chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist concerning a now 66 year old female who in approximately 2003 "about 4 to 6 years ago", was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). The patient informed the pharmacist that she developed GUILLAIN-BARRE syndrome after getting the flu shot "about 4 to 6 years ago". The patient's doctor told her that she could not get more flu shots. On an unspecified date, the patient recovered from GUILLAIN-BARRE syndrome. The patient consulted with the pharmacist and sought unspecified medical attention. Upon internal review, GUILLAIN-BARRE syndrome was considered to be other important medical event. Additional information has been requested.
First 24 hours-body aches and headache, resolved at 48 hours. 48-72 hours felt fine. 72 hours -onset of nausea and severe headache, quickly shifted into diarrhea and two rounds of heavy vomiting (patient rarely vomits even when sick)
This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 1st of 10 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a lot of pain at the injection site. Clinical outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083819 same porter/drug/event, different patient.; US-PFIZER INC-2017083816 same reporter/drug/event, different patient.; US-PFIZER INC-2017083815 same reporter/drug/event, different patient.;US-PFIZER INC-2017083818 same reporter/drug/event, different patient.; US-PFIZER INC-2017083817 same reporter/drug/event, different patient.; US-PFIZER INC-2017083820 same reporter/drug/event, different patient.; US-PFIZER INC-2017083821 same reporter/drug/event, different patient.; US-PFIZER INC-2017083639 same reporter/drug/event, different patient.; US-PFIZER INC-2017083698 same reporter/drug/event, different patient.
Symptoms began 06/09/2022, cough, SOB, congestion and fatigue.
Around 10 minutes after vaccination patient alerted pharmacy staff members at the clinic that she had a "weird taste in her mouth like she has when she has seizures".  Employees of her congregate-care facility came over and told pharmacy staff that she does not have true seizures, but rather "pseudo-seizures" as part of her mental health condition.  The pharmacy staff has the patient immediately sit back down.  She appeared to have lost consciousness one time.  Staff reported her eyes seemed glazed over.  The patient denied any feeling of throat closing or tingly of lips or tongue.  The pharmacy staff was able to obtain a carotid pulse but due to obesity was unable to take a blood pressure even with a large cuff.   At that point pharmacy staff called 911 to get patient further evaluation.  EMS evaluated the patient and declined transport and instead returned her to her apartment.  Congregate-care staff reported that patient has a history of this type of reaction when being around groups of people.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 13th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, myalgia, fatigue, feeling hot, feeling abnormal and mobility decreased. On 14th February 2019, the outcome of the myalgia, fatigue and feeling hot were recovered/resolved. On an unknown date, the outcome of the pain in arm and mobility decreased were recovering/resolving and the outcome of the feeling abnormal was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, myalgia, fatigue, feeling hot, feeling abnormal and mobility decreased to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX vaccine in left arm. The patient experienced a very sore arm which started around 1:00 pm after receiving the vaccine. The patient could barely lift her arm to remove her shirt. That night after receiving the vaccine, she also experienced myalgia, fatigue, and she felt like she had a fever. At the time of reporting, the patient's arm was not as sore compared to vaccination day and she still felt a little "off". The reporter consented to follow up. The reporter gave permission for her physician to be contacted and provided contact details for the same.
Excess tiredness/ sleepiness. Headache. Mouth Ulcer on roof of mouth.
I had chills and aches for 3 days, on day 6, I lost my sense of smell and taste.
I was given a third Shingrix.; This case was reported by a consumer via media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details provided were as follows: Age at vaccination was not reported. The case was reported by patient for himself/herself. The patient received the 3rd dose of Shingrix, which led to extra dose administered. Follow-up would not be possible as no contact details available.
This case was reported by a consumer via interactive digital media and described the occurrence of upper extremity mass in a adult male patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, less than a month after receiving dTpa vaccine, the patient experienced upper extremity mass. On an unknown date, the outcome of the upper extremity mass was unknown. The reporter considered the upper extremity mass to be possibly related to dTpa vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient's daughter's Obstetrics and Gynaecology told the reporter and her husband to go and get the TDAP injection since; the Obstetrics and Gynaecology would keep her daughter when she went back to work. The patient got vaccinated at work. Since he worked at the hospital, it was mandatory but it had been about a month since he got the vaccination and still has a knot on his arm. The reporter guessed she would have to go to the health department to get the vaccination.
Varicelliform eruption (few, scattered vesicles in various stages of development over lower extremity >upper extremity) Pruritic. No systemic on vaccine site sx
Pt stated that shortly after vaccination with flu shot she started having numbness/tingling in her left arm. She also had shoulder pain and limited range of motion which required physical therapy. She states that pain has resolved just recently. MRI results showed rotator cuff inflammation which her PCP stated could have been from the vaccine administered too high.
Patient was originally seen in a virtual visit. He was feeling weak and off balance.  He has a no chest pain or shortness of breath.  No headaches or loss of consciousness.  He has a no appetite.  He has a dry cough. His COVID test came back positive so he was advised to come to the ED.   His chest x-ray is concerning for early infiltrate. His oxygen saturation dropped to 88% in emergency department.  Patient was started on  IV Dexamethasone. Vitamin C D and Zinc. 2-3 L of oxygen via nasal cannula, Remdesivir,
Typical flu-like aching reaction with injection site tenderness and swelling. Acute herpes zoster in C-2 distribution on Lt parietal scalp, starting Nov 22, ie 2 days after vaccination.
PATIENT PRESENTED TO THE PHARMACY ON THE AFTERNOON OF SEPTEMBER 14, 2018 WITH THE LOWER PART OF HER UPPER ARM SLIGHTLY RED AND WARM TO THE TOUCH. SHE REPORTED NO FEVER OR PAIN. WE TALKED ABOUT ICE AND BENADRYL. SHE CAME BACK MORNING OF SEPTEMBER 15, 2018 WITH NO IMPROVEMENT HOWEVER, NOT WORSENING. I RECOMMENDED HAVING IT CHECKED OUT AT WALK-IN CARE. PATIENT REFUSED AT THIS TIME BUT WILL GO IF IT GETS WORSE.
Hives - entire body - for 5 days until doctor visit. Given a shot then for 2 1/2 days after doctor visit. On 9/27 I was given shot - SOLU-MEDROL 125 mg.
DTap was incorrectly administered by Medical Assistant. Tdap should have been administered since patient was over the age of 7.
muscle and joint pain in the should and elbow of the left arm (the injection arm) ever since the vaccination. It feels like muscle soreness that doesn't go away.; muscle and joint pain in the should and elbow of the left arm (the injection arm) ever since the vaccination. It feels like muscle soreness that doesn't go away.; muscle and joint pain in the should and elbow of the left arm (the injection arm) ever since the vaccination. It feels like muscle soreness that doesn't go away.; This is a spontaneous report from a contactable consumer (patient himself).  A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EP6955, Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Age at vaccination 47-years-old) as dose number unknown, single for covid-19 immunisation. The facility Type Vaccine was school or school health clinic. Medical history included High Cholesterol from an unknown date and unknown if ongoing. The patient known allergies was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021, the patient experienced muscle and joint pain in the should and elbow of the left arm (the injection arm) ever since the vaccination. It feels like muscle soreness that doesn't go away. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient rec'd vaccine 6/28/16 and developed injection site reaction that covered from injection down to her elbow and was about 4 inches wide. Patient took pain medications, iced and elevated arm to relieve the pain and inflammation.
Patient reporting that he noticed pain in his left (deltoid) arm last week-no other c/o's and can move his arm without difficulty-he can feel the area where it hurts when he applies pressure on it-has not tried any home remedies and has not been evaluated by his physician at this time.
This subject is an 11 month old male, who died on 3/23/03 from congenital heart disease while enrolled in a Phase IV Daptacel study. The subject received two doses of study vaccine; the last dose prior to the event was given on 11/26/02. The subject had a pre-existing congenital heart disease and Down's syndrome and died 356 days post-immunization. The event of congenital heart disease was reported by the investigator as unrelated to the study vaccine. No autopsy performed. Case is closed.  Follow up on 08/12/2003: "This is a 10.5 month old male seen for evaluation.  The patient has Down's syndrome and was diagnosed by fetal echo to have a permeative atrial ventricular canal.  Initially the patient was placed on digoxin and Lasix but subsequently developed pulmonic stenosis, so these were discontinued.  The patient had an initial cardiac cetherization on 09/10/2002.  This revealed a permeative atrial-ventricular canal with a moderate left-to-right shunt and some right-to-left shunt and a TOR pressure drop across the pulmonic valve.  The patient had pulmonary artery pressures which were twice normal and modestly elevated pulmonary vascular resistance.  Subsequently, the patient on 09/26/2002, had a pulmonary artery band performed for a MD.  Postoperative course was complicated by severe postoperative respiratory syndrome with problems necessitating prolonged intubation secondary to tracheal stenosis.  In addition, the patient had post pericardiotomy syndrome which was treated with ibuprofen without complication.  The patient recently had repeat cardiac catherization on 01/16/2003, which confirmed the above diagnosis.  The patient is presently scheduled for surgery on 02/27/2003. This would consist of having resection of his tracheal ________ by MD and a Glen procedure by another MD.  Since the patient's last evaluation one month ago, there been no symptoms of feeding difficulties, respiratory difficulties, increasing stridor or syncope noted.  Mother states that the patient did have some breathing problems for approximately four or five days after catherization secondary to his intubation.  However, subsequently he has not had inspiratory or expiratory stridor.  Follow up on 04/14/04: "After a medical review of the case, a new version of the report has been generated to add the adverse event term "condition aggravated", and to correct the interval between the date of immunization and the fatal outcome, from 356 to 117 days."
Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: increase in heart rate
This spontaneous report was received from a other health professional refers to a unspecififed number of patients of unknown age and gender. On 2017 the patients were vaccinated with with the improperly stored doses of VARIVAX for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT).
the patient was administered improperly stored VARlVAX; This spontaneous report was received from a physician, referring to a 4-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 04-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX), subcutaneously (strength, dose, vaccination scheme frequency and anatomical site of vaccination were not reported; lot number S032355, which have been verified to be valid, expiration date reported and validated as 14-OCT-2021) as routine vaccination (product storage error). It was reported that the Sterile Diluent used to reconstitute the vaccine was properly stored (lot number S032591, which have been verified to be valid, expiration date reported and validated as 16-AUG-2022).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (13.6 degrees F) for 12 hours (multiple excursions); 15 degrees F to 46 degrees F (16.0 degrees F) for 30 minutes, as recorded by a data logger. There was no previous temperature excursion reported.; Sender's Comments:  US-009507513-2009USA001256: US-009507513-2009USA001233:
site red & swollen;fever 103 beginning a few hr p/inj;28JUL95 & child had febrile sz;4OCT95 f/u high fever 103.5-103, febrile sz, eyes rolled back, drooling, no response to stimulus;sent to hosp
Flu like symptoms beginning with chills at 6 am, progressing to nausea dry heaving and vomiting by 8am. Nausea, vomiting and headache for the next 2-3 hours unable to keep anything down including water.  Headaches and muscle weakness for the next 36 hours
very red splotch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (very red splotch at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A.) for COVID-19 immunization.     NO medical history information was reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (very red splotch at injection site). At the time of the report, INJECTION SITE ERYTHEMA (very red splotch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (very red splotch at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A.) for COVID-19 immunization.     NO medical history information was reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (very red splotch at injection site). At the time of the report, INJECTION SITE ERYTHEMA (very red splotch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
5 hours after shot administered developed a moderate amount of pain in my left arm that continued into the next day. On 12/25/2020 I developed a pretty constant left sided headache. Pain is moderate and is affected my daily life. Unable to complete household chores.
DPH & EPI w/in 1/2hr swollen face, diff breathing, hives;to ER;
4 inch indurated area around vaccine site, hot to touch and very painful started next day after vaccine. Ice to area and all resolved after 5 days.
Headache, nausea, shivering/chills, fever (max 101.2 at 7:15PM).
The patient experienced pain in the deltoid immediately after the injection. The patient was fatigued and light-headed three hours later. The patient had a fever of 99.8F six hours later. The patient's stomach was upset 12 - 48 hours and he could not work for 2 days.
Tenderness in left deltoid (RD), at injection site within 2 hours of vaccine. Pain 3 out of 10 within 10 hours of receiving vaccine. Difficulty raising left arm without without pain. Applied warm compress for comfort. Awaken around 2:30 am, next day,  with nausea. Upon standing to go to bathroom, experienced stomach irritation with large, soft, formed stools and sudden onset of vasovagal response. Did not  lose consciousness. Remained sitting for 2-3 minutes until able to stand (staying low to ground) and returned to bed. Vasovagal response and nausea continued until I fell asleep, approximately 3:30 am. Awaken at approximately 8:00am, tired, general weakness, no appetite and mild nausea. Drank green tea to settle stomach. Fell asleep at 12:30pm until 1:45 pm, on 4/4/2023. Awaken tired and weak. Nausea and vasovagal resolved. I did not have this response with the first dose in the Shingrix series.
his wife might have received the Covid-19 vaccine and tested positive for Covid; his wife might have received the Covid-19 vaccine and tested positive for Covid; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient. A female patient received BNT162b2 (BNT162B2 NOS), as single dose 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), outcome "unknown" and all described as "his wife might have received the Covid-19 vaccine and tested positive for Covid". Patient had taken Paxlovid and she's feeling good and everything and wanted to know as far as the virus went, how long did it take to be not contagious to other people. Patient might have received the Covid-19 vaccine and tested positive for Covid. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had both shots ans had them/Suspected Vaccination Failure; terrible pain; eye shingles; Shingles in ear; on face, forehead, ear, and head; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both shots ans had them/Suspected Vaccination Failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: eye shingles) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles in ear) (serious criteria GSK medically significant), shingles (Verbatim: on face, forehead, ear, and head) and pain (Verbatim: terrible pain). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, herpes zoster otitis externa and shingles were recovered/resolved (duration 3 months) and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, herpes zoster otitis externa, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both shingles shots. The patient had shingles on the right side of his/her face forehead, eye, ear and top and back of his/her head. The reporter stated that terrible pain. The patient had shingles for 3 months. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
This spontaneous report as received from the registered nurse refers to an unspecified number of patients of unknown gender and age. Information about the patients medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, dose number, lot/batch# and expiration dates were not reported) after being improperly stored. Information about concomitant medications was not provided. No product quality complaint (PWC) was involved. This is one of several reports from the same reporter. Additional information is not expected as no consent for contact was given.
October started with dyspepsia; cardiology work up neg, egd in Nov showed esophageal cancer; also with 25 lb wt loss last 2 months.
No adverse reactions noted. Vaccine administered on  01/19/2022. Came to nurses attention at later date that patient had received previous TD vaccine on 06/27/2017.