chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer or other non hcp (patient herself).   A 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration, administered on the left arm  on 28Jan2021 08:15 (at the age of 85-years-old) at a single dose for COVID-19 immunisation. Medical history included sinus disorder. Concomitant medications included mirtazapine (manufacturer unknown), montelukast (manufacturer unknown); and atorvastatin (manufacturer unknown) all taken for an unspecified indication. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered to the patient was at the Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient experienced nausea and vomiting on 28Jan2021 12:15 and the whole evening. Patient was okay in the morning. Events were assessed as non-serious. Treatment was not received for the events. The outcome of events reported was recovered on 29Jan2021. Information on the lot/batch number has been requested.
Pt recvd 2nd dose of Engerix-B mid MAR92 & exp blisters under feet, rash plus malaise, aching, flu sx;
My eye felt like it was like a burning sensation, the right eye it was the corner of the eye, the outer part of the corner of the eye; turning red; it was like sore; My eye felt like it was like a burning sensation, the right eye it was the corner of the eye, the outer part of the corner of the eye; turning red; it was like sore; I felt really weird; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) 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 1), for Covid-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 14May2021, outcome "unknown", described as "I felt really weird"; EYE IRRITATION (non-serious), EYE PAIN (non-serious) all with onset 14May2021 06:00, outcome "unknown" and all described as "My eye felt like it was like a burning sensation, the right eye it was the corner of the eye, the outer part of the corner of the eye; turning red; it was like sore". Therapeutic measures were taken as a result of eye irritation.  Additional Information: Patient got his second Covid vaccine yesterday. Patient had a massage today (at the time of report) and after massage patient felt really weird. Around 6 O'clock patient's eye felt like it was like a burning sensation, the right eye it was the corner of the eye, the outer part of the corner of the eye, it was like burning it was burning sensation so patient took the nap and got up, it felt like it burning really bad. So patient put a cold compress on it and it was turning red and patient took a Benadryl. So its definitely allergic type reaction, when patient took the rag, the cold compress and push it up it was like sore.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 28-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (a couple of drinks a week). Concomitant products included PROBIOTICS NOS for an unknown indication.    On 26-Feb-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 04-Aug-2020 and the estimated date of delivery was 04-May-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound abdomen: normal (normal) normal.     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.   On 27 Mar 2020, the patient had first pregnancy with a live, full term birth. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Upon internal review on 19-Jul-2021, patients, events, analysis tabs and regulatory reports were updated.
Info has been received from a physician concerning a 7 year old female, with no pertinent medical history and no allergies, who on 12/1/99 was vaccinated with an 0.5 ml dose of varicella virus vaccine live (lot 629263/0308J). There was no concomitant medication. On 2/1/06, the pt experienced breakthrough chickenpox with 12 lesions. At the time of the report the pt had not recovered. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Patient received the vaccine Saturday afternoon.  She starting having a mild immune response reaction Sunday evening (mild lethargy, flushed face, chills, no fever).   Tuesday afternoon  around 3pm she started having some lower lip tingling.  Wednesday morning around 8am she noticed that her  lips and right side of face were swelling, around 9 am her throat began swelling.  She went to the emergency room where she was given a shot of benadryl  as well as oral benadryl and famotidine.
Pt had vagel response. Due to high anxiety about the shoot pt , passed out after shot for 2 to 3 s ,and was helped to get down on floor with her legs elevated. Patient was in shock, this her BP was high, but was alter and oriented,  helped to get stable. with in five minutes of the response pt was at her base line but we kept her at vaccine site for 30 minutes to monitor her  response.
Local irritation developed 2 days after ZOSTAVAX. Patient went to Dr due to the redness and swelling and was prescribed LEVAQUIN 500 mg QD x 5 d.
This spontaneous report as received from a physician refers to a 9 months old patient of unknown gender. On 12-NOV-2012, the patient was vaccinated intramuscular with, 0.5 ml VAQTA (lot # not provided). No concomitant medications were reported. The Physician stated that on 12-NOV-2012, a 9 month old patient was given "Hepatitis C vaccine instead of Hepatitis A vaccine". Initially the physician stated Hepatitis C vaccine was given. Follow up information was received on 12-NOV-2012 at 3:40 PM from the physician and stated that, the 9 month old patient received VAQTA in stead of hepatitis B vaccine. No adverse effect reported. Additional information has been requested.
Extreme achiness in back, touching of skin on legs and arms very painful, 100.3 fever. Took Aleve and Ibuprofen.
Severe Chills; Felt tired; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness), CHILLS (Severe Chills) and FATIGUE (Felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness). On 21-Feb-2021, the patient experienced CHILLS (Severe Chills) and FATIGUE (Felt tired). At the time of the report, INJECTION SITE PAIN (Soreness), CHILLS (Severe Chills) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment included Advil.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 28-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 25 microgram. On 30-May-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated.).    Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case
Soreness at the injection site lasting 10 days; no swelling or redness; sore upper arm for the next month, preventing him from throwing football with son
Case previously recorded as MA2009-4181. Initial case report received from a practice administrator via Novartis Pharma, on 12 NOV 2009. A 15-month-old patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m., on a not reporter date. No adverse events was reported. MedCom reference no.: NA09-008109.
chills; fever/ fever was 102; pain at injection site; fatigue; slept all day; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on 11th April 2019, refer case US2019177121).   On 5th September 2019, the patient received the 2nd dose of Shingrix. On 5th September 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, injection site pain, fatigue and sleepiness. Rechallenge with Shingrix was positive. On 28th September 2019, the outcome of the chills, fever, injection site pain, fatigue and sleepiness were recovered/resolved.   It was unknown if the reporter considered the chills, fever, injection site pain, fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows The patient received his Shingrix second dose on and that same day he experienced all the adverse reactions. The fatigue was described as exhausted and slept all day. The fever was 102. The patient was laid up again for a day and a half before the symptoms resolved. Injection site pain again lasted a few days.  On 14th September 2019, the same symptoms presented including the injection site pain and lasted a day before resolving. On 28th September 2019, all of the same symptoms presented and again resolved within a day and a half.  The patient only had the two injections on those two dates.  The reporter Consented to follow up. This case has been linked with US2019177136 having same reporter.
COVID -19 Vaccine, Primary care MD. Wife, 5/23/2021 patient admitted through ED for chief complaint of 5 days shortness of air, tested positive for COVID-19; patient vaccinated 3/30/2021 at 'local church'. 5/24/2021 admitted to ICU - Attending, 5/26/2021 rapid response due to vitals, 5/27/2021 patient intubated due to respiratory failure/distress/hypoxia; identified in septic shock. 5/31/2021 went to surgery for left forearm and hand compartment syndrome. 6/3/2021 Code blue called, 6/3/2021 date of death. Allergies: Losartan (other) and Verapamil (intolerance) Date of Vaccination: 3/30/2021, Dose: 2, Vaccine Manufacturer: Moderna Lot #:  Clinic Administering Vaccine: "local church" - no specific name was provided, Injection site: Description of event/reaction: Patient does not have vaccination card and reports not knowing date of first vaccine or exact clinic location. Date of Hospitalization: 5/24/2021 Reason for clinic visit or hospitalization: Shortness of air COVID-19 positive test result: Yes or No; if Yes, date 05/23/2021
Four hours after injection, shaking profusely, temp 103 degrees. Admitted to Hospital-April 29th released May 1, 2015. Pain in left calf-headache.
Two hours after receiving the influenza vaccine in my left arm, I was walking my dog at our usual fast pace along a familiar route, and suddenly became uncoordinated and giddy.  I had considerable difficulty directing my walk in the desired direction.  This lasted one or two minutes, when I recovered and was ably to complete the walk without falling over or being pulled over by my dog.  I had been walking for 35 minutes without any difficulty before the event occurred.  This was the first and only occasion that I had experienced symptoms of uncoordinated movement.  Also, the vaccination was the first I had been given in the past 61 years.  I did not experience any nausea.
Pt started experiencing periods of blurred vision 15 minutes after vaccine was administered. She explains it as if "everything is floating" and she cannot determine how far objects are from her. She had those symptoms 1-2 times per day for about 10 days. Last it happened 4/19/2011.
Complained of a headache, loss of appetite. Fever of 101 progressed to 102 within an hour.
overall body aches, sore throat, fever 102.5, multiple mouth ulcerations, chest discomfort, cough
pt was tested for COVID at clinic and tested positive; was sent to ED for increasing SOB; c/o fever, chills, generalized weakness, rhinorrhea; diagnosed with COVID pneumonia; treated with antibiotics; condition worsened; made comfort measures; dc'd hemodialysis and pt passed away in the hospital
first dose was Moderna vaccine, followed by accidental use of PFizer vaccine.  Contacted state department of health for guidance.  No observed signs or symptoms experienced.
Two hours after pt's 3rd dose of vax, the pt experienced fever, chills, headache, and felt like he had the flu.
Client called to report that she had the COVID vaccine yesterday morning, that she felt a little dizzy after, but she was okay and able to drive home.  She stated that around 1pm yesterday that she got really dizzy so she took some medication that she had for dizziness, she had it for a previous fall d/t dizziness.  She stated that the medication helped, but around 8pm yesterday her head felt like it was going to explode and her heart was racing, so she called her daughter and her daughter called the ambulance and she was taken to the ER.  She said they ran a bunch of tests at the ER, including a CT scan, she is doing okay now, and is at home.  She stated that she is calling because she does not want to get the 2nd dose of COVID vaccine because she does not want to go through that again.  Client stated that she lives alone but her daughter checks on her frequently.
sciatica; very painful going from back to the ankle; couldn't do anything for 2 weeks because of the pain; A spontaneous report was received from a consumer article concerning a 78 years old, female  patient who developed/experienced Sciatica,very painful going from back to the ankle,couldn't do anything for 2 weeks because of the pain.  The patient medical history was not provided.Concomitant product use was not provided/unknown by the reporter.  On 27-JAN-2021,prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:032L2OA intramuscularly in the unknown site for prophylaxis of COVID-19 infection On 24-FEB-2021,prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:023M20A intramuscularly in the unknown site for prophylaxis of COVID-19 infection.  On 27-JAN-2021,the patient experienced the events Sciatica,very painful going from back to the ankle,couldn't do anything for 2 weeks because of the pain.  Treatment information included Advil and aspercreme with 4% lidocaine in it  Action taken with mRNA with response to events was not provided.  On an unknown date,sciatica,very painful going from back to the ankle ,couldn't do anything for 2 weeks because of the pain was unknown.
I just looked at her arm, two days later and it?s swollen snd red BELOW the injections site. And sore too. But it?s a big lump. This is not COVID arm because it?s only been 48 hours I?ll be calling her doctor on Monday to discuss
Around the end of May 2022 I began to have pain in my legs, my veins and arteries.  I also have bulging veins in the backs of my legs.  My legs hurt and I cannot stand for very long.  I have a bruise (spider vein) on thigh.  On June 13, 2022.  My PCP agreed that I should see a cardiologist.  I saw the cardiologist July 6, 2022.  I am scheduled for tests in July, venous ultrasound and echo cardiogram.
No acute symptoms after vaccine except a mildly sore arm.  Patient died 4 days later
My periods have ALWAYS been incredibly light and easy, 3-5 days and no cramping. Starting the very first cycle after my vaccination my periods are now incredibly heavy (bleeding through Ulta tampons in less than an hour every hour)  very large blood clots, hemorrhage bleeding, sever cramps and are lasting over 10 days in length. My period before last landed me in the hospital where they did blood work (which all came back normal) and gave me an intravenous bag of  tranexamic acid to  slow down the bleeding.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an elderly male patient of unspecified age. This refers to 69 of 84 patients. On an unspecified date in 2017, the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8 degree C) and was administered to the patient (explicitly considered as drug administration error). It was reported that the temperature was no monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received from the reporter on 09-Nov-2017: Added event as no adverse effect. The narrative was amended accordingly.
cough; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer reported for patient (mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cough on an unspecified date. It was reported that patient was scheduled for second dose tomorrow, asked if it was okay to get the second dose even if she had cough. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist refers to a 62 year old male patient with high cholesterol, high blood pressure, glaucoma and allergic reaction to sulfa drug. On 29-DEC-2014, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous. Concomitant therapies included niacin, lisinopril, pravastatin, vitamin D3, aspirin, latanoprost and LUMIGAN. On an unknown date approximately in January 2015 (about 15 days ago) the patient experienced red scaly rash on both the sides of his back and on the arm (opposite the arm that received the ZOSTAVAX injection) on the back of the waist and on the upper part of the back of the legs. Treatment was not given to the patient. Patient sought medical attention, went to see the pharmacist. No Product Quality Complaint (PQC) was involved. Action taken was not applicable. The outcome of events was reported as not recovered/not resolved. Causality was not assessed by the reporter. Additional information has been requested.
Two days after receiving my vaccine, I started to have pain around my right breast because my lymph nodes were swollen. It was painful to the touch. I could not sleep on my right side. I went to the doctor and she told me to wait a week and if it did not get better, I would have a mammogram done. The pain lasted about 5-6 days and I took Tylenol and applied heat to help with the pain. I noticed that I am losing more hair since my vaccines as well.
angioedema of lower extremities lt >rt onset w/in 2-3 min of vax-given DPH orally; BP nl;lungs clear;edema resolved over 1-2hr;cont on DPH x 2-3days;