chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever, incontrollable sweating, muscle fatigue, brain fog, headaches, lack of hunger, vomiting  & extreme muscle soreness.
Patient start with pain in the right shoulder , inflammation and redness in the vaccinated area on March 1 2020. Patient visit provider and was prescribed Augmentin and Zyrtec for 7 days
B/L hand and elbow with several 1-2 mm coalescing erythematous papules with (+) TTP.
This was a booster shot - Moderna COVID-19 Vaccine EUA.  I originally had the J&J single dose on 4/8/21.  Woke up Friday morning at 5:00am with intense body aches across entire body and extremely fatigued.  Later that day I developed a slight fever (99.8) with chills. The following evening I became nauseated to the point of vomiting, shaking and very weak.  The nausea/vomiting lasted about 6 hours.  The body aches and fatigue lasted for approximately 4 days.  Once the aches and fatigue subsided I felt light-headed, like a brain fog for an additional 8 days.  I did not seek medical care since the symptoms were exactly what were listed in the literature.
24 hours after vaccine I had achey and tired. Arm pain lasted 3 days. Perfectly fine day 4-7. Day 8, in the evening my arm started itching. Today is day 9 and it?s still itchy and now a bit swollen, hot to the touch, and hurts when I rub it or bump it. Have not contacted physician yet. Treating with OTC cortisone cream and ice.
The injection site became swollen and red. It was roughly the size of a half-dollar. Has reduced in in size. Is still TTP. No fever/chills. No SOB or difficulty breathing.
the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours; No adverse event; dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7647B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Aug-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured), PRODUCT TEMPERATURE EXCURSION ISSUE (the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours) 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 EXPIRED PRODUCT ADMINISTERED (dose of the Moderna COVID-19 bivalent vaccine was administered to a patient12 hours after the vial was first punctured) and PRODUCT TEMPERATURE EXCURSION ISSUE (the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 52 hours).    No concomitant medication was reported. The expiry date was reported as 15-OCT-2023. The Vial size was 5.0 mL. The vial was initially stored in the refrigerator either 4-JUL-2023 or 5-JUL-2023 and the beyond use date was 5-AUG-2023. The vial was first punctured: on 3-AUG-2023 9:00 AM. The patient had not reported any adverse reactions at this time. No treatment medication was reported.
Eosinophil count was high; granulocyte is low; This spontaneous case was reported by a consumer and describes the occurrence of EOSINOPHIL COUNT INCREASED (Eosinophil count was high) and GRANULOCYTE COUNT DECREASED (granulocyte is low) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced EOSINOPHIL COUNT INCREASED (Eosinophil count was high) and GRANULOCYTE COUNT DECREASED (granulocyte is low). At the time of the report, EOSINOPHIL COUNT INCREASED (Eosinophil count was high) and GRANULOCYTE COUNT DECREASED (granulocyte is low) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No treatment was reported.
DVT right leg. Total obstruction of Popiteal vein, as well as anterior and posterior tibial veins. Subsequent Pulmonary emboli to both lungs.  Symptoms started about a week following 1st vaccine. The symptoms got worse following the 2nd COVID vaccine, and required an ER visit.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Nov2021 as dose 3 (booster), single (Lot number: fe3590) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Negative; (16Jul2022) Positive, notes: On 15Jul2022 started to have cold-like symptoms. Next day tested positive (with a much more distinct positive line on test strip than back on 7/5). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: No. Product=COVID 19 Treatment (start date=05Jul2022, stop date=10Jul2022) indication=Treatment of COVID-19. Adverse event: after testing negative on 10Jul2022 I stopped isolation and wore a mask when in proximity to others. On 15Jul2022 started to have cold-like symptoms. Next day tested positive (with a much more distinct positive line on test strip than back on 7/5). Original symptoms were headache, muscle ache and fatigue. Rebound symptoms are stuffy nose and headache. Note: Paxlovid made me nauseous and gave me a disgusting taste in my mouth during the entire 5 days. Treatment for AE: No. Known allergies: no. Other medical history: none, generally healthy. Device timestamp: 19Jul2022.
Racing heart for a month. Over 140 bpm; This is a spontaneous report received from a contactable consumer (reported for herself).  A 39-year-old non-pregnant female consumer (patient) reported for herself that she received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 240720, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 22Apr2021 at 10:00 (at the age of 39-year-old) as dose 1, single and second dose (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 240720, and Expiration date: Unknown) via an unspecified route of administration, administered in left arm on 13May2021 at 10:00 at dose 2, single for COVID-19 immunization, in hospital. She was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. on an unspecified date in 2021, the patient experienced racing heart for a month. over 140 bpm. Device date was 15Jun2021. The patient underwent lab tests and procedures which included heart rate: racing heart for a month. over 140 bpm (Racing heart for a month. Over 140 bpm). The outcome of the event was unknown.
Within 2 days. a red and warm raised lump appeared at the vaccination site and a slight fever.  An itchy rash--hives--appeared in the next day or so,  just below the lump on my arm.  Symptoms were gone before I got my annual flu shot in the right arm a week later (no reaction).
Patient has a visible mark from his injection.  It looks like a healing ulcer that is about the size of a pencil eraser. He is not experiencing pain, but it did hurt at the time of injection.
Pt had no reaction the day after. No warm to touch, pain in left arm of injection site. But 3 days after pt had cough, mucus, runny nose w/ yellow mucus. Pt had seen her PCP, orthopedic and rheumatologist she describes pain in agony from top left side of her body leg, hip and ankle. Had prednisone, percocet and is still in pain on scale from 1-10, describes pain as 10-11.
Headache started hours after school ended. Motrin did not help. Doctor's appointment November 1st, no meds given. No fever, no body ache.
Sore arm; Body rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Body rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), POTASSIUM CHLORIDE, LISINOPRIL, LATANOPROST, CLONAZEPAM, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN ER), OMEPRAZOLE, LEVOTHYROXINE, VITAMIN D NOS, CALCIUM, ZINC and LORATADINE (CLARITINE) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and RASH (Body rash). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 01-Feb-2021, PAIN IN EXTREMITY (Sore arm) and RASH (Body rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Medications: advair diskus 250/50, albuterol inhaler, Claritin, Vitamin C, Flonase.   This case was linked to MOD-2021-035612 (Patient Link).
Tingling to Right arm, and back. Epigastric distress, Nausea, Weakness, body aches, diarrhea, abdominal pain.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 15-OCT-2012 09:12, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Inconsolable crying, shrieking, thrashing for over 3 hours. Refused nursing for 3 hours.
foggy minded; on first vaccine it made him feel a little sluggish; tired; This is a spontaneous report from a contactable pharmacist. A 36-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular from 18Dec2020 to 18Dec2020 at SINGLE DOSE for COVID-19 immunisation. Medical history included ADHD.  Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and escitalopram oxalate (LEXAPRO). On an unspecified date, the patient stated that on first vaccine, it made him feel a little sluggish, tired and foggy minded. Outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for event mental dullness. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Vaccination administered after storage guidelines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccination administered after storage guidelines) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccination administered after storage guidelines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccination administered after storage guidelines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned No treatment medication was mentioned
Narrative: Patient received first dose of Moderna Covid 19 vaccine at non-VA workplace clinic 2/18. Per outside records, patient became raspy, diaphoretic, felt weak, felt like he was choking. 911 called. BP found to be ~ 200/100. Felt subjectively hot and removed clothing but no temperature reading available. Per report, left workplace to home. No documentation of symptoms treatment. Patient contacted clinic 3/24 to report event, stating he had diaphoresis, weakness, hypertension, dizziness, vomiting delirium, cramping, headache, and "everything was out of whack. My voice was hoarse, and I could not breathe. I still feel no energy".
The pt experienced a headache, severe swelling and red splotches on swollen area, lasting 1 week. The pt took Tylenol and used ice pack on swollen area.
Tested COVID positive, symptoms include fever, chills, muscle aches, cough, nausea/vomiting, and fatigue.
Patient reported sore arm still on 11/15/2017. Her muscle in the vaccinated arm was sore and she was concerned because vaccine was 10/12/2017.
Bilateral joint pains, more significantly in the lower legs, that lasted approximately 2 weeks post vaccine administration. Patient was in 8/10 pain and could not walk, ultimately visiting PCP for immobility evaluation. Xray/MRI was performed to assess if any bones were broken or if joint issues apparent. Patient never fell and MD findings inconclusive for source of pain. Patient continued to report the joint pain for the duration of the 2+ weeks, although pain dissipated slowly.
This spontaneous report has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # M012991, expiration date 14-MAR-2018 (dose, strength, frequency, and anatomical localization were not provided) for prophylaxis. The reporter stated that the temperature range  of the vaccine  was -15Celsius (C) but <-10Celsius(C) and the time frame was 1 hour 3 minutes, also she stated that the vaccine had another previous temperature excursion on 14-DEC-2016 was >-10Celsius(C) but <8Celsius(C) during 1 hour and 54 minutes, and then on 23-JAN-2017 temperature range  of the vaccine  was >-10Celsius(C) but <8Celsius(C) and the time frame was 1 hour 2 minutes. This information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was involved. Additional information has been requested.
In June, I started experiencing muscle pain in legs and abs.  Then had pain in my arms.  In July, started noticing muscle weakness along with the pain.  I have a history of dermatomyositis which has been in remission since initial diagnosis and treatment in 2008.  I went to my doctor and my CPK was slightly elevated.  We began prednisone steroid treatment to treat the symptoms.  When we tapered the steroids in early October, the dermatomyositis came back in a major flare and I cannot work.  I have been having difficulty getting dressed, showering, and doing daily activities.  Elevated heart rate and shortness of breath when moving around.  Pain and weakness are severe.  I also developed kidney stones as a complication from pain medications.
I am reporting a positive side effect. The Moderna vaccine I received seems to have significantly  lessened the arthritic pain in my hands. I noticed less pain within 2 days of the shot and it continues to lessen.  I am hoping the second shot helps even more. Thank you for the improved functionality and the vaccine.
I had multiple breakthrough cases of Covid-19 with flu like symptoms with fever was prescribed PAXLOVID, after about a week symptoms were gone.
Patient accidentally given the Pfizer Booster adult dosage <12 hours ago. Not displaying any symptoms presently.
The patient developed a severe headache. Grandmother (guardian) helped her sit in the car seat and she took 10 steps away from the car, when she looked back at the patient had began seizing.  She was taken to the ER by rescue and diagnosed with having a grand mal seizure.  Grandmother states her lips and around her mouth were blue and the seizure was severe.  She was treated and released from the ER dept.  The patient has been seizure free for 2 years.
Seen 8/20. Increased redness (no induration), (+) warmth site of Varicella, 6.5 cm x 7 cm erythema (symptoms started that night).
My monthly period is coming more often bleeding is heavy ,clotting and cramps; My monthly period is coming more often bleeding is heavy ,clotting and cramps; My monthly period is coming more often bleeding is heavy ,clotting and cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 09:00 (Lot number: EW0183) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product COVID 19, brand Pfizer, lot number EW0167, lot unknown False, administration date 29Apr2021, administration time 09:00 AM, dose number 1, vaccine location Left arm.), administration date: 29Apr2021, when the patient was 47 years old, for COVID-19 immunisation. The following information was reported: MENSTRUAL DISORDER (non-serious), COAGULOPATHY (non-serious), DYSMENORRHOEA (non-serious) all with onset 01Jul2021 03:00, outcome "not recovered" and all described as "My monthly period is coming more often bleeding is heavy ,clotting and cramps". Therapeutic measures were not taken as a result of menstrual disorder, coagulopathy, dysmenorrhoea.  Additional Information: The patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered:  Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Events reported as non-serious.  No follow-up attempts are possible. No further information is expected.
fever; injection site reaction; flulike symptoms; This is a spontaneous report from a contactable Other HCP via Pfizer Sales Representative. A 32-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 16Jan2021, the patient developed injection site reaction, fever, and flulike symptoms after being administered the second dose of the Pfizer/BioNTec COVID-19 vaccine. The patient's symptoms have since resolved on Jan2021.  No follow-up attempts are Possible; Information about batch number cannot be obtained.
Pt was administered second dose of shingrix shot on 04/30/2019. After getting the shot, she started having muscle ache at the site of injection. After few days , the muscle pain went away but she started having itchiness and redness at the site of injection. She started pcp office on or about 05/16/2019 and MD suggested betamethasone oint and follow up with dermatologist, since MD classified it as an adverse rcn. She visited dermatologist after her PCP apt and Dermatologist said it was not an allergix rcn or adverse event. Patient called today ( 05/24/2019) concerned about her itchiness and redness. I suggested her Benadryl tablets and calamine lotion at the site of itchiness and redness .
Confirmed with caller no AE occurred; Caller reported an AE for MMRII. The caller said an expired dose was administered to a patient on 4/24/2023.; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-APR-2023, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection, as prophylaxis (lot number: U011993, which was determined to be valid, with an expiration date on 15-APR-2023, therapy type rHA) (strength, dose, scheme, route and anatomical location of administration were not reported) (Expired product administered).  Caller said the product did not have any temperature excursions prior to administration. No additional adverse event was reported.
Pt is a 68 yoM vaccinated for COVID and hx of HTN, HLD, gout who presents with worsening shortness of breath found to have acute hypoxic respiratory failure 2/2 COVID pneumonia, given rapid worsening started on dexamethasone, remdesevir and barcitinib. He was also found to have a LLE DVT and given worsening oxygenation, possible PE. Pulm, Nephrology were consulted. He eventually needed to be intubated and then developed a pneumothorax requiring a chest tube. He then developed septic shock from superimposed HAP, completed therapy for it and meanwhile went into ARF, initially stable on diuretics, but eventually required HD. Had initial decline in neurologic status with nonresponsive R. Pupil, but unable to perform head imaging d/t clinical instability.  Following another clinical decline on 9/26 where he was found to have another pneumothorax along with worsening s/s of infection. His family decided to make him comfort care at this point and plan to transition with terminal extubation and transfer to hospice scatterbed. He was terminally extubated and TOD was 9/28/21 0202.