chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial literature report received on 01 Nov 2010: This patient participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with seasonal influenza vaccine (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness (ILI) symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in polymerase chain reaction (PCR) assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both criteria and at least one of the laboratory criteria were identified as laboratory-confirmed influenza (LCI). This patient had an antibody titer value of 5, 10, 5, and 20 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient had 4-fold increase in titer value and tested positive for seroconversion of A/H3N2 strain. Therefore this patient was considered as an LCI case of Influenza A/H3N2. The outcome was not reported.
5:20pm reddened areas began to appear on back of neck, head, forehead. 5:30pm reddened areas beginning to improve. No other signs of distress noted. Private physician instructed mom to give Benadryl by mouth. No other treatment was given.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J009827, expire date 10-AUG-2014, dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
Patient developed a full blown psoriatic rash with a couple of days after 1st vaccination and then another flare after her second dose. Suspect an autoimmune trigger. Previous dx of psoriasis/pityriasis lichenoides.
No adverse event; patient received Pfizer vaccine on 4/29/21 and received Moderna vaccine on 5/20/21.
VERTIGO; FOGGY FEELING; CONSTANT HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced vertigo, foggy feeling, and constant headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant headaches, and the outcome of vertigo and foggy feeling was not reported. This report was non-serious.
Information has been received from a licensed practical nurse concerning a 56 year old male with a history of alcohol abuse and no history of drug reactions/allergies who on 24-OCT-2006 was vaccinated with Pneumovax (lot # 651437/0899F0 intramuscularly. Concomitant therapy included influenza virus vaccine (unspecified) given at the same visit. On 24-OCT-2006, the patient experienced pain and warmth at the injection site after vaccination with Pneumovax 23. The patient sought medical attention. No laboratory diagnostic tests were performed. Treatment included warm compresses, AUGMENTIN, and ADVIL. The patient improved while on therapy. At the time of reporting, the patient was recovering. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. A patient of unspecified age and gender received TRUMENBA), lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced vomiting on an unspecified date. Outcome of the event was unknown.  Information on lot number, batch number and expiration date has been requested.
sick; Heart was beating really fast/heart rate went up; shortness of breath; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via Medical Information Team. A 59-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 28Apr2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant was not reported. Patient stated she received the first dose of the Pfizer Covid 19 vaccine last Wednesday (28Apr2021) and since Friday (30Apr2021) she felt sick, her heart rate went up, her heart was beating fast, and she had shortness of breath. She still had these symptoms today. It was queried that if her symptoms go away. She had a patient on the other line who got the COVID 19 vaccine and stated that she has had an elevated heart rate and that is all she told the USMI agent. She normally is brady and her heartrate was normally in the 50s and now it is in the 80s. Sometimes it will go to the 70s too. Her question was how she should continue with the second vaccine whether she get it or should she not get it. She was afraid and asked if it is mandatory to get the second one. If she does not get the second one will something change or happen. She was scared and if wondering if she would be in trouble with her health if she did not receive the second dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A nurse reported that a 72 year old female received an injection of Pnu-Imune 23 and Influenza virus vaccine (manufacturer unknown) on 11/03/00. Subsequently,the patient developed cellulitis at the site of Pnu-Imune 23 administration. She was treated with Advil , Benadryl, and applications of warm compresses. This is 1 of 3 patients from this facility who developed an injection site reaction following receipt of Pnu-Imune 23 lot 470-588. Follow-up info received from the physician on 03/14/01, indicated that the patient experienced the adverse event on 11/04/2000. She was seen by the physician and recovered.
Injection site inflammation, cleared up 3 days after shot then returned 7 days later. Swelling and itching, about 3 inches in diameter around Injection site.
Second shot received at 9:15Am on 4/1/21. Sore and redness at injection site within 2 hrs. At mid-day, took Motrin (2 capsules) for pain and stiffness in arm.   At 6:00PM, suddenly felt extremely unwell, with massive headache, and all over body aches. Within one hour, I was unable to move or talk without being out of breathe and chest pain. I went to the emergency room, for chest pain, unable to walk, talk, move my body without shortness or breath, and chest pain.  Injection are was swollen, hardness like muscle spasm, and skin viisably red and hot to the touch.
Pt experienced chickenpox with 3-4 lesions. The pt was afebrile.
Headaches for days starting several days after vaccine,  diarrhea for days, still going on, nausea and tongue sores.  Tongue sore started on day 8 and is still there
This spontaneous report was received from a pharmacist and refers to a 68 year old female patient. The patient had no medical history, concurrent conditions, drug, allergy history or concomitant medications to be reported. On 05-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N013541, expiry date 23-JAN-2019 in the left deltoid for pneumonia. On 07-MAR-2018, two days later, the patient red rash on her left inner elbow and on an unspecified area on her abdomen. The patient developed the same type of rash on the unspecified injection site arm and an unspecified area of the abdomen after receiving ZOSTAVAX (lot# and expiry date not reported) and PREVNAR 13 on an unknown date in 2016. The patient was given a treatment at unspecified Urgent Care. Diagnostic and laboratory tests were not provided. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX 23 and ZOSTAVAX was not reported.
About 8 minutes after shot felt a very very fast heartbeat and left side of face started feeling numb and hot.  Fast heart beat luckily went down, numbness lasted a couple hours.
No adverse event; HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 11Jan2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they accidentally administered 1 dose of Moderna COVID-19 Vaccine Bivalent instead of the 1st dose of the primary series on 11Jan2023) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.     Patient had no relevant medical history. Patient had not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medications were not reported.  No treatment information was provided
Right side of face inflamed with raised areas of irritation, noted blisters on face and inside mouth, enlarged lymph nodes Diagnosed as Shingles Treated with antiviral medication  (Variflex?) and ibuprofen time course approximately 3 weeks
Day 1: low grade fever, headache, abdominal pain. Went away with Ibuprofen. Day 2: severe abdominal pain; decreased with IV anti-inflammatory in hospital. Tests revealed colitis.
Developed fever of 103-104....medication would bring it down to 101.  Taken to ER - temp monitored and was released.  Temp continued until 9-16-06 - no other sx
This spontaneous report as received from a health worker refers to a current 5 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously vaccinated with a dose of 0.5 ml VARIVAX (merck) (lot number not provided) on 13-APR-2010. Concomitant therapies included PREVNAR 13 and ACTHIB. On an unknown date the patient developed chicken pox at an unspecified time after receiving VARIVAX (merck). It was unspecified if the patient had sought medical attention. No treatment was given for the adverse event. The outcome of the chicken pox was unknown. Additional information is not expected.
This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot # N032569, expiry date: 18-JUN-2019, orally for prophylaxis (strength, dose, frequency, route and anatomical location were not provided). No adverse effects reported. The temperature excursion and time frame for ROTATEQ was between 9°C to 25°C (13.4°C) for a time frame of 2 hours and 36 minutes. No previous temperature excursion was reported. Data logger was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004216: US-009507513-1808USA004217: US-009507513-1808USA004218: US-009507513-1808USA004219: US-009507513-1808USA004192.
This spontaneous report as received from a Licensed Practical nurse refers to a 5 year old patient. On 29-JUL-2013, the patient was vaccinated with an expired 0.5 ml second dose of VARIVAX (Merck) (Lot # 1145AA, expiration date 14-JUL-2013) (route not reported). No adverse effect was reported. Additional information has been requested.
redness, itching, small pustules in a 1" diameter circle at injection site lasting more than 4 days;  on 4th day, pustules erupted leaking clear fluid.  At this time patient is performing self care with antibiotic ointment and keeping site clean and covered.
Aching/sensitivity started in afternoon 2wk after vaccine.  Fever started a few hours later, 100.58 around 10:30pm. Back to 99 by morning, normal by 1:40pm next day with some lingering aches until evening.
Pt's arm extremely red, swollen and hot to touch; measured 10 cm X 20 cm around the site of injection.
Patient presented to the ED and was subsequently admitted on 2/24/21, 2/27/21, 3/24/21, and 4/1/21. On 4/9/21 she presented to the ED.
Numbness and tingling in both arms and hands; Numbness and tingling in both arms and hands; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness and tingling in both arms and hands) and PARAESTHESIA (Numbness and tingling in both arms and hands) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041CZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced HYPOAESTHESIA (Numbness and tingling in both arms and hands) and PARAESTHESIA (Numbness and tingling in both arms and hands). At the time of the report, HYPOAESTHESIA (Numbness and tingling in both arms and hands) and PARAESTHESIA (Numbness and tingling in both arms and hands) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by the reporter.   No treatment medications provided by the reporter.
What is described as Moderna arm. 1 week after the vaccination, I got a round red rash on the same arm as the injection. The rash was approximately 2 inches below where the shot was, and was about 3 inches in diameter. Round; red; itchy and hot.
Small bumps on leg. not really pain but feels like a scab; Am soreness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Small bumps on leg. not really pain but feels like a scab) and PAIN IN EXTREMITY (Am soreness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Am soreness). On 05-Mar-2021, the patient experienced LIMB DISCOMFORT (Small bumps on leg. not really pain but feels like a scab). On 18-Feb-2021, PAIN IN EXTREMITY (Am soreness) had resolved. At the time of the report, LIMB DISCOMFORT (Small bumps on leg. not really pain but feels like a scab) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included blood pressure medication.  No treatment information was provided.
SHE COMPLAINED ABOUT BEING DIZZY AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. VITALS LISTED BELOW. SHE REFUSED ADDITIONAL EVALUATION AND CARE.
The patient confirmed 1st dose of J&J on 6/26/21, NKDA. 2nd dose Pfizer 0.3ml administered 1/19/22 to LA. The patient was vaccinated at 12:15 pm, at 12:30 patient reported feeling left palm itching, body hot and sweaty, no SOB, some dizziness, some headache. BP130/80 pulse 72, respiration 20, O2sat 97%. The patient says she has a history of allergy to seafood, migraines, and takes medication for migraines and for allergies. The patient asked to wait another 30 minutes for monitoring. 12:49 patient reports feeling a little dizzy and vitals stable pulse 64/ min, 18/min, O2 SAT 99%, B/P 132/75. The patient was released at 1:05 pm stable, alert, and oriented. The patient stated feeling okay and was going home to take her medication.
The pain started to become unbearable that evening. My arm started swelling and also my hand and fingers. The following day I had to be taken to the emergency room.
43 hours after vaccination, began to experience: metallic taste in mouth, burned feeling lips, flushed skin on face, chest and neck, slight headache and nausea.
Patient received Moderna  COVID-19 Vaccines for her first and second dose in the series. Due to a misunderstanding and miscommunication the patient received a Pfizer COVID-19 Vaccination for the 3rd dose (booster) dose in the series.
102 degree Fever the entire day after the vaccine was administered with  chills, body aches, soreness of arm
expired vaccine 2/28/22 given  misread extended exp dates ---no symptoms no ill effects--no treatment required
Pt developed chickenpox: varicella rash. Vaccine related. Unknown if any other vaccines were given.
60 YO received pediatric dose; 60 YO received pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 60-year-old male patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.  On 18-APR-2023, the patient received the 1st dose of Engerix B pediatric. On 18-APR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: 60 YO received pediatric dose) and underdose (Verbatim: 60 YO received pediatric dose). The outcome of the adult use of a child product and underdose were unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 18-APR-2023 A pharmacist technician reported that, the patient was injected with Engerix-B pediatric formulation as a first dose.  No other details such as patient´s date of birth or initials were available at the moment of the call. The reporter had denied consent to follow-up. The adult patient received the Engerix-B pediatric dose, which led to adult use of a child product and underdose.
"Pt reports that she took her first COVID19 Moderna vaccine on 3/9. By 6 pm that evening had body aches, pains, chills and fever up to 104. Nausea, no appetite and mild SOB when going up stairs. The next day very fatigued and stayed in bed most of the day. Some pain at the injection site, slight redness and itching . She alternated tylenol and ibuprofen every 4-5 hours. Today she feels much better but still not 100% - still some exhaustion and achy. No fever. Appetite is mostly back, no nausea."
pt awoke during noc screaming; mom described cry as different from any other cry; very hot; taken to ER-seen by MD t102-103; MD told mom pt had tonsillitis & put on ATB;
Sore arm a couple of hours after Headache night of Woke up next day to fever, fatigue, sore body. Got worse at 24-36 hours after shot.
Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood pressure, herpes simplex A mouth sores - saw PMD received muscle relaxer, and antibiotic cream... in the 30 days prior to last event she had been having dizzy spells, chills, hot flashes, shortness of breqth, tightness of chest, darkened urine, muscle cramping and knotting, pitting edema, halo discoloration lower right extremity (she wasnt one to complain and thought her symptoms were from use of muscle relaxer) - woke AM 6/11/2021 with severe shortness of breath and was taken to ER - diagnosed with obesity, cardiomegaly, renal failure, severe anemia, hypoxia, and hypokalemia, she went into respiratory distress AM 6/12/2021 and then went into cardiac arrest.  She died as a result.
When I visited my Optometrist 02FEB2023 he discovered that the pupil of my left eye was misshapen it was looked at by three other Doctors and Doctor diagnosed ICE syndrome.
Patient came to the clinic having experienced severe body aches fatigue, chills, and headaches That came on suddenly and made him feel he was unable to get out of bed
Left thigh began swelling and becoming red at the site of vaccine injection several hours after receiving. Seemed much more swollen and red today (11/16/12).
Approximately 30 mins after Tdap given, pt reported slight difficulty in swallowing.  No SOB, no redness at injection site, no swelling of face or hands, no hives, no coughing, no c/o pain.  VS WNL except B/P elevated at 145/86-96.  Usually runs 135/85.  BENADRYL 50mg PO given & pt monitored for 1 1/2 hours.  Asymptomatic when she left.  No further complications.  I follow up with pt after she left.  She said 3 days after injection, she did develop small lump at injection site, and small reddened raised area below site that itched, but these 2 areas resolved on their own.  Pt was given education on s/s of reaction during & after injection & again during f/u calls.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2021 at 19:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 25 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: CIMZIA, start date: 12May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive; (09May2022) Negative; (11May2022) Negative; (15May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was taking other medication within 2 weeks of starting COVID-19 treatment was Cimzia (Certolizamab) started on 12May2022. The patient experienced Rebound of Covid after taking Paxlovid. Took Paxlovid from 04May2022 to 08May2022. Tested negative on PCR 09May2022 and 11May2022. Negative rapid 11May2022. Became symptomatic with headache, extreme fatigue, congestion in the evening on 14May2022. Tested positive within 5 minutes on a rapid on 15May2022. Positive on at home Cue test as well on 16May2022. No follow-up attempts are possible. No further information is expected.
Pt was exiting the building and became light headed and dizzy. Pt then passed out and was slowly released to the ground. Pt did not hit her head and had no hx of fainting/dizziness spells. EMS were contacted and arrived on scene approximately 5 minutes later.