chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; fatigue; aches; injection site soreness; reddened rash around abdominal /chest area with very intense itching; swollen lymph node esp to left axilla area; reddened rash around abdominal /chest area with very intense itching; This is a spontaneous report from a contactable nurse reported for herself. This 58-year-old non-pregnant female patient received bnt162b2 (COVID 19 VACCINE, Solution for injection, lot number: EL9262), intramuscular on left arm on 26Jan2021 06: 00 (at the age of 58-year-old) at dose 2, single for COVID-19 immunisation. Medical history included allergy to eggs, chicken, seafoods, dust. Concomitant medications were not reported. The historic vaccine included bnt162b2 (COVID 19 VACCINE, lot number: EJ1685), intramuscular on left arm on 05Jan2021 at dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient had no covid prior to the vaccination. The patient had not been tested positive for covid post vaccination. It was reported that aside from expected side effects of fever (lasted 4 days with temps ranging from 102F-103F, fatigue, body aches; soreness of injection site; I had developed reddened rash around abdominal /chest area with very intense itching. Also noted swollen lymph node esp to left axilla area; all on 27Jan2021 at 05:00 PM. The patient received treatment for reported events as Benadryl orally, hydrocortisone topical ointment. Outcome of the events was recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Hearing loss in righ ear; Vertigo; Dizziness; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in righ ear) in a 59-year-old male patient 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 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 DEAFNESS UNILATERAL (Hearing loss in righ ear) (seriousness criterion medically significant), VERTIGO (Vertigo) and DIZZINESS (Dizziness). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in righ ear), VERTIGO (Vertigo) and DIZZINESS (Dizziness) 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 considered DEAFNESS UNILATERAL (Hearing loss in righ ear), VERTIGO (Vertigo) and DIZZINESS (Dizziness) to be possibly related.    Concomitant medications were not provided.   This study includes identifying 18 patients with post-vaccination otologic symptoms. In this case, patient had no prior hearing loss associated issues. The adverse effect was seen in right ear.  Lab test included were the mean pure tone average (PTA) was 52.2 ± 30.6 dB HL for the affected ear, and 21.2 ± 12.5 dB HL for the unaffected ear. The word recognition score (WRS) was 60.6 ± 38% for the affected ear, and 90 ± 23.0% for the unaffected ear.  Company Comment: This case concerns a 59 year old male with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown date after receiving the first dose of Moderna Covid 19 vaccine on unknown date. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns a 59 year old male with no relevant medical history who experienced serious unexpected event of unilateral deafness on unknown date after receiving the first dose of Moderna Covid 19 vaccine on unknown date. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
HEAVINESS IN LEGS; MISSED WORK DUE TO THE  FEVER; PAIN AT INJECTION SITE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no medications prior to the janssen covid-19 vaccine. the patient had no diabetes, no circulation problems, and was not overweight. the patient was not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced heaviness in legs. On 13-APR-2021, the subject experienced missed work due to the fever. Laboratory data included: Body temperature (NR: not provided) 100.1. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from missed work due to the fever, and fever on APR-2021, had not recovered from heaviness in legs, and the outcome of pain at injection site and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
One month after the vaccine, I woke up w/ headache lasted couple of hours. The next morning woke up w/ the headache lasted 6 hours. 3rd morning awoke a big welt size of a 50 cent piece, located on inside of (R) arm - got red, itch for 3 weeks, 2nd welt appeared on same arm - size of quarter. The welts bothered her until 6/6/10 - subsequently disappearing. Medication - none. Vitamin pills-1 daily.
The spot of the vaccination was painful for a few days. I felt sleepy and tired for a couple of days after the vaccination.
Fever 100.5 F, chills, body aches, rash at injection site, insomnia, anxiety
pain, redness, rash, swelling, hot to touch, trouble lifting arm  4x8 inches large
At around 4PM I noticed a large red area around the injections on my left arm, and it was becoming extremely painful, along with extreme fatigue, dizziness, muscle and joint pains, and a headache. That night the headache increased in severity, I had a fever of 102, and developed diaphoresis. The redness expanded to my elbow and shoulder and the pain from it extended up the left side of may neck. I checked my B/P and it was 107/80 pulse of 110 and I was extremely diaphoretic. My husband took me to the ER. Now it is the 19th and I am still very weak, dizzy, achy, and the redness is nearly all the way around my left arm and about an inch diameter on my right arm.
Patient experienced syncope approximately 5 minutes after receiving both shots. She fainted face down on the floor in front of the pharmacy. She quickly regained consciousness and her face was pale at the time of discovery by patient's father
Dry, itchy throat with some throat swelling. Clamminess, dizziness and paleness. Local emergency services requested for assistance
''I'' have a very strong disgusting smell to all good, some drinks and more. It all smelled gross. It had been almost 3 weeks and could not enjoy food because it all  had a very strong odor.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 10Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 13Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 12Apr2021, ever since her second Pfizer vaccine, the patient experienced a very strong disgusting smell to all good, some drinks and more. It all smelled gross. It had been almost 3 weeks and the patient could not enjoy food because it all had a very strong odour ((all the same smell/maybe chemical). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event very strong disgusting smell to all good, smelled gross and patient could not enjoy food because it all had a very strong odour was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
(L) thigh with hives at injection site. Treated with diphenhydramine (mom declined prednisolone) and hydrocortisone cream.
extremely tiredness; Huge (8"X6") area of swollen red hot area; Huge (8"X6") area of swollen red hot area; Headache; itching; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 16Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included diabetic. Concomitant medication was not reported. Patient had no known allergies, was not pregnant and did not have COVID prior to vaccination. On 21Jan2021, the patient reported extreme tiredness, huge (8"x6") area of swollen red hot area, headache and itching. No treatment was received for the events. Patient has not been tested for COVID post-vaccination. Outcome of the events was not recovered.    Information on the lot/batch number has been requested.
Received 2nd in series of Phizer Covid vaccine May 20, 2021 having received the first Phizer vaccine April 29, 21. Initially, due to  worsening of GI issues I did not self report the increasing dizziness as I believed it was related to GI and was working with gastroenterologist to resolve.  However, on Aug 2, 2021 I suddenly became so dizzy, it caused me to fall fracturing right ribs.  Due to presentation in Emergency my physicians ordered complete labs. This lab work revealed that Phenytoin level had shot up from 16.8 during last level Feb. 18, 2020 to 46.4 Aug 2, 2021. This drastic increase to toxic occurred despite no change in Phenytoin dosage.    My Phenytoin was immediately stopped for 2 days and then resumed slowly at a lower dosage. Blood levels were checked more frequently, concerned that the sudden increase in blood level, if in fact caused by Phizer vaccine might suddenly drop as well and place me at seizure risk. This practice has had to continue since that time to closely monitor.
14 patients administered expired vaccine; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to intravenous contrast media.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Significant information was received on 05-Nov-2021 and contains expiry date of vaccine and occupation of reporter; Sender's Comments: This is a spontaneous case concerning a  30-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious events of maternal exposure during pregnancy and expired product administration. The events occurred approximately on the same day after the first dose of mRna 1273-Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRna 1273-Vaccine, is not affected by this report.
Rebound positive test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound positive test) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Sleep apnea and Obesity. Concomitant products included TESTOSTERONE, SIMVASTATIN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022 at 6:00 PM, the patient experienced COVID-19 (Rebound positive test). At the time of the report, COVID-19 (Rebound positive test) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-May-2022, SARS-CoV-2 test: positive (Positive) Rebound positive test. On an unknown date, Blood testosterone: low (Low) Low. On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. No treatment medications were provided. Device date was reported as 25-May-2022. Company comment: This spontaneous case concerns a 39-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 14 days after administration of third dose of mRNA-1273, the second dose of mRNA-1273 was given 13 months prior, the first dose of mRNA-1273 was given on an unknown date. On May 25, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 39-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 14 days after administration of third dose of mRNA-1273, the second dose of mRNA-1273 was given 13 months prior, the first dose of mRNA-1273 was given on an unknown date. On May 25, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Caller reporting AE for improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 16-SEP-2021, the patient was vaccinated with improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (dosage regimen was not reported), lot # 1707457 and expiration date 23-FEB-2022; and with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)  (LIQUID PEDVAXHIB) (dosage regimen was not reported), lot # T026961 and expiration date 02-APR-2023 both administered as prophylaxis.  The improperly stored doses of the suspect vaccines experienced a temperature excursion of 48.7 degree fahrenheit (°F) for 10 minutes on 10-SEP-2021; no previous temperature excursions were reported.
This spontaneous report was received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with a dose of  PROQUAD injection (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The temperature of excursion was 0.2 Centigrade degrees for 7 hours and 14 minutes. Previous temperature of excursion was 0.2 Centigrade degrees for 9 hours and 18 minutes. The temperatures of excursion were detected by a data logger. No adverse symptoms were reported and no product complaint (PQC) was involved. This is one of two reports from the same reporter 1706USA003512. Additional information has been requested. Sender's Comments:  US-009507513-1706USA003512.
Vaccine given on 9/13/02 presented on 9/16/02 with a two inch circular erythema and induration warm to touch.
Decreased heart rate of 43; Increased blood pressure; He woke up got out of the bed to pick things up and down he falls; He was dizzy lethargic; He was dizzy lethargic; Chills; Fever; Nausea; Sore throat; This is a spontaneous report from a contactable Consumer or other non health professional.  This consumer (Wife) reported that a male patient (Husband) of an unspecified age received bnt162b2 (BNT162B2, formulation: solution for injection, Lot number: EN6208, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included colon cancer stage IV from an unknown date and unknown if ongoing (He has stage 4 Colon cancer and the cancer has metastasized to his lungs). The patient woke up, got out of bed to pick things up and down he fell, he was dizzy lethargic, chills, fever, nausea, sore throat, increased blood pressure and decreased heart rate of 43. After receiving the vaccine on 09Mar2021, the patient came home and everything was normal. The next morning he had an appointment with his Oncologist. He had stage 4 Colon cancer and the cancer had metastasized to his lungs. He was supposed to see his oncologist the following morning. He woke up got out of the bed to pick things up and down he fell. He was dizzy lethargic. He was experiencing severe chills, fever, nausea and lethargic and also had a sore throat. 18:00 that night, it seemed got a lot better than Friday he was still having a sore throat and had to take a couple pills but he seemed like he was on the road to recovery. That morning they woke up and he started with severe chills again and he had increased blood pressure and he was on blood pressure medicine as well. Friday his blood pressure was up to 173 over 93 and gave him a 100 mg of losartan, today or Saturday his blood pressure was at 161 over 109 with a heart rate of 77, gave him 200 mg of losartan. Couple hours after that started coming down 145/99 with so increased heart rate later on 148/97 and 155/100 with the decreased heart rate of 43. The patient underwent lab tests and procedures which included blood pressure measurement: 173/93 mmhg on 12Mar2021 Friday his blood pressure was up to 173 over 93, blood pressure measurement: 161/109 mmhg on 13Mar2021 Saturday his blood pressure was at 161 over 109, blood pressure measurement: 145/99 mmhg on 13Mar2021 Couple hours after that started coming down 145/99, blood pressure measurement: 148/97 mmhg on 13Mar2021 later on 148/97 and 155/100, blood pressure measurement: 155/100 mmhg on 13Mar2021 later on 148/97 and 155/100, heart rate: 77 on 13Mar2021 Saturday his blood pressure was at 161 over 109 with a heart rate of 77, heart rate: 43 on 13Mar2021 later on 148/97 and 155/100 with the decreased heart rate of 43. Therapeutic measures taken as a result of, increased blood pressure included Losartan. The outcome of the events sore throat was not recovered and remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
First thing in the morning, my nose began to bleed very heavily.  It took about a half an hour before it stopped, and I had to be lying down.  I had to call in sick to work.
Presented to the emergency department on 05/13 with recurrent pancreatitis. He was treated with gentle fluids d/t his heart failure and had improvement in his symptoms during hospital day 1 his renal function and calcium improved modestly as well. Overnight he was able to get up and use the urinal at 0350 on 05/14/2021, he was rounded on by nursing staff at 0500 and was sleeping well. I went to round on him at 0600 and found him lifeless. Presumed cause of death would be sudden cardiac arrest
On 08/11/02, client developed "chicken pox" like rash which progressed in 'crops". Client also experienced fever up to 100.2 F. Sys resolved bhy Aug 19th.
This spontaneous report as received from a physician refers to a patient of unknown age. The physician reported that the patient received a dose of expired ROTATEQ (suspension 2 ml, lot number H017671, expiration date 25-MAR-2014, 2ml, oral) on 07-APR-2014. No adverse effect reported. The outcome was unknown. Additional information has been requested.
Approximately two days after the Moderna vaccine I began to develop symptoms of burning mouth syndrome: Burning tongue, gums, lips, excessive salvation, metallic taste in mouth. I also developed parathesia all over my body at the skin/surface level. These symptoms have persisted for 5.5 weeks and sadly have not improved.   Additional background: I received three Pfizer COVID-19 vaccinations one in Feb. 2021, one in March 2021, and one in November 2021. I did not have any negative reaction to those vaccinations. In late December 2021, I developed COVID-19, about 4 weeks after my third Pfizer vaccine.