chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomited and saw the second pill of Vivotif in the vomit; Vomited and saw the second pill of Vivotif in the vomit; A spontaneous report was received from a nurse on 25JUL2023 regarding a female patient of unknown age who "vomited and saw the second pill of Vivotif in the vomit" (PT: Product dose omission issue and PT: Vomiting). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that shortly after receiving the second dose of Vivotif the patient vomited and saw the pill in the vomit. Reportedly, the patient was scheduled to receive the third dose today (at the time of report).  The outcome of the event "vomited and saw the second pill of Vivotif in the vomit" (PT: Product dose omission issue) was not applicable while it was unknown for "(PT: Vomiting)".  The action taken with Vivotif with respect to the event "vomited and saw the second pill of Vivotif in the vomit" (PT: Product dose omission issue) was not applicable while it was unknown with respect to "(PT: Vomiting)".  No additional information was reported.  Company comment: It was reported that shortly after receiving the second dose of Vivotif, a female patient of unknown age vomited and saw the second pill of Vivotif in the vomit (product dose omission issue and vomiting). Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting is assessed as possible. Furthermore, the causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that shortly after receiving the second dose of Vivotif, a female patient of unknown age vomited and saw the second pill of Vivotif in the vomit (product dose omission issue and vomiting). Considering the case information, the role of Vivotif cannot be ruled out and the causality of vomiting is assessed as possible. Furthermore, the causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Small rashes appeared inches below the injected area; and it's hot, itchy, and painful; and it's hot, itchy, and painful; and it's hot, itchy, and painful; fever; This is a spontaneous report received from a Pfizer-sponsored program COVAX US Support. A contactable consumer (patient herself).A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in arm left on 06Apr2021 as dose 2, single for covid-19 immunization. The patient previously received Covid-19 Vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 15Mar2021 (2nd dose more than 21days) for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. It was reported that after receiving the 2nd dose of the vaccine on 06Apr2021 small rashes appeared inches below the injected area and it was hot, itchy and painful. Now the pain and itchiness subsided but the rash became bigger up to the entire left arm. Therapeutic measures were taken as a result of event fever and included treatment with took 1 paracetamol. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt given Measles Vaccine in Lt deltoid area.  20 minutes later started to feel itchy (area of injection) lt side of neck, nasal congestion w/catarrh & lt periorbital edema.
Patient states itching 1 day after injection, 2 days after injection develop area of redness, inferior to injection site warm, red, raised, tender extending near elbow. Treated with IM Ancef and Septra 05 BID x 10 days. Area inferior of Pneumovax injection.
no adverse effect; improperly stored doses of proquad; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.   On 16-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S007069 has been verified to be a valid lot number with expiration date:06-SEP-2020, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent and it was unknown if the sterile diluent was stored properly (product storage error). The vaccine was exposed to a temperature -11.5 Celsius for 76 hours. There was no previous temperature excursion. It was reported that the call was because of a digital data logger. The patient experienced no adverse event. No product quality complaints were involved.
PATIENT STATES HE FELT LIGHT HEADED THEN APPEARED TO LOSE CONSCIOUSNESS AND SLUMPED OVER IN A SEATED POSITION DURING HIS 15 MINUTE OBSERVATION PERIOD.  PATIENT APPEARED TO TRY TO GET UP OUT OF CHAIR AND BEGAN COVULSING, BECAME RIGID, AND COLLAPESED TO THE GROUND.  PATIENT BECAME TOTALLY UNRESPONSIVE.  PHARMACY STAFF ADMINISTERED EPIPEN AND WITHIN MINUTES PATIENT BECAME LETHARGIC BUT RESPONSIVE.  PATIENT RECEIVED EMERGENCY CARE ON SITE FROM LOCAL PARAMEDICS AND AFTER APPROXIMATELY 15 TO 20 MINUTES WAS RESPONSIVE AND AWARE OF SURROUNDINGS.  AFTER APPROXIMATELY 30 MINUTES, PATIENT FELT WELL ENOUGH TO REFUSE ADDITIONAL EMERGENCY CARE AND HAD GIRLFRIEND TAKE HIM TO THE HOSPITAL.  INITIAL ONSET OF SYMPTOMS WAS APPROXIMATELY 10 MINUTES AFTER VACCINATION.
lost most the hearing in the left ear; had a bad day generally; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (lost most the hearing in the left ear) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DEAFNESS UNILATERAL (lost most the hearing in the left ear) (seriousness criterion medically significant) and FEELING ABNORMAL (had a bad day generally). In April 2021, DEAFNESS UNILATERAL (lost most the hearing in the left ear) was resolving. At the time of the report, FEELING ABNORMAL (had a bad day generally) outcome was unknown.            No relevant concomitant medications were reported. The patient confirmed lost most of the hearing in the left ear by a visit to the clinic after a hearing exam was done. The patient stated that he can hear better now but the left ear was not usable and could not use a telephone. It was better now but still not ok and was still "metallic." The patient does not know if 2nd dose had influenced the hearing and stated that he did not have prior history of hearing issues. Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Received injection @ 5:29 pm. Approx 14 minutes after developed rash on back with itching. Was given 25 mg BENADRYL. Dev SOB and stated throat closing. Transferred to ER and released same day. Epi-pen administered. Mother reported rash on buttock/ red face x 2 days.
Started with quarter size red patch at injection site, 12 hours after shot. After that it started growing during the day, swelling, turning hard, tender to touch, quite warm to touch with the red patch growing to about 4-5 inches in diameter.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult female patient who received Shingrix for prophylaxis. On 5th June 2018, the patient received the 1st dose of Shingrix. On 5th June 2018, couple of hours after receiving Shingrix, the patient experienced injection site pain. On 9th June 2018, 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 Shingrix. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient experienced soreness at the injection site within a few hours and persisted for 3 to 4 days. The event was resolved without sequelae. The patient denied permission to contact their physician. The reporter declined to provide any contact information for follow-up including patient identifiers. The reporter did not have lot number or expiry date of the vaccine. This case was one of the 2 cases, reported by the same reporter.
Very sore arm(right) , sore swollen underarm gland, no enegry, headache, in bed all day feeling terrible, Same symptoms second day and underarm more swollen, sick in bed again second day, Third day woke up with headache, took tylenol and started to feel better.
Area red, swollen, itchy, tender Area is approximately  2? x 2? Started immediately after dose and am on day 8-going into day 9
Began with stabbing left earache, followed w/chest & neck pains. Rash 1st appeared as insect bite.  Then fully involved across l/side of chest, into armpit & down arm to elbow.  Also had spread across back to spine.  Had accompanying unproductive deep cough.
SIDS death. 3/4/05 Received autopsy report which revealed COD as SIDS.
Eyelid and nasal bridge swelling; Eyelid and nasal bridge swelling; Swelling of hands and wrists; Swelling of hands and wrists; This is a spontaneous report from a contactable physician. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EJ1685), via intramuscular route of administration (right arm) on 18Dec2020 18:15 at a single dose for COVID-19 immunisation. Relevant medical history included depression, hay fever and acne. Concomitant medication included escitalopram, fexofenadine hydrochloride (ALLEGRA) and doxycycline. The patient was allergic to nickel and fragrance. On 19Dec2020 07:00, patient experienced eyelid and nasal bridge swelling; and swelling of hands and wrists. Patient received allegra due to the event. Outcome of the events was reported as recovering/resolving.   Follow-up attempts are completed. The following information on the batch number has been requested.
5 to 10 minutes of visual changes, saw flashing lights in peripheral vision, no headache developed, denies other symptoms
The next morning, 12/24 and I woke up my head was very heavy and I was dizzy and I had a hard time getting out of the bed, my leg felt like jello, like sea legs, like I was on a boat. That continued all day and I also had chills and did not feel good later in the day. I did not work 12/24 and 12/25 I felt a little better but my legs specially my thighs felt really heavy. Saturday the dizziness continued and then that is when I went to the UC (12/26) to get a covid test (rapid and sent out one both negative). The dizziness improved, I still have a funny heavy feeling on my upper tights. I had a little numbness on my hands on the 12/24 and 12/25but it seems to have resolved.
Began on 3/27 with lesions on trunk and extremities, itchy pustules (at least 50) and a high fever. Treated with acyclovir X 5 days.
rash was itchy; rash around the base of her neck; injection site was red; injection site was enlarged; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 010M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency.        Action taken with the drug in response to the events was not applicable.
sore injection site arm; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown) via an unspecified route of administration on an unspecified date (at the age of 39-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included escitalopram oxalate (LEXAPRO). On 26Feb2021, the patient experienced sore injection site arm. The patient was not treated for sore injection site arm. The clinical outcome of sore injection site arm was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
2 weeks after administration of booster vaccine, patient woke with right sided facial paralysis, presented to clinic 12/22/2021 with ongoing complaints, right sided facial paralysis pain in right jaw
arm pain; felt really bad; Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), FEELING ABNORMAL (felt really bad), CHILLS (Chills) and PYREXIA (fever) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain), FEELING ABNORMAL (felt really bad), CHILLS (Chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (arm pain), FEELING ABNORMAL (felt really bad), CHILLS (Chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Client returned to office for #2 GARDASIL states 'after last shot broke out in Hives'.
Eyes were swollen; Heart rate increase; Eyes were burning; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes were burning), EYE SWELLING (Eyes were swollen) and HEART RATE INCREASED (Heart rate increase) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: LIDOCAINE.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced EYE IRRITATION (Eyes were burning) and HEART RATE INCREASED (Heart rate increase). On 13-Jan-2021, the patient experienced EYE SWELLING (Eyes were swollen). On 12-Jan-2021, HEART RATE INCREASED (Heart rate increase) had resolved. At the time of the report, EYE IRRITATION (Eyes were burning) and EYE SWELLING (Eyes were swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Heart rate: (High) Rapid heart beat which subsided..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender'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
tinnitus; sore arm; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of TINNITUS (tinnitus), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, TINNITUS (tinnitus), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown. Not Related      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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-058821 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058821:
vertigo; hearing and vision issues; hearing and vision issues; significant headaches; This has affected my ability to work from the often and I would like to know if others have reported; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "hearing and vision issues", "significant headaches", "vertigo", "hearing and vision issues". The following information was reported: VERTIGO (non-serious), outcome "unknown"; AUDITORY DISORDER (non-serious), VISUAL IMPAIRMENT (non-serious), outcome "unknown" and all described as "hearing and vision issues"; HEADACHE (non-serious), outcome "unknown", described as "significant headaches"; IMPAIRED WORK ABILITY (non-serious), outcome "unknown", described as "This has affected my ability to work from the often and I would like to know if others have reported".  Additional information:Description of Event Outcome: The patient received the first and second Pfizer vaccines for Covid and have been having vertigo, hearing and vision issues as well as significant headaches over the past several months. This has affected patients ability to work from the often and the patient would like to know if others have reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12/16/2020 HEADACHE AND FATIGUE, RASH ON HANDS, RASH ON TRUNK AND ALL EXTREMITIES.  12/20/2020 HA WORSENED PRIMARY AT BASE OF SKULL, DEEP, NOT MUSCULAR. BOTH SIDES. FEVER, BODY ACHE, CHILLS, SKIN HYPERSENSITIVE. COVID TEST; NEGATIVE.  12/21/2020 URGENT CARE; COVID; NEGATIVE 12/21/2020  - AT ER ALL DAY 10/11 AM - 6PM ??? 'ATTRIBUTED TO DRUG ALLERGY; SULFA/BACTRUM' CYPRO, STEROID INJECTION  STILL HAVING HA, UPSET STOMACH AND VERY WEAK.  VITAL SIGNS WITHIN NORMAL LIMITS 'ROUGH NIGHTS'  TELE HEALTH 12/29/2020  DR  REQUESTING ANOTHER COVID TEST
Patient presented to PCP worsening fatigue and spells of shortness of breath, chest discomfort, felt like something was stuck in her throat and not feeling right for the past one week had the chills; legs weak, EKG showed ST  segment elevation.  Patient was transferred to hospital ED and admitted
Mom reports pt ran T 103(R) & cried high pitched for 3-4 hrs /p immun taken to ER same night of vax
pt recvd flu vax & w/in 24-48 hrs pt exp pruritus & devel a vesicular rash on trunk, extremities, palate & in the vaginal area; pt adm to hosp 28OCT92; MD felt may have serum sickness or stevens johnson synd;
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 07-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) live ZOSTAVAX (lot number reported as 671451/1193AA), subcutaneously that had expired on 25-OCT-2012. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
I received an allergy immunotherapy shot the day before my first dose of the vaccine and instantly felt nauseous and extremely tired after receiving the vaccine, which continued for two days after receiving tut. Three days later, I woke up struggling to breathe (but not anaphylactic), covered in hives, itchy all over, shaking, disoriented, and chilled but not truly feverish.  I reported this to my allergist, who prescribed prednisone and suggested the vaccine combined with immunotherapy were too much for my immune system for one week. The hives, itchiness, and difficulty breathing lasted about four days. I struggled with fatigue and nausea for over two weeks, stopping all school and work in the meantime. After my second dose, I feel just a bit tired and sore, so I think this truly was a bad reaction to the two injections combined rather than to the vaccine itself. Still, it was a debilitating experience,  and I would recommend considering putting out guidance that other immunotherapy patients space out their allergy injections and vaccines farther than I did.
shingles; Information has been received on 09-APR-2019 from a lawyer regarding a case in litigation concerning a female patient (age unknown).  The patient's medical history, concurrent conditions and concomitant medication use were not provided.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  In 2010, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (lot# and route not specified) by a pharmacist.  On an unspecified date, the patient was treated by a physician for shingles as a result of vaccination with zoster vaccine live (ZOSTAVAX).  The outcome was not provided.   Additional information has been requested.
Site: Pain at Injection Site-Medium, Additional Details: PATIENT STATES ARM/INJECTION SITE IS STILL SORE/HURTING AFTER MONTHS FROM INJECTION.
Ringing in ears that started within the 15 minute wait time post injection. It waxes and wanes but it is still always present. Both ears.  Hearing not noticeably  impaired.
This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.