chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT IN ABDOMEN AND EXTREMITIES; ANEURYSM CLOTS IN THE ABDOMEN; LOSS OF MOBILITY; LOSS OF APPETITE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. . The patient's past medical history included stent placed on lower extremities few years ago, and concurrent conditions included former smoker, cardiac issues, non-alcoholic and racing heart, and COPD (Chronic obstructive pulmonary disease) and other pre-existing medical conditions included no known allergies and patient does not abuse drug or illicit drug usage On 03-May-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: Unknown)  frequency 1 total, dose was not reported, administered on right deltoid for prophylactic vaccination. Concomitant medications included rivaroxaban, and sildenafil. On 04-JUN-2021, the patient experienced blood clot in abdomen and extremities, aneurysm clots in the abdomen, loss of mobility, loss of appetite and headache. The patient though the pain was due to medicines she had for cardiac disorder. The pain worsened to the point she went to her gastro intestinal doctor, who did CT scan which showed aneurysm. Her Doctor called cardiologist who suggested referral to a vascular surgeon. The vascular surgeon discovered more blood clots in the abdomen. The CT scan with contrast and Doppler studies were performed. The patient was on blood thinners for 3-4 months. The medicines were started prior to vaccination. None of the doctors were aware that she has taken the Johnson vaccine. The patient stated that she had all the side effects. On 28-JUN-2021, Laboratory data included: Oxygen consumption (NR: not provided) increased. On 28-JUN-2021, Laboratory data included: CT scan (NR: not provided) CT scan with contrast showed clots in abdomen and extremities. On 30-Jun-2021, the patient experienced aneurysm clots in the abdomen. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Not reported, and Ultrasound Doppler (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in abdomen and extremities, headache, loss of appetite, and loss of mobility, and the outcome of aneurysm clots in the abdomen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210716346-covid-19 vaccine ad26.cov2.s-Thrombosis. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
This spontaneous report as received from a pharmacist refers to a patient currently 64 years old (unknown gender). The pharmacist reported that on 26-SEP-2012 the patient was vaccinated with ZOSTAVAX (lot# and expiration date unspecified), standard dose, subcutaneous injection in the arm (dose unspecified). The pharmacist reported that in September 2012 the patient developed wide spread bruising after received ZOSTAVAX. The bruising spanned from the injection site to the underarm to the near shoulder which persisted for a few days and then dissipated. At the time of the report the outcome of wide spread bruising was reported as recovered/resolved. Additional information has been requested.
Nurse injected vaccine into upper arm..pain with injection, hurt all the way to fingers...thought it would be painful for a few days, now after 2 months, patient still cannot take off a shirt and it hurts when putting any pressure on it like push to get up out of a chair.  Saw Dr. - flu vaccine bursitis, now receiving physical therapy for it.
I am breast feeding an d I got mastitis from a breast duct.  I was put on a 14 day Clindamycin. My doctor did not think this was related to the vaccine but that I had to report it. I had chills and breast pain and pain at the plugged duct.  I saw my doctor through telemedicine.
Patient received Pfizer vaccine Dose #1 at 0750. 0800: Patient reported feeling flushed and warm. Pt appears clammy and diaphoretic. Complained of tasting the vaccine in her throat, "weird taste peppermint like".  Vitals: BP: 96/54, HR: 71, O2 sat: 100% and RR: 20, T: 98.3.  0810: Hives noted to patient forehead, itching to nasal bridge and upper back. Patient lying supine, vitals: BP: 108/70, HR: 82, O2 sat: 99% RR: 20. Mildly clammy. Reported feeling improved.  0815: Patient reported feeling "like herself",  Still had taste in mouth. Hives noted to have decreased. Vitals: BP: 115/75, HR: 88, RR: 20, O2 sat: 99%. 0830: Vitals BP: 97/66, HR: 93, O2 sat: 98%, RR: 20. Patient reported feeling better. Denies any swelling in face, mouth or throat. Denies any itching or difficulty breathing. Hives resolved. Patient sitting up and speaking in clear sentences, appears in no distress. Advised to follow up with primary providers. ER precautions reviewed or any return or worsening of symptoms. Patient verbalized understanding and left clinic in stable condition.
PAIN IN LEFT TESTICLE; HEADACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 240 pounds, and height was 78 inches. The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 23-JUN-2021) .5 ml, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced pain in left testicle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-APR-2021, and had not recovered from pain in left testicle. This report was non-serious.
p/vax pt called ER & was vomiting, had diarrhea & had hard red-raised area, size of a silver dollar, on arm where vax given;redness @ inj site;
Three weeks after vaccine patient experienced Headache, Fatigue, nausea, chest pressure, deep, cough.  WAs hospitalized 2/3/-2/4 for elevated blood pressure on observation.  took next week off to regulate blood pressure.  Saw PCP on 2/10 and was released for work on 2/15.  Dr., hospitalist at  Medical Center, .
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 19-month-old male patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 04-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 50 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EL0142), on 28Jan2021 as dose 2, single (Lot number: EN5318), on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) and on 22Jul2022 as dose 4 (booster), single (Lot number: FP7139) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Oct2022) positive, notes: first positive test on 25Oct2022; (02Nov2022) negative, notes: Had negative rapid test on 02Nov2022; (04Nov2022) positive, notes: had positive rapid test on 04Nov2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid treatment from 26Oct2022 to 31Oct2022.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccines (bnt162b2, bnt162b2 omi ba.4-5 and bnt162b2) and events.
Information has been received from a registered nurse concerning a 18 year old female who on 6/15/04 was vaccinated in the left deltoid with a first dose of varicella virus vaccine live (lot # 645575/0436N). There was no illness at the time of vaccination. On 6/28/04, the patient experienced atypical chicken pox with vesicular lesions around the injection site. On 6/30/04, the patient's parent called the office to report that she had raised bumps under her breast and on her back. Unspecified medical attention was sought and no treatment was suggested. There was no product quality complaint involved. Follow up information indicated that the patient experienced blisters on her arms, legs, and abdomen. A local reaction, 2cmx2cm was noted at the injection site. Subsequently, the patient recovered. No further information is available.
patient came in for COVID booster wife at chair side who also was getting the vaccine. Patient requested flu along with his COVID.. The patient in exam area wife siting outside curtain. RN brought in all 3 vaccines for the patient and wife. The RN administered Covid vaccine  in patient's right deltoid. RN then administered what Rn believed to be the flu vaccine, however was discovered to be a second covid vaccine. RN administered 2 covid booster's, one in each arm of the patient, instead of the requested flu vaccine. RN then discussed with the pharmacist and the patient was brought to pharmacy's room to discuss the incident that occurred. The patient stated understanding of the incident and has been given instruction by pharmacist and RN to report any untoward side effects after leaving the facility. The patient was given the information on how to contact RN with any concerns. Pharmacist recommends patient now waiting at least a week before returning for the Flu vaccine. Patient was monitored per CDC guidelines. RN then reported the incident to manager on duty, charge RN was alerted as well.
No adverse event/adverse affects experienced by the patient. The first dose of Shingrix was administered on 11/8/2022, so the 2nd dose should have been at the earliest on 1/8/2023. Patient was scheduled for a Boostrix vaccination on 12/23/2022. Our pharmacy has a Td/Tdap Standing Order signed by our Medical director, so the pharmacy is able to generate a prescription for the Boostrix. A note was entered on the shingrix prescription to have a Boostrix Vaccination prescription generated on 12/23/22. Unfortunately, instead of a new prescription for Boostrix being generated, the 2nd dose for Shingrix was filled instead. The pharmacist was unable to catch this error and unfortunately the Shingrix vaccination was administered to the patient 16 days earlier than intended.
Within 90 minutes I was feeling achy all over my body, had a headache, had chills and just felt "off". I did not have a fever. I went to bed, slept for 3 hours, woke up feeling a bit better with a very sore right arm and a slight headache.
Client had Pfizer vaccines for Covid in mid May and mid June 2021.  Developed Covid symptoms on 11/6 - chills, nasal congestion, cough, headache, myalgia, sore throat.  Tested + for Covid with rapid test and PCR on 11/13.  Reported as breakthrough Covid case.
Fevers and low pulse ox. Patient has a history of COVID-19. She was admitted due to acute hypoxic respiratory failure.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves four-years old female patient who received a dose of FLUZONE QUADRIVALENT (batch number, expiration date, dose, route of administration were not reported) (site of administration: Left Deltoid) on 06-Oct-2018. The patient's medical history and concomitant medications were not reported. The child has received FLUZONE every year (1st year: 0.25ml x 2) It was an actual medication error due to vaccine underdose. It was reported that child did not receive the entire 0.5 ml. It was unknown whether the patient had any 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 Directive 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. List of documents held by sender: none.
My daughter received her second GARDASIL shot on 10/12/17. She developed a lump at the injection site. I looked at the possible side effects and saw that this was normal. Now a month later the lump is the size of a tennis ball and the injection site has its own lump. The injection lump almost looks bruised. Her arm is rock hard and her entire arm hurts. She has been to two different doctors and has had an ultrasound done. The are unable to determine the problem. The nurse from the office just called to give her the results of the ultrasound. The nurse was under the impression that the shot was given last week. When my daughter told her it was almost a month she told my daughter to get into an urgent care. Please advise if this is a side effect. I'd like a call back before the weekend. Thank you.
Thirsty; Fever; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (Thirsty) and PYREXIA (Fever) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2021, the patient experienced THIRST (Thirsty) and PYREXIA (Fever). At the time of the report, THIRST (Thirsty) and PYREXIA (Fever) outcome was unknown.            Concomitant medications were not reported. treatment medications were not reported.
delayed reaction known as "covid arm"; itchy big red warm spot on the injection site; itchy big red warm spot on the injection site; itchy big red warm spot on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Eczema and Allergy (skin allergy).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (delayed reaction known as "covid arm"), VACCINATION SITE WARMTH (itchy big red warm spot on the injection site), VACCINATION SITE PRURITUS (itchy big red warm spot on the injection site) and VACCINATION SITE ERYTHEMA (itchy big red warm spot on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported that she took Benadryl daily for allergies.
pt recv vax NOV95 & lab eval revealed IGG titer of 0.82;
Reported problems by phone, temp to 105, shaking, head shaking, fussy, treated for ear infect 30JUL91; per hx; took pt to clinic; 21AUG91 mom says pt fully recovered, no problems;
Nausea, c/o dizziness, became unresponsive - pale complexion - very shallow breathing.
WHOLE FINGER TIP TURNS DARK PURPLE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 14-APR-2021 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 whole finger tip turns dark purple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of whole finger tip turns dark purple was not reported. This report was non-serious.
On Saturday  1/30 had fever, chills , body aches. Starting  Subday 1/31 had vision blurry  and debilitating  headache.  That is still gong on now.  I am unable  to see using my left eye
Headache, Myalgia & Rash Narrative:  Rash on left elbow and inner arm, 2 inch circles, they started appearing 2 hours after injection. Redness on chest, neck, forehead appeared next day. Used Epi-pen with no relief, took Tylenol.  Other Relevant History:
I suffer from Atrial fibrillation since Dose 3 started to experience heart palpitations. I went to the ER and admitted overnight treated with Cortisone drip, Chest X-ray and referred to a Cardiologist. The Cardiologist prescribed Xarelto 20mg and Cardizem to help with the rate of my heart. On April 5,2022, I had a chemical stress test to rule out Coronary Heart Disease and wear heart monitor for 30 days.
Post vax, the pt developed erythema, warmth, and tenderness to area surrounding the injection site on left deltoid.
Patient received her 2nd Moderna dose on 2/12/21 at a vaccination clinic at School, her employer.  She previously received her 1st Moderna dose on 1/15/21 at another School clinic.  On Tuesday, 2/16/21, patient reported to her school nurse, at School, that she "developed hives around the upper arm and a burning sensation in the palm" following receiving the 2nd Moderna dose.  Patient was advised by Nurse, and Executive Secretary to the Superintendent of Schools, to contact her primary care provider as soon as possible.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose number unknown, single (Lot number: El9262), in right arm and on 21Feb2021 as dose number unknown, single (Lot number: En6198) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergy". There was no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received Paxlovid for COVID 19 Treatment from 01Jul2022 to 06Jul2022. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care.
Hepatitis A was reactive; This case was reported by a physician via call center representative and described the occurrence of hepatitis a in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st two doses on unknown dates).   On an unknown date, the patient received the 3rd dose of Twinrix. On an unknown date, 1 week after receiving Twinrix, the patient experienced hepatitis a. On an unknown date, the outcome of the hepatitis a was unknown.   It was unknown if the reporter considered the hepatitis a to be related to Twinrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received three doses of Twinrix. One week after 3rd dose, the patient had blood work done and a Hepatitis panel was drawn and result was found as Hepatitis A reactive. No other information was reported. The reporter consented to follow up.      Lab Comments: on an unknown date lab tests was performed
Right anterolateral thigh is very warm, edematous, erythematous, and indurated. Reaction started in the evening and has worsened. Non tender. Pt returned to office 2/21/18. AUGMENTIN prescribed.
Headache, Sedation, Myalgia, Arthralgia, Fever, fatigue. pain at the injection site.
This case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 73-year-old female patient who received BOOSTRIX. On 11th March 2015, the patient received BOOSTRIX (unknown). On 14th March 2015, 3 days after receiving BOOSTRIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was not recovered/not resolved. The reporter considered the injection site lump to be possibly related to BOOSTRIX.