chrisvoncsefalvay/vaers-outcomes huggingface dataset:
R leg stiff, bruised around site of IPOL and Prevnar, pt having difficulty walking.
Fever, joint pain, chills, muscle aches took 2 Aleve went to bed, sweat it out. Symptoms lasted about 18 hours.
Pt recvd series of 3 Engerix-B vax, 3rd dose given 27FEB91 & it was determined that pt did not respond to Engerix-B series;
1st and 2nd dose of the vaccine then got covid; 1st and 2nd dose of the vaccine then got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE 1, SINGLE and (Batch/Lot number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "1st and 2nd dose of the vaccine then got covid". Additional information: Caller withheld asked If someone received the 1st and 2nd dose of the vaccine then got covid how long they can take the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt woke with faint red raised rash over her arms face and back which developed and included strong itching as the day progressed. Went to MD 11/25/2008 and received a prescription which relieved her symptoms.No reaction to previous  flu vaccine in 2006.
Not truly an adverse event but did develop mild case of varicella infection limited to skin eruptions.
She also experienced pain in the calf of her right leg in Dec2021; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She also experienced pain in the calf of her right leg in Dec2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 21C21A (?) and 38821A (?)) for COVID-19 prophylaxis.     The patient's past medical history included Cancer in July 2013 and Tumor (Grade tumor, intermediate lining of the uterus.). Previously administered products included for Flu: Flu vaccine in 2021. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high, Thyroid disorder (Thyroid disease), Baker's cyst (Between the joint of her right knee (before she got the 1st dose of the vaccine)) and Neuropathy (In both her feet prior to getting the vaccine). Concomitant products included LISINOPRIL, LEVOTHYROXINE and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced PAIN IN EXTREMITY (She also experienced pain in the calf of her right leg in Dec2021). At the time of the report, PAIN IN EXTREMITY (She also experienced pain in the calf of her right leg in Dec2021) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2022-588698 (Patient Link).
Pain/flu-like body ache; Flushing; Pruritus; The lymphatic swelling/lymphatic swelling above my left clavical swelled to about the size of a golf ball, mostly fluid like; Mild headache; I was fatigued for several day; Injection site was itchy; Injection site was sore; Sore arm; Felt crummy/have lost my life; Swelling on the upper part of left collarbone; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt crummy/have lost my life), SWELLING (Swelling on the upper part of left collarbone), PAIN (Pain/flu-like body ache) and FLUSHING (Flushing) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allery to Sulfa drugs. Patient experienced Rash.) since 1990, Drug allergy (Patient experienced Incessant coughing) since 2007, Blood pressure high since 01-Jan-1999, Obesity (Gained 20lbs since the pandemic 2020/2021.) since 01-Jan-2002, Asthma, Hay fever and Hypersensitivity. Concomitant products included BISOPROLOL from 02-Feb-2018 to an unknown date for Blood pressure high.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In April 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt crummy/have lost my life) and SWELLING (Swelling on the upper part of left collarbone). On an unknown date, the patient experienced PAIN (Pain/flu-like body ache), FLUSHING (Flushing), PRURITUS (Pruritus), LYMPHADENOPATHY (The lymphatic swelling/lymphatic swelling above my left clavical swelled to about the size of a golf ball, mostly fluid like), HEADACHE (Mild headache), FATIGUE (I was fatigued for several day), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE PAIN (Injection site was sore). At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt crummy/have lost my life), SWELLING (Swelling on the upper part of left collarbone) and FATIGUE (I was fatigued for several day) had resolved and PAIN (Pain/flu-like body ache), FLUSHING (Flushing), PRURITUS (Pruritus), LYMPHADENOPATHY (The lymphatic swelling/lymphatic swelling above my left clavical swelled to about the size of a golf ball, mostly fluid like), HEADACHE (Mild headache), VACCINATION SITE PRURITUS (Injection site was itchy) and VACCINATION SITE PAIN (Injection site was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided..   This case was linked to MOD-2021-400089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Past medical history is added, Concomitant drugs are added, lot number updated and events added. On 02-Dec-2021: non significant follow up added
Was supposed to take the 2nd shot on 08Oct2021 and caught covid19 and so he had to get quarantined for 14 days/ he got the 2nd shot of the Pfizer vaccine; Whole body broke out in hives again on the upper body and back and lower back was covered in hives except for his arms; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, AE: Broke out with bumps in between his knees and it was a whole bunch and looked like hives), administration date: 17Sep2021, for COVID-19 Immunization, reaction(s): "Broke out with bumps in between his knees and it was a whole bunch and looked like hives", "Covid19", "He got into a car accident". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "Was supposed to take the 2nd shot on 08Oct2021 and caught covid19 and so he had to get quarantined for 14 days/ he got the 2nd shot of the Pfizer vaccine"; URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "Whole body broke out in hives again on the upper body and back and lower back was covered in hives except for his arms"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Not feeling well".  Additional Information: It was reported that, the patient was calling about the Pfizer vaccine he had and had the 2nd shot and when he got the first shot he broke out with bumps in between his knees and it was a whole bunch and looked like hives and then he got the 2nd shot of the Pfizer vaccine. The patient stated he had the 1st shot on 17Sep2021 and then 21 days later he was supposed to take the 2nd shot on 08Oct2021 and caught covid19 and so he had to get quarantined for 14 days and some other stuff happened where he got into a car accident. The patient stated he took the 2nd Pfizer shot and had to wait 24 or 30 days after he got covid to get the next dose and bot the next dose the other day of last week and on Friday or Thursday his whole body broke out in hives again on the upper body and back and lower back was covered in hives except for his arms. The caller was asking what should he do about the hives and so then what should he do and should he go to his regular doctor or what. Caller stated can Pfizer help him with the hives; aware that Pfizer unable to offer medical advice or treatment recommendations and caller was referred to his HCP or doctor; stated he declined the report and stated he was just not feeling well now. Investigation assessment was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received bivalent booster 0.3mL  instead of 2nd primary dose of monovalent moderna.
TC received from FO K.W.  KW had symptoms of temp 100-102, sore throat - red with white patches and pieces of skin coming off.  Also vomiting and diarrhea.  Symptoms lasted about 2 weeks.  Pt evaluated and treated viral illness at a walk-in clinic.
Patient tolerated the HPV vaccine injection well. However 5 minutes after the vaccine was given she fell to the floor she was awake and alert and aware of her surroundings. Stayed in office for 30 minutes with no tender complication.
Fever 101.5 controlled with regimen of tylenol and ibuprofen.    Oxygen saturation lowered to 85 upon waking up at 430 am, was able to control with oxygen here at home and able to maintain at 97 throughout the day with continuous use of oxygen concentrator setting at 5 liters. I am currently on oxygen from previous  bilateral COVID-19 pneumonia infection from January 2022. Lungs have not completely restored to pre-covid. Before vaccine only needed oxygen after physical exertion and o2 was at 98 while resting without the oxygen.
Pt contact initiated. On scene to for a 25 y/o female pt with a chief complaint of syncope. Pt was sitting upright in chair in no apparent distress. Pt demeanor is calm. GCS 15, Aox4. Pt stated she felt dizzy and had a syncopal episode. Pt fell on floor from sitting position. Pt found on floor prone. Pt rolled over to right lateral recumbent position. Pt hit head and has approximately 1 cm abrasion on right anterior face. Controlled bleeding with gauze and bandage. Airway is patent. Speech is clear and even with no noted slur or abnormality. Breathing is non labored and regular with adequate chest rise. Radial pulses with steady rate and rhythm. Skin is intact, warm, and dry. Eyes PERRL. No JVD, tracheal deviation, or peripheral edema. Negative DCAPBTLS other than noted. Pt is able to ambulate. Gait is steady. Pt denies headache or blurred vision, shortness of breath or difficulty breathing, nausea or vomiting, chest pain, dizziness, tingling or numbness in extremities, or any other complaints at this time other than noted.
PATIENT EXPERIENCE SYNCOPE.  SPECIFIC SYMPTOMS INCLUDE PAIN FROM NECK TO BACK, LIGHT HEADEDNESS, SHORTNESS OF BREATH, AND SPIKE OF BLOOD PRESSURE.  ACUTE REACTION SUBSIDED AND PATIENT WAS GIVEN DIPHENHYDRAMINE 25 MG WITH WATER.
medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event; medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 49 years old and unknown gender patient and reporter stated that there was a medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event involving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TENIVAC) for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event (product storage error) (latency: unknown) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  On 22-Sep-2022, the patient received an unknown dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (strength, formulation was unknown, lot UJ899AA and expiry date: 30-Jun-2023) via unknown route in unknown administration site for Immunization.  On 22-Sep-2022 the patient developed a non-serious event of medication error due to temperature excursion that exceeded the stability data were administered to patient with no reported adverse event (poor quality product administered) (Latency: same day) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE.  Action taken : not applicable.  Outcome: Unknown  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.
Patient reported firm red rash at injection site that is getting bigger since vaccination, no itching, tried icy-hot and warm/cold without benefit, no fever or systemic symptoms
Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 11:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included heart attack on an unknown date in 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 11:45, 48 hours after 1st vaccine, the patient experienced severe tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe tinnitus and included treatment with ear wax removal which did not correct the issue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe tinnitus was not recovered at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female in her 70s who "about a year ago" was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not provided).  After receiving ZOSTAVAX (Oka/Merck), the patient experienced "lesions and itching on her eyelid".  The patient had sought medical attention.  At the time of reporting the patient had recovered from the adverse effect.  Additional information has been requested.
Pt's mom reported t102 AX, vomiting on 7AUG91; Also c/o sore leg, unable to bear weight on lt leg; MD reports lt thigh was slightly swollen, full ROM in lt leg; dx mild adverse rxn to DTP; No f/u visit required;
I just noticed a new rash on my chest and on my back which is unusual.  6 macular/papular lesions over lt chest/back. No Pruritus.
Swollen red and sore, itchy right arm, five inches spread,   Cold symptoms .
This spontaneous report was received from a License Practical Nurse referring to a 6 year old male patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 29-SEP-2017, the patient was vaccinated with an improperly stored unspecified dose of VARIVAX Lot # M049127, expiration date: 15-DEC-2018 (also reported as Lot #M005695, expiration date: 16-SEP-2018) for prophylaxis (strength, dose and route were not reported). The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT) Lot #M005695, expiration date: 16-SEP-2018. The patient did not report adverse effects. The vaccine was stored at a temperature of 13 degrees Fahrenheit during 6 hours. Also, it was reported a previously temperature excursion at 32.36 degrees Fahrenheit during 40 hours and 30 minutes. The call was because of a data logger. Until 18-OCT-2017, the patient's parent was unable to search.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reported hx of previous fainting with other vaccines and within 2 minutes of receiving this vaccine if fainted and quickly came to.  We continued to monitor him for 30 additional minutes with no further complications.
Treatment of COVID-19; Treatment of COVID-19; Dose 5: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 at 12:15 as dose 1, single (Lot number: EW6205), in left arm, on 30Mar2021 at 12:15 as dose 2, single (Lot number: Er8732), in left arm, on 15Nov2021 at 12:15 as dose 3 (booster), single (Lot number: FF8028), in left arm and on 30Apr2022 at 12:15 as dose 4 (booster), single (Lot number: FJ4989) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Nov2022 at 12:15 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Patient had no known allergies. Concomitant medication(s) included: SIMVASTATIN, start date: May2005, stop date: 25Jan2023 (Brand: Quallent). The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Nov2022 at 12:15, outcome "recovered", described as "Dose 5: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative, notes: At the conclusion, had no symptoms and a negative antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 26Jan2023 to 31Jan2023.
PATIENT COMPLAINED OF FEELING ANXIOUS. WANTED TO LAY DOWN.  LAYED DOWN ON COT AND WAS OBSERVED.
Information has been received from a Registered Nurse concerning a 65 year old female patient with no allergies and a history of non-Hodgkins lymphoma, which has been in remission for 10 years, who on 19-MAY-2008 was vaccinated SC With a 0.65 mL dose of zoster vaccine live (Oka/Merck) (Lot # 658398/1087U). On 19-MAY-2008, the patient experienced chills and deep bone pain. The symptoms began one hour after the patient received the zoster vaccine live (Oka/Merck). The patient's chills and deep bone pain persisted. No diagnostic laboratory tests were performed. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a Registered Nurse concerning a 65 year old female patient with no allergies and a history of non-Hodgkin's lymphoma with no chemo or radiation, which has been in remission for 10 years, who on 19-MAY-2008 was vaccinated subcutaneously with a first 0.65 mL dose of ZOSTAVAX (Lot# 658398/1087U).  On 20-MAY-2008 the patient experienced chills, severe headache and deep bone pain (also reported as 19-MAY-2008, the symptoms began one hour after the patient received ZOSTAVAX (Merck)).  The physician ordered 1500 mg antiviral given x 3 weeks.  Subsequently, the patient recovered from chills, severe headache and deep bone pain.  No diagnostic laboratory tests were performed.  No product quality complaint was involved.  Additional information is not expected.
R shoulder down arm pain intermitted. Numbness at times when moves certain position. Takes Tylenol at night to help sleep. States shoulder keeps her awake.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EL9267), in right arm, on 18Mar2021 as dose 2, single (Lot number: EP7534), in right arm, on 11Sep2021 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 30Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "polymyalgia rheumatica" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE, start date: 20Mar2021; BREO ELLIPTA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive; (19May2022) Negative; (24May2022) Positive; (29May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course included patient received other medication in 2 weeks. COVID 19 relapse after Paxlovid. Onset of symptoms 08May2022. First positive test 11May2022. Course of Paxlovid 11May to 15May2022. First  Negative test 19May2022. Return of symptoms and positive test 24May2022. Symptoms and positive test still continuing as of 29May2022. The CDC guidance suggested reporting this event
This spontaneous report as received from a nurse refers to  unspecified patients. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot #, expiration date, dose and route unspecified). No adverse effects reported.  This is one of several reports received from same source. Additional information has been requested.
Crying and screaming that evening.   Loss of eye contact.  Lethargic for the next few days.  No new milestones. Won't eat solid foods..  No crawling , clapping babbling.  gross motor skills delay.   Swollen head.
Fever (101.3 F max) for several hours, muscle aches, headache. All symptoms cleared later in the day.