-3 hours before time of call, on 15Apr2021. Patient reported that he felt like he wanted to throw up and he was feeling kind of dizzy. Patient inquired how long feeling like he wanted to throw up and feeling kind of dizzy was going to last. Patient inquired if he needed to go to the hospital or the doctor for the nausea and dizziness. Patient reported that he could deal with feeling like he wanted to throw up and feeling kind of dizzy, but that he wanted to know how long he should wait before he went to the hospital or the doctor. Patient inquired if he should go to the hospital or the doctor after so many hours or days. Patient reported that he wanted to puke but he couldn't puke. Patient reported that he was still feeling dizzy at time of call on 15Apr2021. Patient reported that he did not know if the dizziness has gotten any worse or not. Patient reported that he is a healthy person, and he is not sure why the Covid-19 vaccine is affecting him this way. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
2/9/21 20:00 patient states that left arm injection site is warm to touch, tender, redness, swelling and is traveling down to left elbow. Pt. states that she took benadryl lastnight, and this did not help. Pt. denies itching.
Vaccine administered at less than 16 years of age; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at less than 16 years of age) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at less than 16 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered at less than 16 years of age) outcome was unknown.        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.   Concomitant medication was not reported.  Treatment medication was not reported.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Takotsubo cardiomyopathy, heart failure, arrythymia, sudden  death
Swollen eyes and rashes all on back.; Swollen eyes and rashes all on back.; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male 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 17May2021 at 16:45 (at the age of 12-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications were not reported. The patient had no known allergies. 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 four weeks prior to the vaccination. On 17May2021 at 21:00, the patient experienced swollen eyes and rashes all on back. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events swollen eyes and rashes all on back was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Headache, Myalgia, NauseaVomiting, Localized pain; chills, fatigue  Narrative:
No symptoms immediately, then 3/13 fever No bowel movements since 3/13 3/20 bowel obstruction - over 4 days: initiated enemas, colonoscopy prep gallon, bottles of magnesium citrate to no resolve 3/25 not a candidate for surgery, all solids and liquids d/c. Awaiting end of life
This is a non serious spontaneous case from a physician in the USA of reporting a patient who developed a bacterial infection due to unspecified Steptococcus (Unlabelled, USA) after FluMist. The reporter causality is not provided. At approximately 6 pm on 12/15/04, a 11 year old male received FluMist intranasally and experienced body ache, headache, head congestion, temperature of 103 to 104 degrees Fahrenheit the following morning on 12/16/04. On 12/17/04, the patient experienced a sore throat. Throat culture at office visit revealed "mildly" positive streptococcal infection. The patient was treated with Zithromax. the patient has not yet recovered.
Very large area of erythema that persists; Slight induration; Skin is tense; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Very large area of erythema that persists), INDURATION (Slight induration), SKIN TIGHTNESS (Skin is tense) and VACCINATION SITE REACTION (COVID arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ERYTHEMA (Very large area of erythema that persists), INDURATION (Slight induration) and SKIN TIGHTNESS (Skin is tense). 15-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, ERYTHEMA (Very large area of erythema that persists), INDURATION (Slight induration), SKIN TIGHTNESS (Skin is tense) and VACCINATION SITE REACTION (COVID arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-252560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received: Contains reporter address, demographics, 2nd dose details, new adverse event and event outcome updated.
I had a little soreness after getting the vaccine on Sunday, Jan. 28, and I took an Ibuprofen around 30 minutes later. On Sunday, Feb. 7, my arm started itching and aching a bit. On Monday, my arm was red where I got the shot, and it was feverish and hurting a bit. I took 2 Acetaminophen at 10 am, and it got a little better. It was still hurting and feverish, so I took 2 more Acetaminophen at 4:00pm.
Rash & UrticariaPruritus Narrative: Employee stopped by health to report/discuss onset of the above s/s about 4 hours after shot. Perioral and periorbital itchiness, ~ 2x3 inch red, flat rash over R cheekbone. new reaction, did not occur with first two shots.
2nd Dose only; Fever, chills, body aches, fatigue, headache, Diarrhea, and Nausea. Lasted approximately 24 hours.
LPN was administering a dose of GARDASIL9 to a patient on 5/5/2022 when the finger flange shattered and the LPN cut her finger on the broken device.; This spontaneous report has been received form a medical assistant, regarding a female patient of unknow age (license practitioner nurse (LPN)). The patient's medical history, current conditions, drug reaction or allergies and concomitant medications were not reported.  On 05-MAY-2022, the LPN was administering a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) to a patient (this patient mentioned presented syringe issue, product delivery mechanism issue, no adverse event and poor-quality product administered, which were captured in MARRS # US-009507513-2205USA002063) when the finger flange shattered, and the LPN cut her finger on the broken device (Limb injury). Reporter stated the LPN was wearing gloves at the time the flange shattered and she sought medical attention after the incident. The outcome of the event was not reported.   The causal relationship between the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event limb injury was not reported.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2205USA002063:
Fatigue, coughing, exacerbation of seasonal allergies, severe shortness of breath leading to hospitalization.
COVID; COVID; Moderna- 24Oct2021/ Pfizer- 30Mar2022/ Moderna- 06Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 as dose 2, single (Batch/Lot number: unknown), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06Sep2022 as dose 5 (booster), 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: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Mar2022, outcome "unknown", described as "Moderna- 24Oct2021/ Pfizer- 30Mar2022/ Moderna- 06Sep2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jan2023, outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jan2023) Positive; (06Feb2023) Negative; (08Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Ritonavir (Paxlovid) started on 30Jan2023. Paxlovid rebound started on 07Feb2023. No admission to hospital due to the event. Tested positive for covid-19 on 30Jan2023 and began a 5 day dose of Paxlovid on the same day, began feeling better by Feb, tested negative for Covid on 06Feb2023. Feeling bad again on 07Feb2023 and Covid symptoms (cough, fever, congestion, low energy) returned. Tested positive again on 08Feb2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At site of injection, a rash broke out; cherry red color. Circumference size was about 1.5 inches. It itched and was very warm. I contacted my physician and he recommended Benadryl.
GBS.  Sensory issues, numb feet, can?t walk. Received 5 Ivig treatments in the hospital in a step down unit
Three days after administration hives developed wide spread, has been treated with benadryl every 4 hours with hives returning 3.5 hours after benadryl administration.
A few days after the vaccine there was itching all over the body and we went to see the primary care doctor. The doctor was , she gave me medicine called hydrocortisone cream and Prednisone 20 mg tablet. With those medications not making a difference we decided to consult with another primary care doctor who was   who gave me the medicine Cephalxin 500 mg capsule, Methylprednisolone 4 mg Dosepk, and told me to take Zyrtec allergy medicine every day. I took the allergy medicine for 15 days. He also suggested going to a dermotologist. So we took that in consideration and when to . She gave me Clobetasol Propionate Lotion 0.05%. All of these did not make a difference so we went to another doctor whose name was  who game me Doxycycline Hyclate 100 mg Capsule, Prednisone 10 mg Tablet, and Clobetasol Propionate Ointment. After consuming and using all of these medications I have found no difference than what I had in the beginning, which was more than a month ago.
Approx 6 days post vax, PT began to experience chest pains, heart palpitations and pain in left arm. Still experiencing left arm pain everyday and heart palpitations periodically.
SPIKE IN BLOOD PRESSURE ONE WEEK LATER, SEVERE VERTIGO FOR 8 DAYS.  VOMITING, EXTREME DIZZYNESS. UNABLE TO WALK WITHOUT HELP
pt was administered #3 DTP about 3 hrs p/vax began w/high pitched crying, unable to console & cont w/this behavior for about 4 hrs; t101;
This spontaneous report as received form a medical assistant refers to unknown number of patients of unknown age. On unknown dates patients were vaccinated with PNEUMOVAX 23 (dose, lot no. and route unknown). No concomitant medication was reported. The patients were inadvertently administered vaccine that had been improperly stored. No adverse effects were reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Pfizer-BioNTech Covid-19 Vaccine EUA 2/7/2021 @3am- fever which subsided at 11:30am, chills, body aches, headache, fatigue lasting all day 2/8/2021- swollen lymph node left axilla, soft tissue swelling left axilla, no redness
2 1/2 x 2 inch area of warmth and erythema starting day of vaccine then progressing treated with KEFLEX (250/5) 5 ml po q6 hours x 10 days.
On 5/5/98 pt. recv. vax.  On 5/13/98 exp. injection site swelling, eosinophils increased, injection site warmth, pruritus, injection site erythema.  Pt. treated with cephalexin (Keflex) and instructed to elevate and apply warm compresses.
Developed darker discolored urine Monday afternoon of my 2nd vaccine (orange to tan in color). This persisted throughout the day and night of Tuesday but resolved Wednesday morning. I also had a sore arm, headache and some intermittent nausea and slight fatigue. Had another (single episode) discolored orange using the evening of Monday May 10, 1 week post vaccine.
his second dose of GARDISAL 9 was over a year late; This spontaneous report was received from a male pharmacist of unknown age, who refers to himself, via agent. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, dose, site and route of administration were not provided) for prophylaxis. On an unknown date, he was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, dose, site and route of administration were not provided) for prophylaxis, which was over a year late (inappropriate schedule of product administration).
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) outcome was unknown. Not Provided      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 medications were reported.  No treatment product were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-122781 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122781:
going to fall over; Nauseous; Headache; Wasn't balancing  right/going to fall over; felt sick; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than a month after receiving Shingrix, the patient experienced nausea, headache, loss of balance and feeling unwell. On an unknown date, the patient experienced fall. On an unknown date, the outcome of the nausea, headache, loss of balance, feeling unwell and fall were unknown.   It was unknown if the reporter considered the nausea, headache, loss of balance, feeling unwell and fall to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported.  The patient felt sick for the whole month of September. She was nauseous, had a headache and wasn't balancing right. She felt like she was going to fall over. The reporter did not consented to follow up.  The reporter provide any additional information.
I was vaccinated on Tuesday, felt normal reaction. Woke up Saturday morning with excruciating pain from my right armpit to the bottom of my rib cage. Pain was worse every time I inhaled. My breast on the right side swelled up and became red splotchy and hot. Had fever symptoms for 2 to 3 days afterwards. The excruciating pain in my chest and rib cage subsided within 6 to 8 hours. However the swelling in my right breast and redness did not subside for about three days.
Fever (103), Body Aches, diarrhea, extreme fatigue, back pain, groin pain, upset stomach, migraine.
Pt recv vax on 1/26/99; 5 hr post vax pt exp pain x 3 day, chills, bruised area, cold illness x 1wk, could not sleep
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-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 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Sep-2020 and the estimated date of delivery was 29-Jun-2021. On 08-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 08-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
syncope approx 10 minutes after injection,   clammy , sweaty skin, pale .   Put flat in floor with cool compresses.  After some time encouraged  water , coke, granola bar (  from wife )   Aprox 45 minutes later was able to walk well out of store, not wobbly or fall risk.  escorted to car.
4 hrs p/vax pt rt leg got sore; red from site to knee & began crying-t103; pt very irritable the rest of day & through the noc the next day leg would become red for 5-10 mins & then be ok for about 1/2-1 hr then become red again;
Right knee swelled up and was very painful.   Lasted about 12 hours then went away.   I cna only assume it was related to the Vacine as I did no activity and had no Trauma.
This spontaneous report was received from a health care worker regarding a patient of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patient were not reported. On 05-APR-2016, the patient was vaccinated with improperly stored M-M-R II lot # L024268, expiry date 01-JUL-2017 (dose number, dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at temperature of 20 degree Centigrade for 11 hours, 15 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Severe dizziness; Headache; Soreness/ body ache; Fatigue; Nausea throwing up; Pain; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Severe dizziness), HEADACHE (Headache), MYALGIA (Soreness/ body ache), FATIGUE (Fatigue) and NAUSEA (Nausea throwing up) in an 83-year-old female patient 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Severe dizziness), HEADACHE (Headache), MYALGIA (Soreness/ body ache), FATIGUE (Fatigue), NAUSEA (Nausea throwing up), PAIN (Pain) and CONFUSIONAL STATE (Confusion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Severe dizziness), HEADACHE (Headache), MYALGIA (Soreness/ body ache), FATIGUE (Fatigue), NAUSEA (Nausea throwing up), PAIN (Pain) and CONFUSIONAL STATE (Confusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Pt. describes scab (L) arm injection site, scratched it off - drainage from site. Onset of LE itching & rash. Generalized body aches. 4 # weight gain in one week.