chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Parent reported event to Health Center 12/1/2022. Parent reports child had "head to toe" rash with onset approximately 3 days post vaccination and resolved 1 week post vaccination. The parent also reports the child was lethargic and spiked high fever 3 days post vaccination and resolved 7 days post vaccination. Parent did not specify that she notified healthcare provider after this incident. Parent reported to me today "the same events occurred with vaccinations received 3/22/18, 5/10/18, 7/19/18, and 5/8/19." In all encounters with the parent consent, the parent said "no" to questions "does your child have allergies to medications, food, a vaccine component or latex" AND "has your child had a severe allergic reaction to a vaccine in the past."
Bleeding; Cramping; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 12Sep2021 12:00 (batch/lot number was not reported) at the age of 40 years old,  as DOSE 2, SINGLE for COVID-19 immunization. The vaccine was administered at a Pharmacy or Drug Store facility type. The patient's medical history was not reported. Patient had no history of COVID-19 infection prior to vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks and other medications in two weeks. The patient previously took aspirin [acetylsalicylic acid] and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 21Aug2021 11:45 AM (batch/lot number was not reported) at the age of 40 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced cramping and bleeding which started the next day (on 13Sep2021) after the 2nd shot. It was reported that patient was still bleeding at the time of reporting (day3 post injection). The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received treatment for the events. The patient has not recovered from the event bleeding. Outcome of the event cramping was unknown. Patient has not tested for COVID-19 post vaccination  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
current_age: 12; Sore arm; This is a spontaneous report from a contactable 12-year-old male consumer reported for himself that he received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EWO0182), via an unspecified route of administration in the right arm on 17-MAY-2021 15:45 as 1 ST DOSE SINGLE for covid-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested positive for covid-19. The patient's medical history and concomitant medications were not reported. On 17May2021 at 04:00pm, the patient experienced sore arm. Since the patient was 12-Year-old Off label use in unapproved age group was added as an additional event. The outcome of the event was recovered.
Dose administered greater than 12 hours post puncture/ Vaccine was first punctured on 2Mar2022 at 11:30 a.m. and a syringe loaded; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture/ Vaccine was first punctured on 2Mar2022 at 11:30 a.m. and a syringe loaded) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2022 at 8:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2022 at 8:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture/ Vaccine was first punctured on 2Mar2022 at 11:30 a.m. and a syringe loaded). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture/ Vaccine was first punctured on 2Mar2022 at 11:30 a.m. and a syringe loaded) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was mentioned that the vial was initially stored in the refrigerator on 02-Mar-2022. The vial did not undergo any temperature excursions. Total amount of time the vial exposed to room temperature range (8 degree to 25 degree Celsius = 46 degree to 77 degree Fahrenheit ) for 4 and a half hours.
Experience sharp and ongoing pain immediately after urinating.  As my mother had UTI a couple of days after getting her Moderna shot, I suspected the same.  But went to ER bc of how sudden pain occurred and because of closeness to me taking the second vaccine.
24 hours after receiving the injection, I had a 100.5 temperature, joint aches, body aches and a headache that lasted about 24 hours.
Reactions causing arthritis flairs, less to the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRITIS (Reactions causing arthritis flairs, less to the booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Reactions causing arthritis flairs, less to the booster). At the time of the report, ARTHRITIS (Reactions causing arthritis flairs, less to the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines was reported.  No treatment medicines was reported.  This case concerns a patient of an unknown age and gender with no medical history, who experienced the unexpected non-serious adverse event of special interest, Arthritis. The event of occurred on an unknown interval after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the second dose was given. It was reported that the outcome of the events was unknown. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-428053 (Patient Link). Sender's Comments: This case concerns a patient of an unknown age and gender with no medical history, who experienced the unexpected non-serious adverse event of special interest, Arthritis. The event of occurred on an unknown interval after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the second dose was given. It was reported that the outcome of the events was unknown. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
R arm at injection site very warm to the touch; approx. 3 inch red, raised area around site; palm sized area very tender + slightly hard.
red, warm, itchy area around inject site about size of nickle; scattered red, discrete macules upper lt arm & both legs (itches) pt is also taking sulfa x 7-10 days;
Phone call from mother on 3/2/04 stating right arm from shoulder to middle upper arm swollen 2-3 times normal size. Warm to touch and red also states low grade fever since late afternoon 3/1/04-unable to contact mother for follow-up this am. Phone number given-no longer in service.
Itchy at the injection site; Little warm at the injection site; Rash around 4 * 2 inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Itchy at the injection site), VACCINATION SITE WARMTH (Little warm at the injection site) and VACCINATION SITE RASH (Rash around 4 * 2 inches at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE IRRITATION (Itchy at the injection site), VACCINATION SITE WARMTH (Little warm at the injection site) and VACCINATION SITE RASH (Rash around 4 * 2 inches at the injection site). At the time of the report, VACCINATION SITE IRRITATION (Itchy at the injection site), VACCINATION SITE WARMTH (Little warm at the injection site) and VACCINATION SITE RASH (Rash around 4 * 2 inches at the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported. No concomitant medication was reported.
About 1 hour after administration of vaccines, developed rigors, shortness of breath, nausea and vomiting.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history was not reported. On 01-JUN-2015 the patient was vaccinated with the first dose of ZOSTAVAX (strength, lot#, expiration date, dose and route were unknown). On approximately 10-JUL-2015 (reported as "about 40 days" after the first dose), the patient was inadvertently administered a second dose of ZOSTAVAX (strength, lot#, expiration date, dose and route were unknown). No adverse effects were reported. Follow up information has been received from the registered nurse on 13-JUL-2015. The registered nurse reported that the patient had not been administered a second dose of ZOSTAVAX "about 40 days" after the first dose. The patient had not been administered any doses of ZOSTAVAX on 01-JUN-2015 or 10-JUL-2015. The patient had been administered the first and second doses of RECOMBIVAX HB (strength, lot#, expiration date, dose and route were unknown) on 01-JUN-2015 and on 10-JUL-2015, respectively. The second dose of RECOMBIVAX HB was administered more than one month after the first dose. There was no product quality complaint (PQC). Additional information has been requested. Product information, event information and narrative were updated.
Rapid heart rate (105) for 3 days, shortness of breath,dizzy, nausea, diarrhea .Diagnosis, blood clots in lungs
broke out into a rash on the trunk of her body and arms that was also itching as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunisation, reaction(s): "no adverse event"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation, reaction(s): "She had horrible intense itching to the booster for 6 weeks". The following information was reported: RASH PRURITIC (non-serious), outcome "not recovered", described as "broke out into a rash on the trunk of her body and arms that was also itching as well". The events "broke out into a rash on the trunk of her body and arms that was also itching as well" required physician office visit.  Additional information: Reporter stated she was immunocompromised and had an autoimmune disease. She had a reaction a year and a half ago to the Pfizer Biontech Covid 19 vaccine booster. She had horrible intense itching to the booster for 6 weeks. She stated it was internal from the inside out and she took 10 antihistamines a day. She had no reaction to the primary series. She received the Comirnaty 2023/2024 vaccine in the beginning of Oct and broke out into a rash on the trunk of her body and arms that was also itching as well. She still had it. Patient asked if anyone reported having a rash with this product. She had doctor and immunologist. She asked for a referral to a dermatologist.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357094 Same patient/product, different dose/events;US-PFIZER INC-202300357092 Same patient/product, different dose/events;
Information has been received from a pharmacist concerning a female patient with high blood pressure who "more than a year ago" was vaccinated with ZOSTAVAX (Merck) (lot number not reported). Subsequently the patient developed shingles twice since vaccination. It was unknown if medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
rash covering right side of body has not cleared completely after three weeks still has spider veinlike appearance and colorless bumps.  Began as red/raw irritated and bumpy.
Initial report received from health care professional on 08 Jan 2010: This patient was vaccinated with FLUVIRIN (batch no. 102125P) 0.25 ml, intramuscular (injected into thigh), on unknown date. The vaccine was inadvertently given to 6 months old. No adverse effect was noted after administration. The outcome of event was not reported.
ON DAY 10 HAD NEW SMALL BLISTER APPEAR ON ARM. APPROXIMATELY 3.5 CM FROM INITIAL SITE--DIFFERENTIAL SATELLITE LESION VS. AUTOINOCULATION. **PT RECEIVED 6 JABS **
diagnosed with colon cancer; Sore arm; This is a spontaneous report form a Pfizer sponsored program. A contactable consumer (the patient) reported that: A 73-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On an unspecified date, the patient was diagnosed with colon cancer and also experienced sore arm. It was reported that the patient and her husband had both doses of the Pfizer COVID19 vaccine and had only experienced sore arm as side effect of the vaccine. The patient stated that she was diagnosed with colon cancer and has been undergoing chemotherapy (12 cycles). Using a special blood test that helped in detecting tumor markers and cancer cells, the patient reported that before her 1st dose and up until her 1st dose, her cancer/tumor marking detection was 0. However, 3 days after getting her 2nd dose, there was an observed elevation on the said markings. The patient had already reported this to her physician, and her PCP highlighted that it was not because of the vaccine. In line with this, the patient would like to know if there are any information in regards tumor markings/cancer cells markings elevation in patient who had received the Pfizer COVID19 vaccine with pre-existing Cancer diagnosis. On unspecified date, the patient underwent lab tests and procedures which included special blood test: cancer/tumor marking detection was 0 (before her 1st dose and up until her 1st dose), special blood test: observed elevation of cancer/tumor marking (3 days after getting her 2nd dose). Therapeutic measures were taken as a result of diagnosed with colon cancer. The outcome of events was unknown.  Information about lot/Batch number has been requested.
On 02/10/2023 I started feeling very fatigue, coughing, headaches, that lasted for four days. After reaching out to the doctor I was diagnosed with Covid-19. I was treated with Paxlovid and Remdesivir infusion. Symptoms are ongoing
Patient has experienced papular, pruritic rash on arms, knees, neck, face repeatedly since second dose of pfizer covid vaccine.  Will intermittently experience symptoms of anaphylaxis which resolves with antihistamines and does not require epi.
MD reported that pt was vaxed w/MMR approx 14AUG92 & 24AUG92 pt devel nephrotic synd;
Approximately 10 minutes after the patient received the immunization, she fell face first to the floor - without warning - from a standing position. As she was turned over onto her back she appeared to have a seizure - she was unresponsive and had clonic tonic movements that lasted 10 - 15 seconds. She was placed on her side until the movements ceased and then turned to her back - with feet elevated - to assess for injury and/or airway obstruction. She was slightly disoriented and her mother was encouraged to ask her questions. The patient could not explain what happened but knew her name and where she was. The patient was gradually assisted into a sitting position and a cold water bottle was applied to her chin (slight redness noted, no lacerations). She was assisted to stand about 20 minutes after the fall and was able to do so without support. Her mother was encouraged to seek emergency attention if this happened again and to follow up with her primary care provider to apprise them of the situation. The patient, her mother and younger sibling exited the mobile unit without incident. The patient was able to ambulate without apparent disability and without assistance.
Information has been received from a county health registered nurse concerning a 7 year old male who on 25-OCT-2000 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
light headed, dizziness, sweating, anxious, vision blur saw yellow,   had him sit extra 15 minutes until felt better took temperature - low registered 95,  drank juice had a granola bar , stayed seated until felt better was with friend who was able to help when left temperature was at 96
patient came in 1 week early to get booster.  This was not caught during checkin and patient received vaccine.  No adverse symptoms are being reported
Starting getting a rash in the form of chicken pox like bumps that itched all over my body.; Starting getting a rash in the form of chicken pox like bumps that itched all over my body.; This is a spontaneous report received from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: El1284, Expiration date was not reported), via an unspecified route of administration in Arm Left on 16Jan2021 15:30 as single dose for covid-19 immunization. The patient had no relevant medical history and had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC), buspirone HCL and Yeast Gard supplement. On 26Jan2021, the patient started getting a rash in the form of chicken pox like bumps that itched all over my body. The patient's adverse event resulted in emergency room/department or urgent care. The patient received treatment with steroid pill and topical cream. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was recovering.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M014908, expiration date 25-MAR-2018 (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced temperature excursion of 41 degrees Fahrenheit (>14 but <16 degrees Fahrenheit) for 8 hours. Data logger was involved. It was also reported a previous temperature of excursion of 10 degrees Fahrenheit (>5 but <14 degrees Fahrenheit) for 2 hours. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA006257: US-009507513-1703USA006256: US-009507513-1703USA006254: US-009507513-1702USA010414.
no adverse event; lot that had been expired was administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (no adverse event) in a 53-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patients).    Patient age was reported as 53 Year 7 Months.  No concomitant medication was provided. ID number was reported as 80777027399.   Lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
Patient said the her arm started hurting when the shot was given.  She said a rash developed at the injection site and became hot and itchy on the 2nd day.  It continued to spread down her arm from the injection site.  She said it was a little better today (5/27/2019).  She said she is going to call her doctor tomorrow.
pt admitted to hospital with headache, confusion and left sided weakness; tested positive for COVID; CT scan showed a large SDH with midline shift; pt intubated; pt had a right craniotomy; pt's condition declined; family decided to extubate and pt died in the hospital
Baby had episode of high pitch crying and was inconsolable > 3 hours following first set of immunizations given 3/11/13. She had a decrease in appetite. Also low grade fever of about 99F per Dad. Decrease in feeding lasted approximately 1 week.