chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very little reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very little reaction) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol (takes an unknown statin) and Blood pressure high.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very little reaction). At the time of the report, VACCINATION COMPLICATION (very little reaction) outcome was unknown.            Treatment information was not provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable as the patient received the second dose on 11 Feb 2021.     This case was linked to MOD-2021-052746 (Patient Link).
Information has been received from a physician concerning a female (age unknown) who, on an unspecified date was vaccinated with a 0.5 mL dose of Gardasil (Lot # unavailable). Subsequently, on an unspecified date the patient experienced fatigue after receiving Gardasil. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
mild arm pain; very mild chills; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mild arm pain), CHILLS (very mild chills) and FATIGUE (mild fatigue) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 003B71A) 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) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (mild arm pain), CHILLS (very mild chills) and FATIGUE (mild fatigue). At the time of the report, PAIN IN EXTREMITY (mild arm pain), CHILLS (very mild chills) and FATIGUE (mild fatigue) outcome was unknown. Not Provided    No concomitant medication was reported. Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114359 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114359:1st dose case
Very painful arm right after vaccine given, and by the end of the day there was already a limited range of motion. Still painful at injection site almost 3 months later, still limited range of motion, hard to raise arm above shoulder height, much weaker in arm (especially when raised up) - very hard to take shirts off over my head now, especially if I need to try to use any strength to pull it off if it's not loose enough and then followed by pain after I finally can exert enough strength to finally get the shirt off. Painful to lay in bed or change sleep positions if needing to use left arm at all.
This spontaneous report was received from a pharmacist via company representative and refers to a female patient of unknown age. The patient's concurrent condition included multiple reactions to medications. On 09-MAR-2012, the patient was vaccinated with ZOSTAVAX vial at the pharmacy (lot number, dose, site and route of administration not reported). In March 2012 (reported as one week later), the patient developed zoster like rash and the patient was prescribed with VALTREX for approximately 3 months. The outcome of zoster like rash was unknown. The causality of zoster like rash with ZOSTAVAX was not reported. No further information was provided. No product quality complaint (PQC) was filed. This is one of the two reports of the same reporter. Additional information has been requested.
covid vaccine breakthrough case  dose 1 Moderna 1/22/21  029L20A dose 2 Moderna 2/19/21  023M20A
LLE discoloration and pain developing approximately 12 hours after administration of vaccine at local neighborhood church in the afternoon around 4pm by individuals who did not identify as medical professionals giving the J&J COVID vaccine, cellulitis developed in left with discoloration initially started in lower section of leg and ascending with engorgement of blood vessels and surrounding tissue becoming edematous and darkly discolored up to the knee ending at the area of the tibial tuberosity. Patient then had extension of discoloration without palpable vessels in the right lower extremity the following day and had swelling worsening in the left leg and required medical attention of amoxicillin and bactrim to treat the cellulitis. Patient refused to have blood draw nor be sent to the ED. Patient followed up in the clinic a week later and had some resolution of affected limbs with persistent discoloration that was not present prior to the vaccine administration.
MISSED A DOSE; This spontaneous case (PVX2019-979) was received from a nurse on 23-Apr-2019. It describes an adult male consumer who "missed a dose", while being on Vivotif for an unknown indication.  Case report: The consumer missed a dose of Vivotif, which was due on 22-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "missed a dose" was unknown.  Company's Comment: The causality of the event "missed a dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed a dose" was considered as not applicable.
8 days after receiving 1st dose of COVID vaccination,  I experienced itching, redness, swelling, slight warmth at the site of the injection in left arm.  Applied small amount of hydrocortisone 1% cream to the area to decrease itching.
Patient developed a non-productive cough, fever, chills, arthralgias, joint pain, nausea and headache.
Visual hallucinations. Initial non-serious case received from a patient's parent on 17 October 2008. A two year old male patient received an intramuscular right thigh injection of FLUZONE No Preservative 2008-2009 (lot number UT2785DA) and 15 - 20 minutes later, while riding home in the car, the child was having "hallucinations" in which he saw a dog in the car and a snake in the car seat. The patient returned to the doctor's office and was being seen by the physician at the time of the report. Patient outcome was unknown. Follow-up information was received from a physician on 17 November 2008. The patient recovered from the event. It was reported that at the time of the doctor's visit, the patient was doing fine and had not experienced any more hallucinations.
Tested positive for covid-19 on 8/3/2021. He was an exposure and did not have any symptoms at the time.
Right arm injection site became red, swollen, sore and warm to touch. Around 4 inches in diameter. Client took Ibuprofen and applied warm compresses.  Is completely better today.
just a sore arm at injection site---BUT CONSTANT HEADACHES SINCE GETTING THE SHOT-in varian degrees mild to borderline migrans not going away and its been a month now
At presumed PNEUMOVAX  (PPSV-13) site (L) upper arm burning sensation, swelling, welts x 2, warmth and arm discomfort by evening of vaccine. Seen in office with swelling 5 cm erythema and warmth. No urticarial. No fever. Prescribed treatment today 8/9/16.
Two days after second dose of Moderna COVID19 Vaccination, left arm at injection site red, swollen, warm, painful, itchy. Lymph nodes under left arm swollen and tender. At this reporting it continues into the third day after observation,  6 days after injection. I am taking OTC antihistamines. Will speak to MD if no improvement after the weekend.
slight fever; aches; chills; nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included covid-19 in December in case it might be a factor. The patient's concomitant medications were not reported. On an unknown date, reported as next day, the patient experienced slight fever, aches, chills and was nauseated. It lasted for that day and was over. The reporter would like to know if the side effects from the covid vaccine would be worse after the 2nd dose or could she get the dose without having any symptoms. The outcome of the events was unknown. There was no product quality complaint (PQC) present.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 25-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
In Jan, my eyelids started to swell up an spread to my entire eye when I was at home. It happened at work and I went to the doctor. They gave me eyedrops.
I had swelling in my left armpit 10 days after the first dose of the vaccine.   pregnant, due date: august 20, 2021
Lt arm blotchy & red; Pt will not let anyone touch arm; Not swollen;
Chills, fatigue, mild myalgia starting 3/1/22, received third dose Moderna vaccine 2/28/22 day before, history of dental infection recently and on po antibiodics for, seen ER Dr initially and finished on 3/1/22, Dr discharged on 3/1/22 with diagnoisis of Adverse effect of COVID-19 vaccine, suspected combinatio nof ongoing dental infection and recent COVID vaccine, IVF's and PO tylenol given in ER, Lactate initally elevated at 2.5 but after IVF's repeated and down to 1.3,  temp. 100.2 in ER, pt. discharged home and to follow up in 3 days with primary Dr.
Baseball sized swelling and injection site pain requiring use of alternating ibuprofen/acetaminophen use over two days.
J96.00 ACUTE RESPIRATORY FAILURE 4/22/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Entire Joint paint 6/15/2021 throughout physical body, achy, stiffness, sore, feeling very arthritic seen in  Urgent Care on following dates:  6/17/21, 6/24/2021 and 6/30/2021 Upon completion of consecutive Steroid treatment soreness subsides on left side dulls, still very apparent on right extremeties. Blood work ordered and completed on following dates:  6/18/21 and 6/24/21 Prescribed:  MethyIPREDNISolone 4 mg first week and on 6/24/21 a second Prednisone order, on 6/30/21 referred to Primary Seen by primary care physician on 7/8/21, 7/16/21 and 8/16/21 Blood work on 7/8/21 and xrays of lower extremities taken MRI ordered and completed on 8/12/21 of Brain with and without contrast Prescribed:  Ibuprofen 800 mg and Hydrocodone, and high dose of Vitamin D Referred to Rheumatologist, that appointment not until 10/08/2021 earliest
Left arm in excruciating pain  - could not move without incredible difficulty and pain. Could not get dressed. Headache, Nausea, Dizziness, White lights in left eye, Stuffy + Runny nose; Chills, Fatigue.
lung cancer after the shot, and she was gone within months; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LUNG NEOPLASM MALIGNANT (death, medically significant), outcome "fatal", described as "lung cancer after the shot, and she was gone within months". The patient date of death was unknown. Reported cause of death: "lung cancer after the shot, and she was gone within months". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250402 same reporter/product, different patient/AE;; Reported Cause(s) of Death: lung cancer after the shot, and she was gone within months
Pt called pharmacy on 10/27/2014 to report that she had a reaction 10 days ago and went to ER. Stated that she felt hot all over, skin burning all over, and vomited. Stated that she took a Klonopin to make her feel better, but that it didn't help and she went to ER and they said that it was definitely a reaction to the flu shot. Pt could not recall what all ER did to treat her. Stated that they did EKG and xrays and a lot of other tests. She did not know what kind of meds they gave her. She did not have to stay in ER over night.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Moderna product on 01/28/2021 and 02/25/2021. They entered home hospice care on 08/18/2022 due to cancer. They tested positive for COVID-19 on 09/27/2022. I see no indication they were hospitalized around this time.  They were admitted to a hospice care facility on 11/01/2022 and hospice status was renewed on 11/05/2022. The individual died on 11/06/2022.
This spontaneous report was received from a medical assistant referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. It was reported that, on unknown dates since 17-JAN-2017, the unspecified patients were vaccinated with improperly stored doses of ROTATEQ  (lot# M018958 expiration date 03-MAR-2018, lot # M019707 expiration date 25-OCT-2017) for prophylaxis (strength, dose and route were not provided). The vaccines were exposed to a temperature excursion between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 2 hours 20 minutes. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse experiences had been reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA003572:
Patient developed progressive weakness and was diagnosed with Guillain-Barre Syndrome based on physical exam findings (ascending muscular weakness), lumbar puncture, and MRI findings. Disease course complicated by acute hypoxic respiratory failure which required endotracheal intubation and mechanical ventilation. He was treated with intravenous immunoglobulin x4 days.
pt recv vax 19OCT98 150PM & broke out w/hives on 20OCT98;hives are on rt & lt thigh extending around buttock, abd, et lower back;
Moderna COVID-19 Vaccine EUA. Fever, aches/pains, ear ache and vertigo, stuffy nose, injection site pain
Information has been received from a physician concerning a patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). After receiving the second dose of varicella virus vaccine live (Oka/Merck) the patient had a large rash on their thigh. The patient previously had an allergic reaction to the first shot of varicella virus vaccine live (Oka/Merck), but the physician was not aware of this until after the second dose was given. No diagnostic labs were performed. It was reported the patient sought medical attention at their doctor's office. The patient recovered from the allergic reaction to varicella virus vaccine live (Oka/Merck) and the large rash on their thigh. A product complaint was not involved. Additional information has been requested.
After having a regular checkup, my doctor recommended at my age I take the preventative pneumonia shot. I saw no reason not to do so however, following the PCV13 Vaccine, the injection site was very sore and within 3 hours I had a high fever, chills, chest/stomach cramps. Later my chest became congested and I have been in bed for 4 days.  I did  notify my doctor and he indicated it was unusual to have a negative side effect. I have been consuming liquids and resting.
24 hours after Vaccine injection I became nauseous and had a strong headache, I went to bed early that night and woke up feeling better after about 11 hours of sleep. 9 days after vaccine injection, the injection sight on my right arm is raised at about 1.5-2in in diameter and red, itchy, and right arm burns/tingles as if it were ?sleeping? all the way down to my hand.
Covid arm. Pain initially in hours and days following shot. Pain subsided after 2-3 days but on day 8 an itchy, raised rash appeared. Looks like a target sign. Day 8 was very itchy. Day 10 less itchy but more red and circular
Red, swollen, hard area at injection site appro. 6-8 cm in diameter, warm to touch.
I'm experiencing numbness in my whole body even my face I don't know what to do; I'm in pain; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 15:00 (Lot number: Fr3592) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 22May2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Oct2021 15:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; HYPOAESTHESIA (non-serious) with onset 26Oct2021 07:00, outcome "not recovered", described as "I'm experiencing numbness in my whole body even my face I don't know what to do"; PAIN (non-serious) with onset 26Oct2021 07:00, outcome "not recovered", described as "I'm in pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, pain.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Device date was reported as 26Oct2021.  Follow-up attempts are completed. No further information is expected.
pt recv vax 21JUN96 & 22JUN96 pt exp pain @ inj site & soreness of lt arm;pt recovered;
Arm soreness; 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 7th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 7th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for himself. The patient had arm soreness after receiving his dose of Shingrix in left deltoid. The reporter was provided medical disclaimer.  The reporter did not consent to follow-up.
This is in follow-up to report(s) previously submitted on 11/14/2008. Information has been received from a physician concerning a 21 year old female patient who on 01-JUL-2008 was vaccinated with the first dose of GARDASIL (lot number 659655/1486) intramuscularly. Concomitant therapy included YASMIN. On 01-JUL-2008 the patient experienced severe flu like symptoms, generalized achiness, fatigue, swollen glands and was feverish but without temperature. Subsequently, on 11-JUL-2008, the patient recovered from severe flu like symptoms, generalized achiness, fatigue, swollen glands and feverish symptoms. No further information was provided. Additional information is not expected.
severe chronic allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 25Jul2021 at 11:00 as dose 1, single (Lot number: FA6780) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe chronic allergic reaction". Therapeutic measures were taken as a result of hypersensitivity.  Additional information: Patient's Medical History (including any illness at time of vaccination) was None. Prior Vaccinations (within 4 weeks) were None. Vaccination Facility Type was Pharmacy or drug store. Relevant tests were none. Since Jan 2nd week and up today, the patient tested negative and healthy. After 4 months after the 2nd dose (03Jan2022) covid-19 vaccine, the patient got sick/tested positive. 7 to 8 months taking anti-histamine (Zyrtec/allergy 24hours allergy). A healthy 43 years old female individual, who does not have any allergy history, who does not have any medication maintenance yet developed a severe chronic allergic reaction after taking the 1st and 2nd vaccine covid-19, specially the 2nd dose.  Follow-up attempts are completed. No further information is expected.
Dizziness, lightheadedness. Duration 20 min. Pt. sip water and lay flat resolved with no issue.