chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, 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 12-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.  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: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002494: US-009507513-2104USA002492: US-009507513-2104USA002495: US-009507513-2104USA002451: US-009507513-2104USA002491:
pt has been experiencing itching, and a rash all over body. he states that during that week after he received the vaccines he began to feel the itching. he states he bought otc bendaryl but experienced no relief. it has been over 2 months after the vaccines and he is still having itching and a rash. he states it has improved a little.
After receiving vaccine, client fell to floor. Initially pale and unresponsive. Became responsive after a few seconds. Stated unable to feel (L) arm and knees initially. By 1:00 pm, able to move all extremities. Monitored until 2:00 pm before allowed to leave with an adult.
Information has been received from a physician a 6 year old female who in February 2007, was vaccinated with a dose of Vaqta (duration and does not reported). Suspect therapy included Varivax (duration and dose not reported). It was reported in February 2007, that on an unspecified date, a patient received Vaqta and Varivax during the same visit and experienced an immediate choking response. The patient was given an EPI-PEN and was monitored in the office prior to being sent some. While the patient was at home she developed a rash (the date the rash occurred was unknown). No product Quality complaint. The physician considered the choking response to be serious due to an Other Important Medical Event. Additional information has been requested.
RPh called the patient on 4/25/2021 to verify receiving second dose. Patient's wife reported he developed a rash, hives, and swelling following his first vaccine dose.  He was treated twice at the ER over a two week period.  Both treating physicians advised that he not receive the second dose of the COVID 19 vaccine.
"Developed Eczema on my ears and chest"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 68 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Vegetable allergy" (unspecified if ongoing), notes: Spinach Allergy; "Sinus tachycardia" (unspecified if ongoing); "AFib" (unspecified if ongoing), notes: lone afib. The patient's concomitant medications were not reported. Past drug history included: Streptomycin, reaction(s): "Drug allergy". The following information was reported: ECZEMA (non-serious) with onset May2021, outcome "recovering", described as ""Developed Eczema on my ears and chest"". The event ""developed eczema on my ears and chest"" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of eczema on ears and chest and included treatment with steroidal cream from an unknown date. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12/29/2021: Event occurred after 2nd vaccine. 77-year-old male who comes to the emergency department today for shortness of breath.  Patient states that he has been Covid positive and has had symptoms for about 7 days now. He states his symptoms are shortness of breath, cough, weakness, diarrhea.  Denies any syncope, vomiting, chest pain, abdominal pain. He does have some crackles in the bases and was given a dose of Bumex as CHF could be contributing to his shortness of breath with a combination of his Covid illness.  On mid flow patient's oxygenation would not get above 87%.  Given this he will be placed on BiPAP as it will help improve his oxygenation and help get some of the fluid out of his lungs.   Re 01/06/2022- remains in hospital. Outpatient positive for COVID-19 12/24.  S/p remdesivir,  Dexamethasone 6 mg daily for total 10 days
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates between 18-AUG-2016 and 15-NOV-2016, the patients received unspecified doses in series of VARIVAX (lot # M008171 with expiration date 16-FEB-2018; lot # M004326 with expiration date 25-JAN-2-18; lot # M006724 with expiration date 08-FEB-2018; lot # L044525, expiration date 09-NOV-2017; dose and route were unknown) that were improperly stored. The vaccines were stored under the temperature 15.5 Fahrenheit degree for 1 hours 11 minutes. There was a previous temperature excursion for lot # M008171 and lot # M004326 (10 Fahrenheit degree, 37 minutes). A digital logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Had the vaccine scheduled for 9:45am. It was busy so I got the shot about 10:00am. in left arm. After shot walked around the pharmacy. 6-7 min later my mouth/tongue felt numb and I started to have a metallic taste in my mouth. I went back to pharmacy and told them my symptoms. They suggested I drink water and gave me Benadryl. When I took the Benadryl the numbness in my mouth went away but the metallic taste lasted 2 days.
tested postive with home test kit; tested postive with home test kit; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 09:15 as dose 5 (booster), single (Lot number: GJ6742) at the age of 55 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), on 18Mar2021 as dose 2, single (Lot number: EN6200), on 01Nov2021 as dose 3 (booster), single (Lot number: FF8839) and on 04Apr2022 as dose 4 (booster), single (Lot number: FL3197), all intramuscular for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 28Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "cholesterolemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Dec2022, outcome "recovering" and all described as "tested postive with home test kit". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2022) Positive, notes: tested postive with home test kit; (04Dec2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had been tested for COVID-19. Patient had no known allergies.; Sender's Comments: As per the available information the causality of the events vaccination failure and covid-19 with the suspects can not be ruled out completely.
Patient presented to the emergency department with complaints of hypoxia, cough, fever who tested positive for COVID-19. He was subsequently admitted to for management of COVID pneumonia. He was discharged to a group home in stable condition 5 days later.
I felt sluggish a little bit off, mild headache's next day after my vaccine. My abdomen started to hurt where my liver is. I went home after my work because I started to get headache and feeling flushed. I did not have a fever at work just later on. I went to a walk on clinic on the walk in clinic on 01-14-2022.  I also had nausea when I felt my abdomen pain.  They performed the covid flu test, ran a CMP to check the liver but did not do an ultrasound.  The liver the pain did go away, then I got sick with covid afterwards and at home sick right now with it. On 01-25-2022 I started to feel better from my abdomen and liver.
received an unknown Tdap on 5/17/2021, Boostrix on 5/20/22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   Previously administered products included tdap (on 17th May 2021 the patient received unknown Tdap).   On 20th May 2022, the patient received Boostrix. On 20th May 2022, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments: The reporter was a medical assistant. The reporter stated that the patient received an unknown Tdap and now received Boostrix. The reporter inquired what to look for and how to proceed. The reporter consented to follow up. Additional Supportive Information: The patient received an unknown Tdap and now received Boostrix prior to recommended interval, which led to shortening of vaccination schedule
Patient was given Afluria Vaccine at 3 months old at Flu Line. (no adverse symptoms)
didn't feel well / felt sick; Sick & Unable to work; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th January 2020, less than a day after receiving Shingrix, the patient experienced feeling unwell and inability to work. On 21st January 2020, the outcome of the feeling unwell and inability to work were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient was didn't feel well after getting the 1st dose of Shingrix. On 18th January 2020 the patient feeling sick and was unable to work until 21st January 2020. The reporter did consent to follow up.
Severe adhesive capsulitis documented by MRI and physical exam.  (times and dates are approximate). Was fine until shot, then local pain that I thought was nothing, then pain moving shoulder that persisted.  Saw orthopedic surgeon, had one cortisone shot with little effect.  Have had ongoing physical therapy with no improvement in about 6 months.  May need surgery.  Radiologist said worst adhesive capsulitis ever seen.
Rash near injection site started early on day 15 and has gotten larger / more red as day wore on.
On the fourth day after my injection my lymph node underneath my left armpit became swollen and sore, almost stinging sometimes.  I was concerned, but read a few articles indicating that this does happen, but that it has not been printed in Modern?s literature as a possible side effect. It has been 4 days and it?s till there. I also had a headache for 4 days after the vaccination.
pt stated that felt like going to faint;this lasted for 2min p/which head fell forward & pt was unconscious for 30-40sec;both arms jerked 4-5x;finger tips tingled, pt dazed;muscle tone returned;
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist).  A 9-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Additional information: The patient experienced a sore arm day after injection.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient tested positive on 1/17/22 while admitted.  Admit date was 12/26/2021.  The primary encounter diagnosis was Delirium, . Diagnoses of Urinary tract infection without hematuria, site unspecified and Anemia
without warning and approximatly 5 minutes after patient recieved vaccine patient passed out and fell face first onto floor.  patient was approached lying face down on floor bleeding and sounds of gurgling  coming from patient patient was unreponsive.  When patient was brought around and returned to conciousness patient did not know where he was or what had happened.  Patients pulse was very low at 58 and dropping to as low as 39.  Patient pulse did not stabilize the entire time patient was under our care.  Patient had about a inch and a half laceration about eye and possible facial fracture.  It was noticed that patients face was swollen when leaving with ambulance to be transported to er.
I woke up in the middle of the night, head burning, I applied ice packs. It went away and came back, then I started getting lesions on my scalp. They started treating me for shingles twice and it turns I had to go see a dermatologist and they have done a biopsy. The biopsy was clear of CA, no psoriasis, no fungus and could not find anything. I have all these lesions on my scalp and it burns. The name of my dermatologist. I got the stiches out today from my biopsy. I will see a neurologist for the burning of my scalp and will have an appointment on 07-11-2022. The itchiness will come and go but now it is chronic and that is what my dermatologist states. I am not in pain but it is annoying.
Loss of appetite; Loss of taste; Loss of smell; Fever; Chills; Nausea; Joint ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever) and CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), ARTHRALGIA (Joint ache) and FATIGUE (Fatigue). On 09-Mar-2021, DECREASED APPETITE (Loss of appetite), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), ARTHRALGIA (Joint ache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Headache, Arthralgia, Fever, left arm soreness at injection site, chills Narrative:
The patient was 13 years old at the time and received the Pfizer COVID-19 5-11 year old dose of the vaccine on 11/18/2022 and then again 3 weeks later on 12/9/2021. No known adverse outcomes
Woke up following morning with sudden hearing loss. Left ear nearly no hearing at all present, Right ear only able to hear some sounds. Both ears unable to hear running water such as a faucet turned on and washing hands, unable to hear sausage sizzling in a hot pan when standing directly in front of hot pan, unable to hear swishing sounds of items being rubbed together or people walking near by. Unable to hear the sounds similar to the sound the letters "s" and "f" make.  VERY LOUD ringing in ears both left and right, Left more frequently.  Changes in hearing was never an issue prior to vaccination. It comes and goes and lasts all day/ night sometimes for multiple days at a time before it settles down. Once settled it comes back on very suddenly without warning or trigger. Almost as if its being turned on and off again by a switch or button. This causes great frustration, anxiety and uncertainty of surroundings due to sudden lack of hearing.
numbness in bilateral legs, SOB- states her GBS symptoms have slowly been progressively getting worse since Feb. after receiving the 1st dose of the COVID vaccine.
2 spots on injection arm / look scaly; Redness at site of injection; Pain / at site of injection; This case was reported by a pharmacist and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 6th May 2022) for prophylaxis.   Concurrent medical conditions included pinched nerve (in neck).   On 9th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and injection site erythema. On an unknown date, the patient experienced rash scaly. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the rash scaly was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, rash scaly and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the left arm. The patient experienced pain and redness at site of injection of Shingrix. At the time of reporting, the patient had two spots on injection arm which were the size of a mosquito bite and look scaly. The patient would follow-up with her doctor. The reporter did not consent to follow-up.
A few days before my second dose I have had a rash that came out of nowhere. My eczema medication had no effect on it, I was proscribed steroids and the rash cleared up. After the second shot the rash has spread down my leg. Previously my eczema was very limited to my eyelids and anti-cubital area. Doxycycline has not helped anything this round. The second shot has exacerbated my joint pain. I am also experiencing hair loss where my hair comes out in clumps in the shower. My migraines have more of a burning quality to them. My cough does not seem to be vaccine related more of a allergic cough.
COVID-19; This is a spontaneous report from a contactable consumer (caregiver) who reported on behalf of her father.  A 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 06Feb2021 at single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. Patient received the first dose of the vaccine on 06Feb2021. 3 days after vaccination (Feb2021), he experienced "strong symptoms" including fever and muscle pain, he tested positive for COVID-19 in Feb2021. The second dose was scheduled for 27Feb2021. It was asked if patient should receive his second vaccination if he tested positive for COVID-19 after his first dose. The outcome was unknown.No follow-up attempts are possible, information about batch number cannot be obtained
Patient received his vaccine with no problems; he was extremely nervous and gripping his pants while getting the vaccine. He took two steps after getting his vaccine and passed out/ fell into his parents arms. His hands were very red and he was sweating profusely; he was confused about where he was and couldn't see anything. I fanned the patient and waited for paramedics to arrive;  they checked his blood pressure/ pulse rate and pulse oxi. No treatment was needed.
After administering nasal vaccine he threw up.  Prior to administration patient showed high anxiety.  Patient vomited again in nurse's station and was sent home.  Patient was breathing, walking and acting normal when left site.
On 1/9/01 child began having diarrhea, loose brown 5-6 times day, no vomiting, taking bottle. Only small amount temperature did not take it, playing, still having diarrhea today when went to Dr. 1/12/01.
5pm after injection: injection site and surrounding area became sore 6pm-12pm next day: experienced chills, body aches, headaches, fatigue, and mild nausea 3/30/2021: lymph nodes in underarm on the side of the injection became painfully swollen 3/31/2021 8am: woke up with small red itching spot near site of injection, has increased in size to that of a silver dollar by 2pm. It is blotchy and slightly raised.
3RD DOSE MODERNA COVID VACCINE GIVEN 12/8/21, #012H21B; pt brought to hospital 10/4/22 and admitted with worsening abdominal pain, nausea, vomiting, diarrhea with dark colored stools; severe anemia secondary to GI bleed; ESRD on dialysis; abdominal CT showed large ventral hernia; poor oral intake; given PRBCs; one dose of Dexamethasone, dc'd due to UGI bleed; pt worsened; eventually transitioned to comfort measures and she passed away in the hospital
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 years old female patient (pt). There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided.  On an unspecified date in 2013, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a healthcare due to the event. It was reported that the pt would continue suffer ongoing injuries, losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster was not reported.   The reporter considered the event of  herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).