chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-JUL-2017, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, via subcutaneous route in the abdomen instead of the recommended subcutaneous route in the deltoid area of the non-dominant arm as recommended in the prescribing information (dose, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported and no further information was provided. No product quality complaint (PQC) was involved.
A non-serious spontaneous report of "administration of expired product" was received from a registered nurse concerning a five-year-old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The product expired on 19-Jan-2010. On 01-Feb-2010, the patient received expired product. 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.
I have had daily headaches starting in April, 2021.  I have been to the primary care doctor; neurologist; and heart doctor.  I have a brain MRI and it shows normal.  After the 3rd Moderna vaccine, the intensity of the headaches have increased.
Information has been received from a nurse in a physician's office concerning a pediatric patient who may have been vaccinated with a dose of Varivax (lot# not reported). Subsequently the patient developed a mild case of chicken pox, 8-15 lesions. The patient's outcome was not reported.
World smells of mold/earthy; Everyday sounds seem way too loud; Immediate metallic taste all food taste metallic; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 07Apr2021 at 17:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously took malarone on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 17:00, the patient experienced immediate metallic taste, all food tasted metallic. On 09Apr2021 (Friday morning), the patient began to experience world smelled of mold/earthy and everyday sounds seemed way too loud; the metallic taste lessened by Friday, but still overridden the taste. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events metallic taste, world smells of mold/earthy and everyday sounds seem way too loud were not resolved.  No follow-up attempts are needed. No further information is expected.
Patient reports heat and swelling at injection site, followed by fever which started around 8 am on 8/15. Pt complaints of "heavy chest feeling that hurts to take deep breaths". Patient states that she has been "hurting from head to tow and has stayed in bed all day". Patient called pharmacy to report these symptoms at approximately 6:30 pm on 8/15/18.
pt to ED for increasing SOB over several days; was seen a dr's office for SOB and hypoxemia and told to come to ED; c/o cough; O2 sats in 70s on RA; started on 6 L O2 via NC; eventually transitioned to BiPAP due to worsening oxygenation; COVID test positive; placed on steroids, antibiotics, remdisivir, baricitinib; eventually required intubation and went into septic shock; condition deteriorated and pt expired in the hosp; acute hypoxic respiratory failure with multiorgan failure secondary to COVID
This spontaneous report as received from a medical assistant referring to a 22 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. It was unknown if the patient was previously vaccinated with M-M-R II. On 20-NOV-2017, the patient was vaccinated with a dose of M-M-R II, 1 dose, lot # reported as N029919 with expiration date 13-JUN-2018, for prophylaxis (route of administration was not provided). Concomitant therapies included sterile diluent (STERILE DILUENT). On an unspecified date in 2017, the patient had "negative bloodwork for immunity" to all three components of M-M-R II. At the time of reporting the outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was unknown. The causality assessment between the events and M-M-R II was not provided. Lot number N029919 is an invalid lot number for  M-M-R II.
developed a scratchy throat at 2100 and by 2130 felt like throat was tightening. Went to ER  and received Benedryl 50 mg IV, Solu medrol IV and protonix IVPB.
Patient received dose of Pfizer EN6200 on 2/19/21 and then received a dose of Moderna 003A21A on 3/6/21.  No adverse reactions were reported to health department
Gained 18 pounds in about 1 week with pitting edema around both ankles and lower legs. Pitting edema resoved after second shot and weight gain is slowly resolving. I have lost about half of it at this time
24 hrs p/vax pt began to cry inconsolably-w/episode of falling into deep sleep;
Narrative: Was pt previously covid positive?- Yes. Initial- 10/27/2020, 11/29/2020, 12/22/2020 Are there any predisposing factors for patient experiencing adverse drug event?- Yes, patient had multiple co-morbidities including GI bleed, hepatitis congestion due to cardiac issues, treatment for PE, NSTEMI, or antibiotics for PNA, also on concurrent medications APAP, Atorvastatin, Mirtazapine and Duloxetine. Pt with 2 doses of covid-19 vaccine, second one on 01/08/2021, 2 days pre-death Any occurrence of an ADR at time of administration? Did not specify injection site issues, per RN admin note- Vaccine "administered without complications." Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation period and date of death? No Did patient recover from event? No (01/08/2021 event, died 01/10/2021) Was patient hospitalized prior to vaccination? Yes, in between inpatient and nursing home Was patient hospitalized prior to death--was hospitalization attributable to ADE? Yes re-admitted to inpatient on 12/31/2020. GI bleed Is there an alternative cause of death? Yes, as noted above. Quite a complicated case with many comorbidities/concurrent medications as noted above. Primary Diagnosis: Upper GI Bleed in the death note from 01/10/2021
The patient visited the pharmacy to receive the Pfizer Bivalent dose, instead the pharmacist administers the Pfizer monovalent dose. Patient received the Pfizer Monovalent.
Approximately 9 days post vaccine, patient developed redness, warmth, itching at and around site of injection about palm size. For the past 5 days the site has slowly enlarged. Current Treatment:  started 01/12- Keflex 500mg 4x day q 10 days.  Status: no increased spreading Current Treatment: fresh aloe, topical Status: no itching
Fever within 1 1/2 hrs of immunization fever spiked to 103.4 was taken to emergency room had a high white blood count of 24.0 was given rocephin injection doing much better 24 hrs later.
HPV vaccine for right foot finger warts; This literature marketed report has been received from the authors of the published article, concerning a 32 year old male patient. The patient's pertinent medical history included therapy with liquid nitrogen, duct tape and curettage. The patient's current conditions and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for left foot (plantar) warts (product use in unapproved indication( (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  This is one of several reports received from the same literature.  Sender's Comments:  US-009507513-1912USA001729:
inadvertently received a two dose of FLUZONE QUADRIVALENT vaccines instead of PENTACEL (VERO) with no adverse event; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case received from a physician and non-healthcare professional via Medical information (under reference number - 00786957).  This case involves a patient of (unknown demographics) who inadvertently received a two dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] vaccines instead of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (extra dose administered).  The patient had no medical history, concomitant disease or risk factor.  Past medical treatment, vaccination, family history and concomitant medications were not reported.  On 27-Sep-2021, the patient received a two dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was case of actual medication error due to extra dose administered.  At the time of report, no adverse event was reported.  There were no laboratory data/results available.  Event outcome was 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.  There will be no information available on the batch number for this case.
I experienced a breakthrough bleed and went to see my doctor because I'm post menopausal. My doctor decided to do an ultrasound and found that the lining of my uterus was thicker than normal. A Hysteroscopy to exam the inside of the cervix and uterus to collect tissue for a biopsy along with removing a polyp. I'm currently awaiting the results of the biopsy.
Patient developed a very faint, nonerythematous, slight hyperpigmentated, flat circular lesion on the upper LEFT deltoid at the site of a vaccine injection.  Very subtle, visable with close exmaination of patient.  No treatment required.
Flu like effects. Mild fever, aches, light headed, tired, lack of appetite.
Elevated heart rate; Pain in injection site area; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Elevated heart rate) and VACCINATION SITE PAIN (Pain in injection site area) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 21 (indecipherable) and 025BUN) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced HEART RATE INCREASED (Elevated heart rate) and VACCINATION SITE PAIN (Pain in injection site area). On 17-Apr-2021, HEART RATE INCREASED (Elevated heart rate) and VACCINATION SITE PAIN (Pain in injection site area) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Heart rate: high (High) upto 110 bpm, elevated for a while.         No Concomitant product use was reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-080063 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080063:dose 1
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 16-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, when the vaccine received to pharmacy on 23-Feb-2022, the pharmacy staff member looked up the expiration date and came up with expiry date of June 2022. However, the vaccine expired on 01-Apr-2022.  The vial was initially stored in refrigerator on 04-Apr-2022 and the vial did not undergo any temperature excursions.  No treatment information was reported.
About 25 minutes after receiving vaccine complained of dizziness and being hot and nauseated. No difficulty breathing. No chest pain. B/P was 130/90 and was monitored. It went down to 124/80 after he started feeling better. He was wearing sweater over shirt and it was warm in building. Took sweater off. Cool wet cloth applied to back of neck. States he had only had a donut and cup of hot chocolate before receiving vaccine. Sprite and peanut butter crackers given. Became nauseated after eating peanut butter crackers Blood pressure monitored monitored. He laid on exam table for about 15 minutes. He felt better. Stood up and walked to conference room for another 15 minutes. Stated he felt much better and was ready to leave. Coworker drove him back. Received email from him letting us know he had made it back and they had stopped and eaten pizza on the way. Received text from coworker that he was dizzy and seeing spots and that his blood pressure had been 120/80 and then spiked to 160/100. Coworkers taking him to ER at Hospital for evaluation.
TSH became severely elevated. ( Greater than 150 .  Range is 0.40-4.5)  Thyroid became swollen and painful.  Treatment is still being mapped out.
Patient called this am and stated that since she had her injection yesterday, has a sore throat, fever and doesn't feel well.
Pustular/papular rash on extremities  R>L Low grade fever (99.3), Headache, nausea
pt reported that 7 days after receiving moderna 1 she developed an intense headache that shes never experienced before and it lasted 6 days-she went to the er and also felt pain behind her left eye. she had a Cat scan that showed bleeding in brain and saw neurosurgeon in icu for 2.5 days then had repeat testing mri done which showed bleed was stable. she was transferred by ambulance to another medical facility to see ophthalmologist to check pressure behind eye, she stayed for observation until repeat mri with and without contrast and decision that blood would be absorbed into tissue and surgery not needed. pt said she tried to report event three times from hospital but was unable to get through to vaers via phone
whole family started to get sick and experiencing same things she experienced (chills, not feeling well); whole family started to get sick and experiencing same things she experienced (chills, not feeling well); This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported similar events for two patients. This is the second of two reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported her mom received COVID vaccine on the 23Dec2020. On the 29Dec2020, her whole family started to get sick and experiencing the same things she experienced (chills and not feeling well). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. On 13-AUG-2015 the patient was inadvertently vaccinated with an expired dose of MMR II (dose, frequency were not reported, expiration date 11-JUL-2015) subcutaneously. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Severe nausea, chronic vomiting. Inability to keep anything down including water, tea, broth.
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 26-OCT-2015 23:34, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 6.0 and 2.8 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.
This spontaneous report was received from a physician refers to a 80 years old female patient who in 2008, was vaccinated subcutaneously with a 0.65 ml dose ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included SYNTHROID, LIPITOR, PLAVIX, TOPROL XL TABLETS, lisinopril (manufacturer unknown) and LEXAPRO. The physician reported that on 29-AUG-2012, the patient came to the office and was diagnosed with a case of shingles. Prednisone and VALTREX were given as a treatment for the experience. At the time of the report, the patient had not recovered.  The relatedness for patient was diagnosed with a case of shingles was unknown for ZOSTAVAX. Additional information has been requested.
First day: chills, headaches, muscle aches, joint aches, second day: itchy rash on hands, feet, and breasts, itchy eyes and nose, sneezing
I24.8 DEMAND ISCHEMIA 3/15/2023 DIASTOLIC HEART FAILURE, CHRONIC R09.02 HYPOXIA 3/4/2023 DIASTOLIC HEART FAILURE, CHRONIC I24.8 DEMAND ISCHEMIA 3/15/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA R09.02 HYPOXIA 3/4/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
This spontaneous report as received from a registered nurse refers to a 3 months old patient of unknown gender. The nurse reported that on 17-JAN-2014, the patient was vaccinated with the first dose of ROTATEQ, (Lot # J007283), expiration date: 27-SEP-2014. Route and dose were not reported. On 04-MAR-2014, the patient received the second dose of ROTATEQ, (Lot # J007283), expiration date not reported. No other co-suspect or concomitant medications were reported. The nurse reported that both doses received by patient were vaccines improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading in the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Swelling face; Chills; Face is deep red; following day my face started getting red; Swelling is going down a little bit now, but it itches; Swelling is going down a little bit now, but it itches; I have been sleeping for 2 days; This is a spontaneous report received from a contactable consumer (patient). An 84-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and Lot Number: EL3247) via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. The patient medical history included Blood pressure. Concomitant medication included VITAMINS NOS. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EJ1686; Expiration Date: unknown) on 21Jan2021 for COVID-19 immunization. The patient experienced swelling face, chills, face is deep red; following day my face started getting red swelling is going down a little bit now, but it itches, I have been sleeping for 2 days. The patient underwent lab tests and procedures which included blood test and results was unknown on 21Jan2021. The outcome of events swelling face, chills, face is deep red; following day my face started getting red, swelling is going down a little bit now, but itches was unknown. The swelling is going down a little bit now was recovering. The outcome of event I have been sleeping for 2 days was recovered on an unspecified date.
Case number PHEH2015US018332, is a spontaneous report initial received from a consumer (patient) on 17 Sep 2015. This report refers to a 65 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1516101, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly into left arm on 15 Sep 2015. She got the vaccine at her work place. On 16 Sep 2015 she started experiencing flu symptoms and felt miserable. She had symptoms of flu for two and a half days after the flu shot. The patient was not treated by a physician. The outcome, seriousness and causality of the event were not reported. Follow up information received from the consumer on 26 Oct 2015: Updated expiry date of suspect vaccine and clinical notes.