chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous reprot was received from a health care professional refers to a patient of unknown age and gender. On 21-MAY-2015 the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K008868; expiry: 19-DEC-2015) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
I had the injection on 12/22/20. I started having deltoid left arm pain that night. It was fairly intense and it was very difficult to sleep because of it. Fast forward to today, 9/22/2021, and I am still having severe pain. I also have developed a raised, brown spot where the needle was inserted. If I try to lift any weight at all, the muscle in my left arm only, is incredibly painful and I have to stop. I had the second injection on 1/20/21 in my right arm. I had a little arm pain the first couple of days and then nothing. It hasn't bothered me since.  My left arm pain is unrelenting  and the brown spot continues to grow thicker and larger in circumference. I have taken Tylenol and Motrin for it but the fact that I am having to continue to deal with these adverse symptoms so long after getting the injection is very abnormal.
Patient was given unnecessary second dose of the Tdap  & Menevo  vaccine off schedule. The patient's father was unaware that the patient had vaccine in another facility until technician checked state record.
Information has been received from a physician concerning a 44 month old male with a history of anemia who on 12/10/2001 was vaccinated with a first dose of MMR SQ in the arm. There are no  concomitant medication or illness at time of vaccination. Subsequently the pt's mother reported that the pt developed swollen eyes in 07/04. It was reported tht the pt was referred to a nephrologist who obtained mumps titers. It was reported that on 07/02/04 the pt did not have protective antibodies to mumps. It was also reported that the pt was positive for mumps antibody. On 07/29/04 the pt did not have protective antibodies to rubella. It was reported that the pt recovered. No further information is expected.
Patient admitted for COPD exacerbation from COVID with concurrent acute on chronic diastolic heart failure exacerbation
Systemic: dysgeusia-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: dysgeusia at onset followed by vomiting 3 days pater precipitating a trip to er and subsequent rx for ondansetron
Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56-year-old male patient received BNT162b2 (BNT162B2), 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) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "heart disease" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no known allergies. No other vaccine in four weeks. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 05Jun2022 at 14:30, outcome "recovering" and all described as "Contracted COVID". The event "contracted covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient received treatment with monoclonal antibodies.  Clinical course: The patient did not have covid prior vaccination and did not tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Face: numbess, burning, throbbing pain. Difficulty swallowing. Face symptoms started on left side but appear on both sides. Left arm is numb. dizziness, weakness, fatigue. Full body itching.
Complained of dizziness as he was ready to leave. Pt hypotensive and diaphoretic. Resolved after laying on stretcher with legs elevated.  Taken to ED for further evaluation.  -flushing, dizziness, hypotension, vasovagal response, lightheadedness
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 30-JAN-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
COVID BIVALENT GIVEN INSTEAD OF COVID REGULAR FOR PRIMARY SERIES. ATTEMPTED TO CONTACT BUT UNABLE TO LEFT MESSAGE.
tenderness in the arm were he was injected; Received a vaccine that was 8 days expired; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (tenderness in the arm were he was injected) and EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was 8 days expired) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was 8 days expired). On an unknown date, the patient experienced VACCINATION SITE PAIN (tenderness in the arm were he was injected). On 06-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received a vaccine that was 8 days expired) had resolved. At the time of the report, VACCINATION SITE PAIN (tenderness in the arm were he was injected) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported. Vial was initially stored in the refrigerator: 14Sep2021 at 1.2°C. Reporter had said the vials actually expired on 29 Oct 2021.
Patient stated she had a red itchy rash  on the arm she received her injection. Rash began 5-7 days after injection on left arm. Rash was the size of tennis ball and disappeared 3-4 days later. Patient did not take or use any medication to treat the rash.
Starting 12/26/2021, I starting feeling lethargic and coming down with a cold/sore throat. I took a COVID test on 12/26/2021 and it was positive. I was in bed for a couple of weeks and constantly stayed in touch with my PCP and dermatologist. For about 3 months, I went to speech therapy, Covid Therapy and now I'm in physical therapy for long COVID symptoms. The brain fog still persists to this day.
pt devel profuse presistent diarrhea w/in 24 hrs of 1st Hep B inoculation; recovered p/3 wks illness; 1 wk later recvd 2nd Hep B shot & similar diarrhea began the next day;
Initial information received on 27-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff). This case involves a 16 months old female patient who received a single dose of vaccine PENTACEL (lot C5324AC (expiry date: 05-Sep-2019) via intramuscular route in unknown administration site) without ACTHIB component on 12-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was stated that the dry lyophilized component of in the Hib vaccine vial in the PENTACEL packaging should only be reconstituted with the liquid DTaP-IPV component of PENTACEL. If any other liquid was used (except for 0.4% NaCl saline solution) the dose of such Hib vaccine administered would not be considered valid. It was not reported whether adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: done.
Approximately 24 hours after 3rd doze, I suddenly got an intense headache and could not put words together and communicate that fact to my family.  I eventually just took an aspirin (325 mg) and went to bed.  When I woke a couple of hours later, I could communicate,  but continued to have short term memory and word retrieval problems for the rest of the week.
On 4 October 2022 I received a Pfizer Omicron COVID booster vaccine. On 10 November 2022, I noticed a lump under the skin at the frontal base of my neck. The tissue was removed surgically on 20 January 2023. The tissue was identified as a Melanoma by lab using Next Generation sequencing. Of note is that the tissue location was just under where I had a skin Melanoma removed in April 2013. I receive regular examinations from my Dermatologist every six months since 2013 and until the recurrence appeared after my COVID booster, I had been cancer free. I believe there may be a link between the Pfizer Omicron COVID booster vaccine received on 4 October 2022 and the recurrence of Melanoma observed on 10 November 2022.
My shoulder started itching and was warm to the touch, looked at it and its swollen and feels extremely firm compared to my other and it is not my dominant arm.
I started with fever which i believe is normal and general body pain. Super intense migraine all day and full body aches. Fever throughout the day. Really headed, i cant walk from my room to the kitchen downstairs cause i feel in gonna pass out.  What concerns me and my family the most is that i got black eyes under my eyes. Not super intense but really noticeable. My eyes hurt as well. We dont know if this is normal.
faint; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (caregiver) reported for a 13-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient got fainted (syncope) (medically significant). Reporter considered the event as serious. Caller is asking if there would be a component that would cause her daughter to faint a few minutes after getting the first dose of the Pfizer BioNTech Covid-19 Vaccine. Caller wanted to know if fainting is a reported side effect after getting the first shot of the Pfizer BioNTech Covid-19 Vaccine. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Information has been received from an office manager concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, unspecified patients received doses of improperly stored ROTATEQ (lot # M031802, expiration date 09-NOV-2017). The storage detail was a temperature excursion for ROTATEQ at 50 F for 1 hour 12 minutes. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected since there is no consent to contact the physician.
Headache, muscle pain, nausea, extreme fatigue, feeling tired. Last 48 hours.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 15-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
shingles; This case was reported by a nurse via sales rep and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CE5S, expiry date unknown) for prophylaxis.   On 13th October 2022, the patient received the 1st dose of Shingrix. In October 2022, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comment: The patient received Shingrix and was seen back in the clinic 5 days later on 18th October 2022 with shingles. The patient also received 2nd dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of GARDASIL 9, lot # M041212 with expiration date 21-JUN-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011014: US-009507513-1808USA006003:
Information has been received from a RN concerning a 7 year old female with a history of strep on 06Feb2004 and ear infections recently who on 06Sep00 was vaccinated with a dose of varicella virus vaccine live. There were no concomitant vaccinations. On 02Mar04 the pt develop a breakthrough described as 20-25 lesions, both vesicular and maculopapular, itching, had a decrease in appetite and low grade fever. There were no diagnostic laboratory tests performed. It was noted that the treatment was nonspecific symptomatic. Medical attention was sought. There was no product quality complaint involved. No other information was provided. Information was received which pertained to the events which occurred approximately 4 years after vaccination with varicella virus vaccine live. This information contained the following adverse events: strep and ear infections recently (in approximately 2004). No additional information has been requested.
Pt is a recruit at military boot camp. Five minutes after receiving immunizations experienced angioedema and hived. 50 mg Benadryl and 0.3 mg epinephrine given. Transported via EMS to ED.
After receiving the Zostavax vaccine, the next day my arm began to itch.  When I looked at it there was a red area about an inch or so wide and three inches long.  To the side of that my arm bruised along the side about the same dimensions.  This lasted for approximately a week and a half then gradually faded.  Was not painful.
I felt fine for the 20+ minutes in waiting area after, and my 15 minute drive home. I noticed my cheeks were VERY flushed. I took my temperature. Though it was 98.5, that is higher than my personal 'normal' temp. I am typically 97.3-7.  Checked again on my flushed cheeks to see that my face was swollen. I ran into a neighbor, though wearing a mask, she didn't see/say anything, and I felt okay enough not to bring it up. By the end of the day, swelling in my cheeks was less noticeable so I went to bed thinking I wasn't having more than a typical vaccine reaction. I woke up the next day with swollen eyelids.  I've only become concerned after googling the general side effects and saw 'swelling of the face' and/or 'swollen eyelids' listed as both "common" and "when to call a doctor". My (non)fever is up and down over the past few days though I still feel flushed with more pink in my cheeks.
Caller reports after having her 1st dose of the vaccine having pain in her "under arm" and assumes this is in her lymph nodes; Pain in arm; tender; This is a spontaneous report from contactable nurse (patient) reported for herself that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, expiry date and NDC number, Batch/Lot number was not reported), via an unspecified route of administration on 24Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her first vaccine on 24Jun2021. After that on an unspecified date in 2021 patient had the usual pain in her arm that subsided 2 days later. States that in that time period patient began feeling pain in her underarm, patient assumes its lymph nodes; The patient states that it was tender and ongoing on an unspecified date in 2021, that it was still there. The patient was asking if this does not subside does she get the 2nd dose of the vaccine. The outcome of the event pain in arm was recovered on an unknown date in 2021, however the other events was not recovered.
pt presented to ed a few days after vaccine administration with sob bl le pitting edema. pt was found to have bl pleural effusions, pericardia effusions. pt was tested for infectious causes, pleura fluid was drawn and tested showed highy lymphocytes and exudative pattern no infectious organisms seen. pt was sent home as she felt subjectively better with o2 prn. pt felt worse at home and having to use o2 and came back to hospital (12/4) still shown to have bl plerual effusions and pericardial effusion. no infectious sources were found. pt was started on antibiotics and steroids and 4x day nebs and placed on high flow oxygen. Pt was slowly weaned of high flow oxygen and stopped on antibiotics.
1/7/2021 @1600 nausea lasted 2hr 1/8/2021 @ 0200 body aches & chills lasted off & on & continues presently. Woke up 1/9/2021 @0400 with headache & severe body aches & chills lasted 2hr Currently: body aches, chills, exhaustion (these symptoms come & go since 2nd injection)
Pt came to ED due to rapid heart rate (pt has atrial fibrillation) and feeling short of breath.  He was found to be COVID positive.
This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines.    No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms.   Company Comment: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-245527, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284008 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.
Day after injection, a painful swelling of the lymph node in the left armpit began; eventually swelling to around the size of a softball. Consulted physician via telehealth appointment. Used Advil and a warm compress to treat over the next few days. Swelling lasted until today (Nov 5, 2021), 4 days after the injection. It seems to have begun subsiding and is no longer as painful/tender.
Dizziness, sweating, profound extremity weakness, loss of appetite, nausea, difficulty swallowing.
Onset of localized pain at injection site, approximately 48 hours after the injection accompanied by a raise red bump at the injection site.
Rash of shingles rt forehead, eyelid, top of head & around rt ear, few spots on rt cornea; Pt seen by MD; rx'd inflamase eye drops; rash resolving by 4MAR92; t<100.0 for 8-9 days;
Initial misuse report received from a healthcare professional on 13 November 2013. The patient had received FLUZONE HD vaccine which was expired. Expired vaccine was administered. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Inconsolable crying, decreased appetite, fever to 103, staring episodes, and red measles rash. This lasted for three weeks and involved five office visits to address patient's ill health.