chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling weird,body feels a little different; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling weird,body feels a little different) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced FEELING ABNORMAL (Feeling weird,body feels a little different). At the time of the report, FEELING ABNORMAL (Feeling weird,body feels a little different) 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 did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Patient felt dizzy while at work and some chest tightness about 1 1/2 hours after receiving vaccination.  Client sat down and drank some water. Continued working for about 2 hours but then left work because she was still not feeling good and still felt dizzy. Client was seen at Ottawa County Health Department at 3pm.  Client still complaining of dizziness and some chest tightness.
Rash, believed to be Shingles Rash, flared up two weeks after vaccination.   This also occurred when I had Covid infection last year; shingles flared up two weeks after onset of illness.
Vaccine given and child sitting, looking at coloring book for approximately 10 min. Stood from chair and immediately fainted. Eyes with blank stare for approximately 30 sec. Awoke with amm, but continued to be pale and feel ill.
soreness on her arm; felt like she had a bruise; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm) and CONTUSION (felt like she had a bruise) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness on her arm) and CONTUSION (felt like she had a bruise). At the time of the report, PAIN IN EXTREMITY (soreness on her arm) and CONTUSION (felt like she had a bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.
Even after getting the shot still get shingles; Still get shingles- I am one of those; The nerve pain is ridiculous; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's comment: This case was reported by a patient via interactive digital media. Even after getting the shot, there were a select few that would still get shingles.  The patient was one of those, the physicians did not know why some still get it after the shot, but the patient would not wish this on my worst enemy. The nerve pain was ridiculous. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
56 adults patients received doses after its expiration date 13Jul2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date 13Jul2022).    Concomitant medications were not reported.  Vial size was 5 ml. The vial did not undergo any temperature excursions. This case contains information for the 49th of 56 adult patients. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Arm is aching around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is aching around the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is aching around the injection site). At the time of the report, VACCINATION SITE PAIN (Arm is aching around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Student developed mild facial edema s/p administration of vaccines which included: Td; IPV; MMR; HBV; MCV4.  Patient had received MMR in past seperately from Varicella and had no reaction.  Student was taken to school health center and given 50 mg of Benadryl and monitored for 3 hours.  Symptoms resolved, no additional symptoms developed.
The vaccine did not prevent shingles as intended; herpes zoster or shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated at a clinic, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
8NOV93 recvd vax; 9NOV93 inject site size fifty cents, red, sl swollen whole arm is tender;
Pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (got the 1st shot for shingles got shingles 3 years later ).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient got the new two shots but it had been a year and a half and he/she still get pain at night. The patient take medivations for the pain.  The patient stated that this pain was a walk in the park compared to having full blown shingles. He/she pray for all those going through this sickness its horrible.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR206648:same patient
swollen again in face and down by her throat; scratchy voice; face got swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face got swollen), PHARYNGEAL SWELLING (swollen again in face and down by her throat) and DYSPHONIA (scratchy voice) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Postnasal drip.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SWELLING FACE (face got swollen). On 05-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swollen again in face and down by her throat) and DYSPHONIA (scratchy voice). At the time of the report, SWELLING FACE (face got swollen), PHARYNGEAL SWELLING (swollen again in face and down by her throat) and DYSPHONIA (scratchy voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  treatment for the event included Benadryl .
Significant changes to menstrual cycle. Period is twice as long as it had been prior. Cramps are way worse, almost unbearable. Started getting headaches during menstruation as well.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek) and JOINT STIFFNESS (Tightness in shoulder) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included THYROID and BETA GLUCAN (CHOLESTEROL BALANCE [BETA GLUCAN]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine). On an unknown date, the patient experienced PRURITUS (Itching on spine), ERYTHEMA (Red spot 2 inches long on the middle of her spine), EYE PRURITUS (Itching around her eyes), PRURITUS (Itching around face), EAR PAIN (Ears were painful) and PRURITUS (Back was itching). At the time of the report, HYPERSENSITIVITY (Little mild allergic reactions), INJECTION SITE PAIN (Slight soreness at the injection site), SKIN TIGHTNESS (Tightness in facial), SKIN TIGHTNESS (Tightness in cheek), JOINT STIFFNESS (Tightness in shoulder), MUSCLE TIGHTNESS (Tightness in neck), DYSGEUSIA (Medicinal taste in back of her throat), INJECTION SITE PAIN (Sore to touch at injection site), MOBILITY DECREASED (Not able to lift arm past hip), PAIN IN EXTREMITY (Painful to lay on side), BONE PAIN (Clavicle was sore when laying down), EAR PRURITUS (Ears were itching), ERYTHEMA (Ears were pink), FEELING HOT (Ears warm to the touch) and URTICARIA (Welp on her spine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 as dose 4 (booster), single (Lot number: 331308A) at the age of 52 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of covid-19. Clinical course: Therapeutic measures were taken as a result of covid-19. Anti-viral details: Product = COVID 19 Treatment, Brand = Paxlovid, Treatment start date= 27May2022, Treatment start date= 31May2022, Indication=Treatment of COVID-19. No other medication in 2 weeks. Patient had no known allergies.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
High fever, lethargic, lymph node swollen (size of a softball) under left arm, chills, nausea, migraines, labored breathing and heart pumping hard.   Took over a week to two weeks for all symptoms to subside.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient had passed out after injection.  Blood pressure was 86/50 with HR 52.  After about 40 min vitals were retaken and were 94/55 with HR 71.  We had patient in pharmacy for a round an hour until his vitals were normal and he felt better.
Feeling sick to my stomach, and stiffness in my right arm where the shot was injected. Feels as if something is just sitting there.
10 minutes after getting the shot my throat began to itch, but then stopped after one minute. The next morning sinus/ears full, sore throat, temperature, back hurt where lower part of lungs are, and exhausted.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M043308 expiration date 24-APR-2018 (dose was not reported), for prophylaxis. The ZOSTAVAX was reconstituted with properly stored diluent (lot# M024781 and expiration date 21-FEB-2019). No symptoms were reported. Administered dose of vaccine was improperly stored for 1 hour and 38 minutes in a temperature range between 6 degrees Fahrenheit and 14 degrees Fahrenheit and for 7 minutes in a temperature range between 15 degrees Fahrenheit to 46 degrees Fahrenheit. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA008355: US-009507513-1704USA006447:
two instances of memory loss, cognitive problems, and forgetfulness; two instances of memory loss, cognitive problems, and forgetfulness; two instances of memory loss, cognitive problems, and forgetfulness\shopping at the same exact store and spot and "kept on thinking he was forgetting something but couldn't think of what it was". It was "really frustrating"; really frustrating; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (two instances of memory loss, cognitive problems, and forgetfulness), COGNITIVE DISORDER (two instances of memory loss, cognitive problems, and forgetfulness), MEMORY IMPAIRMENT (two instances of memory loss, cognitive problems, and forgetfulness\shopping at the same exact store and spot and "kept on thinking he was forgetting something but couldn't think of what it was". It was "really frustrating") and FRUSTRATION TOLERANCE DECREASED (really frustrating) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included Accident automobile (head injury, broken neck, and fractured skull from a car accident in 1986.) in 1986, Head injury in 1986, Broken bones (broken neck) in 1986 and Skull fracture (fractured skull) in 1986. Concurrent medical conditions included Balance difficulty (balance issue from the car accident).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced AMNESIA (two instances of memory loss, cognitive problems, and forgetfulness), COGNITIVE DISORDER (two instances of memory loss, cognitive problems, and forgetfulness), MEMORY IMPAIRMENT (two instances of memory loss, cognitive problems, and forgetfulness\shopping at the same exact store and spot and "kept on thinking he was forgetting something but couldn't think of what it was". It was "really frustrating") and FRUSTRATION TOLERANCE DECREASED (really frustrating). At the time of the report, AMNESIA (two instances of memory loss, cognitive problems, and forgetfulness), COGNITIVE DISORDER (two instances of memory loss, cognitive problems, and forgetfulness), MEMORY IMPAIRMENT (two instances of memory loss, cognitive problems, and forgetfulness\shopping at the same exact store and spot and "kept on thinking he was forgetting something but couldn't think of what it was". It was "really frustrating") and FRUSTRATION TOLERANCE DECREASED (really frustrating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
6-8 hours post vax, the pt developed muscle twitching, in addition to E. nodosum.  The pt was diagnosed with Von Willebrands type I in 9/99.
Persistent irritability; fever x 3 days beginning w/in 8 hrs of vax; fever 104.2;
7 people had  died from Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An elderly (reported as "50-99" and "Age Group: Elderly (greater than equal to 65 years)") male 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 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "7 people had  died from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Age + years/months/days: 50-99. Age Group: Elderly (greater than equal to 65 years). Moderna has proven to be effective against COVID-19; Pfizer is not that effective when the reporter first heard about it. 7 people had died from Pfizer; So that made a change in mind about taking Moderna. Plus, the Primary Care doctor suggested Moderna based of these stories that the reporter heard. The reporter considers the event as caused by the suspect product.  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-PV202300139954 Same reporter/event/drug, different patient;; Reported Cause(s) of Death: 7 people had  died from Pfizer
Information has been received form a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed break through varicella with lesions by being exposed to the wild type disease. Additional information has been requested.
Client had reported to clinic to receive the COVID Vaccine being offered. Denied that he had had the vaccine prior to receiving the vaccine on 4-23-2021.
Mother reports that Patient has a localized reaction at the site of the injection. It is indurated, warm to the touch, tender and itchy, and has gotten bigger. Now measures about 8 cm in diameter. Patient also had a low grade fever of 100.4 orally. Has improved.
juvenile rheumatoid arthritis, onset 6 wk p/ rubella vax;HLA-OR5;at age 22, severe JRA w/ paresthesia;
Donated blood May 1, 2021 (i.e., three weeks after receiving vaccine). Received letter from a medical facility shortly after indicating: HIV 1/2 screening - positive HIV 1/2 supplemental - negative HIV NAT - negative Follow-up sample drawn July 1, 2021 generated same results.  I?ve been advised, ?This is unlikely to indicate infection, and it does not have any implications for your health.? However, I am also no longer eligible to donate blood.  I recognize there is no absolute connection to the vaccine, but I can think of no other reason this would have shown up in my blood when it did, after donating for years with no problems.
About 72 hours after her 2nd Moderna vaccine, patient developed an uncommon condition known as Lipschutz ulcers. It is a non sexually transmitted condition characterized by the rapid onset of painful, necrotic ulcerations of the vulva or lower vagina.  Pt presented with moderate unilateral labial swelling, several vulvar ulcers noted to inner labia minora with yellow/bloody discharge. Some ulcers with necrotic appearing tissue. Extremely tender to touch. Pt without hx of EBV infection.
w/in 3 days of Engerix-B vax pt devel severe systemic reaction including general achiness, low grade fever, nausea & diarrhea;
Four hours  after shot I started feeling warm and my left knee started to hurt.   24 hours later while I was taking a walk, my right knee started to hurt .  That evening, about 36 hours after getting the shot, my right knee swelled up and hurt alot.  The next morning I could barely walk, with much pain.  I called a pharmacist and they said I could take Motrin for pain, which I did.