chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 78 y.o. male patient of, MD with a history of past Medical History: Diagnosis; Date; Cancer (HCC); prostate COPD (chronic obstructive pulmonary disease) (HCC); Diabetes mellitus (HCC); Diabetic retinopathy (HCC) Hyperlipidemia; Hypertension; Neuropathy; Sleep apnea. A 78-year-old man admitted to Hospital on October 16, 2022 with dyspnea.  Found to have COVID-19 and superimposed right middle lobe pneumonia.  Symptoms started around October 12.  Symptoms present on admission included mild hypoxemia, cough and dyspnea.  COVID-positive test was done on October 16, 2022.  Patient's vaccination status included 2 vaccines and 1 booster for COVID-19.  Chest x-ray pulmonary CT and interval change chest x-ray all demonstrate stable right middle lobe pneumonia likely secondary to COVID-19.  Treating as CAP with azithromycin and cefdinir to complete antibiotic course on discharge.  Patient did need intermittent supplemental oxygen at 2 L per nasal cannula for O2 sats in the mid to high 80s at the lowest.  Of note patient also has underlying COPD.  Patient initially received steroids.  Patient also has known history of hypertension.  His hydrochlorothiazide was stopped during hospitalization and was not continued on discharge secondary to hyponatremia and hypokalemia.  Can have a risk-benefit discussion with PCP about reinitiating this as an outpatient.  MRSA, strep pneumonia, Legionella all negative.  Urine culture was never collected due to nonproductive cough.  Patient was encouraged to continue to use his incentive spirometer. Discharge Diagnoses: 1 right lower lobe pneumonia; COVID-19 virus; Acute hypoxemic respiratory failure; Type 2 diabetes; History of COPD  Hypertension; Hyperlipidemia; Leukocytosis; Hyponatremia; Hypokalemia.
From initial information received on 22OCT2003 from a health care professional regarding an adverse event occuring in the USA, it was reported that a 44 year old female patient received a dose of FLUZONE 2003-2004, administered IM in the left deltoid on 20OCT2003. The following day, the patient developed left eye angioedema, left earache and a sore throuat. The patient was treated with Benadryl 25mg orally , two doses given. Reportedly,t the events fully resolved.
Extensive Lymph Swelling; This case was reported by a other health professional via call center representative and described the occurrence of lymphadenopathy in a child male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number Z7275, expiry date 30th June 2021) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season (intramuscular). On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was unknown.   It was unknown if the reporter considered the lymphadenopathy to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported the patient had extensive lymph swelling, which led to lymphadenopathy. No further information was available. The reporter consented to follow up.
Patient was given her 1st dose of the Moderna Covid-19 vaccine. She was from out of state and had never filled anything with our pharmacy. She stated both on her informed consent paperwork and verbally during counseling prior to receiving vaccination that she had never received a prior dose of any other COVID vaccination. Checking the vaccination registry, no prior doses of COVID vaccination were seen. Upon processing her vaccination through insurance (she stated she had none) it was discovered that she had received a dose of the Janssen COVID-19 vaccine on March 9th at a pharmacy in another state. Patient had already left the pharmacy and was not reachable after several attempts to call her phone #
Within one minute of my injection l felt numbness surround my mouth.  Three minutes later I felt flushed.  I asked my wife if my face was  red and she said, ?yes?. I felt somewhat weak and paramedic called the Dr over.  We talked and he determined that I had not eaten.  Walked me around car, put me in the passenger seat.  My wife  then drove.  I was a little disoriented late but didn?t complain. Since then I have felt like I did in July 2019 when I had coronial virus.  Felt bad, 93oxygen, 77 heart beat which is high for me.   Friday I did not get out of bed nor went outside. Sat more of the SamE.  Woke up at midnight sat and felt better.  I?m better but weak.
FLUZONE PFS, that were expired was administered to 19 patients; Initial information was received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case US-SA-2022SA417187(CLUSTER).  This case involves a 3 years old male patient and reporter reported Influenza quadrival A-B vaccine [Fluzone QIV] that were expired was administered to 19 patients.  No other vaccines. The patient's past medical history, medical treatment(s) and family history were not provided.   On 07-Oct-2022, the patient received a total dose of suspect Influenza quadrival A-B vaccine suspension for injection 0.5 ml (lot UT7378MA, expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for immunization which was expired (expired product administered) (latency: same day).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  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 the 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.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL (dose, route and lot # not reported) on 04-FEB-2009 and 27-APR-2009 and would like to receive the third dose on 05-JUN-2013. No adverse symptoms reported. Additional information has been requested.
Pruritic rash at both injection sites with scaling, lasted 6-7 weeks. Scaling still present on left arm at injection site.
I was achy like between my ribs were sore as if I had the flu; I was achy like between my ribs were sore as if I had the flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: EW0158) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (ongoing); "Anxiety" (ongoing). Concomitant medication(s) included: Trintellix taken for depression (ongoing); Hydroxyzine taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (First dose: , Time: 03:45 PM, Anatomical site of injection: Left Arm, Route of administration: Intramuscular , Batch/Lot number: ER8730, ), administration date: 24Mar2021, for COVID-19 immunization; Tdap (Anatomical site of injection: Left Arm), administration date: 31Mar2021, when the patient was 30 years old. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), MUSCULOSKELETAL CHEST PAIN (non-serious) all with onset 15Apr2021, outcome "recovered" (Apr2021) and all described as "I was achy like between my ribs were sore as if I had the flu". Therapeutic measures were not taken as a result of influenza like illness, musculoskeletal chest pain.  Additional information: A day after second shot, I was achy like between my ribs were sore as if I had the flu. After 24,solid 36 hours I felt completely fine.  No follow-up attempts are possible. No further information is expected.
significant pain and the injection site; swelling in her lymph nodes; rash at the injection site; injection site that is red; injection site that is itchy; weepy (rash); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red) and VACCINATION SITE PRURITUS (injection site that is itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Radical mastectomy. Concurrent medical conditions included Cancer. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red), VACCINATION SITE PRURITUS (injection site that is itchy) and RASH (weepy (rash)). At the time of the report, VACCINATION SITE PAIN (significant pain and the injection site), LYMPHADENOPATHY (swelling in her lymph nodes), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE ERYTHEMA (injection site that is red), VACCINATION SITE PRURITUS (injection site that is itchy) and RASH (weepy (rash)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
vomit 12 hours, nausia gradually decreasing, vertigo gradually decreasing, both still ongoing after 9 days
Sudden death.  Cardiomegally with four chamber dilation.  Histologic diagnosis of myocarditis.  At the time of this report toxicology is still pending.
He had fever on and off x 4 of 104, rash on shoulder 3x days. Decreased appetite.
Dehydrated; Tired; Shaking; Vomiting; Diarrhea; This spontaneous case was received on 22-Oct-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04102) and concerned a female patient. Discrepant information about the age was provided. Date of birth was reporter as the patient was 69-year-old, but it was also reported that the patient was 59-years-old.  The patient's medical history included thyroidectomy. The patient's concomitant medications included Synthroid (levothyroxine sodium), Wellbutrin (bupropion hydrochloride), both used for unreported indication.   On 20-Oct-2020, at 11:55 am, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left shoulder) for influenza prophylaxis. The batch number reported was 276557 and expiry date 30-Jun-2021.   On the same day, between 10:00 pm and 3:00 am, the patient experienced severe vomiting and diarrhea and shaking (three episodes), the patient contacted the pharmacy and reported that she never had a reaction to a flu vaccine.  On 21-Oct-2020, the patient felt tired and dehydrated.   On 22-Oct-2020, the patient recovered from the events felt tired and dehydrated.    The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A patient was administered Flucelvax QIV vaccine. On the same day, the patient experienced vomiting, diarrhoea and tremor. One day later, the patient developed fatigue and dehydration. The patient's medical history included thyroidectomy. The patient's concomitant medications included Synthroid (levothyroxine sodium), Wellbutrin (bupropion hydrochloride), both used for unreported indication. Concomitant medications may have contributed to development of the events. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related due to plausible chronology.; Sender's Comments: A patient was administered Flucelvax QIV vaccine. On the same day, the patient experienced vomiting, diarrhoea and tremor. One day later, the patient developed fatigue and dehydration. The patient's medical history included thyroidectomy. The patient's concomitant medications included Synthroid (levothyroxine sodium), Wellbutrin (bupropion hydrochloride), both used for unreported indication. Concomitant medications may have contributed to development of the events. However, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related due to plausible chronology.
Headache, inmobility of the arm where administrated, nausea, vomiting, diziness
pounding h/a, nausea, woozy, shoulder & neck tense;h/a lasted about 3hr other sx about 1hr;
Patient received 3rd dose of vaccine on 10/25 and experienced cardiac arrest and subsequently passed on 10/28.
Severe aches, malaise, and headache which began about four hours after the shot was administered and which lasted almost exactly 24 hours. Two days after that, mild stomach upset and malaise on and off for about three more days, then nothing.
SEVERE PAIN AND PER PT SHE WAS DIAGNOSED WITH SHINGLES OVER THE PHONE. BLISTERS ON NOSE
Patient presented to pharmacy one day after receiving Pneumovax-23 with a topical red rash on her bicep-area of the left arm.  No topical rash or any visible reaction within the area of the deltoid muscle, where the immunization was administered.  Patient verbally confirmed to pharmacist that the deltoid area of her arm where the immunization was administered did not hurt and was entirely unaffected.  She said that her bicep area was somewhat warm to touch and painful/tender.   Pharmacist advised that the patient closely monitor the site for any worsening of symptoms and to contact her primary-care physician for further evaluation/follow-up.  Pharmacist advised the patient to apply a cold compress to the site, keep the site elevated, and take an oral analgesic & antihistamine to help relieve pain and inflammation/rash.
could hardly get out of bed in the morning; muscular achyness, muscle pain; connective tissue disorder nos; stiffness in the shoulders, buttocks and upper thives; This spontaneous case was reported by a health care professional and describes the occurrence of CONNECTIVE TISSUE DISORDER (connective tissue disorder nos), MUSCULOSKELETAL STIFFNESS (stiffness in the shoulders, buttocks and upper thives), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could hardly get out of bed in the morning) and MYALGIA (muscular achyness, muscle pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE), MELOXICAM and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced CONNECTIVE TISSUE DISORDER (connective tissue disorder nos) and MUSCULOSKELETAL STIFFNESS (stiffness in the shoulders, buttocks and upper thives). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could hardly get out of bed in the morning) and MYALGIA (muscular achyness, muscle pain). The patient was treated with PREDNISONE for Pain, at a dose of 10 mg. At the time of the report, CONNECTIVE TISSUE DISORDER (connective tissue disorder nos), MUSCULOSKELETAL STIFFNESS (stiffness in the shoulders, buttocks and upper thives), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could hardly get out of bed in the morning) and MYALGIA (muscular achyness, muscle pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-246715 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2 days after administration developed large red raised welt size of 1/2 dollar no fever malaise or rash.
Fever, chills, nausea, SOB, cough, fatigue, headache. Cough and sore throat present at 1-month from time of vaccination.  Negative COVID-19 test, negative for other viral diseases
pt eyes rolled back & pt appeared to be unconscious x 2 episodes since getting the shots; when pt comes to pt cries unconsolably; mom reported pt had a 30 sec to 1 min stare in which pt looked unconscious, limp & lifeless & wouldn't respond
Increased temp 102, irritable, rash, diarrhea. Onset at 1:30 pm. Child was seen in ER in the evening of 8/13/15 and was sent home.
admitted w/ hematuria found to have IgA nephropathy confirmed on kidney biopsy; admitted w/ hematuria found to have IgA nephropathy confirmed on kidney biopsy; This is a spontaneous report from a contactable Physician. A 17-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 17-years-old intramuscular on Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation.  Medical history was none.  The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported.  The patient experienced admitted w/ hematuria found to have IgA nephropathy confirmed on kidney biopsy in Apr2021. History suggestive of symptom correlation with pfizer covid 19 vaccine doses. Pt first noted 1-2d hematuria immediatly after first dose. Sx resumed few days after second dose.  The patient was hospitalized for admitted w/ hematuria found to have IgA nephropathy confirmed on kidney biopsy for 5 days.  The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome was recovering.   Information about lot/batch number has been requested.; Sender's Comments: Limited information regarding patient medical history , any concurrent medical conditions ,family history of nephropathy ,clinical course of events and concomitant medications preclude a comprehensive causality assessment of event IgA Nephropathy and Hematuria post- vaccination.
recurrent urinary tract infections; sore arm; 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.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Jun2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cystocele" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, All of her previous 4 covid vaccines and boosters, the last one in June 2023, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 2, SINGLE, All of her previous 4 covid vaccines and boosters, the last one in June 2023, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm"; Bnt162b2 (DOSE 3(BOOSTER), SINGLE, All of her previous 4 covid vaccines and boosters, the last one in June 2023, have been from Pfizer and the most she got from them was a sore arm.), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "unknown", described as "sore arm"; URINARY TRACT INFECTION (non-serious) with onset 10Jul2023, outcome "unknown", described as "recurrent urinary tract infections". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: All of her previous 4 covid vaccines and boosters, the last one in June 2023, have been from Pfizer and the most she got from them was a sore arm.  She has been having recurrent urinary tract infections and has had one July 10, September 12 and September 27th.    The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Injection site (L leg thigh( became swollen, warm and hard at 8 hors post vaccination after Dtap.
Patient had immediate pain at injection site with radiating pain down the arm.  Then about 30  mins had iching all over her body with  hives and tingling around her lips.  Then  headache.  Then she began to have pain in her upper back that radiated through into her chest.   Was taken to ER and given additional Benadryl and Prednisone.  The following morning she is still itchy. Advised to f/u by phone with her PCP
swollen lymph nodes; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (Batch/Lot number was not reported), Solution for injection, via unspecified route of administration on 19Apr2021 (dose number: 02) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Apr2021, patient experienced swollen lymph nodes and had taken Tylenol and started putting warm compress since yesterday, but swelling was still the same. Patient wanted to know how long these symptoms can last and also if any medical treatment can be recommended. Representative stated that Swollen lymph nodes (lymphadenopathy), which generally get resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. Patient should always talk with a vaccination provider, doctor, or other qualified health care professional about whether a specific treatment or medication was right for you and before starting a new treatment or activity. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Macular rash along same arm as injection, spreading over arm for next 48 hours.