chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ANXIETY; NERVOUSNESS; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 63 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 to right deltoid  for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced anxiety. On 31-MAR-2021, the subject experienced nervousness. On 31-MAR-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, lightheadedness, and nervousness. This report was non-serious.
Allergies; Body ache; Eveny joint in body hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergies), MYALGIA (Body ache) and ARTHRALGIA (Eveny joint in body hurt) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concomitant products included CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergies), MYALGIA (Body ache) and ARTHRALGIA (Eveny joint in body hurt). The patient was treated with DICLOFENAC ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergies) had not resolved and MYALGIA (Body ache) and ARTHRALGIA (Eveny joint in body hurt) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2022-592712 (Patient Link).
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N012618 with an expiration date 21-APR-2019 (dose and route of administration were not reported) reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 11 days and 9 hours. Data logger was not involved. There were no previous excursions. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA009893: US-009507513-1711USA009892.
Side effects; Fever of 102 degree Fahrenheit; Massive body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects), PYREXIA (Fever of 102 degree Fahrenheit) and MYALGIA (Massive body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects), PYREXIA (Fever of 102 degree Fahrenheit) and MYALGIA (Massive body aches). At the time of the report, VACCINATION COMPLICATION (Side effects), PYREXIA (Fever of 102 degree Fahrenheit) and MYALGIA (Massive body aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient refused to provide email and denied further follow up.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Event outcome was updated to resolved from unknown for all events.
Verified pt by name/DOB. Patient was administered a Pfizer Orange Pedi( 5-11 yrs) vaccine IM in left arm. After the vaccine was administered the nurse was unable to document the correct vaccine lot number. The nurse called supervisor to discuss why lot number was not in the system. Nurse was told the lot number was from an expired vaccine. The nurse looked at the label on the vial which had a expiration date of 12/6/2022 and inventory dispersion paperwork with the exact lot number with expiration date of 12/6/2022, which all came from immunization clerk from main office at County. Nurse was told vaccine was mislabeled. Nurse supervisor contacted Pfizer and medical director for direction and treatment of patient. After speaking with Pfizer and medical director it was determined patient needed to return for another covid vaccine injection as soon as possible. Parents were contacted and brought patient  into clinic the same day for another covid vaccine without any complications or adverse reactions
No adverse reaction to the actual vaccine but patient is 16 but received Moderna vaccine that is only approved for 18 years or above.
Information has been received from a physician and a nurse concerning a female who on 14-AUG-2007 was vaccinated with her second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 656992/0450U). Subsequently, the patient developed a nodule and experienced local injection site pain and swelling after vaccination. Unspecified medical attention was sought. The patient was treated with Septra twice a day for 7 days. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
This spontaneous report as received from a nurse refers to a multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On multiple unknown dates, the multiple unknown patients were vaccinated with improperly stored doses of PROQUAD (lot# M037651 with expiry date: 28-FEB-2018, lot# M034691 with expiry date: 24-JAN-2018, lot# M031945 with expiry date: 27-DEC-2017 and lot# M029801 with expiry date: 10-DEC-2017) for prophylaxis along with properly stored sterile diluent (lot and expiration date unknown by the reporter). The doses of PROQUAD were exposed to temperature excursion of 6 degree Fahrenheit (°F) to 14 °F for 5 hours. There were no previous temperature excursion reported. The call was not due to data logger. No adverse effects were reported. No product quality complaint was filed. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA001926: US-009507513-1709USA001928.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that he was only able to draw up 0.64mL from a STERILE DILUENT vial today on 24-FEB-2014, so he used an additional STERILE WATER DILUENT vial to draw out at least a total volume of 0.7mL, and used this amount of diluent from both vials to reconstitute a ZOSTAVAX vial and administered this dose to an unspecified patient. No adverse effect reported. PQC filed. This is 1 of 2 reports received from the same reporter. Additional information has been requested.
Child began vomiting in lobby, was given acetaminophen 160/5ML oral SOLN 3.8ML. Pt. spit the medication out, would not take. Pt seen in ER, 5/31/18 at 04:39. Reported green and brown diarrhea throughout the night.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 70-year-old female patient who received SHINGRIX (batch number N9CA2, expiry date 2nd July 2021) for prophylaxis. The patient's past medical history included thyroidectomy (about 30 years before the reporting date). Previously administered products included SHINGRIX with an associated reaction of adverse event (1st dose received on an unknown date, refer case US2019GSK043645). On 21st February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 21st February 2019, less than a day after receiving SHINGRIX, the patient experienced dizziness. On 22nd February 2019, the patient experienced influenza-like symptoms, fever, flushing, general body pain, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness, erythema of extremities, extremities hot feeling of and sickness. On an unknown date, the outcome of the influenza-like symptoms, fever, flushing, general body pain, dry throat, stomach virus, stomach pain, cold, sleepiness, extremities hot feeling of, dizziness and sickness were recovered/resolved and the outcome of the sore throat was not recovered/not resolved and the outcome of the erythema of extremities was recovering/resolving. It was unknown if the reporter considered the influenza-like symptoms, fever, flushing, general body pain, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness, erythema of extremities, extremities hot feeling of, dizziness and sickness to be related to SHINGRIX. Additional details were reported as follows: The reporter was the patient. The patient received SHINGRIX vaccine on the left arm. The next day of the vaccination at night, the patient experienced flu like symptoms, fever, flushing, body ache, sore throat, dry throat, stomach virus, stomach pain, cold, sleepiness and red hot area on the arm about 6 inches long and wide. The patient reported that she was sick for 7 days after receiving SHINGRIX vaccine. The patient stated as redness left the arm was started feeling better. The patient's symptoms were lasted for about 6 days. The patient was on the phone with the gentleman for 47 minutes discussing what the situation was with this shot and telling him there experienced with SHINGRIX vaccine. The patient was under the impression that at the end of the phone call that he would reach the reimbursement center and the patient would be able to talk to them. The reporter consented to follow up. No further details were provided. This case has been linked to case US2019041406 and US2019GSK043646, reported by same reporter for the patient's husband.
Tingling on the toes after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on the toes after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 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 an unknown date, the patient experienced PARAESTHESIA (Tingling on the toes after second dose). At the time of the report, PARAESTHESIA (Tingling on the toes after second dose) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-398550 (Patient Link).
Site of injection felt like burning, area very red, hot and hard.  Prescribed antibiotics, redness continued to grow to 2 1/2" x 4 1/2" area, remained red, hot and hard for 4 days.
Information has been received from a physician concerning an approximately 50 year old male, who "about four months ago," was vaccinated with a dose of Pneumovax 23. "Two months post vaccination" in approximately August 2007, the patient had been diagnosed with "invasive pneumococcal disease." The patient was admitted to the hospital and put on a ventilator. Bloodwork was performed (no results provided). At the time of the report, the patient was recovering. No product quality complaint was involved. The "invasive pneumococcal disease" was considered to be life threatening and an other important medical event by the reporting physician. Additional information has been requested.
Since I received the vaccine I have been having night sweats and hot flashes that I did not have prior to the vaccine. I have an appointment scheduled with my primary care provider to address. I have spoken to my doctor briefly and will have blood work drawn on  January 26, which is the same date of my appointment.
This spontaneous report was received from a pharmacist concerning to a unspecified patient with unspecified demographics. The patient's concurrent conditions, medical history, drug reactions and/ or allergies were not reported. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of  RECOMBIVAX HB lot # M046373/expiration date 04-NOV-2018, as well as an improperly stored dose of VAQTA lot # N005605/expiration date 08-APR-2018, both for prophylaxis (the route, strength, frequency and dose were not provided). It was reported that the vaccines were exposed to temperature of 47° F to 77°F (9°C to 25°C) for a time frame of 6 hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. Additional information has been requested.
Injection site is warm to touch; Injection site developed a itchy arm; Injection site is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Injection site developed a itchy arm) and VACCINATION SITE ERYTHEMA (Injection site is red) in a 76-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 VITAMIN C [ASCORBIC ACID], HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN HYDROCHLOROTHIAZIDE), CALCIUM, MAGNESIUM, ZINC (CALCIUM + MAGNESIUM + ZINK), DORZOLAMIDE and LATANOPROST for an unknown indication.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Injection site developed a itchy arm) and VACCINATION SITE ERYTHEMA (Injection site is red). At the time of the report, VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Injection site developed a itchy arm) and VACCINATION SITE ERYTHEMA (Injection site is red) outcome was unknown.            Other concomitant medication included centrum.
patient started noticing some itching around the injection site. then the next day afte itching some redness and warmth has occured. patient was seen by dr on 08/03/20. treating with zyrtec. will f/u with pt
Swelling; pain; redness itching at injection site. Red, itchy oval became 2" by 2 ½." Continued to itch after pain ceased. Still a little itchy 11/6/2021. Redness almost gone.
pt recv vax 17AUG95 & pt exposed to varicella from an unvaccinated sibling 14 days later 8APR96 pt devel less than 100 varicella lesions;it was reported as a vaccine failure;
Scattered hives: mostly face and trunk. Treated with Benadryl qd . Hives resolved 11/5/04.
Chills that night headache, nausea, diarrhea, body aches, fever at 102 overnight. Next day fever decreased to 101. ADVIL taken every 4 hours symptoms resolved 2 days later.
Flu vaccination injected into ver upper deltoid at shoulder joint. Within days acute intense and lasting pain developed. Seen at both urgent care and Emergency room and initially dignosed as tendinitis caused by vaccination placement.
Diagnosed Heart Attack on 06Dec2021; initial symptom started on 02Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 09:00 (Lot number: FJ1661) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure that was managed." (unspecified if ongoing), notes: Other medical history: High blood pressure that was managed; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. Concomitant medication(s) included: MOTRIN [IBUPROFEN]; LISINOPRIL. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: FE3590, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 28Oct2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, life threatening) with onset 02Dec2021 04:00, outcome "recovering", described as "Diagnosed Heart Attack on 06Dec2021; initial symptom started on 02Dec2021". The patient was hospitalized for myocardial infarction (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 5 day(s)). The event "diagnosed heart attack on 06dec2021; initial symptom started on 02dec2021" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Dec2021) negative. It was unknown if therapeutic measures were taken as a result of myocardial infarction. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.
She reported a headache. and pressure to the L side of her neck and chest. BP 136/105. Patient waited for 30 minutes and bp was 141/83. At that time she only reported having a headache. She declined to go to the medical clinic for evaluation. She said she would go home and take an aspirin. If symptoms worsened, she would go to the ER.
RASH AROUND FACE, NECK, CHEST; This spontaneous report received from a pharmacist concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced rash around face, neck, chest. Treatment medications (dates unspecified) included: calamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash around face, neck, chest. This report was non-serious.
First dose of the Moderna COVID-19 vaccine on 03/01, 4 days later she developed a red rash on the site of the injection on the lateral side of the upper arm, it has been very itchy, she used OTC HC cream yesterday and took a Benadryl last night, the area is not warmer than the rest of her skin and is not indurated, no pain with arm movement. No fever, no chills.   Objective:   There were no vitals taken for this visit.  There is a red patch of about 5 cm on the outer upper arm. Per patient is not hard or painful. Arm movement does not cause pain.
medication error due to vaccines being given post temperature excursion with no reported adverse event; Initial information received on 06-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 months old female patient who experienced medication error due to vaccines being given post temperature excursion with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 03-May-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT7376NA(expiry date: 30-Jun-2022)  via intramuscular route in the left thigh for Immunization.  On 03-MAY-2022 the patient developed a non-serious medication error due to vaccines being given post temperature excursion with no reported adverse event (medication error) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error due to vaccines being given post temperature excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for the event medication error due to vaccines being given post temperature excursion with no reported adverse 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.
Edema (from elbow to breast on injection arm), moderate to severe pain, chills, fever, nausea, vomiting starting after shot until 3 days later; no treatment was given.
On 12/16/97 and 7/3/98 pt recv first and second dose of vax.  Four weeks after each vax pt exp fever-103-104, arthralgia(knees & ankles), general muscle ache, and fatigue lasting 2-2.5 hours.
I got my shot, 18 hours later I woke up with a mild headache and it go worse. I went into work and had to have my wife come get me because it was so bad. It lasted 3 days. I had some arm soreness.
Patient developed tics that never went away.  His behavior dramatically declined shortly after receiving his flu shot.  He's currently living in a residential setting.  His dx include ASD, ADHD, intermittent explosive disorder, Tourette's, pANDAS.
RED RASH, NO ITCHING, ROUGH TO TOUCH. LOCATION: INNER ARMS, LOWER ABDOMEN, LEGS PATIENT WENT TO DERMATOLOGIST-PREDNISONE AND TRIAMCINOLONE CREAM
This spontaneous report received from a patient concerned a 54 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced arm soreness. On an unspecified date, the subject experienced excessive sleeping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, had not recovered from weakness, tiredness, and arm soreness, and the outcome of excessive sleeping was not reported. This report was non-serious.
This is the most recent shingles vaccination (not-live). Sharp pain with injection, burning and aching. Immediately swelled up to the size of a tennis ball, turned red and hot to the touch. The entire shoulder area ached down the entire length of the arm. Lasted 3-days, and ached severely enough to prevent sleep or touching it. Could see the tennis size swelling through clothing. The older shingles vaccination (live) had NO effect afterwards.
Patient leaving office complained of throat feeling funny and difficulty swallowing. Mom did not report to physician at the time but called back 2 hrs later. Mom also states this happened last year with other vaccines. Symptoms better in 2 hrs.