chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 60 days after the 1st one) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056D21A and 939911) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 60 days after the 1st one). On 27-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 60 days after the 1st one) had resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient received their second dose of the Moderna COVID-19 vaccine 60 days after the first dose. The patient received both the doses at the same vaccination facility.   Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Significant follow up was received which contains the batch number for the second dose, dosage date for the second dose and event start date. Incorporated these information in the report.
stomach cramps Feeling of compression of entire thorax pain at the back of the neck extream flushing elevated blood pressure
Seriousness criteria other medically significant (OMIC). initial report received on 07 December 2006 from a health care professional. A 19 month old male patient had received a first dose, left thigh injection of Fluzone, lot number 2191AA, on 01 December 2006. Approximately ten hours later, the patient experienced a fever of 102.6 degrees F, seizure, body shaking, eyes rolled back which lasted for two minutes. He was examined in an emergency room and treated with Rocephin. Additional symptoms included runny nose. Blood cultures obtained in the emergency room were pending. He was re examined the following day by his personal physician to determine if the seizure was due to fever. Information related to this exam was not provided. The patient recovered from the event.
I contracted Covid19 on 3/8/2022 and was asymptomatic at time of testing, and for most of the illness with only a couple days of myalgia, congestion and headache. I have fully recovered with no lingering symptoms.
Vaccine was drawn from multidose vial on Friday 12/16/22 and expired 12 hours after being drawn. Dose was not used and remained in refrigerator over the weekend. Dose was administered on Monday 12/19/22.    Patient experienced no symptoms or adverse effects, no harm was noted after administration.
Mild nausea, tiredness, injection site pain, and headache for 56 hours.
Psoriasiform spongiotic dermatitis. Histology consistent with chronic eczetamous dermatitis reacutized. Heavy growth of Staphylococcus aureus. Fast heart beat. Areas affected: primarily right arm and hand. Other areas greatly affected: back and legs. Rest of body also affected in low intensity. Treatment included: Cephalexin 500 mg 4x/day for 8 days followed by Sulfamethoxazole 2x/day for 8 days; Mupirocin ointment 2x/day; Trimcinolone cream on the affected areas when itching (still in use); Chlorhexidine soap on affected areas twice daily; Levocetirizine dihydrochloride 5mg and Hixizine 25mg once daily for 2 weeks, then for another 2 weeks after a month of pause; Diprogenta cream (betamethasone dipropionate, gentamicin sulfate) on affected areas for 2 months.
On Monday 4/9 - First dose of vaccine. On Wednesday 4/11 - After2nd dose of vaccine, I felt some tingling and "numbness" on my upper lip. This was not an immediate reaction, I dismissed this as seasonal allergies. These symptoms continued for the rest of the week. On Sunday 4/15 - I completed my last dose of the vaccine. On Tuesday morning I woke up with a huge swollen upper lip and approximately 6 small raised, closed sores on my bottom lip. I had a case of what looked like Chelitis on both the corners of my mouth. My lips were tingling and sore. On 4/17 my dermatologist placed me on a low dose of Prednisone 40mg for 5 days and Acyclovir 800mg BID for 5 days. I took one dose of Prednisone before out clinic Internist disagreed with the course of Prednisone and suggested I only use Benadryl due to the live nature of the vaccine. I did not take the Prednisone on the 18th, and on the 19th of April my lips were swollen and sore just as before. The Internist put me back on Prednisone. I finished my last dose on Tuesday 4/24. I did not take a dose of Prednisone yesterday. This morning on 4/26 I woke up to 4-5 new red small bumps on my lower lip and returned swelling in my lips. (Continued Acyclovir). 4/26 (a.m.) used topical steroids on lips - no Prednisone 4/26 approximately 6pm I experienced a fever of 101.2, some stomach cramping and nausea. This was followed by diarrhea. 4/27 Prescribed Cipro BID x 7 days 5/4 Finished last dose of Cipro 5/6 Swelling (primarily upper lip) with some redness around lips returned. Advised to try Zyrtec and resume Acyclovir after a small cluster of Herpes - like bumps appeared on lower lip. 5/15 I have an appt with an allergist in the community.
10cm localized swelling to left deltoid; stiff and limited ROM from left shoulder to left elbow.
Pt recvd 2nd DTP/OPV/HIB on 23JUL91 & 4 hrs later devel rash lasting x 1 wk; Seen by MD mom noted rash; 3rd set of vaxs given 18SEP91 & 4 hrs later broke out in rash which cont intermittently for 2 days then disappeared completely;
This is a 20 y/o ? black active duty military member who received her primary smallpox vaccination on 12/08/03. She states that she progressed fine through the first week after her vaccination and did not develop any viremic symptoms. On 12/15/03 she reported with her fellow soldiers to immunizations to have a 7-day wound check. She stated that the medic told her it looked great and was "just exactly how it is supposed to look". She told me that the medic pressed all around the outside edges of the site. He was wearing gloves, however patient states that she never saw him change gloves between patients and "there were a lot of us".  On 12/17/03, she removed the bandage and states that the area under the gauze part of the bandage was "red and blistered". She also began having viremic symptoms of fever, chills and nausea at this time. Her viremic symptoms last approximately 4 days.
Patient received 2 m vax and shortly afterwards had associated facial erythema and swelling. No treatment given.
Experienced chills starting about 3 hours after the shot , followed by a low grade fever ( 100.5 to 100.9 ) throughout the night . Fever down to normal by noon the 24th of Jan . Loss of energy on day 2 and 3 following the shot
Symptoms starting coming on about 20 Hours after the shot. Sever Chills and shaking for about 2 hours. Top of head numb and tingling . Severe Fatigue. Sore across the shoulders. Slight Blurred Vision. Fever of 100.5 Usually run around 97.1 on a normal day. Body ache to the point walk very slowly. Lose of appetite and only had about 10 oz of water during the adverse event time.  With Tylenol and resting through the evening by 5:00 AM the next morning I was close to full recovery. Top of Head was still still slightly numb. 24 hours after the onset of the event I am back to normal.
This spontaneous report as received from a nurse (registered nurse, RN) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unspecified dates, improperly stored doses of GARDASIL (strength, dose number, dose, frequency, lot number and indication were not reported) were administered to an unspecified number of unspecified patients. No adverse effects were reported.  Concomitant medications were not specified. This is one of several reports received from the same reporter (linked to MARRS # 1406USA000382, 1406USA000549, 1406USA000550, 1406USA000552). Additional information has been requested.
This case was reported by a nurse and described the occurrence of screaming in patient who was vaccinated with Pediarix for prophylaxis.  On 17 October 2005 the subject received 1st dose of Pediarix.  On 17 October 2005, the subject was also vaccinated with Haemophilus influenzae type b conjugate vaccine and Prevnar. At an unspecified time following receipt of the vaccinations, on 17 October 2005, the subject "screamed for 7 hours and then, (on 17 October 2005,) became lethargic."  On 18 October 2005, the subject experienced a decreased appetite.  Patient was seen at a physician's office, "but not given any treatment."  The screaming resolved on 17 October 2005.  The lethargy and decreased appetite resolved on 18 October 2005. The immunization series with Pediarix was discontinued.  The nurse considered the events to possibly be related to vaccination with Pediarix.
Patient called 9/02/2022 to state possibly one to two days after administration of Novavax vaccine on 8/30/2022, she became extremely fatigued and could barely get out of bed. She had a headache that was extremely painful and persisted until this phone call. The patient said she was having intestinal difficulties including multiple bowel movements while she typically never had more than two. She also had some bladder incontinence. She reported her blood sugar had gone up to 133 while it was normally around 103-108. Patient stated she does not use any analgesics.
Positive Covid; Positive Covid; pulmonary congestion developed; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer: unknown, dose 1, single), for COVID-19 immunization; Covid-19 vaccine (Manufacturer: unknown, dose 2, single), for COVID-19 immunization. The following information was reported: PULMONARY CONGESTION (medically significant) with onset 01Jan2022, outcome "not recovered", described as "pulmonary congestion developed"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Positive Covid"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Positive Covid test this morning. It was reported that, the patient experienced fever, aches, cough, congestion, wheezing, pulmonary congestion developed on 01Jan2022. Fever persisted until 02Jan2022, other symptoms continue to now, 05Jan22. Stated that, the events took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 5 minutes after receiving vaccine, patient appeared to lose consciousness for less than 30 seconds. Upon regaining consciousness he appeared disoriented. Family reported last food/drink intake was 4AM this morning. Patient drank orange juice and appeared to become more alert. Patient denied any trouble breathing or swallowing. EMT were called and checked blood pressure and pulse.  EMT asked if patient wanted to be brought to hospital and patient declined that request. Patient was able to leave on his own with family.
administered series only 3 weeks apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th June 2021, the patient received the 2nd dose of Shingrix. On 24th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose of Shingrix on 3rd June 2021. The reporter stated that, the patient received 2nd dose of Shingrix, 3 weeks apart, which led to shortening of vaccination schedule. The patient did not have any adverse effects, it was just discovered by chance when the patient went in for an office visit and the physician noted the dates of administration. The reporter consented to follow up.
Drastic personality change overnight. Attention span decreased, hyperactive. Will visit the doctor today to start testing for ADD.
Information has been received from a nurse practitioner concerning a 65 year old female who in 2000 was vaccinated with the first dose of PNEUMOVAX 23 with no problems. In 2005, the patient received a second dose of PNEUMOVAX 23 and developed what was described as an "allergic reaction". No specific details about the reaction was known. Subsequently, the patient recovered from allergic reaction. The adverse event was not reported to the physician at the time of the reaction. Additional information has been requested.
Injection site swollen the entire arm starting at injection site radiating to elbow. Red and warm to the touch. Instructed to apply ice then heat. Was prescribed prednisone 10 mg. everyday.
Localized type IV hypersensitivity reaction around injection site with 25cm erythemic indurated area over anterior thigh region onset 24-36 hours, post vax.
Welts from Shingrix Vaccine took 9 months to finally go away. No other adverse effects.
Case called to report symptoms he developed after his vaccination. He was vaccinated on 4/30/21 with the Pfizer vaccine. He reported soreness in his arm the first few days. On 5/11/21 he developed extreme fatigue, subjective fever, increased back pain, and urgency to urinate. He has a history of sciatica, back pain, high blood pressure, and high cholesterol. He states he is still experiencing the fatigue, back pain,  urinary urgency, and subjective fever. He also states that he has developed neck pain as well. He feels that the vaccination has exacerbated his underlying medical conditions. The case states he has been reporting this symptoms to the V-Safe program but has received no follow up. RN encouraged case to call his physician ASAP to report these symptoms as it could be other issues and he needs to have physician follow up. He states he would call his physician directly. Case asked if he should have the second COVID vaccination. RN encouraged patient to talk to his physician and for them to decide together if he should have the second vaccination.
Possible Product temperature excursion issue; patients administered Moderna vaccine while temperature excursion assessment was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Possible Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Possible Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Possible Product temperature excursion issue) and POOR QUALITY PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants were reported. No Treatments were reported.
I had a fever for about two days, maximum temperature was 101.5. I had flu-like symptoms with chills and body aches.
Woke up the morning following vaccination and had swollen lymph nodes in the armpit of the left arm.  Unable/painful to extend arm or move arm above head.  Symptoms improved with Ibuprofen for about 6 hours and then would return.  Each morning (the last 2)the symptoms have been just as severe as the first morning requiring Ibuprofen.
During a review of the Health internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
Red, erythematous indurated non-urticarial rash extends from left shoulder to elbow. Low grade fever (T 101).
circular red rash, slightly raised, about size of a softball, around injection site area. Itchy and sore to touch
she thinks it did something to her heart rate/Her heart rate is usually 80 to 100 and it was around 50; she still felt really tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Sep2021 (Lot number: FD8448) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC taken for hypertension. The following information was reported: HEART RATE DECREASED (non-serious) with onset 2021, outcome "recovered" (2021), described as "she thinks it did something to her heart rate/Her heart rate is usually 80 to 100 and it was around 50"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "she still felt really tired". The events "she thinks it did something to her heart rate/her heart rate is usually 80 to 100 and it was around 50" and "she still felt really tired" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Concomitant products bystolic she has been on it for years. AE(s) following prior vaccinations were none. Family medical history relevant to AE(s) were none. After the first shot she thinks it did something to her heart rate. She can't prove it. It was a few weeks after the first shot that she noticed she still felt really tired. She checks her blood pressure on a regular basis because she is on blood pressure medicine. Her heart rate is usually 80 to 100 and it was around 50. She went to the emergency room and they did heart test. Nothing came back. Everything seems ok now. They will do a stress test in the future on 23Dec2021.   No follow-up attempts are possible. No further information is expected.
Pt. states that after receiving the 3rd dose of Booster Phizer 10/06/2021, started experiencing symptoms 10/07/2021 of throbbing pain throughout the backside of back and side area. Throbbing in the fingers to the point numbness, and vomiting. Extreme fatigue, weakness, and continued pain in the right side and armpit. Still continuing to experience the pain throughout the right side, self-treating with Tylenol. No noted Primary visit.
2-month-old female received the DTap/IPV component; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received only DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Oct-2019, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Lot # U6216AB, exp date 10Oct2020) via intramuscular route in the left thigh.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had a sore arm for the day and then it was gone. Sunday morning, I woke with my face hot and red with a rash on my chin, forehead and left cheek.  The second week, my chin started burning and my face was covered in a dermatitis rash. I saw the dermatologist for this.
Awakened with red, itchy face and mild fever (not measured).  Also had raised hard lump at ID insertion site; diameter greater than a quarter but smaller than a half dollar.  Site tender to touch.
Nurse inadvertently gave client MenB (BEXSERO) rather then Meningococcal. Physician contacted for recommendation. As client was 15 years and 10 month at time of injection - physician believes that MenB will be effective. Client contacted and has been scheduled to receive Meningococcal vaccine as schedule suggests - received 03/05/2019. No adverse events experienced.
tingling in arm; numbness; Pinched Ulnar nerve; Tightness in forearm; limp hand no grip no control; rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve), MUSCLE TIGHTNESS (Tightness in forearm) and COORDINATION ABNORMAL (limp hand no grip no control) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve), MUSCLE TIGHTNESS (Tightness in forearm), COORDINATION ABNORMAL (limp hand no grip no control) and RASH (rash on left arm). On 05-Mar-2021, COORDINATION ABNORMAL (limp hand no grip no control) had resolved. At the time of the report, PARAESTHESIA (tingling in arm), HYPOAESTHESIA (numbness), ULNAR NERVE INJURY (Pinched Ulnar nerve) and MUSCLE TIGHTNESS (Tightness in forearm) was resolving and RASH (rash on left arm) outcome was unknown.        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.   Other relevant medication history included Multivitamin. No treatment information was provided.
DEMAND ISCHEMIA 4/11/2021 HX OF RADICAL NEPHRECTOMY PULMONARY EMBOLISM, UNSPECIFIED. 4/11/2021 HX OF RADICAL NEPHRECTOMY ACUTE RESPIRATORY FAILURE 4/11/2021 HX OF RADICAL NEPHRECTOMY