chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OUT OF BREATH; HIGH BLOOD PRESSURE; BACK SORENESS; SLEEPLESSNESS; TIREDNESS; SLIGHT HEADACHE; INJECTION SITE SORENESS; LOOSE STOOL; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, amoxicillin allergy, shellfish allergy, back soreness, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 55, and expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On JUL-2021, the subject experienced loose stool. On 28-JUL-2021, the subject experienced injection site soreness. On 29-JUL-2021, the subject experienced back soreness. On 29-JUL-2021, the subject experienced sleeplessness. On 29-JUL-2021, the subject experienced tiredness. On 29-JUL-2021, the subject experienced slight headache. On 30-JUL-2021, the subject experienced out of breath. On 30-JUL-2021, the subject experienced high blood pressure. Laboratory data included: Body temperature (NR: not provided) 97.2 F. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. Treatment medications (dates unspecified) included: zolpidem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, injection site soreness, and out of breath, and the outcome of slight headache, back soreness, sleeplessness, high blood pressure and loose stool was not reported. This report was non-serious.
PCV13  & Rotavirus vaccines administered error on 06/26/2020.  No adverse event observed. Parent aware and will call office if symptoms occur.
mind was bad and clouded; depressed; Tiredness; Vivid dreams; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 (Lot number: EW0182) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "she has thin blood, things like that, nothing else besides that, which she clarified to being low platelets", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEPRESSED MOOD (non-serious) with onset 02May2021, outcome "recovered", described as "depressed"; FATIGUE (non-serious) with onset 02May2021, outcome "recovered", described as "Tiredness"; ABNORMAL DREAMS (non-serious) with onset May2021, outcome "recovered", described as "Vivid dreams"; THINKING ABNORMAL (non-serious) with onset 06May2021, outcome "recovered", described as "mind was bad and clouded"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "Chills". Therapeutic measures were taken as a result of chills.  Additional information: Patient stated that she had no other vaccinations 02May2021 or in the four weeks prior to getting the Pfizer COVID-19 vaccine. She stated she had started no new medications. Patient got the shot Sunday 02May2021 and as she had that shot, she got depressed but she was tired, it made her tired, she was having wild vivid dreams. She said it got progressively worse almost like she just declining, and the getting depressed went on from Monday-Wednesday, then she hit Thursday which was the absolute worst day, a terrible day, something was so off, and her mind was so bad and clouded. She says it was awful, but she made it through that day, and then Friday she was fine, everything was back to normal. She said she wanted to report this because she doesn't know if others have experienced something similar or if it even could be from that. She said it was scary the way it got worse and worse, then hit bottom, then the next day it was just gone. She said she was having chills too, and that is why she took a bit of paracetamol (TYLENOL). She said she bought a TYLENOL powdered packet of quick dissolve 500mg, and she took half of that, so 250mg.  No follow-up attempts are possible. No further information is expected.
Patient states that she developed a rash the day after receiving her vaccine and that 2 days after the rash has spread a little more.  She states that she had no other reaction other than that. She did not have trouble breathing or swallowing. The rash has not gone away.
There is swelling, hardness, redness and pain at the site of injection with some itching. The area also feels warm compared to other arm.
The nurse at the pediatric office gave the above patient twice the Hepatitis A vaccination necessary. She was only required .5 ML and was given an adult size dose of 1 ML. This report is to report not any reaction, as of yet, but to report a baby getting an adult dose of a vaccine.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  Date of refrigeration was reported as 07-May-2021.   This case was linked to MOD-2021-363226, MOD-2021-363032 (Patient Link).
2 Masses; This is a spontaneous report from a contactable nurse (reported for herself). A 37-year-old female non-pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Eh9899), via an unspecified route of administration, administered in Arm Left on 29Dec2020 (at the age of 37-year-old) as single dose for covid-19 immunisation. Medical history included known allergies: sulfa. The patient previously took cefdinir and experienced known allergies: cefdinir. Concomitant medications included escitalopram oxalate (LEXAPRO); levothyroxine sodium (SYNTHROID); propranolol; lisdexamfetamine mesilate (VYVANSE); trazodone hydrochloride (TRAZODON). The patient did not receive other vaccine in four weeks. The patient did not had Covid prior vaccination. The patient experienced 2 masses on 16Jan2021. The patient underwent lab tests and procedures which included Covid test post vaccination Nasal Swab with negative result on 04Mar2021. This event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of 2 masses included surgical removal. The patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El8982) on 26Jan2021 in Right arm as single dose for covid-19 immunisation. The outcome of the event was recovering.; Sender's Comments: The causal relationship between BNT162B2 and the event mass (2 masses) cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 91-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 91 years for Covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Colon Cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (1st Booster), for Covid-19 immunization. The following information was reported: SUDDEN VISUAL LOSS (hospitalization, medically significant) with onset 25Apr2022 at 21:00, outcome "not recovered", described as "Sudden onset left side monocular visual loss"; OFF LABEL USE (hospitalization, medically significant), IMMUNISATION (hospitalization, medically significant), outcome "unknown" and all described as "4th Pfizer Booster". The patient was hospitalized for sudden visual loss (start date: Apr2022, hospitalization duration: 3 day(s)). The event "sudden onset left side monocular visual loss" required emergency room visit. Therapeutic measures were taken as a result of sudden visual loss. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented with sudden onset left side monocular visual loss that start within 24 hours after receiving a booster dose vaccine. Patient received High dose steroid x 3 days as a treatment medication. Since the vaccination, the patient was not been tested for COVID-19. Patient had no known allergies. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of Sudden visual loss, Off label use and Immunisation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Informatoin has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L011846, expiration date 16-JUN-2017, dose and route unknown). This is one of several reports received from the same reporter. Additional information has been requested.
Pt called 5/5/11 complaining of burning skin of the axilla on side of vaccine - progressed to involve chest. Pt seen 5-13-11 with ongoing complaints in chest/axilla area so VALTREX 1 gm tid started. Called again 5/13 with eye symptoms so referred to eye doctor - he diagnosed zoster of the eye.
Swelling/redness tennis ball sized- increased heat to area. Sent to ER for evaluation 8/28/19.
Severe Vertigo - spinning dizziness, nausea on 4/24/2022 that lasted only 10 minutes but on 4/26/2022 symptoms started again and lasted for 3 days.
First shot there was swelling, complained of chest pains and followed up with ER visit and visit to heart specialist Second shot there was swelling in hands and arms, breathing difficulty, death within 12 hours.
Low grade fever (100.6 orally), petechiae to face (eye area) and neck. Nausea and vomiting.
Right Thigh erythematous, swollen, indurated 2 days after vaccine, fever 100.9 oral.
Post vaccine patients felt itchy on her arms and legs. Given 25 mg PO diphenhydramine and felt better
This case was reported by a healthcare professional and described the occurrence of erythema in a 4-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included live attenuated measles, mumps and rubella vaccine (right arm), live attenuated oral poliomyelitis vaccine (left arm) and varicella virus vaccine (right arm) all given on 28 March 2007, same day as the 5th dose of Infanrix. On 28 March 2007, the subject received 5th dose of Infanrix at 0.5 mL in the left arm. One day later, on 29 March 2007, the subject experienced erythema, swelling and warm to touch at the site of injection. The subject was treated with Benadryl and cold compresses. At the time of reporting the outcome of the events was resolved. The healthcare professional considered the events were related to vaccination with Infanrix.
Development of Bells Palsy approximately 48 hours after initial (dose 1) vaccination with Pfizer vaccine.
Patient had swelling in arm for 2 days and pain in injection site area for 3 days.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. On or about 2007, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about May 2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Left antior thigh with 8cm area of redness and warm; slight swelling, non-tender, no fever/limp or other symptoms of discomfort. No treatment given at this time. We will just observe and consider antibiotic treatment if fever or pain develops.
This spontaneous report as received from an other health professional refers to a patient of unknown age. On 26-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # M042853 for prophylaxis. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA004691: US-009507513-1708USA004692: US-009507513-1708USA004694: US-009507513-1708USA002122.
Diarrhea; Severe flu symptoms; Abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the right arm on 19Mar2021 at 14:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient's medical history was not relevant to COVID -19. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 20Mar2021, the patient experienced severe flu symptoms 3 days after with diarrhea, continue to have diarrhea after 6 weeks with catamount and on an unknown date in 2021, the patient also experienced abdominal pain. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe flu symptoms, diarrhea and abdominal pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a 50 years old male patient who is also a physician with hypothyroidism, multiple vitamin deficiencies due to a bowl resection and penicillin allergy. The patient's medical history included bowel resection and peritonitis. In 2009 ("About 4 years ago"), the patient "had two outbreaks of shingles" and on an unspecified date "two months after the second outbreak" he "was vaccinated with ZOSTAVAX, lot#, dose and route unspecified. Concomitant therapies included vitamin d, folic acid, vitamin B 12, vitamin K and vitamin e. The patient reported that on an unspecified date "less than 12 months after" receiving ZOSTAVAX, he "had a shingles outbreak". The patient reported that he "has had a shingles outbreak about every 6 to 7 months". The patient reported that "each outbreak of shingles was multi-dermatomal and varies in severity. The primary dermatomes affected are C7, C8, T2 and T8". The physician also reported that "each time a shingles outbreak occurred", he also "had pneumonia at the same time". The patient went to physician's office for medical attention and VALTREX was given for treatment. No lab diagnostics studies performed. The patient reported that he was currently "recovering" from a shingles outbreak that began on an unspecified date. VZVIP packet faxed. The reporter considered pneumonia and shingles as significant disability or incapacity. Additional information has been requested.
Muscle/joint pain in his upper legs/hips; Muscle/joint pain in his upper legs/hips; Started hurting right on my legs like coming out of my body; This is a spontaneous report from a contactable consumer (Patient) via Medical information team. Follow-up (15Feb2021) was received from same reporter and processed together with initial information.  A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration on 08Feb2021 as 2nd dose, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 via an unspecified route of administration on 21Jan2021 as 1st dose, single for COVID-19 immunization and had no problems. The second one the patient took on 08Feb2021. On an unspecified date in FEB-2021, the patient started hurting right on legs like coming out of body. On 08Feb2021, the patient experienced muscle/joint pain in his upper legs/hips. The patient was calling to find out, he hasn't had any kind of problems up until now and wanted to know could this be the part of symptoms. The outcome of the events was unknown.  Further probing could not be initiated as consumer was unwilling to further answer the questions.   Information on batch/lot number has been requested.
Patient stated around 1800 on 23 Jan 2021 he began to notice a tightness in his throat, and had a headache. He went to sleep, and woke up Sunday (24 Jan 2021), felt fine until that evening, when the symptoms returned, this time he also felt that his heart was racing. He stated he went to sleep, and early Monday afternoon (25 Jan 2021) he felt like it was harder to breathe and had an increased tightness in his throat. He then went to the ER. He was seen on 25 Jan 2021 around 1530. Nothing conclusive was found at this visit, he was seen by MD and was prescribed Prednisone 20mg PO, 2 tabs daily for 5 days. Member stated he is feeling well today.
Patient returned home and later in the afternoon experienced a period of apnea which lasted about 1 1/2 minutes. Patient taken to hospital via ambulance and remains in hospital for observation.
Pt died of Respiratory failure- ARDS, sepsis. This was not a Covid related death
Fever and hive-like rash started several hours after vaccinations. Fever resolved next day but hive-like rash persists.
This case was reported by a nurse and described the occurrence of inappropriate schedule of vaccine administered in a patient who received PEDIARIX. Previously administered products included PEDIARIX. On 19 December 2005, the patient received PEDIARIX 2. On 27th January 2006, the patient received PEDIARIX 3. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown. Additional information: PEDIARIX schedule of administration deviated from the prescribing information. Dose 1 was given on 13 June 2005, dose 3 on 19 December 2005 and dose 3 on 27 January 2006.
Headache; excessive saliva; burning sensation in the throat.; This is a spontaneous report from a non-contactable other HCP (patient). A 39-year-old non-pregnant female patient reported for a herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: El8982) via an unspecified route of administration on her left Arm on 04Feb2021 (at the age of 39-years-old), at single dose for COVID-19 immunization. The patient's historical vaccine included received first dose of BNT162B2 (Comirnaty, formulation: Solution for injection; lot number=Ed0142) on 14JAN2021 at 12:00 pm via intramuscular route on left arm for COVID-19 immunization. The patient's medical history was not reported. It was reported that covid prior vaccination and covid tested post vaccination as No. Also, allergies was reported as no. The patient's concomitant medications included sertraline hydrochloride (Zoloft), bupropion hydrochloride (Wellbutrin), levothyroxine sodium (Levothyroxin), pregabalin (Lyrica) and spironolactone; all start and stop date were not provided and used for unknown indication. On 04Feb2021 at 02: 30 PM, the patient developed headache, excessive saliva and burning sensation in the throat for which she did not received any treatment. The outcome of all the events was recovered in Feb2021.  No follow-up attempts were possible. No further information was expected.