chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bladder infection; acquired shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9261) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "acquired shingles"; CYSTITIS (non-serious) with onset 2021, outcome "unknown", described as "bladder infection".  Additional information: COVID 19 vaccine and booster declined report not able to confirm number of doses, or age. she got COVID virus , experienced weird sensation in right arm , right foot has this been reported? Caller reports that she had all of the vaccines, first two primary and one of booster doses. The sensation happened after the booster, not distinctly after , it's just happened, not immediate, not right away. all this is registered with my Doctors office.  - It's been in the last couple of months, happening about once a month for the last 3 months. It's a dragging of her right foot and dragging of her right arm. She is calling it like thing. the foot is kind of like flapping, and arm is feeling like dragging. Wants to know if she can relate it to that (the vaccine), she is gathering information for her doctor. She has been waiting on going to him. "I just want to know if it would be symptoms of maybe that vaccine, because I gotta tell you, I also had a bladder infection and acquired shingles, this occurred after the first dose of the Pfizer COVID 19 vaccine and then from there I kind of let that go, I gotta tell you in the back of my mind, I could get shingles because I put off getting the shingles vaccine. I had this feeling about something not right here. I should get, I have looked at tons of stuff and talked to tons of people before calling you. I am disappointed I did end up with COVID, I thought I was protecting myself to the fullest. thought there was something underlying with the shingles. Foot and arm, it goes away and comes back. I have been experiencing headaches, kind of achy headaches, I have never had that before either, I am not a headache kind of person. I don't know if it's neurological, I am gathering as much information as I can. I may go to the ER,. If my doctor doesn't call me back by tomorrow morning, I am going to go in the ER. "Response: A review of the Prescribing Information for Pfizer  COVID 19 vaccine did not find information regarding intermittent dragging sensation of her arm or flopping sensation of foot. ?Pfizer cannot assess causality (i.e., cannot assess if what you described/are experiencing is associated with the Pfizer COVID 19 vaccine. Recommended to speak with her HCP and informed caller if her physician has questions they are welcome to call Pfizer. Informed caller that the CDC also offers consultation for HCP's for discussion of patients reactions.
Subject BIT010149, a 27 year old female with no previous medical condition, received the 2nd dose of Anthrax vaccine (lot FAV048B) on 10/16/2001. No other vaccinations were given on that date and the pt was taking no concomitant medication. The pt received the 1st dose of Anthrax vaccine (lot FAV048B) on 09/20/2001 with no adverse reaction. At 19:30 on 10/17/2001, the pt noted an erythematous, pruritic area (105mmx 100mm) of the right upper arm which was not painful. The pt took Benadryl 30mg, po at 21:30 on 10/17/2001. At 10:00 on 10/18/2001, the pt was seen by the nurse who applied hydrocortisone cream and ice to the area. On 10/18/2001 at 13:00, the pt was seen by the hospital physician who prescribed Allegra and topical hydrocortisone that the pt took from 10/18/2001. by 17:00 on 10/19/2001, all symptoms had resolved.
Initially, other than a sore arm, I felt fine until about 8 hours after receiving the vaccine. I then developed a bad headache, chills, muscle aches,  and when I checked my temperature it was 102. Shortly thereafter, I noticed a definite burning sensation when urinating. At that point, I stated taking both Advil and Tylenol every 6 hours. The fever and chills continued for approximately 36 hours . I ended up going to an immediate care clinic the next day to get checked out just to be sure. The doctor who examined me thought that the most likely cause of my symptoms had been my bodies reaction to the vaccine.
Sore arm, induration about 2-3" around injection site, mildly warmer than surrounding skin.  Headache that felt like blood vessels on the side of my head were expanding and then in spasms that came periodically in the night.  Severe shaking and chills during the night that felt like all my muscles deep inside me were in spasms, lasting about 30 seconds or so during the night;  this occurred twice.   I feel that the vaccine has more severe side effects and according to the literature that I was provided affects a significant number of recipients that the formulation should be changed to be less harmful to people, especially since it's marketed to people over 50 and they are more likely to have chronic medical problems  which my render the side effects more severe to them.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 1/17/21 (lot NA) Pfizer Dose 2 2/7/21 (lot NA) COVID Positive 12/4/21  12/4/21: Patient is a 76-year-old female with a past medical history significant for end-stage renal disease on hemodialysis Tuesday Thursday Saturday, hypertension, hyperparathyroidism.  The patient presents to the ED today with complaints body aches, generalized illness over the last 2 weeks.  The patient's accompanying symptoms include loss of taste, loss of smell, nasal congestion, headaches, nausea, vomiting, diarrhea.  The patient denies any fever, cough, shortness of breath, chest pain, abdominal pain. The patient states she has not gone to any of her dialysis treatments this week due to significant weakness.  The patient had a known ill contact with her daughter.  The patient states she has been taking over-the-counter medications with no relief of her symptoms.  The patient is vaccinated against COVID-19. The patient attempted to ambulate in the ED but became very tachypneic and tachycardic requiring oxygen supplementation.   Upon arrival to ED patient's temperature is 97.1°, heart rate 87, respirations 16, pulse ox 99% on room air, blood pressure 163/99. CT chest reveals no evidence of PE, patchy opacities in the lungs would be compatible of viral pneumonitis, enlargement of the ascending aorta up to 4.2 cm in diameter.  Patient's laboratory findings are significant for chloride 95, a gap 22, glucose 102, BUN 78, creatinine 8.05, ALP 142, troponin 0.04, WBC 4.06, hemoglobin 7.8, hematocrit 25.1.  Patient received 500 mg IV azithromycin, 1 g IV Rocephin in ED.  12/7/21: Patient is admitted hospital, started on empirical IV antibiotics.  COVID-19 test is reported positive. Patient is not hypoxic.  Nephrology consult requested patient had hemodialysis on Monday and Tuesday back-to-back.  She did have drop in hemoglobin, was given 2 unit PRBC transfusion, H&H is stable now.  Patient is discharged to home on oral antibiotics in stable condition. She is discharged with Agency services.
has injection site pain; swelling in left ankle; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored study. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced injection site pain and swelling in left ankle. The patient was unsure if it was normal side effects. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Extreme fatigue; feeling very weak; heart palpitations; heart would skip a beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Lot number: EN6201) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose , date-04Feb2021, Lot number-EL9265), administration date: 04Feb2021, for COVID-19 immunization, reaction(s): "Weakness", "Palpitations", "Skipped beats". The following information was reported: ASTHENIA (non-serious) with onset 2021, outcome "recovered", described as "feeling very weak"; PALPITATIONS (non-serious) with onset 2021, outcome "recovered", described as "heart palpitations"; HEART RATE ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "heart would skip a beat"; FATIGUE (non-serious) with onset 11Mar2021, outcome "unknown", described as "Extreme fatigue". The events "feeling very weak", "heart palpitations", "heart would skip a beat" and "extreme fatigue" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, palpitations, heart rate abnormal, fatigue. Additional information: On 11Mar2021 the patient experienced extreme fatigue and had a trip to ER chest x-ray, lab chemistry / hematology - EKG/ECG general resulted in no heart attack, no discernable issues. Out filled with 5 lead, 30 day heart monitor (Preventice). On 30Mar2021 the patient left for trip to and in month of April the doctor advised the patient to heart monitor report would be received mid-april. On returning the patient had heart monitor on 04Apr2021 the leeds "drained energy" while attached. The patient sew him on 23Mar2021 f/u to ER visit). Up on Follow up the patient saw doctor in mid May to see results of monitor-said interpretation was needed by Cardiologist. On 25May2021 sound nothing to be concerned about and the patient sated his heart just didn't like the vaccine shot. No follow-up attempts are possible. No further information is expected.
Exhaustion and depression side effects for 7 to 8 days; Exhaustion and depression side effects for 7 to 8 days; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Exhaustion and depression side effects for 7 to 8 days) and FATIGUE (Exhaustion and depression side effects for 7 to 8 days) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (No medical reported history). Concomitant products included CAPECITABINE and CAPECITABINE (XELODA) for an unknown indication.    On 22-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 DEPRESSION (Exhaustion and depression side effects for 7 to 8 days) and FATIGUE (Exhaustion and depression side effects for 7 to 8 days). At the time of the report, DEPRESSION (Exhaustion and depression side effects for 7 to 8 days) and FATIGUE (Exhaustion and depression side effects for 7 to 8 days) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The  patient was using an inhaler for asthma (details regarding medication not provided). Patient also reported that treatment medications for exhaustion  and depression were taken (details not provided).  Crosslinked to case, MOD21-022704.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Reporter information updated.
2020-04-05 - Fatigue with some diarrhea (also common with Nivolumab/BMS986016 that I'm also taking) 2020-04-07 - Noticeable malaise and back pain near left shoulder blade 2020-04-08 - Mild rash developing on left side of chest above nipple (same height as back pain) 2020-04-09 - Rash progresses - diagnosed with Shingles via text chat with photos with provider
doesn't feel right; felt kind of blah; arm was red; think it's red/ arm was red/ red spot had diameter of 2 inches wide perfectly like a circle/ raised up by about an inch/; right arm hurts/ getting worse; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (doesn't feel right), FEELING ABNORMAL (felt kind of blah), ERYTHEMA (arm was red), RASH (think it's red/ arm was red/ red spot had diameter of 2 inches wide perfectly like a circle/ raised up by about an inch/) and MYALGIA (right arm hurts/ getting worse) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (MONO LINYAH) for Birth control, LEVOTHYROXINE, OMEPRAZOLE, SERTRALINE and VITAMIN D3 for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, 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 experienced DISCOMFORT (doesn't feel right), FEELING ABNORMAL (felt kind of blah), ERYTHEMA (arm was red), RASH (think it's red/ arm was red/ red spot had diameter of 2 inches wide perfectly like a circle/ raised up by about an inch/) and MYALGIA (right arm hurts/ getting worse). At the time of the report, DISCOMFORT (doesn't feel right), FEELING ABNORMAL (felt kind of blah), ERYTHEMA (arm was red), RASH (think it's red/ arm was red/ red spot had diameter of 2 inches wide perfectly like a circle/ raised up by about an inch/) and MYALGIA (right arm hurts/ getting worse) outcome was unknown.        Treatment medication included ice. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-116337 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116337:
My 10 y/o daughter experienced severe migraines and fatigue the day after  her first vaccination. For 2 weeks.  She is feeling 85% better
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 11-year-old male patient who received MENVEO (batch number M17004, expiry date 31st October 2018). Concomitant products included ADACEL and GARDASIL. On 13th September 2017, the patient received MENVEO. In September 2017, less than a week after receiving MENVEO, the patient experienced injection site welling, injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site tenderness and injection site erythema were not recovered/not resolved. The reporter considered the injection site swelling, injection site tenderness and injection site erythema to be possibly related to MENVEO. Additional details were reported as follows: On 13th September 2017, the patient concomitant products included ADACEL in left arm (batch number U5810AB, expiry date 22nd November 2019 and GARDASIL. In right arm (batch number N013695, expiry date 21st March 2019). In September 2017, the patient had an injection site reaction after receiving MENVEO. The patient had swelling, tenderness, and a quarter sized area of erythema. The health care professional did not have dose number in any of the vaccines series and time or date of onset of event was not collected.
no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 18-MAR-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851:
Injection arm went numb, almost immediately along with dizziness and headache. By the time I got home, I was so tired I couldn?t keep my eyes open. I had night sweats that evening when I took a nap (no fever). My injection arm was in so much pain I woke up multiple times through the next two nights, sometimes screaming out in pain, then I felt sick and lethargic for the next 4 days and couldn?t lift my or move my arm for that same duration.
Got the vaccine and within a few hours felt weak, but that night had a fever, few chills. She got in the bed, had some aches and pains, and that lasted for about 2 days.  She took some Tylenol and after a few days she was okay, took about 7 days before she was back to her before vaccine condition.   She did have COVID virus in 4/13/20, and was down for 4 weeks, and this felt similar to that but not as severe as that.
RECEIVED PARTIAL DOSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: G200707, and batch number: G200707 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced received partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received partial dose was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient has drug reactions/allergies with penicillin, cephalosporin and triptans. On 08-NOV-2013, the patient was vaccinated with the first dose of RECOMBIVAX HB injection, 10mcg/mL, intramuscular for immunisation (lot #, expiry date not provided) with no adverse effects. On 10-DEC-2013, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot #, expiry date, route, dose and indication not reported). The pharmacist reported that the patient developed a rash on 10-FEB-2014 ("two weeks ago"). The pharmacist stated that the rash was reported to her by the patient's daughter who described it as, "hive-like, itchy and getting worse". The pharmacist stated that the patient had not yet sought treatment for the rash and had not seen a physician. No lab diagnostics studies were performed. The patient sought medical attention by call to pharmacy. At the time of reporting the outcome of the events was not recovered. Additional information has been requested.
Pt states that after the vaccine, she had a migraine for 3 days.  On 4/25, severe diarrhea, arthritis in hands, way worse than ever before, unable to grip.  Low back pain that felt like it was a pain level of 8-10.  Sharp nerve pain in her right foot and ankle, spiked a fever of 100.2-100.4, kept down with tylenol.   04/29/2021- Developed a rash that is extremely itchy near the injection site that is about 3"x6".Patient said rash on arm is still very itchy, although less red.  States that her lower back is still very painful.  Also states that she was constipated. 04302021-States that she now has a rash on her lower back, opposite of the side that she has the severe back pain.  It's red and raised.   05042021- States that over the weekend, her lower right side shooting down her leg was really bad, felt like sciatica.  Fatigue is extreme.  States that there is tenderness when she puts her arms down on the table, feels muscular.  Rash is fading, temps remain in the high 99 range, each arm is heavy, right hand, forearm and wrist pain, breast pain, night sweats.- 05052021-Patient states that she has a red lump that seems to go through her vein on her arm that she recevied the Covid vaccine on.   05112021-  States that on 5/7, had diarrhea again. 5/10-rash better, diarrhea better, but started with a migraine and has not been able to get rid of it yet.
Small lump with slightly reddened skin at site of injection, appeared 2 days after immunization in right thigh - pneumo conj.  Treated with warm compresses.
Day after receiving vaccines patient awoke with left breast redness and tenderness. Vaccine doses were given in left arm. No adenopathy.  Diagnosed with mastitis and placed on oral antibiotics 8/16 when seen at office. No other clear etiology for breast symptoms.
Patient's daughter called the clinic to inform the staff that the patient passed away.  She reports that a couple of weeks after getting the vaccine, the patient began experiencing weakness in his knees, slurring of his words and developed hallucinations.  Patient was ultimately admitted to ER and passed away 10 days later.
On 9/11/02 around 8:30 PM, mom noticed swelling of right arm and warm to touch but no fever. Child has complained of some soreness but not has limited use of limb. Was given Motrin Liquid for discomfort. 9/12/02 on exam there is swelling and redness localized in the deltoid region of right arm; none below. No limitation of arm. There is no tenderness to touch but when asked, child states a little. Temperature at 9:45 AM 96.6.