chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of feels like having a heart attack in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline) and received Omeprazole. A physician or other health care professional has not verified this report. Concurrent medical conditions included severe allergies and high blood pressure. Concurrent medications included Lisinopril. In October 2008 the subject received unspecified dose of FLUARIX (unknown). The following day, the subject took Omeprazole. That same day, she experienced leg cramping. The leg cramping became worse as the days progressed and she soon developed a funny feeling in her chest and she felt that she was having a heart attack. The subject consulted a healthcare professional regarding the events. Medical attention was required at a doctor's office. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe, Additional Details: Approximately 5-10 min after dose was administered the patient fainted and hit his head against the wall.  He regained conciousness almost immediately.  Patient was laid on his side.  He was given water and crackers.  The clinic nurse took him in for an appointment.  His blood pressure was noted to be low.  After he was determined to be stable his mother came to the pharmacy to pick him up and take him to the urgent care for further eval. He stated he had been fasting for 24 hours prior.
When patient's information was entered, it was discovered that although this was the 2nd dose of Pfizer was administered and it also noted that she had received a previous dose of Janssen. She explained that she is being treated by an oncologist who wanted her to receive the full series of Pfizer in addition to the Janssen.
pt presented to ED with fever, chills, dyspnea; found to be positive for COVID; treated with remdesivir, steroids, ABX, baricitinib, O2 supplementation; respiratory status worsened; transferred to ICU where pt was intubated with mechanical ventilation; pt continued to worsen; pneumothrorax and pneumodiastinum; ET secretions were positive for staph aureus; treated with appropriate ABX; developed anemia and thrombocytopenia due to COVID; pt's condition worsened; she was palliatively extubated and transitioned to comfort measures; pt passed away in the hospital
Patient began to feel dizzy ~10 minutes after receiving her second dose of the Moderna. She then continued to decline in responsiveness however never lost consciousness. Her blood pressure was monitored (elevated upon 1st check, then upper limit of normal on second check) and oxygen saturation declined and patient was started on oxygen. EMS was called and patient was transported to the ER.
stroke; blood clot in the heart; Hospitalization with racing and irregular heart beat; Hospitalization with racing and irregular heart beat; loss of motor function; This is a spontaneous report from a non-contactable consumer.  A 46-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. If other vaccine in four weeks was unknown. Other medications in two weeks was unknown. If covid prior vaccination was unknown. If covid tested post vaccination was unknown. Known allergies was unknown. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand=Pfizer) on an unspecified date for COVID-19 immunization. Patient experienced hospitalization with racing and irregular heartbeat, blood clot in the heart, stroke, loss of motor function on an unspecified date. Treatment included intubation. The outcome of the events was unknown. Events resulted in hospitalization, life threatening illness (immediate risk of death from the event).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax 13NOV95 & 28NOV95 pt devel approx 50 maculopapular lesions on trunk that last for only 1day;pt afeb;no further details were reported;
Pain, swelling, hard lump, rash, itch, 99.8 degree F temp, chills. Pt went to MD - severe allergic RXN, given prednisone.
Body aches, chills, muscles was sore and joint aching and stiffing , 100.9 temperature second day the same thing and took Ibuprofen for  two to three days, sniffles, synise  infection for a week.
Immediately after receiving vaccine patient reported symptoms of fatigue, nausea, dizziness, chest pain, palpitations and intermittent syncopial episodes.
shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-year-old male patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EN6207) via an unspecified route of administration, administered in arm left on 13Mar2021 (at the age of 65-year-old) time the vaccination was given: in the afternoon at dose 2, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. Patient previously received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot Number: EN6203, Expiry date: Jun2021) via an unspecified route of administration, administered in arm left on 20Feb2021 (at the age of 65-year-old) at dose 1, single for covid-19 immunisation. On an unspecified date in 2021 the patient experienced shortness of breath. Reporter has received the 2nd dose of the Pfizer Biontech Covid vaccine and is about to get his 3rd shot. He asked if there has been reports of shortness of breath as the vaccine's side effect. Reporter stated that he is calling about the Pfizer covid vaccine and states he is talking about getting the 3rd shot and after getting the 2nd shot of the vaccine he wound up in the hospital with shortness of breath and they went in and looked. Stated that he was just wondering if that shortness of breath was a side effect before he gets the 3rd dose of the vaccine. Reporter stated that his 1st dose of the Pfizer COVID Vaccine was administered on 20Feb2021 with lot EN6203 and expiry date Jun2021; states the 2nd dose was administered on 13Mar2021 with lot EN6207 and states the 2nd dose does not have an expiry date written on his patient card; states his patient card has no NDC numbers written on it. Stated that he was not going to do anything until he has to get the 3rd dose of the Pfizer covid vaccine and when he went to the hospital the reason he went to the hospital was for the shortness of breath and the shortness of breath occurred probably about 2 weeks after the 2nd dose of the Pfizer covid vaccine and they scoped his heart; caller states he was not admitted for hospitalization but it was outpatient. Stated that he does not know the date the shortness of breath began but it was about 2 weeks after he had the 2nd dose of the vaccine; stated he does not have shortness of breath now and it has resolved and it resolved right when his heart was scoped. Reporter stated that he takes 10 different pills but none were started within 2 weeks prior to the reported event and declined to provide further information. States he did not have treatment for the reported event and they just went in with the camera and ran it up the veins to the heart and injected the stuff to look at it. Adverse event required a visit to emergency room, physician office. Outcome of the event was resolved on an unspecified date in 2021.  Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
extreme fatigue; she couldnt get out of bed for days; fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 17Sep2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hepatitis vaccine, reaction(s): "Tiredness", notes: 5 doses of Hep vaccine to get titres at acceptable range/level; Typhoid shot, reaction(s): "sick for 3 months". The following information was reported: PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 22Sep2021, outcome "unknown", described as "chills"; FATIGUE (non-serious), outcome "recovering", described as "extreme fatigue"; BEDRIDDEN (non-serious), outcome "unknown", described as "she couldnt get out of bed for days".  Additional information: The patient stated that she had a weird body when she gets vaccines. She experienced fever and chills lasting until 5th day after the first shot then extreme fatigue set in and she could not get out of bed for days. Extreme fatigue resolving however she still feels tired. She was given an appointment for 2nd shot 4 weeks later. It should be at 3 weeks. Six years ago however she was on no medications.   Information about lot/batch number cannot be obtained. Follow-up attempts completed. No further information is expected.
sz on 13JUN95 @ home & ER; t105R; 102.8; given APAP
administered in error to a 12 year old /no AE; Initial information received on 14-Dec-2021 regarding an unsolicited valid non-serious case received from a other healthcare professional via call center via Agency (Reference number- 00897856).  This case involves a 12-year-old (unknown gender) patient who erroneously received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  It was reported "What is the next steps for them to do?"  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on the batch number for this case.
Patient received vaccines approx 0920-0925: 4 shots 2 on each deltoid. After receiving vaccines patient complained of feeling dizzy. Rested on table in exam room in 5-7 minutes, when questioned: Patient stated she felt fine. Patient escorted to chair seated with dad in 0945 noticed patient to have laid head back in chair with hands in a fist unresponsive quickly brought patient to floor and she awaken right away.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-OCT-2015 18:18, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date:13-APR-3017 (dose and strength unspecified). No concomitant medication were reported. No adverse effects were reported. The high temperature and low temperature were 5.5 and 2.9 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
pt recvd flu vax & 2 wks later, pt c/o of lt arm pain w/limited ROM, & weakness in the lt hand;
patient had platelet count of 141,000 on 4/6/2021 Had COVID vaccine #1 on 4/13/2021 Had COVID vaccine #2 on 5/13/2021 Developed petechiae 5/30/2021 Platelet count 23,000 on 5/30/2021 Started on prednisone 60 mg daily on 5/30/2021
Chickenpox diagnosed in office 6/1/06. 20-30 pox on back, scalp, face, arms, chest and stomach.
Chills, headache, sweats, aches, lethargy   Taking ibuprofen for discomfort
STARTING THE NIGHT AFTER VACCINE, WAS UNABLE TO SLEEP FROM SUNDAY 3/14/2021 UNTIL WEDNESDAY 3/17/2021. BEGAN GETTING A FEW HOURS A NIGHT STARTING WEDNESDAY NIGHT 3/17 - SATURDAY NIGHT 3/20. BEGAN NORMAL AVERAGE NIGHTLY SLEEP SCHEDULE OF 6.5 HOURS STARTING SUNDAY 3/21.  DURING THE WHOLE PERIOD OF TIME DID NOT FEEL TIRED OR HAVE MANY SIGNS OF EXHAUSTION.  ACTUALLY FELT A FEELING OF REJUVENATION DURING PERIOD.  CURRENTLY FEELING AS DID BEFORE DATE OF FIRST VACCINATION.
Information has been received from a physician concerning a 26 month old white male with a history of a sacral dimple (normal MRI) who on 11Apr2002 was vaccinated SC in the right thigh with a first 0.5mL dose of varicella virus vaccine live. The pt had a small hematoma on his right toe at the time of vaccination. Concomitant therapy that day included a first dose in the right leg of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (MSD), a fourth dose in the left leg of Streptococcus pneumoniae vaccine (PREVNAR), and a fourth dose in the left leg of HIB conjugate vaccine (HIBTITER). There were no other concomitant medications. On 28Apr2003 the child presented to the office with a rash on his right thigh. A dermatology consult stated that the rash was herpes zoster. The rash was described as "maculopapular and disseminated in crops over the entire right thigh". No other symptoms were noted. The physician indicated that upon follow up with the child's mother, the rash had almost completely cleared. Follow up information received from a physician indicated that on 28Apr2003, one year after receiving the varicella virus vaccine live injection, the child developed a herpetic rash in the same location as the injection. The physician indicated that the rash is resolving. There was no rash at the site of the injection or elsewhere within 42 days of the the vaccination. It was also noted that the child did have a fever 2 weeks prior to the rash, but was afebrile at the time of the herpes zoster onset. It was noted the child's pain was quantified as 0 to a 1 (10 being the most), indication that it was just a little itchy. There were no other systemic symptoms. There was no history of chickenpox or recent exposure to chickenpox or herpes zoster. No direct flourescent antibody was done. No specimen was collected for PCR. No photo was taken. It was also noted that when the child was 22 months old he was vaccinated with a fourth dose of diphtheria toxoid (+) pertussis vaccine and developed a swollen right arm at the injection site. There were no adverse events following prior vaccinations for the pt's siblings. Relevant diagnostic tests and laboratory data are located in the lab's section of the report. As per the consultation report, the clinical impression and diagnosis was: 1) well developed 24 month old boy at 90% and 98% for height and weight. 2) Immunization up to date. 3) S/p Herpes Zoster lesions (shingles). 4) Normal CBC and differential. 5) Normal Lymphocyte Subpopulations. 6) Normal Immunoglobulins,G, A, M, E, and IgG subclasses. 7)Protective Pneumococcal, Tetanus, Diphtheria, and H Influenzae B titers. 8) Normal Complement. The pt was recommended to have at hand acyclovir (ZOVIRAX) ointment to apply using a finger cot or rubberglove QID for 7 days (if a similiar lesion reappears), and to follow up as needed. No further information is expected.
feel worse than 1st dose; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (received 1st dose on unknown date, refer case US2020AMR029032).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and feel worse.
Pain; Flu like symptoms; Vaccination site tenderness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Vaccination site tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Vaccination site tenderness). At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Vaccination site tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Reporter did not allow further contact
Leg pain, Leg weakness, numbness,(both legs)fast heartbeat, diarrhea, chills,
red swollen lump the size of a golf ball at the injection site; arm is tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 17:10 (Lot number: EN6205) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 1993 (ongoing), notes: Verbatim: Fibromyalgia; "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: PROLIA taken for arthritis, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 (Vaccine Name: Covid-19 Vaccine, Manufacturer: Pfizer, Lot Number: EL9266 , Anatomical location: right arm), administration date: 20Feb2021, when the patient was 72 years old, for Covid-19 immunisation.  The following information was reported: VACCINATION SITE MASS (non-serious) with onset 14Mar2021, outcome "not recovered", described as "red swollen lump the size of a golf ball at the injection site"; TENDERNESS (non-serious) with onset 13Mar2021, outcome "not recovered", described as "arm is tender".  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the pfizer suspect was reported as none. The patient did not visited to emergency room or physician office.  No follow-up attempts are possible. No further information is expected.
Severe meningitis starting 30 min after vaccine. Stiff neck; headache; nausea; eye pain; light sensitivity; altered consciousness; blacking out; dizziness. Still sick after two weeks later.
Information has been received from a registered nurse concerning a 6 year old male who on 04/26/1996 was vaccinated with varicella vaccine. According to the nurse, the child is normally healthy with no other health problems and does not take any medications. On 06/17/2001, the pt developed a fever. The next day, he developed chicken pox with over 300 lesions that presented in less than 24 hrs. The pt was seen in the physician's office on 06/18/2001. The fever was gone and vesicles were present all over his body, including on his face and around his eyes. He was started on therapy with acyclovir, 200 mg/5ml, 10 ml four times a day for five days. The pt was seen in the office on 06/21/2001. Most of the vesicles were scabbed and reportedly "the child felt fine." There was no known exposure to chicken pox. In follow-up, the registered nurse reported that the child recovered well with no other medications or hospitalization. No additional info is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 10:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 10:23 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered 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.   The age of patient was provided as 28.31. Concomitant products were not provided. On 22-Jun-2021, Excursion time was 08 AM, temperature was 35, total doses given for the day was 36 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-May-2021, vial was moved to clinic on 22-Jun-2021. 4 vials were sent to clinic. Vaccine BUD date was 26-Jun-2021. On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43 and 5 PM: 43. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
8AM on 27FEB94 woke up having sz: turned blue, labored breathing, rigid, unconsious, disoriented, drooling from mouth & shaking: lasting 15-20mins;