chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No soreness of injection site until next date, 12-19-20.  Slight soreness at injection site but woke up with body aches/pain, very stiff neck and head on left side of body, migraine type headache.  Extremely fatigued. Symptoms were throughout entire day.  Was flushed in the face that early evening, took temperature, normal, 97.9.  Took 3 Alleve every 3 - 4 hours throughout day.  Felt best for that date about 8pm.  Woke up on 12-20-20 with headache still but overall felt much better though did have some upset stomach with diarrhea.  12-21-20 feel fairly well. Went to work.  Left arm still slightly sore.  Slight stiffness in head and neck with slight headache still remain.
PATIENT RECIEVED 2 VACCINES IN SAME (LEFT) ARM - PREVNAR 13 AND FLUZONE HD - PATIENT STATED CAME BACK ABOUT A WEEK LATER WHEN PICKING UP A PRESCRIPTION TO INFORM US ABOUT HER EXPERIENCE WITH 2 VACCINES IN ONE ARM. THERE WAS A LARGE BUMP THAT FORMED  IN THE INJECTION AREA IN THE BEGINNING THEN SLOWLY CHANGED TO A LARGE DARK BRUISE. PATIENT STATED SHE FEELS OK NOW AND IS NOT UPSET, BUT WANTED TO TELL US TO ADVISE FUTURE PATIENTS TO NOT GET IN THE SAME ARM IN THE FUTURE.
I feel like I got hit by a truck; 101.5 fever; My arm got sore; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm got sore), FEELING ABNORMAL (I feel like I got hit by a truck), CHILLS (Chills) and PYREXIA (101.5 fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A2A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm got sore) and CHILLS (Chills). On 26-Feb-2021, the patient experienced PYREXIA (101.5 fever). On an unknown date, the patient experienced FEELING ABNORMAL (I feel like I got hit by a truck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CLONAZEPAM at an unspecified dose and frequency. On 26-Feb-2021, PYREXIA (101.5 fever) had resolved. At the time of the report, PAIN IN EXTREMITY (My arm got sore) had not resolved, FEELING ABNORMAL (I feel like I got hit by a truck) outcome was unknown and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature increased: increased (High) Bit higher than normal.         Relevant concomitant product usage were not reported by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD21-040423, MOD21-040424 (E2B Linked Report).; Sender's Comments:  MOD21-040423:Cross link MOD21-040424:Cross link
They both later tested positive for COVID at around the same time; They both later tested positive for COVID at around the same time; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. Covid prior vaccination was unknown. Covid was tested positive post vaccination. The patient reported that they both later tested positive for covid at around the same time, coughing, sneezing on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101120179 Same reporter/drug/event for different patients.
Fever of 102. Shakes,  chills,  aches, lethargy, exhaustion. All symptoms started at 2am following my second dose (apx 16 hours post injection).   Fever, chills, aches lasted for apx 24 hours.  Tiredness lasted for more than 50 hours post injection
About 7 minutes after receiving vaccine, pt was out in waiting area and told mother wasn't feeling well. Slumped over and she caught him and gently brought him to the ground. Mother called out for provider who then came to patient who was laying down on the floor. Patient was able to speak coherently and had no pallor or sweating. He was able to sit up after a couple minutes but stayed sitting as directed on the floor until full 15 minutes had passed. Mother stayed with patient and they were able to leave without any residual side effects from vasovagal response.
Dizziness like being sitting down; if I stand up quickly I am really Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Lot number: ER8737) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing). Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Apr2021, outcome "not recovered", described as "Dizziness like being sitting down"; DIZZINESS POSTURAL (non-serious) with onset 16Apr2021, outcome "not recovered", described as "if I stand up quickly I am really Dizzy". Therapeutic measures were not taken as a result of dizziness, dizziness postural.  No follow-up attempts are possible. No further information is expected.
NO ADVERSE EVENTS- date of last menstrual period is 04/15/2017 as  per records of 08/2017 family planning visit.
On 11/11/2022 I received my Covid-19 vaccine. On 01/21/2023 I had an alarm stated that I had a very low heartbeat that lasted 10 mins. My pulse then returns back to the normal beat however during the day it started fluctuating again. I reached out to my doctor with concerns and started testing. Still in the process of getting results from the test done.
ecchymotic appearance; rash on the buttocks or upper thigh; This is a spontaneous report  from a contactable nurse reporting same event under the same suspect product for #4 patients. This is one of the patient among four patients. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient developed a rash on the buttocks or upper thigh within a few days to a week after getting a Pfizer Covid-19 vaccine. The rash begins with an appearance similar to shingles. After about a week the lesions are flat with an ecchymotic appearance. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021375444 same drug, event, different patient;US-PFIZER INC-2021375445 same drug, event, different patient;US-PFIZER INC-2021375443 same drug, event, different patient
Information has been received from a physician concerning a 7 year old female who on 18-JUL-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (fill# 656260/Lot# 1502F). On 18-JUL-2007, the patient developed redness around the injection site right after the dose that became hot to the touch more so than average. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint reported. Additional information has been requested.
Patient tested positive for Covid at medical center on 12/31/2021.  No interview or charting was found in the disease reporting system for details.
06/03/2021 1800 - Headache duration 24 hours. 06/03/2021 1900 - Elevated blood pressure, mild hypertension continues. 06/03/2021 1900 - Pain at injection site rated 6/10, 24 hours duration. 06/04/2021 1500 - Severe flu like symptoms, 24 hours duration. 06/04/2021 2000 - Fever 101.00, 8 hours duration. 06/04/2021 2000 - Nausea 24 hours duration.
mom stated pt started running inc temp 103 on 10DEC98 p/vax 3DEC;had a few spots on 11DEC;had more spots;took to MD 14DEC98 dx as measles w/solid breaking out;
Common symptoms (fever, chills, aches, fatigue, headache) were experienced starting about 7 hours after injection and continued for about 18 hours. Swelling under eyes for about 8 hours, started about 40 hours after injection, applied ice and took Advil, the swelling went down but then flared up again in the morning, washed face, applied ice again and took Advil. The swelling was gone after about 8 hours total. I did apply anti-aging eye cream, under the eyes, which I've used for over a year with no issues, prior to bed the night the swelling occurred.
patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 65-year-old male patient 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) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patient had been administered dose while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold by the State at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment with the State.   The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-501575 (Patient Link).
Arm swelled up from shoulder to elbow, real tight, hot and painful. I went to Urgent Care and Dr. prescribed Diphenhydramin 25 mg; Ranitidine 150 mg; and Prednisone 20mg for me to take around 08:00 am.  I went to pharmacy and filled them. By 8:00pm I noticed the swelling is going down and it is not as hot as it was.
This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (small temperature increase), ASTHENIA (lost of any physical function, could not stand, no strength o his body) and DIZZINESS (light headed, dizzy) in a seventy-three-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (Batch nos. 017B21A and 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (small temperature increase) and ASTHENIA (lost of any physical function, could not stand, no strength o his body). On 29-Mar-2021, the patient experienced DIZZINESS (light headed, dizzy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, BODY TEMPERATURE INCREASED (small temperature increase), ASTHENIA (lost of any physical function, could not stand, no strength o his body) and DIZZINESS (light headed, dizzy) outcome was unknown.            His normal temperature is 97.5F but the following day he had 100.6-100.8 F after the vaccine, "small temperature increase"". 11.30 on Friday lost any physical function could not stand, laying on his back, no strength on his body. The following day he was better, could walk. Today feels dizzy and light headed.
past the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (past the expiration date) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (past the expiration date). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment details were not given.
Chills; Pain in muscles; Upset digestive system; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, myalgia and gastrointestinal upset. On an unknown date, the outcome of the chills, myalgia and gastrointestinal upset were not recovered/not resolved.   It was unknown if the reporter considered the chills, myalgia and gastrointestinal upset to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experienced chills, pain in muscles and upset digestive system. The reporter was wondering about how long the side effects last.
Pt. was given ZOSTAVAX vaccine on 8-6-10 & since has had 3 cases of shingles. On 2-11, 8-11 & 2-12.
1/25/14 - patient called to report noticed itchy red (hives) spots at injection site on night of 1/23/14. Stated spots had started to improve already but wanted to report reaction. Not able to finish conversation at that time. I called her again on 1/26/14, said rash was continuing to improve but not able to talk at the time. I called 1/27/14 to complete form.
I had head pressure that felt like a headache In my temples and the back of my skull around 9-10 hours after the vaccine. Left arm pain starting about 11 hours after shot. Difficult to move arm without intense pain and intense pain at the slightest touch of the arm on or around the vaccination spot. Starting the morning after the vaccination, my glands in my neck were tender and aching like they do when I?m fighting off a cold, I had body aches that you would get if you had a fever for the entire day all over my body. I took ibuprofen that night and they started to go away and I felt hot like I was breaking a fever. I woke up the next morning which is 2 days after the vaccination and felt completely back to normal besides residual arm pain. This pain is bearable and I can move my arm with only a dull pain and I can touch the spot without intense pain however it is still painful.
Information has been received from a physician concerning a 1 year old patient who was vaccinated with ZOSTAVAX instead of varicella vaccine live (Oka/Merck). Staff error only. The patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Within 30 min of injection: headache, dizziness. Well tolerated. Within 16 hours of injection: syncope, prostration, chilling, fever of 103.1. Duration of 10-12 hours. Subsided to fatigue and genral malaise for approximately 72 more hours, gradually subsiding.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with oral ROTATEQ (lot#, expiration date, dose and route unspecified), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe headache, tingling in hands/wrist/forearms and around mouth, hot flashes, flushed face. No rash, no wheezing.
Extreme pain in back, left shoulder, neck to the point of severely restricted movement & pain when taking full breaths. Sunday evening 6/6/21 around 8:00PM I thought I was experiencing heartburn & took 20mg of famotadine which didn't alleviate my symptoms. Overnight the pain in my chest moved to my neck, back, & left shoulder. I called the hotline & was advised to go to the ER to be checked for a heart problem. The ER staff ran tests & discovered nothing wrong with my heart. I was prescribed 500mg Acetaminophen & 40mg Pantoprazole. The Acetaminophen helped with the muscle pain & as the muscle pain eased, so did the pain that came with breathing so I think I never had heartburn, just bizarrely extreme muscle pain.
Symptoms presented 10 days after 1st Dose. Acute Vertigo, followed by vomiting, followed by fever and sweats. Lasted 2 days all the above.. Then we had a  moderate to sever headache that never went away for two weeks. Dizziness.  Went to bed with a headache. Woke up with one. Treated with moderate and consistent 400-1200 Ibuprofin daily. During this time very difficult to think and concentrate, I guess you could say I had brain fog as it were, and slept most of the time. Headache symptoms started to fade after two weeks, but even after all this time I don't feel right and haven't felt like a can resume normal physical activity. I still had symptoms 3 weeks later when I was supposed to get the second dose so I didn't. I am in the military and now I have been ordered to get fully vaccinated. I am scared and don't know what to do.
HTN and SOB chest pain activity intolerance I have to take BP meds now and rest all of the time.
Muscle soreness, fever, chills, headache, nausea - all supportive treatment. Neck pain, ear ache.
Diagnosed with an autoimmune reaction chronic idopathic optic neuritis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: Apr2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: OPTIC NEURITIS (hospitalization, medically significant) with onset 17Oct2021, outcome "unknown", described as "Diagnosed with an autoimmune reaction chronic idopathic optic neuritis". The event "diagnosed with an autoimmune reaction chronic idopathic optic neuritis" required emergency room visit. The patient underwent the following laboratory tests and procedures: lab test: unknown results, notes: all lab tests has ruled out the other auto immune causes. Therapeutic measures were taken as a result of optic neuritis.  Clinical Course: Patient did not receive any other vaccines within 4 weeks. No other medications the patient received within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 post vaccination. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Military facility. The patient received BNT162B2 dose 2 on May2021 at 09:00 AM. Reported Event: Diagnosed with an autoimmune reaction chronic idiopathic optic neuritis with the first even in Oct2021, subsequent Apr2022 and Aug2022. All lab tests have ruled out the other auto immune causes. The patient received Plasmapheresis and steroids as a treatment for event.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the event optic neuritis and the suspect drug BNT162B2 cannot be excluded. Statement-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.
Sx were noticed by pt in the AM and shown to the school nurse. In the afternoon left upper arm showed a redness (4"x2") pain, swelling and itching. Sx persisted throughout the weekend with some numbness of the arm described by the patient.
Roof of mouth (left side only) small blisters for one day only. Left arm rash like. Maybe 8 inches around, blotchy and very very itchy for 6 days now.. getting slightly better with time.