chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in the injection side after 2 month. Running down her shoulder to wrist. Aggravating pain. Holding at a certain way almost poking. 41 y/o post partum female given Tdap after deli (1-24-10) no complaints for 2 wks then arm started hurting at injection site when arm raised. Has been seen by PCP. No TX.
This spontaneous report was received from a pharmacist via field representative refers to a 62 year old male patient. Patient's medical history and concurrent conditions were not reported. On an unspecified date in September 2015 the patient was vaccinated with ZOSTAVAX of unspecified dose and frequency. No information on concomitant medication was provided. On an unknown date, the patient developed a raised, itchy rash extending from injection site to his elbow. The patient sought medical attention with an unspecified physician and was treated with BENADRYL. The patient recovered from the events on an unspecified date. No further information was provided. No product quality complaint (PQC) was involved. The relatedness of the event with the suspect therapy was not provided. Additional information is not expected since there is no consent to perform follow up.
Headache, Sedation, Myalgia, Arthralgia, Fever,  NauseaVomiting, NUMBNESS IN FINGERS OF ARM OF INJECTION SITE  Narrative:
no adverse event; lot that had been expired was administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (no adverse event) in a 94-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients).    Patient age was reported as 94 Year 11 Months.  No concomitant medication was provided.  ID number was reported as 80777027399.   Lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Moderate to severe body aches, entire body. Severe back pain. Lasted 1.5 days.
Pt reports flu like symptoms to include tingling down left arm to hand, uncontrollable chills, and body aches for 3 days. Pt reports recovered.
Employee states that after 2 hours of getting the Flu Vaccine she had blurred vision which lasted for a few minutes.
Pt. was vaccinated in the (L) deltoid with Hep. B and in the (R) deltoid with Flu vaccine around 4 pm. At 4:30 pm pt. returned stating he had itching all-over his body. No hives, redness, or breathing problems noted received BENADRYL 50mg po liquid, only.
hearing loss; This is a spontaneous report from a contactable consumer reporting for self. A 77-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via an unspecified route of administration in right arm on 08Feb2021 (Age at Vaccination was 77 years old) 13:00 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient stated overall in good health. Concomitant medication included finasteride, gabapentine. From 11Feb2021 12:00, patient almost a total hearing loss right ear. He wore hearing aids and they were checked to be working properly. He was concerned about this hearing loss and went to urgent care today. He was given a prescription for PredniSone and also a prescription for Neomycin- Polymyxin-hc (ear drops). 2- For the first time in 77 years, he had been given a prescription for glasses this week. Outcome of event was not recovered.
Myalgia, SkinRash, NausearVomiting, Abdominal pain, skin ulcers, chills, fatigue, exercise intolerance Narrative: Employee reports initially noticing chills following vaccination He states that progressed into myalgia and lower abdominal pain (without vomiting or diarrhea) which was accompanied by nausea and fatigue. Employee states he noticed 2 skin ulcers-1-2cm in size (one on his R hand and one on his L hand). He is currently being tx'ed for a MRSA like infection. He is has completed 7 days of a 10 day course of abx.
Pt rec'd flu shot L upper extremities and developed fever to 104F, chills and a severe cellulitis VS allergic reaction requiring admission to hospital. WBC count of 25  15x7cm area of induration and erythema site of injection.
Pt c/o pain, swelling, redness and hot to the touch over entire Lt thigh. Started morning of 09/15/20 after immunization administration. Pt evaluated today in office and treated with benadryl.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4: Pfizer/Dose Number: 3:Moderna /Dose Number: 2: Moderna/Dose Number: 1: Moderna; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07May2022 as dose 4 (booster), single (Lot number: FX9894) at the age of 68 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose 1, single (Lot number: 048A21A), in left arm, on 15Apr2021 as dose 2, single (Lot number: 040B21A), in left arm and on 20Nov2021 as dose 3 (booster), single (Lot number: 066F21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LISINOPRIL; PRAVASTATIN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07May2022, outcome "not recovered", described as "Dose Number: 4: Pfizer/Dose Number: 3:Moderna /Dose Number: 2: Moderna/Dose Number: 1: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (03Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment, treatment start date was 20Sep2022, treatment stop date was 25Sep2022 and indication was treatment of COVID-19. No known allergies were reported.; Sender's Comments: Based on the available information in the case, the causal association between the events of and the suspect drug BNT162B2 cannot be excluded.
Patient undressed at 2:30 pm from work and noticed redness and swelling at injection site. Stated it itched and burned at site. Rash spread through the next day. Patient came in today, redness and swelling at site and warm to touch. Itches mildly today. Patient hydrocortisone cream and Benadryl and an ice pack.
I became ill as though I had an unusual flu which lasted for 1 1/2 days. Around 12 AM, my arm felt achy, and a sensation went from my arm across my chest. I began to have joint pain and extreme chills and was shaking slightly.  I could not sleep soundly and got up 3 times to urinate.  I got up at 6 AM and was still very cold and too weak to stay awake. I wrapped up in a winter comforter and slept until 12 noon when I woke up soaked in sweat. The chills and pain were gone. I showered and ate a light meal. I went back to sleep and woke up several hours later again wet with sweat. I showered again, but I was still very tired. I went back to sleep until about 12 noon on Saturday when it passed.
pt recv vax 4NOV97 & 18FEB98 pt devel chickenpox w/approx 40 lesions;
anxiety; sleeping; emotional; fatigue; high fever of 102 degrees; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), SOMNOLENCE (sleeping), EMOTIONAL DISORDER (emotional), FATIGUE (fatigue) and PYREXIA (high fever of 102 degrees) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 006B21A and 007M20A) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, SERTRALINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ANXIETY (anxiety), SOMNOLENCE (sleeping), EMOTIONAL DISORDER (emotional), FATIGUE (fatigue) and PYREXIA (high fever of 102 degrees). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 28-Oct-2021 for Adverse event, at a dose of 5 or 6 Tylenol. At the time of the report, ANXIETY (anxiety), SOMNOLENCE (sleeping), EMOTIONAL DISORDER (emotional), FATIGUE (fatigue) and PYREXIA (high fever of 102 degrees) outcome was unknown.            Patient's concomitant medication includes rheumatoid arthritis weekly shot.   This case was linked to MOD-2021-374981 (Patient Link).   Reporter did not allow further contact
Patient received 0.5ml dose of Moderna after an initial dose of Johnson and Johnson in April. He should have received 0.25ml as a booster dose. Patient was told of the error immediately and said he was fine.
After routine exam, I was administering MENACTRA and Tdap, I gave MENACTRA in Left Deltoid, and placed a band aid, and as I walked to patient's right side, the patient fainted as I laid her on the exam table. I had not even attempted to administer the Tdap. Patient attempted to sit up too soon and became faint again. After 15 minutes, the PA examined patient and the Tdap was administered in the right deltoid while patient lying down. Second injection tolerated well and no fainting, or ill effect. Patient waited 15 minutes after the 2nd injection (Tdap) and had no fainting, was feeling fine, color good and patient left in excellent condition.
Contracted COVID-19. Congestion and cough for 4-5 weeks after.
Lichenoid Reaction on skin; This spontaneous case was reported by a physician and describes the occurrence of DRUG ERUPTION (Lichenoid Reaction on skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRUG ERUPTION (Lichenoid Reaction on skin). At the time of the report, DRUG ERUPTION (Lichenoid Reaction on skin) outcome was unknown.        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.   It was reported that after 5 months of vaccination patient experienced the event.  Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.   Reporter did not allow further contact
After two weeks of receiving the first shot I had ringing in the ears. The ear that is affected by this is my left ear, I have ringing in my left ear.  I was diagnosed with Tinnitus.
fever 102.5, extreme joint pain, large rash on upper right arm from shoulder to elbow, large mass at injection site
Second lot: EK9231 on 1/14/21 After 1st dose I have noticed more frequent tachycardia episodes on my iwatch, After 2nd dose the tachycardia episodes lasted much loner and eventually stayed all the time, my iwatch gave a warning of Afib, I have seen my PCP first, who did not believe I have Afib because I was asymptomatic. She even did not do an EKG on me, told me to by a Kardia device, which i did and it confirmed Afib. Then she referred by to an EP cardiologist who did an EKG on me showing Afib. A Zio patch actually did show persistent Afib (consistently my iwatch was showing tachycardia all the time). I underwent cardioversion, I was back in SR for a week, then back to Afib. I was scheduled for an ablation but we tried flecaimide as a last chance approach and it surprisingly did work, i am in SR currently and ablation was postponed.  In my opinion there is a clear temporal association with the COVID19 vaccine.
Mother called reporting increase temp up to 103 with nausea and vomitting. Temps are controlled with Motrin and Tylenol. No reports or redness, swelling or pain at the injection site
Chronic diarrhea; weight loss; stomach cramps; bloating; debilitating; depression; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "anemia" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG; NEXIUM [ESOMEPRAZOLE SODIUM]. Past drug history included: Bactrim, reaction(s): "known allergies Bactrim"; Metropolal, reaction(s): "known allergies Metropolal"; Injectafer, reaction(s): "known allergies Injectafer". The following information was reported: DIARRHOEA (disability) with onset 29Jan2021, outcome "unknown", described as "Chronic diarrhea"; ABDOMINAL DISTENSION (disability) with onset 29Jan2021, outcome "unknown", described as "bloating"; ASTHENIA (disability) with onset 29Jan2021, outcome "unknown", described as "debilitating"; DEPRESSION (disability) with onset 29Jan2021, outcome "unknown"; ABDOMINAL PAIN UPPER (disability) with onset 29Jan2021, outcome "unknown", described as "stomach cramps"; WEIGHT DECREASED (disability) with onset 29Jan2021, outcome "unknown", described as "weight loss". The events "chronic diarrhea", "weight loss", "stomach cramps", "bloating", "debilitating" and "depression" required physician office visit. Therapeutic measures were taken as a result of diarrhoea, weight decreased, abdominal pain upper, abdominal distension, asthenia, depression. The patient had second dose of BNT162b2 (lot number EN6200) on 17Feb2021 in left arm and third dose (lot number 30155BA) on 01Oct2021 in left arm.  The patient had chronic diarrhea, weight loss, stomach cramps, bloating. She went to a doctor and tried several different things. She ended up going to two different gastroenterologists and was put on several different diets. She had at least a dozen lab tests done. Upper and lower GI, colonoscopy with biopsy, 3 CT scans, Ultrasound and X-rays and cause could not be found. The only thing that changed was that she had the vaccines. This was debilitating as she could not leave the house for more than 20 minutes at a time. She have had to see a counselor because of depression related to this.  The patient did not had Covid-19 prior to vaccination and the she did not test Covid post vaccine.
covid vaccine breakthrough case   Dose 1:  6/18/2021  EW0158 Dose 2:  8/3/2021  EW0191
After being exposed to a friend that was COVID-19 positive, two days before getting my booster. 12/4/2022 I had a fever that spike to 102, it would not go down. It stayed at that for 5 days. I took aspirin. The fever would not stay down, after two hours of dropping it would creep back up. I had muscle cramps in my leg and throughout my body. About 8 days into it I lost my taste and smell. The cough worsened on the 4th or fifth day. The congestion is in my sinuses, and I still got. It has triggered a worsening of my asthma. I decided to go to the ER on 12/11/2022. I had extreme dehydration and was recommending fluids. On 12/20/2022 the doctor sent a prescription for a stronger inhaler. I tested negative on the same day. I still have shortness of breath, fatigue and dizziness and congestion. I also have cough syrup bromine to help control the cough. I also, started on the third day, I woke up actively peeing the bed. Then made it to the bathroom and still had to pee. I had not had a lot to drink, this happened a couple of times, I would just be walking, and it would pee down leg. There was no infection found. I could not get PAXLOVID because I was too far gone. I am still having the after effects.
Administered vials that were exposed to room temperature for more than 12 hours; A spontaneous report ) was received from an employee and a physician concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with product that was exposed to room temperature for more than twelve hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, a freezer containing a vial of mRNA-1273 failed.  At 1:11 A.M. the vial experienced a temperature excursion, exceeding 8 degrees Celsius. Over time the dose thawed and reached room temperature.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and was administered with product that was exposed to room temperature for more than twelve hours.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, administered with product that was exposed to room  temperature for more than twelve hours, was resolved on 04 Jan 2021.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product that was exposed to room temperature for more than twelve hours without any associated adverse events.
Pateint was given 12 and up  Pfizer in error 0.3ml dose, she was observed in store then  instructed parent to continue to watch patient over the next couple of days.  Watch for side effects, anything heart related call md or go to er.    pediatrician would be contacted.  Vaerrs would be filled out. Contacted parent at 630pm  12/18 (evening of vaccine dose) he reported sore arm.  Contacted parent on 12/19, nothing new, continued sore arm .
Information has been received concerning a 17-month-old female who on 19-DEC-2006 was vaccinated intramuscularly with a dose of ProQuad (lot #656165/1387F). Concomitant therapy included AMOXIL. On 25-FEB-2007, 68 days post vaccination, the patient experienced a papular rash and 20 pustules diffuse on the trunk. The patient complained of itchiness. Subsequently, on 05-MAR-2007, the patient recovered from papular rash and itchiness. Additional information has been requested.
shingles shot several years ago. Had outbreak/suspected vaccination failure; outbreak; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for covid-19 prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles shot several years ago and had outbreak of shingles after the second corona shot. It was unknown if the reporter considered the shingles to be related to Covid 19 vaccine. Follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 01-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation (60-80): 60-80 %, notes: pulse oxygen saturation levels ranged 60-80%; sars-cov-2 test: negative. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. There were 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions. 5 were long term residents and 3 were short term residents. 5 of them passed within a two week period. One of the above patients were sent to the hospital and was pumped with 20L of oxygen but there was no success. 1 of the above patients tested positive for Covid-19 and 4 tested negative for Covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200376657 same reporter/drug, different event with similar event.; Reported Cause(s) of Death: hypoxic conditions