chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood in her urine with clots; felt bad like the flu; went to sleep and woke up dizzy; buzzing in her ears; she feels with altitude sickness; Plugged ears; tiredness; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE URINARY TRACT (blood in her urine with clots) in a 56-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.     No patient medical history reported.  Concomitant products included METOPROLOL for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (blood in her urine with clots) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (felt bad like the flu), DIZZINESS (went to sleep and woke up dizzy), TINNITUS (buzzing in her ears), HYPOBARISM (she feels with altitude sickness), EAR DISCOMFORT (Plugged ears), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HAEMORRHAGE URINARY TRACT (blood in her urine with clots), INFLUENZA LIKE ILLNESS (felt bad like the flu), DIZZINESS (went to sleep and woke up dizzy), TINNITUS (buzzing in her ears), HYPOBARISM (she feels with altitude sickness), EAR DISCOMFORT (Plugged ears), FATIGUE (tiredness), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Additional concomitant medications included reflux medication when needed and asthma medication when needed. This case concerns a 56-year-old female with a serious unexpected event of hemorrhage urinary tract, and nonserious unexpected Influenza like illness, dizziness, tinnitus, ear discomfort, hypobarism, and expected headache, fatigue, nausea. Hemorrhage urinary tract latency 22 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-090443, US-MODERNATX, INC.-MOD-2021-090371 (E2B Linked Report).; Sender's Comments: This case concerns a 56-year-old female with a serious unexpected event of hemorrhage urinary tract, and nonserious unexpected Influenza like illness, dizziness, tinnitus, ear discomfort, hypobarism, and expected headache, fatigue, nausea. Hemorrhage urinary tract latency 22 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-090443:Dose 1 US-MODERNATX, INC.-MOD-2021-090371:Son's case
patient 1 month of age received by mistake Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old female patient who received Men B NVS (Bexsero) (batch number Z39XM, expiry date 31-OCT-2026) for prophylaxis.   On 02-OCT-2023, the patient received the 1st dose of Bexsero. On 02-OCT-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: patient 1 month of age received by mistake Bexsero).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 2 Oct 2023 Medical assistant reported that a patient 1 month of age received by mistake Bexsero, which led to inappropriate age at vaccine administration. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter.
I was developing fever, chills, body aches, sinus pressure and cough. Major congestion was a factor and made sleeping difficult and wheezing began. I took a COVID-19 test just in case and was going to see my allergist, my test was negative. I went to see my allergist or nurse Practitioner, I was put on a ten day antibiotic and was diagnosed with a sinus infection plus I had  congestion with pressure on my face, cheeks, nose, and forehead mainly on my left side, this included pain and sensitivity in my forehead, jaw and head. I also had swelling of my lymph nodes in my  left armpit area. I was prescribed a steroid recently 10/12/2022 Prednisone and was told to take Sudafed over the counter.
Sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Sick) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Multiple sclerosis, Cough, Ache NOS, Chills, Headache and Fever.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) 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.   No concomitant product information was provided No treatment medication information was provided.
Induration at site of injection, 1 1/2" diameter, painful, redness 2" diameter-24 hrs after injection. Then, arthralgia, itching at site for 1 week after injection. Tx'd w NSAID'S.
pt recvd vax approx 2 1/2 hrs later began itching all over & devel hives no SOB began DPH; seen by MD 12MAR & treated w/Seldane & DPH; 15MAR93 pt overly tired;
1759 BP 135/79 HR 78 Reports feeling woozy, like she just gave blood, hands shaky, lunch was eaten at noon, brownie eaten mid afternoon 1800 8oz water given and 8oz of orange juice and granola bar 1809 Associate reports feeling better- less woozy, less shaky 1818 B/P 134/57 HR 77, no rash, no swelling, no respiratory complaints; dr evaluated associate and offered ED for continued support and associate declined.
Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; Blurry vision; darkening in the eyes; I felt like something in my eye like heaviness; has pain in her rib cage close to the arm pit occurring mostly at night; hot at night; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 13Jan2021 this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient). This 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left upper arm on 11Jan2021 at 11:00 at single dose for COVID-19 immunisation. Relevant medical history included knee pain. There were no concomitant medications. On 11Jan2021, the patient experienced "blurry vision; darkening in the eyes; I felt like something in my eye like heaviness" and in Jan2021 she experienced pain in her rib cage close to the arm pit occurring mostly at night and hot at night. The patient stated "I wanted to tell you that after the shot I was for 15 minutes sitting on a chair and I didn't feel anything and then I left and went for a walk and when I was walking by the gift shop at hospital, I noticed I just got blurry vision like when I looked at the stock, it kind of looked darkening in the eyes and blurry". She stated also "You know exact time I wouldn't tell but for the day like it happened first time near the store and later in the day when I was working, I felt like something in my eye you know like heaviness I don't know if that's blurriness but then runs away so like later yesterday I am fine and today I am okay". The patient also specified that blurry vision started 20 minutes after the vaccine and lasted 10-20 seconds and later during the day when she was reading. The patient also reported she was hot at night and has pain in her rib cage close to the arm pit occurring mostly at night. The patient did not receive corrective treatments; she just blinked and then she went and sit down, it never came back again. At the time of the report, the outcome of the events was unknown.   The information on the lot/batch number has been requested.
pt recvd vax for prophylaxis; 12 hrs later exp a rash on her trunk; resolved;
She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.; Lack of effect; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) and VACCINATION FAILURE (Lack of effect) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown that the patient had any allergies to vaccines, medications, food, and other products-describe reaction in parentheses (e.g. Sulfa (hives)).     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) and VACCINATION FAILURE (Lack of effect). At the time of the report, COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) had resolved and VACCINATION FAILURE (Lack of effect) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  It was reported that patient was contracted with Covid twice. Also experienced the Covid like symptoms with vaccine.  The symptoms from virus and shots were lasted a couple of days before subsiding.  Treatment Medication use information was not provided by reporter.  Company comment: This spontaneous case concerns a female patient (age not specified), with no relevant medical history reported, who experienced unexpected non-serious event of COVID-19 that occurred in the context of a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine. Latency could not be assessed as the exact date of vaccination and onset date of the event was not available. Vaccination failure is also reported. No further information on additional vaccination details, clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to MOD-2023-718540 (Patient Link).
Patient came back up to the counter stating the bandage fell off because of the blood and that his arm hurt. I activated an instant ice pack and applied it to the right arm to ensure pressure and cold was being applied. We continued to apply the ice pack for 15 minutes checking periodically for additional swelling etc. After the 15 minutes the patient said the arm still hurt but the bleeding stopped and no additional adverse reaction was seen.
Day after RSV vaccine woke up not feeling well and with a fever.  Took blood pressure at home which was low.  By evening experienced hard time taking deep breaths and went to ER 10/25 because worried it may get worse overnight.  Within a couple hours of walking into ER couldn't breath and had to be intubated and put on ventilator.  Doctors performed numerous tests over a period of 10 days and couldn't find out what was wrong and what triggered his lungs filling with blood and fluid.  Doctors said this wasn't a known reaction from RSV vaccine and therefore thought it wasn't related.  Had just gone to his doctor the Friday prior and received clean bill of health from primary care physician.  After 10 days on a Ventilator we had to make tough decision to let him go due to kidneys failing and couldn't get answers to what was wrong.  He passed away on Sunday November 5th at 1:53am at Hospital
LEFT ARM FELT LIKE IT WAS JUST VACCINATED FOR ONE DAY ONLY; BOTH ARMS HURT; FLU/CHILLS SYMPTOMS; BACK ACHE/ BACK DISCOMFORT/PAINS ARE BETWEEN SHOULDER BLADES; RIBCAGE ACHE/ RIB DISCOMFORT; FEELING TIRED; NO FEVER BUT FELT LIKE IT WAS BURNING UP INSIDE; LITTLE ACHINESS; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 120 pounds, and height was 63 inches. The patient's concurrent conditions included: bronchitis, allergenic asthma, environmental allergies, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 11-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2021, the patient experienced little achiness. Laboratory data included: COVID-19 virus test (NR: not provided) negative, negative. On 11-DEC-2021, the patient experienced no fever but felt like it was burning up inside, and feeling tired. On 12-DEC-2021, the patient experienced flu/chills symptoms, back ache/ back discomfort/pains are between shoulder blades, ribcage ache/ rib discomfort, and both arms hurt. On 22-DEC-2021, the patient experienced left arm felt like it was just vaccinated for one day only. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no fever but felt like it was burning up inside, flu/chills symptoms, and both arms hurt, and left arm felt like it was just vaccinated for one day only on 23-DEC-2021, had not recovered from back ache/ back discomfort/pains are between shoulder blades, ribcage ache/ rib discomfort, and little achiness, and the outcome of feeling tired was not reported. This report was non-serious.
Patient is a 30-year-old previously healthy Mediterranean woman complaining substernal squeezing chest pain for 2 days in the setting of 2nd Pfizer COVID vaccine 2 days ago.  The chest pain is pleuritic but otherwise has no exacerbating or relieving factors.  It does not radiate.  She has never had this pain before.  The patient is worried about myocarditis or blood clot as she has heard the can be reactions from the vaccine.  The pain is associated with shortness of breath.  She denies vomiting, diarrhea.  She has had some fever, chills and myalgias over the past few days.  She denies cough.  She denies history of VTE, hemoptysis, history of immobilization or trauma, estrogen birth control.  She denies family history of early cardiac death or MI.   38y/o woman with no significant past medical history who had her second Pfizer vaccine on Monday and later that day developed low grade fever/ diffuse myalgias/ pleuritic and positional central dull 5/10 chest pain. On Tuesday and Wednesday she remained bedridden with same sx. Thursday morning felt improved except had persistent chest pain for which she presented to the ED for evaluation. She had tachycardia, +troponins, and +DDimer. EKG was negative for acute changes. She was admitted to the cardiology service for suspected myocarditis. She was started on colchicine, standing ibuprofen, and metoprolol.  Echocardiogram complete on 5/21 was normal with an EF of 60%. She was evaluated again after her echo. She continued to feel significantly improved on medical therapy and was discharged home on 05/21/21. She will continue medical therapy as listed. She will follow-up with as arranged on 5/25/21.
Hives - first outbreak on arm the day after my 2nd dose, June 24th. Went to urgent care, was given Zyrtec  Approximately a week later and ongoing, sporadic pains in hands and feet with red spots, often times crippling depending on site.  Pain varies from a few hours to a few days. Occasional hives on skin on arms, legs and stomach. Multiple trips to primary in person and virtual. Sent for blood work & CT Scan. Pain in feet was so extreme recently went to ER and had leg ultrasound to rule out blood clots. Dx with hives.
Worn out; severe chill attack; teeth were chattering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Aug2021 10:30 (Batch/Lot number: unknown) at the age of 78 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 25Aug2021, outcome "recovered" (26Aug2021), described as "severe chill attack"; CHILLS (non-serious) with onset 25Aug2021, outcome "unknown", described as "teeth were chattering"; FATIGUE (non-serious) with onset 26Aug2021, outcome "unknown", described as "Worn out".  Additional information: The severe chills happened that same night at around 12 am. He put on 2-3 blankets, but that didn't work. He then tried a heating pad and blanket, and that helped. It lasted an hour or so. He was worn out the next day. He feels better not, but he isn't where he normally was. He still feels a little worn out, but that could be because he was 78 years old. His wife has his card in her pocketbook so he doesn't have it right now. He has never had anything like this happen before. He did not have to go to the emergency room or doctor's office. After the heating pad he was fine, and went back to sleep. The patient was due for his second shot of the COVID 19 vaccine this Wednesday. The patient enquired whether it was safe to even get the second dose. The patient did not receive any other vaccines within 4 weeks.   Follow-up (13Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medications were not specified. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ (lot # M025565, expiry date: 06-NOV-2017) (dosing regimen and frequency unknown) for prophylaxis (incorrect product storage). No adverse effects were reported. On an unspecified date between 03-SEP-2016 and 10-OCT-2016, the vaccine was exposed to temperature of 49.5 Fahrenheit (F) for 10 hours. No further information was provided. No product quality complaint (PQC) was reported. This case is linked to case number 1612USA006604 via same reporter link. Additional information has been requested.; Sender's Comments: US-009507513-1612USA006604:
Patient experienced some tingling in her hand. She has no other symptoms or complaints. She was observed for 20 minutes with no other symptoms. Symptoms fully resolved within 15 minutes.
I took a rapid test and also was Positive; I took a rapid test and also was Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: FL9264), in left arm, in 2021 as dose 2, single (Lot number: EN6201), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "history of sporadic/rare/non-chronic A-fib" (unspecified if ongoing), notes: history of sporadic/rare/non-chronic A-fib. Concomitant medication(s) included: ROSUVASTATIN, start date: 04Nov2019, stop date: 18May2022. Past drug history included: Codeine, reaction(s): "Known Allergies: Codeine", notes: Known Allergies: Codeine. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "I took a rapid test and also was Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect reported as no. Proprietary medicinal product name: Pfizer/Paxlovid, Batch/lot number: N/A, Indication for use in the case: Treatment of COVID-19, Date of start of drug: 19May2022, Date of last administration: 24May2022. Reported Event: Rebound COVID. Took full course of drug (5 days). Only two side effects: 1) foul metallic taste; 2) difficulty sleeping. By day 5 I felt fine and on day 6 registered neg on at-home antigen test. My wife was one day behind me in cycle and sicker during her illness. She also took Paxlovid and was neg on her day 6. But by her day 7/my day 8 she became sick again with severe headache, fatigue, etc. We went to see doc for help. While there she took a PCR test and was positive again. After we got home I took a rapid test and also was positive. My symptoms initially were mild - worst was bad cough, also sneezing/dripping - and are milder yet on this rebound. Her rebound symptoms are a little less bad than first round but worse than mine; no sore throat as with initial illness but splitting headache. Biggest downside for me is having to redo the 5/5 isolation/masking.
5 patients received a full vial (3.0 ml reconstituted dose) of yellow fever vaccine by mistake.  There is currently no symptomatic complaints. This patient was identified as one of the possible recipients.
Pt had rash and full body hives x 2 days. Itching and redness. Pt given Benadryl. Atarax and Allegra after seeing provider.
continuous tingling in her hands; This is a spontaneous report from a contactable consumer. and from a Pfizer sponsored program  This consumer (patient's mother) reported for a 17-year-old female patient (reporter's daughter).  A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiration date: unknown), via unspecified route, administered in left arm on 20May2021 (at the age of 17-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 21May2021, 1 day after the vaccination, the patient experienced continuous tingling in her hands. When the patient woke up both of her hands were tingling, almost like when they fell asleep, it was non-stop,; felt like needles in her hand. The tingling was worse when the patient first woke up. The tingling was always there but it changed with pressure. Second dose scheduled on 10Jun2021 from her school. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
(R) upper sore arm with 12 x 12 cm red warm swollen. Tender to touch area.