chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Today, a dose of 0.25mL of the new Moderna Covid-19 Bivalent was given to a patient, instead of the 0.5mL dose.).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Information has been received from a physician concerning a 26 year old female who on 28-OCT-2008 was vaccinated with the first dose of GARDASIL, lot number 661703/0651X.  Within a week of receiving her first dose the patient experienced blurriness in the left eye, pain and tingling in her hands and feet, and joint pain and headache.  The patient sought medical attention at the physician's office.  Patient recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Follow up information was received from her physician. The patient was a female attorney (height 64 inches, weight 106 pounds) with no known pre-existing allergies, birth defects or medical conditions who was vaccinated in the morning of 20-OCT-2008 with first dose of GARDASIL, 0.5 mL, in the deltoid. In approximately October 2008, the patient experienced blurry vision in one eye, pain and tingling in hands and feet, joint pain and headaches. The patient's outcome was unknown. Additional information is not expected.
approx 20 mins p/vax mom describes: pale, listless, ? apneic-responded immed to stimulation-cried-color nl; adm to hosp-home in 24 hr;
4/2/21- increased fatigue and right arm reddened and itching in right arm 4/3/21- Temp to 101.7, decreased appetite, worsening tremors and weakness.  worsening Parkinson's symptoms that lasted 24 hours.
Patient received COVID 19 (Pfizer) vaccine. Within a few minutes of receiving vaccine patient had a fainting episode before he sat down in the chair in the lobby. Patient hit his head on floor. I went to patient to find him conscious/alert and breathing normally. A technicain called 911 since he hit his head and I stay with him until EMS arrived. I kept him laying on the ground and elevated his feet on a chair. EMS to vitals and all were good. They stayed with him for another 10-15 mintues, then release him home with his mother.
Tenderness in left arm; Armpit of left arm is very painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness in left arm) and AXILLARY PAIN (Armpit of left arm is very painful) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness in left arm) and AXILLARY PAIN (Armpit of left arm is very painful). At the time of the report, VACCINATION SITE PAIN (Tenderness in left arm) and AXILLARY PAIN (Armpit of left arm is very painful) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
Headache, fever, chills, rash below site of injection, fatigue. I thought I had the flu. These symptoms lasted for 3 days.
He currently has a leg problem; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program.    A male patient of an unspecified age received (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation.  Medical history included diabetic. Concomitant medications were not reported.  On an unspecified date, the patient experienced currently has a leg problem. It was reported that patient will get his second dose on 23Feb2021, and since patient is diabetic, need to take MOBIC (meloxicam). It was reported that the patient does not want to mess up with the vaccine and wanted to know if he can take the medication. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SMALL STROKES; This spontaneous report received from a patient via social media via a company representative concerned a 74 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: polio. The patient was previously treated with polio vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date it was reported that, "I took it. No problem. I got polio from the polio vaccine at age 15 and had been advised to never take a flu shot. Didn't until now. 74 years old. Took the chance. So far, so good. Caveat: it did cause 2 or 3 small strokes. All is good" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of small strokes was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via a company representative concerned a 74-year-old of unspecified sex, race, and ethnicity who experienced cerebrovascular accident after an unspecified duration since vaccination. Patient had medical history of polio after polio vaccination 15-years-ago. No concomitant medications were reported. The patient experienced 2 or 3 small strokes after an unspecified duration of vaccination. No further information was provided. Information is limited in this case, and the occurrence of cerebrovascular accident could represent background incidence of such events in the general population. Therefore, the relationship of cerebrovascular accident to vaccination is considered unclassifiable due to insufficient information.
He got his vaccines all in the same day.  8 days later he was not able to get out of bed, could not bend down, had problems moving on Friday, Saturday or Sunday.  0n 9/26/22 he went in to see his Doctor, Dr. who wanted him to go to the ER.  He was examined and diagnosed with sciatica, gave him a referral to a center for therapy, therapy office.  He has been going to therapy this morning, which is helping.  He wants to go back to work, but wants to find out what's going on before he can go back to work.  He has very dry, ashy skin.  He has flaky skin, ashy.  He has to lotion them 2-3 times a day and they are still ashy.  He still has lower back pain and has an appointment to go back on Friday.    He had his COVID vaccines with no problems.
Muscle spasm upper extremities. Hyperventilation. Dizziness, paleness.
Swelling of throat and face Shortening of breath Dizziness/feeling of going to pass out Red face
Initial information received on 15-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves an unknown age female patient who experienced cellulitis, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date the patient experienced a serious looked like cellulitis (cellulitis) Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. Nurse was not sure if it was from FLUZONE HD, as patient had also get other immunizations. Other relevant tests included no lab data. Final diagnosis was looked like cellulitis. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none. Sender's Comments: This case involves an unknown age female patient who experienced cellulitis post vaccination with FLUZONE HIGH DOSE. Time to onset is unknown. There is, however, no information regarding patient's medical condition at time of vaccination, site of cellulitis, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
Information has been received from a pharmacist concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent for the first time. Subsequently the pt experienced "sore arm/ underarm" and nausea and developed swelling, induration, and fever. After "at least 4 days," the pt's symptoms subsided. The pt sought unspecified medical attention. A product quality complaint was not involved.
Patient had gotten flu shot 2 days prior to this vaccine - got chills, aches, reduced appetite, and headache.
DIZZINESS WHEN STANDS UP; This spontaneous report received from a patient concerned a 56 year old male. 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: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced dizziness when stands up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizziness when stands up was not reported. This report was non-serious.
Itchy red rash at site of injection, ~1in diameter; symptoms resolved after taking cetirizine
Fever 101.7.  Severe chills, diarrhea  Johnson and Johnson Covid 19 vaccine
Breakthrough COVID; Breakthrough COVID; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 13:45 (Lot number: FF8839) at the age of 42 years as dose 3 (booster), single, administered in arm right, administration date 25Mar2021 13:15 (Lot number: El3248) as dose 2, single and administered in arm right, administration date 03Mar2021 13:15 (Lot number: EN6203) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU.  The following information was reported: IMMUNISATION (medically significant) with onset 02Dec2021 13:45, outcome "unknown", described as "booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "recovering" and all described as "Breakthrough COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19 Clinical course: The patient did not receive any other medication within two weeks of vaccination and the patient had no COVID-19 prior to vaccination. The patient had no known allergies.
I have a skin rash that starts right below the injection site and goes down to my elbow and wraps around half of my arm, it is read swollen and sore.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosus in a adult female subject who received Flu vaccine unspecified for prophylaxis. On an unknown date, unknown after receiving Flu vaccine unspecified, the subject developed systemic lupus erythematosus. Serious criteria included GSK medically significant. The outcome of systemic lupus erythematosus was unknown. The investigator considered that there was a reasonable possibility that the systemic lupus erythematosus may have been caused by Flu vaccine unspecified. Additional information provided. This case was reported in a literature article and described the occurrence of systemic lupus erythematosus (SLE) in a young female in late 20s who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of study in which vaccine side-effects related studies were discussed. No information on patient's medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed SLE. It was initially manifested with lupus neuritis presenting as classical fortification spectra permeated by the diversity of different colors. Treatment was unknown. The outcome of the event was not provided. The author stated, "The vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart. This might direct towards slightly altered pathologic mechanisms directed at vaccine-related phenomena. The incidence of autoimmune reactions to influenza vaccines is currently unknown, but it can no longer be assumed that a coincidental (i.e., unrelated) association exists between immunization and the onset of RA and systemic lupus erythematosus (SLE)". The author concluded, "Although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, we might be able to find the at-risk groups and lower the incidence. Similar to analyzing HLA-B*5801 status in the high-risk population before prescribing allopurinol for gout, we might be running special panels for those at-risk communities before vaccinating". This is 1 of the 3 valid cases reported in this literature article.
tested + for covid  2-10-22,  passed on 5-1-22;  I have no further info available
About 9 hours after vaccination, patient reports he felt pain, inflammation, and redness at injection site on right deltoid.
7 days after second shot rash appeared on right arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 IMMUNIZATION, reaction(s): "3 days after first shot in right arm rash developed on upper arm". The following information was reported: RASH (non-serious), outcome "unknown", described as "7 days after second shot rash appeared on right arm".  Additional information: Reporters wife had delayed reaction. 7 days after second shot rash appeared on right arm, however second shot was administered in left arm.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
redness; itching below the arm pits; rash; body ache; headache; chills; fever; allergy to vaccine; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergy to vaccine), TACHYCARDIA (tachycardia), ERYTHEMA (redness), PRURITUS (itching below the arm pits) and RASH (rash) in a 38-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 Allergy to animal dander (Cat fur allergy). Concomitant products included MULTIVITAMIN FOR WOMEN for an unknown indication.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ALLERGY TO VACCINE (allergy to vaccine). On an unknown date, the patient experienced TACHYCARDIA (tachycardia), ERYTHEMA (redness), PRURITUS (itching below the arm pits), RASH (rash), MYALGIA (body ache), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) from 23-Apr-2021 to 25-Apr-2021 at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (CETRIZINE) (oral) from 23-Apr-2021 to 25-Apr-2021 at an unspecified dose and frequency. At the time of the report, ALLERGY TO VACCINE (allergy to vaccine), TACHYCARDIA (tachycardia), ERYTHEMA (redness), PRURITUS (itching below the arm pits), RASH (rash), MYALGIA (body ache), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Heart rate: 115 (High) Above 115 bpm, continued for a month on and off. On 12-Mar-2021, Electrocardiogram: normal (normal) Normal. On 26-Mar-2021, Blood immunoglobulin E: 4.3 (Inconclusive) 4.3 <11.0 ug/L. On 26-Mar-2021, Complement factor: 30.2 (Inconclusive) 30.2 <114 Ku/L. On 26-Mar-2021, Electrocardiogram ambulatory: abnormal (abnormal) Tachycardia. On 20-Apr-2021, Body temperature: 101.4 °F (High) 101.4 F. On 20-Apr-2021, Heart rate: 140 (High) 140 bpm. On 21-Apr-2021, Electrocardiogram: 115 (High) 115 bpm. On 21-Apr-2021, Heart rate: 135 (High) 135 bpm. On 23-Apr-2021, Blood pressure measurement: 116/76 (Low) 116/76 mmhg.         This case was linked to MOD-2021-044263 (Patient Link).
pt recv vax 2APR96&14APR06 pt devel a fever;fever 14APR96 103.6 ax;pt given APAP on 16APR96;pt devel maculopapular rash on chest&abd;mom thought it was chickenpox;devel hive on top lip;lip was swollen;given DPH
Information has been received from a health care worker concerning a 72 year old female patient with diabetes and hyperlipidemia and no drug reactions or allergies who on 16-OCT-2006 at 14:05 was vaccinated intramuscularly in the right deltoid with a dose of Pneumovax 23 (lot #651357/0391F).  The patient was also vaccinated intramuscularly with a dose of Fluzone (Lot # U2202AA) in the left deltoid on 16-OCT-2006.  Concomitant therapy included simvastatin (MSD), lisinopril (manufacturer unknown), verapamil and hydrochlorothiazide (manufacturer unknown).  On 17-OCT-2006 in the morning, the patient's proximal basilic vein area on her right arm became sore and very swollen and she developed redness in the vaccinated arm and irritation almost down to the elbow.  Unspecified medical attention was sought on 19-OCT-2006.  On 19-OCT-2006 the patient's blood pressure was 94/59 RUE (sitting).  It was noted that the right arm was mildly, minimally erythematous and did not hurt.  At the time of report the patient recovered but the outcome of the low blood pressure was unknown.  It was noted that the patient was last vaccinated with a dose of Pneumovax 23 in 1998.  No product quality complaint was noted.  The physician requested a lot check for lot number 0391F.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information is not expected.
THERE S NOT ANY ADVERSE EFFECT.  THE VACCINEN WAS GIVEN TO PATIENT AROUND 60 MIN PAST BEYOND -USE DATE . CONTACT MODERNA MANUFACTURE. THEY DIDN'T HAVE ANY DATA ,SO THEY DIDN'T HAVE ANY RECOMENDATION.
A non-serious spontaneous report of "administration of expired product" was received from a non healthcare professional concerning a 31-year-old male out of 18 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 20-Jan-2010, the patient received expired H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.