chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (tested positive for covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) 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.
Within 48 hours of the vaccine, the pt developed a sterile abscess on his left thigh at the injection site. Further information has been requested. From additional correspondence received on 7/18/00, it was reported that the pt recovered from this experience.
1.  On March 10, I received dose 1 of Moderna Covid-19 vaccine (lot #03UA21A) with no observed side effects 2.  Day 7 - itching and rash at injection site.  No swelling or hardness just itching and pink 3.  Day 8:  7:30 pm - Temperature check - normal (temperature check for class)        9:30 pm - recommended dose of PEG- 17g PEG3350 in 250ml water        11:30 pm - intense chills and shakes that last for 15 - 20 minutes.           12:00am - Temperature check- normal                       6:00am - Temperature check - normal 4.  Day 10:  Rapid Covid test - negative
Information has been received from a registered nurse (R.N.) concerning a male who in 1996 was vaccinated with a dose of Varivax (Oak/Merck). Subsequently, "now" on approximately 17-APR-2006, the patient experienced severe case of chickenpox. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The R.N. also reported that the patient's sister had a severe case of chickenpox (WAES#0604USA02691).
ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2022, the patient experienced TINNITUS (ringing in ears). At the time of the report, TINNITUS (ringing in ears) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient did not experience any additional symptoms/events. There were no lab data/results available. No treatment information was reported.
This spontaneous report was received from a certified medical assistant regarding a 2 months old patient of unknown gender. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # N004817, expiration date: 06-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in a temperature of 2 degrees Celsius to 8 degrees Celsius for 4 hours and in 9 degrees Celsius to 25 degrees Celsius for 76 hours (multiple excursions were reported). No previous temperature excursion. Call was due to digital data logger. No adverse effect reported. This is one of the several reports received from same reporter.
the site hurts if she touches it/she also has an itchy and a sore sensation; she had developed redness in the site of the injection that has the shape of an octagon,; she also has an itchy and a sore sensation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 18Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization; Bnt162b2 (Second dose), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Oct2021, outcome "unknown", described as "the site hurts if she touches it/she also has an itchy and a sore sensation"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Oct2021, outcome "unknown", described as "she had developed redness in the site of the injection that has the shape of an octagon,"; VACCINATION SITE PRURITUS (non-serious) with onset 18Oct2021, outcome "unknown", described as "she also has an itchy and a sore sensation". Therapeutic measures were taken as a result of vaccination site pain, vaccination site erythema, vaccination site pruritus.  Additional information: The patient received her booster dose of the Pfizer´s COVID-19 vaccine, she wanted to know if she should be concerned about her side effects or if these will go away. She received the dose 4 days ago (on Monday) since then she had developed redness in the site of the injection that has the shape of an octagon, she also had an itchy and a sore sensation, the site hurts if she touches it. Reporter declined to get transferred to the as she wanted to wait a couple of days to see how her side effects would evolve. Reporter mentioned that she had been using Hydrocortisone on the site of the injection but it had not worked.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
no adverse effect; GARDASIL 9 that underwent temperature excursions was administered; This spontaneous report was received from a nurse referring to male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-JUN-2021, the patient was vaccinated with an improperly stored dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) pre-filled syringe, lot # T026323, expiring on 22-FEB-2023, for prophylaxis (dose, route and site of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of -13.5°Celsius for 1 hours and 16 minutes, and of 1.8°Celsius for 7 hours and 30 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. 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: T026323; expirationdate: 22-FEB-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
used 0.7ml of sterile water to mix the acthib instead of the diluent provided in the carton with no reported adverse event; Initial information received on 21-Dec-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 15-month-old and unknown gender patient who experienced used 0.7ml of sterile water to mix the ACT-HIB instead of the diluent provided in the carton with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, batch number, expiry date: unknown) via unknown route in unknown administration site for Immunization.  On 09-Dec-2022 the patient had a non-serious used 0.7ml of sterile water to mix the ACTHIB instead of the diluent provided in the carton with no reported adverse event (product preparation error) (unknown latency) following the administration of HIB (PRP/T) vaccine.  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
pain at injection site, body aches, chills, vomiting.  Symptoms started @7pm on the 15th and on the 16th still have
1 to hours started feeling spacey/weird. Then starting hurting all over, stomach pain, slight nausea, could not focus and not get much done. Bed for 12 plus hours; Symptoms dissipated after 2 PM the next day or at 24 hrs after shot. Was most unpleasant.
Hives at the injection site; Rush at the injection site; Little pain at the injection site; A spontaneous report was received from a consumer concerning a 43-years-old, female patient who experienced a little pain at the injection site, hives at the injection site, and rush at the injection site.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 Dec 2020, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 025G20) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, patient had a little pain at the injection site for a couple of days but yesterday on 07 Jan 2021 started experiencing significantly flowing, hives, rush and pain in the same area of her left arm. Treatment for the event included ibuprofen since 08 Jan 2021 but symptoms still ongoing.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events little pain at the injection site, hives at the injection site, and rush at the injection site was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse refers to a child of unknown age. On 18-JUN-2013 the patient was vaccinated with GARDASIL (route, dose, Lot # and expiration date were not provided). The patient was vaccinated with improperly stored vaccine. The patient experienced no adverse effects. It was reported that revaccination will be scheduled. This case is linked by same reporter to case # 1309USA006535 of a child who received improperly store COMVAX vaccine and case # 1309USA006536 of a child who received improperly stored ROTATEQ vaccine. Additional information has been requested.
ONE DAY AFTER 1/9/21 VACCINE DOSE, DEVELOPED ARTHRITIS AND ARTHRALGIA OF MP JOIN- IMPROVFED 1/13/21 2-3 DAYS AFTER VACCINE DEVELOPED A TRUNCAL ERYTHEMATOUD MACULAR RASH, NOT PRURITIC, IN TRUNK ARMS AND FACE.  AS OF 1/4/21 RASH PERISTS FATIGUE SINCE VACCINE BENADRYL NOT HELPFUL
Child given outdated Pediarix vaccine on July 16th 2004; wanted to repeat vaccination 3 weeks after it was discovered. 3 weeks early by state regulation.
Patient had itching arm  of injection site and left hand. Patient given water and 15 min later recovered.  Patient said felt dehydrated. After drinking full bottle of water the itch went away. It could be anxiety induced.
mild gen itching p/3rd dose in pre exposure series;tx w/DPH & recovered;
depressed,on edge;date of inj also felt cold;now sleepy a lot;lethargic;did cont w/series 24JUN & 1JUL94;states feels wacked out;tx w/orudis which may have helped a little but is not nl;works in animal shelter;cat + for rabies;
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. in 2015 these patients were vaccinated with does of PNEUMOVAX23 (dose, frequency and route were not reported, lot#/batch# was reported as K018294 with expiration 28-APR-2016; lot#L011531 with expiration 07-JAN-2017), which had been improperly stored since January 2015 (incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Pt started having a pain in arm 1 hour after shot that has limited range of motion, no pain upon touch.
Patient was given vaccines that were not needed.  He had already received the vaccines that that were given this day.  No adverse effects after.
swollen axillary nodes & supraclavicular puffiness-deltoid red, swollen & hot;pt used warm soaks, took claritin & was advised to watch for fever;
Fever, chills, myalgias x 48hrs. Required tx with NSAID's, missed work x 2days.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 02May2023 as dose 6 (booster), single (Lot number: 010H22A) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Feb2021 as dose 1, single (Lot number: 007M20A), on 15Mar2021 as dose 2, single (Lot number: 003A21A), on 27Oct2021 as dose 3 (booster), single (Lot number: 026D21A) and on 01Apr2022 as dose 4 (booster), single (Lot number: 066K21A) for covid-19 immunisation. The patient's relevant medical history included: "thyroid" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 13Sep2023 to 17Sep2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308228 Same patient, different drug and different event;
painful bump; cysts; This spontaneous case was reported by a patient and describes the occurrence of PAIN (painful bump) and CYST (cysts) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high and Diabetes.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second 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 an unknown date, the patient experienced PAIN (painful bump) and CYST (cysts). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (painful bump) and CYST (cysts) outcome was unknown.            No concomitant medications were reported.  The patient went to the doctor and they want to get cysts removed.
Patient is complaining of a burning arm that is not red or warm to the touch. She says the burning is in her whole arm and very painful and constant
Emphysema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: immunocompromised individuals. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: EMPHYSEMA (non-serious), outcome "unknown", described as "Emphysema".  Additional information: Caller was asking about the 2nd booster shot for immunocompromised individuals for the Pfizer Covid-19 vaccine. The 1st booster dose 6 months ago (no specific date provided) and he mentioned that he had Emphysema and it was not mentioned if the condition was acquired after getting vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have HSV-2 and experienced an outbreak after getting the vaccine. I hadn't had a noticeable outbreak in years, and this reaction was on par with the first reaction I had when contracting the virus.
Symptoms:  Itchy rash on arms, no throat closing/SOB. Had same issue with first dose of Pfizer. Patient premedicated with 25 mg of Benadryl PO 45 minutes prior to her vaccination.     Treatment:  Given 25mg IM Benadryl.  VSS, Felt better, itchiness resolved, family drove her home.
Early menstruation.  Regular cycle ended approximately one week before vaccine.  I just began spotting today, enough to require a sanitary napkin.
Rash and itching started on hands and back as of 2/17/21. By the next day full body rash (bumpy, red, itchy) had begun. Cleared up as of 2/21/21. Not pregnant.
felt fuzzy; She reports that after the first shot she had a sore arm; little tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt fuzzy), MYALGIA (She reports that after the first shot she had a sore arm) and FATIGUE (little tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN for Arterial disorder, MACROGOL 3350 (MIRALAX) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FEELING ABNORMAL (felt fuzzy), MYALGIA (She reports that after the first shot she had a sore arm) and FATIGUE (little tired). At the time of the report, FEELING ABNORMAL (felt fuzzy), MYALGIA (She reports that after the first shot she had a sore arm) and FATIGUE (little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided.   This case was linked to MOD-2021-242413 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received and patient contact information updated.
Delayed allergic reaction; Itchy at injection site; Hard at injection site; Injection site is red; Vaccination site swelling; Pain at the injection site; Raised at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site) in a 29-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.     Previously administered products included for Granulomatosis with polyangiitis: rituximab (She takes Rituximab for an autoimmune disease: Granulomatosis with polyangiitis and an ANCA-Associated vasculitis. She receives Rituximab  to reduce her B-cells.) until November 2019. Concurrent medical conditions included Granulomatosis with polyangiitis.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site). On 14-Jan-2021, the patient experienced HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site) had resolved. At the time of the report, HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Vaccination site swelling) 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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Additional information added to case on 01FEB2021, contains significant information, about new events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sore arm pit; Body aches esp.legs; Sore arm; Chills; Headache; Vomiting; Swollen lymph nodes; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration on 03Apr2021 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), denosumab (PROLIA), cholecalciferol (MANUFACTURER UNKNOWN), phytomenadione (MANUFACTURER UNKNOWN), calcium carbonate (CALCIUM) and ergocalciferol (VITAMIN D) all from an unknown date for an unknown indication. The patient was allergic to hypaque (a dye with X-rays). Patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not 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 vaccination. On 03Apr2021 at 23:00, the patient experienced sore arm, chills, body aches especially in legs, mild headache, vomiting, swollen lymph nodes and sore arm pit. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore arm, chills, body aches especially in legs, headache vomiting, swollen lymph nodes and sore arm pit was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended recoded concomitant product. check no for pregnant at time of vaccination.  No follow-up attempts are needed. No further information is expected.