chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right 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 had no relevant medical history. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: I also re-tested and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks was Lexapro (generic). Patient had no known allergies. Patient received Paxlovid (anti-viral) from 22Jul2022 to 26Jul2022 for COVID-19 treatment. Patient was prescribed Paxlovid for the treatment of Covid and symptoms started to resolve after about 3 days. However, at day 5 or 6 they returned and were worse than before with cough, sore throat, body aches, fatigue and headache (all had resolved previously) patient also re-tested and tested positive again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the causal association between the reported events Drug ineffective, Covid-19 and suspect drug Comirnaty cannot be excluded.
Pt recvd 3 doses of Engerix-B 22NOV90, DEC90, MAY91 & it was determined that pt was a non-repsonder;
Anti-MDA5 dermatomyositis; This literature-non-study case was reported in a literature article and describes the occurrence of DERMATOMYOSITIS (Anti-MDA5 dermatomyositis) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:      No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DERMATOMYOSITIS (Anti-MDA5 dermatomyositis) (seriousness criterion medically significant). At the time of the report, DERMATOMYOSITIS (Anti-MDA5 dermatomyositis) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered DERMATOMYOSITIS (Anti-MDA5 dermatomyositis) to be related.    No concomitant and treatment medications were reported.  Company Comment: This is a Literature-non-study case concerning a 45-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Dermatomyositis (reported as Anti-MDA 5 dermatomyositis), which occurred on an unknown date after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Literature-non-study case concerning a 45-year-old male patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) event of Dermatomyositis (reported as Anti-MDA 5 dermatomyositis), which occurred on an unknown date after vaccination with mRNA-1273 vaccine, administered as second dose within COVID-19 vaccination schedule. Since no vaccination dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.
he got moderna booster and developed gout 2 days later. he previously had gout about 2 years ago and will get a flare ever 1-2 years. He also admits to drinking "a few too many" beers
Uveitis; Eye inflammation; eye redness; eye pain; eye pressure; blurred vision; This case was reported by a other health professional and described the occurrence of uveitis in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 10th July 2020, the patient received the 1st dose of Shingrix. On 20th July 2020, 10 days after receiving Shingrix, the patient experienced uveitis (serious criteria GSK medically significant), eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision. The patient was treated with unknown steroid eyedrops (Steroid Eye Drop (Unknown)). On an unknown date, the outcome of the uveitis, eye red, eye pain, sensation of pressure in eye and blurred vision were unknown and the outcome of the eye inflammation was not recovered/not resolved.   It was unknown if the reporter considered the uveitis, eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient exerianced uveitis, eye inflammation, eye red, eye pain, sensation of pressure in eye and blurred vision. The patient was having no symptoms at time of vaccination.  The patient was asking, if the patient would be able to get 2nd half of vaccination.
Pt did not experience any adverse event out of the normal (i.e. sore arm, feeling tired). Pt is under the age of 18. Currently Moderna is only supposed to be used at 18 years old or older.
Second vaccine I am now 3 weeks of uninterrupted illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 93-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm, administration date 26Feb2021 (Lot number: ENG203) at the age of 93 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing); "HTN" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "dairy allergy" (unspecified if ongoing). Concomitant medication(s) included: THYROID; CARVEDILOL; AMLODIPINE; TORSEMIDE; PRAVA [PRAVASTATIN SODIUM]. Vaccination history included: Bnt162b2 (Dose Number: 01, Lot Number: EL9264, Administration time; 11:00AM, Vaccine location; Left arm), administration date: 05Feb2021, when the patient was 93 years old, for Covid-19 Immunization, reaction(s): "fever", "chills", "fatigue", "lack of appetite". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "Second vaccine I am now 3 weeks of uninterrupted illness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Patient developed right subconjunctival hemorrhage approximately 3 hours post vaccine. Patient given artificial tears and was told to follow-up with a visit to "eye clinic".
4/15 Swollen Lymph node on R side on neck 4/20/21 ED - U/S Lymphadenitis on R neck - Augmentin 4/21/21 ED - Swollen gland & discomfort - Acetominophen  4/22/21 PCP office - flu - lymph gland softening                      continue Augmentin till complete.
Heart problems.  Irregular heart beat  resulting is plaque dislodge from right coronary artery.  Doctors placed stint.  Irregular heartbeat and mild angina still persist.
Chicken pox - pustules, papules with broad erythematous base on face, trunk (anterior and posterior), thighs, groin, hairline. No frank vesicles. Treatment: Benadryl. Began 02/15/2000.
I had the Moderna shot last evening. At first, just a sore arm and slight headache.  Started feeling worse 12 hours later. Main complains: Diarrhea, feeling faint - so much so, I laid down three times and crawled so as not to pass out, chills
1st dose 2019, due to the Covid-19 Pandemic, 2nd dose June 30 2022; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M39A, expiry date 28th August 2023) for prophylaxis.   Previously administered products included Shingrix (On 25th August 2019,the patient received 1st dose of Shingrix).   On 30th June 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment: The second dose of Shingrix was administered late to the patient due to the covid-19 pandemic. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The second dose of Shingrix was administered late to the patient due to the covid-19 pandemic, which led to social problem.
Less than 5 minutes after getting the vaccine, I had hot head coming from my head to me feet. The nurses giving the  vaccinations, told me to sit in a secluded area. About 15 minutes later, my heart started racing, a nurse took my BP it was around 180ish. They gave me a bottle of water and one bar of granola. After 30 minutes they checked my BP again and then they called the paramedics and I went to the ER. When I got to the ER they took blood work, an EKG, a urine sample, and they gave me IV fluids. They ruled out a heart attack. I was there for about 8 hours and left around 8:30pm. I didn't work the next day, but 7-8 days after I had a persistent headache. My PCP just told me to stay hydrated and take ibuprofen. It went away after a week.
Nausea, chills, low grade fever, headache, body aches, fatigue - started at 5:00pm five days after vaccination - fever resolved with Tylenol - remaining symptoms resolved with rest. Still feeling fatigued and fuzzy-headed on day following onset of symptoms.
24 hours of chills; fever; body aches; fatigue; redness at site of injection; itchiness at site of injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 46-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 07Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 46 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED., UNKNOWN MANUFACTURER.), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "24 hours of chills"; PAIN (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering"; PYREXIA (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "fever"; VACCINATION SITE PRURITUS (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "itchiness at site of injection"; VACCINATION SITE ERYTHEMA (non-serious) with onset 07Oct2023 at 21:00, outcome "recovering", described as "redness at site of injection". Therapeutic measures were not taken as a result of chills, pyrexia, pain,  fatigue, vaccination site erythema, vaccination site pruritus.  Additional information: the patient did not have covid prior to vaccination, and not tested for covid post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Initial report received on 29 September 2009 from a health care professional. A 63 year old male patient with no reported past medical history developed redness at the site which blistered within 24 hours of receiving FLUZONE SV 2009-2010 (lot number U3216AA) intramuscularly in the left deltoid on 23 September 2009. One year prior, the patient had a influenza vaccine, but did not experience any reactions to the vaccine. Concomitant therapy included blood pressure and cholesterol medication (name of medication was not specified). On 24 September 2009, the patient also experienced redness to the left side of his chest, forehead, shoulders, and armpits which also turned to blisters. The patient was advised by the reporter to contact his primary care provider for treatment. The patient was seen in the emergency room on 29 September 2009 and was diagnosed with herpes virus outbreak. The patient was prescribed antiviral medication. No further information was provided. The patient did not recover. List of Documents held by Sender: none.
Fever of 102.1 after Tylenol, body aches, chills, headache
pt states his tongue has been sore and swollen since about 9 hours after getting the vax.  Pt is also having issues with SOB, and being short tempered and has had these  symptoms for about 36 hours.   Pt can barely speak because of his tongue being swollen and it does not seem to be getting any better.  Pt will contact his PCP.
Golf ball size induration just below injection site, red, painful. Hives all over arm of injection. Increased H/A.
Started to experience a stabbing pain from back between shoulder blades through to heart area several  times, short of breath, fatigue, dizziness, heart palpitations . Patient did have a Bypass  Surgery in August 20, 2021 however his Drs felt this was to far out to experience Pericarditis like he was diagnosed with recently.
Pain began in shoulder and then travelled down the arm to debilitating pain in the elbow and growing now to the wrist. Rash around arm and on chest.
This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reaction or allergies were not reported. On 03-OCT-2018, the patient was vaccinated with an unspecified dose in immunization series of improperly stored M-M-R II injection (strength, route of administration, lot# with expiration date were not reported) for prophylaxis. M-M-R II was stored in the temperature of 12 degrees Celsius for 2 hours. Sterile diluent was stored properly. No previous temperature excursions were not reported. Data logger was not involved. No adverse effects were reported.
Headache, moderate to severe fatigue, chills, body aches, tired, dizziness while walking, shortness of breath, nausea, mild fever.  Events lasted 3 days at full effect, tapered off to day 5-6.
mild heart pain; Body fatigue; chills; Dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) via a regulatory authority. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 12:30 (Batch/Lot number: unknown) at the age of 27 years(not pregnant) as dose 3 (booster), single for covid-19 immunisation in Pharmacy/drug store. Relevant medical history included: "Drug allergy" (unspecified if ongoing), notes: Drug name was not reported. There were no concomitant medications. The patient didn't receive other vaccines in 4 weeks and no other medications in 2 weeks. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 07May2021, when the patient was 27 years old, for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 12Apr2021, when the patient was 27 years old, for Covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 05Dec2021 12:30, outcome "unknown", described as "Dose 3"; ANGINA PECTORIS (medically significant) with onset 06Dec2021 04:00, outcome "not recovered", described as "mild heart pain"; FATIGUE (non-serious) with onset 06Dec2021 04:00, outcome "not recovered", described as "Body fatigue"; CHILLS (non-serious) with onset 06Dec2021 04:00, outcome "not recovered", described as "chills". Therapeutic measures were not taken as a result of angina pectoris, fatigue, chills. The events were not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Left anterior thigh rash - treated with BENADRYL only - Dr office. Improved next day in office.
Shingles shot gave discomfort for a few days after; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (dad had shingles, he was in so much pain) and pain (Family History) (dad had shingles, he was in so much pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-APR-2022 Reporter's comment: This case was received from consumer via interactive digital media. The case was reported by patient's wife. The reporter stated that the both herself and her hubby got shingles shot and her hubby had discomfort for a few days after. The reporter felt happy to be protected. Additional Supportive Information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR066683:Same Reporter
Discovery that patient received a total of 8 COVID vaccinations, when attempting to bill a Moderna booster dose and receiving an insurance rejection.  According the patient has received a 3 dose series of Pfizer covid-19 vaccine, 3 dose series of Moderna covid-19 vaccine, and a 2 dose series of the Janssen covid-19 vaccine.
On 06/25/21 at approximately 1500 patient received MMR and Menactra vaccines.  Immediately after receiving the vaccines, patient became very anxious and stated her left arm hurt at the site of the Menactra vaccine.  This nurse advised Mom and patient that it was normal to have some pain at the injection site.  Patient waited 15 minutes in the exam room and was going to be in the clinic for another 15 minutes getting her form and checking out,  While at the front desk waiting on the form, patient laid her head down onto the counter and said she felt faint.  Skin was pale and clammy.  Attempted to take BP x 2 with automatic VS machine and an error message was displayed both times. RN retrieved a manual BP cuff and stethoscope. RN checked patient's BP, which was WNL, as well as her pulse.  Complained of numbness and tingling of left arm down to her fingertips.  A cold pack was placed on patient's left arm and damp paper towels were provided for her face/neck.  Transferred back to clinic room via wheelchair and assisted onto exam table with feet elevated.  BP and pulse continued to be normal (averaging 115/60 and 80).  After approximately 30 minutes of monitoring VS and elevating lower extremities, patient's skin was pink, warm and dry.  She was also smiling and laughing with Mom and this nurse.  Denied any numbness or tingling to her left arm, just soreness at the Menactra injection site.  Pt was offered transport to the vehicle via wheelchair - she declined.  Patient ambulated with Mom to her car in the parking lot without difficulty.  The patient never lost consciousness and was awake, alert and oriented during the entire episode.
Patient wrote on his consent form that he was 18 years of age, when he was technically 17y and 8m. Therefore, vaccine was administered off label. He has not contacted us to report adverse events. We have attempted to contact him but he has not returned our calls at the time of this report.
Severe lip swelling began at 7pm 8/6/21 did not subside until 5:30pm on 8/7/2021
Noticed a lump on the left side of my neck, about an hour later there was another lump right above the first one.  As the day went on the swelling continued to get worse.  Also the location of the smallpox vaccine has turn into multiple blisters. It just wouldn't stop oozing. I finally called my doctor and made an appt for the next day.  By the time I got to my doctor the next day the right side of my neck was swollen.  The inflammation was traveling down my arm.
diluent that was used for the dose had expired, no AE; Initial information received on 27-May-2020 regarding an unsolicited valid non-serious case from the nurse.  This case involves an 6 months old male patient, who received 0.5 ml second dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ033AA, expiry date: 07-Oct-2020) via unknown route in the right thigh for prophylactic vaccination on 21-May-2020. It was reported that the diluent that was used for the dose was expired (lot: U6205AA and expiry 22-Apr-2020).  Medical history, medical treatment, vaccination, family history were not provided.   Concomitant medication included IPOL, Rotavirus vaccine and Prevenar 13 vaccine.  It was a case of an actual medication error due to expired product administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Narrative:  Severe: 42yr male direct admit from OSH through the ED for COVID symptoms in setting of heart transplant 2019 on immunosuppressant post-transplant medications. OSH started patient on remdesivir (loading dose) and dexamethasone; requested transfer to agency hospital. Also notably has an AKI with creatinine of 2.8 (Baseline 1.8-2.0). Patient remains on BiPAP upon transfer and to ICU. Oxygen Status: BiPAP upon arrival eventually transitioned to HFNC 60L/60% and intubated for 20 days in ICU Days in ICU: 9/10 to 10/15; transition to Med Unit until discharged 11/2 COVID Therapeutics: Remdesivir and dexamethasone Pertinent PMH: CKD III, CMV viremia, s/p heart transplant Pertinent Labs (9/10/2021)on admission: COVID-19: Positive, eGFR: 27ml/min (< 30ml/min with history of CKDIII though AKI), AST/ALT: 60/70 H COVID Vaccination Status: Vaccinated Moderna x 2 (Feb and March 2021)
pain in chest felt like crystals in lungs  off and on over a few hours- no shortness of breath hurt to move arm and could not lay on it , day after shot cannot get warm
rt ear began ringing and has not stopped. I went to ear nose & throat & had test run