chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided. On 26-OCT-2021, the patient was vaccinated with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T042012, expiration date 22-JUL-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine was stored in a temperature of 34.8 degree Fahrenheit (F) for 192 hours. No previous temperature excursion occurred. No adverse effect was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2112USA000790: US-009507513-2112USA000791: US-009507513-2112USA000792: US-009507513-2112USA000785: US-009507513-2112USA000789.
SICK AFTER COVID VACCINATION; COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG; COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (SICK AFTER COVID VACCINATION), HIDRADENITIS (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) and CONDITION AGGRAVATED (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. On an unknown date, the patient experienced ILLNESS (SICK AFTER COVID VACCINATION), HIDRADENITIS (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) and CONDITION AGGRAVATED (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG). At the time of the report, ILLNESS (SICK AFTER COVID VACCINATION) had resolved and HIDRADENITIS (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) and CONDITION AGGRAVATED (COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of SICK AFTER COVID VACCINATION and COUPLE OF HIDRADENITIS SUPPURATIVA FLARES UNDER ARM AND ON LEG was not provided.  No treatment medication were reported.  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.
Patient c/o feeling hot immediately after HPV injection.  She fainted, was placed on her left side on exam table.  She was alert and responsive in 3-4 seconds to verbal stimuli.  Vital signs stable. Dc'd  home with mom.
Vaccine was mixed with Merck diluent instead of the diluent that comes with the shingrix vaccine
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 03Aug2021 as dose number unknown, single (Lot number: EW2164) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 01Jan2013. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". 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 drug ineffective, covid-19.  Clinical Information:Anti viral details: Product: COVID 19 Treatment,Brand: Paxlovid,Treatment start date=06Jul2022,Treatment stop date=10Jul2022,Indication-Treatment of COVID-19.
At noon 8 days  after I was vaccinated (Wed 04/14) I suddenly became extremely fatigued.  I barely made it out of bed for the next 36 hours.  The first afternoon I felt a bit feverish with chills and took a couple Tylenol which removed the feverish feeling but not the fatigue.  The second night I had full body trembles on and off for about an hour - not strong enough to disturb my wife who was sleeping in the same bed.  I felt much better Friday morning but there is a little lingering fatigue.
Stomach has been a mess since the day after injection. Constipation, burning, bloating, sometimes diarrhea. Uncomfortable feeling throughout whole day. Still occuring 2 weeks later. Some queasiness/nausea.
slightly painful enlarged left axillary node that is on ipsilateral side of injection; slightly painful enlarged left axillary node that is on ipsilateral side of injection; paraspinal muscle pain resolved by next day; In evening had mild pain site injection gone in a day; This is a spontaneous report from a contactable physician (patient). A 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number EK5730), intramuscular on the left arm on 20Dec2020 12:00 at SINGLE DOSE as COVID-19 immunization at the hospital.  Medical history included Graves disease. The patient also had allergies with penicillin. Concomitant medications included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (BABY ASPIRIN), and colecalciferol (VITAMIN D). It was mentioned that prior to vaccination, the patient diagnosed was not with COVID-19 and had not been tested for COVID-19 since vaccination. On 21Dec2020 in evening, the patient had mild pain site injection gone in a day (22Dec2020). On 22Dec2020 (day after injection), the patient then had paraspinal muscle pain resolved by next day (23Dec2020). The patient took ibuprofen (MOTRIN) in evening and gone by morning. Day 7 (28Dec2020), the patient noticed slightly painful enlarged left axillary node that was on ipsilateral side of injection which was still present (no treatment was received for the events). The patient recovered from the event of mild pain site injection on 22Dec2020 and paraspinal muscle pain on 23Dec2020 while not recovered for the remaining events.
Increasingly nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Increasingly nauseous) 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 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced NAUSEA (Increasingly nauseous). At the time of the report, NAUSEA (Increasingly nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.
Information has been received via a company representative from a physician referring to a female patient in her 30's. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L09113, expiration date: 27-MAR-2017, first dose, intramuscular, dose was unknown) for recommendation vaccination. On an unknown date the patient experienced, fever, soreness, muscle tenderness, and extreme redness after receiving PNEUMOVAX 23. The patient sought medical attention via phone call or office visit for the events. The outcome of the events was reported as recovered/resolved. The causality between the events and PNEUMOVAX was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Severe headaches daily from the day immediately follow the administration of the first dose until, September 2021, through  March 2022.
When I got shot hurt extremely/left arm got sore; Hadache; Joints started hurting/right shoulder and back hurt; Fatigue/really tired; Nauseous; Dry heaves; No appetite; whole body shaking; chills/ teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired) and NAUSEA (Nauseous) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.). Concomitant products included SERTRALINE, ATORVASTATIN, AMLODIPINE, LISINOPRIL and NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired), NAUSEA (Nauseous), RETCHING (Dry heaves), DECREASED APPETITE (No appetite), TREMOR (whole body shaking) and CHILLS (chills/ teeth chattering). At the time of the report, VACCINATION SITE PAIN (When I got shot hurt extremely/left arm got sore), HEADACHE (Hadache), ARTHRALGIA (Joints started hurting/right shoulder and back hurt), FATIGUE (Fatigue/really tired), NAUSEA (Nauseous), RETCHING (Dry heaves), DECREASED APPETITE (No appetite), TREMOR (whole body shaking) and CHILLS (chills/ teeth chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for headache and pain  included tylenol.
pt recv vax 1995 & w/in 10-14d pt devel a diffuse, morbilliform rash which devel into a vesicular rash; raised, red circ lesion warm to touch at inj site; pharmacist reported 4 patients;
pt. reports nausea.  pt. denies any other s/s.  pt. waiting an additional 15 mins. to be monitored
Awoke with right lower leg paresthesias.  Intermittent, anterior aspect of leg, no other explanation for symptoms.  Normal exam, no swelling, normal neuro exam.
Severe vertigo (was unable to walk), projectile vomiting, high fever,  severe diarrhea, possible dementia.
Initial report was received from a Nurse on 03 Feb 2010: This patient (under four years of age) was vaccinated with 0.5 ml of FLUVIRIN (batch number 102135P1) intramuscularly on 03 Feb 2010.  The outcome of patient's condition was not reported.  The seriousness criteria of the patient was not reported.
Severe pain at injection site (the same night), which was reduced the following day. Chills; fatigue; headache lasted approximately 14 days.
This spontaneous report as received from a registered nurse via a company representative reported that numerous patients (number unspecified) developed a sore arm following the first dose of GARDASIL (dose, route and lot # not reported) on unspecified dates. The patients reported to the nurse the sore arm when returned for the second dose of GARDASIL, but the arm was no longer sore (time frame development of the sore arm and time frame resolution of the sore arm were unspecified). No treatment was given for adverse event. The patients did not see medication for the event. Additional informations is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Mark is bright red), VACCINATION SITE PRURITUS (Mark is itching like poison ivy.), TENDERNESS (Arm was tender to the touch), VACCINATION SITE SCAR (3" mark at injection site) and VACCINATION SITE REACTION (reaction was bright red again and larger 4-5" with bottom half brighter red but no itching.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The patient's past medical history included Mastectomy. Concomitant products included ALBUMIN HUMAN, GLUCOSE, INTERFERON BETA (BETASERON [ALBUMIN HUMAN;GLUCOSE;INTERFERON BETA]), OXCARBAZEPINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced TENDERNESS (Arm was tender to the touch). On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Mark is bright red), VACCINATION SITE PRURITUS (Mark is itching like poison ivy.) and VACCINATION SITE SCAR (3" mark at injection site). On 08-Feb-2021, the patient experienced VACCINATION SITE REACTION (reaction was bright red again and larger 4-5" with bottom half brighter red but no itching.). At the time of the report, VACCINATION SITE ERYTHEMA (Mark is bright red), VACCINATION SITE PRURITUS (Mark is itching like poison ivy.), TENDERNESS (Arm was tender to the touch), VACCINATION SITE SCAR (3" mark at injection site) and VACCINATION SITE REACTION (reaction was bright red again and larger 4-5" with bottom half brighter red but no itching.) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details included cortisone cream. Reporter did not allow further contact.
Patient received Hep B vaccine that was expired. Vaccine expiration date was 11/06/2020 and patient received vaccine on 11/10/2020.
Employee has severe pain and unable to lift left arm.  Treatment: Advil, ice hot, lidocaine patches.
The night of the injection came home extremely fatigued and tired immediately went to bed. Next morning woke up trying to go to work with extreme fatigue migraine and dizziness. My condition got worse I was unable to eat or drink, severe nausea, shaking since there is a light sensor it at all sound severe hot and cold flashes. My stability and gate was off so I could not stand or walk by myself without holding onto a wall. This lasted for about a month. I am still having problems
Per PCP note 11/15/13: Patient complains of: rash on anterior abdominal wall x 2 weeks. Hx of DM, HTN, depression, anxiety, abdal obesity. Rash started in midline of chest wall about 2 days after received the flu and hepatitis A vaccinations. Has spread and is very itchy. Had received the same vaccinations 3/13 in liver clinic. Methylprednisolone 80 mg once, diphenhydramine PRN.
developed an autoimmune condition; probably has sjogren's syndrome; she couldn't walk; morning stiffness; joint pain; This is a spontaneous report from a contactable nurse (patient).  This 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at age of 69-year-old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date (at age of 69-year-old) for covid-19 immunisation. The nurse stated she was a registered nurse and recipient of the Pfizer COVID vaccine. The nurse stated she had called and reported that a few weeks after receiving the second dose of the Pfizer COVID vaccine she had a reaction or potential reaction from the vaccine and she reported it to be cautious. The nurse stated she developed an autoimmune condition which was something that she never had before. The nurse stated a colleague of hers also developed the same symptoms. The nurse stated she tested positive for all of the ANA panels which were indicative of autoimmune disease. The nurse stated her rheumatologist stated that she probably had Sjgren's syndrome. The nurse stated she had a few symptoms of rheumatoid arthritis but the rheumatoid arthritis test was negative. The nurse stated she would still receive a third dose of the vaccine but just reported her side effects for Pfizer's tracking. The nurse stated she was already being treated and on a low dose prednisone while they figure out what's going on. Her husband was a physician and his office was next door to a rheumatologist. The nurse stated her husband started her on prednisone because she couldn't walk with the morning stiffness and joint pain she was experiencing after the vaccine. Therapeutic measures were taken as a result of all events. Events outcome was unknown.  Follow-up (11Aug2021): This follow-up is being submitted to notify that the Batch/lot number not available for [Vaccine/BNT162B2] despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: based on the available information the events auto immune disorders , sjogrens syndrome , arthralgia , stiffness  musculoskeletal , and the suspect vaccine BNT162B2 cannot be ruled out completely ,Linked Report(s) : US-PFIZER INC-202101002751 same product/event, different patient
SOB, myalgia, fever to 101.5 R arm pain, Headache
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 9:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 9:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.86.  Concomitant medication information was not provided by the reporter.  Product moved to clinic on 13-Jan-2021. Vial was moved to fridge on 09-Feb-2021. Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. Beyond use date for the vial was reported as 10-Mar-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
severe itchy scalp in evening of inject; Also flu-like sx; Itchiness subsided but had pain & tenderness @ inject site; Rash developed on chest & back;
No additional ae; VARIVAX was administered following temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 01-MAY-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W031815, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse events reported.  The vaccine was stored in a temperature of 9 degree Fahrenheit (°F) for 2 hours and 6 minutes. There was no previous temperature excursion reported.
Systemic: Rash (other than injection site)-Mild, Systemic: Other- SWELLING OF UPPER LIP-Mild; lasted 1 day
COVID-19; COVID-19; 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 (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "recovered" (12Jun2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No known allergies reported for the patient. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient phoned the pharmacy to complain of injection site reaction on 09/06/2009.  I was not in so the pharmacist on duty instructed the patient to call my home.  She described redness and itching at the site, so I told her to stop in the next day to see me.  When she stopped in today, she complained of redness and itching.  She also had a large bruise where the injection was givin.
body aches, muscle aches and swollen axillary lymph node under right arm (golf ball to tennis ball size)
Left arm 3 cm induration with erythema from shoulder to mid arm. 3/28/06 - per mother's report, swelling and redness resolved. No fever.
Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a female customer (age not reported) who on an unspecified date was vaccinated with PNEUMOVAX23. (It was reported that the PNEUMOVAX, manufactured by Merck, was involved in the incident.) The facts of the incident are the customer sustained a severe reaction after receiving the PNEUMOVAX vaccine. The "date of loss" was reported as 22NOV2013. The lot # reported for the PNEUMOVAX23 was reported to be J009827 with an expiration date of 10AUG2014. Treatment and outcome of the adverse experience was unknown. Additional information has been requested.