chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Having heart arrhythmia every day; Rapid Heart Beat; Flu-like symptoms; Migraines; Iitchy throat; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Having heart arrhythmia every day) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arrhythmia (Heart arrhythmias was reported.). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ARRHYTHMIA (Having heart arrhythmia every day) (seriousness criterion medically significant), HEART RATE INCREASED (Rapid Heart Beat), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIGRAINE (Migraines) and THROAT IRRITATION (Iitchy throat). On 11-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIGRAINE (Migraines) and THROAT IRRITATION (Iitchy throat) had resolved. At the time of the report, ARRHYTHMIA (Having heart arrhythmia every day) and HEART RATE INCREASED (Rapid Heart Beat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: rapid heart beat (High) Rapid Heart Beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included for the events were ibuprofen, acetaminophen and diphenhydramine.  The patient had recently relocated so she does not have a primary care physician at this time. Company comment: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.
Information has been received from a pharmacist concerning a now 59 year old patient who contracted shingles after close contact with individuals that had received ZOSTAVAX (Merck) (0.65ml, SC, one time shot). The reporter did not think that the patient had been hospitalized and also stated that the patient was still recovering. It was unknown if the patient sought medical attention. Addition information has been requested. This is one of several reports received from the same source.
pharmacist gave an expired fluzone high dose quadrivalent on Saturday, with no reported adverse event; Initial information was received on 11-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 75 years old male patient who administered an expired Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] on saturday, with no reported adverse event.  No other vaccines. The patient's past medical history, medical treatment(s) and family history were not provided.   On 08-Oct-2022, the patient received a dose of expired vaccine Influenza quadrival A-B high dose HV 0.7 ml (lot UJ7048A, expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported.  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.
Child received immunization (Varivax) left thigh 5/25/05. On 8/18/05 presented with rash. 8/20/05 Rash diagnosed as varicella zoster on left thigh at site of immunization.
Date of injection put in to system was 9/22/22 but vaccine actually given 9/21/22.   She received it at apartment complex.  Records show that she also received covid booster in right arm but she had refused covid booster and only had injection in left arm.  The same evening of injection, her left arm became hot, edematous and very red with an area of ecchymosis extending mid upper arm to elbow.  She went to urgent care and they instructed her to go to ER. She was given Deltasone 60 mg in ER and given a prescription for prednisone 50 mg orally x 5 days.  She was instructed to rest and elevate the arm.  The edema and redness did subside within the 5 days that prednisone was given.  The area of ecchymosis is still fading.
Employee developed headache on 4/16 and several maculopapular bumps on head and left hip that day.  Over the next everal days additional bumps developed over her entire body.  A mix of maculo-papular and small vesicular lesions.
Syncope episode @ 6:30pm -taken to school nurse office BP 80/40. Given orange juice (4oz). 7pm BP 92/60, pulse ox 96%, pulse 72. returned to school 11/19/09
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR, start date: 31Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was not pregnant. Other medication in 2weeks reported as yes. Anti-viral details: covid 19 treatment start date was 19jun2022 and stop date was 23jun2022. Adverse event was rebound on day 12. Positive test. Mild headache and body aches. Congestion and coughing. Mild fatigue. Adverse events start date was 29jun2022. Patient was not recovered. Treatment ae and known allergies were reported as no.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included consumes alcohol occasionally, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 09:30 to Left Arm for prophylactic vaccination. The batch no. was not reported but it has been requested.  No concomitant medications were reported. On 08-MAR-2021 17:30, the subject experienced body aches. On 08-MAR-2021 17:30, the subject experienced chills. On 08-MAR-2021 17:30, the subject experienced headache. On 08-MAR-2021 17:30, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, and chills, and had not recovered from headache, and fever. This report was non-serious.
Caller reports having a sore arm and being tired after the first dose; Caller reports having a sore arm and being tired after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 61 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "muscle skeletal problem" (unspecified if ongoing), notes: from Whiplash years ago; "degenerating disc", start date: 2001 (unspecified if ongoing), notes: degenerating disc in my neck and back,  take the magnesium and I see the chiropractor. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Caller reports having a sore arm and being tired after the first dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pain in extremity. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200332997 similar report from same reporter
Severe flu like symptoms, 101° F. fever, nausea, lack of appetite, body aches, fatigue and exhaustion, headache, neck and back pain, pain at sight of injection, swollen lymph in armpit, dizziness and lightheadedness started 8 hours after vaccine and lasted about 30 hours after.
Chills; Nausea; Headache; Fatigue; Fever is coming for her.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever is coming for her.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever is coming for her.). At the time of the report, CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever is coming for her.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided Treatment information was not provided
Patient was sitting on exam table; he was talkative and alert until after receiving  third injection, HPV. Patient suddenly slumped forward and then backward. He was placed in the lying position onto his right side. Eye rolling and upper body jerking was noted for less than 30 seconds. Patient became alert and was able to recall the previous events after about 2 minutes. He was kept in an upright position and given ginger ale. Father of patient reported that the patient had nothing to eat or drink prior to visit.  After another 10 minutes, patient was back to baseline. Nearly, 24 hours later, patient's family was contacted via phone. Patient has continued to do well and has no complaints
Arrived home between 1-2PM had fever & was given APAP; 6PM t102 R; Pt woke crying mo picked pt up & started jerking & could not get breath;
Pt had Covid infection in Dec 2020.  She had "long covid" symptoms including new onset of essential tremor in head and arms following this infection, as well as anosmia and fatigue, worsened migraines.  Pt reports these symptoms improved slightly over the next several months, but after her first Pfizer shot, she had recurrence/ worsening of the same symptoms.  The day after the vaccine, she had diarrhea and abdominal pain so severe she was unable to perform ADL's.  After this she had a severe migraine headache that lasted for a week and caused her to miss work.  Pt also reports arm and joint pain in the L arm such that she was not able to move this arm x 1 week.  Pt continues with neurological symptoms; neuro eval and MRI were negative for anatomic lesion and pt was told no treatment for her tremor is available.  Pt had covid antibodies drawn, and results of SARS-COV-2 IgG were >50,000 on 8/30.  Additionally, pt had low TSH of 0.3 and low vit d at 24 on 8/30/2021. Follow up  SC IgG on 10/11/21 was 41426 and tsh was in normal range .48.
Mother states patient ran a fever of 104 degrees for 8 hours and developed hives fever and hives resolved after 8 hours, but patient continued to be nauseous.
I also did the home pregnancy test and I am pregnant; Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable nurse (patient). This is a maternal report. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date was not provided), intramuscular via the left deltoid on 29Dec2020 11:15 at a single dose to prevent COVID. Medical history was none. There were no concomitant medications. It was reported that the patient received the Pfizer COVID vaccine on 29Dec2020 at 11:15am. She tested positive for COVID on 11Jan2021. She is supposed to be scheduled for her second dose on 19Jan2021. The patient asked the doctors and they don't know if she should get the second dose of the vaccine or postpone it. The patient called to ask if she should get the second dose. The patient took a home pregnancy test on 11Jan2021 and it came back positive, stated that this all occurred since she got vaccinated. Stated her last period was 13Dec2020. The patient reported that she is experiencing mild covid symptoms. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Myalgia, UrticariaPruritus, diaphoresis Narrative:
Patient developed a red rash over the shoulder of injection down to the elbow. They did not describe any other symptoms such as itching or flaky skin. Patient did not seek medical attention.
Tachycardia, high blood pressure 186/146, weakness, shaking. I followed up with pt's husband today. Pt. is doing fine and the diagnosis was anxiety attack. Pt stated the way I administered the vaccine the technique may be to blame. I did it slowly instead of jabbing it and she thinks that was the wrong technique.
no adverse event; AE related to a 17-year-old patient receiving PROQUAD; This spontaneous report was received from a nurse referring to a 17-year-old patient of unspecified gender whose medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose (lot number: W035472, which was verified to be valid with expiration date: 06-MAY-2024), administered for prophylaxis (strength, dose, frequency, vaccination injection site, and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse events were reported.
Flu vaccine and polio vaccine given first in left deltoid with client sitting on exam table. Within 10 seconds of administration of both vaccines client stated she felt dizzy. I observed her eyes roll in the back of her head and stood in front of her to lie her down gently on the exam table. Client had pale face and overall appearance. Client woke up shortly, within about 10 seconds. Remaining vaccines were given to client in right deltoid while client remained supine. Client stayed in supine position for 10 minutes then sat up for 10 minutes and drank water. Client regained color in her face and stated that she felt much better. Client's mother in attendance during vaccine administration.
pt recv vax & pt became diaphoretic, pale, nauseated, BP 90/50 pulse, 60 resp 16;DPH;observed until 415PM & then discharged home;
On evening of 3/24/21 patient has weird sensation in mouth, altered sensations like tingling. Patient woke up 3/25/21 with more pain and lesions in mouth. Patient called PCP and is being prescription magic mouthwash for symptoms.
About 3 hours after her vaccine, pt. developed numbness of the bilateral hands, hand tremors, and visual "blackouts." She felt as if she was going to faint but did not lose consciousness. She had a headache for 2 days.
This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 52-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 2 September 2014, the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, right arm). On 3 September 2014, 1 day after vaccination with BOOSTRIX, the subject experienced a quarter sized swollen knot, arm soreness and redness at injection site redness and arm pain. The redness at injection site resolved after approximately 2 days. At the time of reporting pain and soreness in arm were improved. The quarter sized swollen knot had improved to dime sized swollen knot. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. No further information was available. The case was closed.
Diagnosed MS after vaccination approximately 3 days; bilateral foot drag and general exacerbation symptoms. Treated with Solumedrol and Prednisone.
a total of 8 pts had local reactions following immun; 6 of these 8 pts exp inject site react which included erythema, hot to touch, pain & swelling w/in 15 mins of immunization; dx allergic topical reaction; treated w/Decadron & kenalog;
hallucinating; hands are very swollen; fever; she was also 'really swollen' not just on the injection site but on her hands and face.; she was also 'really swollen' not just on the injection site but on her hands and face.; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982), via an unspecified route of administration on an unspecified date single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced hallucinating, hands are very swollen, fever, she was also 'really swollen' not just on the injection site but on her hands and face, all on an unknown date. The events outcome was unknown.
administered moderna vaccine: approx 1-2 minutes post administration, pt stated she was experiencing dizziness, tingling, flushing, rapid heart beat and difficultly breathing. i retrieved epipen from crash cart after few seconds pt stated her symptoms were improving. i admistered ice pack to back of neck . pt did not want to lie down, said she was not having any more symptoms. i recommended a dose of benadryl and pt accepted. . pt remained seated for 5 minutes. she said she could stand and move to waiting area where her mother was waiting. after 10 minutes in waiting area pt stated she was starting to experience dizziness, flushing. i recommended calling 911 and pt agreed for further medical assistance. i helped pt to floor to lie down and elevate feet. i remained with pt until emts arrived
Rash at both sites that spread to the whole body which lasted for 2 days. She also stated that she experienced prickly head sensation on the back of her head. Her wrists, elbows and fingers started hurting. She also felt sensation of numbness on both lower limbs and some degree of weakness.
1 week after vomiting, smelly diarrhea and stomache cramps lasting close to a week. 2 weeks later vomiting and loose stool , 1 week after that severe stomache pain, vomiting and diarrhea for close to 1 week.
I had chills, fever 101/4, dizziness, problem focusing vision, very bad headache, rapid heartbeat, nausea, vomiting, diarrhea, and extreme thirst.
This spontaneous report was received from a certified medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. Since 07-JUL-2015, the patients were vaccinated with RECOMBIVAX HB lot # J009051, expiration date 26-MAR-2016 (route was not provided). Concomitant therapy information was not provided. Since 07-JUL-2015, there had been incorrect product storage as the multiple unspecified patients were given doses of improperly stored RECOMBIVAX HB. On 07-JUL-2015, the temperature excursion started. No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown.  Additional information has been requested.
giving a pediatric dose to two adults; giving a pediatric dose to two adults; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult male patient who received HAV (Havrix pediatric) for prophylaxis.   On 13th February 2020, the patient received the 1st dose of Havrix pediatric. On 13th February 2020, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details provided were as follows: The age at vaccination was not reported. The health care professional called to report that a pediatric dose of Havrix was administered to an adult which led to underdose and adult use of a child product.  The health care professional did not have the batch number or any additional information.  The reporter consented to follow up. The case has been linked with case US2021183445, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183445:Same reporter
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium
I experienced itchy hands as a side effect 3 hours after I received the 2nd administration of the Pfizer Covid19 vaccine.  The side effect ended approximately 48 hours after I received the injection.    Also, please be advised that I previously notified you that I experienced the following side effects 45 minutes to 1 hour after I received the 1st administration of the Pfizer Covid19 vaccine on Feb. 5, 2021.  The side effects ended 24 hours after I received the injection. 1- Sneezing 2- Excessive Running Nose 3- Watery Eyes
Clerk in observation noted pt looked unwell during observation. Per report no fall at time of reaction, pt was seated and did experience LOC.
No additional AE information provided; patient was administered an improperly stored dose of PEDVAX HIB; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 10-DEC-2019, the patient was vaccinated with a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) injection, lot number S006471, with expiration date on 22-JAN-2022 for prophylaxis (concentration, dose number, route of administration, and anatomical location were not reported), that had been improperly stored in a temperature of 48.5F for a time frame of 1 hour. No adverse events were reported. Additionally, it was reported that the vaccine experienced a temperature of 48. 5 degrees Fahrenheit (F), for 1 hour. There was not previous temperature excursion and the temperature was recorded by a data logger.   The outcome of the event was unknown.