chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of tested positive for influenza A has been received from a certified medical assistant concerning a six-year-old male, subsequent to FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 30-Oct-2009. On 31-Oct-2009, the patient developed a fever of 104 degrees Fahrenheit and flu-like symptoms. On the same day, he tested positive for influenza A and was treated with oseltamivir. The outcome of the event was not provided.
Within 36 hours of patient receiving flu vaccine, she had acute onset of redness of hands and feet with complaint of pain and inability to bear weight on feet. Admitted to hospital.
Patient given shots yesterday at 4 year old check up visit.  This am Mom noticed left thigh swollen, warm to touch and hard at shot site.  Evaluated by doctor, left thigh 12 1/2 diameter, right thigh 10 1/2 diameter.  Rocephin 500mg im today, Keflex 250mg.
Anxiety, fast heart beat, panic attack, severe pain in arm? made it extremely stiff, chest pain.
Time of injection felt a stinging sensation, lasted a few minutes.  Within hour, iced arm as was quite sore.  Woken during night with chills, sweats and feeling of numbness from shoulder down to elbow and unable to raise arm.  Took 2 acetominophen and iced arm, able to fall back to sleep. Very sore and difficulty in raising arm for 2 days.
Patient reported bruising for the past 7 days since the injection. She was concerned that the injection was given SC as she reports that the administering pharmacist pulled the needle back, and that she felt the medication stung as it was being pushed. The bruising was evident, with a greenish bruise around the perimeter and a darker purple in the center. Patient was advised that we would be reporting to VAERS and to let us know if bruising does not resolve.
Information has been received from a nurse, for the pregnancy registry for GARDASIL, concerning a female with no known allergies and no pertinent medical history who in approximately July 2007, was vaccinated IM with a dose of GARDASIL (lot#, and site not reported) 0.5 ml. There was no concomitant medication. The patient sought unspecified medical attention. The nurse reported that the patient is pregnant and "she's probably in labor now" but was not positive. The LMP (last menstrual period) and estimated date of delivery were not reported. Method of pregnancy confirmation was also not reported. The nurse did not have the patient's chart in front of her, so exact details could not be provided. Follow up information was received, for GARDASIL, a Pregnancy Registry product, which reported that the patient delivered a baby via C-section on 24-MAY-2008. The reporter said that the patient had mild pregnancy-induced hypertension (PIH), but she was not sure why the C-section was performed. The baby just turned one and was normal and healthy with no congenital anomalies. The patient worked in the office and everything turned out fine. Upon internal review, C-section was determined to be an other important medical event. No further information is available.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 01-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot # reported as M012498, expiry date 09-OCT-2017 (dose was not specified). The administered dose of ROTATEQ was stored at 33.4 Fahrenheit degrees for 52 minutes. There was no previous temperature excursion. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Gave birth on 23Sep2021 and postpartum bleeding stopped first week of October/1 hour post 2nd covid vaccine on 16Oct2021 bleeding began again and hasn't stopped; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FF8839, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 16Oct2021 12:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation. Patient did not have any other vaccine in 4 weeks. Patient was not pregnant at the time of vaccination. Patient was not tested for COVID post vaccination. Medical history included Chronic migraine from an unknown date and unknown if ongoing. Patient has known allergies of reglan. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; minerals nos, vitamins nos (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0168) administered in right arm on 24Sep2021 14:30 (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. Patient gave birth on 23sep2021 and postpartum bleeding stopped first week of october/1 hour post 2nd covid vaccine on 16oct2021 13:00 bleeding began again and has not stopped. Patient did not received treatment for event. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
On the day of my shot (given at 10 am) I began to feel very nauseous around 2pm. By 6pm I was so nauseous I could not stand up or care for my children. I went to bed only to start dry heaving. On and off all night I woke up to feeling nauseous and had severe muscular aches. Friday morning I was still nauseated on and off, continued muscle aches and fatigue. Saturday and Sunday (today) my appetite has still not returned. All other symptoms have faded by Sunday afternoon.
Patient developed a measles rash approx 10 days after receiving vaccine. This rash was accompanied by fever, aches and itching.
Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 10/7/2022 Discharge Date: 10/9/2022  PRESENTING PROBLEM: Anemia [D64.9] Anemia, unspecified type [D64.9] COVID-19 [U07.1]   HOSPITAL COURSE:  95 year old female with known dementia admitted with weakness and cough. Found to be Covid positive, but was already positive 7/29/2022. She was given dexamethasone in the ED and started on remdesivir here. She has not been hypoxic since presentation.Her hemoglobin is stable and actually increased, She was given IV iron. Discussed CHF, anemia, atrial fibrillation, hypertension, and dementia with the caregiver (who was bedside). Explained that I would like an echocardiogram on Monday. Just feels terrible, but due to dementia cannot specify. Denies chest pain or shortness of breath or abdominal pain.   No notes on file Family decided later today that she would go home with Hospice. Initially plan was tomorrow after echocardiogram, but the family decided she should go home today and have Hospice intake tomorrow.
Nauseous; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient supposed to be calling after she get vaccine to report any side effects. The patient just nauseous, fever, chills, headache. The patient had started symptoms on 09Jan2021 and still had her symptoms today (10Jan2021). The outcome of the events was not recovered.
Received vaccine 12-28 with no reactions observed until 1-6, when awoke with red feverish area approx 4 1/2 x 2 1/2 inches rt upper arm where vaccine was given. Observed in Health Department 1-7, area of redness has decreased to approx. 2 1/2 X 2 1/2 inches.
dermatographia started appearing - skin would become itchy with raise welts when lightly irritated by touch, clothing, etc
reveled mild pneumonia; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262; expiry date: unknown) via an unspecified route of administration in the left arm, on 28Jan2021 at 15:00, at a single dose, for COVID-19 immunisation. Medical history included known allergies to penicillins. Concomitant medication included acyclovir (ACICLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) in the left arm, on 06Jan2021 at 13:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccination. The patient had dry cough and difficulty getting deep satisfying breath about 12Feb2021 (2 weeks + 2 days) after 2nd dose of Pfizer vaccine. The patient tested positive for COVID-19 nasal swab on 19Feb2021 (3 weeks +2days) after 2nd dose of vaccine. On 24Feb2021, patient was seen in a physician office for symptoms of cough and shortness of breath (SOB). On the same day (24Feb2021), chest X-ray revealed mild pneumonia. Patient was now on prednisone, azithromycin and albuterol inhaler. Patient was a little better and was now on 3rd day of taking 3 medications. Outcome of the events was recovering.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 24-DEC-2015 at 11:37, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.3 and 5.3 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Breakthrough case admission after 4 vaccines Moderna 2/11/21 Lot# 007M20A;  Moderna 3/11/21 Lot# 023M20A;  Moderna 12/8/21 Lot# 005C21A;  Moderna 8/10/22 Lot# 006M21A
27Feb90 pt vax w/ 1st dose hepta B, 22Mar90 exp sudden onset of severe vertigo, n/v, extreme lethargy + facial flushing,  sx persisted for  1 week.
After initial soreness, redness, and small lump around injection site in upper left arm, I am unable to lift my arm past a 45 degree angle. It is extremely painful to lift my arm to be level with my shoulder, and then there's pain down to my elbow to lift my arm above my head. There was not a reaction like this to the first two shots, and I had no other reactions in the three shots other than this. Two months later, I still cannot lift anything with my left arm.
Patient received the Pfizer vaccine on 2/10/21 and 3/3/21 so was fully vaccinated when they tested positive for COVID-19 on 9/20/21.
PT IN WAITING AREA STATUS POST 1 ST DOSE PFIZER VACCINE. PT HAS KNOWN ALLERGY TO IODINE AND SHELLFISH. APPROX 30 MIN AFTER INJECTION COMPLAINT OF SCALP, THROAT, EARS ITCHING. STATES "THIS HOW I FEEL WHEN I EAT SEAFOOD" BENADRYL 25MG PO GIVEN AND PT MOVED TO OBSERVATION AREA. NOTED FLUSHED FACE, NO RASH OR HIVES NOTED. 1230 BP 148/73, HR 93.  1245 BP 118/79 HR 77. "FEELING A LOT BETTER" STILL WARM, FAN AND ICE PACK GIVEN.  1300 BP 134/50 HR 78, PT STATES FEELS OK TO LEAVE. HAS BENADRYL AND EPI PEN AT HOME. PT HAS APPT WITH PRIMARY MD TOMORROW, ENCOURAGED TO DISCUSS TODAY'S EVENTS AND TO SEEK GUIDANCE FOR 2ND DOSE. PT AWARE OF S/S TO WATCH FOR AND WHEN TO SEEK MEDICAL ATTENTION. LEFT STABLE WITH DAUGHTER.
Patient was scheduled for Covid booster and Flu shot, he was given his booster and the nurse prepped 2nd arm for what he though was flu shot and she administered another booster. The nurse then proceeded to give him a third shot<flu>. She told him what she did and told him not to worry about it...take some tylenol if you don't feel good. Overnight he had the sweats and fatigue with severe muscle aches. No serious effects as of yet. Contacted poison control  last night and they had no idea what i should do.
These case reports were previously actioned by Crucell (CRX-2013-001116). The data was taken directly from the database repository and entered verbatim (including labeling and causality assessments) on to the safety database. Where labeling and causality assessments were absent, facility took the decision to assign according to company guidelines. This case was forwarded by Crucell with the reference number CVAE-056-2013. Initial spontaneous case received on 11-Sep-2013 from a physician and from the patient and processed together with follow-up information received on 13-Sep2013 from the physician, which concerns a 46-year old male patient who received 3 oral doses of Vivotif (batch 3000421, expiry date not reported), as a prophylactic vaccination. First dose of Vivotif taken on unspecified date in Aug-2013 (24.Aug.2013 and 25.Aug.2013 were reported), second capsule on 27-Aug-2013 and third capsule on 29-Aug-2013 respectively. The patient did not take the fourth capsule. The patient had no medical pre-existent condition. The physician reported the patient had normal physical examination with normal routine chemistries and complete blood count (CBC) before vaccination. Concomitant medication not provided. On 26-Aug-2013, the patient experienced diarrhea. On 27-Aug-2013, he took second dose and experienced intense abdominal pain. On 28.Aug.2013, the pain subsided, but not completely. After intake of the third capsule of Vivotif, on 29-Aug-2013, the patient reported recurrence of intense abdominal pain and diarrhea. Tests showed negative / normal abdominal CT and MRI, normal blood tests after the patient stopped the vaccine course two weeks before the date of this report. No treatment taken for the reported events. The reporting physician was considering antibiotic therapy with azithromycin or ciprofloxacin to treat the patient. As per the physician, at the time of report, the patient still having persistent burning abdominal pain and diarrhea several weeks after vaccine administration. The events were assessed as serious, medically important by the reporter physician. No further details were provided. Follow-up information received from the patient on 04.Oct.2013: The expiry date of the Vivotif capsules used was 31.Jan.2014. The patient had no concomitant medications. The patient reported he was 90% recovered. No medication was prescribed to treat symptoms. After several unspecified tests, which all came out normal, it was determined that the patient was producing excessive gas. Treatment included enema, which helped. Case updated on 11.Mar.2014: Test previously coded as 'CT scan' was recoded to 'computerized tomogram abdomen'. Pharmaceutical form of Vivotif was updated as 'capsule'. Initial receipt date previously reported as 12.Sep.2013 in the narrative was corrected to 11.Sep.2013. Case version [4] was created using [11-MAR-2014] as the date to action case quality corrections to legacy data. The following fields were updated [Country Where Drug Obtained] no other changes were made to the case.
Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml; Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml); No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml), ACCIDENTAL OVERDOSE (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml)) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml), ACCIDENTAL OVERDOSE (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml)) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml), ACCIDENTAL OVERDOSE (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml) and ACCIDENTAL OVERDOSE (Nurse is calling to report that 3 adult patients received Monovalent booster from a pediatric 6y-11y vial NDC 80777-0275-05 (0.5ml)).    No concomitant medications were reported. The nurse told that the product was in the refrigerator less than 30 days.There was no prior temperature excursion. No treatment medications were reported.
Within 2 minutes of receiving the vaccine, the patient reported she felt very light headed and though she may pass out.  She did not pass out, but did need to lie down for approximately 10 minutes before she began to feel better.
Daptacel was inadvertently administered instead of Tdap with no reported adverse event; Daptacel was inadvertently administered to 11 year old patient with no reported adverse event; Initial information received on 31-Mar-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old female patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was inadvertently administered instead of (Tdap) diphtheria, tetanus and acellular pertussis vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine (hpv vaccine) and influenza vaccine for Prophylactic vaccination.   On 28-Oct-2022, the patient received 0.5 ml dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (strength: unknown) (lot C5829BA; no expiration date available) via intramuscular route in the left deltoid for Immunization was inadvertently administered instead of Tdap with no reported adverse event (wrong product administered) (latency: on same day).  On 28-Oct-2022 the daptacel was inadvertently administered to 11 year old patient with no reported adverse event (product administered to patient of inappropriate age) (latency; on same day). It was reported that patient was supposed to get tdap. Medical assistant confirms that the patient has already completed their dtap series; states that daptacel was inadvertently administered instead of tdap.   Action taken : not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult patient who experienced patients were given vaccines that were outside of the recommended temp range, while he/she received vaccines PENTACEL, QUADRACEL, MENACTRA and FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. It was a case of actual medication error due to incorrect product storage. The patient outcome is reported as Not Applicable for patients were given vaccines that were outside of the recommended temp range. 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 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.
Information has been received from a registered nurse concerning a 55 year old female who on 3/31/03 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On approximately 4/14/03, 2 weeks after vaccination, the patient developed 5 vesicular lesions on her arm and chest. No other symptoms were reported. No prescription drug was required. Unspecified medical attention was sought. Follow up information received from a registered nurse indicated that the event was not considered an adverse event with only 5 lesions. Additional information has been requested.
Myalgia & Fever Narrative:  She received second vaccine on 1/20/21. She reported low grade fever, sore arm and malaise.