chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a physician (pediatrician) on 30 May 2015. A 05-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of IPOL (batch number, route and site of administration were not reported) on an unspecified date. Illness at the time of the vaccination was not reported. On an unspecified date after vaccination, the patient experienced fine motor, gross and speech development delay. The reporter stated that a mother was trying to find out if the 5 doses of IPV her child received could be related to the events. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was unknown. Upon medical review, the case was considered as serious due to important medical events: slow speech development, fine and gross motor delay. Documents held by sender: none.
Bladder spasms and pressure, frequent urination began one or two days after vaccine.  Tested, and NOT an infection.
Crohns disease aggravated;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4163864-00 (Abbvie).  A 17 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf pen for crohn's disease. Relevant medical history included: "Moderate To Severe pediatric Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. It was unknown if patient was enrolled in a Covid-19 vaccine trial. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohns disease aggravated". The event of non-serious Crohn's disease getting worse versus better with Humira (Adalimumab). The action taken for adalimumab was unknown.  The reporter's causality for the event Crohn's disease getting worse versus better with HUMIRA(ADALIMUMAB) was no reasonable possibility while for Crohns disease aggravated was not reported.  The reporter's causality for the event Crohns disease aggravated with Pfizer Biontech Covid-19 Vaccine was possible.  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 available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Crohns disease . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.] retained for this spontaneous serious HCP report .
Received TB Skin test and Hep B vaccine - reported numbness left hand radiating up arm approximately 5 minutes after receiving Hep. B injection.
This shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot and shot was hurts. The follow-up would not possible as no contact details were available.
Pt complains of hardened knot area and soreness worse every day since vaccination.  "I feel like I have a bouncy ball in my arm."  Pt has tried otc, compresses, Tylenol, and muscle relaxers.
Redness, swelling measuring 15x 11.5cm with central area of multiple small blisters 5x3 in surrounding vaccines site.
Information has been received from a physician concerning a 72 year old patient with diabetes who on 28-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 658361/1090U). It was reported that the patient developed an outbreak of shingles. The rash was on the right side of her back and leg. The patient was seen in the office on 22-APR-2009. It was reported that the patient was given MEDROL dose pack and VALTREX. The patient was not hospitalized and it was not life threatening. The outcome of the patient was not reported. Additional information has been requested.
huge lump on the arm with pain. with ice and ibuprofen it went down 80% over night and sore for 3 days.
having a PE after routine hip replacement; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (having a PE after routine hip replacement) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Hip replacement (routine hip replacement).    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 PULMONARY EMBOLISM (having a PE after routine hip replacement) (seriousness criteria medically significant and life threatening). At the time of the report, PULMONARY EMBOLISM (having a PE after routine hip replacement) outcome was unknown.            Concomitant medications were not provided.  The reporter needed to find info to either condemn or verify whether blood clots were tied to the mRNA vaccination. Patient was clinically dead except for the husband who literally saved her.  Treatment medications were not provided.  Company comment: This is a spontaneous case regarding a female patient of an unknown age, with medical history of hip replacement, who received third dose of mRNA-1273 vaccine and experienced medically significant and life-threatening event of pulmonary embolism (AESI). Vaccination date and onset date of the event were not provided, latency cannot be assessed. According to the reporter, patient experienced pulmonary embolism  after a routine hip replacement and she was convinced it was from her COVID vaccines which it has been at least 4 months since her 3rd shot. Patient was clinically dead except for her husband who literally saved her. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Medical history of hip replacement represents a risk factor for pulmonary embolism. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-661268 (E2B Linked Report).; Sender's Comments: This is a spontaneous case regarding a female patient of an unknown age, with medical history of hip replacement, who received third dose of mRNA-1273 vaccine and experienced medically significant and life-threatening event of pulmonary embolism (AESI). Vaccination date and onset date of the event were not provided, latency cannot be assessed. According to the reporter, patient experienced pulmonary embolism  after a routine hip replacement and she was convinced it was from her COVID vaccines which it has been at least 4 months since her 3rd shot. Patient was clinically dead except for her husband who literally saved her. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Medical history of hip replacement represents a risk factor for pulmonary embolism. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-661268:Reporter's case
I started getting red marks that looked like pimples on my right cheek that went into my nose, then it started itching and swelling and then it started burning. The only thing that helped me was an ice pack. I tried to get to the doctor and on the 03/25 or 03/26 they got me in. I put in cortisone on it and I did not know it should not be used on the face. When I got there he saw that I got shingles and when he looked at it it did not look like shingles, the medicine he gave me was the PIM, and I put that on and it did not cure it but it calm it down. What happened is that after that it move to my lips and I had a lot of pain on my teeth on both sides and the middle, and then it shifted to the other side. Now what I have is everything is calmed down but there are times that my teeth really hurt on those same places or I can feel some tingling like I felt before everything started itching and swelling on every part of my face.  It lasted for weeks. I am going to a Neurologist to take a look at it and my health.
This spontaneous report as received from a nurse refers to a 66 year old patient. Medical history and concurrent conditions were not reported. On 16-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 lot #J009689; expiration date: 29-JAN-2015 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored PNEUMOVAX 23 was administered to patient. No adverse effects reported. On 13-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm-4 pm) the temperature recorded was 50F. On 18-JAN-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (2 pm - 4pm) the temperature recorded was 49.1 F. On 10-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (12 pm- 6 pm) the temperature recorded was 51.8 F. On 16-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 F. On 22-FEB-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 F. On 09-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 F. On 15-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 F. On 16-MAR-2014, PNEUMOVAX 23 was stored outside of recommended temperatures for 20 hours (2 am- 10 pm) the temperature recorded was 64.4 F. On 17-MAR-2014, PNEUMOVAX 23 the temperature reading on the morning was 64.8 F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; bumps size of half a dollar on injection arm; Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; Soreness red and hot around the injection site, bumps size of half a dollar on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm). At the time of the report, VACCINATION SITE WARMTH (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm), VACCINATION SITE INDURATION (bumps size of half a dollar on injection arm), VACCINATION SITE ERYTHEMA (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) and VACCINATION SITE PAIN (Soreness red and hot around the injection site, bumps size of half a dollar on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment for the event was not provided.
Patient is past 42 days since 1st dose which was administered 16Mar2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past 42 days since 1st dose which was administered 16Mar2021) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past 42 days since 1st dose which was administered 16Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient is past 42 days since 1st dose which was administered 16Mar2021) outcome was unknown. Not Provided      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.   No concomitant medications were reported.  No treatment information was reported.
A report has been received from a Health Professional concerning a 13 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient experienced fever of 103 F and neck pain which started on 15-Oct-2013 and sensitivity to light. The patient recovered from the event of fever of 103 F, neck pain and sensitivity to light on an unspecified date. The report was considered to be non-serious.
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M2CA) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-054725 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054725:1st dose
Date and time of vaccination: (list both if they received both shots):   2-25-21 10:30AM 3-18-21 9:15AM Brand and lot of vaccine:   LOT # EL9263 LOT # EN6206  spouse reported she was talking and able to swallow did not voice any SOB or difficulty breathing. recommended benadryl immediately and to seek care at an ER for IV therapy to help with symptoms. Caller verbalized understanding and reported they would be heading there now.
Exhibiti ng signs of what has now been determined to be transvers myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Exhibiti ng signs of what has now been determined to be transvers myelitis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MYELITIS TRANSVERSE (Exhibiti ng signs of what has now been determined to be transvers myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (Exhibiti ng signs of what has now been determined to be transvers myelitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: abnormal (abnormal) Diagnosed with transvers myelitis..         No concomitant medications were provided.  Within three weeks of the second shot the patient began exhibiting signs of what has now been determined to be transvers myelitis. The patient have gone through a battery of test and the symptom seem to lead to this conclusion by all of the neurologist. There appears to be a likely causation between the vaccine and transvers myelitis.  No treatment medications were reported.  Company Comment - This regulatory authority case concerns a male patient of unknown age with no relevant medical history, who experienced the serious (medically significant) unexpected event of myelitis transverse. The event occurred three weeks after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This regulatory authority case concerns a male patient of unknown age with no relevant medical history, who experienced the serious (medically significant) unexpected event of myelitis transverse. The event occurred three weeks after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 034F21A, 009C21A and 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Asthmatic and Immunocompromised.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Patient was on medications and did not want to provide the medications because it was a lot of them. No treatment information was provided.   This case was linked to MOD-2022-570997 (Patient Link).
Had vaginal ulcers and pain/burning upon urination. Went to a medical facility to be evaluated. The physician was convinced I had genital herpes. Symptoms lasted about 7 days
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium
Started bleeding after the shot/bleeding Hemorrhoids; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included allergies, Cholesterol, depression, and haemorrhoids. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol abnormal, and depression, start and stop date were not reported. On an unspecified date, it was reported that the patient experienced Started bleeding after the shot/bleeding Hemorrhoids. The event was described as: "I wanted to know if it is ok to keep taking my allergy medicine, my Lipitor for cholesterol, for depression, and cream for hemorrhoids because I began to bleed from them, since getting the Pfizer Covid vaccine." Therapeutic measures were taken as a result of the event. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Pt. developed HA, dizziness & chest pain within 1 hr. Later in evening had shaky legs, was mumbling his words. By the following morning still had headache, chest pain, dizziness and trouble with word retrieval.
Had flu shot (L) arm pneumonia (R) arm. Had reaction to pneumonia shot (R) arm red, swollen. Patient took TYLENOL and used ice on arm. Had fever which could be from flu or pneumonia.
Patient was given 0.5ml for a booster.  Sore arm and nausea for 24 hours
Patient states that she was given the shot "pretty high in the arm" and the next day woke up with a lot of pain, over the course of the next two months the pain remained and moved in to her shoulder, she spoke to the doctor and said she may have gotten bursitis/frozen shoulder from the shingrix vaccine. The patient said the pain has remained to this day.
I have an artificial knee, and that whole area swelled up, my scar stretched out wider, I could barely bend it or walk on it. It was stiff and very painful , lasting several days before it finally began to slowly  fade some.
No adverse reaction of the patient physically. Dr checked vaccination record at the end of work day and informed this nurse that vaccination was not correct one. Should have been MENACTRA given. Nurse contacted a nurse at the health department and she instructed first nurse to file report and contact patient and his mom. Nurse contacted patient and his mom. They state they understand situation. Will have patient come back to clinic and receive correct vaccine when the vaccine order is here at the clinic.
Ten days after patient got vaccine started getting grand mal seizures and since then has still been getting them.
Skin rash on back presented days after Covid 19 vaccine #1.  Skin biopsy on June 15/2021 c/w lichenoid dermatitis. Treated wth TAC cream BID. Better.  Not worse after 2nd dose.  Also fatigue which has persisted since first Covid 19 vaccine dose.
Pt's mom notified Dr. at ofc. visit 1 wk. after getting injection that his leg had become red and swollen after vaccine. Mom says red and swollen area was approx 2-3" diameter on his Rt. thigh. Mom gave Benadryl. Area went away post several days.
7 cm x 5 cm area of erythema and induration left arm at shot site.  7-8 urticarial lesions on chest and abdomen.  1 urticarial lesion left forearm.