chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DVT in my leg; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT in my leg) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (DVT in my leg) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (DVT in my leg) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     It was reported that patient had DVT in leg 10 days after and had to visit emergency room (ER) hospital.  No treatment medications were reported.  This case contains information for the 21st of 63 patients described by the reporter.  Company comment: This spontaneous case concerns an 83 year old female patient with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Deep vein thrombosis (reported as DVT in my leg) after receiving a dose of mRNA-1273.222 bivalent vaccine. It was reported that patient had DVT in leg 10 days after and had to visit emergency room (ER) hospital. No information on risk factors, investigations, treatment of the event and outcome was available in the report. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
flashes behind her eyes; felt like her breast was firm, swollen and sensitive; felt like her breast was firm, swollen and sensitive; tingling sensation on her breast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHOTOPSIA (non-serious) with onset 28Mar2021, outcome "unknown", described as "flashes behind her eyes"; BREAST DISCOMFORT (non-serious), BREAST SWELLING (non-serious) all with onset 28Mar2021, outcome "unknown" and all described as "felt like her breast was firm, swollen and sensitive"; PARAESTHESIA (non-serious) with onset 28Mar2021, outcome "unknown", described as "tingling sensation on her breast".  Additional information: According to patient, she experienced flashes behind her eyes while she was getting the vaccine and it felt that it was going to her breast, there was a tingling sensation on her breast and felt like her breast was firm, swollen and sensitive. The patient received second dose on 18Apr.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After receiving imm, pt got in car and drove 2 hrs.  Arm was sore appx 3 hrs after injection.  The following morning he c/o difficulty moving his arm over his head.  The symptoms started to improve (was throbbing & sore), but on Tuesday, July 6th, developed shooting pain from site into right side of neck with increased right arm use.  Also has burning at site.  No redness, swelling noted at site.  Denies numbness/tingling extending down arm.  Denies weakness, but states pain gets so bad with increased use he has to stop activity.  Denies known cause or recent injury/trauma to R shoulder, upper arm, neck other than tetanus vaccine.
Information has been received from a medical assistant concerning a 5 year old male patient with no known allergies or pertinent medical history who on 12-AUG-2008 was vaccinated SQ with a first 0.5ml dose of MMR II (lot # 655380/1326F). There was no concomitant medication. Subsequently, on 14-AUG-2008 the patient developed cellulitis. Medical attention was sought, the patient was seen. There were no lab studies performed. The patient was prescribed AUGMENTIN. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. A lot check has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the center and was released by the regulatory agency. Follow up information was received from the physician who reported that the patient was a female with asthma and a history of pre-term birth (at 35 weeks) who in the afternoon of 12-AUG-2008 was vaccinated SQ in her left leg with a first dose of MMR II (rHA) (lot# 655380/1326F). There was no illness at the time of vaccination. At 13:40 of 12-AUG-2008, within 48 hours, the patient's injection site was red, warm to touch which was initially treated as left thigh cellulitis. The patient was treated with AUGMENTIN. Within 24 hours her cellulitis improved, then worsened. On the 4th day post injection, antibiotic was changed to clindamycin, the patient was also seen in the emergency room (ER). The patient presented at the ER with a red circular area on her left thigh. She denied pain, fever and no distress was noted. It was also reported that the patient had experienced cellulitis since 14-AUG-2008. The patient was treated with IV ROCEPHIN 1gm. The patient was told that it was an allergic reaction to MMR II. The patient was advised to continue AUGMENIN as prescribed by PCF, alternate MOTRIN and TYLENOL for fever. The patient was directed to return to the ER if she experienced increased erythema, drainage or other concerns. No any laboratory or diagnostics tests were performed. On 25-AUG-2008, 13 days post injection, the patient developed a rash that started from her cheeks and spread downward. At the time of this report, the patient recovered. Additional information is not expected. This is one of several reports from the same source.
Vertigo, brain fog, headache, muscle pain, tingling in arms and face, Titania, ear piercing
03/23/2021 felt tired, within second hour sever shaking uncontrollable, vomiting, muscle, and diarrhea for 10 day. Let it run its course until it subsided. Called in spoke with manufacturer with a questionnaire. Called physician and they indicated it was normal. Never recovered from dose 1, continued to have additional issues after the fact. 18 hours of day of fatigue, memory fog, and taste and smell gone.
Contracted COVID-19 after vaccination; Contracted COVID-19 after vaccination; dose number=3; other vaccine same date product=Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Lot number: 301558A) at the age of 28 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: ER2613) as dose 2, single and administration date 25Feb2021 (Lot number: EN6200) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administration date 06Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant medical history included: "Asthma" (unspecified if ongoing); "overweight" (unspecified if ongoing); "known allergies Sulfa based medications" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; BUPROPION received within two weeks of vaccination. The patient was not diagnosed with COVID-19 Prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 31Dec2021, outcome "recovering" and all described as "Contracted COVID-19 after vaccination"; IMMUNISATION (non-serious) with onset 06Oct2021, outcome "unknown", described as "dose number=3"; PRODUCT USE ISSUE (non-serious) with onset 06Oct2021, outcome "unknown", described as "other vaccine same date product=Flu". Awareness Date was 31Dec2021. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) unknown results, notes: Nasal Swab covid test result=Pending; (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant referring to a 14 month old patient with a cochlear implant. On 26-DEC-2017, the patient received a dose of PREVNAR 13. The patient's drug reactions/allergies and concomitant medications were not reported. On 31-JAN-2018, the patient was vaccinated with PNEUMOVAX 23 lot number: N030111 (expiration date: 21-APR-2019), for prophylaxis (strength, route and dosage schedule date were not reported). No side effects were reported.
C/O near syncope following vaccination. No HX of similar. No CP/SOB. No HA. No focal deficits. No HX diabetes. FSBS: 86; BP: 130/80; HR: 52 (regular); no B-blockers or other rate controlling medications. EKG: sinus bradycardia. No blocks No ST/T changes. Intervals normal. Symptoms resolved at rest. HR remains in 50s. Care transferred to ambulance paramedics & patient transported to acute care ED.
The lot number for the first dose of vaccine taken on 03/17/2021 is: 044A21A.  And the lot number for the second dose of vaccine taken on 04/14/2021 is: 036B21A.  About a week after the second dose, my skin on clavicle started changing and getting harder and there are two sections the size of a little finger, also it is on my back and neck and right arm and below the panty line. the hard skin feels like a callus. It is mainly on my torso.
I developed a hiatal hernia, I was prescribed two medications for a month. I also had to follow a diet that avoids many different things. I had to sleep in an elevated position, and I had an endoscopy.
Pt developed a swollen knot the size of a small apple at injection site; also had redness and itching at injection site.
Patient is a 83 y.o. female patient of with history of CAD with stents ,hypertension ,anxiety, diastolic CHF, hyperlipidemia,and seizures presented to Hospital with leg weakness, fever, nasal congestin and was found to have COVID 19 infection, her husband also has COVID 19.    Lower extremity weakness r/o CVA SIRS Fever-resolved Acute on Chronic low back pain T-max 101.2 CT brain - negative for acute process MRI brain-no acute intracranial process or recent infarction CTA head/neck- no acute intracranial process UA- negative Urine Cx-negative Neurology signed off- follow up as needed PT/OT Care management Monitor CBC   Covid-19 Virus Infection Date of onset of symptoms: 10/21/22 Symptoms present on admission: yes Date of covid positive test: 10/21/22 Vaccination status: vaccinated Imaging: Chest x-ray-no focal pneumonia Oxygen requirements on admission: none Current oxygen requirements: none Medical therapy:Remdesivir-completed 3 days Consultants following: ID consulted Anticipated special isolation end date: 10/31/22   CRP, (86) Sedrate (41) D-dimer (0.57) ferritin(424) LDH (174) Sputum Cx-normal flora, many WBC Incentive Spirometry pen Inhalers prn Oxygen prn Encourage prone positioning   CAD Hypertension Hyperlipidemia History of stents 7 years ago Continue ASA, Losartan,  Plavix, Crestor Monitor BP, BP stable   Chronic Diastolic CHF Echocardiogram-pending- previous Echo 3/5/21-left ventricular diastolic function is grade 1, EF 58% Continue Lasix, Spirolactone Daily weights Strict I & O's   History of seizures Last seizure 15 years ago Continue Dilantin Seizure precautions Neurology -signed off follow up as needed   Incomplete micturition Patient void spontaneously however has to self cath twice a day and this has prevented her from having recurrent UTIs per urology Patient remains on low-dose trimethoprim daily No urinary symptoms
Immediate stinging 24 hours: egg sized hot red swelling with itchiness at site of vaccination 48 hours: decrease in swelling but itchy rash 3"x5" on left upper arm 72 hours: swelling mostly resolved , itchy rash persisted 2 weeks after vaccination the itchy rash resolved completely
Break through infection starting with Covid like symptoms deep bronchial cough spasms, 101 temp for 48 hours, runny nose sneezing. Bronchio spasms, difficulty getting berth to speak. Negative Binax home test 12/29 five days after  symptoms began. Positive PCR test 1/6/22 Treated with 5 day series of Prednisone 20 mg. And Albuterol inhaler as needed. Negative Binax test 1/11/22. Developed UTI infection  one week later. Very usual for me to have such an infection. Treated with 2x500mg daily for 10 days amoxicillin. After this series felt the best I had felt since 12/29/21! AMOXICILLIN mopped up not only the UTI symptoms but the Covid cough and bronchio symptoms and I got my energy back..
Patient with no prior otologic surgery. 3 weeks after getting COVID vaccine had sudden hearing in the right ear. Treated with oral steroids and currently receiving intratympanic steroid injections
Pt present about 45 minutes after vaccine administered with lethargy, vomiting, urticaria and mild facial swelling. Was given PO Benadryl and sent by ambulance to ER.
patient given 3rd dose of COVID-19 (Pfizer)vaccine unknowingly. 1st dose: 2/8/21, 2nd dose: 4/20/21, 3rd dose: 5/1121.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 12 mg. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received contains no new information
redness from the injection site to the inside of the elbow; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness from the injection site to the inside of the elbow) and NAUSEA (nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced NAUSEA (nausea). On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness from the injection site to the inside of the elbow). At the time of the report, VACCINATION SITE ERYTHEMA (redness from the injection site to the inside of the elbow) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided by reporter.
expired Daptacel vaccine was administered to a patient, no adverse event; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old male patient who was vaccinated with a 0.5 mL dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (4th dose in series) (lot C528LAA and Exp. Date 05-Oct-2019) via intramuscular route in the left thigh on 23-Oct-2019.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used.  No adverse event reported at the time of reporting.  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 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.
Pt felt ill and feverish for 1 day, post vax. Pt's arm was red and sore at the injection site about 2"-3". As of 5/9/01, is still sore and firm, but is improving. It is no longer red.
Pt noted to have a non-tender 10cm X 7cm local reaction on the left anterior thigh. Complaining of a macular blotchy, blanching rash.
Approximately 10 mins post Pfizer vaccine patient notified EMT she was going to have a seizure. She was placed in a safe position, seizure lasted about 30 seconds. Mild body movement, patient urinated, no physical injury. Mother was present, primary historian. Described course of seizure as regular and last seizure 6months ago. As EMT began taking vitals, she expressed feeling nauseous, and vomited. Afterwards patient stated feeling very tired and wanted to leave. Refused paramedics to be called. Patient wanted to rest, left at 3:00PM. Alert and oriented, no complaints besides feeling tired, able to walk with steady gate. Counseled patient to follow up with provider as soon as possible.
sounds as if he had marbles in his mouth; Acute congestion; Drooling; he seemed spaced out for a brief time period.; Allergic reaction; This spontaneous report was received from a nurse concerning a 4 years old male patient on 24-SEP-2020. No concurrent condition, medical history or concomitant therapy was reported.      On 10-SEP-2020 at around 16:30, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) once (lot # T013536, expiry date: 17-OCT-2021; dose was not reported) subcutaneously in the right arm for prophylaxis. On the same day, he also received diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX) intramuscularly in the left arm (dose, frequency and indication were not reported).   On that day, he had allergic reaction. At around 18:00 at the dinner table before he ate anything, he became acutely congested, drooling, and he sounded as if he had marbles in his mouth. The mother gave the boy diphenhydramine hydrochloride (BENADRYL), and about 10 minutes after he seemed spaced out for a brief time period. On an unspecified date in September 2020, the patient's symptoms resolved with no residual effects, and he has not had any prior vaccine reactions. Action taken with suspect therapies was not applicable.   The causality between the events and suspect therapies was not reported.
fever 102 day p/vax;also had some vomiting;still c/o earache;MD did not feel this was vaccine related did given ATB & feeling better;
L arm localized swelling around injection site. Treated with Benadryl, Tylenol and cool compresses.
Pt states that the right arm, where she received her Flu vaccine, started to hurt about 4 hours after the injection. The pain was so severe, it kept her up all night and the next day, she couldn't move the affected arm and had severe pain. MD advised her to use warm compresses. Pt is unable to take NSAIDS.
Following day (3/9), the patient experienced vomiting , body ache et fever at home. Nursing tried to call patient multiple times. Patient has a full mailbox.
He got his vaccine, towards later evening he started to get chills and shakes.  Then somewhere between 11-12:00 PM he started having breathing problems, but it was so bad that he was considering having somebody take him to the hospital, but he did not.  This went on for hours until he finally passed out and went to sleep and woke up the next morning and was fine.  He was fatigued the entire next day and had a really bad headache, which he took some Naproxen sodium and took an Excedrin, and the headache did go away, and he seems to be back to normal.
Pain in arm and left chest wall with under arm swelling and swollen lymph nodes on morning vaccine + 1
I got my first shot on 24Jan2022 and it IMMEDIATELY stopped my period which I had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Jan2022 at 16:00 as dose 1, single (Lot number: FK9729) at the age of 47 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "anemia" (unspecified if ongoing); "stress disorder" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: LOSARTAN; AMLODIPINE. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 24Jan2022 at 16:30, outcome "not recovered", described as "I got my first shot on 24Jan2022 and it IMMEDIATELY stopped my period which I had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day". The events "i got my first shot on 24jan2022 and it immediately stopped my period which i had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day" required physician office visit. Therapeutic measures were taken as a result of menstruation irregular.  Additional information: The patient later received second dose of BNT162b2 (BNT162B2), on 14Feb2022 at 16:30 as dose 2, single (Lot number: FK9729) at the age of 47 years, in left arm for covid-19 immunisation. No other vaccine was administered in four weeks. She got her first shot on 24Jan2022 and it IMMEDIATELY stopped her period which she had been on for 4 days within a matter of an hour and it didn't return on the "normal" cycle day because she got the second shot on 14Feb2022, from 24Jan2022 to 05Apr2022 she did not have a period and at her old age of 48 my periods were regular. She was not going through menopause (been did all that testing) didn't have fibroids or none of that and as of 24Apr2022 she have been on her period for 20 days since 05Apr2022. This has caused her to have severe anemia and even with medication like medroxyprogesterone 10mg it was NOT stopping. The patient was not tested for covid post vaccination. The patient did not have any known allergies.
(8 months later) to get her second shot; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2021).   On 7th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient reported for herself's. The patient received 2nd dose of Shingrix later (8 months after 1st dose) than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.