chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered Shingrix to a patient who was 37 weeks pregnant; he inadvertently administered Shingrix to a patient who was 37 weeks pregnant; 26 year old patient received shingrix; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number M9F2T, expiry date 06-AUG-2024) for prophylaxis.   On 21-AUG-2023, the patient received Shingrix. On 21-AUG-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: he inadvertently administered Shingrix to a patient who was 37 weeks pregnant) and inappropriate age at vaccine administration (Verbatim: 26 year old patient received shingrix). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administered Shingrix to a patient who was 37 weeks pregnant). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Shingrix): 37 Weeks Pregnancy Exposure (Shingrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 17-AUG-2023 Pharmacist reported he inadvertently administered Shingrix to a patient who was 37 weeks pregnant. She was supposed to get Boostrix which led to wrong vaccine administered, inappropriate age at vaccine administration. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
positive syphilis test was revealed; This case was reported by a consumer via call center representative and described the occurrence of syphilis test false positive in a 47-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2020, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. In November 2020, less than 2 months after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced syphilis test false positive. On an unknown date, the outcome of the syphilis test false positive was unknown.   It was unknown if the reporter considered the syphilis test false positive to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received the vaccine in September 2020 and in November 2020 and December 2020, a false positive syphilis test was revealed when the patient was attempting to donate blood.   The patient was an active blood donor and these false tests are keeping him from providing blood to those who need it.  The patient was contributing the false positive test directly to the Fluarix vaccine. The reporter consented to follow up.
Three days after the vaccine I noticed something like a rash on my skin. I tried to take Benadryl, and nothing helped. It is a rash that does not look like hives. It was on my right side of my abdomen and then spread to my back, chest and thighs but not on my chest, hands and feet. It is a raised rash spots that are small. The rash was not very itchy and it was not warm to touch. It seemed to get worse and worse over the course of seven weeks. It seemed like after an area cleared up another area would flare up. It then started to subside but it is still present on my upper legs at the moment which is four months out from the vaccine. Initially it was thought to be a virus, but all tests were negative. I actually ended up getting the Johnson & Johnson vaccine as advised instead of the second of the Moderna on 04/06/2021. I have seen a Dermatologist and an Allergist and ruled out a Viral Infection and any kind of Bacterial. I was told it might be Pityriasis Rosea.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a health professional concerning an 11 year old female who on 19FEB2003 at 13:00 was vaccinated SC in the deltoid with a first dose of varicella virus vaccine live. The patient's three siblings were vaccinated the same day. On approximately 30SEP2003 she had full blown chickenpox and was treated with acyclovir. It was reported that two of her siblings  (WAES#0311USA01047 and 0401USA005383) also developed chickenpox. The reporter expressed a concern with the lot. Unspecified medical attention was sought. There was no product quality complaint involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Follow-up information indicated that the patient was seen on 08-Jun-2003 and she developed a rash and fever on 07-Jun-2003 (previously reported as approximately 03-Sep-2003), some cough and minimal runny nose were noted. It was noted that all the patient's vaccinations were up to date and she had no immune disorders. Lesions were classic dew drop appearance and disseminiated throughtout her body with a few in her oral cavity and oral pharynx. No secondary infection was noted. Lesions were in various stages and were vesicular in nature, because of the severity of her rash and her age the patient was started on acyclovir 800 mg QID for 5 days. She was also given hydroxyzine hydrochloride (Atarax) 25mg q 6 hours for itching. Subsequently the patient recovered. The patient received additional vaccinations on 22-Jan-2003 at 13:37 which included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live which was given SC in the thigh, a first dose of diphtheria toxoid (+) tetanus toxoid given IM in the thigh, a first dose of poliovirus vaccine inactivated (unspecified) which was given SC in the deltoid and a first dose of hepatitis virus vaccine (unsepcified) given IM in the thigh. No further information is expected.
RED LUMP AT THE SITE OF INJECTION; RED AT THE SITE OF INJECTION; HOT AT INJECTION SITE; SORE AT INJECTION SITE; ITCHY AT INJECTION SITE; FATIGUE; BODY ACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced body ache. On 09-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced red lump at the site of injection. On 10-MAR-2021, the subject experienced red at the site of injection. On 10-MAR-2021, the subject experienced hot at injection site. On 10-MAR-2021, the subject experienced sore at injection site. On 10-MAR-2021, the subject experienced itchy at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and fatigue on MAR-2021, and had not recovered from red lump at the site of injection, hot at injection site, sore at injection site, itchy at injection site, and red at the site of injection. This report was non-serious.
Information has been received from a registered nurse concerning a 14 month old white male who may be allergic to eggs, with no medical history who on 11/3/04 was vaccinated SC into the right leg with a first dose of MMR (lot # 646897/1173N). There was no illness at the time of vaccination. On 11/3/04, the patient developed localized swelling at the injection site. Subsequently, the patient recovered. No product quality complaint was involved. Further information is not expected.
Erectile dysfunction, specifically difficulty to obtain and maintain an erection.  The symptoms lasted for approximately 5 weeks with a slow resolution during the 5th week.
Headache; Nausea; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Jan-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (Tylenol) for Headache, at an unspecified dose and frequency.   At the time of the report, HEADACHE (Headache) had not resolved and NAUSEA (Nausea) and MYALGIA (Muscle pain) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant information was reported.
Injection site area was hard; Injection site area was swollen (left arm); Vaccine not given in the deltoid muscle correctly; A spontaneous report was received from a consumer (patient), an 84 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced injection site area was hard (vaccination site induration), injection site area was swollen (left arm) (vaccination site swelling), and vaccine not given in the deltoid muscle correctly (incorrect route of product administration).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 09 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: 031L20A), intramuscular in the left arm for the prophylaxis of COVID-19 infection.   The patient was concerned that they did not give him the vaccine correctly in the deltoid muscle on 09 Feb 2021. On 10 FEB 2021, the patient experienced that the injection site area was hard like a rock and swollen, approximately five inches below the actual injection location. No further information was provided. Treatment information was unknown.  Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, injection site area was hard, injection site area was swollen was considered as unknown, that of event they did not give him the vaccine in the deltoid muscle correctly was considered recovered on 09 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,  a causal relationship cannot be excluded.
Pt recvd vax 11AM 13APR92 & went to bed & sleep @ 8PM awoke @ 845Pm vomiting, pale, unresponsive, limp; vomited 3x; taken to ER in ambulance; vomited once 2 days later w/return to deep sleep for 3 1/2 hrs;
10/16/2013 mild seizures within 3 days of Vx. 5 minutes after patient received shot he started having seizure like activity that lasted 45 seconds. Patient was seen by Dr., fully recovered and left an hour later.
Pt's arm swelled up around injection site. Pt went to see her doctor and was prescribed an abx course of Cephelexin.
experienced side effect of rash 2 to 3 hours later; This is a spontaneous report from a non-contactable physician (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received vaccine 2 days ago and experienced side effect of rash 2 to 3 hours later. The patient wanted guidance on 2nd dose. She was unsure if it was due to taking a shower with warm water. She took Benadryl and was fine afterwards. She was asking if she can take steroids before the second dose, if there is any contraindication of steroids and the vaccine, and about taking Benadryl before the second dose. She was asking for any specific data on participants in the study that had taken steroids that were permitted in the study. She also stated that they were doing a great job. Therapeutic measures were taken as a result of experienced side effect of rash. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Patient reported feeling hot and experiencing tingling in her hands several minutes after administration. For approximately the next hour her symptoms remained the same, did not worsen or improve. At approximately 11:15 AM, the patient had what appeared to be a momentary loss of consciousness resulting in her falling from her seated position in her chair, landing on her head. She suffered a contusion and laceration at the point of impact. I ran over to her and by the time I got to her she had already regained consciousness and was alert and aware of her surroundings and what day it was. I waited with her until EMS arrived without further incident
High pitched ringing in my ears started 29 hours after the injection was given along with pain from both of my shoulder blades over the top of shoulders into both sides of my chest pectoral muscles.
Right upper arm from shoulder ---> elbow with erythema and edema including entire circumference of right upper arm.
Information regarding PREVNAR was received from an emergency room physician regarding a 3-month-old (114 day-old) female patient who experienced pyuria, Streptococcus pneumoniae meningitis and Streptococcus pneumoniae sepsis and died. The patient received a dose on 25-Jan-2010. On an unknown date in Feb-2010, the patient experienced pyuria and was empirically placed on an unknown antibiotic thought to be either KEFLEX or OMNICEF. On an unknown date in Feb-2010 the urine culture was negative. On 25-Feb-2010 the child was transported to the emergency room where she died due to Streptococcus pneumoniae meningitis and Streptococcus pneumoniae sepsis. The patient was not hospitalized. The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis and the autopsy cause of death was meningitis pneumococcal and pneumococcal sepsis. The serotype of the pneumococcal bacteria was not identified. No additional information was available at the time of this report.
Felt light headed and 'flu-like' symptoms all day during day after.  Web-like rash on inner left thigh discovered 6 days later.
Administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that the vial did not undergo temperature excursion. Total number of doses administered from lot number- 026C21A were 102. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains updated reporter details.
4/3/21 -  Strep throat diagnosis by ER doctor.4/8/21 - Thrush diagnosis (not strep) by PCP. Otherwise normal. 4/9/21  7:30 am - Woke up with sudden onset dementia. Was totally disoriented in home. Could not remember his name. Used nonsense words. Took Ambulance to ER.  Admitted to hospital. 4/12/21 - Rare bilateral Herpes Zoster in throat. Herpes caused encephalitis. 4/14/21 - Dementia symptoms gone. Strong metallic taste & pain caused him to gag and vomit everything, including water. 4/15 - Discharged. Picc Line w/ Acylovir infusions. No food or water thru mouth. 4/27 - Readmitted to hospital. Severe dehydration. Lost 65 lbs. PEG Tube installed. 5/10 - Discharged on full Bolus Feedings. Aug.- Resumed regular diet
Soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 3 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by patient's mother The age at vaccination was not reported. The patient received a dose of Bexsero and had experienced soreness at injection site for approximately 7 days after receiving Bexsero. The reporter did not provided demographics for the patient. All information provided was reported. The reporter did not consented to follow-up.
woke up with my gown totally soaking wet; This case was reported by a consumer and described the occurrence of sweating in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2020, the patient received the 2nd dose of Shingrix. On 31st May 2020, 1 days after receiving Shingrix, the patient experienced sweating. On an unknown date, the outcome of the sweating was unknown.   It was unknown if the reporter considered the sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and her gown totally soaking wet. Never happened to patient before. The reporter asked could this be a side effect if receive second shot.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation. The patient's relevant medical history included: "heart attack 10 years ago" (unspecified if ongoing), notes: heart attack 10 years ago. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, treatment start date: 20May2022, treatment stop date: 24May2022, indication: Treatment of COVID-19. Adverse event: It was reported that 5 days post completion of treatment patient developed a bad cough that he didn't had before and he was tested a strong positive for covid. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date : 03Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 2/21/21 both feet started tingling.  Went to an urgent care on 2/26/21 where they completed labs to rule out that possibility.  All labs were normal.  Did a brain MRI with and without contrast on 3/4/21. MRI showed a prominent active enhancing lesion in the right frontal centrum semiovale.  On 3/26/21, tingling moved from feet to torso and felt electrical sensations up and down torso and body.  Did a spine MRI on 4/6/21.  Spine MRI showed 3 lesions. Saw neurologist on 4/21/21 who thought this could be a vaccine injury  3/25, 4/14, 4/22, and 5/5/21 saw a naturopath who tested food allergies and heavy metals.  Suggested multiple supplements. 4/15 went to acupuncture  Tingling sensations still ongoing
Right arm began to ache and swell later in the afternoon. The right arm was warm to touch with visible red streaks radiating down the arm.
Fever of 101.2F starting at 11:30pm day of 2nd dose Covid Pfizer vaccine. Took Tylenol and fever went down to 99.8F by 6am. Body aches and pains lasted from 9pm (day of vaccine) till noon next day.
Dry mouth pain in both arms tightness in chest face red nausea/lightheaded - occurred 1-5 minutes after shot. Called 911 paramedics performed vitals everything okay.
Adverse effects started at 3am the morning after being vaccinated. Fever : 100.4, chills, body aches, fatigue, lasting roughly 24 hours, managed symptoms with Tylenol and Ibuprofen.