chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 02-APR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, (lot # N022728 with an expiration date in 31-MAY-2020), for prophylaxis, (dose, frequency and route were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815: US-009507513-1804USA003816: US-009507513-1804USA003817: US-009507513-1804USA003818: US-009507513-1804USA003819: US-009507513-1804USA003820: US-009507513-1804USA003821: US-009507513-1804USA003822: US-009507513-1804USA003823: US-009507513-1804USA003824.
pt recv vax 3APR95 & devel arthralgia, fever, h/a & upon return to US was found to have DM; 14JUN95 was given meds; also had LFT-has diabetes mellitus
For past two days since and continuing... fever (tmax 101.6) & GI upset. Diarrhea (frequency) , nausea, stomach pain, poor appetite. And arm pain.
severe migraine in the center back of my head and tinnitus; blood pressure is normally 105/62 and it was 144/98
Patient tested positive for COVID-19 on 7/26/2021 Seen in the ER on 7/29/2021 for a cough
On 12/5/03 received flu vaccine, "Aventis" left deltoid, lot #U1097AA, exp. 30-06-04, and that evening noted raised itchy areas on arm. Sat 12/6 increased areas noted on chest and back. Referred to RNNP, Tx allegra, Benadryl
Rash; Red; Slightly swollen towards the injection; Tender; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), RASH (Rash), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Slightly swollen towards the injection) and VACCINATION SITE PAIN (Tender) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Slightly swollen towards the injection) and VACCINATION SITE PAIN (Tender). On an unknown date, the patient experienced RASH (Rash). At the time of the report, VACCINATION SITE REACTION (Covid arm), RASH (Rash), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Slightly swollen towards the injection) and VACCINATION SITE PAIN (Tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she developed covid arm which was characterized by 2 inch circumference of red and round circle at injection site  Concomitant product use was not provided by the reporter.  Treatment information included antihistamine every night and antihistamine cream for rash.
"Blurry" vision at left lateral visual field brief and onset of headache in school 9/13/2006 am.  Visual changes resolved spontaneously, but headache intensified.  Headache resolved after treatment with ibuprofen.  Positive family history of migraines but no prior headache history in this patient.
received flu vaccine on 9/18/09. that same afternoon c/o itching. today (9/23/09)reports to health center c/o fine red rash and increase itching to neck, upper chest, ears and B/L forearms. Benadryl 25 mg po, benadryl cream, Medrol dose pak.
Information has been received from a physician concerning a 40 year old male who on 10/23/2001 was vaccinated with a dose of varicella vaccine. On 11/12/2001 the pt was presented to the physician's office with chicken pox. The pt had 20-30 lesions. There were no other symptoms reported. The pt sought unspecified medical attention. Additional info has been requested.
Nausea followed by heart palpitations; Nausea followed by heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 01:30 (as reported), the patient experienced nausea followed by heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea followed by heart palpitations was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
VARIVAX give 6/17/2016 - rash started 6/22/2016. Anytime varicella vaccine given-family members break out with rash.
got infected with COVID-19; got infected with COVID-19; difficulty of hearing; ears are stuffed up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group, Program ID: (172086). The reporter is the patient.  A 76-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single and as dose 4 (booster), single for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Lot number: FD8448) and as dose 2, single (Lot number: FP7138) for covid-19 immunisation. The patient's relevant medical history included: "Sinus infection" (ongoing), notes: Yes, I am on antibiotics because I have sinus infection. The patient took concomitant medications. The following information was reported: HYPOACUSIS (medically significant) with onset 2023, outcome "unknown", described as "difficulty of hearing"; EAR CONGESTION (medically significant) with onset 2023, outcome "unknown", described as "ears are stuffed up"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "got infected with COVID-19". The events "got infected with covid-19", "difficulty of hearing" and "ears are stuffed up" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood test: (Nov2023) Unknown results, notes: I had a blood test about may be two weeks ago. Therapeutic measures were taken as a result of drug ineffective, covid-19, hypoacusis, ear congestion with paxlovid. Clinical course: She mentioned that she has had the Pfizer COVID-19 vaccine in the past. She said the original one and two boosters and she reports that she's recently got COVID-19 infection and she was prescribed Paxlovid. Her ears are stuffed up from this virus as well and so she just turned on 76 and she was having a little bit difficulty of hearing. She said she was on antibiotics because she had sinus infection. So, she was on two kinds of antibiotics. She was on a lot. She had a blood test about may be two weeks ago. She met with her doctor this week and besides her normal little issues (Further clarifications unknown) he did not mention anything that is abnormal. She said got the first two that came out and she had two boosters. She asked if she need to take a third booster after having COVID.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381460 Same reporter/patient, different product/event;
Immediately after receiving the injection I had some vision changes.  Ignores it and went to my seat to wait the with the timer.  Approximately 5 to 7 minutes later, all of the joints on the left side of my body began I to hurt and my throat felt like it was starting to swell, so I got alarmed and I went to get the nurse.  The nurse immediately gave me two Benadryl tablets and when she checked my vital signs, my blood pressure was high, my heart rate had increased and my oxygen level had deceased.  As I waited to get in the normal range, I had a burning sensation on skin, I felt like someone was poking me with a needle,  itch and I felt like I was going to get hives, but never surfaced on my skin. I waited  a total of 45 minutes until all my levels were in the normal range and I was instructed to seek medical attention of I had a rash, hives, diarrhea or vomiting..
Swollen at injection cite, painful at touch, itchy, and hard at touch It is about four inches big, circular shape Only taken acetaminophen for arm pain
Vaccine given on 7/6/2021 which was day 35 in refrigeration. Vaccine was moved from freezer on June 1, 2021 and was labeled in refrigerator as hitting the beyond use date on July 1. This was an oversight on monitoring. Pfizer was notified and patient notified and counseled on next steps. No adverse events reported by patients prior to or after notification.
6OCT92 pt given vax & 12OCT came to clinic c/o intermittent low fever x 6 days; fever temporarily relieved by APAP; no signs of infection present; 16OCT92 PC to dad pt is ok now; no fever;
Nausea/vomiting, fevers, painful supraclavicular lymphadenopathy, body aches
Arm was swollen,sore immediately after injection. Patient has rash on torso, (front and back), in armpit and elbow.
About a month after the second dose, I began feeling fatigued, had swollen feet and ankles and a general feeling of being unwell. I went to the emergency room on June 1, 2021, where I was given a blood test, CT scan, and x rays. They discovered severe anemia and low iron and immediately admitted me to the hospital where I received two pints of blood and some other medications. I had a colonoscopy at the hospital on June 3 and sent home. I subsequently had two endoscopies, and all three tests were normal. Subsequently, I received two iron infusions. I have never had a history of anemia, nor had I ever needed a blood transfusion. I had another blood test on Feb 3, 2022--lower iron level.
Injection site was raised, red and hard, beginning one week after the 1st dose. The redness and hard bump were about the size of a half dollar and the spot itched, but wasn't uncomfortable. All symptoms have primarily gone away now, about 72 hours after it was first noticed. The spot is only very slightly red now.
Developed leg swelling; Had ascites; CT scan in Feb2022 showed liver cirrhosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 93-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 93 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (previous dose product=COVID 19, brand=Pfizer, brand unknown=False, lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion, dose number=2), for COVID-19 immunization; Bnt162b2 (product=COVID 19, brand=Pfizer, brand unknown=False, lot unknown=True, lot unknown reason=Not available/provided to reporter at the time of report completion, dose number=1), administration date: 2020, for COVID-19 Immunization.  The following information was reported: HEPATIC CIRRHOSIS (death) with onset Feb2022, outcome "fatal", described as "CT scan in Feb2022 showed liver cirrhosis"; PERIPHERAL SWELLING (death), outcome "fatal", described as "Developed leg swelling"; ASCITES (death), outcome "fatal", described as "Had ascites". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (Feb2022) liver cirrhosis, notes: CT scan in Feb2022 showed liver cirrhosis; SARS-CoV-2 test: (09Feb2022) Positive, notes: covid test type post vaccination=Nasal Swab. Therapeutic measures were not taken as a result of hepatic cirrhosis, peripheral swelling, ascites. The patient date of death was 13Apr2022. Reported cause of death: "Liver cirrhosis". No autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202200655288 similar report from same reporter; Reported Cause(s) of Death: Liver cirrhosis
This spontaneous report has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of M-M-R II, lot # N023024 with expiration date in 23-AUG-2019, and lot # N025895 with expiration date in 19-SEP-2018 (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. The vaccines was reconstituted with properly stored Merck sterile diluent. No adverse effects were reported. The vaccines were exposed to a temperature range between 47 degrees F to 77 degrees F during a time frame of 54.15 minutes, which was called by a data logger. No previous temperature excursions.
Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 08-Nov-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 08-Nov-2021) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 08-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 03-Oct-2021 and then stored in refrigerator on 08-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 08-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Fevers of 102...general severe body aches, nausea, headache, felt some difficulty breathing. Symptomatic tx for fevers, po fluids (also treated with antibiotics for otitis media.
Breakthrough case of COVID sx onset 05/04/2022 Began with cough, congestion, nose which was continuously running nonstop, and I was tired. I had some serious aches and pains, that went away after starting the Paxlovid. Most of the sx I had were things I have had, only more.  I started Paxlovid 05/06/2022 and once I finished, I was still tired. I would think I was okay, and I wasn?t. I still had a light cough. The fatigue has since subsided.
7JUN t101.0-104.5; 9JUN temp @ 430 103.4; clinically looked well; no source of fever detected; 10JUN temp101;
Localized reaction- redness, swelling, itchy. L, warm to touch. Treated with cortisone cream
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
Five days after getting the first dose of Covid vaccine, I started having severe pain in buttocks/hip area that radiated down both legs. I tried sitting, standing, laying, propping, etc. Nothing relieved the pain! It lasted about 6 hours. I mentioned this episode to my General Practitioner during a virtual visit a couple of weeks later. Since then, I've had almost constant severe joint and muscle pain throughout my body every day. I plan to talk to my doctor about this at my next visit.
Onset of diffuse itchiness starting about 3 - 4 days after second dose of Pfizer. No reaction with first dose. Itchiness was severe enough to wake me up at night. Also developed small discrete rash on arms.  Treated at home with antihistamine. Resolved in one week.
Pt reports onset of lower ext soreness, swellness, extreme fatigue, chills with fever, aches onset eve of vaccine administration. Preceded by h/a, facial pressure, congestion in morning prior to vaccine. Sx lasted thru 2/16 - seen at PCP office 1/16 who did not tx or dx but told her to report to facility who gave vaccine.
The patient passed out shortly after receiving the vaccine. The patient was talking and looking around shortly after passing out and the paramedics were called as a precautionary measure.
No adverse event; Patient administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient 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 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient administered with doses of 0.25 mL instead of 0.50 mL of  bivalent booster).    No concomitant medication details was reported.  No treatment medication details was reported.
5/23/09 - chest & back rash red, bumps mild itching x 1 1/2 hrs without fever, general malaise saw MD 5/23/09. 6/1/09 Blood work showed low white blood cell count. Rash resolved now have flu like symptoms with partial recovery.
Presented to ED w/SOB; admitted for COPD acute exacerbatin and COVID-19; tx with O2, steroids, DuoNeb, Brovana, Pulmicort Respules, mucolytic and antitussives; all symptoms resolved and pt returned to baseline 3L O2 for home
Patient received Flucelvax on 10-18-19. Within 3 days, his mobility & energy declined significantly. His Md believes that it triggered a relapse of Lyme disease contracted in 1997.
Patient came to clinic on 8-17-09 complaining of rash on body.  Was examined by attending Dr. who is an infectious disease doctor and it was determined that the patient had a measles rash.  There were no major concerns about the child's health.
Information has been received from a registered nurse concerning a 22 year old female, who on 05-OCT-2007 was vaccinated with Gardasil vaccine (lot number "1062U"). On 27-OCT-2007, the patient received her second dose of Gardasil vaccine. Concomitant therapy included Ortho Tri-Cyclen Lo. The registered nurse reported that on approximately 05-OCT-2007, the patient's arm was swollen and sore since the vaccination and there was a persistent collection of fluid at the injection site. She confirmed that the vaccine was administered in the deltoid muscle (IM) and that the patient was evaluated by several other physicians (at other offices), one healthcare professional stated that the site looked as if fluid needed to be withdrawn. Subsequently, the patient was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007; 1/17/2008. Initial and follow up information has been received from a registered nurse and the doctor's office concerning a 22 year old female who on 03-OCT-2007 (previously reported as 05-OCT-2007) was vaccinated IM into left deltoid with a first dose of GARDASIL vaccine (lot # 658560/1062U). On 27-OCT-2007, the patient received her second dose of GARDASIL vaccine. Concomitant theraphy included ORTHO TRI-CYCLEN LO. The registered nurse reported that on approximately 05-OCT-2007 the patient's arm was swollen and sore since the vaccination and there was a persisitent collection of fluid at the injection site. She confirmed that the vaccine was administered in the deltoid muscle (IM) and that the patient was evaluated by several other physicians (at other offices), one healthcare professional stated that the site looked as if fluid needed to be withdrawn. Subsequently, the patient was recovering. In follow up information from the doctor's office it was reported that the patient called on 10-OCT-2007 with complain of left deltoid injection site swollen and reported that as if fluid was collected at site. It was reported that the site was very tender. The patient recovered on an unknown day. Additional information is not expected.
Rv day vaccine at 9:25pm and starting having symptoms around 10am next day. Body aches, headache, chills, lethargy, fatigue.  Finished AM work (substitute teaching) and then came home. Minimal appetite: stuck to diet, slept 2.5 hours. Have taken 3 Advil at 4pm.
Information has been received from a health professional concerning a patient in the third grade who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.