chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a dose of MENACTRA post temperature excursion, temperature went down to 31.1F for 45 minutes, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Global Medical Information (GMI) (Reference number- 00708386) and transmitted to Sanofi on 03-Aug-2021.  This case involves a patient of unknown demographics who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] post temperature excursion, temperature went down to 31.1F (Fahrenheit) for 45 minutes, no adverse (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  On 02-Aug-2021, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: 06920AA; expiry date: 15-Apr-2022 via unknown route in unknown administration site.  It was case of actual medication error due to product storage error temperature too low (latency: unknown).  It was reported, "caller states that she had a case from a temperature excursion call made on 02AUG2021. Caller states that the information given on that case was inaccurate and that the refrigerator temperature went down to 31.1F for 45 minutes. Caller also states that a patient received a dose of MENACTRA on 02AUG2021 in the office post temperature excursion. Caller states that excursion was caused by the door being left open."  At the time of reporting, no adverse events were reported.   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.
pt recv vax 7FEB97 & 20FEB98 pt exp 24 pruritic varicella-like lesions on head, 6 to 12 lesions on trunk as well as extremities;no fever or any other sx were noted;
mom called @ bedtime t104;mom gave ibuprofen temp dec;mom slept w/child mom awakened in noc pt sitting up in bed w/eyes open but would not respond;then pt urinated on self;mom finally aroused pt by tapping on face;
Information has been received from a registered nurse concerning an approximate 10-year-old patient who on 21-JUN-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Rapid heart rate of 80BPM; Mettalic taste in mouth; Diaphoretic; Low back ache; Blood pressure shoot up to 163/93; numbness of tongue and lips; Tingling of the tongue; Rash; A spontaneous report was received from a nurse concerning a 60 year-old, female patient who received Moderna's COVID-19 vaccine and experienced rash, became diaphoretic, rapid heart rate, metallic taste, tongue and lip numbness, tongue tingling, low back ache and high blood pressure.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 26 Dec 2020, approximately 10 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient developed a rash and became diaphoretic shortly after receiving the vaccination, She developed a heart rate of 80 beats per min (BPM) from baseline 60 BPM. She reported metallic taste in her mouth, her tongue and lips were numb, and she had tongue tingling. She also noted that she developed low back pain and her blood pressure increase to 163/93. Treatment for the event included diphenhydramine hydrochloride.  Action taken with mRNA-1273 in response to the events was not reported.   The event, rash, was considered recovering/resolving. The outcome of the events, diaphoretic, rapid heart rate, metallic taste, tongue and lip numbness, tongue tingling, low back ache and high blood pressure was unknown/not reported.; Reporter's Comments: This case concerns a 60 Y/O F who had NS unexpected heart rate increased, blood pressure high, hypoaesthesia oral, paraesthesia oral, dysgeusia, diaphoresis, back pain and NS expected rash.  Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment included diphenhydramine. Rash resolving, other outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Starting 06/06/2022, I lost hearing in my right ear and felt extremely dizzy. I went to my PCP and they sent me for an MRI. They referred me to an ENT and audiologist. They determined I had Meniere's disease and, since changing my diet, it has helped.
caller received both doses of the Moderna vaccine, she only had a little soreness; she had her mammogram and breast ultrasound, and doctors found swollen lymph glands on the left side, she hadn't noticed them previously; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (caller received both doses of the Moderna vaccine, she only had a little soreness) and LYMPHADENOPATHY (she had her mammogram and breast ultrasound, and doctors found swollen lymph glands on the left side, she hadn't noticed them previously) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Idiopathic thrombocytopenia (remission.).   On 05-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) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced LYMPHADENOPATHY (she had her mammogram and breast ultrasound, and doctors found swollen lymph glands on the left side, she hadn't noticed them previously). On an unknown date, the patient experienced MYALGIA (caller received both doses of the Moderna vaccine, she only had a little soreness). At the time of the report, MYALGIA (caller received both doses of the Moderna vaccine, she only had a little soreness) and LYMPHADENOPATHY (she had her mammogram and breast ultrasound, and doctors found swollen lymph glands on the left side, she hadn't noticed them previously) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, Mammogram: abnormal (abnormal) Swollen lymph glands on the left side. On 26-Jul-2021, Ultrasound breast: abnormal (abnormal) Swollen lymph glands on the left side.         No concomitant medications were reported.  No treatment medications were reported.
This spontaneous report as received from a healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patients received improperly stored M-M-R II (lot # L036853, expiry date: 24-SEP-2017; lot # M002518, expiry date: 12-JAN-2018, lot # M010426; expiry date: 01-MAR-2018, lot # M015931, expiry date: 30-MAR-2018 and lot # M004899, expiry date: 22-OCT-2018). She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There was no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a Certified Medical Assistant refers to multiple patients of unknown age and gender. It was reported that on unknown dates, the patients were vaccinated with ROTATEQ orally, lot number L038536, expiration date 19-AUG-2017 (dose not reported). The vaccine was stored in temperature of 29.8 F for 256 hours (date logger: yes). There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Received vax 2/18/03. Mom called 2/19/03 stating child was sick (throwing up) all night - choked once, turning blue. Child recovered shortly. Next morning (2/19) child had "whelps" (big, red) all over her body. No trouble breathing on 2/19. Child still throwing. ER vs. PMD said "allergic reaction to one of shots." Child ok on 2/20/03.
Welt like rash on abdomen, trunk, back. Swelling of hands and feet.
diarrhea, nausea, and loss of appetite for 4 days so far.....
This spontaneous prospective pregnancy report as received from a nurse refers to a 32 years old female patient with drug allergies to sulfa drugs. The patient had no pertinent medical history. On 10-JUN-2016 the patient was vaccinated with VARIVAX (Lot #, expiration date, dose, and the frequency were unspecified), subcutaneously. There was no concomitant therapy. On an unknown date in June 2016, the patient experienced unspecified abdominal pain and the patient was seen in the office on 20-JUN-2016 for the event. A "urine pregnancy test" was performed which came back as positive. The patient became pregnant with last menstrual period (LMP) of 17-MAY-2016 and estimated date of delivery (EDD) of 21-FEB-2017. No treatment was given for the events. The pregnancy outcome was pending. The outcome of abdominal pain was unknown. Additional information has been requested.
This spontaneous report was received from a phlebotomist and refers to a 6-month-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 15-OCT-2017, the patient was vaccinated with unknown vaccines which possibly included a hepatitis b vaccine (recombinant) (manufacturer unknown) for prophylaxis (dose, frequency, lot#, expiration date and route of administration were not provided). On 15-OCT-2017, four hours after the vaccination, the patient came in non-responsive and very sick. The patient was also in distress. It was unknown if she had come in to a hospital or if the child was admitted to a hospital. At the reporting time, it was unknown if the child would continue to take unknown vaccines, including possibly a hepatitis b vaccine (recombinant) (manufacturer unknown). The outcome of the events and the causal relationship between the events and a hepatitis b vaccine (recombinant) (manufacturer unknown) were not provided. Upon internal review, the event of non-responsive was considered as medically significant.
This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age. Concurrent conditions and pertinent medical history were not reported. On an unknown date the patients were vaccinated with improperly stored doses of (Merck) VARIVAX, lot number L023588, expiration date 26-JUN-2017 (dose and route not reported). Concomitant therapies were not mentioned. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Received Flu Shot at work (hospital) around 1:00 pm. Developed GI discomfort and frequent stooling between 1:30 to 5:00 pm. At 8pm noticed itching on tops of feet. Woke up at 4 am to itching/hives on tops of both feet, around both armpits, and behind left knee. I've worked in healthcare for over a decade, have gotten my flu shot every year while working in healthcare, have gotten both sets of pfizer Covid vaccines (december 2020/jan 2021) and have never had a reaction to any vaccine previously.
Narrative: 06/11 COVID swab, result: not detected COVID infection following COVID vaccine series 01/06, MODERNA, dose #1 02/03, MODERNA, dose #2 08/12 pt cc: cough, myalgias, rhinorrhea exposure: unknown 08/13 -08/18 pt symptoms continue 08/13 COVID swab, result: detected 08/13 SARS-COV-2 LINEAGE result: B.1.617.2 08/13 SARS-COV-2 CLADE result: 21A
The patient was given 0.2ml dose of an undiluted Pediatric Pfizer vaccine.
Pt had Moderna Covid vaccine on 1/31/21.  She reported injection site pain and no other side effects for the 2 days after receiving the vaccine.  Yesterday 2/8/21 she began noticing itching and a red rash developing at the injection site and surrounding area of the arm which is continuing to today. Pt took OTC Zyrtec, contacted primary care provider, and is monitoring for changes.
positive for HPV; Information has been received from a nurse practitioner via a company representative concerning a female patient of unknown age. The patient's concurrent conditions, medical history, historical drugs, and concomitant medications were unknown.  On an unspecified date (reported as years ago), the patient was vaccinated with the three-dose series of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), administered intramuscularly, to prevent human papillomavirus (dose, anatomical location of administration, lot number, and expiration date were not reported).  The nurse practitioner stated that a female patient tested positive for human papillomavirus on an unspecified date. The outcome for the Human papillomavirus test positive event was unknown. The patient did not have an overdose.  The reporter did not provide the causality assessment between Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb vaccine (GARDASIL) administration and the Human papillomavirus test positive event.  This is one of several reports received from the same reporter.
YELLOW ORANGE URINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced yellow orange urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of yellow orange urine was not reported. This report was non-serious.
This patient developed a severe pneumonia, clinically diagnosed as COVID-19 pneumonia, with hypercapnic and hypoxemic respiratory failure, and expired.  I am not sure if it was related to the vaccine, but the rapid antigen for Sars-CoV2 was positive and the PCR was negative.  I am reporting this event because of the lack of clarity on this issue and the positivity of the Sars-CoV2 was beyond the parameters of 14 days in the phase three trials.
Breakthrough case admission after 5 vaccines Pfizer 3/2/21 Lot# EN6205;  Pfizer 3/23/21 Lot# EP6955;  Pfizer 10/1/21 Lot# FC3181'  Pfizer 4/14/22 Lot# FK9894;  Pfizer 10/10/22 Lot# GJ6665
THE PATIENT REPORTED INCREASED BLOOD PRESSURE, DRY MOUTH, AND DIFFICULTY BREATHING.
Syncope event after receiving second dose of Pfizer covid vaccine. He walked away into observation area after getting vaccine.  Approximately 10 minutes later , patient became pale and diaphoretic. Limbs began to shake and it appeared to be having seizure-like activity.  Pl lowered to the floor and legs were propped up. Heart Rate was inthe 40's, BP was unmeasurable. After several minutes HR came up to mid 80's and SA02 sats were normal. EMS notified for transport to ED.. Hx diabetes and had not eaten all morning. Last seizure was 2 years ago
I got shingle shot on 28-JAN-2016, just found out a week ago. I may not have been protected.; I could not afford another shot; This spontaneous report was received from a 65 years old female patient referring to herself. The patient's concomitant medications included metformin, venlafaxine hydrochloride, methimazole, buspirone hydrochloride, vitamins (unspecified) and procaterol hydrochloride (PROAIR). The patient's pertinent medical history included chronic obstructive pulmonary disease (COPD), diabetes and disability. The patient's drug reactions/allergies was not reported.   On 28-JAN-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and expiration date were not provided; route: injection) to prevent shingles.  On approximately 15-MAR-2021 (reported as a week ago), the patient said she might not have been protected. She had pay a lot of money for shot which made her annoyed. The patient needed another shot and would like to reimbursement. The patient was disabled and by the time she got another shot, it would cost her another bunch of money. She stated that she could not afford another shot with her disability payment.   The outcome of vaccination failure was not provided. The causality assessment between vaccine zoster vaccine live (ZOSTAVAX) with the aforementioned event was related.; Sender's Comments:  US-009507513-2103USA002742:
Pt called the pharmacy on 7/30/21 after having received the vaccine 7/27/21.Pt reported strong back pain radiating to the right leg. Pt stated he received shot in left arm but was having right shoulder pain. Pt also reported blurry vision for the last two days. Pt was advised to seek medical care immediately.
Patient reports white spots (looks like skin is bleached) on arms and legs that appeared ~2 days after vaccination and has not gotten better 1.5 weeks post vaccination.
After leaving office pt. had nose bleed that would not stop. Taken to convenient care where they packed it. They told grandmother to let Health Dept. know about problem. Said they thought it might have been "coincidence." No further problem.
aggravated tinnitus, ringing in the ears; This is a spontaneous report from a contactable consumer (patient's sister). This consumer reported same events for 3 patients. This is the third of three reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunisation. Medical history included tinnitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  On an unspecified date, the patient experienced aggravated tinnitus, ringing in the ears. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021546995 same reporter/drug/event, different patient;US-PFIZER INC-2021548332 same reporter/drug/event, different patient
pt exp fainting spell & was diff to arouse;would open eyes briefly & breathe deep when instructed to but cont to act very drowsy;BP 110/70;pulse 99;02 sat 96%;checked by EMS personnell & transported to hosp;dx faking sx of fainting;
Poor feeding. Decreased activity. vomited x 1, Low grade temp less than 24 hours post vaccine. Resolved in less than 12 hour time. Had neg sepsis work up. Received antibiotics. MR received from pediatrician for several well child exams and a F/U for an ER visit for low grade fever 1 day post Hep B vax. Assessment: "Adverse Effect, Other Vaccines"./pc Hospital MR received which revealed admission to hospital to R/O sepsis in previously healthy 5 week old, due to parental report of fever up to 100'F, and decreased oral intake, decreased activity, and emesis x1.  IV fluids and antibiotics given and infant was afebrile, taking po, and acting normally.  D/Cd after 1 night. DISCHARGE DX: Viral Illness and fever of unknown origin.
Broke out over entire forehead starting 3 days following vaccine and worsened over ~2 days.
SM received MMR on 3/2/10. Had positive pregnancy test on 3/4/10.
tingling like feeling in her foot; Numbness in her foot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot). At the time of the report, PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; 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.
Muscle pain in the site, felt chills , tiredness and pain on left earlobe on 12/7/2020 and 12/8/2020.
Broke out in a rash, burning sensation all over body, along with itching. Injection site swollen red and warm.
A non-serious spontaneous report of inadvertent administration to six-month-old infant has been received from a Registered Nurse concerning a six-month-old male subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medication were not reported. On 07-Oct-2008, the physician's office inadvertently gave FLUMIST to a six-month old infant. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 21-Oct-2008, 14 days after the patient received FLUMIST. indicated that there were not adverse events.
COVID Vaccine Breakthrough Dose  Moderna Dose 1 3/2/21 (002A21A) Moderna Dose 2 4/1/21 (017B21A) COVID Positive 11/23/21  11/23/21: Patient is an 86-year-old female from home. Patient reported falling to the ground while going to the nursing home to visit husband. She was brought into the ER by EMS services and patient denied losing consciousness. Patient has a right forehead laceration and a right dislocation. A sedation and reduction procedures performed in ER and was successful. Patient was noted with low oxygen sats and was on 15 L during the procedure. Orthopedic was consulted from the ER and no plans for intervention at this time.   Blood work in ER showed BUN 42, ALT 52, AST 66,. Her COVID-19 test came back positive. Patient reported fully vaccinated with COVID-19 and has not received her flu vaccination yet. Chest x-ray negative for any acute processes. I met with the patient in ER and she reported improvement on a symptom at this time. She denies fever chest pain, numbness tingling, abdominal pain, headaches shortness of breath. I discuss the plan of care with patient and she is agreeable to stay in hospital for further management. Awaiting for Orthopedic recommendation. Will have patient work with PT to address her needs for discharge.  12/1/21: 2019 novel coronavirus detected, Acute COVID-19. COPD exacerbation. Closed dislocation of hip. Hypoxia. Closed head injury. Abrasion. Requires assistance with activities of daily living (ADL)