chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart palpation 2 to 3 times a week. Shortness of breath during the Heart Palpation.
Soreness; redness; swelling; reaction site was hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling) and INJECTION SITE INDURATION (reaction site was hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling) and INJECTION SITE INDURATION (reaction site was hard). The patient was treated with DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling) and INJECTION SITE INDURATION (reaction site was hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
throwing up/Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 21Mar2021, outcome "unknown", described as "throwing up/Vomiting". It was reported that the patient received the 2nd shot on 19Mar2021 (Friday) and had all the symptoms (as provided by the reporter, pending clarification). On 21Mar2021 and 22Mar2021 (Sunday and then on Monday), the patient has been throwing up and it has been at least 6 to 7 times. And on 24Mar2021, the patient was again vomiting and only had liquid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
-ADR: Allergic reaction (SOB and throat tingling/swelling -Inpatient - 0.9% NaCl Bolus, famotidine (PEPCID) injection 20 mg ,diphenhydrAMINE (BENADRYL) injection 25 mg, methylPREDNISolone sod succ (SOLU-Medrol) injection 125 mg, diphenhydrAMINE (BENADRYL) injection ADS Med, famotidine (PEPCID) injection ADS Med -Treatment: discharged with Benadryl and Medrol Dose pack
03/10/2005 - Mild erythematus rash on the forehead and on injection site, right thigh, also on the legs and bilateral.  Child had fever was in ER.
Patient is immunocompromised, given 0.25 ml instead of 0.5 ml for 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient is immunocompromised, given 0.25 ml instead of 0.5 ml for 3rd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient is immunocompromised, given 0.25 ml instead of 0.5 ml for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient is immunocompromised, given 0.25 ml instead of 0.5 ml for 3rd dose) outcome was unknown.  or mRNFA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Patient reported worsening chest pain for 5 days following booster dose (0.25mL) of Moderna. Mild exertion (e.g. walking up stairs) and lying down worsens pain. Sitting and leaning forward helps pain. Patient was referred for stat echocardiogram and completed same day. Echocardiogram demonstrated mild pericarditis. Patient started on ASA 650 mg TID x 2 weeks, then decrease to 325mg TID x 1 week. Colchicine 0.6mg BID for 3 months. Pantoprazole 20 mg for duration of ASA treatment.
Initially the sensation was mild but intensified 2 days later; Intense smell and taste of chlorine bleach/metallic taste in mouth and nose that started the day of the vaccine (5/27/21).; This side effect has prevent me from eating food or drinking liquids as the smell and taste results in gagging and repulsion/difficult to eat or drink.; This side effect has prevent me from eating food or drinking liquids as the smell and taste results in gagging and repulsion.; This is a spontaneous report from a contactable other Healthcare Professional (patient) reported for herself. A 54-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0169, Expiry Date: unknown) intramuscular, administered in left arm on 27May2021 at 09:00 am (age at vaccination was 54 years) as 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had known allergies to chlorine bleach and mayonnaise. The patient did not receive any concomitant medications or any other medications within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. On 27May2021 at 15:00 pm, the patient had an intense smell and taste of chlorine bleach/metallic taste in mouth and nose that started the day of the vaccine. Initially the sensation was mild but intensified 2 days later (30May2021) and was still intense and present that day (on 01Jun21). She had continuous metallic taste and smell since day of vaccine. Nine days after the vaccine the metallic taste and smell persisted with the same intensity. That side effect had prevented her from eating food or drinking liquids as the smell and taste resulted in gagging and repulsion. It was difficult to eat or drink as the intense taste and smell resulted in a gagging reflex. The patient received smell training therapy for the adverse event. The device date was reported as 05Jun2021. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.  Follow up (05Jun2021): New information received from a contactable other Healthcare Professional (patient) reported for himself included: Updated the clinical course, adverse event start time (from 18:00 to 15:00 pm) and device date (from 01Jun2021 to 05Jun2021).
Allergies reviewed. Pt tolerated well. PT monitored for 15 mins, while pt was waiting in the waiting area mom states there was something wrong. Pt started getting pale and pt lost and regain consciousness. Pt monitored for 30 mins. Was laid supine on bed and BP was checked. Pt was stabilized.
Guillain-Barré syndrome with facial diplegia and significant neuromuscular weakness without respiratory failure, requiring treatment with IVIG and steroids.  Patient improved and is transferring to an acute neuro rehab today.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medication was reported. On an unspecified dates in 2016 (reported as "since 05-JAN-2016"), the patients were vaccinated with an improperly stored doses of GARDASIL lot # K008931, expiry date 04-MAR-2017 (dose, route of administration and anatomical location were not reported). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Within 5 minutes of receiving vaccination, the patient began to feel like she was dreaming and passed out while she was seated. We moved the patient to the floor where she regained consciousness . The patient had further complaints of numbness in the arms, light- headedness  and was nauseated and vomited. 911 was called and responded,  and the patient said she was ok and did not want to go to hospital.
After administering immunizations client became diaphoretic and when asked if he was okay he nodded yes X1 then was not responding well. Clt with difficulty understanding english and speaking as well as he is a foreign exchange student. Client's fellow foreign exchange student did translate and client answered him appropriately. Ice was applied to clt's back of head and HR 64 was lowered to the floor for precautionary reasons and was doing well then to a wheelchair and was able to get out of the wheelchair go around the car and get into the car and was joking around with his fellow student. Patient when returned home did share with his host mother that he had this same reaction from previous vaccinations.
My daughter experienced chest pain, mainly on the left side about one week after her third vaccine. My daughter also received her flu shot on the same day. Today she has a sore throat that comes and goes. Her doctor did not find anything wrong when listening to her heart and lungs. She will be having the EKG exam tomorrow.
Area of left upper arm measuring 3" x 2 1/2" - pink, warm to touch and slightly firm.  Patient describes it as "sore". Area of injection is not included in this area and is slightly echymotic.
A nurse reported that a 33 year old male received TD, Japanese encephalitis virus and Pneumovax-23 on 7/26/99. He subsequently, developed a "constant" headache.
Hep B vaccine administered 06/17/2008 approximately 4:15pm. 06/18/2008 evening began coughing, coughed all night, very sore throat, woke at 5am 06/19/08 with lungs feeling tight, no wheezing, no rash, very weak, dizzy.  Took vit.supplements, used albuteral inhaler (which helped somewhat) went to work, after work went to ED where she received 3 doses of inhaled epinephrine and felt better.  Had blood tests to rule out infection and was told they were normal.  Told it may have been a reaction to the Hep B vaccine.
Mother reports rash in diaper area within 24 hours from shot.  Rash moved to torso then whole body within 3 days - 0 fever.  Feeling normal other than rash.
Pt developed redness over injection site that day following injection. Vaccine given in that arm was Prevnar 13. On 8/2/10 developed urticaria that started at injection site and spread over arms, legs, and torso.
12/01/2022 I started feeling like I had a head cold with congestion. I took a home COVID-19 test, and it was positive. I reached out to my Physician via teleconference. I was instructed to stop taking Lovastatin (for cholesterol) and prescribed a 5-day course of Paxlovid. I started feeling much better. 10 days later I started feeling the same symptoms I reached out to my Physician and prescribed OTC Wal-fed. About 10 days after I tested negative for COVID-19
Patient here for his second dose, however it's been 6.5 weeks since his first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient here for his second dose, however it's been 6.5 weeks since his first dose) in a male 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 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient here for his second dose, however it's been 6.5 weeks since his first dose). On 29-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Patient here for his second dose, however it's been 6.5 weeks since his first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Fever 101.5, chills, muscle aches, joint aches, injection site pain, heart palpitations
Starting at around 7pm on 1/24, I started to get severe headaches (did not have such severe ones on my first dose). Then at about 10pm, my bones & joints started to ache severely. Ache so much they felt like they were going to break. The most severe aches were in my elbows, wrist & fingers as well as my knees. That lasted through the night. I also started to experience chills to the point I had shivers and could not get warm, even while under a heated blanket. I did not have any fever, although I did feel clammy and felt like I had a temp, but I took my temp every hour through the night & was normal. As of today the side effects have subsided a little, but still present and still affecting my ability to function normally.
First dose - in 2018 / i would have to start over and got the shot in sep 2020.; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2018).   In September 2020, the patient received the 2nd dose of Shingrix. In September 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient had reported the case for himself. The patient received 1st shot in September 2018 and never got the 2nd shot and he thought he would have to start over and got the shot in September 2020, delayed than the recommended interval, which led to lengthening of the vaccination schedule. The patient did not experience any side effects.  The patient asked if he need another shot or not. The reporter did not consent to follow-up.
Patient received 3 vaccines: 2nd dose Menveo, 2nd dose Hepatitis A, and First dose of Gardasil. After vaccines were given, patient stood up to walk toward our waiting room for wait time after receiving vaccines. Patient was going to wait in waiting where his mother was sitting. At the time he reached the waiting room door, he lost balance, physically turned around twice and ran 5 steps into a wall and fell to the floor.
Tingling in vaccination arm and right leg Narrative:  water given with additional monitoring time until symptoms resolved.
Gagging while vomiting, fever, foul smelling gas and diarrhea.
Patient was given a Tdap, MCV4 and then the HPV9 vaccine. Upon injection of the HPV4, the child had a syncope episode and fell out of the chair. He was not out for more than a few seconds.
Joint aches (all joints); severe in neck. Sore throat, epistaxis, hematemesis, mild headache. *F/UP report on 3/28/03: Gradual onset of complaints of severe stiff neck.*
Initial and follow up information has been received from a pharmacist concerning a retired male patient with no known allergies and status post hip replacement who on 10-AUG-2008 was vaccinated via intradermal route into left forearm with 0.5 mL dose of PNEUMOVAX 23 (lot not reported). The reporter reported that the patient's arm turned red, swollen and it was sore. The condition resolved after three days and patient recovered. Additional information is not expected.
Widespread body ache and intense pain in joints, fever for past 48 hours, and migraine headache that has yet to resolve. Unable to work.
Headache; Fever; Sore arm; Tight chest; Swollen lymph nodes; Exhausted; Shortness of breath; Sore throat; Ear ache; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 12:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07May2021 at 16:45, the patient experienced headache, fever, sore arm, tight chest, swollen lymph nodes, exhausted, shortness of breath, sore throat and ear ache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, sore arm, tight chest, swollen lymph nodes, exhausted, shortness of breath, sore throat and ear ache was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pain in (L) arm extending down into wrist. No fever, head/neck pain. No swelling, redness at injection site.
I developed a rash and it started to itch.  I thought it was a bug bite.  I also thought it was poison ivy.  After a week of trying different things to help it.  I decided to message my doctor and he said to continue to taking Benadryl.  He advised to come see him on the 22nd of June if it was not better.  I also tried Aloe Vera which dried it up.  It doesn?t itch or burn as of right now, it is just red.
Third dose was supposed to be given on 01Apr2023 but the patient didn't come with no reported adverse event; Initial information received on 03-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old male patient and reporter reported third dose of Rabies (Hdc) Vaccine [Imovax Rabies] was supposed to be given on 01apr2023 but the patient didn't come with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Mar-2023, the patient received a Dose 1  of suspect Rabies (Hdc) Vaccine Powder and solvent for suspension for injection (with an unknown lot number, strength, dose, expiry date) via unknown route in unknown administration site for Immunization. On 28-Mar-2023 he also received a Dose 2 of the same vaccine .  On an unknown date, the reporter reported third dose of Rabies (Hdc) Vaccine was supposed to be given on 01apr2023 but the patient didn't come with no reported adverse event (Strength-Standard) (inappropriate schedule of product administration) (latency: unknown).  It was reported, Call received from pharmacy intern with questions on how to proceed with IMOVAX if the patient has deviated from the schedule for a post exposure dose series. Caller reports the first dose was administered on day zero on 22MAR2023, second dose was given 28MAR2023, and the third dose was supposed to be given on 01APR2023 but the patient didn't come in but is expected to come in today for their third dose.  Action taken: not applicable.  Outcome: Unknown  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 the 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.
Patient received injection 5/18/21. She had routine labs drawn on 5/27/21 that included a CMP and it resulted with elevated LFTs: AST 624 and ALT 282.
Tinnutis began with 24 hours of vaccination.  Had hearing evaluation. Symptoms continue unabated.
5x5 cm area or erythema at site of Varivax injection. Slight tenderness
achy; a fever of 101.5; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), PYREXIA (a fever of 101.5) and CHILLS (chills) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (achy), PYREXIA (a fever of 101.5) and CHILLS (chills). At the time of the report, PAIN (achy), PYREXIA (a fever of 101.5) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5 (High) 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up information received on 23-APR-2021 and contains no new information.
Day 1 Arm soreness; Day 2 - alternating times of trembling/chill with fever conditions throughout the day. After 5PM mainly 101 fever, tired, muscle aches, headcahes, chills, hair follicles hurting ( had this when I had COVID-19 mid-March 2020); My symptoms from the 1st shot brought back memories of how the COVID-19 virus felt, except I did not have the congestion and sinus issues.  Fever broke at 3AM morning of March 13, woke up soaking wet, entire body and hair drenched as if I stepped out of the shower, did not dry off and got into bed. Felt fatigued Day 3 but feeling a lot better, able to be more active. Today is March 19, 8 days since shot #1 and my arm at the Vaccine site is still a bit sore, redness has subsided however.  Worried post shot 2 may be worse.
PATIENT HAD A TONIC CLONIC SEIZURE. HE WAS HOSPITALIZED AND FOUND TO HAVE AN ABNORMAL EEG. HE IS NOW ON ANTI-SEIZURE MEDICATION.