chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- 2 days after the injection he started to with chest pressure or tightness with intermittent sharp chest pain that is occasionally on the left and occasionally on the right. Sometimes feels short of breath with the sharp pain. - Submitted to ER 11 days after receiving vaccine - with chest pain and pounding palpitations.  - EKG detecgted occasional premature atrial contractions (PAC). - Referred to cardiologist for additional evaluation. Cardiologist prescribed a 3 day heart monitor, which detected SINUS RHYTHM WITH SINUS ARRHYTHMIA, WITH OCCASIONAL PREMATURE ATRIAL COMPLEXES and OCCASIONAL PREMATURE VENTRICULAR CONTRACTIONS; OTHERWISE NORMAL ECG. - Care plan includes heart monitor, labs for inflammation, and echocardiogram.
Devel SOB & cough 4-6 hrs p/vax recvd; dx r/o rxn to immun; rx DPH, Epi, Guaifenedin; rx last 1 day DPH x 3 days condition improved dec cough upon d/c;
PRESENTED IN OFFICEWITH RASH ONSET @  48 hrs.ago.dx varicella
Swelling, redness, hot to touch, about 4 inches in diameter?? bed wetting
sore throat; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and FATIGUE (fatigue) outcome was unknown.        This case was linked to MOD-2021-311155 (Patient Link).  Concomitant medication was not reported. Treatment information was not reported.
This spontaneous report as received from a pharmacist refers to a 63 years old female patient with no drug reactions/allergies and no pertinent medical history who on 16-NOV-2012 was vaccinated with a dose of PNEUMOVAX23 subcutaneously (dose not reported) (lot # 672781/1706AA, Exp: 03-OCT-2013). Other suspect therapies included ZOSTAVAX (dose, route and lot # not reported) given on the same time on 16-NOV-2012. Concomitant vaccination included: FLUVIRIN given on the same time. The pharmacist noted that on 18-NOV-2012, the patient developed cellulitis around the injection site of PNEUMOVAX23 that spread to her wrist. The patient was seen at the emergency room and administered an antibiotic. The patient was not admitted to the hospital and did not stay overnight in the emergency room. Present patient status was not recovered. No laboratory diagnostic studies were performed. The relatedness for the events was unknown for PNEUMOVAX23 and ZOSTAVAX. This is one of several cases received from the same source (related MARRS # 1211USA008896). Additional information has been requested.
back ache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jan2021, the patient experienced back ache. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  Information about lot/batch number has been requested.
arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days; arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) and RASH PRURITIC (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3 and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) and RASH PRURITIC (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days). On 03-Mar-2021, PERIPHERAL SWELLING (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) and RASH PRURITIC (arm became swollen, with a rash of 6 inches in size and it was itchy, lasting for 5 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug also included LUTEIN for the prevention of Macular degeneration  No treatment drugs were reported   This case was linked to MOD-2021-051262 (Patient Link).
feels like fluid build up in center of back of neck at top of spine; tenderness in arm, neck and spine was reported as worsened; tenderness in arm, neck and spine; tenderness in arm, neck and spine; tenderness in arm, neck and spine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 08:30 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 37 years 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: PAIN IN EXTREMITY (non-serious), NECK PAIN (non-serious), SPINAL PAIN (non-serious) all with onset 30Mar2021, outcome "not recovered" and all described as "tenderness in arm, neck and spine"; EFFUSION (non-serious) with onset 31Mar2021, outcome "not recovered", described as "feels like fluid build up in center of back of neck at top of spine"; CONDITION AGGRAVATED (non-serious) with onset 31Mar2021, outcome "unknown", described as "tenderness in arm, neck and spine was reported as worsened".  No follow-up attempts are possible. No further information is expected.
pt states that she started itching between the left shoulder and left breast.  As she scratched her breast she felt a small bump and noticed a brown spot.  She contacted her OB/GYN via portal to let her know that about these symptoms.  The Doctor advised her to see a Dermatologist.  She contacted her once again since she felt like something was wrong and was told again to see a Dermatologist.  Pt saw Dermatologist  on 3/4/2021 and was told it did not look skin cancer and ordered some cream.  Pt let Dr. know that she had taken the vax recently and that she also has breast implants.  The Doctor did a small exam but did not feel a lump, but this doctor is not an OB/GYN.  Pt went to an already  scheduled mammogram on 3/11/2021 but they would not complete the annual exam since she was having pain issues so she was rescheduled for a diagnostic exam on 3/17/2021.  Pt believes she has felt swollen lymph nodes under her left arm and has had intermittent pain for about 3 weeks now.  The pain seems to move around from breast to her back.
6/6 60y.o. female who presented with worsening SOB and fatigue over the past 3 days.  She has history of A-fib s/p cardioversion, DM, GERD, Grave's disease s/p partial thyroidectomy, HTN, CKD Stage 3, HOCM, diastolic CHF, OSA (CPAP), obesity (BMI 39) and CVA.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No Adverse Events.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There is no lab data provided by the reporter
Second day on December 21 had moderate arm pain extending up neck to base of head. Dec 22 pain was gone but began to have continuous twitching of left eyelid, Dec 23 eye pain.  Started prednisone dose pack on Dec 22.  Eye twitching gradually improved and am currently having minimal symptoms
CONVULSION; SPOTS ON LEFT LOWER ARM TOWARDS OUTSIDE/COVERED FROM HEAD TO TOE; PATIENT REACTED TO COVID19 VACCINE; ACHED ALL OVER; SHAKING; NOT FELT GOOD; HIGH FEVER; This spontaneous report received from a patient concerned a 56 year adult old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included abstained from alcohol. Patient had no known allergies and had no tobacco use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date in FEB-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Skyrizi (risankizumab) (solution for injection, subcutaneous, batch number was not reported) dose was not reported, 1 time every 1 day, from 2020 for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date in 2021, the patient experienced convulsion, spots on left lower arm towards outside that covered from head to toe. The Skyrizi had cleared it all up. He had reacted to the Covid-19 vaccine and had convulsion, fever, ached all over and was unable to go to work as he did not felt good at all for about a day. He had missed a day at work due to shaking. The physician had advised to give a little bit of time about convulsions, just that the body was fighting at the time of reporting. He had missed a 150 milligram Skyrizi dose due to delivery issue. She had physical examination and everything was fine and normal. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) not reported, and Physical examination (NR: not provided) not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of risankizumab was not changed. The patient recovered from convulsion, spots on left lower arm towards outside/covered from head to toe, shaking, not felt good, and high fever, and the outcome of patient reacted to covid19 vaccine and ached all over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211215241-COVID-19 VACCINE AD26.COV2.S-convulsion. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
shortness of breath, pain in chest increasingly more severe as time went on. Noticed shortness of breath about 12 days after the vaccine was given. I am a 2 mile a day walker and very healthy. It was below freezing and I attributed the shortness of breath to weather. I went to an ER on March 8, 2021  after realizing symptoms were worse. I was admitted with Pulmonary embolism in both lungs and pneumonia in both lungs. The hospitalist could  not give me a reason why this happened. He encouraged me to report this incident. You would need to contact him for tests and such. I am a patient. I live where medical help is limited. The vaccine was administered at a clinic but the ER I went to was a different system.
On patient request administered vaccine believed to be his first dose but later determined he had completed the two dose series in 2021.
Pt felt dizzy and fell on the carpet. Sustained no injury pt stated feeling better after few minutes and was sent home with his other after nurse practitioner assessment. Advised to seek medical care if any further symptoms appear.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm), hypersomnia (slept a lot), fatigue (felt tired) and nausea in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028A21A and 006C21A) for COVID-19 immunization. No medical history reported. Concomitant products included Trintellix (vortioxetine hydrobromide) for an unknown indication. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 29, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 30, 2021, patient experienced pain in extremity (sore arm), hypersomnia (slept a lot), fatigue (felt tired) and nausea. The patient treated with ibuprofen; 1 dosage form; after the first dose. On Mar 31, 2021, fatigue (felt tired) resolved. On Apr 2, 2021, pain in extremity (sore arm) resolved. At the time of the report, hypersomnia (slept a lot) and nausea outcome: unknown. Action taken with the drug in response to events: not applicable.
Patient came in for second COVID-19 vaccination.  Asked for Pfizer at drop off window.  Pharmacist confirmed twice he needed Pfizer in the vaccination room.  He left the room.  I had an uneasy feeling about the conversation and checked MICR to confirm he had his first vaccination.  He had a Moderna COVID-19 vaccination in April as his first dose.  When I went to tell him, he had already left without waiting the requested 15 minute observation.
AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in an adult patient of an unknown gender 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 ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFib) 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 was provided. No treatment medications was provided.  Company comment:This spontaneous case reported by a unknown age and gender, with no medical history, who experienced the unexpected serious (medically significant) AESI event of atrial fibrillation, which occurred unspecified days after a dose (dose number nor specified) of mRNA-1273 bivalent BA.4/BA.5 vaccination. At the time of reporting outcome of the event is unknown. No further information for medical history, lab data, concomitant medication, clinical course. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccination is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-719402, US-MODERNATX, INC.-MOD-2023-719297, US-MODERNATX, INC.-MOD-2023-719332 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2023: Upon internal review on 20-Apr-2023, it was identified that previous reports were submitted with incorrect WWID number (US-MODERNATX-MOC20230413000001). Hence, significant correction was performed to update the E2b company number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719402:This case is for Doctor 1 out  of 2 doctors US-MODERNATX, INC.-MOD-2023-719332:This case is for Doctor 2 out  of 2 doctors US-MODERNATX, INC.-MOD-2023-719297:This case is for Doctor 2 out  of 2 doctors
pt. recvd 1st dose of hepatitis B vac & exp. flushing,fever,lightheadedness,diarrhea,sweating,shakiness,chest fluttering,red skin,& facial edema. Treated w/ meds in ER; later exp nausea, sinus infect;
Deceased 12/03/2021; Hospitalized 11/23/2021; COVID-19 positive 11/25/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: , MD Primary Care Physician at Discharge:, MD  Admission Date: 11/23/2021 HOSPITAL COURSE: Patient presented to local HCF ED with symptoms of SOB, orthopnea, and chest pressure that had been worsening over the last three days.  CT showed large pericardial effusion, bilateral small pleural effusions, and cecal diverticulitis.  He was transferred to another HCF and Cardiology was consulted, recommending stat ECHO, EKG.  ECHO showed large pericardial effusion with RV collapse, hemodynamically significant, early signs of tamponade.  He was started on colchicine and indocin  Pt was started on flagyl and levaquin for the cecal diverticulitis. Pericardiocentesis with drain placement was performed the following morning. ECHO post-procedure with trivial remaining effusion.   On 11/25, patient became hypoxic (had been using lasix PRN for fluid overload) and CTA was suggestive of bilateral PE's, heparin gtt was started after significant education provided to patient and wife regarding risk for brain bleed in the setting of untreated brain metastases.  Pulm was consulted and they felt that the amount of clot burden did not accurately explain his degree of hypoxia.  Pt was started on HFNC.  ECHO repeated and this was unremarkable.   COVID re-swab (negative at admission) was positive on 11/25.  Pt was started on remdesivir and dexamethasone.  Pericardial drain removed 11/26.   Stroke code called morning of 11/27 in the setting sudden slurred speech, left facial droop, and loss of motor/sensory function in LUE, LLE.  Neurology was consulted.  Stat HCT showed right MCA stroke 2/2 right ICA and MCA occlusion, not a candidate for MT due to lung cancer with brain mets.  Heparin gtt stopped.  Neurology recommending crani in the setting of worsening malignant edema, patient declined, hospice recommended.  Patient declined escalation of care, was made DNR on 11/27.  Hospice meeting on 11/28, originally planning for home with hospice, met criteria for GIP hospice on 11/29.   Patient was seen per nursing request this evening as patient had expired.   Upon evaluation, patient was unresponsive with wife at bedside.   Patient's pupils were fixed and nonreactive to light.  Patient was without heart or lung sounds upon ascultation.    Patient was without pulses x4 extremities.   Patient was pronounced as having expired today, 12/03/2021, at 11:36 PM.   Attending Dr. notified.
always got sick after getting the flu shot; Initial information received on 03-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involves a patient of an unknown demographic who always got sick (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) the patient always got sick after getting the flu shot.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Urticaria 30min post DTaP, IPV and MMR administered. Patient treated with diphenhydramine 6.25 mg po q 6hrs pm and Pediapred 20mg po qdx 7 days.
sweaty wet and hot; redness; itching; fever; headache; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweaty wet and hot), ERYTHEMA (redness), PRURITUS (itching), PYREXIA (fever), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (Inconclusive) developed fever temperature 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported.
Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion).    No concomitant medication was provided.   The patient received booster dose.  The vial was in frozen storage condition at the time of the excursion. The individual vials were unbroken cartons. The vial size was both 2.5 milliliter and 5.5 milliliter. The Maximum or minimum temperatures reached, were unknown, only have manual twice a day recording. Excursion duration was also unknown. The vials were returned to the freezer it was frozen at the time of reporting. Temperature excursion was for the first time.   No treatment medication was provided.