chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 48-year-old male called by his care team at facility. He has been getting surveillance labs status post liver transplant 7 months ago and had gone from every 2 weeks to every month. He was phoned because about 36 hours ago, he had a blood draw that showed an elevated potassium of 6. Treated and released. ED visit within 6 weeks of receiving the COVID vaccine. ED to hospital 4 days later for Hyperkalemia - Hyperkalemia treated IV insulin, D 50, and calcium gluconate. He also received one dose of Lokelma in the ED. Potassium in the AM was 5.0. Recheck at 4 PM was 5.2 and he received 10 mg of Lokelma. He was discharged to home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
I woke up with a severe sore throat.  I went to the pharmacy to inquire about the sample inhaler that I had been given by my doctor.  The pharmacist felt my symptoms were from the vaccine but I think it was the inhaler.  My doctor recommended I go to the urgent care and the urgent care doctor thought it was the vaccine as well.  Today I received my second shot and the nurse thought it was the inhaler that caused by reaction.  I was given prescription strenth Tylenol and Lidocaine Viscous (2%).
This spontaneous report was received from a registered nurse referring to an unknown number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD for prophylaxis, that underwent a temperature excursion of - 14 degrees Celsius to -10 degrees Celsius for a time frame of 18 hours and 17 minutes and the Digital data logger was involved. Concomitant therapies included sterile diluent. No adverse effects were reported and no product quality complaint was involved. This is one of two cases from the same reporter. Additional information is not expected as no consent for follow-up was provided. Sender's Comments:  US-009507513-1705USA008607.
Information has been received from a male who was "diagnosed with a mental condition when he was young" who on approximately 03/23/1995 was vaccinated with varicella vaccine live. The pt reported that he believed that on approximately 03/23/1995 he was possibly injected with the varicella vaccine by his live-in-partner who was testing "a chicken pox vaccine" at the time. The pt alleged that the woke up the next morning with no knowledge of what took place the previous night, but was in excruciating pain. He reported his "penis felt like it was on fire, and that he ended up having something like shingles on his back, lesions inside his penis and urethra, and neurological damage." Unspecified medical attention was sought. The pt reported that a "vet" thought that he might had legionnaires. The pt also reported that he "exposed friends and animals to whatever it is that I have and they died" (WAES0201USA01919). Additional info has been received from the pt who reported that he would be speaking to his physician on 02/19/2002. The pt also stated that he was concerned that he had "infected his horses with the vaccine." Additional info has been requested.  Follow up information has been received from the pt who indicated that he was infected through his penis with varicella, combined with a wart virus. He said that nobody would test him to see there has been damage to the parts of his body that have been affected by the infection and to see just what he was infected with. He also reported that he is concerned because his mother told him that they might try to have him committed. Follow up information from the pt indicated that he had a positive PPD. He also indicated that he had a lot of phlegm in his chest. He mentioned that his penis had become impotent. He indicated taht the disease ruined his penis and teeth and has caused chronic pain, visual changes, severe gastric problems, and diarrhea that lasted for over three years. He indicated that he still is not right, that even the cold bothers him so bad that he can't go out during the winter. Follow up information indicated that since the vaccination the pt has had chronic swelling of the spine, uncontrollable grinding of his teeth, he has become impotent, his vision has worsened and he has lesion on his scalp. Additional information has been requested.
5 MINUTES AFTER RECEIVING HER FIRST DOSE IN THE MODERNA SERIES - PATIENT STATES THAT SHE SUDDENLY FELT VERY WEAK /LETHARGIC, BECAME BOTH PALE AND FLUSHED AND VERY DIAPHORETIC. SHE WENT TO THE LOCAL ER. VITALS WERE TAKEN. NO IV FLUIDS OR MEDICATIONS WERE GIVEN. NO DIAGNOSTICS TESTS WERE PERFORMED. AFTER MONITORING, SHE WAS DISCHARGED HOME.
After the shot I began experiencing fever, chills, and an extreme headache.  Two days after I was experiencing neurology issues on my right side.  I have also having waves of dizziness that accompanied the speech, hand, and movement impairment.
Patient described symptoms of possible bursitis. Patient complained of lingering pain, and no mobility in arm where injection was given.
Headache; Nauseous; A little bit of the sore arm; I was extremely tired; Just start really achy; I am hungry, I want to eat but when I want to try to put food to my stomach and it makes me sick to my feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: FF2593) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 Immunization; Bnt162b2 (Dose Number:02), for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: HEADACHE (non-serious) with onset Oct2021, outcome "recovered" (Oct2021), described as "Headache"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "Nauseous"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "A little bit of the sore arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "I was extremely tired"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Just start really achy"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I am hungry, I want to eat but when I want to try to put food to my stomach and it makes me sick to my feet". No follow-up attempts are possible. No further information is expected.
Within 30 minutes I felt confused and light headed and it reminded me of feeling like I had a concussion. I had dark spots in my vision and intense pressure in my head. As I had been told to expect random side effects I went home and went to sleep early. The next day I had a lack of motor function with continued intracranial pressure and confusion. I called my doctor and went to the Emergency Room where my Blood Pressure was recorded to be Hypertensive and then retaken. I was given a CT scan and sent home. I was unable to work  the rest of the week and was out of work after being sent home sick the following week. I continued to experience intense intracranial pressure and an inability to form short term memories for three weeks after vaccination. I still continue to experience intracranial pressure and episodes of hypertension but have more ease in forming short term memories. Intracranial pressure has nonetheless decreased significantly compared to the immediate onset following inoculation. My medical testing is ongoing.
fever blister appear on her lip; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (fever blister appear on her lip) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Fever blister (History of fever blisters) since an unknown date.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ORAL HERPES (fever blister appear on her lip). On 21-Mar-2021, ORAL HERPES (fever blister appear on her lip) had resolved.            Concomitant medication use was not reported.  Patient used Abreva topical ointment for treatment of the event.    This case was linked to US-MODERNATX, INC.-MOD-2021-076534 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076534:1st dose
Information has been received from a consumer concerning her 11 year old daughter who on 26-Oct-2006 was vaccinated IM with "one shot" of Gardasil vaccine (yeast). The patient felt like it was burning. She is recovering on an unspecified therapy. No further information is available.
4/26/21 Shortly after the shot, I felt funny the whole day.  4/27/21 Sore left arm.   02/02/21 Left arm pit's lymph node is swollen, left arm/hand loss of feeling. Feels tingly. Permanent damage? Maybe, hopefully not. I'm checking the box anyway.
weird dreams; slight dizziness; headache; nausea; fatigue; difficulty sleeping; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER2613) at right arm, via an unspecified route of administration at left arm on 22Mar2021 14:30 (at the age of 65-year-old) at single dose for covid-19 immunization. Patient not pregnant at the time of vaccination. Medical history included depression, anxiety and hypothyroid. No known allergies reported. Concomitant medications included Synthroid and Estradiol. On 23Mar2021 12:00, day after starting the therapy, the patient experienced headache, nausea, fatigue, difficulty sleeping, on 25Mar2021 third day after the vaccination slight dizziness and weird dreams. The patient not received treatment for the adverse events. No covid tested post vaccination. The patient had no covid prior vaccination. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not been tested for COVID19, Since the vaccination. Seriousness as reported non-serious. The outcome of events was not recovered.
11/8/2018 5:30pm Headache, neck ache, difficulty moving arm, swollen injection site. 11/9/2018 5:00pm Mild headache, all other symptoms resolved.
A report has been received from a Health Professional concerning a male patient. No medical history and concomitant medications provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal) started on 03-Sep-2014. Patient inadvertently received a dose of FLUMIST on 03-Sep-2014 and 15-Sep-2014. Patient was doing fine. Next follow up was scheduled for 15-Oct-14. The outcome of the event of patient inadvertently received a dose of FLUMIST on 09/03/2014 and again on 09/15/2014 was unknown. The reporter considered the case to be non serious.
Patient had a large red swollen patch on her upper arm the size of a softball. She complained that it hurt to touch and felt warm.
My head was always heavy; I had lot of cold; headache and fever; My head was always heavy; I had lot of cold; headache and fever; My head was always heavy; I had lot of cold; headache and fever; head was always heavy; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EW0176 and Expiration date was not reported) via an unspecified route of administration, in right arm, on 21Apr2021 (at the age of 67 years) and second dose of BNT162B2 (lot number: EW0176) on 04May2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. On an unknown date, consumer stated 'she took the COVID vaccine, the first one was not bad because her head was always heavy, she had lot of cold and a headache and fever. Reporter seriousness for her head was always heavy; she had lot of cold; headache and fever were unspecified. Outcome of the event was reported as unknown.   Information on lot and batch number is available. Other information is expected.
It's been 11 days and injection site is swelling and red, feels like a bee sting.
(R) arm at varicella injection site 1st showed sm. amt. bruising, then next day became red, swollen, & hot to touch. Approx. 2x6cm. Ice pack applied to site. Ibuprofen given. Redness lasted approx 5 days before resolving.
After 5:00 PM  on date of vaccine, patient had fever (102 F Max), chills, muscle aches, nausea, vomiting, and dizziness. Patient reports severe symptoms lasting until following morning. 2 Tylenol ES (1000 mg total) taken 22Jan20201  at 8:00 am followed 600 mg ibuprofen at 1:00pm. At current time (2:55 PM) only muscle aches/weakness remain reported.
Lost power in legs feet couldn?t t walk lost control of blaster urine released no control broke out in psoriasis very severe ALL over body some bleeding  major severe pain all over body   Was like body exploading inside out  felt like seriously gonna die for first 20 days went to 2 different hospitals 2 days in first one 4 days in second one ,,,, neither hospital knew what was wrong. With me after ct scans and blood urine tests d,,,, NO Answers. Been here 5 weeks getting better no treatment s
Patient presented with His Mother for his primary dose of Pediatric Pfizer today. I withdrew 0.2 ml from the vial and forgot to reconstitute the vial prior with 1.3 ml of Sodium Chloride 0.9%. I administered the vaccine and counselled his Mother on adverse reactions. I advised that they wait 15 minutes out side the pharmacy just in case of allergic reaction. I went to draw up another dose for the next patient and that is when I realized the vial was not reconstituted. I did not see the patient or his Mother in the waiting area, so I phoned the patient's father and asked him to ask his wife to return to the pharmacy. Patients mother returned to the pharmacy and the patient remained in the toy isle with his older brother.  I explained to patients mother what had occurred and again explained the common adverse reactions that might occur due to the patient getting a higher dose. Patients mother said that patient was not currently experiencing any adverse reactions. I asked her to please return to the pharmacy if he started having any type reaction or please call and let me know if he does once they leave the store. I called patients mother later that day and she said patient was still not experiencing any adverse reactions.
2 days after vaccine right armpit extremely swollen and tender (lymph nodes in armpit); 2 days after vaccine right armpit extremely swollen and tender (lymph nodes in armpit); Body aches; Fatigue the following day; Patient was administered Booster dose 3, BNT162b2; Patient was administered Booster dose 3, BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Oct2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received other vaccines within four weeks prior to the vaccination, which included tetanus vaccine (MANUFACTURER UNKNOWN) in the right arm on 29Sep2021 for immunisation. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Mar2021 (at the age of 32-years-old) and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 06Oct2021, the patient experienced body aches, fatigue the following day. On 07Oct2021, two days after vaccine, his right armpit was extremely swollen and tender, it was the lymph nodes in armpit. 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 not been tested for COVID-19. The clinical outcome of the events, body aches, fatigue the following day; two days after vaccine right armpit was extremely swollen and tender, it was the lymph nodes in armpit were resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
1505 c/o palpitations; heart flip flopping and light-headed 1509  BP 170/98  P 135 R 16  SpO2 96%  Alert and oriented x 3; skin pale, cool and clammy; resps unlabored; pulse weak and heart bounding and regular - very rapid; no rash VS repeated every 5 min without appreciated stabilization. Assessment remained the same EMS called 1520.    EMS arrival 1527; care handed off and report given. Client declined to be transported to the emergency room and was dispositioned home with instructions to go to the ED if symptoms do not abate or worsen. BP and P remain elevated on disposition per EMS (Fire Dept EMS).
Stomach upset; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), HEADACHE (Headache) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Foot surgery (surgery on foot several months earlier). Concurrent medical conditions included White blood cell count (Low white blood count) since 09-Oct-1971, Nerve pain (Chronic nerve pain in foot from accident) since 10-Jun-2014, Thyroid nodule (thyroid issues and nodules) since 2009, Gastritis (acid reflux/gastritis) since 2010, Osteoporosis (Left hip) since 2016, Sulfonamide allergy (Allergies to medications : Sulfa), Drug allergy (macrodantin), Sulfonamide allergy (gantrisin), Allergy to antibiotic (Erythromycin), Allergy to antibiotic (ampicillin), Drug allergy (Chlorhexidine), CRP increased and Allergy (not specified). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), LORATADINE for Allergy, VITAMIN D3 and MAGNESIUM for Bone density abnormal, ATORVASTATIN for CRP increased, TRAMADOL for Chronic pain, VITAMIN C [ASCORBIC ACID] for Immune system disorder (NOS), CALCIUM CITRATE for Osteoporosis, COENZYME Q10 [UBIDECARENONE] for Supplementation therapy.    On 27-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021 at 9:00 AM, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 29-Jan-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high (High) High CRP level. On an unknown date, White blood cell count: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stomach was upset but he never vomited he could only eat lightly all day like soup ,ginger ,ale and toast.   This case was linked to MOD-2021-253907 (Patient Link).
States 02/01/02 woke up with hurting ankles-legs went to family MD. Referred and states "arthritis" but other MD dx fibromyalgia. Currently on study for adverse rx to hep B vaccine. Currently taking Naprogiad and Tylenol pre q 45.
A serious spontaneous report of post viral cerebellum ataxia with symptoms of falling down and unable to walk has been received from a physician concerning a female, subsequent to FLUMIST. Neither the patient's past medical history nor any concomitant medications were reported. The patient received FLUMIST on 21-Oct-2009. The patient received FLUMIST and then started falling down a lot on 23-Oct-2009 and then was admitted to the hospital on 24-Oct-2009 because she couldn't walk. The patient was diagnosed with post viral cerebellum ataxia and treated with intravenous immunoglobulin and steroids. The outcome of post viral cerebellum ataxia with symptoms of falling down and unable to walk was unknown.
Patient received vaccines, then felt nauseous, dizzy, was pale and diaphoretic, BP decreased to 80/50, pt placed supine with feet elevated, given Benadryl 20 mg PO, sips water, felt better after about 1 hour.
Pt received Moderna COVID vaccine dose #1 on 1/29/21.  Pt then received a Pfizer COVID vaccine on 3/31/21.
About 10 days later I started getting high fever, headache, no appetite, and not able to sleep from head pain. I went to care twice and ER they gave me Codeine.
Bell(s) palsy on right side of my face.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 12:00 as dose 2, single (Lot number: FH8027) at the age of 30 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FF2593, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 28Oct2021, when the patient was 30-year-old, for Covid-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 03Mar2022 at 14:00, outcome "recovering", described as "Bell(s) palsy on right side of my face.". The event "bell(s) palsy on right side of my face." required physician office visit and emergency room visit. Therapeutic measures were taken as a result of bell's palsy.  Clinical course: Patient did not have any known allergies. Patient did not receive any other vaccine in four weeks and not received other medications in two weeks. Patient did not had covid prior vaccination and not tested covid post vaccination. Received treatment for AE with Steroids and Viral medicine.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported serious event Bell's Palsy and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient developed rash and itching on trunk of body and arms the day following immunization. She applied ice and took diphenhydramine by mouth. Symptoms had resolved by 11/9/14 (3 days after vaccination).
Since administration of flu vaccine, right arm has ached a lot. (Bicep area) pain wakes me up at NOC; must take Ibuprofen freq. Difficulty using right arm.