chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a female fetus whose 24 year old mother with a history of one elective termination (date unspecified) and no known allergies who on 20-APR-2009 was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number 1702X). On 22-JUN-2009 the mother was vaccinated IM with the second 0.5 ml dose of GARDASIL (lot number 0294Y). There was no concomitant medication. On an unspecified date, the mother was determined to be pregnant by urine pregnancy test. The last menstrual period (LMP) was 07-JUN-2009 and the estimated delivery date (EDD) was 15-MAR-2010. Medical attention was sought in the office (date unspecified). On 06-AUG-2009, the mother had an ultrasound to confirmed dating results were reported as within normal limits (WNL). On 02-SEP-2009 an "ultrascreen" was performed in order to rule out early detection of Down syndrome, Trisomy 19/13. The result of the test was within normal limits. On 19-MAR-2010 the mother gave birth via C-section due to cephalo-pelvic disproportion to the patient. The patient weighed 7 pounds 8 ounces, 18 inches long. The Apgar score was 8 at one minute and 9 at five minutes. Medication during pregnancy included prenatal vitamin daily. There was no complication during pregnancy, however, the patient's cord was wrapped around her neck twice. No fetal distress was noted. Neither mom nor baby has been back to the office for follow up care. Their current status was not reported. Upon internal review, C-section was determined to be an other important medical event. The mother's experience has been captured in WAES # 0908USA00845. Additional information has been requested.
Patient had told me while checking PCQF with him that he has a history of passing out and gets extremely anxious when he gets shots. I tried to have everything ready for him to give the shot as quickly as possible and had a technician ready with a cold pack and a water bottle. About 1 minute after I administered he got very hot and started having some ringing in the ears. He laid down on the floor and we elevated his feet on a chair. Technician called the code white and helped assist me.  We gave him a cold water and cold pack. We fanned him and got him some candy. We kept an eye on his pulse. Manager filled out the code white form. I will  call patient tomorrow to check on him. He stayed in the pharmacy area for about 55 min total.
Patient received Spikevax '23-'24 and a few days later was still lethargic and had brain fog. The patient also stated that his arthritis had worsened and his joint pain was much worse than ever before. He also stated that he had labored breathing, which could be heard over the phone when speaking to the patient. It was suggested that the patient contact his primary care physician to discuss symptoms and treatment options. He has an appointment with PCP sometime next week (10/30/23 to 11/3/23).
STORAGE IN REGRIGERATOS (2-8 C) UP TO 30 DAYS. VACCINE USED AFTER 10/16/2021
04/01/2021 - First dose of Moderna  Immediately - Bad taste in my mouth! Stole my wife's large cup of tea, but could not get rid of the taste for 20-30 minutes.  04/16/2021 - Clinic check-in: Blood pressure measured at 180/120. My charts/records had never been higher than 120/70 prior to this, including March.  04/29/2021 - Second dose of Moderna  05/12/2021 - Started Lisinopril + HCTZ to control blood pressure.  07/21/2021 - Trip to ER: Chest tightness, EKG shows no irregular rhythm even though this is how it feels. It is ruled a "panic attack."  08/06/2021 - Start taking metoprolol to control heart rate.  October - learn about Moderna, myocarditis/pericarditis, and intravascular injection. Planning to see a cardiologist to confirm this is what happened. As I'm older than the young men who normally have issues, I note that I am not "issue free," either. I connect the last few months and changes in medication/health to the first vaccine with the bad taste in my mouth. Right now, I am trying to determine the damage done, if any, and what can be done about it.
Pt c/o fever 100 day following vaccine, lasting 2 days. Redness and hardness developed at site 3 days after injection, tenderness: 2 cm of induration. Apply cold packs to arm/site: antibiotic if induration/edema increased. Did not take antibiotic.
Allergies; This non-serious spontaneous case, initially received from a physician via pharmaceutical manufacturer Merck (reference number: 00843915) on 12-Jun-2018, concerning a female patient of an unspecified age.  The patient had been allergic to morphine, nickel, formaldehyde and bee stings.  On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient experienced allergies (unspecified).   At the time of this report, the outcome of the event was not reported.   Th reporter considered the causality of the event as related to suspect vaccine.; Reporter's Comments: A female patient of an unspecified age experienced allergy (unspecified) on an unspecified date, after vaccination, the causality of the event is unassessable due lack of information regarding vaccination date, onset date of the event and type of allergy.
headaches on both sides of his head; This is a spontaneous report from a contactable Physician reporting for himself. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 0.3ml single dose on 30Dec2020 in the left deltoid for COVID-19 immunisation at the age of 53-year-old. Lot number was EK9231, expiration date 30Apr2021. Medical history and concomitant medications were unknown. On 31Dec2020, headaches on both sides of his head; the event was considered medically significant. The patient received TYLENOL for the event. The patient did not recover from the event. The physician considered the event was related to suspect vaccine. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
A non-serious spontaneous report of we gave 14 doses of expired FLUMIST of was received from a health professional concerning a 12-year-old female. Neither the patient's medical history nor the concomitant medications were reported. The product expired on 22-Jan-2012. On-27-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 at the age of 29-years-old (Lot Number: EL9266) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included vaginal delivery on 16May2020; known allergies to Bactrim, sulfa; historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 27Jan2021 at the age of 29-years-old, Lot number EL8982. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS); lecithin (reported as sunflower lecithin). Back pain, urinary urgency and frequency began 25Apr2021. Went to urgent care and was prescribed antibiotic. 28Apr2021, extreme back pain with nausea and vomiting occurred, so presented to the emergency department and was admitted. Abdominal CT scan was performed in Apr2021, revealing kidney stones, one stuck in the left ureter 2 mm in size, an additional 2 mm stone in the left kidney with other smaller stones; left kidney was swollen and right kidney was unremarkable. Multiple pain medications, Flomax, and Zofran administered throughout the hospital admission. Left ureteral stent placed on 30Apr2021 and discharged from the hospital that evening. Stent removed 10May2021 in urology clinic. Additional kidney stones still in fact. Pending follow up ultrasound and 24 hour urine profile due in 5-6 weeks. AE treatment included medications and left ureteral stent. The outcome of events was recovering.
Inflammation in the muscle, blue veins, swelling of tongue and in the legs, constant, arms vasculitis.
2nd dose Moderna given at 0729 0740 throat felt like closing, bright red flushed  0741 Epi given 131/92 94 0742 head/face shaking rapid eye movements with attempted eye contact, Alert/oriented appropriate in conversation, sitting position 0743 110/83 face redness resolving, flush/red BUE, feeling better 0744 106/76 Rapid Response called 0747 106/68 benadryl 25 given 0751 911 called per Dr. recommended for further eval/potential reactions 0752 129/95 80 99% room air 0756 ambulance here 0801 left via stretcher with EMS to nearby hospital ED, patient tolerated activity to stretcher well 0925 reported by vaccinator of team member return to pick up rest of belongings to go home, tolerated activity well.
pressure in my chest; Shortness of breathe; rash; fever; headache; This spontaneous case was reported by a physician and describes the occurrence of CHEST DISCOMFORT (pressure in my chest), DYSPNOEA (Shortness of breathe), RASH (rash), PYREXIA (fever) and HEADACHE (headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Ventricular contractions premature on 01-Jan-2015. Concurrent medical conditions included Penicillin allergy. Concomitant products included FLINTSTONES MULTIVITAMINS WITH IRON from 01-Jan-2000 to an unknown date, PROBIOTICS NOS from 01-Jan-2019 to an unknown date and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) from 01-Jan-2019 to an unknown date for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (headache). On 21-Apr-2021, the patient experienced CHEST DISCOMFORT (pressure in my chest), DYSPNOEA (Shortness of breathe), RASH (rash) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Apr-2021, HEADACHE (headache) had resolved. On 22-Apr-2021, PYREXIA (fever) had resolved. On 25-Apr-2021, DYSPNOEA (Shortness of breathe) had resolved. At the time of the report, CHEST DISCOMFORT (pressure in my chest) and RASH (rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 100.4 (High) 100.4. On 22-Apr-2021, Heart rate: 90-150 (High) Increase 90-150 beats per minute. On 23-Apr-2021, Blood pressure measurement: 128/71 mmHg (High) high. On 23-Apr-2021, Body temperature: 97.5 (High) 97.5. On 23-Apr-2021, Computerised tomogram: abnormal (abnormal) there was a 0.5 cm ground glass optical left.. On 23-Apr-2021, Heart rate: 91 (High) 91 beats per minute. On 23-Apr-2021, Respiratory rate: 18 breaths per minute (abnormal) 18.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In the ER, patient received a CT chest which showed glass opacities.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: update reporter, patient details, lab data, additional event (shortness of breath) and events outcome.
12:15pm= Patient reported isolated five bumps on lower lip, No shortness of breath, No fever,No itching, No swelling of face or lips Pharmacist consulted to take Diphenhydramine and seek ER if symptoms worsen. 12:48pm= Primary care physician consultation: Her recommendation was to continue Benadryl, seek ER if symptoms worsen 1:25pm= Called patient, no change in symptoms, No worsening of symptoms
Information has been received from a 72 year old female, with no pertinent medical history of drug reactions/allergies who on 08-JAN-2007 was vaccinated with Zostavax. There was no concomitant medication. In late February 2007, the patient experienced a painful burning sensation around her mid torso. The patient did not have a rash. She was seen by her physician and was not diagnosed with zoster. The patient's painful burning sensation around her mid torso persisted. Additional information is not expected.
Patient was admitted 11/14/03 with fever and was diagnosed with pneumonia with empyema and required a surgical procedure (VATS decortication) and coverage with IV Penicillin G. The hospital discharge summary received on 1/6/04 states dehydration, vomiting and diarrhea.
Information has been received from a healthcare worker (medical assistant) referring to a 12 month old patient of unknown gender. On 27-JAN-2016 the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (HSA, lot # L003221, expiration date 30-JUL-2016) (dose and route were not reported) and a dose of VARIVAX (Merck) (lot # L017144, expiration date 13-MAY-2017) (dose and route were not reported) at the same office visit (accidental overdose). No adverse effect was reported. Additional information has been requested.
Left upper arm dark red in color extending to lower 1/3 of upper arm; noted at clinic appointment 9/12/02. Seen in ER 9/11/02; Rx written Keflex PO through ER. 9/11/02 fever 103 previous to ER visit. To follow up PCN and finish course of antibiotics.
2 WEEKS AFTER 1ST PFIZER SHOT: PT WAS WATCHING TV, THEN SUDDENLY HEARD A VERY LOUD RINGING NOISE IN HER RIGHT EAR. IT LASTED FOR AN HOUR. AFTERWARDS, PT LOST HEARING IN HER RIGHT EAR.
Information has been received from a physician concerning a 14 year old female who on 24-AUG-2007 was vaccinated with a second dose do GARDASIL. There were no concomitant medications. On 29-AUG-2007 the patient experienced facial stinging, generalized rash on trunk, extremities, and buttocks, and hands and feet were swollen. No cervical nodes, no joint swelling, no allergies. The nurse reported that the patient is in good health. The patient is being treated with oral BENADRYL. Laboratory data revealed Complete Blood Count was normal, Antinuclear Antibody test performed the results was negative and RAST test was negative for latex. The nurse reported that the RAST test were performed due to the client played with water balloon. It was unsure if the patient would receive the third dose. Additional information is not available.
Weakness; Fever; A spontaneous report was received from a consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever and weakness.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on an unknown date. On 03 Mar 2021, at around 11:30 am, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 013M00A) Intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events fever and weakness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events, fever and weakness was unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Company assessed the events to be unlikely related to company product.
arm soreness and chest tightness x 3 wks.  Both symptoms started the evening after getting the 2nd shingrix that afternoon.  the arm soreness has resolved.  chest tightness has been constant x 3 wks but is getting better.  no treatment needed
6/14/2022 Woke up with a sore throat, tested that day with an at home antigen COVID 19 test, positive. 6/15 tele visit with doctor, who prescribed PAXLOVID. Tested again positive with at home antigen COVID 19 test. 6/16 Headache and low grade fever continued with loss of appetite. Late at night blood sugar levels dropped to hypoglycemia levels of 70-60. This stopped when the PAXLOVID had been all taken.
Information has been received from a physician concerning a 4 month old male who on approximately 26-FEB-2008 was vaccinated PO with his second dose of Rotateq. Suspect vaccination included "other four month shots" a dose of PREVNAR, a dose of Recombivax HB (manufacturer unknown) and a dose of PedvaxHIB (manufacturer unknown). On 29-FEB-2008 about 2 to 3 days after vaccination, the patient experienced fever and blood in stool. The patient's mother brought the patient into the physician office and was then sent to the hospital. At the hospital the patient had lab work done which showed the patient's ALT level was above 1000 and the patient was hospitalized. On 07-MAR-2008 the patient was scheduled to be discharged from the hospital. Subsequently, the patient recovered on an unspecified date. It was noted that during hospitalization the patient was seen by a specialist who did not believe it was intussusception. There was no product quality complaint. The events were considered to be disabling by the physician. Additional information has been requested.  3/25/08 Reviewed vax record. 4/15/08 Reviewed ER records of 3/5/08. FINAL DX: salmonella enteritis Records reveal patient experienced fever, decreased appetite, cough bloody stools x 1 day.  Exam revealed sunken fontanelle & eyes.  D/C to home on oral antibiotics.
About 10-15 minutes after receiving vaccine, patient was still shopping at store and collapsed/lost consciousness at self checkout registers.  Paramedics arrived shortly after to help patient.  Was told patient regained consiousness but was told not to get up and paramedics assisted him with getting out of store.
I have a circular rash right below injection site that has been there for 4 days now.  It has gotten better but still is warm to the touch and just a little bit red.
Presented 09/05/2021 with SOB, AMS, chills, rigors, temp 103.2,  O2 sat 83% on room air. Diagnosed Covid +; Hypoxic Respiratory Failure
DIARRHEA; FEELING OFF; NAUSEA; This spontaneous report received from a patient concerned a 73 year old female. 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced feeling off. On 20-MAR-2021, the subject experienced nausea. On 21-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 21-MAR-2021, feeling off on 25-MAR-2021, and nausea on 24-MAR-2021. This report was non-serious.
Chest pain; Big rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) and VACCINATION SITE RASH (Big rash around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) and VACCINATION SITE RASH (Big rash around the injection site). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, PHENYLPROPANOLAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE;PARACETAMOL;PHENYLPROPANOLAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain) and VACCINATION SITE RASH (Big rash around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
01/16/22 presents to EC ED for "Intentional Ingestion". PMHx of "anxiety/depression, ODD, and past suicide attempt"
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. On unknown dates, the patients received doses of improperly stored vaccinated with VAQTA (dose, frequency, route and lot number not provided). No adverse effect reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001855 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (sixth out of nine).  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Aug-2022 included the country of occurrence.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the local case ID.  This case is linked to cases no. US-BN-2022-001839, US-BN-2022-001851, US-BN-2022-001852, US-BN-2022-001853, US-BN-2022-001854, US-BN-2022-001856, US-BN-2022-001857 and US-BN-2022-001858, concerning the same reporter.; Reporter's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.