chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 75 year old female patient with thiazide diuretic allergy. The patient had no pertinent medical history. On 08-OCT-2013 the patient was vaccinated with PNEUMOVAX23 (lot # H022280), Exp date: 16-JUL-2014), 0.5 ml, intramuscular in the right deltoid. Other suspect therapy included FLUVIRIN, dose, frequency, lot # and route unspecified, on 08-OCT-2013 in the right deltoid. There was no concomitant medication. The pharmacist reported that the patient was unsure if she had ever had PNEUMOVAX23 in the past. The patient reported that shortly afterwards, her arm felt "hot to the touch" and the "top of her arm was whiter than normal and the underside of her arm was very red". The patient reported that her arm was painful when she tried to lift it, and that it "felt full". The patient also reported fever and chills and dizziness and on 13-OCT-2013 she had a fall. The patient's injuries were unspecified, but the patient reported to the pharmacist that she was seen by her physician and that she did go for an Magnetic Resonance Imaging (MRI), but no result provided. No treatment was given for these events. Patient sought medical attention via office visit. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Extreme chills, fatigue, stomach pain, diarrhea, aches in joints, pt used heating blanket and is going to take Tylenol
12/18/20 Pfizer Covid vaccine 1/7/2021 Pfizer Covid vaccine 8/10/21 ill 8/16/21 + Covid PCR 8/21/21
Information has been received from a health professional concerning a 15 month old female who on Nov 18 2005 was vaccinated with a 0.5ml dose of varicella virus vaccine live (lot 646669/0626R). Concomitant vaccinations that day included a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) and a dose of influenza virus vaccine (unspecified). On Nov 19 2005 the patient developed cellulitis at the injection site with a pea sized lump at the center. The patient went to an urgent care  clinic on Nov 19 2005 and was treated with cephalexin (Keflex). Over the next week the lump tripled in size and started to itch. The child was taken back to the urgent care clinic and placed on sulfamethoxazole (+) trimethoprim (Bactrim). The child was assumed to be recovering. There was no product quality complaint involved. The patients adverse experiences were considered to be other important medical events (OMIC). Additional information has been requested.
The morning following vaccine left arm was in extreme pain. Could not move it and bruising formed at injection site. Brushing continued to spread. Monday morning pain had receded, and the bruise had stopped growing.
Information has been received from a Doctor of Pharmacy (PharmD) concerning a 66 year old male who on 02-OCT-2006 was vaccinated with a 0.5 mL dose of Pneumovax 23 (Lot # 654593/0358F). On the same day of the vaccination (02-OCT-2006), the patient reported that 2/3 of his left arm was swollen and red. On 03-OCT-2006, by the next day, the patient's arm was swollen from the elbow to the shoulder. The patient sought unspecified medical attention. At the time of this report, the outcome was  unknown. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of abscess leg in a patient who received KINRIX (batch number D592C, expiry date 29th September 2017). On an unknown date, the patient received KINRIX. On an unknown date, less than a day after receiving KINRIX, the patient experienced abscess leg (serious criteria GSK medically significant), allergic reaction, throat irritation, generalized rash, cough and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the abscess leg, allergic reaction, throat irritation, generalized rash, cough and pruritus were unknown. It was unknown if the reporter considered the abscess leg, allergic reaction, throat irritation, generalized rash, cough and pruritus to be related to KINRIX. Additional details were provided as follows: The reporter stated that 2 patients received KINRIX and experienced allergic reactions. The patient experienced scratching of throat, abscess on right leg, rash on entire body and coughing. The patient was kept in clinic for 3 hours until side effects subsided. The patient was treated with BENADRYL 5 ml. The reporter had minimal information. These were reports from other offices. She believed even though they were indeed KINRIX. She felt as though there was a mistake and this was not KINRIX. This case was linked to case US2016GSK093516 as reported by the same reporter.
Information has been received from a physician concerning a 16-year-old female patient with no medical history who was vaccinated with the second dose of GARDASIL. Concomitant therapy included Depo-Provera. A week or two after the second dose of GARDASIL the patient developed idiopathic thrombocytopenic purpura and was admitted to hospital and given intravenous immune globulin (IVIG) 2 doses. The following lab diagnostics studies was performed: Complete blood count, Comprehensive Metabolic Panel, Antinuclear Antibody Test, serum complement C3/C4 ratio, Immunoglobulin A, Bone marrow biopsy. The patient has been discharged. The patient's idiopathic thrombocytopenic purpura was considered to be disabling and an other important medical event. The patient had not been recovered. Additional information has been requested. 6/22/09-records received for DOS 5/28-5/30/09- DC DX: ITP status post 2 doses of IVIG with slight improvement of platelet count. Presented with newly diagnosed ITP with mild bruising. ICD-9 287.31.
Got very sick; cold not eat; loss sense of taste; legs really weak; Hard time walking; feeling misearable; situation was not fun; scared to death; Fever 103F; loss sense of smell; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ILLNESS (Got very sick), FEEDING DISORDER (cold not eat), AGEUSIA (loss sense of taste), ANOSMIA (loss sense of smell) and RESTLESS LEGS SYNDROME (legs really weak) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 22-Jul-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2020, the patient experienced ANOSMIA (loss sense of smell). On 25-Jul-2020, the patient experienced ILLNESS (Got very sick), FEEDING DISORDER (cold not eat), AGEUSIA (loss sense of taste), RESTLESS LEGS SYNDROME (legs really weak), GAIT DISTURBANCE (Hard time walking), FEELING ABNORMAL (feeling misearable), ANXIETY (situation was not fun; scared to death) and PYREXIA (Fever 103F). In August 2020, ILLNESS (Got very sick), FEEDING DISORDER (cold not eat), AGEUSIA (loss sense of taste), ANOSMIA (loss sense of smell), RESTLESS LEGS SYNDROME (legs really weak), GAIT DISTURBANCE (Hard time walking), FEELING ABNORMAL (feeling misearable), ANXIETY (situation was not fun; scared to death) and PYREXIA (Fever 103F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt received 1st dose Moderna about 3:30pm on 4/7/21, by midnight pt began experiencing nausea, vomiting and fever. Symptoms worsened each day following and began showing signs of jaundice on 4/10. Pt went to ER on 4/11 and was admitted to the hospital for elevated liver tests (inflamed liver) and dehydration. Pt remained in hospital until 4/16, and will follow up with PCP on 4/30 for blood work.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left 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. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive; (12Jul2022) Negative, notes: tested negative on 12Jul; (19Jul2022) Positive, notes: tested positive again 19Jul and 20; (20Jul2022) Positive, notes: tested positive again 19Jul and 20. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Patient took paxlovid starting 07Jul after being diagnosed with Covid on 06Jul. Patient quickly felt better and tested negative on 12Jul. Patient finished her course of paxlovid on 13Jul. Patient began having symptoms again on 19Jul. Patient tested positive again 19Jul and 20.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
16 days of diarrhea beginning at 5 pm May 27 and ending 12pm June 12, 2021. During that time I had received testing at (ER), PCP ordered tests (Marjan Narghi-Arani DO) and more tests from Gastroenterology MD.  All stool tests came back negative.   Since the event subsided I have been experiencing bowel issues including abnormal constipation and occasionally tearing of the anus upon exit of the bowel movement causing blood. Ive had constipation before and changed my diet which relieved the constipation. I was not constipated at all for many months until after the diarrhea event and have been struggling with it since. Ive waited to contact CDC because I was hoping the feelings in
The pt experienced a several minute generalized tonic/clonic seizure with post-ictal period. Taken to the ER. The pt was febrile at the time. The pt had a positive exposure to varicella. The pt now has pox on 6/11/01.
Discharge Date: 7/18/2022  PRESENTING PROBLEM: Intractable nausea and vomiting [R11.2] Non-intractable vomiting with nausea, unspecified vomiting type [R11.2] COVID-19 virus infection [U07.1]   HOSPITAL COURSE:    very pleasant 94 year old gentleman with past medical history reviewed and noted who presented with intractable n/v/d and was found to have covid 19 and mild diverticulitis with possible aspiration. Patient did not require supplemental oxygen and did not need additional treatment for COVID 19.  His n/v/d improved however he found to be possibly aspirating . Speech pathology recommended dysphagia three diet but patient declined.  Patient and family aware of risks of aspiration with a general diet and understand risk of aspiration pneumonia leading to sepsis leading to death.  Patient was discharged home in stable condition.
Broken leg; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of LOWER LIMB FRACTURE (Broken leg) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced LOWER LIMB FRACTURE (Broken leg) (seriousness criterion medically significant) and COVID-19 (COVID-19). At the time of the report, LOWER LIMB FRACTURE (Broken leg) outcome was unknown and COVID-19 (COVID-19) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication were reported.  Company Comment: This spontaneous case concerns an adult female patient (age not specified) with no medical history reported, who experienced the unexpected serious (medically significant) event of Lower limb fracture and unexpected non-serious AESI of Covid-19 unspecified days after a dose of mRNA-1273 vaccine (dose number not specified). No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event Covid-19 was reported as not resolved and the event Lower limb fracture reported as unknown. Current ongoing pandemic of Covid-19 could be confounding for the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient (age not specified) with no medical history reported, who experienced the unexpected serious (medically significant) event of Lower limb fracture and unexpected non-serious AESI of Covid-19 unspecified days after a dose of mRNA-1273 vaccine (dose number not specified). No further details on clinical course, other lab test results and treatment received were reported. The outcome of the event Covid-19 was reported as not resolved and the event Lower limb fracture reported as unknown. Current ongoing pandemic of Covid-19 could be confounding for the event Covid-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
09/05/21 I woke up at 230 am with left rib and shoulder pain.  This pain was a radiating, sharp pain. I went to an urgent care clinic that diagnosed it as a pulled muscle. This pain resolved on 09/10/21. On 09/11/21 while sleeping I woke up to a more sever pain that was moving from my rib around my left breast. This pain resolved on 09/18/21. On 9/20/21 a different left rib started having the same symptoms.  I went to the urgent care again on 09/20/21, they did an EKG and it came back abnormal. I went to the emergency room for treatment and was diagnosed with pericarditis. All three events were on the left side with the same pain as described. This pain increases when I lay down or take a deep breath. I still have pericarditis and am taking 600mg of ibuprofen every six hours for 14 days in hopes that it fully resolves. I will be getting an echocardiogram to see the severity of the pericarditis.
Awoke at 2:30 with extreme chills, teeth chattering, fever, severe body aches and severe fatigue; it hurt to move. I had a severe headache that would not be relieved with 500mg. of Tylenol every 5 hours. The next day I also had nausea and fever and continued fatigue and pain, so that I slept for 24 hours with only fluids and fruit. Muscles were tense and achy for 18 hours. Also had heart racing and racing thoughts during the night. Extremely uncomfortable. I had no reaction with the first dose.
Erythema and swelling to right deltoid/PAC gave pt. BENADRYL, Ibuprofen and KEFLEX.
Developed soreness in L arm at injection site that has persisted since. Now 5 weeks post vaccination and still with discomfort. Of note, also received immunotherapy from his allergist in L arm. Had at least 2 and maybe 3 immunotherapy injections since receiving his 2nd SHINGRIX.
Suspected anaphylaxis:  Client vaccinated at 10:48am. Sat in wait room area for brief time, then out to car in parking lot. Client experienced dry mouth, raspy voice, cough & continued clearing of through. Sat and drank water in car for 40 minutes. Came back into clinic at 11:35 to report symptoms. No SOB noted; regular respirations; mild anxiety noted. VS @ 1143am:  BP 138/98, P 68, R 16. Client continually observed. No improvement in dry mouth,  raspy voice, cough & continued clearing of throat. Client continually observed.  EMS called at 1210p for further assessment of possible anaphylaxis. VS @ 1215p:  BP 150/100, P 70, R 18. EMS arrived and recommended transport to local ED for further assessment. Client transported at 1225pm from clinic.
Patient received her 1st dose of the Moderna vaccine over 92 days ago (14APR2021); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose of the Moderna vaccine over 92 days ago (14APR2021)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose of the Moderna vaccine over 92 days ago (14APR2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose of the Moderna vaccine over 92 days ago (14APR2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received: reporter contact details updated
bacterial infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: BACTERIAL INFECTION (non-serious), outcome "unknown", described as "bacterial infection". Therapeutic measures were taken as a result of bacterial infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date, single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced flu like symptoms and blister around his lips after taking this vaccine on an unspecified date with outcome of unknown. Follow-up (08SEP2015): Follow-up attempts completed. No further information expected.
Sunday evening developed lower pelvic pressure which continued to Tuesday. Called my OB MFM office and was instructed to come in for a check up. I am currently 18wks 4 days (was exactly 18 weeks on date I received  dose 2).  At the OB MFM  clinic I was discovered to have a shortened cervix of 2cm. I did not have this occur in my prior term pregnancy.  Although there may be no causal link I felt it important to report as there may be an association with the vaccine and  cervical length/risk of preterm delivery.
Information has been received from a 71 year old female retired nurse with drug reactions/allergy to shellfish, penicillin, ANCEF, ROCEPHIN, CIPRO, vancomycin, other antibiotics unspecified, morphine, DILAUDID and iodine, who on 01-OCT-2009 was vaccinated subcutaneously with a single dose of PNEUMOVAX 23. Concomitant therapy included VIACTIV SOFT CALCIUM CHEWS, vitamin D (unspecified) and aspirin. The nurse reported that she received PNEUMOVAX 23 and experienced a rash and hives on both arms, stomach and both legs and pain at the injection site. On 04-OCT-2009 the patient recovered from all symptoms. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow up information has been received from the physician who reported that the patient had a significant allergy to iodine and all antibiotics except erythromycin. On 01-OCT-2009 the patient was vaccinated intramuscularly in the right deltoid with a dose of PNEUMOVAX 23. The patient experienced urticaria and recovered on 03-OCT-2009. No further information is expected.
pt recv vax;devel rash;devel vesicular lesions on buttocks & abd;
After taking the vaccine she started having a urinary tract infection. Coughing up blood an mucus together. Went to the dr
MMR, Varicella and Hep A all given at 2 months instead of at 1 year.
Patient received Pfizer covid vaccine instead of flu vaccine.  Left message for patient to call pharmacy. Patient not aware yet.
ON 11/20/07 MMR GIVEN IN LEFT THIGH AND INFULENZA AND HEP. A GIVEN IN RIGHT THIGH.  MOTHER STATED BABY DEVELOPED FEVER-101 AND A COMPLETE BODY RASH ON 12/02/07.  WENT TO SEE HER PEDIATRIC MD, AND SHE STATED THAT THE BODY RASH WAS POSSIBLY FROM THE MMR.  MOTHER CAME IN TODAY FOR THE 2ND FLU INJECTION AND INFORMED ME OF THE ABOVE.
The next day after vaccine administration, patient had fever of 103 F. He then broke out in a full body rash (diffuse maculopapular) 3 days after vaccine administration. (+) Pruritus. Office visits 4/3/17-UA, rapid strep were negative. Rx'd Prednisone and BENADRYL. 4/5/17-50% improvement in rash Rx'd CLARITIN x1 mo. 4/19/17-Doing well, no residual symptoms.
About 10 days after the 2nd dose, I began experiencing GI issues including bleeding, irritable bowels which lasted about two weeks. Around the end of July, the same symptoms started up again except more severe. I went to see my PCP in Aug who referred me to a specialists whom I saw in Sept. In November, I was diagnosed w/ulcerative colitis. They provided hydrocortisone enemas and tablets. In Jan, I had a bad fever which triggered a severe incident of diarrhea which lasted for 2 weeks so they put me on prednisone which I'm still taking. They symptoms didn't change/worsen after my 3rd dose.
Pain in left armpit about 12 hours after vaccination. Felt swollen and tender. About 2 weeks after vaccination all another vaccination symptoms were gone but still felt slight discomfort in arm pit.  Symptom continued and started to become more annoying/noticeable as it never went away. It has been 3 months since vaccination and issue still persists.
Left arm is very sore, and swollen with a large red area that is warm to the touch.
Numbness in left arm right after receiving the booster lasting all day and through the night. The next morning numbness and tingling in right hand and lower arm and occasionally right and left leg lasting all day the second day after reciting the booster. Third day after, slight tingling in right hand.
It was discovered during medication count that a extra dose of HIB and Polio were given to the patient. The injections were recorded on the system and checked off by 2 other staff. They were not scanned into computer before giving, which would have caught the error. Provider contacted patient mother ,Patient mom informed. No questions for provider. Questions answered. Nothing additional.
breathing problems, cough, fever, chills, body aches, fatigue, shortness of breath
Soreness, bright redness, and slight swelling for five days. Applied antibiotic cream and it took three more days for symptoms to disappear.
Administered Novartis H1N1 (4 yrs & older) vaccine 0.25 mL IM right deltoid.  Should have given Sanofi Pasteur H1N1 (6 mo & older) 0.25 mL IM.  No signs or symptoms distress noted.