chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site erythema; Bump at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site erythema) and VACCINATION SITE SWELLING (Bump at injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site erythema) and VACCINATION SITE SWELLING (Bump at injection site). At the time of the report, INJECTION SITE ERYTHEMA (Injection site erythema) and VACCINATION SITE SWELLING (Bump at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter wanted to know if patient can get her second dose with an upset stomach.  Concomitant medications were not reported. Treatment information in response to events was not provided.
shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.      On 18-MAR-2013, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provided at a medical office for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).         Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a healthcare provider for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The outcome of herpes zoster was reported as not recovered.     The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Information has been received from a medical assistant through a pregnancy registry concerning a 19 year old female with a history of miscarriage who was vaccinated with the first dose of Gardasil. It was reported that later the patient found out that she was pregnant. The patient was 2 months pregnant at the time of the vaccination. It was reported that the patient miscarried 2 weeks after the vaccination. At the time of the report it was unknown, if the patient recovered. Upon internal review, it was determined that miscarried was an other important medical event. Additional information has been requested.
received expired 2nd booster of Moderna COVID-19 vaccine 28 hours after first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired 2nd booster of Moderna COVID-19 vaccine 28 hours after first punctured) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired 2nd booster of Moderna COVID-19 vaccine 28 hours after first punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired 2nd booster of Moderna COVID-19 vaccine 28 hours after first punctured) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The vial was initially stored in the refrigerator was on 22-Jun-2022, the vial was first punctured on 29-Jun-2022 around 11 am, the vaccine was administered on 30-Jun-2022 at approximately 3 pm, the vial was stored at room temperature post puncture, the vial did not undergo any temperature excursions and the total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius= 46 degree to 77 degree Fahrenheit) was 28 hours.  The reporter reported that the patient had not reported any adverse event.  No treatment information was provided by the reporter.
nausea, "feeling like throat closing", dizziness. Evaluated by EMS-Cleared
pt states that the night after getting the vax she had in pain in the left arm.  A couple of days later she started itching on her upper back.  She doesn't see a rash but has itching that comes and goes.  Pt still has these symptoms. Pt will contact her PCP regarding her symptoms.
Narrative: Patient presented to non-facility ED on date he received 3rd dose of COVID-19 vaccine with chief complain of rigors and shaking. He got the vaccine in the morning and became ill with a fever later in the afternoon. Patient found to have lactic acidosis. Given 2 L of fluids and 2 gm of IV rocephin due to fever of unknown origin. Due to rigors, fever and lactic acidosis admitted to hospital (9/3-9/7/21). Blood cultures negative. Initially started on Zosyn for possible pneumonia. His workup otherwise negative (clear CT of chest (pleural effusion), negative urine culture, negative acute respiratory panel, sputum culture with normal oral floral, CT abdomen and pelvis with no clear evidence of infection). Continued to have intermittent fevers. Slight productive cough so discharged on Augmentin. ID specialist felt this may possible be vaccine reaction with immunosuppression and multiple myeloma treatment. Discharged diagnoses = sepsis with unclear etiology, possibly due to vaccine reaction versus pneumonia, hypoxia with dyspnea and other chronic conditions.
No additional adverse effects reported; patient received improperly stored dose of VARIVAX; This spontaneous report was received from a physician, referring to a patient of unknown age and gender.   No information regarding the patient's pertinent medical history, current conditions, drug reactions or allergies was provided.  On 11-MAR-2020 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dosage form (route of administration, vaccination scheme and  anatomical site of vaccination, were not reported); lot number S025609, expiration date 18-AGU-2020, as prophylaxis.  The used of a properly stored sterile diluent were reported.   The administered dose of the vaccine experienced a temperature excursion -5.48 degrees Celsius for 7 hours, as recorded by a data logger. There was no adverse effect reported.
Patient reported about 8 to 10 days after receiving the shingrix vaccination that she started to develop a really itchy rash on her back and that she and her husband both felt it looked like shingles.  Patient ended up going to the local Clinic and the provider there did diagnose the rash as Shingles.  Patient received a short course of antiviral drug valacyclovir.
No adverse reaction. Several days later the vaccine was deemed spoiled due to fridge temps dipped below proper temp levels.
pt recvd vax; 3 hrs later devel varicella; md felt pt sxs not related to vax;
10/23/09 pt. presents with hives, firm, swollen R deltoid.
Joint pain, inflammation and swelling  in left ankle, neck and right knee & shoulder. Fevers, sweating, fatigue. Couldn't walk and in a lot of pain in all areas listed
Had her 1st dose of the Moderna COVID-19 Vaccine on 30-Mar-2021 but had not gotten 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Had her 1st dose of the Moderna COVID-19 Vaccine on 30-Mar-2021 but had not gotten 2nd dose yet) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 PRODUCT DOSE OMISSION ISSUE (Had her 1st dose of the Moderna COVID-19 Vaccine on 30-Mar-2021 but had not gotten 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Had her 1st dose of the Moderna COVID-19 Vaccine on 30-Mar-2021 but had not gotten 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment information was not provided.  Patient wanted to know if she could get the 2nd dose or had to start over.   Reporter did not allow further contact
No issues with first 2 vaccines.  10/12 received booster.  10/13 started having symptoms.  Severe chills and shaking, had to stop dialysis early.  Diarrhea x2 days.  Redness, hardness, swelling, heat, pain at injection site, wrapped around to backside of arm.  Continued worsening until 4th day after injection.  Still sensitive to the touch, but no longer red and hot for another couple of days.
nauseas; when she goes to cough the right side of her head hurts; when she goes to cough the right side of her head hurts; injection site it was itchy; injection site it was red; injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (when she goes to cough the right side of her head hurts), VACCINATION SITE PRURITUS (injection site it was itchy), NAUSEA (nauseas), HEADACHE (when she goes to cough the right side of her head hurts) and VACCINATION SITE ERYTHEMA (injection site it was red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site it was itchy), VACCINATION SITE ERYTHEMA (injection site it was red) and VACCINATION SITE SWELLING (injection site was swollen). On 30-Apr-2021, the patient experienced COUGH (when she goes to cough the right side of her head hurts), NAUSEA (nauseas) and HEADACHE (when she goes to cough the right side of her head hurts). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, COUGH (when she goes to cough the right side of her head hurts), NAUSEA (nauseas) and HEADACHE (when she goes to cough the right side of her head hurts) had not resolved and VACCINATION SITE PRURITUS (injection site it was itchy), VACCINATION SITE ERYTHEMA (injection site it was red) and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included hot compress on arm No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient developed a red, bumpy, blistering rash over her body around 8/10/17-8/12/17 (approximately 17-20 days after vaccination).
Child received immunizations on Tuesday, 5/29/07 around 1:30pm.  Around 7:00pm that evening, mother noticed white spots on tip of tongue and blisters on his lip.  The next morning, it was spread over his whole tongue and had more blisters on his lip.
3 days p/vax lt breast swollen & sore; couple days later rt breast swollen & sore; swelling & pain went down under rt arm also; joints swollen & sore have heat in them; hurt all over;
Pt experienced multiple syncopal episodes after being vaccinated. Pt was monitored by the provider, and eventually released to self care.
Was given seasonal flu vaccine in left deltoid on 10/1/09. Began having soreness & difficulty lifting her arm that night. Warm to touch. Seen by Dr. Dx cellulitis antibiotic given.
Blood pressure has risen by over 10 systolic and more diastolic; Blood pressure has risen by over 10 systolic and more diastolic; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 03Sep2021 at 11:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, emphysema, chronic obstructive pulmonary disease (reported as copd), hypertension and many allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included insulin glargine (TOUJEO), metformin (MANUFACTURER UNKNOWN), rosuvastatin (MANUFACTURER UNKNOWN) and fenofibrate (FENOFIBRATE MICRO); all from unknown dates for unknown indications and unknown if ongoing. On 03Sep2021, the patient had hypertension and her blood pressure had risen by over ten systolic and more diastolic. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event blood pressure had risen by over ten systolic and more diastolic was not resolved at the time of this report.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (unknown strength, route and lot#). Concomitant medications were not reported. On an unknown date, 8-9 months later, the patient was diagnosed with severe pneumonia. The outcome the event was unknown. There was no product quality complaint involved. Additional information has been requested.
Symptoms: Chills, body aches, insomnia  Starting in the evening after receiving the vaccine I began experiencing chills where I felt so cold that I would wrap in a blanket immediately followed by feelings of feverishness where I threw off the blanket, repeatedly. This feeling was accompanied with feelings of whole body aching and the inability to sleep.
CLIENT BECAME THIRSTY AND FELT LIGHT HEADED. DRANK A FEW SIPS OF WATER AND FELL OFF LEFT SIDE OF CHAIR ONTO LEFT SIDE OF FOREHEAD. AREA RED BUT NO BUMP. LOST COLOR, CONSCIOUS AND BODY STIFFENED FOR 5-10 SEC. WOKE UP ALERT TO TIME AND PLACE. SLOWLY SAT BACK UP AND RETURNED TO CHAIR. GIVEN SIPS OF WATER, CANDY, ICE BAG FOR FOREHEAD, COOL COMPRESSES. STATED HADN'T EATEN THIS AM. BP 110/60, P 60. STATED FELT OK AFTER 5 MINUTES AND WANTED TO LEAVE WITH MOM. COLOR WAS IMPROVED. ENCOURAGED TO GET SOMETHING TO EAT WITH PROTEIN/CARBS, TAKE IT EASY TODAY AND CONTACT DOCTOR IF FURTHER PROBLEMS. STATES THIS HAPPENED 2 TIMES BEFORE WHEN YOUNGER AFTER BEE STING AND WHEN DEHYDRATED.
Ovarian cyst; heavier period at 22 day cycle/10 day shed/ 27day cycle with liquid like menstruation with clumps 9 day duration; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Left arm, on 27Apr2021 09:00 (at the age of 43-year-old), as DOSE 2, SINGLE for covid-19 immunization. Medical history included type 1 diabetes mellitus and Ferritin deplete anemia. The patient's concomitant medications were not reported. The patient previously received fluorescein and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on Left arm, on 06Apr2021 (at the age of 43-year-old), as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has been tested for COVID-19. The patient experienced heavier period at 22 day cycle on 18May2021, ovarian cyst in Jun2021, 10 day shed on 09Jun2021,  27day cycle with liquid like menstruation with clumps 9 day duration on Jul2021. It was reported that events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Pct (nasal swab) in 2021 (unknown result). The events were assessed as non-serious. The patient didn't receive any treatment for the events. The outcome of the events was not recovered at the time of report.  Information on the lot/batch number has been requested.
Patient said he experienced muscle pain that moved around his body beginning the day he received the immunization. He still has this pain today.
Diplopia due to left 6th (abducen) cranial nerve palsy; Diplopia due to left 6th (abducen) cranial nerve palsy; This is a spontaneous report from a contactable physician. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), intramuscular, in the left arm, on 05Jan2021 07:30 at a single dose for covid-19 immunization. Medical history included type 2 diabetes. Concomitant medications were unspecified. The patient took unspecified medications in two weeks. The patient did not have any other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. The patient had no known allergies. On 07Jan2021, the patient experienced diplopia due to left 6th (abducen) cranial nerve palsy. The event resulted in doctor office/clinic visit, and emergency room visit. Therapeutic measure was taken as a result of the event which included fresnel prism on current glasses to alleviate diplopia. Outcome of the event was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported diplopia due to left 6th (abducen) cranial nerve palsy and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.
4 days post vax, the pt developed papular, semi-vesicular lesions all over with lymphadenopathy.
Admitted to the hospital after receiving COVID vaccine.  Admit due to fall on coumadin causing subdural hematoma, not COVID.
allergic; Covered in hives; Swelling in my face; This case was reported by a consumer via interactive digital media and described the occurrence of drug allergy in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   The patient's past medical history included cold and influenza. Previously administered products included Proair.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced drug allergy, hives and facial swelling. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the drug allergy, hives and facial swelling were unknown.   It was unknown if the reporter considered the drug allergy, hives and facial swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, had only pro air and nebulizer to fall back on and tried to avoid cols and flu. The patient reported that, after vaccination had very allegic to flu shot and covered in hives, and swelling on face past 2 times.
pt has sz is on Depakene;platelet count dropped (27,000); reduced depakene, platelets remained low a few days;dx viral infect, bronchitis, OM, fever, thrombocytopenia & sz exacerbation;
I have severe, random, and unprovoked bruising covering both legs. I have abdominal pain that has persistent since being vaccinated. I?m dizzy. I?m bleeding in my urine, stool, and vaginally. Period came early (unrelated to previous vaginal bleeding) and is not clotting. Just significant amounts of red blood, soaking through one ultra absorbency tampon an hour. I have a headache. Went to the ER and my platelets were (345) and my blood sugar low. My bp was 145/90 which is high for me, from the bleeding.  They said I have a ?higher chance of being bitten by a shark? than having a side effect. They diagnosed me with a single contusion and sent me home. Have been feeling worse since leaving the hospital.
Information has been received from a physician concerning a 14 year old female who approximately "4 years ago" (in 2006) was vaccinated with all three doses of GARDASIL (dates, routes, sites of injection and lot numbers not reported). The physician reported that the patient had a Papanicolaou (PAP) test and the result came in as Human Papillomavirus (HPV) positive but HPV type was unknown (date unspecified). At the time of the report the outcome of the patient was recovered (date not reported). The patient sought unspecified medical attention. Follow up has been received from a nurse practitioner who reported that her patient is 14 year old now and she received all 3 doses of GARDASIL when she was 11 year old. The sexually active patient had an abnormal Papanicolaou (PAP) test (Atypical Squamous Cells of Undetermined Significance (ASC-US) (date unspecified). The colposcopy was done (date unspecified). And the result of the biopsy was pending. In the follow up information the physician had a question that if company has information on the breakthrough disease after vaccinating 11 year old patient with the GARDASIL. The physician would plan to run the Cervista test (Hologic) to determine what HPV type may be causing the Atypical Squamous Cells of Undetermined Significance (ASC-US). Additional information has been requested.
This spontaneous report was received from a registered nurse and referred to a 28-year-old female patient. No information regarding the patient's medical history, concomitant therapies and concurrent conditions was provided. On an unknown date in 2013, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). The following day (on an unknown date in 2013), the patient experienced a fever. The outcome of fever was reported as recovered (date unspecified). The causality assessment between the event of fever and GARDASIL was not reported.
Two days after receiving ZOSTER vaccine, pt reports pain, redness, swelling, tenderness and extreme warmth/heat at the injection site. Also reports a lump under the skin approx. 3 inches in diameter. Nausea but no vomiting. No fever, SOB, dizziness or chest pain. Treated with doxycycline, calamine, cool compresses.