chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were unknown. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # L045713 and expiry date: 14-JAN-2017 (dose and route were not reported) for prophylaxis. The call was because of a data logger. There were no adverse effects reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007518: US-009507513-1612USA007517: US-009507513-1612USA007519.
This is a spontaneous report from a Pfizer sponsored program COVAX US support via contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced chilling and little fever in Mar2021. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in (L) shoulder, weakness and limited range of motion to (L) shoulder has been present since receiving vaccine in October 2018.
Flu like symptoms; Generalized aching/body aches; Fever; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Generalized aching/body aches), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PANCREATIN capsule for Pancreatic insufficiency.    Concurrent medical conditions included Pancreatic necrosis (pancreatic insufficiency), Non-smoker and Abstains from alcohol. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), VITAMIN B COMPLEX and VITAMIN A [RETINOL] for an unknown indication.   In 2011, the patient PANCREATIN (Oral) dosage was changed to at an unspecified dose four times per day. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PANCREATIN (Oral) at an unspecified dose once a week. In May 2021, the patient experienced PAIN (Generalized aching/body aches), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In May 2021, PAIN (Generalized aching/body aches), PYREXIA (Fever), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The daily dose for Co-suspect Pancreatin was reported as 2 with each meal and 1 with snack.  Patient had flu like symptoms after her second covid-19 vaccine and experienced fever, body aches, nausea, and headache for two days and it went away. She was taking an unknown blood pressure medication.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Action taken with Co-suspect Pancreatin was reported as Dose not changed.  The reporter's causality for the Co-suspect Pancreatin and event(s) of fever, body aches, nausea, headaches, and flu like symptoms after second covid 19 vaccine was not provided.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-620271 (Patient Link).   Reporter did not allow further contact
Fever 100.1 F; Chills; Muscle aches; Sore throat; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included lamotrigine (LAMICTAL), bupropion hydrochloride (WELLBUTRIN), methylphenidate (MANUFACTURER UNKNOWN) and ethinylestradiol; ferrous fumarate; norethisterone acetate (JUNEL FE). Prior to the vaccination, the patient was 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 COVID-19 vaccination. On 07Apr2021, the patient experienced a fever of 100.1 Fahrenheit (F), chills, muscle aches, sore throat and headache. The patient underwent a body temperature test on 07Apr2021, and the result was observed to be a temperature of 100.1 F. Therapeutic measures were not taken as a result of the events fever of 100.1 F, chills, muscle aches, sore throat and headache. The clinical outcome of the events fever of 100.1 F, chills, muscle aches, sore throat and headache was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
bloody stools; fever; generalized body aches; This case was reported by a consumer via other manufacturer and described the occurrence of blood in stool in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included tofacitinib citrate (Xeljanz) tablet for product used for unknown indication.   On an unknown date, the patient received the 2nd dose of Shingrix. On 1st January 2020, the patient started Xeljanz 10 mg at an unknown frequency. On an unknown date, less than a day after receiving Shingrix, the patient experienced blood in stool (serious criteria GSK medically significant), fever and general body pain. The action taken with Xeljanz was unknown. On an unknown date, the outcome of the blood in stool, fever and general body pain were unknown.   It was unknown if the reporter considered the blood in stool, fever and general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. Within 24 hours of receiving 2nd Shingrix injection, the patient developed fever, generalized body aches, and bloody stools. It was unknown if the reporter considered the blood in stool, fever and general body pain to be related to Xeljanz. The reporter did not consent to follow up.
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.On 08-Nov-2021, the vial was initially stored in the refrigerator.It was stated that, there were 36 doses per vials and the vial did not undergo any temperature excursions. No concomitant medications were reported.  No treatment information was reported.
Immediate metal taste in mouth after receiving the Modern booster shot.. Sore mouth and tongue. Pepper taste in mouth with tongue coated. Saw doctor on 11/1 said it was Thrush gave me Nystatin to clear it up which it did not. Week later tried Diflican 2 pills, still no relief. Had a covid test which came out normal. 2 weeks later had a mouth swab done which also came out normal. Beginning of December went to see and ENT, she thought it might be BMS (Burning mouth sysndrome) prescribed Magic mouthwash, to date I still have the irriatation. My first 2 Moderna vaccines I had not adverse reaction too.
On day of administration, had flu-like symptoms including chills, aches, and vomited X1. Today (1 day after vaccine administration) she has a runny nose and a sore throat. Treatment for symptoms: Patient took tylenol every 4 to 6 hours.
Tingling, numbing, feels like her legs were given way. Arms and hands have some feeling-tingling feels like they maybe going to sleep. Advised to see her Doctor.
Severe muscle ache; joints pain; rash at the site of injection on 5th day.  Menstrual period disruption on the 4th month following vaccination. Persistent dull chest pain above left breast starting gradually about 2mo after vaccination and still occurring.
Red, tender and swollen arm at site of injection. ER visit on 10/28/00.
Pain in his left arm/Pain; weak on the legs while walking; Felt sick; Stay in bed the day after the injection; Dizziness / vague sensation of dizziness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th September 2020, 1 days after receiving Shingrix, the patient experienced sickness, bedridden and dizziness. On an unknown date, the patient experienced pain in arm and weakness of limbs. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the sickness and bedridden were unknown and the outcome of the dizziness and weakness of limbs were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, sickness, bedridden, dizziness and weakness of limbs to be related to Shingrix.  Additional details were reported as follows: Consumer had first vaccination of Shingrix.  He had Pain in his left arm for more than one week. He stated that he just felt sick and stayed in bed the day after the injection.  He also reported Dizziness which started the day after receiving the vaccine ( 24 hours later patient started to feel a vague sensation of dizziness). weak on the legs while walking but symptoms were not present while driving. Symptom was on going till the time of reporting according to patient and reporter.  The Dizziness is of constant intensity and remains present till the time of reporting. Consented to follow up.
History provided by patient. Client is a employee who presents sinus pressure, congestion, draiange and cough since Saturday. She denies fever. She has been taking sudafed pe with mild relief. She has had both covid vaccines. No exposure to covid she is aware of.   Tested positive 2 weeks post 2nd booster vaccine
Rash on face and upper body (around neck). No anaphylaxis. Gave BENADRYL.
Patient was fully vaccinated with Pfizer 2 dose series (12/27/20 and 1/17/21). However, patient tested started having COVID symptoms on 7/27/21, tested COVID positive on 7/29/21 in the community. Patient came to our facility, on 8/5/21 with profound diarrhea, nausea, vomiting, and SOB with exertion. Patient was admitted in our facility from 8/5/21 to 8/10/21 and left the  hospital AMA in stable condition on 8/10/21. Dexamethasone was given during admission, and diarrhea resolve prior to discharge.
Approximately 8 minutes after vaccine administration, patient reported feeling clammy and light-headed. I provided cold compresses and water. Patient remained sitting in his chair and after about 5-10 minutes he reported feeling closer to normal. His father was accompanying him so they remained in our booth for about 20 minutes longer and he reported that he was feeling 98%.
weakness; fever for a day; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (She had the flu vaccine sometime in Oct or Nov2021.) in 2021. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Chronic arthritis, Hypertension and High cholesterol. Concomitant products included ATENOLOL, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ASTHENIA (weakness), PYREXIA (fever for a day) and FATIGUE (felt tired). In February 2021, PYREXIA (fever for a day) had resolved. At the time of the report, ASTHENIA (weakness) outcome was unknown and FATIGUE (felt tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had no history of COVID-19 infection. Patient height was reported as  5' 2 2/1"-3". No treatment information was reported.   This case was linked to MOD-2022-517821 (Patient Link).
Pentacel reached 33.5C; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA192618, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192656, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a nine weeks old patient (gender not reported) who was vaccinated with a 0.5 ml first dose of  vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ013AAA and Exp. Date 10-OCT-2020) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) received 0.5 ml dose via intramuscular route on 09-Jul-2019 and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) received 0.5 ml dose via intramuscular route on 09-Jul-2019.  It was an actual medication error case due to incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and of the 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.  List of documents held by sender: none.
PRESENTED IN OFFICE WITH RASH MOM PRESENTLY HAS SHINGLES 02/10/2006.
Patient developed bruising, oral bleeding and petechiae on 11/19/2018, found to be pancytopenia, consistent with aplastic anemia. Hospitalized 11/20/18 -11/28/18. Multiple labs done as well as bone marrow aspirate. Required multiple platelet and pRBC transfusions. Continued to be pancytopenic requiring transfusions as outpatient. Readmitted 12/3/18 - 12/7/18 for varicella lesions at prior vaccine site (L thigh) as well as on back and scalp. Received IVIG, acyclovir and VZIg.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from Regulatory Authority. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 23Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 24Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 07Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (May2022) Negative, notes: after Paxlovid course was negative; (May2022) Positive, notes: the Ag became positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had return of viral symptoms after complete Paxlovid course about 5 days later. Original course was very mild and return symptoms were also mild. A Treatment of COVID-19 after Paxlovid course was negative, but when symptoms returned, the Ag became positive again. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever of about 101 (+ or - 2 degrees because our thermometer wasn't working right) for about 3 days.
Sister in law called on 3-19-2021 to report that had died a day after receiving his Moderna vaccine. She stated he was found in his driveway and was unable to be resuscitated after being rushed to the hospital.
PRODUCT PLACED INTO FREEZER SINCE 03-NOV-2021; OUT OF SPECIFICATION PRODUCT USE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced product placed into freezer since 03-nov-2021, out of specification product use, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product placed into freezer since 03-nov-2021, out of specification product use and off label use was not reported. This report was non-serious.
February 10, 2021 my right arm at the injection site felt tight and appeared a little red. The pain I have experienced has been short pains which radiate up into my neck.  I was told that one one the side effects could be a knot but this is a slight swelling  which leaves the upper right arm puffy.  The only medication that I have taken for pain is Aleve.
This is not what I would call a side effect but rather an autoimmune reaction. I experienced what I would call pulsing in the lymph nodes, in order left underarm, right underarm, left groin, right groin and my neck, like nothing I have experienced before. It felt like someone was playing Operation and poking and activating them, followed by inflammation of my gastrointestinal system top to bottom with sporadic pains in different areas. I am still recovering a week later. I postponed my second shot until 4/15.
swelling in my hands /swelling in my feet; swelling in both knees; since the vaccine my joints have been aching; dizziness; my arms and chest turned itchy; my arms and chest turned bright red; nausea; chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (dizziness), PRURITUS (my arms and chest turned itchy), ERYTHEMA (my arms and chest turned bright red), SWELLING (swelling in my hands /swelling in my feet) and JOINT SWELLING (swelling in both knees) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DIPHENHYDRAMINE, NAPROXEN and PREDNISONE for an unknown indication.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced DIZZINESS (dizziness), PRURITUS (my arms and chest turned itchy), ERYTHEMA (my arms and chest turned bright red), NAUSEA (nausea) and CHILLS (chills). On an unknown date, the patient experienced SWELLING (swelling in my hands /swelling in my feet), JOINT SWELLING (swelling in both knees) and ARTHRALGIA (since the vaccine my joints have been aching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Joint pain, at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), PRURITUS (my arms and chest turned itchy), ERYTHEMA (my arms and chest turned bright red), SWELLING (swelling in my hands /swelling in my feet), JOINT SWELLING (swelling in both knees), NAUSEA (nausea), CHILLS (chills) and ARTHRALGIA (since the vaccine my joints have been aching) outcome was unknown.        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.
ACHES; ACHED -BACK OF THE INSIDE OF MY EYEBALLS AND IT HURTS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced aches, ached -back of the inside of my eyeballs and it hurts, and fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from ached -back of the inside of my eyeballs and it hurts, and the outcome of aches and fever was not reported. This report was non-serious.