chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his thyroid is not producing enough hormone, so he is hypothyroid; experienced pain under left armpit; pain on the glands in his throat.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Caller stated that on his 1st dose, he experienced tiredness.), for COVID-19 immunization, reaction(s): "Tiredness"; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "experienced pain under left armpit"; HYPOTHYROIDISM (medically significant) with onset 2021, outcome "unknown", described as "his thyroid is not producing enough hormone, so he is hypothyroid"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "pain on the glands in his throat.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive.  Clinical course: Caller verified the information provided by the transferring agent. States his 3rd shot was in Oct2021, and he got Covid 19 on New Years weekend. He has been having lingering symptoms, one of which being his thyroid is not producing enough hormone, so he is hypothyroid. He is hoping that maybe the 4th shot will help that improve. Declined to complete the report. States that he is thinking about getting the 4th shot this weekend, but wants to make sure it won't make his thyroid issue worse. Requests to be transferred.    Follow-up attempts are completed. No further information is expected.
Pt received vaccine and was asked to have a seat and wait for 15 minutes.  Pt reported feeling faint and like she was in a tunnel at about 3 minutes post vaccine.  Pt was given water and a wet cloth for her forehead.  She said she felt like her vision was blurry.  She said her throat felt tight.  She was given 10ml of diphenhydramine 12.5 mg/5ml.   I told her if she did not start to feel better I would need to call EMS.   Pt took her blood pressure at the blood pressure machine and it was 143/103.  Pt left after about 7 minutes post vaccination despite the fact that we urged her to remain at the pharmacy.
Large red, hot, itchy and painful 7/10. Began to hurt 30 minutes after injection. has been using ice packs. Today - 47mm induration.
Shingles; A spontaneous report was received from a healthcare professional concerning their patient, of unknown age, female patient who developed shingles/herpes zoster, open sores/ulcer.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on unknown date at the unknown injection site for prophylaxis of COVID-19 infection.   The patient experienced shingles and open sores. Treatment of the events included Valtrex.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events shingles and open sores was not provided.; Reporter's Comments: 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.
Sore arm; This spontaneous case was reported by a physician assistant and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-435187, MOD-2021-435192 (Patient Link).
Pain and cramps in left arm where shot was administered. Cramps and pain with any movement, any lifting. Have had to hire out household duties, getting groceries etc. In elbow up to shoulder.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving 1 dose of fluogen for influenza; above sx occurred 12 hrs p/flu vax & resolved w/in 48 hrs;
8 days after first injection, injection site swelled up, was hot, itchy, uncomfortable. Lasted 3 days.
approx 3 hr p/inj was given started w/excessive crying would not move lt leg, cries when leg is touched or moved; leg swollen fever 100-101 p/APAP; sx only lasted 24 hr pt not seen in office;
Facial and neck swelling, started 30 min after vaccine and lasted 1 hour, took Benadryl  Extremity swelling, started 1 hour post shot and lasted 6-8 hours Less important sided effects- fatigue, arm soreness, nausea, diarrhea, headache- lasting 24-48 hours Hair is falling out in clumps
Adverse Event: Weakness, a fast heart beat, dizzines, itching arms & chest Treatment:  Benadryl 2 Tablets @ 4:00PM 10/13/09 & 1 Tablet 10/14 10/15/09 all symtems gone
SWELLING AND PAIN ITCHING AND RED CIRCLE THE SIZE OF A LEMON CONTINUING TO THE SIZE OF AN ORANGE SWELLING LASTED 5 DAYS
On 11/18/2008 patient called and stated she was having tooth, stomach, shoulder and elbow pain, she was concerned that this was related to her vaccination. We have tried to contact her again but have not gotten a response.
Left costo-vertebral angle pain with radiation in a dermatomal manner around the flank to the anterolateral abdomen lasting three days. No evidence of Zoster, probable neuritis.
My symptoms started about 15 minutes after shot. Initially I felt slight dizziness begin in my head. Then I felt slight uncomfortable feeling in my lungs, throat, and tongue. They were very slight so I left the vaccine center about 25 minutes after injection. On drive home my lips started to feel numb as well as my tongue & throat. Arriving home very tired. BP 135/ 80 P70 R20 T97.6 Blood sugar 101. Slept for about 4 hours. Called in sick for 7PM shift. Too weak & tired.
ALL DAY: Sore arm; body aches; fatigue; OFF & ON ALL DAY: 100.3 to 100.8 fever TREATMENT: Tylenol
stuffed nose; cough; no fever but chills; feels warm; mucus; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via intramuscular route of administration in the left arm on 14May2021 at 14:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient did not receive any medications within two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021, the patient experienced stuffed nose, cough, mucus, no fever but chills. feels warm, but no measurable fever. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events stuffed nose, cough, mucus, no fever but chills. feels warm, but no measurable fever was unknown.   No follow-up attempts are needed. No further information is expected.
On 12/15/2021, in the afternoon, I experienced extreme Vertigo, uncontrollable vomiting. I was treated in the emergency room and released.
02/19/04 8-9AM: Rash for 2 days, fever 100.4, cold symptoms for 3 days.  Seen in MD office, scattered red papules on trunk and extremities. Various sizes.  No actual vesicles.  Itchy, fever began 02/18.  Diagnosis: rash (presumed), possible varicella (atypical).
Information has been received from a registered nurse concerning a female patient who in 2008 was vaccinated with two doses of VARIVAX (Merck) three months apart. VARIVAX (Merck) titers were checked in 2010 and the patient had detectable antibodies but not considered to be in protective range. At the time of the report, the outcome of the patient was not reported. It was unspecified if the patient sought medical attention. Additional information is not expected.
Chills, diarrhea, achy, headache, leg muscles became very weak, dizziness, very tired
I started getting full body hives one week after receiving my Moderna booster shot. My first and second doses of the Covid vaccine shot were both Moderna and I have no serious side effects. It has now been 3 weeks since my hives first started to appear and I still get them daily and all over my body. The hives break out in patches all over and flare up my skin is rubbed, scratched, or exposed to heat (i.e. a hot shower).
patients over 60 years of age with Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse reported that, the patients over 60 years of age were administered Menveo, which led to  inappropriate age at vaccine administration. The nurse inquired for extended data on patients over 60 years of age and getting both Menveo and Bexsero vaccinations. No data available for patients when asked. No further information was available. The consented to follow up.
Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progressed to entire left side of body. 02/05/21 03:30 PM presented to ER for evaluation of left side body numbness. Numerous test & blood work performed. D/C home with diagnosis of transient cerebral ischemia & instructed to follow up with neurologist.
This spontaneous report was received from a nurse refers to a 3 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 03-OCT-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054:
This spontaneous report as received from a healthcare worker refers to 2 patients of unknown age. No information about medical history, concurrent conditions was reported. Healthcare worker reported that on 25-JUL-2014, two doses of improperly stored (Oka/Merck) PROQUAD, have been administered to two patients (lot# not reported, 0.5 milliliter (ml), subcutaneous). No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Lip numbness starting 08/07/14 at 12:30 pm. Numbness in lip and thumb and index finger of right hand 08/08/14. Will follow up with PCP.
Arm was sore at injection site; Injection site turned red; Injection site swollen; The temperature is up at injection site; Injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (The temperature is up at injection site), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE PAIN (Arm was sore at injection site), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (Injection site swollen) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus since 24-Jan-2002, Breast cancer since 2011 and Hypertension since 2008. Concomitant products included LOSARTAN from 02-Oct-2008 to an unknown date for Blood pressure high, TAMOXIFEN from 22-Feb-2011 to an unknown date for Breast cancer, SIMVASTATIN from 12-Jan-2001 to an unknown date for Cholesterol, METFORMIN from 20-Jan-2002 to an unknown date for Diabetes, OMEPRAZOLE from 23-Jan-2002 to an unknown date for Stomach ulcer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE WARMTH (The temperature is up at injection site), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (Injection site swollen). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (The temperature is up at injection site), VACCINATION SITE PRURITUS (Injection site started itching), VACCINATION SITE PAIN (Arm was sore at injection site), VACCINATION SITE ERYTHEMA (Injection site turned red) and VACCINATION SITE SWELLING (Injection site swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received and updated patient demographics, medical history, concomitant medications and outcome of the events.
Prior to 2/1 my daughter began showing extreme restlessness and an overall discontented state. Prior to this, she rarely cried and was as close to perfect as you can get in a baby. Beginning 2/1 she began breaking out in hives all over her body, non-stop throughout each day since. She cries constantly, is rarely comforted by virtually anything possible to try. Today, 2/4 she was taken to her pediatrician and it was confirmed to be hives due to an allergic reaction and to give her Benadryl during outbreaks (which are, since onset, 24/7) and to make an appointment with an allergist if they persist beyond a week. My daughter has not been introduced to any new foods/fabric cleaners/baby hygiene items. My sweet baby who was so happy all the time has, in the past two weeks been inconsolable, discontent and unhappy. Its breaking my heart and I don't know what to do.
Itching all over body; nausea; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198), via an unspecified route of administration, administered in the left arm on 26Feb2021, at 10:45 (at the age of 70 years old) as dose 1, single for COVID-19 immunisation. Medical history included pacemaker, SVT, and known allergies. The patient was not pregnant, and she was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included heart meds, vitamins, and diphenhydramine hydrochloride (BENADRYL). She did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Feb2021, the patient experienced itching all over body and nausea. She has not been tested for COVID-19 since the vaccination. No therapeutic measures were taken as a result of itching all over body and nausea. The patient was recovering from the events at the time of report.   No follow-up attempts are possible. No further information is expected.
a week and three days late for her second shot; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a week and three days late for her second shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (a week and three days late for her second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a week and three days late for her second shot) outcome was unknown.        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.   No concomitant and treatment medications were reported.
chest tightness; palpitations; elevated heart rate; fatigue; This is a spontaneous report from a contactable Other HCP. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. Medical history included Dermatographia. The patient is allergic to Penicillin, lactose, Cephalosporins and Beepen-VK.  There were no concomitant medications. Seventy two hours after the vaccine was given the patient had an elevated heart rate, chest tightness and fatigue. Are this consistent with the vaccine. She does not have a history of elevated heart rate or palpitations. She checked her heart rate with her Apple watch and sent in a strip to the doctor. The doctor is concerned and is asking if this is related. She went to the ER to make sure she was ok but was not admitted. Outcome of event heart rate increased as recovered on 05Jan2021, of fatigue was not recovered, of others was recovering.   Information about Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of elevated heart rate, chest tightness, palpitations and fatigue due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including 12-lead EKG , counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.
Tested positive for COVID-19 after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after the first dose) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after the first dose). At the time of the report, COVID-19 (Tested positive for COVID-19 after the first dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Light energy; Fever; Arm hurt pretty bad; Chills; Body aches; Fatigue; Passed out twice; Felt like ran over by truck; A spontaneous report was received from a consume who is a female patient who passed out twice/ loss of consciousness, felt like she was run over by truck/ feeling abnormal, fatigue, chills, body aches/ myalgia, fever/ pyrexia, arm hurt pretty bad/ pain in extremity and light energy/ asthenia.  The patient's medical history was not reported. Patient's concomitant reported included Lexapro and Spironolactone.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041l20A) intramuscularly for prophylaxis of COVID-19 infection. On 19 Jan 2021, same day of receiving vaccine, the patient passed out twice and felt like she was run over by truck. She also experienced fatigue, chills, body aches, fever and arm hurt pretty bad. On 21 Jan 2021, 2 days later, she had light energy.  No treatment information was reported.  Action taken with mrna-1273 in response to the events was not reported.   The outcome of events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (pyrexia, pain in extremity, chills, myalgia, asthenia, fatigue, feeling abnormal) a causal relationship cannot be excluded. Very limited information regarding the event (LOC) has been provided at this time. Further information has been requested.
I got the vaccine at 0750 in the morning and was fine right after getting it, my arm was a little sore no big deal, then by 0900 both arms were sore and my neck, by 1100 I had aching and chills, but I powered through because those are common symptoms by 1300 I had a headache, by 1500 I had some abdominal cramping, by 1600 some dizziness and nausea, 1730 diarrhea, 1830 more diarrhea and 1850 hives all over my chest. By 1900 my tongue felt heavy and tingly So I walked down to the ER. When I got to the ER I felt like I was going to pass out. By 2040 I was admitted to the ER and given Benadryl, Prednisone,  Pepcid, and Zofran. I was Held for observation until 0300.
wave of neurological effects app 5-6 inches wide in a swath starting at back of neck and proceeding up over top of head & down my face to my chin; tingling lips; minor headache; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiry date: unknown), via an unspecified route of administration, in the right arm, on 24Jan2021 10:45 at a single dose for covid-19 immunization. Medical history included occipital neuralgia, migraines, and known allergies: chlorine, latex. The patient's concomitant medications were not reported. The patient previously took erythromycin and experienced allergy. The patient is not pregnant. The patient has not had any vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 24Jan2021 15:00, the patient experienced "a wave of neurological effects app 5-6 inches wide in a swath starting at back of neck and proceeding up over top of head and down my face to my chin. It included tingling lips and minor headache." The patient had no change in blood pressure (BP), heart rate or respirations. No flush or sensation of heat-almost a sensation of numbness. The patient did not receive any treatment for all the events. Outcome of all the events was recovering.