chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is a 50 y.o. female patient of CNP with a history of Morbid obesity, COPD, Chronic respiratory failure on 3 L oxygen, Hypertension, Hyperlipidemia, GERD, Anemia, Tobacco abuse, presented with cough.   Acute on chronic respiratory failure with hypoxia and hypercapnia Secondary COVID-19 pneumonia, PNA, COPD exacerbation on suspected underlying OSA/OHS, and pulmonary HTN  VBG reveals compensated respiratory acidosis Required HHFNC, now on NC, at home reports she is on 3L 02  Discharged on home 3L 02  IS, pulm hygiene  Pulm followed   COVID-19 pneumonia Date of onset of symptoms: 12/27 Symptoms present on admission: Cough, subjective fever/sweats Date of covid positive test: 12/31/2022 Vaccination status: vaccinated Imaging: Groundglass throughout bilateral lungs with consolidation lower lobes on CTPA Oxygen requirements on admission: HHFNC Medical therapy: remdesivir and steroids,  IV Lasix prn given, will give rx for decadron on discharge  Consultants following: Pulmonology Anticipated special isolation end date: 1/11/2022   Community-acquired pneumonia Covid -19 pneumonia with superimposed bacterial pneumonia  Subjective fever, cough  CT with bilateral ground glass, R trace effusion  Cont  Rocephin and Zithromax Micro unreavling, complete course omnicef on discharge    COPD exacerbation Decadron as above Schedule DuoNeb/PRN albuterol nebs Symbicort and albuterol rx given on discharge    AKI Creatinine 1.07 (9/12/2022) -- > 1.25 on admission Held benazepril, will now resume     Atypical chest pain Likely MSK etiology CTPA motion limited, negative for large central PE Initial troponin 21 setting of AKI EKG NSR, normal PR interval, normal QTC, T wave inversion lead III stable compared to EKG 9/12/2022 Troponin trend flat; no further work-up  Essential hypertension Holding benazepril secondary to AKI Continue amlodipine   Cigarette nicotine dependence Smoking 1ppd  Nicotine patch, PRN nicotine gum Encouraged cessation    Morbid Obesity Body mass index is 45.42 kg/m².
ACUTE NON ST ELEVATION MI 3/27/2023 ASTHMA, UNSPECIFIED
26Jan: Pt reported to Dr. with pain and some redness below injection site. Apprx 8in in diameter. Dx:Cellulitis Rx: Cephalexin 500mg x6hrs. 27Jan: @1025 had increased in size by +3in. Rx: Ceftriaxone 1gm IV. 27Jan: @1700 redness increased by +1in. Transported Pt to ER.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 17-JUN-2016, the patient was inadvertently vaccinated subcutaneously with one dose of M-M-R II (lot # K024824 and expiration date 02-DEC-2016, albumin status therapy type was not reported) that went through a temperature excursion. The nurse reported that there were no adverse effects from the administered product. Additional information has been requested.
some places in the back of her throat; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 06Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient lived in an assisted living community and received dose 1 of BNT162B2 on 06Feb2021. She was scheduled to receive her second dose of BNT162B2 three weeks after her first dose but the assisted living would not let her receive her second dose at that time because she had "some places in the back of her throat." She felt fine and had no symptoms. The patient underwent lab tests and procedures which included a COVID-19 test on an unspecified date with the result of negative. The patient received dose 2 of BNT162B2 on 20Mar2021. The outcome of "some places in the back of her throat" was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient Received 12 and older vaccine instead of 5-11 year old Pfizer COVID vaccination.
About ten minutes after the vaccine I had a strange feeling that something wasn?t right. Vaccine arm started going numb with tingling. That hand then became completely numb. Then my throat went numb and face was tingling and couldn?t swallow properly. Found nurse at the vaccination site and reported not feeling well. She immediately noticed I was bright red and breaking out in hives. Nurse gave me an antihistamine shot and an oral antihistamine for an allergic reaction. I?ve never had an allergic reaction before or ever experienced any of these symptoms before. After a few minutes the symptoms started going away. I was advised to not drive myself home. About an hour later some milder symptoms came back, such as slight tingling of face and lips. Went away again gradually. Fell asleep (not sure how long) and woke up with swollen and numb lips so I took some more antihistamine. No more allergy symptoms after that.
Case number PHEH2014US019382 is an initial spontaneous report received from a pharmacist on 25 SEP 2014. This report refers to  a 51 year old female patient. Her medical  history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1410901) intramuscularly on 19 SEP 2014. On the same day after vaccination, she experienced an orange sized swelling in her armpit which was painful and palpable. Outcome for swelling was reported as complete recovery (subsided). Outcome for pain was not reported. The seriousness and causality were not reported.
had my injection 8 days ago and I still have a hard lump; it's hot to the touch; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (had my injection 8 days ago and I still have a hard lump) and VACCINATION SITE WARMTH (it's hot to the touch) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (had my injection 8 days ago and I still have a hard lump) and VACCINATION SITE WARMTH (it's hot to the touch). At the time of the report, VACCINATION SITE MASS (had my injection 8 days ago and I still have a hard lump) and VACCINATION SITE WARMTH (it's hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Pt reports arm swollen/tender to the touch 2 days after vaccine was given. Told to follow up MD.
approx 3 months post 2nd vaccine, huge hives appeared on my torso and inner arms. They persisted for 3 months, largely non-responsive to anti-histamines and steroids, then disappeared
Patient woke up next day after receiving vaccine to arm swollen and pink. Patient then developed rash at the site. Taken to hospital ER two days after administration and given medication at ER.
This spontaneous report as received from a pharmacy technician refers to 2 unspecified patients of unknown gender and age. On 17-JUN-2014, the patients were vaccinated with an expired doses of VARIVAX (merck) lot # H011913, expiration date: 14-JUN-2014 (dose, dose number, indication not reported). It was reported that the vaccines have not have any previous temperatures excursions. No adverse symptoms were reported. Additional information has been requested.
FALLEN SEVERAL TIMES; BARELY MOBILE; DIFFICULTY SPEAKING; SHORTNESS OF BREATH; BARELY ABLE TO SLEEP; HEADACHES; FEVER; This spontaneous report received from a patient concerned a 64 year old male other race and unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered to right deltoid on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced fever, headaches and shortness of breath. He stated that he was barely mobile (severe discomfort, feels like a handicapped, needs assistance to do anything) after receiving vaccination about 2 months ago. He felt like a handicapped person who needs assistance to do anything. He was barely able to sleep and found it difficult to speak. He stated he had fallen several times after receiving the vaccine. On an unspecified date, he had been hospitalized at 2 different hospitals and both instances did not help with his symptoms. He stated his HCP was aware and he could not help. He sounded to be in severe discomfort and as stated several times to fix it. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from barely mobile, fever, difficulty speaking, shortness of breath, headaches, fallen several times, and barely able to sleep. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: - fallen several times, barely mobile, difficulty speaking, shortness of breath, barely able to sleep. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). - headaches, fever. This event(s) is labeled per RSI and is therefore considered potentially related.
WITHIN 28 DAYS OF MY LAST VACCINATION I STARTED HAVING EPISODES OF PASSING OUT AND HAVING SEIZURES. I HAVE HAD SEIZURES NOW EVERY DAY SINCE THE BEGINNING OF MARCH. NOTHING HAS CHANGED IN MY LIFE BESIDES GETTING THIS VACCINATION.
Patient developed chest pain and shortness of breath 4/15 Presented to hospital emergency department 4/17 found to have a pulmonary embolism without heart strain, however with pulmonary infarction of left lower lobe with associated right lower extremity DVT Patient admitted to the hospital, initiated on therapeutic anticoagulation with Lovenox, started on oxygen therapy for acute hypoxic respiratory failure Discharged home 4/20 on therapeutic anticoagulation with Xarelto and home oxygen as needed
evening of vax 2AM pt would not sit up in bed d/t pain in legs & apparent fever, felt warm to touch-states mom;the following day pt had noticeable sore legs guarded them;fine red rash on face & chest, abd & neck & balance off x 3 episodes
Red, swollen area at vaccination site 12 hours after injection of TDAP and Influenza. 2in x 1 1/2in oval area with swelling and redness.
Chest pain, shortness of breath, severe myocarditis, rhabdomyolysis developed 2 days after his second shot.
I got the vaccine and I'm very sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I got the vaccine and I'm very sick) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I got the vaccine and I'm very sick). At the time of the report, ILLNESS (I got the vaccine and I'm very sick) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
After receiving my second dose of Moderna about 1-2 weeks after that I started noticing pains in my neck, and left shoulder.  Pain spread to my other shoulder, hips, knees, and eventually elbows, wrists, and hands/fingers.  Pain was so much that I had extreme pain getting dressed, getting out of bed, standing up from a chair, walking, using my hands for anything that required the use of muscles.  When going in for my Dr appointment I had extremely high BP.  Less than a year ago I had normal BP range and since then have even lost weight.  Was figuring it is Vaccine Induced Polymyalgia Rheumatica. After blood work result came back it confirmed thoughts of Polymyalgia Rheumatica.  Currently taking Prednisone to reduce inflammation.
Severe cramping and minor yellow/pink discharge on day 3 took tylenol, lasted for 4 hours  I am going through menopause and haven't had a period in 7 months...  Felt like I was going to have a period, these cramps were as bad as labor pains.
Upon injection, patient immediately complained of pain and asked if that was normal. I told him it was possible to have some pain/discomfort at injection site, and sometimes the arm may be sore afterwards for a day or so. He said he'd gotten shots before but never had any pain. There was a small drop of blood which I had covered with a bandaid. I uncovered the area and sat with him for a few minutes to see if there were any visible changes. There was no evidence of redness, irritation or swelling. I asked the patient if he wanted to put some ice on it and he refused. I got another bandaid for the patient - although there was no more bleeding- and placed the new bandaid over the area. I asked patient to please contact the pharmacy if he continued to have problems or it worsened, and he left the pharmacy. We never heard from him again.
Patient states that he experienced fever, shortness of breath, and his muscles ached and were extremely weak. Patient reported symptoms to pharmacy on day 13 after the vaccine was given. Patient recovered shortly after reporting symptoms to the pharmacy.
Information has been received from a consumer concerning an 11 yr old female who was vaccinated with a dose of varicella virus vaccine live. Within the last month, in Mar 2005, the pt experienced chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
I received the vaccine on 03/03/2022 about and hour later my tinnitus got louder, I'm getting dizzy when walking and  I'm started to get pain deep in my ear like ear ache.
Excessive tiredness Severe low back pain under severe kidney area Weakness in the arms Constant fatigue Joint pain Numbness tenderness in the fingers Cramping sensation
Localized reaction at the site of injection- pain, redness, warm to touch, and swelling.
Pediarix and Engerix given on the same day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 13-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number N7HL3, expiry date 15-APR-2024) for prophylaxis.   Co-suspect products included HBV (Engerix B 10 mcg) (batch number 34G75, expiry date 15-FEB-2024) for prophylaxis.   The patient's past medical history included febrile seizure (Febrile seizures as prior medical history). Concomitant products included Pentacel.   On 06-APR-2023, the patient received the 1st dose of Pediarix and the 2nd dose of Engerix B 10 mcg. On 06-APR-2023, an unknown time after receiving Pediarix and Engerix B 10 mcg, the patient experienced overdose (Verbatim: Pediarix and Engerix given on the same day). The outcome of the overdose 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: 06-APR-2023 The clinical pharmacist enquired any guidance? Any concern for the patient? The registered pharmacist (RPH) reported a patient received both Pediarix and Engerix doses administered on the day of reporting. The RPH mentioned had concern with too much Hepatitis B for the patient. The patient previously received Pentacel. The reporter did not consent to follow-up.    The patient received Pediarix and Engerix-B on the same day, which led to overdose
First shot taken 4/30/2021 and second taken 5/21/2021. No immediate discomfort but a few weeks later my  thumb andwrists began feeling weak and tingles. Visited othepedic doctor asking if it was arthistis or something relative to light weightlifting. No visible signs of arthiritis but suggested to keep excerise. The pain is more intense at times so I no longer use weights. The only connection I found was that I may have developed RA due to the vaccine.
Patient had localized swelling left arm and difficulty swallowing. Patient went to E.R and had antibiotics.
This spontaneous report was received from a nurse and refers to multiple patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # N008828, expiration date 16-MAR-2019 (dose and route of administration were not reported) for prophylaxis. Concomitant therapy included properly stored sterile diluent (MERCK). No adverse events were reported. Administered doses of vaccines experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit (also reported as 6.8 degrees Fahrenheit) for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA005371.
tested positive for COVID months after receiving the vaccine; tested positive for COVID months after receiving the vaccine; This is a spontaneous report from a contactable patient reporting via representative. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID months after receiving the vaccine it was reported that event took place after use of product. The events assessed as medically significant. The patient underwent lab tests and procedures which included Covid-19 (sars-cov-2 test): positive on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. The information available in this report is limited, and the reported events covid19 and drug ineffective cannot be totally excluded or assessed. The case will be reassessed when the new information available.
Patient called tonight to ask about his flu shot that he received on 8/11/20. He is reporting shoulder pain. Upon talking to him, he stated that when he got the shot it hurt but he did not say anything because it is a shot. His arm was sore (dull ache) for 3 days and then the pain went away. But 3 days ago, he states the pain came back and every time he lifts his arm, he has a sharp pain in his shoulder. He did have a slight fever the next day after the shot. He was also very familiar with the terminology of SIRVA. I asked him multiple times about the dull pain going away and he said yes. The sharp pain did not start until 3 days ago (8/17/20). I also referred him to see a doctor and he is seeing one tomorrow.
Severe pain at injection site  (upper left arm) that has persisted to dat  (6/14/15). Pain can be dealt with by taking NSAIDS but becomes severe enough to wake me up at night. I can no longer do "easy" things such as picking up items with my left (dominant) hand, and interferes with putting on/removing clothing items. The pain persists/ is strongest around the injection site, but can spread as far as wrist and up into the shoulder.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: About 5 to 6 months prior to the date of reporting, the patient received her 1st dose of SHINGRIX on the left arm, the exact date for vaccination was not provided. The patient noted soreness to arm. The soreness was described as, she was unable to sleep on the arm for well over a week. The soreness completely resolved on the 3rd week after the vaccination, the exact date for recovery was not provided. The reporter did not have batch number, expiry date or dose of the SHINGRIX vaccine. The patient had denied permission to contact their physician. For tolerance after 2nd dose of SHINGRIX, refer case US2018GSK140958.
Vomited immediately, within 10-15 minutes and had generalized hives, pallor and tachycardia. Given 12.5mg Benadryl po and 0.1cc Epi 1:1000 SC with good response. Sent to ER for observation by EMS.
The site was swollen, red, warm to touch with a bump and affected a large part of her arm/ Patient was treated for cellulitis with an unspecified antibiotic; patient had a "skin reaction" at injection site. The site was swollen, red, warm to touch with a bump/ Patient was treated for cellulitis with an unspecified antibiotic; The site was swollen, red, warm to touch with a bump and affected a large part of her arm/ Patient was treated for cellulitis with an unspecified antibiotic; patient had a "skin reaction" at injection site. The site was swollen, red, warm to touch with a bump/ Patient was treated for cellulitis with an unspecified antibiotic; Information has been received from a pharmacist via a field employee referring to an 11 years old female patient, the daughter of the reporter. In October 2019 (also reported as the same day), the patient received concomitant vaccines included influenza virus vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient had no pertinent medical history. The patient was allergic to ant bites. The patient was not pregnant.  In October 2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 ml once, intramuscular; lot # and expiration date were unknown) for human papillomavirus (HPV) prevention.      In October 2019, the patient had a skin reaction at injection site. The site was swollen, red, warm to touch with a bump and affected a large part of the patient's arm (cellulitis). The reporter sought assistance for the patient at unspecified pediatrician office. There was no lab diagnostics or studies performed. The patient was treated for cellulitis with an unspecified antibiotic and her condition resolved in one week. The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Pt. c/o possible reaction to flu vaccine.  Noted to have 3X2" red area to L delt.  Area noted with inc. warmth and dry to touch.  Sl swelling noted.  Pt. c/o minimal discomfort.  No diff. with mobility of L arm/shoulder.  T 98.5.  Has not taken any otc meds for relief.  Discussed with Dr.  Advised pt. to apply ice and to take Tylenol/ibuprofen if tolerated prn.  To monitor s/s.