chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DAY 1 ? 08/17/2022 Patient had an appointment with her pediatrician for recent weight loss and intermittent fever/joint pain. She had multiple labs drawn on this day. She received the HPV vaccine in the left arm. She received a Meningococcal B OMV and MCV4O/MCV4P vaccine in the right arm.  Within 2-3 hours after the vaccines were administered, she developed a half-dollar sized, flat, reddened area at the HPV vaccination site. Within 6 hours of the vaccinations, she developed a fever of 102+, body aches, and headache.   DAY 2 ? 08/18/202 Patient continued to have high fever, body aches, and headache. She developed chest discomfort, a dry cough, and weakness.  The reddened area at the HPV vaccine site had spread to the upper left arm (from shoulder to elbow) and had changed to numerous, slightly raised, non-itchy, non-painful areas of redness. Her pediatrician was notified, and we were advised that her labs from 08/17/2022 were abnormal and were instructed to have her evaluated at the Emergency Room.  She was discharged from ED visit #1 with instructions for close monitoring.  DAY 3 ? 08/19/2022 Patient continued to have high fever, body aches, headache, dry cough, and weakness.  Her chest discomfort progressed to sharp chest pain, and she developed rapid heart rate, rapid breathing, nausea, and abdominal pain. Her rash remained unchanged. Her pediatrician was notified and again we were instructed to have her evaluated at the Emergency Room.  Due to her symptoms and our location, she was evaluated at the closest facility, the Emergency Room. She was transferred to Emergency Department for further evaluation.  She was discharged from ED visit #2 with instructions for close monitoring, to establish new patient care with Rheumatology, and to follow-up with pediatrician.  DAY 3 ? 08/2022 Within 6 hours of discharge from Emergency Department, Patient woke up suddenly with severe shortness of breath and pale/clammy skin. She continued to have chest pain, tachycardia, rapid breathing, high fever, body aches, headache, dry cough, weakness, abdominal pain, and nausea. She was evaluated and treated at a local ED, Hospital. She was transferred to Hospital for low oxygen levels, abnormal labs, ground glass opacities in lungs, fluid overload, and a pulmonary mass. She was admitted to Hospital and was also diagnosed with hepatosplenomegaly, bilateral pleural effusions, pericarditis, and thyroiditis.  She was oxygen dependent for 5 days. She underwent a left-side pleurocentesis and had multiple abnormal labs. She remained hospitalized until 09/02/2023.  Since this hospitalization, she as been hospitalized twice. Both of those hospitalizations were in February 2023. Due to this issue and the continued sequalae, Patient is not able to attend school. She has had numerous follow-ups with multiple physicians. She will continue to have follow-ups until they can determine the cause of this issue and see if there is any ongoing and long-term damage.
The day after the vaccination, I started having a very bad dizziness, and vertigo, and they are ongoing up to today.  I went to the doctor and she prescribed some pills called LOSARTAN 25 mg. but they have not done anything, and on the contrary they gave me very bad leg cramps, and a bad pain on my right leg.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: Patient felt faint immediately upon receiving the vaccination. received instruction to sit down. upon sitting down patient passed out/fainted/ muscle contractions in both hands were observed. 911 emergency services were contacted. patient then taken into ambulance for further evaluation.
MD ordered HPV-Injection given as noted below, with no sxs or reaction after leaving exam room. Mom called out for glass of water then approx 1 min after that mom called out needing help as pt had passed out she passed out for just a few seconds. She was alert and oriented immediately after. Glucose 89, BP 90/60, she was supine and recovered for a few min. Then given crackers and water and felt better a few in later BP 102/60.
Patient received the flu shot on Monday and she started feeling dizzy on Tuesday and have been feeling dizzy throughout the day ever since. She's not on any blood pressure medications.
Bleeding large clots.  Occurred at the time of implantation and placenta attached abnormally.  Genetics came back normal and miscarried .  During D&C, lost 2L of blood
MMR II was given to a patient intramuscularly instead of subcutaneously; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, historical drugs and concomitant medications were not reported.      Nurse reported that on 24-AUG-2020, a patient was given measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA), (M-M-R II) 0.5 milliliter, administered intramuscularly instead of subcutaneously (lot number S013719, expiration date 05-MAY-2021) for prophylaxis. Nurse stated no additional adverse event (AE) details.
3hrs after administration: headache, neck pain, myalgias. 6hrs: myalgias worsen, chills, fever, night sweats. The next morning: fever, nausea, myalgias, chills, fever, generalized weakness, night sweats,nausea.Day two  post vaccination, afebrile, myalgias continued. Day three symptom free
Information has been received from the Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL (dose and route not reported) on 06-DEC-2012 (lot number 670048/0963AA, expiration date 09-NOV-2013) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
(L) deltoid erythema, heat & tenderness. Mild erythema at injection site also. Tx for cellulitis - cephalexin. Sx occurred on day 1 & worse on day 2 after IZ.
A few days after first injection the site became hard,  bumpy, red, warm to touch, and itchy.  At peak the site measured 3 inches wide and 3 inches in length.  Site very red and extreme itching.  Lasted 4  or so days.   Before second injection, I took Zyrtec 10 mg and Singular 10mg .   Sight hard, warm and itching day or so later but minimal.
Fever 102, chills, body aches, fatigue, headache, sore throat, nausea, vomiting.
Information has been received from a male with a history of herpes simplex who was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) (lot # not reported) on Saturday, 20-DEC-2008 and experienced a little headache and tiredness. The caller mentioned that he took a nap and when he woke up he noticed a herpes simplex on his chin. The caller took 3 doses of acyclovir (manufacturer unspecified) an wanted to know if that would interfere with the vaccine virus. Patient's outcome was not recovered. No further information is available.
No adverse effects; the patient was inadvertently administered two live virus vaccines within 28 days of one another; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  The patient was inadvertently administered two live virus vaccines within 28 days of one another. On 07-OCT-2013, the patient was vaccinated with the first dose of influenza virus 3v reassortant vaccine live intranasal (cold adapted ann arbor master strain) (FLUMIST) (lot number, expiration date, dose and route of administration were not reported). On 25-OCT-2013, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number: J005180, expiration date: 03-NOV-2014; dose and route of administration were not reported) (inappropriate schedule of vaccine administered). No adverse effects were reported.
Patient is overdue for Tdap/adacel vaccine with no reported adverse event; Initial information received on 13-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics and it was reported that the patient is overdue for tdap/adacel vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergic to thimerosal (Allergy to chemicals).   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength, route: unknown) lot number not reported in unknown administration site for Immunization.Lot number was requested.  On an unknown date the patient was overdue for tdap/adacel vaccine with no reported adverse event (product dose omission issue) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.The physician with whom the patient work with wanted to know if there were components of thimerosal in Adacel as the patient was possibly allergic to thimerosal.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (Patient is overdue for Tdap/adacel vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   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 the 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.
Localized reaction, arm being red, swollen and hot 7 days after receiving vaccination.
had a fever of 104 and it subsided at 2am but it is back at 102; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer reported for his daughter (patient). A 12-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration, on 09Jun2021, as 1ST dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 09Jun2021, patient had a fever of 104 (unit unspecified) and it subsided at 2am but it is back at 102(unit unspecified) on 10Jun2021. He wanted to report that and to make sure that he is doing the right thing by giving her Motrin. The outcome of the event was unknown.
Information has been received from a physician concerning a now 15 year old male who in approximately 1994 (The reporter was "assuming when he was 12 months" old) was vaccinated with VARIVAX (Merck). Concomitant therapy included ACCUTANE. In approximately 1995 ("a year later") the patient's mother (not medically confirmed) that the patient had a mild case of chicken pox, about 10-14 spots. On approximately 26-APR-2009 ("last week") the patient experienced herpes zoster on his buttocks and was seen at the office. Viral culture was taken and diagnosed of herpes zoster was confirmed. The patient had began VALTREX in light of this diagnosis. The patient's status was recovering. Additional information has been requested.
Patient came to ED complaining of sore throat and wanted to be tested for Covid.  She was admitted to the hospital for Covid pneumonia and treated with remdesivir.
SARS-COV-2 test positive; co-administration flu and 3rd dose; co-administration flu and 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm, administration date 16Nov2021 (Lot number: FG3527) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), intramuscular, administered in arm, administration date 16Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Site and route of injection: , Anatomical site if injection: IM(Arm), Route of administration: Intramuscular, Batch/Lot number: # EP6955, Exp 30Jun2021), administration date: 11Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 02, Site and route of injection: , Anatomical site if injection: IM(Arm), Route of administration: Intramuscular, Batch/Lot number: # EP6955,Exp 30Jun2021), administration date: 07Apr2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "co-administration flu and 3rd dose"; COVID-19 (non-serious) with onset 20Dec2021, outcome "recovered", described as "SARS-COV-2 test positive". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19.  Additional information: Prior vaccinations included Flu vaccine. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none. No symptoms, but result was positive.  No follow-up attempts are possible. No further information is expected.
Blood pressure 65/33. Severe Diarreaha, moderate abdominal cramps, severe dizziness, close to fainting. Minor chest pressure
Flu like symptoms; Body aches; Hot and cold; Nausea; Headache; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 13:00, the patient experienced flu like symptoms, body aches, headache, hot and cold and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event flu like symptoms, body aches, headache, hot and cold and nausea were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Unknown number of improperly stored RECOMBIVAX HB (dose, route, lot # not reported) were administered to patients. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
PATIENT ARM WAS SWOLLEN AND RED. THE AREA WHERE THE ARM IS SWOLLEN IS ITCHY AND THE PATIENT HAS ALREADY TRIED USING CORTISONE 20 AND NOT RELIEF FROM TREATMENT. THE PHARMACIST WAS NOTIFY ON 9/28 AND INSTRUCTED PATIENT TO TAKE IBUPROFEN TO HELP WITH SWELLING, A BENADRYL TO HELP COUNTERACT THE REACTION.
Red bumpy dot; Inflammation; Red rings; Itchiness; Hives all over his body; Rash; Arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), ERYTHEMA (Red rings), PRURITUS (Itchiness), URTICARIA (Hives all over his body) and RASH (Rash) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 30-Jan-2021, the patient experienced ERYTHEMA (Red rings), PRURITUS (Itchiness), URTICARIA (Hives all over his body) and RASH (Rash). On an unknown date, the patient experienced MACULE (Red bumpy dot) and INFLAMMATION (Inflammation). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYTREC) (oral) ongoing from 30-Jan-2021 for Hives, Itching and Redness, at a dose of 1 dosage form once a day; METHYLPREDNISOLONE for Rash, Erythema, Itching all over and Hives, at an unspecified dose and frequency; CETIRIZINE for Rash, Redness, Itching all over and Hives, at an unspecified dose and frequency and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for Inflammation, at an unspecified dose and frequency. On 30-Jan-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. At the time of the report, ERYTHEMA (Red rings), URTICARIA (Hives all over his body), RASH (Rash) and MACULE (Red bumpy dot) had not resolved, PRURITUS (Itchiness) was resolving and INFLAMMATION (Inflammation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up added 30-Apr-2021 had information regarding reporter details, patient demographics, vaccination facility information, event added, outcome of event and treatment added to the case. On 11-Jun-2021: Follow up added on 11-Jun-2021 had outcome of the hives as continuing.
Itchy arm for 5 days after injection, itches to the point she "can't stand it." Has not tried treat.
I didn't feel good, but it wasn't bad; slightly nauseated; head hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I didn't feel good, but it wasn't bad), NAUSEA (slightly nauseated) and HEADACHE (head hurt) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced FEELING ABNORMAL (I didn't feel good, but it wasn't bad), NAUSEA (slightly nauseated) and HEADACHE (head hurt). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 23-Nov-2021, FEELING ABNORMAL (I didn't feel good, but it wasn't bad), NAUSEA (slightly nauseated) and HEADACHE (head hurt) had resolved.            It was reported that Approximately 12-14 hours after receiving 1st booster shot of the Moderna vaccine, patient started experiencing slight nausea and head was hurting. patient said that patient was not feeling well but it was not as bad as patient had felt after receiving the primary series. This time patient symptoms lasted for 1 day, after which patient felt better.   This case was linked to MOD-2021-047816, MOD-2022-609315 (Patient Link).
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 01-NOV-2012 14:06, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacy technician refers to a 22 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 07-JUN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
On 2/3/2022 patient woke with blisters on R breast and bilateral painful and sswollen lymph nodes
pt c/o of left arm pain after vaccination of the vaccine.  and tingling of the left fingers.  symptoms was resolved and patient went home
Pt was stable when he left the clinic on 2/3/22. However, he went to the ER on 2/5/22 (two days later) stating that he had CP since 15 minutes after he was vaccinated. This was not true because he was kept at the clinic for 15-20 minutes after receiving the vaccine and states he felt fine when he left. There is a note in the chart that he called the clinic the next day, reporting CP and was advised to go to the ER.
Myopericarditis requiring hospitalization and cardiac MRI.  Patient experienced chest pain. Patient treated with Ibuprofen 600mg TID and Colchicine 0.6mg BID.
I am at my peak ovulation day today (28), have had a regular period since age 10, with no bleeding during ovulation from any point in time. I woke up at 6:48am with a hardened uterus and went to the bathroom at 7:00am. I saw that I had light bleeding within my underwear, which had just started.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. On 21st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. The reporter considered the chills to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 65 or 66 years. The patient was a hospital employee. The patient did not have any previous vaccination with ZOSTAVAX. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. Additionally, this case has been linked with case US2018GSK117828, reported by the same reporter for the same patient (2nd dose). The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.