chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold; Episodes with iritis; Ankylosing Spondylitis bad flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4328741.  A 46-year-old female patient received BNT162b2 (reported as "Pfizer COVID-19 vaccine"), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), since 06Mar2020 (ongoing) (Lot number: 1172971), subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant) with onset 24May2021, outcome "recovered", described as "Ankylosing Spondylitis bad flare up"; IRITIS (medically significant) with onset 02Oct2022, outcome "recovered", described as "Episodes with iritis"; NASOPHARYNGITIS (non-serious) with onset 26Feb2023, outcome "unknown", described as "Cold". The action taken for adalimumab was dosage not changed. Clinical course included: Solicited report from  a consumer of a female with events of and non-serious Ankylosing Spondylitis bad flare up, cold, red bump injection site, episodes with iritis, felt tired, and red bump injection site with Adalimumab Solution for Injection, Single Dose Pen. On 06Mar2020, the patient experienced red bump injection site with outcome recovered on an unknown date. On 07Mar2020, the patient experienced felt tired with outcome recovered on an unknown date.  The reporter's causality for the event(s) of Ankylosing Spondylitis bad flare up, cold and episodes with iritis with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event of "ankylosing spondylitis bad flare up" with BNT162b2 was Reasonable Possibility .   The reporter's assessment of the causal relationship of "episodes with iritis" and "cold" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported event (Ankylosing Spondylitis) cannot be excluded. However, due to limited information there is not a reasonable possibility that the other reported events are related to BNT162b2 (COMIRNATY)  administration. This case will be reassessed should additional information become available.
Early periods; Late periods; Irregular cycles; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, asthma and allergy to topical drugs. The patient previously received diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the arm left on 11Feb2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation ( also reported that the patient was menstruating at time of 1st dose). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Mar2021, the patient experienced next menstruation was a week early, 2 hours after second dose. On an unknown date in 2021, the patient experienced the following menstrual cycle which was 4 days late, then menstruating again 15 days into her menstruation cycle. The patient had not been in any other medication, no stress, no illness, and never had irregular cycles. This was completely new since the vaccine.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events early periods, late periods and irregular cycles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient presented to pharmacy with rash that starting on ankles and moved up the body to her trunk area.
No adverse effect; Administration of VAQTA 1.0 ml to an 18 year old patient; This spontaneous report was received from a pharmacist refers to a 18 year old female patient. Information on pertinent medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2010, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1.0 ml dose, lot # R027987, expiry date: 09-AUG-2019 via unknown route for prophylaxis. Thus the 18-year old patient received 1.0 ml of hepatitis a vaccine, inactivated (VAQTA) (incorrect dose administered). There was no adverse effects (no adverse event) mentioned.
got the first shot and 3 days later I got Covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got the first shot and 3 days later I got Covid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got the first shot and 3 days later I got Covid). At the time of the report, COVID-19 (got the first shot and 3 days later I got Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not reported.  Treatment Information was not reported.
He started not feeling right about four hours after getting vaccine. First took blood pressure about 5pm. At that time it was 148/72. About 1/2 hour later it went to 160/76. About 8pm it was 177/90. He took Lisinopril 20mg. By about 10pm it had gone up to 198/98 and he took Nitroglycer  .4mg. At this point we went to the Emergency Rm
Pt did not want to get Anthrax shot but did comply as directed. 5 minutes, post vax, he reported to Flight Med front desk complaining of dizziness. Orthostatics were wnl, no respiratory symptoms. Neuro exam was wnl. After 15 minutes, pt felt better. Released from duty and deployed to air base the next AM.
Bloody nose (only one he has ever had) started shortly after vaccination.  It was a slow oozing that took an hour to stop. He has also spiked to mild fevers (101 degrees F), had long fits of inconsolable crying and had disrupted sleep (difficulty falling to sleep and then waking through the night). This is all very out of character.  There have been no other changes to his health or environment during this time.
Extremely Sore arm for over 10 days. Can't lift arm over my head. Very weak.
Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Mitral Valve Prolapse (MVP). The patient was allergic to penicillin. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 09:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021, the patient experienced severe tinnitus. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severe tinnitus was not resolved at the time of report.
Pt given HEP A vaccine too early.  0 symptoms or signs of adverse reaction.
Tender to touch, erythema, warm to touch, swelling 2 1/2 inch x 2 inch left deltoid per parent.
Information has been received from a consumer her approximately 12 month old daughter with no medical history who on approximately 25-Sep-2004, "when she was almost exactly one year old" was vaccinated with one dose of MMR II vaccine. There was no concomitant medication. The reporter believes that the patient has autism and other illnesses caused by the vaccine. In approximately 2004, "in the 12 months following vaccination" she notices a slow regression in the patient. It was reported that the patient had croup twice, her first and only ear infection and rotavirus. The mother noted that the patient was treated with acyclovir for the rotavirus and it caused a seizure. It was also noted that the child's posture deteriorated to the point where "the curl in her back was visible". The patient started getting sick all the time. She also started to distance herself from the family. She showed no interest in the baby sister and would always sit away from everyone. She cannot kick or throw a ball without falling over. It was reported that she would pace and flap her hands constantly until her parents got her intervention. The reporter indicated that physicians believe she may be "carrying viral encephalitis". Her measles titers have increased significantly from 1.4 to 2.42. She has "leaky gut syndrome" and "HHB6". She is being treated with IMIG once weekly to keep her from getting sick, but the child has been hospitalized over night at least once since being vaccinated (adverse experience not reported). At the time of the call, the reporter could not provide information regarding the specific reason for hospitalization or the length of time the patient was hospitalized. Regular measles titers and an EEG were done but results were not provided. It was reported that the patient was not recovered. Unspecified medical attention was sought. Upon internal review the patient's autism and encephalitis were considered other important medical events. Information received on 25-Jan-2007 contained the following adverse experience, seizure (approximately 2004). Upon internal review, the seizure was considered to be an other important medical event. No further information is available.
Blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EL8982 and EL1284) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced BLISTER (Blisters). At the time of the report, BLISTER (Blisters) was resolving.            Concomitant medication use was not provided Treatment information included Benadryl.
Fever 102, nausea, soreness, redness, hardness to injection site (L) deltoid.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concomitant products included lorazepam and DEXILANT. On 8th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, 1 days after receiving SHINGRIX, the patient experienced nerve pain and activities of daily living impaired. In April 2018, the patient experienced injection site pain. The patient was treated with ibuprofen. On 10th April 2018, the outcome of the nerve pain was recovered/resolved. On an unknown date, the outcome of the injection site pain and activities of daily living impaired were unknown. The reporter considered the injection site pain and nerve pain to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medication included INTRAROSA. At 12:40, the patient received SHINGRIX on left arm. The pharmacist reported that the patient experienced extreme nerve pain centralized to her torso. The pain was bad enough that she could not do anything that day. Less than week after vaccination, the patient also had some arm pain around the injection site.
Severe hives developed 10 days after injection. Treated with 4-day course of prescription antihistamines.
Rash on forearms, tummy, back & legs/ progress into blisters; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (Rash on forearms, tummy, back & legs/ progress into blisters) and PAIN IN EXTREMITY (Arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 11-Mar-2021, the patient experienced RASH VESICULAR (Rash on forearms, tummy, back & legs/ progress into blisters). The patient was treated with PREDNISONE for Blistery rash, at a dose of 1 dosage form. On 11-Mar-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, RASH VESICULAR (Rash on forearms, tummy, back & legs/ progress into blisters) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Patient became dizzy after shot. she was dizzy for 30 minutes. refused medical attention. color was normal and was talking then entire time. Her husband came and brought her home
covid test date=17Aug2021, covid test result=Positive; covid test date=17Aug2021, covid test result=Positive,; Body aches; fever; Headache; This is a spontaneous report from a contactable Nurse.   A 62-year-old female patient received bnt162b2 (BNT162B2, Formulation: solution for Injection, Batch/Lot number: EL3248) dose 2 via an intramuscular route of administration, administered in Left arm on 16Feb2021 1:30 (at the age of 62-years) as dose 2, single dose for covid-19 immunisation. The patient medical history were not reported the patient past drug therapy included BNT162B2 (Lot number=EL3248) dose 1 via an intramuscular route of administration, administered in Left arm for covid-19 immunisation on an unspecified date in Jan2021 01:45. The concomitant medications were not reported. The patient experienced covid test date=17Aug2021, covid test result=Positive (vaccination failure and COVID-19), body aches, fever, headache on 17Aug2021. The patient underwent lab tests and procedures which included PCR/Nasal Swab was positive on 17Aug2021. The outcome of the events experienced covid test date=17Aug2021, covid test result=Positive was unknown, body aches, fever, headache was not recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported event "Covid-19" and suspected vaccine BNT162B2 cannot be completely excluded.
Anterior STEMI with symptom onset (chest pain, n/v) occurring  5 hours post vaccine
I woke up with a sore throat, I had sinus issues, and I was tired. That lasted a few days. I went and got tested for Covid because my son in law tested positive. It came back negative. I don't remember how many days later but I had a telehealth visit with my doctor. I was having really bad headaches, sinus pressure, and cough. Since my test came back negative he thought it might be a sinus issue so he prescribed me antibiotics. I took that for a couple of days but the side effects were too severe so I did not continue with those. Then he prescribed me a second antibiotic and I had side effects as well so I did not continue to take those either.
Child received vaccinations on 8/9/06. On 8/13/06 mom noticed red, rash on right thigh. Area is 4" x 3 1/2" with 1 1/2" circumference at IM site remains clear. Child denies both itchiness or pain. Area is not hot to the touch nor is it swollen. No rash noted at other Bandage site. Mom removed each spot bandaid on 8/9/06. Mom gave 1 dose of Benadryl 8/13/06pm.
left arm became angy red; covid arm; rash on arm was warm; rash was 3.5 inches wide and 5 inches in length, slightly raised; slightly raised rash; little sore; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (left arm became angy red), VACCINATION SITE REACTION (covid arm), INJECTION SITE WARMTH (rash on arm was warm), VACCINATION SITE RASH (rash was 3.5 inches wide and 5 inches in length, slightly raised) and VACCINATION SITE SWELLING (slightly raised rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced ERYTHEMA (left arm became angy red), VACCINATION SITE REACTION (covid arm), INJECTION SITE WARMTH (rash on arm was warm), VACCINATION SITE RASH (rash was 3.5 inches wide and 5 inches in length, slightly raised), VACCINATION SITE SWELLING (slightly raised rash) and VACCINATION SITE PAIN (little sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at a dose of 25 mg. At the time of the report, ERYTHEMA (left arm became angy red), VACCINATION SITE REACTION (covid arm), INJECTION SITE WARMTH (rash on arm was warm), VACCINATION SITE RASH (rash was 3.5 inches wide and 5 inches in length, slightly raised), VACCINATION SITE SWELLING (slightly raised rash) and VACCINATION SITE PAIN (little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-May-2021 contains no new information.
Received a dose that past 24 hs withdrawn from the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose that past 24 hs withdrawn from the vial) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose that past 24 hs withdrawn from the vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose that past 24 hs withdrawn from the vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
This initial spontaneous report was received from a physician referring to a 5 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015 at 14:03 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
hearing is gone, cotton in his ear; A spontaneous report  was received from a consumer, concerning a male patient of unspecified age, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced hearing loss.  The patient's medical history was not provided but it was reported he sees a dialysis doctor. concomitant product use was not provided by the reporter.  On 24-FEB-2021, prior to the onset of the symptoms, the patient received his first vaccination of mRNA-1273 (lot/ batch number unknown) via intramuscular route for COVID-19 infection prophylaxis.  On 25-FEB-2021, the patient's wife reported his hearing was gone, seems like the patient had cotton in his ear. No treatment medication was reported.  Action taken with mRNA-1273 in response to event was unknown.  The outcome of the event was considered to be unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Vomiting and lethargy. Normal pregnancy 36wk 4 day EDD 8/27/17.
This spontaneous report was received from a medical assistant, concerning to an approximately 14 year old male patient. His medical history, concurrent conditions and drug reactions/allergies were not reported. In September 2015, when the patient was 13 years of age, the patient received his first dose of GARDASIL (frequency, route, lot # and expiration date were not reported). Subsequently, it was reported that, on 03-NOV-2016, the patient went to the reporter's office to receive his second dose of GARDASIL 9 (frequency, route, lot # and expiration date were not reported) (interchange of vaccine products and inappropriate schedule of drug administration). No product quality complaints or adverse effects were reported. Additional information has been requested.
bleeding gums & sore mouth w/purulent material; also nausea & abdo discomfort; bitten by rabid bat; no other details expected;
Redness & swelling (about 1/2 dollar size accdg to grandmother) on injection site persistent after injection.