chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two-months old male patient who was vaccinated with an expired dose of PENTACEL (batch number, expiration date, dose, dose in series, were not reported) in left thigh via intramuscular route on an unknown date. The patient's concomitant medications included PREVENAR for Immunisation; ROTAVIRUS VACCINE for Immunisation; and HEPATITIS B VACCINE for Immunisation. It was a case of an actual medication error due to expired vaccine used. It was not known whether the patient experienced any adverse events or not. It was unknown if any adverse event occurred following the vaccination. 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 party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
left leg felt hard and little purple bruise #6  that feels and looks like blood clots. no treatment. heading to er
02/16/2021 3PM, firm lump in arm and some itching 02/17/2021 11 AM,  Swelling, red rash 2 1/2" to 3" diameter, warm to touch, itching, started taking Benadryl 02/18/2021 8 AM , stopped taking Benadryl  02/18/2021 2 PM, minimal swelling, some redness, some itching, warm to touch 02/19/2021 , all day, no swelling, a little itching, a little redness in the morning but gone by evening 02/20/2021 , AM, no swelling, redness, or itching
Information has been received from a physician concerning an 11 year old patient who was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot #658059/0838U). Subsequently, the patient experienced abnormal swelling and abnormal redness at injection site. The patient's outcome was not reported. Additional information has been requested.
PRESENTED IN OFFICE C/O RASH ALL OVER BODY  PRURITIC RASH ALL OVERFACE SCALP TRUNK EXT. & GENITALIA. NOTED GREATER THAN 50 POX.
pericarditis; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Lot number: GH9702, Expiration Date: 05Jan2023) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer Unknown.), for COVID-19 Immunization. The following information was reported: PERICARDITIS (medically significant), outcome "unknown". Clinical course: The pharmacist had a 62 year old patient who received the Pfizer covid-19 bivalent vaccine for adults last year, and within 5 months of receiving the vaccine, she developed pericarditis. Because of that, her primary care physician is not recommending she get Comirnaty 2023-2024 formulation. The reporter asked, "Do you have information on the incidence of pericarditis and know if it would be safe to give for this patient?"; Sender's Comments: Based on known drug safety profile, the events of Pericarditis are assessed as related to suspect product bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
temp 100, rash, itching, left upper underarm 11X12cm red, warm, 4cm area of blisters, oricedyre: 2 blisters opened for Zoster culture and lg blister popped. Dr. (physician who wrote rx for zostavax) prescribed omnicef 300mg bid X7d and silvadene cream
Given PREVNAR 13 on 4-15-16. Woke up next AM with temp 100.2, weakness. Called 911 and patient transferred to hospital where he was admitted x 5d. Placed on LEVAQUIN.
Pentacel was given to a five-year-old with no reported adverse event; Initial information received on 29-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a female patient for whom diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was given to a five-year-old 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 varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 29-Sep-2023, the five-year-old patient received a standard total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml (lot UJ858AA, expiry date- 29-MAR-2024) via intramuscular route in the left deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day).  Reportedly, Caller is asking What is recommendation for this? Do she need further vaccination or would this be her completed dose. This would have been patient last dose.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
nausea; dizzy; fever; chill; body aches; difficulty breathing; chest pain; sweating; This is a spontaneous report from a contactable consumer (patient herself). A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9263; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on 03Feb2021 12:15 (at age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included breast cancer female, drug hypersensitivity; known allergies: antibiotic. Concomitant medications included letrozole (LETROZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN), trazodone (TRAZODONE) and fluoxetine hydrochloride (PROZAC) taken for an unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took levaquin and experienced drug hypersensitivity. On 04Feb2021 13:00 the patient experienced nausea, dizzy, fever, chill, body aches, difficulty breathing, chest pain and sweating. Patient did not receive any treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of all events was recovered on an unspecified date in Feb2021.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Exposed to chicken pox prior to 12 months of age. No documented infection. Presents today with classic shingles left leg.
This spontaneous report was received from a registered nurse via a company representative refers to a approximately 17 year old male patient. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (lot # H016238, expiry date and dose were not reported) intramuscularly. On an unknown date, after administration of the vaccine the patient passed out for a few seconds, appeared to have had a seizure. The patient did not eat or drink till the morning of the shot. The patient sought medical attention (was at the office at the time of the adverse experience). The outcome of the event was unknown. Upon internal review, the event of Patient passed out for a few seconds, appears to have had a seizure was considered as medically significant event. Additional information has been requested.
HCP called to state that the patient was given PROQUAD after a TE event.; No additional AE reported; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneous injection as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported). (Product storage error). The administered dose underwent a temperature excursion, but parameters where not reported. It was unknown if any previous temperature excursion happened. No additional adverse event was reported.    This case is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2303USA006967:MSD US-009507513-2303USA006931:MSD US-009507513-2303USA006933:MSD US-009507513-2303USA007031:MSD US-009507513-2303USA006940:MSD US-009507513-2303USA006990:MSD US-009507513-2303USA007041:MSD
Systemic: high heart beat-Mild, Systemic: Hypertension-Medium, Additional Details: he felt his heart was pounding,and it went away after few minutes
Low grade squamous intraepithelial lesion; Abnormal pap smear; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 18-Jun-2019, concerning a 22-year-old adult female, pregnant subject, of height: 63 inches, body weight: 136 lbs, body mass index (BMI): 24.1, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine during pregnancy.  The subject's obstetrical history noted that the subject did not have any previous pregnancy. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject's concomitant medication included Prenatal vitamins (minerals NOS, vitamins NOS) as supplement.   The subject's last menstrual period (LMP) date was 15-Oct-2018. The type of pregnancy was singleton. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The pregnancy status of the subject was collected and there were no complications noted.  On 14-Dec-2018, the subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF42609, dose, route of administration, anatomical location, expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day, after vaccination, the subject underwent pap smear test which showed low grade squamous intraepithelial lesion (pap smear abnormal). The subject also underwent prenatal ultrasound and no major congenital malformations were noted.   On 11-Jan-2019, the subject underwent prenatal test (sequential 1) and Nuchal Translucency and no major congenital malformations were noted.  On 08-Feb-2019, the subject underwent prenatal test (sequential 2) and no major congenital malformations were noted.   The outcome of the event low grade squamous intraepithelial lesion was not recovered.  The subject's corrected expected delivery date (CEDD) was reported as 22-Jul-2018 and expected delivery date (EDD) was reported as 23-Jul-2019 and; Reporter's Comments: A 22-year-old female pregnant subject was diagnosed with low grade squamous intraepithelial lesion by pap smear test (pap smear abnormal), on the same day after receipt of Flu Vaccine Egg Split QIV (considered as vaccine exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event low grade squamous intraepithelial lesion, the company assessed the causality as not related to study vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
The system alerted that the Pfizer covid-19 second shot was given only 15 days apart from the first dose.    Patient did not have any adverse reactions.
Pt states he woke up Wednesday 02Mar2011 with callus like bumps on both palms. Pt states they are sore and tender to the touch.
slight fever,light heated (almost fainted) profuse sweating then coldness, blood pressure was 81 over 53 weakness @ 2:30 AM  on Oct. 3 hot & redness soreness at injection site on Oct. 4 2014
Child was at clinic to receive 3rd dose in Pfizer 6month- 4yr COVID-19 vaccination. The 3rd dose is bivalent, however, the child received the monovalent vaccine.
Malaise, poor appetite, nausea/vomiting, left arm pain and soreness. Unable to attend school since 3-30-09. Out of character for this child. Arm pain started afternoon on 3-30-09 and increased in intensity the rest of that day and next. No fever.
Awoke feeling very dizzy - rapid heart rate, low B.P. after several hours in bed, felt better. Pain at site for approx. 1 wk. Large red spot about 6" wide lasting approx 1 mo. Still have some pain and weakness at site.
01/10/2022:  Event occurred after 2nd vaccine.  83-year-old female with a history of hypertension presenting to the emergency department after an episode of decreased responsiveness today.  The patient has been feeling somewhat unwell for the past 5 days with muscle achiness and sore throat.  she denies nausea, vomiting, chest pain, or shortness of breath. 01/11/2022: Remains in hospital
Patient came to the ED for complaints of exhaustion and was admitted to the hospital with Covid and impaired kidney function.  Patient was treated with remdesivir.
Information has been received from a licensed practical nurse referring to multiple unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M038209, expiration date 23-APR-2018) via oral route for prophylaxis. No adverse effect was reported. No product quality complaint (PQC) was involved. The vaccine was stored in temperature between 46 degrees Fahrenheit and 77 degrees Fahrenheit for 5 hours and 50 minutes. "Data logger" was involved and there was no previous temperature excursion. This is one of several reports from the some source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001072: US-009507513-1703USA009129:
MISSED TO TAKE THIRD AND FOURTH DOSE ON SCHEDULE; A spontaneous case report was received from a nurse on 19-Jun-2019 for two consumers.  Based on the information obtained from the nurse, two individual case safety reports PVX201906-000516 (PVX2019-1598; husband) and PVX201906-000517 (PVX2019-1599, wife) were created and cross-linked in the database.  This case describes a 57-year-old adult female consumer who "missed to take third and fourth dose on schedule", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took the first two dose of Vivotif on 03-Jun-2019 and 05-Jun-2019. Then, she went to a non-endemic zone trip from 07-Jun-2019 to 17-Jun-2019. Hence, did not take remaining two doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.   Company's Comment: The causality of the event "missed to take third and fourth dose on schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed to take third and fourth dose on schedule" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000516:
Pt. states that after receiving the 1st dose of J&J 03/13/2021, started experiencing Anaphylactic shock 30mins after of tongue/throat swelling, treated with Epi-pen and Benadryl, recovered following treatment. 08/09/2021 Pt. has tested Covid + following vaccination.
Information has been received from the patient's sister concerning her sister with no pertinent medical history or drug reactions or allergies who on unspecified dates was vaccinated with three doses of GARDASIL. There was no concomitant medication. After the third dose of GARDASIL, the patient experienced numbness in both legs. The consumer reported that the patient could not walk so she was admitted to a hospital for one week. When the patient was in the hospital they did many tests (also reported as no lab tests were performed) but could not find anything wrong and the patient was told it was psychological. The consumer also reported that in 2009, "recently", the patient was just administered a fourth dose of GARDASIL, but no adverse event was involved. At the time of this report, the outcome was unknown. No further information is available.  4/23/09 MR received from PCP with vax rec. Multiple vax received 9/10/07. Admitted to hospital 11/11-14/2007 with D/C DX:  Convulsion Disorder (no mention of convusions in MR-conversion d/o dx by psych).  Anxiety, convulsion reaction and asthma. Pt presented with increasing weakness and numbness of arms and legs. Recent viral gastritis. Psych consult to deal with family related anxiety.  Able to walk with crutches at d/c. HPV#2 given 11/15/07. No mention of hospitalization in record.  MD unaware of admission.  Viral syndrome 3/27/08.  HPV#3 5/13/08. OV 6/24/08 to r/o UTI 2' to urinary incontinence x 10 with dysuria. Tx abx. Reporting leg pain and dizziness 10/24/08.  Diarrhea reported 12/27/08. Stomach pain and diarrhea reported 2/3/09.  Recieved 4th dose Gardasil 2/26/09   4/27/09 MR received for DOS 11/11-14/07 with DX as above.  Conversion Disorder (not convulsion disorder mentioned by neuro consult). Admitted to r/o TM or GBS. Pt reports cannot feel legs, arms are weak, with neck pain 7/10. Pt reports recent virus. (+) Waddell's sign.  Medical w/u has been (-), so physch consult requested.. Pt has had multiple stressors recently. (+) insomnia. DX:  Conversion Disorder.  Anxiety Disorder./
NauseaVomiting inj site soreness, fatigue, nausea, vomiting, episodes of profuse diaphoresis Narrative:  Day 1 through 3 - inj site soreness, fatigue, nausea, vomiting, episodes profuse sweating
No adverse events were reported. The pt was noted to be taking prenatal vitamins throughout her pregnancy. At an unspecified time it was noted that there was premature labor. An ultrasound done on 26-SEP-1999 showed no anomalies. It was reported that during pregnancy the patient was positive for Group B strep. Follow up information received from a physician indicated the patient "moved to Texas". However, on 10/05/99, the patient gave birth via vaginal delievery to a healthy baby girl 8 lbs 6 oz and 20 1/4 inch long, 41 weeks from her last LMP. It was reported that there were no varicella zoster syndrome noted.The baby was seen by a physician on 10/09/99 who noted that she was jaundice. It was reported that the baby was breastfeeding and had two stoools on 10/07/99 and one on 10/08/99. Her bilirubin levels were 17.1 on 10/08/99, 16.1 on 10/09/99, and 11.1  on 10/10/99. No further information is expected.
10 minutes post first dose, tongue began tingling. Felt puffy but did not look swollen. Throat unaffected. 20 minutes post first dose, tongue tingling, jaw, teeth, and gums felt congested/tight. Currently 18 hours post vaccine, jaw mostly improved, tongue feels dry and burnt as if by hot food, but not actually burnt.
PATIENT WAS GIVEN VFC PURCHASED VACCINE WHEN SHE WAS INSURED AND TD SHOULD HAVE BEEN GIVEN DUE TO AGE AND NOT TDAP.
Acute renal failure secondary to hypovolemic shock. See attached history and physical 1/15/08-Discharge summary received with report for DOS 12/15-12/17/07-DC DX: Hypovolemic shock, resolved. Acute renal failure, secondary to hypovolemic shock resolved. Acute gastroenteritis, sepsis ruled out. Gastroesophageal reflux disease. Presented to ED with one day history of persistent vomiting, diarrhea, irritability and low grade fever. Day after immunizations developed diarrhea, 25 episodes, no blood or mucus. Vomiting. Temperature 99.1.
Pt returned the ED on 08/21/2017 reporting viral symptoms that started the day of immunization (4 days).
Patient develop a red lump on upper left arm where she received vaccine.  After going to the doctor, she was diagnosed with Cellulitis and given an antibiotic
3 days after injection:  Severe headache, severe fatigue, injection site pain and swelling, nausea, inability to eat, disorientation, dizziness, brain fog, pain and swelling of right occipital lobe (base of skull), zapping pain to right base of skull.  Shortly thereafter: Swelling and pain left side of throat and lower left jaw and face, tinnitus, chest pain, zinging electrical sensation to feet and hands (fingers), continuing brain fog, dizziness, inability to focus and concentrate, frequent migraine-type headaches, sensitivity to bright light, blurry vision.  Magnetism of injection site, forehead, upper chest (dime stuck to skin stayed on skin indefinitely and with movement  Shingles outbreaks in and around mouth
6NOV95 flu vax given immed rxn @ site finger size welt @ site which inc to nickle size;pt took DPH;7NOV95 area warm, red & swollen, seize of quarter;18NOV area red, swollen, warm & dark red area to center 2 1/2inches x 4 inches in diameter
Janssen COVID-19 Vaccine EUA.      Seven hours post-injection was dizzy. A half-hour later started chills, shaking, back ache, thigh ache. By 10 hours post-injection also had headache and fever of 101.0. Took 1 Tylenol 500mg. By 11 hours post-injection the headache progressed to migraine. Took 1 OTC migraine pill (like Excedrin Migraine). By 12.5 hours post injection, fever reduced to 99.3 and headache improving, however nausea started. Through-out the day, nausea and mild migraine continued. They were mostly resolved by 24 hours post-injection.
Hot injection site; Red injection site; Site of injection started itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot injection site), INJECTION SITE PRURITUS (Site of injection started itching) and INJECTION SITE ERYTHEMA (Red injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Site of injection started itching). On 21-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hot injection site) and INJECTION SITE ERYTHEMA (Red injection site). At the time of the report, INJECTION SITE WARMTH (Hot injection site), INJECTION SITE PRURITUS (Site of injection started itching) and INJECTION SITE ERYTHEMA (Red injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Since receiving the vaccination, patient has suffered from spontaneous breakouts and lesions on back, face, neck, and legs leaving scarring throughout the body.  Postules have formed and never permanently disappeared, sometimes leaving hard cyst like pockets beneath the skin.