chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles on his stomach and back; This is a spontaneous report from a contactable consumer (patient sister). A 38-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET9096), via an unspecified route of administration on 04Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter was calling on behalf of her 38-year-old brother who had the first dose of the Pfizer Covid-19 vaccine on 04Aug2021 and on 13Aug2021 started seeing shingles on his stomach and back. The reporter was asking if her brother can get the second dose of the Pfizer Covid-19 vaccine due to the above complaints. Outcome of the event was unknown.  Information on lot number/batch number has been requested.
p/vax pt exp rash on forehead, red blotching rash. pt observed x30' lesions
Pt came in on 12/20/18 and presented symptoms of swelling redness, warmth to touch, painful to touch at injection site. Symptoms started on 12-12-18 but pt didn't call in until 12/20/18. Pt was prescribed BACTRIM 800-160 MG 1 Tab, orally, twice a day, for 14 days. Lab: CBC with Differential/Platelet.
I have a Nexplanon implant and haven't had my period for more than a year now. After getting the vaccine, I noticed some bleeding again. I have two other coworkers who had the same experience. One with an implant and another taking pill contraceptive.
Diarrhea x 4 days starting evening of shot (12/8) symptoms resolved by 12/12/12.
Patient walking and seemed to be walking to the (R) right after vaccination. The next day mom said pt fell 4 x, complained of blurred vision. I advised pt go to ER but pt. didn't go.
HPI Details: a 66-year-old female presenting today for evaluation of high blood pressure.  Patient notes that she went to the dentist on March 24 and was having a root canal revised.  She was told that she had very elevated blood pressure at that time, 173/81.  When they rechecked her blood pressure it had gone up even higher.  She was not feeling necessarily bad at that time but did start noticed that she was having some pounding headaches and felt like her heart was pounding out of her chest.  She has not really changed activity or diet.  She is not on any new supplements or over-the-counter meds that would cause this.  The only thing different was that she did receive the Johnson & Johnson COVID-19 vaccine just prior to onset of this.  Patient was concerned about her blood pressure running so high, and she is a physician so she did prescribe herself some atenolol.  She took a couple of doses of this on March 29 when she received her blood pressure cuff in the mail from online store and was checking her blood pressure and found that her numbers were running quite high, such as 207/107.  She contacted our office.  I did go ahead and start her on lisinopril 10 mg p.o. daily.  This did not make a significant improvement in her blood pressure.  We did go ahead and get lab work done.  CBC was unremarkable.  CMP notable for potassium 3.3 and alk phos minimally elevated at 129.  TSH was within normal limits.  Patient does bring in a log of her blood pressures with her today.  Again these are not really improving significantly with the lisinopril 10 mg daily.
Patient  received a dose of only the liquid vial without reconstitution with the lyophilized powder; Patient  received a dose of only the liquid vial without reconstitution with the lyophilized powder; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date: 13-JUN-2022 Reporter's comment: The patient safety specialist reported that one of 43 possible patients might have received a dose of only the liquid vial of Menveo without reconstitution with the lyophilized powder. The consent to follow up could not be gathered, the HCP (Health Care Professional) mentioned not caring if we followed up with them or not and just wanting to receive medical information. Additional Supportive Information: The patient received a dose of only the liquid vial of Menveo without reconstitution with the powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
arm was extremely sore from the distance of the shot; t was also red, hot; t was also red, hot; severe chills, fever all day; severe chills, fever all day; she's been sick all day; she hasn't been able to get out of her bed; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she's been sick all day; she hasn't been able to get out of her bed), PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot), ERYTHEMA (t was also red, hot), FEELING HOT (t was also red, hot) and PYREXIA (severe chills, fever all day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced MALAISE (she's been sick all day; she hasn't been able to get out of her bed), PYREXIA (severe chills, fever all day) and CHILLS (severe chills, fever all day). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot), ERYTHEMA (t was also red, hot) and FEELING HOT (t was also red, hot). At the time of the report, MALAISE (she's been sick all day; she hasn't been able to get out of her bed), FEELING HOT (t was also red, hot), PYREXIA (severe chills, fever all day) and CHILLS (severe chills, fever all day) had resolved and PAIN IN EXTREMITY (arm was extremely sore from the distance of the shot) and ERYTHEMA (t was also red, hot) was resolving.            No relevant concomitant medications were reported. Treatment details included Not provided
After vaccine, I had pain around my eye and developed MRSA around my eyes, and I  felt "off". I had heart pains, and took a shower and had a heart rate of 130. I took Ativan and felt some better. I thought about going to the ER, but I emailed my doctor instead. He told me to rest. Dr. suggested I go to the ER if I felt worse. I did feel some better after hearing from him. He said he was not to concerned about it, he didn't think it was my heart. He said after I had Covid and the vaccine he wasn't surprised.
This spontaneous report was received from a Licensed Practical Nurse concerning to an unspecified number of patients of an unknown age and gender. The patients' concurrent conditions, medical history, historical drugs a concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX (lot numbers M003658, expiration date 02-JUN-2018; M033334, expiration date 11-AUG-2018; M034894, expiration date 11-NOV-2018; L014419, expiration date 15-MAR-2017; L030609, expiration date 26-JUN-2017; M013639, expiration date 15-SEP-2017, dose, route and anatomical location were not reported) for prophylaxis. The temperature was between 0 Centigrade degrees and 2 Centigrade degrees, the time frame was 33 hours and the previous temperatures excursion were: 4 previous excursions: 1. between 0 Centigrade degrees and 2 Centigrade degrees for 32 hours; 2. between 0 Centigrade degrees and 2 Centigrade degrees for 30 hours; 3. between 0 Centigrade degrees and 2 Centigrade degrees for 29 hours; 4. between 0 Centigrade degrees and 2 Centigrade degrees for 36 hours. Data logger was involved. No adverse effect was reported. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1701USA008041:Original Case : 1701USA008041; US-009507513-1701USA008610:Original Case : 1701USA008041; US-009507513-1701USA008608:Original Case : 1701USA008041; US-009507513-1701USA008609:Original Case : 1701USA008041.
Quizzes; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Quizzes) and PAIN IN EXTREMITY (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Penicillin allergy and Seasonal allergy (Summertime allergy). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, METOPROLOL, IPRATROPIUM BROMIDE and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced NAUSEA (Quizzes) and PAIN IN EXTREMITY (Sore arm). At the time of the report, NAUSEA (Quizzes) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided          No treatment information was provided.   This case was linked to MOD-2021-060126 (Patient Link).
Observation RN noted a "30 second seizure" less than 15 minutes post vaccination.  Initial steps taken by staff on duty, including calling EMS, which arrived shortly.  Pt transported to local ED.  Pt's SO states this has happened a few times previously associated with blood or needles.  Pt was in a drive-thru vaccination/observation facility without AC on a nearly 100 degree day.
3rd Singrix given; Shingrix given instead of Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2024) for prophylaxis.   On 17-APR-2023, the patient received the 3rd dose of Shingrix (left deltoid). On 17-APR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd Singrix given) and wrong vaccine administered (Verbatim: Shingrix given instead of Twinrix). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 18-APR-2023 The medical assistant reported on 18th April 2023 that patient received a 3rd dose of Shingrix by mistake when Twinrix was supposed to be given due to ending of names sound similar. The reporter wanted to know do GlaxoSmithKline have safety information. The Vaccine Administration Facility is the same as Primary Reporter. The patient was given Shingrix instead of Twinrix which led to wrong vaccine administered. The patient received 3rd dose of Shingrix which led to extra dose administered. This case was identified as duplicate of US2023056786. Case US2023056786 was deleted and all the future correspondence will be added in the present case US2023056785 which stands as a case of record for this patient. The reporter did not consent to follow-up.; Sender's Comments:  US-GSKCCFUS-Case-01680571_AE-94793:FU 1 -Deleted
Have constant headaches since 3/23/2021 and went to see my doctor. Tried to find a medicine with my doctor to assuage these migraines and nothing helped. Blood work from 6mo check-up is the only labs done. No medical test as of yet.
Significant soreness; stiffness of right arm following administration of influenza and pneumococcal in right arm. Treatment: Ice; Analgesic; Manipulate arm gently.
After 45 minutes of receiving vax. symptoms were itching, shortness of breath, dizziness, light headed
moderate rash, warmth and discomfort to left deltoid area, continuing on day 11 from vaccination
Information has been received from a physician and a nurse concerning a 21 year old female with glaucoma who on 09 Sep 2006 was vaccinated with a first dose of Gardasil (yeast). Concomitant therapy included Xalatan. On 12 Nov 2006, the patient was vaccinated IM, in the right deltoid, with a 0.5 ml second dose of Gardasil (yeast) (lot #653736/0868F). On 12 Nov 2006, 13 hours after the vaccination, the patient developed a rash on both arms. The patient used alcholol on these areas and the rash went away. On approximately 12 Sep 2006, at an unspecified time, the patient developed hives. The hives were itchy and "looked like slap marks all over her body" including her legs, abdomen, back and face. The welts were raised and swollen. The patient was treated with Benadryl. At the time of the report, the patient was recovering from the hives. There were laboratory or diagnostic tests performed. It was reported that the patient had no reactions after the first dose of Gardasil (yeast). Additional information has been requested.
patient felt light headed and got sick. after throwing up, he felt better. patient have always had same reaction to all vaccines due to anxiety.
Metallic taste in mouth. This occurred very quickly after the shot was administered and is currently ongoing.
Initial report received from healthcare professional on 23 October 2013. A 64-year-old female patient whose medical history and concomitant medications were not reported received FLUZONE (lot number UH908AA and expiration date unknown) intramuscularly in left deltoid (dose number not reported on 29 September 2013). On 29 September 2013, the patient developed fever in her right shoulder with pain that radiates down the arm that persists as of today when she cane in to show the pharmacist her right arm. Record shows vaccines was given in the left arm. The patient's past medical condition includes morphine and VICODIN.  Laboratory investigation and corrective treatment were not reported. As of this report, the patient was recovered for event localized feeling of warmth and had not recovered from the event pain in arm. Documents  held by sender: none
Information has been received from a physician concerning a 7 year old male who in 98 was vaccinated with varicella virus vaccine live.  On 02/16/04 the pt was seen by the physician complaining of a sore throat and a slight fever. Upon examination the physician discovered a varicella rash on his trunk and groin area. The physician stated that the pt had greater than 50 lesions. The pt was not complaining of itch. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "hypercholesterolemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN [OLMESARTAN MEDOXOMIL] oral, start date: 01Mar2021, stop date: 12Oct2022; ATORVASTATIN oral, start date: 01Mar2017, stop date: 28Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Positive, notes: Confirmed positivity with RT-PCR; (30Sep2022) Positive, notes: After testing positive on 30Sept2022 on rapid antigen test; (10Oct2022) Positive, notes: Positive rapid antigen test on 10Oct,11Oct2022; (11Oct2022) Positive, notes: Positive rapid antigen test on 10Oct,11Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
COVID Positive On Antigen Test; COVID Positive On Antigen Test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "COVID Positive On Antigen Test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: COVID Positive On Antigen Test. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: If other vaccine in four weeks was reported as unknown. If covid prior vaccination was reported as no. If covid tested post vaccination was reported as yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3/20/22  I have a history of PVC?s.  I felt like I had a cold and had started taking Zicam about three days before . The PVC?s got really bad where I was short of breath, and I was exhausted. They would last 8-10 hours without letting up. I saw a doctor who ordered tests, nothing showed up. Two days later, I went to the Emergency Room. I was diagnosed with PVC?s and was put on Metoprolol and said to follow up with my doctor and my cardiologist. I had an Echocardiogram the next week which showed no abnormalities in my heart. I have continued the Metoprolol and waiting to see a Cardiologist.
I already had the Moderna vaccine back in March but wanted to let CDC know I wanted a booster shot now and decided to get the Pfizer. No issues and I from what I read online I am getting even more protection.  Also would it be wise to seek out the J&J vaccine as well?
Left breast pain close to arm pit radiation shooting pain to my chest; Left breast pain close to arm pit radiation shooting pain to my chest; Neck/back pain; Neck/back pain; severe migraine; blurry vision in left eye; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Ff2587) via an unspecified route of administration, administered in left arm on 06Oct2021 13:45 (at the age of 31-year-old) as dose 3 (booster), single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included asthma and obese from an unknown date and unknown if ongoing and known allergies from coconut and latex from an unknown date and unknown if ongoing. Concomitant medications in two weeks included Buspirone, Bupropion. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142) administered in right arm on 22Jan2021 10:00 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8982) in left arm on 12Feb2021 10:00 for covid-19 immunisation. Patient did not receive other vaccine in four weeks. Patient had no Covid prior vaccination. Patient not tested for covid post vaccination. On 07Oct2021 12:00, the patient experienced left breast pain close to arm pit radiation shooting pain to my chest, neck/back pain, severe migraine, blurry vision in left eye. No treatment taken for adverse events. Outcome of the events was not recovered at the time of reporting.
A report has been received from a Pharmacist concerning a 13 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The patient was administered only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
a big patch of red, irregular shape border redder, itch to touch only;warm to touch; this area was anterior side of arm, 5 to 7 inches below shoulder
After the shot itself he just had a sore arm for two days and then on Tuesday the 3rd of August in the evening and Wednesday the 4th he had congestion. So we did an over the counter Covid test which was positive and we called the pediatrician and got a PCR test as well. On Friday he continued with his symtoms and really has been in isolation since the 6th. The symptoms were improving by the 7th or 8th and he just has some lingering congestion still.
5 hours after shot, I felt a slight ache in my knee. Within the hour, my whole body was engulfed in aches, chills, pain and uncontrollable shaking. Then my head starting hurting and I felt extremely hot. My legs and chest were pink and hot to the touch. Very high fever, head pain , nausea and heart palpitations. I took Tylenol which helped with the fever. The next day I had some minor aches and dizziness. Later the same day, I had  sharp aches/pains down my back and an upset stomach. That night I had a fever again but not as high. Today, two days later, I feel back to normal with the occasional ache or cramp.
Began with a headache and the beginning of muscle pain and stiffness in neck and shoulders. The muscle pain continued to progress each day to other areas mid back and hips. Headache left on the 4th day, Muscle pain is described as a burning and needle like and squeezing at times. There is no sign of the pain diminishing. Now in the 14th day. Treating with 400mg Ibuprofen  every 4 hours.
Patient passed out almost immediately after receiving the vaccine. She was unconscious for only a few seconds. After she awoke, she was aware of surroundings but did not remember passing out. Her color returned and she said she felt ok. EMS was called and after questioning her, they felt that transport to hospital was not necessary but did recommend that she be checked out at the hospital. A family member was there to drive her home.
My second dose after 6 / its been 7 months since my first shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this case. The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter did not consented to follow up.