chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported.; patient was administered a dose of improperly stored ROTATEQ; patient was administered a dose of improperly stored ROTATEQ; This spontaneous report as received from a medical assistant refers to a 9 week old male patient. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 07-NOV-2019, the patient was vaccinated with a dose (1 dosage form) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot #R033252, expiration date 29-JUN-2020 (anatomical location was unknown) for prophylaxis (product storage error). On 11-MAR-2020, the patient was vaccinated second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The vaccine was exposed to above 47 Fahrenheit scale (52F) for the time frame of 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was filed.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003851: US-009507513-2005USA003275: US-009507513-2005USA003150: US-009507513-2005USA003276: US-009507513-1911USA003851:
pt recv vax; itchy rash on shoulders, back, arms; started as fine red rash; welt type rash;
Discharge Provider: MD Primary Care Provider: PA-C Admission Date: 9/18/2022 Discharge Date: Sep 25, 2022  PRESENTING PROBLEM: Intra-abdominal abscess  Enterocutaneous fistula  COVID-19    HOSPITAL COURSE:  54-year-old female with multiple intra-abdominal surgeries most recently an open enterocutaneous fistula takedown, repair of enterotomy, incision and drainage of right abdominal wall abscess and repair of duodenum on 7/21/2022 who is presenting with recurrence of her enterocutaneous fistula and intra-abdominal abscesses,  now s/p wound exploration and debridement on 9/20/2022 with Dr.     9/18: Admitted, bedside I&D of right abdominal abscess  9/19: febrile overnight, ID consulted, IR planning drain today, NPO, +BM, 1L bolus for hypotension 9/20: No drainable collection per IR. Dressing changes. Consider TPN. Wound explored in the OR on 9/20/2022 with placement of malecot drain in the right abdominal wall abscess. Wound manager on the superior aspect of the midline. 9/21:  Tolerating general diet.  Malecot drain in right side - minimal output.  Changed packing this morning near wound manager. 9/22: Tolerating general diet. Malecot drain in place with minimal output. Having BM and good UOP. Pain well controlled.  9/23: Dizziness/lightheadedness. Symptomatic. Nauseated. BM and voiding. Taking in PO intake. Still requiring IV dilaudid for dressing changes 9/24:  Still endorsing weakness and heaviness with no appetite though 2200 mL oral intake recorded.  Heart rate improved.  Still up ambulating.  Requiring IV Dilaudid for dressing changes.  IV pain meds discontinued.  Loose stools, C difficile pending 9/25:  Pain significantly improved with dressing changes.  Improved appetite without nausea or emesis.  Up ambulating frequently.  He feels comfortable doing dressing changes at home by herself.  Ongoing loose stools, C difficile pending.  Anticipate will initiate today really today and likely discharge home
Numbness and tingling in R side of face and R arm. Lasting 2+ days but improving over time. No treatment only diagnostic tests, all negative so far.
patient presented to emergency department on 10/20/21 with abdominal pain, cough and congestion patient was admitted for further management of covid-19 infection patient took a home covid test and said it was positive on 10/19/21 patient did not require treatment for symptoms associated with covid-19  patient was discharged to home on 10/25/21
Essentially I threw a blood clot after having the booster. About three weeks after getting the booster, I noticed that I was having swelling in my right calf- I did not think it was related to the vaccine as I was having backpain. I saw my doctor and they stated that it was not related to the back pain so I went to a specialist. I ended up seeing them for the swelling and she put me on an anticoagulant medication. I was concerned because this periodic swelling continued in my right calf for the next few months. I experienced what I thought was pulling a muscle in my left knee and this led to me being unable to walk and extreme pain. I followed up with my hematologist and again, we said that the swelling was not normal so I saw another specialist on and had an MRI and Ultrasound 3/18- DVT detected in the right leg. This has led to many ER trips and visits as well. I saw a vascular specialist and we concluded there may be another clot and that this would be related to the booster since nothing else had changed that would have led to this occurring.
no additional adverse events reported; Proquad that was administered improperly stored; This spontaneous report was received from a Certified Medical Assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 20-SEP-2021, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # T027115, expiration date 07-FEB-2022 (formulation, strength, frequency, route of administration, were not reported) for prophylaxis. No additional adverse events reported.  On an unknown date, the temperature excursion was 8.5 (6 to 14) degrees Fahrenheit, for a time frame of 18 minutes and 11.9 (6 to 14) degrees Fahrenheit for 1 hour. There was no previous temperature excursion. The digital data logger was involved.
This spontaneous case reported by a consumer, describes the occurrence of rhinorrhea (runny nose) and vaccination site pain (pain around the injection site for three days) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 032MIVA) for COVID-19 vaccination. No reported medical history. On Mar 17, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 20, 2021, patient experienced rhinorrhea (runny nose). On an unknown date, patient experienced vaccination site pain (pain around the injection site for three days). On Mar 25, 2021, vaccination site pain (pain around the injection site for three days) resolved. At the time of the report, rhinorrhea (runny nose): resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication reported.
chills; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills) and MYALGIA (Body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and High cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Fever). On 13-Mar-2021 at 3:00 AM, the patient experienced CHILLS (chills) and MYALGIA (Body aches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. On 14-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, CHILLS (chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101 (High) 101 degrees Fahrenheit and 104 (High) 104 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included unspecified high blood pressure medication and an unspecified cholesterol medication.   Treatment included aspirin for the fever.
Rash x 1.5 days. No fever, diffuse rash face, trunk, arms.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. It was unknown, whether the patient had any concomitant therapies, pertinent medical history or known drug reactions or allergies. On unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M003659, expiration date: 20-SEP-2017, (dose and route of administration were not provided). No information whether any adverse event occurred was provided. Administered doses of vaccines experienced a temperature excursion of 25 degrees Fahrenheit for 7 days. There were no previous temperature excursions. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported that she received Covid 19 vaccine 2 weeks after receiving a steroid injection for O.A. of the spine and hips.  She woke up during the night following the vaccination w/ terrible burning pain in her hips and buttocks.  The pain subsided after 1 day.  She also reported intermittent nausea w/ one episode of vomiting over the few days following the vaccination.  Patient reports that she continues to feel tired and "very stiff" since the vaccine, commenting that she is "worse off" now than she was before receiving the vaccine.
This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4164537-00 (RA).  A 24-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Jul2021 (Batch/Lot number: unknown) at the age of 24 years as dose 2, single and intramuscular, administration date 04Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous, administration date Sep2021 (Batch/Lot number: unknown) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown", described as "Lack of drug effect". The action taken for adalimumab was temporarily withdrawn on Sep2021. The reporter's causality for the event(s) of HUMIRA WAS NOT WORKING was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.   The reporter considered "lack of drug effect" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per information, the causal association between the event THERAPEUTIC PRODUCT EFFECT DECREASED and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Swelling redness, warm to touch, tender to touch: injection site, varicella vaccine, right arm.
Broke out in hives all over body 10 days after injection. Not cleared up by anti-histamines.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAR-2014 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5ml dose (HSA, lot # H014989, expiration date 10-AUG-2014, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion for four times. The total cumulative excursion time of the first time was 144 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the second time was 312 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the third time was  48 hours with the lowest recorded temperature of 6 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the fourth time was 112 hours with the lowest recorded temperature of 8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse referring to a 6 month old patient of unknown gender. On 03-AUG-2015 the patient was vaccinated with ROTATEQ (oral, lot # K022990, expiration date and dose were unknown) which excursed the storage temperature. No reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Admitted: 10/2/2023 Discharge Date: 10/05/23    PCP Handoff    Recommended Outpatient Testing Follow-up with PCP in 1 to 2 weeks   Results Pending At Discharge    Blood Culture Aerobic/Anaerobic Preliminary result Blood Culture Aerobic/Anaerobic Preliminary result      Clinical Summary   Patient is a 87 y.o. female patient of MD with history of C. Diff, HTN, HFpEF, COPD, CVA, seizure disorder presented to Hospital with cough and shortness of breath.   Acute respiratory failure with hypoxia COPD with possible exacerbation Suspected secondary to recent COVID-19 infection, possible developing secondary lung injury versus secondary bacterial pneumonia. Had COVID symptoms in early September, treated with Paxlovid though was never tested for. COVID (husband tested positive) and did improve with worsening over 5 days prior to admission Treated with medrol dose pack and azithromycin as outpatient without improvement prior to admission. CTPA on admission with interstitial and ground-glass infiltrates are most pronounced in the right lung; bilateral bronchial wall thickening is suggestive of bronchitis. Respiratory PCR,urinary antigens for Legionella and strep pneumo--unremarkable except for COVID. Given levaquin in ED, transitioned to ceftriaxone/azithromycin given higher risk of C. Diff with flouroquinolones.  With patient having diarrhea, discontinued Rocephin and continued azithromycin.  Continued Zithromax to complete the course at discharge. Started decadron for COVID and COPD exacerbation and continued at discharge. Checked O2 requirement prior to discharge.  Qualified for 2 L of oxygen ATC. Patient to follow-up with PCP in 1 to 2 weeks     Recent COVID-19 viral infection Date of onset of symptoms: early September initially, then improved, then 5 days prior to admission Symptoms present on admission: shortness of breath, cough Date of covid positive test: was not tested in early September but treated with Paxlovid due to husband being positive; tested positive on admission 10/2 Vaccination status: vaccinated Imaging: CTPA as above Oxygen requirements on admission: 2L Current oxygen requirements: RA Medical therapy: steroids Consultants following: n/a Anticipated special isolation end date: given unclear timing, remain in isolation 5 additional days   History of recurrent C. Diff infection With prior fulminant infection in Sep 2022, prior FMT Prophylactic PO vancomycin while on antibiotics Patient started having diarrhea in the hospital but stool C. difficile negative   Chronic anemia Baseline hemoglobin 9 to 10 g/dL Admit Hb 9.2> 8.2 most likely due to hemodilution On B12 and iron supplementation   History of CVA With some residual left sided weakness Continue home plavix and statin   Seizure disorder Continue home Keppra   HTN Home Rx: Lisinopril 5 mg daily.  BP was running low.  Discontinued lisinopril.  May restart as an outpatient based on BP readings   HFpEF, chronic Continue home furosemide 20 mg daily
Swollen neck from the side where I had the shot. Pain in my neck and headaches dizziness
Major body aches; Dose received: 3; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A male patient of unspecified age received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  It was unknown if the patient received any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 05Oct2021, the patient experienced major body aches. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event major body aches was unknown at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Broke out in hives on back of both thighs, back of both arms, and both hands.  Itchy...Took 2 doses of Benadryl at home with little relief.
Reported large nodule in arm at vaccination site; nodule increased in size and effected the left side of the neck and shoulder.  Reported inability to lift arm and turn neck; pain; inflammation; stiffness.  Flu shot recieved at work as part of staff vaccination program and it was reported as an on the job injury.
After the  vaccine 30-40 mins driving home felt weird tingling in right arm. The tingling went to shoulder later that day. Then on 1/17 I exp fatigue, shaking and still exp tingling in right arm/fingertips after 12 hours.
Patient presented with copious rash on the left arm, more prominent around the injection site that occurred 10 minutes after the administration of the vaccine. 25 mg of diphenhydramine IM were administered. Patient recovered after 15 minutes after the diphenhydramine was administered. Patient was observed for 1 hour.
I fell down and I started to bleed and I had some swelling; I fell down and I started to bleed and I had some swelling; Two medications are overlapping; I fell down and I started to bleed and I had some swelling; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose single for covid-19 immunisation. Medical history included Haemophilia type A ongoing. The patient's concomitant medications included antihemophilic factor, human recombinant (ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT), (Batch/Lot number was not reported) to an unspecified date, for factor viii deficiency.  It was reported that, Consumer stated, that took the second dose for the Pfizer Biotech dose, and second dose was at the last Sunday. However in the next few days had to take my own Pfizer antihemophilic factor recombinant because had a Haemophilia type A and just wanted to know if there is any complex with taking both the dose in short period of time because recently had to take the Antihemophilic Factor 8 because fell down and started to bleed and had some swelling and have not seen that much complex and she wanted to know two medications are overlapping or there is anything to worry. The out come of the events was unknown  Information about lot/batch number has been requested.
three children received a dose of the V ARlV AX that was stored out of recommended temperature range; This spontaneous report was received from the office manager and refers to an infant patient of an unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On 31-AUG-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml, lot # R035226 and expiration date of 04-DEC-2020 (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 57.9 Fahrenheit (F) for 49 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2009USA001387: US-009507513-2009USA001758:
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was administered the first dose of GARDASIL series on 15-MAY-2008, the second dose of 03-NOV-2011 and the third dose on 08-AUG-2013. No adverse effects were reported. The patient did not seek medical attention. Additional information has been requested.
Fatigue; vomiting; This is a spontaneous report from a contactable consumer. A 26-year-old female patient (non pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 at the age of 26-year-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue and vomiting on 06Apr2021 21:00 with outcome of recovered on an unspecified date in Apr2021. No treatment was received for the adverse events. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  No follow-up attempts are possible, information about batch number cannot be obtained.
I have been getting headaches daily; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jun2021 15:00 (Lot number: EW0191) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfur, reaction(s): "Drug allergy", notes: Known allergies: Sulfur; Naproxen, reaction(s): "Drug allergy", notes: Known allergies: Naproxen. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0171; Anatomical site: Arm Left; Administration time:15:30), administration date: 16May2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 06Jun2021 16:00, outcome "not recovered", described as "I have been getting headaches daily". The event "i have been getting headaches daily" was evaluated at the physician office visit. Therapeutic measures were taken as a result of headache.  Additional Information: Patient stated that she was thinking she should buy stock in paracetamol, acetylsalicylic acid, caffeine (EXCEDRIN) since she had to take that daily to help with the headaches. She stated that she refused to be on narcotics, so hopefully, they will stop eventually. Therapeutic measure was taken as a result of the event which included treatment with paracetamol, acetylsalicylic acid, caffeine (EXCEDRIN).   No follow-up attempts are possible. No further information is expected.