chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; Heart rate increased; Chest pain; Inflammation; This case was received via VAERS on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and INFLAMMATION (Inflammation) (seriousness criterion hospitalization). 26-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate increased) (seriousness criterion hospitalization). The patient was treated with COLCHICINE for Inflammation, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Myocarditis), HEART RATE INCREASED (Heart rate increased), CHEST PAIN (Chest pain) and INFLAMMATION (Inflammation) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Angiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Chest X-ray: not provided (Inconclusive) Not provided. On 26-Feb-2021, Echocardiogram: not provided (Inconclusive) Not provided. On 26-Feb-2021, Heart rate: increased (Inconclusive) Increased. On 26-Feb-2021, Lipids: not provided (Inconclusive) Not provided. On 26-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 26-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 26-Feb-2021, Urine analysis: not provided (Inconclusive) Not provided. On 27-Feb-2021, Full blood count: not provided (Inconclusive) Not provided. On 27-Feb-2021, Metabolic function test: not provided (Inconclusive) Not provided. On 27-Feb-2021, Troponin: not provided (Inconclusive) Not provided. On 01-Mar-2021, Echocardiogram: not provided (Inconclusive) Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Patient received treatment to Lower Heart rate and Inflammation.  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.; 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.
having bad pains in the middle of her chest; has a sore throat; she is dizzy all the time; sweaty; foot doctor who told her she did not look good; fatigue, she spent a whole week in bed; her blood pressure elevated to 220/120 mmHg; heart started racing; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (her blood pressure elevated to 220/120 mmHg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030MZ0A) 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 reported).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERTENSION (her blood pressure elevated to 220/120 mmHg) (seriousness criterion medically significant) and PALPITATIONS (heart started racing). On an unknown date, the patient experienced CHEST PAIN (having bad pains in the middle of her chest), OROPHARYNGEAL PAIN (has a sore throat), DIZZINESS (she is dizzy all the time), HYPERHIDROSIS (sweaty), GENERAL PHYSICAL CONDITION ABNORMAL (foot doctor who told her she did not look good) and FATIGUE (fatigue, she spent a whole week in bed). At the time of the report, HYPERTENSION (her blood pressure elevated to 220/120 mmHg), PALPITATIONS (heart started racing), CHEST PAIN (having bad pains in the middle of her chest), OROPHARYNGEAL PAIN (has a sore throat), DIZZINESS (she is dizzy all the time), HYPERHIDROSIS (sweaty), GENERAL PHYSICAL CONDITION ABNORMAL (foot doctor who told her she did not look good) and FATIGUE (fatigue, she spent a whole week in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 67-year-old female with a serious unexpected event of hypertension, and nonserious unexpected general physical condition abnormal, dizziness, hyperhidrosis, chest pain, palpitations, oropharyngeal pain, and expected fatigue. Based on 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.; Sender's Comments: This case concerns a 67-year-old female with a serious unexpected event of hypertension, and nonserious unexpected general physical condition abnormal, dizziness, hyperhidrosis, chest pain, palpitations, oropharyngeal pain, and expected fatigue. Based on 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.
Over 102 fever for 48 hours. Bad stabbing pains in  bones in shins, leg joints and hands all night.  Felt like Lyme Disease which I had 4 times in the past over 10 years ago.
Systemic: slight numbness left leg,patient was able to walk-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: patient complained of slight numbness in his left leg after the shot. according to daughter he sometimes gets numbness in his leg. it has happened before, just not with a vaccine.
RN, was attempting to vaccinate the client and pierced the skin with the needle. At this time, the client moved and the needle came out of the client's arm. The registered nurse vaccinating called over lead RN and she was able to observe the needle and syringe that had pierced the client's skin. Both Registered nurses confirmed that the entire dose of 0.2ml remained in the syringe. The area of the arm that was pierced was not bleeding and it was barely visible to see where the needle had pierced the skin. The client was then vaccinated with the full vaccine dose. No reaction occurred while client sat for 30 minutes in the observation area.
On 04/27/2022 I had vaccination. On 07/20/2022 in the evening I started to experience aches and feverish. My temperature was high but I don't remember the number. It did not improve on 07/21/2022 with Theraflu the previous evening. I got in touch with my doctor by email on 07/22/2022 and that afternoon I realized he was out of town. I then got on Facility had a phone call and message from a nurse that evening. In consulting with the nurse I was prescribed Plaxovid. Temperature did get up to 103.4 but I don't remember exactly when.  07/28/2022 I am still testing positive. I do not have any more aches temperature is normal and nasal issues.  No one in your circle has tested positive at this time and I do not know where it came from. When I do the nasal spray I am noticing yellow mucous and my nose is running like crazy.
SOB, throat tightness 5 minutes after vaccination 4 mg decadron, epi and benadryl given IM on scene transferred to Emergency room via ambulance C/) SOB, itching and swelling at the back of her throat and in her neck.  No hives. No syncope. Described as moderate and later mild. No radiation, no vomiting, no wheezing.  Patient discharged from ED at 09:30 am
She was exposed to a Covid positive patient and she tested positive for Covid-19; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history included ongoing exposure to COVID. Concomitant medications were not reported. The patient called in to know why one would be tested positive after getting the vaccine. Patient was exposed to a Covid positive patient and she tested positive for Covid-19 (in 2021). She got her first dose last 27Apr2021 and scheduled to have her second dose on 18May2021. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.
burning in the arm into which the Menactra vaccine was given and patient felt as his body were on fire; crying; did not feel normal for a long time after getting the vaccine; upset; pain all over his body; anger outbursts; pain in the arm into which the Menactra vaccine was given; experienced sleeplessness; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a non-health care professional (patient's father).  This case involves a 14 years old male patient who had pain and burning in the arm into which the vaccine was given and felt as his body were on fire, upset and crying, pain all over his body, was upset, did not feel normal for a long time after getting the vaccine, sleeplessness and anger outbursts, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s) and family history were not provided.  The patient did not experience any symptoms like this with any of the other vaccines he has been given in the past.  Patient did not receive any concomitant vaccines at that time.  At the time of the event, the patient had ongoing Autism spectrum disorder, as he was on the autism spectrum. Patient was seeing a psychiatrist during this time but had been seeing a psychiatrist in relation to his autism even before being given Menactra.    On an unknown date, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiration date were not reported) via unknown route in an arm for prophylactic vaccination.  On an unknown date, approximately 3 years ago, the patient developed non-serious events of pain and burning in the arm into which the menactra vaccine was given (pain in extremity) ;(burning sensation) ; upset (depressed mood); crying (crying);pain all over his body (pain) ; and did not feel normal for a long time after getting the vaccine (feeling abnormal) ;sleeplessness (insomnia) and anger outbursts (anger) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient recovered from all the events. However, it took a year and a half for him to return to normal. Patient was now doing very well in school, and athletically, and now feels normal in his body again.   Reporter also stated that it would be a good idea to reconcile the minimum period of 4 years between Menactra injections recommended, with the minimum period of 8 weeks between Menactra injections recommended by the Advisory Committee.  There will be no information on the batch number for this case.
the first dose was not the easiest on my body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (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: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "the first dose was not the easiest on my body".  Additional information: Caller received her 1st dose of the vaccine 26Feb2021 and was scheduled for the second dose on 22Mar2021 (24 days away from first one), however she received a call from the pharmacy today telling her that she would need to come in today to get the second dose otherwise she will have to start the series again, but she is out of town and will be back on Sunday.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a healthcare student and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 27-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) that was reconstituted with an unspecified sterile water that was not diluent supplied for the vaccine. No adverse effects reported. Additional information has been requested.
12 years patient was given Dapatacel instead of Adacel; 12 years patient was given Dapatacel instead of Adacel; Initial information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 years old patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (batch number, expiry date, route and site of administration were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.  Information on the batch number was requested  Documents held by sender: none.
Patient started to arch back, draw uppper extremities up, eyes rolled back in head, then she slumped forward. At this time two staff members assisted her to exam table to lay down. She was responded by nodding head and her eyes were open. BP at this time 80/60 and she reported feeling lightheaded and nauseated. She continue to be very pale and lethargic for approximately 15 minutes. Ambulance was called and transported to hospital for evaluation.
she received two separate doses of VARIVAX and "did not seroconvert."; This spontaneous report has been received from a pharmacist concerning a currently 19 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2001 (reported as "around the age of 1 year old"), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, lot number and expiration date were not provided), administered subcutaneously for prophylaxis.   It was reported that the patient needed to have confirmation of positive immunity to varicella for an unspecified reason, therefore the physician ordered a serum testing done on an unknown date, which was negative for titers to varicella (seroconversion test negative).  On 20-JUN-2019, the patient was vaccinated with the second dose (reported as "the first adult") of varicella virus vaccine live (oka/merck (VARIVAX) (dose, lot number and expiration date were not provided), administered subcutaneously as re-vaccination due to failure to seroconvert.   The patient confirmed that the two separate doses of varicella virus vaccine live (oka/merck (VARIVAX) did not seroconvert.  At the time of reporting, the outcome of seroconversion test negative and the causal relationship between the event and varicella virus vaccine live (oka/merck (VARIVAX) were unknown.
A non-serious spontaneous report of patient received expired FLUMIST was received from a health professional concerning a two-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Feb-2011. On 25-Feb-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Information has been received from a nurse referring to a patient of unknown age and gender. On 29-SEP-2015, the patient received a dose of ZOSTAVAX (unspecified Lot#, exp. Date and dose), and then on 19-JAN-2016 the patient was vaccinated with another dose of ZOSTAVAX (lot # L024997, dose, expiration data were not reported), which was outside the recommended per the ZOSTAVAX prescribing information. No adverse effects were reported. Additional information has been requested.
8/17/09 - stopped in to Emp Health Prog office to show me a swollen area LDT area: red, sore, warm, approx. 4" in diameter. Afebrile and stated never had a fever. Using over the counter meds for relief. Appears to be a "mod. reaction" by V/S form. 10/8/09 - Employee contacted me to relate L shoulder discomfort, and pain with certain motions L arm. says ROM on left side is limited. Ref to private provider - don't know if went. Did not contact me again. Has been working - no further complaints.
4 hrs post = nausea, sharp headache, dizziness. Went to urgent care next day -> "reacted to protein in shot that lot reacted with her." Arm very sore for 4 days, not red. Still sick day 3. Better day 4. No increased headache with plane take off or land -> traveled day 2.
Child required vaccine for completion of vaccine scheduled. HIB vaccine ordered. Hep B vaccine administered in error. Child did not require Hep B, 4 doses had already been received.
This spontaneous report was received from a registered nurse and refers to a 9 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 23-NOV-2016, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # L016124 with expiration date of 06-MAY-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 57 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
Information has been received from a registered nurse concerning a 33-year-old female with no known drug a history of depression, fibrous dysplasia of bone, hip surgery and femur surgery who in 1994 was vaccinated with one or two doses of varicella virus vaccine live (Oka/Merck). On 02-FEB-2007, a varicella immunoglobulin titer reported no immunity to varicella. Medical attention was sought at the physician's office. The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Patient had second shingrix shot on 2/28/2020 and she started with pruritic maculopapular erythematous rash on trunk and all extremities on 2/29/2020 that has been persistent up until seen today on 3/12/2020. She has had no other skin contacts of concern and no otc/prescription medications. No fevers,chills. No other family members in her house have symptoms.
Woke up with vertigo, dizziness with vertigo has continued through today (day 9). Dizziness is always there but can now be controlled as long as I do not put my head forward, backward, or lay flat.
itchiness at the injection site; swelling at the injection site; redness at the injection site; joint pain; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain) and HEADACHE (headache) in a  patient of an unknown age and gender 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 02-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 VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.
She was supposed to get the Covid booster bivalent vaccine.  She was given the Covid pfizer original vaccine.  She hasn't had any adverse reactions but is worried she will get covid because she states over half of her coworkers have covid. She thinks she will die. I explained we contacted Pfizer and it would boost her immune system and we could give her the bivalent vaccine in 2 months.
Information has been received from a consumer concerning her 4 month old daughter with no pertinent medical history and no known drug allergies/drug reactions who on 05 Mar 2009 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg + Hib conj vaccine (OMPC) (Lot # 655548/1243F) intramuscularly. Secondary suspect therapy included rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (MSD). Other concomitant therapy given on  the same day included the second dose of PEDIARIX ("the first dose was given at 2 months of age") and a dose of PREVAR. It was reported that her daughter developed a "slight rash and fever for a few days after the vaccinations". The patient sought medical attention with an office visit. There was no laboratory diagnostic tests performed. it was reported that the patient had recovered "a few days later.
Blisters initially on my chest and my neck and shoulder had pain. I went to a walk in clinic where I was staying at the time.  I received an antiviral medication.