chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart irregularities; high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (heart irregularities) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported. ).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (heart irregularities) (seriousness criterion medically significant) and HYPERTENSION (high blood pressure). At the time of the report, ARRHYTHMIA (heart irregularities) and HYPERTENSION (high blood pressure) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
bleeding from rectum; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding from rectum) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced RECTAL HAEMORRHAGE (bleeding from rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (bleeding from rectum) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. No treatment information was provided.  The colonoscopy was scheduled for May.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient woke up 8 days after second dose and started experiencing itching under arms, breast, back, and in groin area. A red color rash developed in all these areas. Patient went to ER and was giving a steroid, pain, and allergy medication but patient not sure names. Patient states rash is still present on back and left arm and is still taking prescribed medication from ER.
The day after the shot, I had upset stomach, stiff neck and shoulders, and chills in afternoon.  2nd day after the 1st shot, I came down with a severe case of a rash (similar to shingles) across my entire back, and left side mostly.  After 2nd shot, the same symptoms as the first shot and 2 new areas of rash broke out again.  Dr. put me on steroids. ( Methylprednisolone 4 mg)
No additional AE reported; A nurse reported a patient inadvertently received PROQUAD instead of MMR II.Interchange of vaccine products; A nurse reported a patient inadvertently received PROQUAD instead of MMR II.; She also states only about half of the medication (0.25mL) was administered because the patient moved their leg during administration and the needle slipped out.; This spontaneous report was received from a nurse and refers to a 14-month-old patient, of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not provided.  On 24-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin-rHA) (PROQUAD), 0.25 ml administered, lot number U015480, expiration date: reported as 13-NOV-2022, (strength, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong vaccine administered-drug use for unapproved schedule). Also, the patient only received the half of the vaccine dose (0.25 milligram (ml)) because the patient moved their leg during the administration and the needle slipped out (incomplete dose administered). On the same date, the patient was also vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX); and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13),(strength, formulation, dose description, lot number, expiry date, and route of administration were not provided for none on both), which the nurse reported that the patient received the full dose of both vaccines. No additional adverse event was reported.  .
Not quite a week after getting the first dose of the vaccine I noticed a lump  on my neck.  The following Monday I made a Dr apt   She told me that it was a swollen lymph node snd to watch it for a week to see if it went down.  It didn?t do I had an ultrasound on it.  It looks ok, but there is still a lump on my neck that I can feel in my throat.   I am currently 1 week out from my 2nd vaccination.
right arm red, swollen, hot to touch starting 4 inches below acromian process approximately 3.5x4.5 inch area.  This is about 1-2 inches below the injection site and appears to be subcutaneous.
Significant ringing is occurring in my ears. Never had any symptoms or ear problems in the past and it is now non stop.
no adverse effect reported; improperly stored dose of Varivax was reconstituted with a non-Merck diluent; This spontaneous report was received from a nurse and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 27-JUN-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX), lot # R003301, expiration date 01-FEB-2020, (dose and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion from -9 degrees Celsius to 8 degrees Celsius for 5 days. There were no previous excursions reported. Data logger was not involved. Concomitant therapies included sterile diluent. No adverse effects were reported.
10/4/2021 started with severe fatigue, muscle aches.  started having mid throat pressure and it radiated to upper chest.  constant.  no sweating, no relief with Tylenol or nsaids.  Hx of afib and increased in short runs of RVR rate 120-130.   10/5/2021  Pain throat/chest intensified and continued.  fatigue arms legs ache and felt tired.   went to er  10/6/21 discharged after tests.  fatigue aching nausea
Breathing rate is 79 bpm; Does not have pain in the area, but it is red; Slightly sore arm that started around 8PM, which is about 5 hours after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATION ABNORMAL (Breathing rate is 79 bpm), PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination) and ERYTHEMA (Does not have pain in the area, but it is red) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient is currently receiving cancer treatment.) and Cellulitis (She is also receiving IV treatment for cellulitis and the area that has cellulitis is red.).    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination). On an unknown date, the patient experienced RESPIRATION ABNORMAL (Breathing rate is 79 bpm) and ERYTHEMA (Does not have pain in the area, but it is red). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RESPIRATION ABNORMAL (Breathing rate is 79 bpm), PAIN IN EXTREMITY (Slightly sore arm that started around 8PM, which is about 5 hours after vaccination) and ERYTHEMA (Does not have pain in the area, but it is red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.4 (normal) temperature 98.4F. On an unknown date, Heart rate: 70-71 bpm (normal) heart rate is at 70-71 bpm. On an unknown date, Oxygen saturation: 96% (normal) pulse oxygen level 96%. On an unknown date, Respiratory rate increased: 79 bpm (High) breathing rate is 79 bpm.         Patient was receiving IV infusion treatment for cellulitis and treatment for cancer. Her dermatologist had recommended to take Allegra during the day and Zyrtec in the evening. But she would prefer to just take Benadryl. No concomitant drug details were reported. Patient received 1st dose of Moderna Covid-19 vaccine on 04-Feb-2021 or 08-Feb-2021 and 2nd dose of Moderna Covid-19 vaccine on 04-Mar-2021 or 08-Mar-2021.   This case was linked to MOD-2022-440018, MOD-2022-439924 (Patient Link).
Febrile, fussy, inj. site reddened, lethargic.
AIDP (Guillain-Barre) shortly after influenza vaccine. N.B. Do NOT know the exact influenza shot type -- just picked the first option on drop down menu.
Achy - body/weak, headache, discomfort pain in upper chest, sharp pain with movement and deep breaths (lasted four days), lower abdominal cramps X 2 days (no diarrhea/ no vomiting/ no constipation). No nausea.
itching around stomach area gradually went down to limbs and up to back and arms; black and blue blotches all across the torso; Rashes; Weal; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching around stomach area gradually went down to limbs and up to back and arms), RASH MACULAR (black and blue blotches all across the torso), RASH (Rashes) and URTICARIA (Weal) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 024M20A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Angina pectoris (Patient was diagnosed with angina years ago). Concurrent medical conditions included Acid reflux (oesophageal) (Patient has acid reflux for a long time), Slipped disc (Patient has bulging disc pain), Numbness in leg (Patient has been taking Gabapentin for 10 years for numbness of legs due to bulging disc pain), Cholesterol total abnormal NOS, Blood pressure abnormal, Drug allergy (Patient has known allergy to Levaquin) and Overweight. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), METOPROLOL for Blood pressure management, SIMVASTATIN for Cholesterol total abnormal NOS, POTASSIUM CHLORIDE and HYDROCHLOROTHIAZIDE for Diuretic therapy, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), COLECALCIFEROL (D3) and MULTIVITAMIN [VITAMINS NOS] for Immune enhancement therapy, GABAPENTIN for Numbness in leg, CALCIUM, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MAGNESIUM 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 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (itching around stomach area gradually went down to limbs and up to back and arms), RASH MACULAR (black and blue blotches all across the torso), RASH (Rashes) and URTICARIA (Weal). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of Benadryl once daily; HYDROCORTISONE for Rash, at a dose of several times daily; HYDROXYZINE HCL at a dose of 10mg 1 tablet once a day and increase to 2 tablets twice day and METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE [METHYLPREDNISOLONE ACETATE]) at a dose of Methylprednisolone Steroid for 6 days. At the time of the report, PRURITUS (itching around stomach area gradually went down to limbs and up to back and arms), RASH MACULAR (black and blue blotches all across the torso), RASH (Rashes) and URTICARIA (Weal) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's height is 5 feet and 2 inches. Patient consulted 2 doctors that included a dermatologist. Patient reported that taking a shower relieved itchiness.   This case was linked to MOD-2021-043729.
This spontaneous report has been received from a medical assistant concerning a 3 month old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 19-SEP-2017 the patient was vaccinated with PROQUAD with lot number M044719 and expiration date on 07-MAY-2018, for prophylaxis (dose, dose number and route of administration were not provided). Concomitant therapies included the sterile diluent. No adverse effects were reported.
This spontaneous case was reported by a consumer and describes the occurrence of BREAST TENDERNESS (Horrible breast tenderness, really bad), ILLNESS (Sick) and FATIGUE (Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced BREAST TENDERNESS (Horrible breast tenderness, really bad), ILLNESS (Sick) and FATIGUE (Fatigue). At the time of the report, BREAST TENDERNESS (Horrible breast tenderness, really bad), ILLNESS (Sick) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-May-2021 contains non-significant information.
Sudden onset dizziness, near syncope, tachycardia, shortness of breath, facial numbness, shaking/rigors
pt recv vax & noted 4inch x 4 inch area;where pneumonia vax given;area is rashy w/streaks has fever in arm & physical fever-area is raised-swollen;
A non-serious spontaneous report of '29 patients received expired FLUMIST" was received from a physician concerning a nine-year-old female. The patients' medical history included no history of asthma. Concomitant medication were not available. On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008). The reporting physician was concerned regarding efficacy and loss of potency due to the expired product. Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of associated with these medications errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error.
Since the day of the first booster (which is 3rd shot) my arm has hurt. It has been over a year and it still hurts and wakes me up at night with pain. Not sure if others have reported this adverse.
Information has been received from a licensed practical nurse concerning a 5 year old white male with hay fever, an allergy to amoxicillin trihydrate (+) clavulanate potassium (AUGMENTIN), and a history of asthma who on 03/21/2002 at 14:00pm was vaccinated subcutaneosly in the right leg with a second dose of measles virus vaccine live (+) mumps virus vaccinel ive (+) rubella virus vaccine live (second generation)(Lot # 640912/1521L).  Concomitant vaccination on 03/21/2002 at 14:00pm included a fourth dose of poliovirus vaccine (IPOL)(Lot # V0426) subcutaneously in the left leg (also reported as given in the same leg as measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)) and a fifth dose of aluminum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia)(V0541BA) intramuscularly in the left leg.  The patient also takes allergy extract shots every two weeks.  The patient had no prior history of a reaction to a vaccine, and there was no illness at the time of vaccination.  On 03/24/2002, 3 days post vaccination, the patient's leg developed a large blistered area with swelling over the injection site.  The reaction lasted "one week" and is entirely resolved.  Unspecified medical attention was sought.  It was reported that no treatment was necessary and cortisone cream was used for itching.  Additional information is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Dysautonomia" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: METOPROLOL, start date: 15Dec2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Negative; (Mar2023) Positive, notes: 4 days later symptoms resumed and patient tested positive again. Patient continued to test positive with mild symptoms for more than 2 weeks after the rebound; (unspecified date) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300139790 Same patient, different product/event;
Pt was 19 y/o at the time, given adult dose when she should have received a peds dose. No reaction, pt tolerated well. This was d/t human error and should have been prevented, yet with the dosage for Hep B peds up to and including 19 year olds and Hep A up to and including 18 years old, it seems this was an error waiting to happen. The information (dosage age) should AT LEAST be written on the outside of the vaccine box.
A report has been received from a Pharmacist concerning a 17 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that the patient received only a half dose of FLUMIST in one nostril which started on 11-Nov-2013 at a mobile clinic. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Approx. 48 hrs after vaccine, pt reports shaking chils with nausea and induration at injection site that developed that night of the vaccine. Symptoms lasted a week then resolved completely. Pt also  had pneumonia in April.
Narrative:  Patient called 3/31/21 (4 days) reporting symptoms after 2nd dose of COVID vaccine; patient advised to go to ER; pt went to outside facility and received antibiotic. Patient reported on 4/1/21 that symptoms have resolved and she feels much better.
Headche, significant muscle/body aches, fatigue, injection site swollen, red and hot to the touch, arm pain.
12/5/21: rash, nonpruritic, started in left arm after covid vaccine, but spread over past 2 days. Widespread blanching maculopapular rash with rare urticaria. Reassuring exam. Discharged home.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA lot # N005274, expiration date 03-APR-2018 and lot# N005796, expiration date 26-MAY-2018 (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 32 degree Fahrenheit to 35 degree Fahrenheit for 480 hours and 10 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA004176: US-009507513-1708USA004188: US-009507513-1708USA004189.
chills, vomiting, severe joint pain, heavy chest (difficulty breathing), headache, fever
7/25/00 2" in diameter redness Lt arm swollen warm to touch. DTaP given 7/23/00.
Patient developed sob. Admitted on 2/16/21 with cardiogenic shock, acute renal failure and liver inflammation. Diagnosed with multisystem inflammatory disorder from COVID-19. Thought to be related to diagnosis on 1/25/21 but given recent receipt of vaccine reporting in case there are trends.
196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received additional booster dose. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant follow up received contains updated age group and case narrative.