chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a 16 year old female patient. On 18-FEB-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020901, expiry: 05-JUL-2015) in the arm. On 18-FEB-2013, the patient experienced numbness in the arm that was vaccinated. Patient sought medical attention. Physician stated the patient came into the office on an unspecified later date, to receive another dose of GARDASIL, and reported this adverse event to the physician. The patient reported the numbness resolved itself within 24 hours (approximately on 19-FEB-2013). This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Developed a know on left arm with pain and itching. She put ice pack and  took ibuprofen and hydrocortisone cream to area.
Temp of 101.1, headache, body aches,  malaise for about 30 hours
This 74 year old male had a flu vaccine 7 days ago in his physicians office.  He was doing well until 3 days ago when he developed fever to 102 degrees, chills, nonproductive cough, myalgias, arthralgias.  He has also developed some painful swollen palms and soles of his feet with redness.  No vesicles, no sore throat or conjuctival discharge.  No known exposure.  He has been taking aspirin since yesterday for this.
In August I was hospitalized for diabetes. I was going into diabetic shock. I began taking insulin shots daily.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2 (BNT162B2), on 07Jul2021 as dose 1, single (Lot number: FA6780), in left arm and on 23Aug2021 as dose 2, single (Lot number: FC3181) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE, start date: 12Jul2020; LUPIN, start date: 12Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Sep2023 to 14Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300306860 same patient, different drug and event;US-PFIZER INC-202300306916 same patient, different dose and event;
extreme immediate fatigue  blood pressure 122/72 heart rate 84 Skin pink warm and dry.  Respirations even and unlabored.  Patient given juice and monitored after laying her on a cot to rest.  Later released with no further problems.  At 3:40 follow up phone call made, no answer.
Received immunization on 1/9/06.  Mom noticed red raised area in the spot where shots were given.  L thigh was a baseball size, R thigh was a nickel size.  Raised areas still present.
Within 48 hours, pt developed trembling of body about 10 seconds, fussiness, lethargy, decreased appetite. Pt had blood work done and EEG ordered (to rule out seizures).
This spontaneous report received from a patient who was a health care professional via other manufacturer (Pfizer Inc) concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: ESRD (end stage renal disease), chronic kidney disease, anxiety, allergy (drug name not specified) and depression, and other pre-existing medical conditions included: The patient was a health care professional. The patient was not pregnant at the time of reporting. The patient was previously received two doses of Pfizer biontech covid-19 vaccine (Tozinameran) (Dose number in series 1) (form of admin, route of admin was not reported, batch number: unknown and expiry date: unknown) doses were not reported, administered on 28-JAN-2021 at 19:00 (first dose) and on 21-FEB-2021 at 16:00 (second dose) for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with 2 doses of Pfizer biontech covid-19 vaccine (Tozinameran) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (third dose) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 06-JUN-2021 15:00 for prophylactic vaccination. Age at time of vaccination 26 years old. The batch number was not reported and has been requested. Concomitant medications included belatacept (Nulojix), bupropion hydrochloride (Wellbutrin), ferrous sulfate  (iron), mycophenolate mofetil, and prednisone. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (Dose number in series 2). The patient received additional dose of non-company suspect vaccine Pfizer biontech covid-19 vaccine (Tozinameran) (Dose number in series 3) (fourth dose) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 26-SEP-2021 at 16:00 for prophylactic vaccination. The patient was prescribed with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 10-MAY-2022 and last dose on 15-MAY-2022 for covid-19 infection. On 21-MAY-2022, at 08:00, the patient started having cough and nasal congestion/ runny nose approximately 6 days after patient last day of the 5 day treatment course of paxlovid. The patient reported that she was coughing a fair bit every few minutes or so and also had rhinorrhea (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from cough/ coughing a fair bit every few minutes or so, nasal congestion/ runny nose, and rhinorrhea. This report was non-serious.
pt recv vax 21MAY96 & was found to be pregnant; the pt reported that devel 2 lesions on leg & a few days p/vax menstrual type cramping in abd;
After 2nd injection, acute pain in the left shoulder/arm/neck region, which lasted for during the first month.  Arm movement was greatly limited, and included acute pain duirng this time.  After a month, the chronic pain fluctuated on a daily basis, and has continued throughout the last 6 months, and continues to flare up.  I have had to make two trips to the Emergancy Room and once to Urgent Care due to the severity of the shoulder pain.  This pain has caused tremendous stress, sleep loss, and depression with loss of my life involvement with my family and friends. I have been prescribed a variety of prescriptions and blood work analysis, all the while having muscle spasms in the trapezious. I have also been received  16 sessions of  physical therapy, beginning on 5/18/21 and has continued through 10/14/21.   I also visited my chiropractor on two separate treatments, with no relief.  Throughout the course of the last six months, I experienced to "jolts" of nerve pain in my neck an lower jaw area, too.  On 9/17/21, I also consulted with an orthopedic surgeon. After refiew of my latest MRI he diagnosed an impingement in my left shoulder.  After lengthy conversation, it was decided that surgery would be the most efficient method of dealing with this problem.  It MUST be noted that PRIOR to receiving either dose, I have NEVER had shoulder problems with my left shoulder.
HYPOTENSION 12/31/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
MY DAUGHTER STARTED HAVING SEIZURES ON 3/20/2011, EXPERIENCES HEADACHES, FATIGUE, BEHAVIOR CHANGES, DIZZINESS, AND BLURRED VISION AT TIMES.
Patient called pharmacy to inquire about adverse effects of 1st dose. She experienced severe swelling and redness of the right arm as well as fatigue for 2 weeks. It was discovered that her 1st dose was administered incorrectly. Pharmacist apologized to patient and called GSK to verify 1st dose would still be effective. GSK said per DCD guidelines, 1st dose still effective. GSK said IM is the only approved method of administration because it results in less adverse effects than SC. Pharmacist reported incident per company policies and is reporting to VAERS.
Tingling sensation; redness; rash; Dizziness; Soreness right at the site of injection; Raised area on her left arm; COVID arm; Chills; she noticed 3 spots on her bicep/spots moved up to the back of her left side of neck/shingles; Arm was sore; Arm was itchy/itchy area on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (she noticed 3 spots on her bicep/spots moved up to the back of her left side of neck/shingles), DIZZINESS (Dizziness), PERIPHERAL SWELLING (Raised area on her left arm), PARAESTHESIA (Tingling sensation) and VACCINATION SITE REACTION (COVID arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to amoxycillin.drug rash - little checkered spots). Concomitant products included LORAZEPAM from 30-Jan-2021 to 20-Jun-2021 for Anxiety.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (Arm was itchy/itchy area on her left arm). On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 10-Mar-2021, the patient experienced HERPES ZOSTER (she noticed 3 spots on her bicep/spots moved up to the back of her left side of neck/shingles). On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Raised area on her left arm), VACCINATION SITE REACTION (COVID arm) and CHILLS (Chills). On 17-Mar-2021, the patient experienced DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Soreness right at the site of injection). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation), ERYTHEMA (redness) and RASH (rash). The patient was treated with VALACYCLOVIR [VALACICLOVIR] from 15-Mar-2021 to 25-Mar-2021 at an unspecified dose and frequency. On 07-Mar-2021, PAIN IN EXTREMITY (Arm was sore) had resolved with sequelae. At the time of the report, HERPES ZOSTER (she noticed 3 spots on her bicep/spots moved up to the back of her left side of neck/shingles), DIZZINESS (Dizziness), PERIPHERAL SWELLING (Raised area on her left arm), PARAESTHESIA (Tingling sensation), VACCINATION SITE REACTION (COVID arm), PRURITUS (Arm was itchy/itchy area on her left arm), VACCINATION SITE PAIN (Soreness right at the site of injection), ERYTHEMA (redness), RASH (rash) and CHILLS (Chills) had resolved with sequelae.        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.   Complaint title: Vaccine too strong for thin persons   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Added other relevant history. Added concomitant medications. Added treatment medication details. Updated event outcome.
Bed wetting at night, then constant thirst and urination for weeks. Brought to Pediatrician and then was referred to Hospital because of extremely high blood glucose levels. Hospital Endocrinology department diagnosed him with Type 1 Diabetes and he spent 3 days in the hospital.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion in October 2018 and Hernia (As a child). Family history included Family history of cardiovascular disorder, Diabetes and Rheumatoid arthritis. Concurrent medical conditions included Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 30-Jun-2018 to an unknown date for Pregnancy.    On 29-Dec-2020 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Jul-2020 and the estimated date of delivery was 27-Apr-2021. On 29-Dec-2020 at 1:15 PM, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The vaginal delivery occurred on Apr-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. It was a full term vaginal delivery without any complications, mother didn't experience any problems during delivery. There were no perinatal complications for the infant. There were no identified fetal/infant abnormalities on delivery and no identified infant abnormalities at 1 month post partum. On 29-Dec-2020 at 1:15 PM, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2020, Pregnancy test: positive (Positive) positive.     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.   Treatment medications information not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow Up received on 08-JUN-2021 Contains Pregnancy Outcome Information and Updated date of Pregnancy Test, Updated start date and Route of administration of Concomitant Medications.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 at 14:00 as dose 1, single (Lot number: EV6202) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Aortic aneurysm" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Peripheral neuropathy" (unspecified if ongoing); "Complication HCV infection" (unspecified if ongoing), notes: the infection has resolved. Concomitant medication(s) included: GABAPENTIN; OMEPRAZOLE; ZOLPIDEM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had also received other medication in 2 weeks. The patient had no known allergies. The patient had received Paxlovid as COVID-19 treatment from 12Jul2022 to 17Jul2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
Swelling, itching, redness at injection site that increased to a 6 inch diameter and lasted 2 weeks. Very painful.
events: low-grade fever about 5-6 hours after dose, lasted about 3-4 hours. sore/scratchy throat about 5-6 hours after dose, lasted about 48 hours; fatigue about 3 hours after dose, lasted about 48 hours.  treatments: ibuprofen 400mg at 2 hour mark of fever; cough drops for sore throat; water for hydration; sleep outcomes: all adverse effects subsided by 48 hour mark.
Atrial Flutter. On 10/11/15 upon rising - Ocular Hyperemia.
Began experiencing achiness and fatigue around 12 hours after vaccine. Ran 103.7 fever during the night. Uncontrollable chills, severe headache, exhaustion, nausea, diarrhea continued through the night and into the next afternoon 4/11. Chills, fever faded but insomnia, nausea, headache, diarrhea remain as of 4/13
About 10 days after first dose of Moderna COVID-19 Vaccine, began to have itchy rashes all over the body. 3 days later as I write this, I still have these rashes.
Pt. began throwing up, shaking, running a fever, was cold & couldn't get warm, and had difficulty breathing (couldn't get air in) about 4 hours post-vaccination.
Developed pain of right thigh the evening after the injection.  Was not putting weight on the right leg. The next morning there was thigh swollen and erythematous.  Right thigh was 14 inch diameter, left thigh 13 inches diameter.  2cmx5 cm area of redness on skin.   When patient seen in clinic 2/19 (the following day), patient was weight bearing and jumping around.  Suspect it to be a large local reaction developing.   Dtap #5, IPV #4 (first Kinrix) MMR#2, Varicella #2 (first Proquad)
Day 9 after my booster I experienced major itching across entire body.  Next day I had hives erupting in various parts of my body and continued itching.  Day 11 following my booster vaccine I went to care.  They prescribed steroids which I took only two days.  I have been continually been taking antihistamies (benadryl, claritin, zyrtec).   The hives are not as agreesive, but rashes continue to appear and disappear with discomfort and itching 24 hours a day.   Antihistamines provide some relief.   I had no skin reactions to first two Moderna shots.
No additional AEs reported; Expired vaccine used; This spontaneous report was received from a Nurse Practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 09-DEC-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, subcutaneously, lot # S017237 and expiration date on 01-DEC-2020 (strength, frequency and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse events reported.
This case was reported by a technician and described an adult male subject who was vaccinated with Engerix-B and subsequently tested positive hepatitis B surface antigen. The subject was a dialysis patient. On 20 March 2006, the subject had a negative hepatitis B surface antigen blood test. On 12 April 2006, the subject received a dose of Engerix-B (lot number AHVB268CA). This was thought to be his first dose of Engerix-B, vaccine. On 17 April 2006, five days after the vaccination with Engerix-B, the subject's blood-work showed a positive result for hepatitis B surface antigen.
Approximately 30 minutes after receiving vaccine, patient developed a feeling of warmth at the back of the throat, some throat tightness and tongue swelling. Patient was given Benadryl.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
reconstituted Menveo lyophilized powder with sterile water and administered to a patient; reconstituted Menveo lyophilized powder with sterile water and administered to a patient; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA397A, expiry date 31st August 2021) for prophylaxis.   On 30th April 2021, the patient received Menveo. On 30th April 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The case was reported by a medical assistant. The reporter stated that, they reconstituted Menveo lyophilized powder with sterile water and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:59 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 30-Mar-2021, moved to the clinic on 31-Mar-2021 and proposed beyond use date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 08:00 A.M., the temperature recorded was 32 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 32 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Symptoms started with diarrhea and then progressed to vomiting and dehydration. Fatigue and headache.  Per work guidelines (healthcare provider at hospital), needed to be Covid tested due to symptoms. Symptoms resolved in approximately 36 hours.