chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 40 year old female. Initial information was processed along with the additional information received on 21-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (with wheat and soy), and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 for covid-19 prophylaxis. Concomitant medications included beclometasone dipropionate, levocetirizine dihydrochloride, levothyroxine, montelukast, and tranexamic acid for drug used for unknown indication.  The patient received treatment with non company suspect Paxlovid (form of admin, route of admin, batch number, and expiry were not reported) dose was not reported, administered on 22-JUN-2022 for Covid-19 treatment. On an unspecified date, the patient tested negative after finishing the paxlovid then six days later she started feeling nasal congestion (confirmed covid-19 infection) and tested positive again on 11-JUL-2022 (confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with Paxlovid was treatment discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000243164.; Sender's Comments: V0- 20220737625-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient was given half dose of Moderna Bivalent Booster 0.25mcg not 0.5mcg. Wrong dosage given
Chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included SPIRONOLACTONE, PRAVASTATIN, LISINOPRIL, LORATADINE (LORATADIN), LATANOPROST and TIZANIDINE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (Chills) and PYREXIA (fever). In March 2021, CHILLS (Chills) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was unknown.   This case was linked to MOD-2021-379721 (Patient Link).
Information has been received from a physician concerning a female who was vaccinated with her first dose of Gardasil. Subsequently the patient experienced rash. The physician thought it might be an allergic reaction. Additional information has been requested.
Information has been received from a 42 year old female patient with acid reflux, a history of measles as a young child, and no allergies, who on 21-JAN-2006 was vaccinated with a subcutaneous dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Concomitant therapy included tuberculin purified protein derivative, hepatitis B vaccine, recomb (manufacturer unknown), tetanus toxoid, medroxyprogesterone acetate (DEPO-PROVERA) and omeprazole. On 21-JAN-2006 the patient experienced hot flashes at night and during the day she felt flushed and warm. At the time of the report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information is not expected.
Renal failure; Liver failure; Unresponsive; Died; Stomach pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive), DEATH (Died), RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Primary biliary cirrhosis.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced DEATH (Died) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criterion hospitalization) and HEPATIC FAILURE (Liver failure) (seriousness criterion hospitalization). On 23-Apr-2021, RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) had resolved and NAUSEA (Nausea) outcome was unknown. The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, UNRESPONSIVE TO STIMULI (Unresponsive) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.            The concomitant medication included liver medications, as reported by the reporter. On 07Apr2021 around 1230pm, the patient experienced stomach pain and nausea which the family attributed to her liver medications. The patient went to sleep later that evening. The next day, 08Apr2021, the patient was found to be sleeping around 8am but was unresponsive around 1:30pm. She was taken by ambulance to the local hospital. The patient was eventually placed on life support and passed on 23Apr2021.  No other treatment medication were reported.  Company comment: Very limited information regarding this events has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.; Reported Cause(s) of Death: unkown cause of death
This spontaneous report was received from a nurse, referring to a 4 months patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 29-JAN-2018, the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # N013884, expiration date 05-DEC-2018, for prophylaxis (strength, dose and frequency were not reported). The temperature excursion was 9 °C to 25°C (11.3°C) for 1 hour 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
employee states she started with symptoms 2 days post injection to left deltoid . symptoms are as follows: redness 3 in across injection site, warmth and hardness around injection site.
Minor Soreness at injection Site, Severe fatigue, muscle pain, general malaise,loss of appetite,confusion, acceleration of metabolism,,loss of regulation of body heat and cold. Lowered blood pressure, high pulse rate.(100). Continues for about 36 hours and subsided. Note that same reaction for second dose but not as severe.
I awoke with facial paralysis on the Right side of my face (could not close my eye, my mouth was drooping and I could not talk well or eat/drink).  A trip to the emergency room ruled out a stroke, and Dr. determined it was Bell's Palsy. I was given prescriptions for Prednisone, Acyclovir, White petrolatum mineral eye ointment and Artificial Tears, and was told to take OTC pain medication for the pain and headaches. Improvement began after approximately 4 weeks and is slowly improving, though I still cannot close my eye, mouth droops, and I wake with terrible headaches and pain on the right side of my head and neck.
101 fever, vomiting, pain behind knees, armpits neck, swollen bump on collar bone, headache
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In September 2018, less than a week after receiving SHINGRIX, the patient experienced adverse reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse reaction and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: On 17th September 2018 (Monday) or on 18th September 2018 (Tuesday), the patient received a dose of SHINGRIX vaccine subcutaneously instead of intramuscular route at a local pharmacy, which led to incorrect route of vaccine administration. The patient came in to report on Wednesday, with adverse reaction to SHINGRIX, which was based on that. The nurse stated that the office called GlaxoSmithKline (GSK) to make sure that, the dose was a valid dose and stated, they received a Medical letter from GSK about it. The reporter agreed for follow up. This case was linked to the case US2018171032, reported by the same reporter.
Discharge Provider: Primary Care Provider: MD Admission Date: 3/2/2023 Discharge Date: Mar 6, 2023  PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE: 80 y.o. male with a PMH of OSA C-pap, Obesity, Essential Hypertension, GERD, T2 DM, and Migraines, who presents today with severe generalized weakness. That started 2 days prior to arrival. Patient admitted for further management of weakness associated with COVID. In the ER the patient was febrile with a temp 39.1 C.  COVID positive. Patient without respiratory distress saturating well on RA, and thus did not warrant treatment for COVID, was treated with supportive care. PT/OT evaluated patient and recommended SAR initially but was able to progress to home with home health care. Patient medically stable for discharge home 3/6. Also enrolled in transition to home program for further monitoring once discharged
This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 04-SEP-2015, the patient was vaccinated with improperly stored VARIVAX (lot # L006386 and expiry date: 25-FEB-2017) injection of dose 0.5 milliliter (ml) once, subcutaneous. No concomitant medications were reported. No adverse events were experienced by the patient. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. No further information was provided. Additional information has been requested.
Bad headache in back of head.  Pain behind both ears.  Fever of 102.1 for short time.  Extreme fatigue.
Patient stated that he had a rash like chickenpox all over his body that started the next day. It lasted about a week. He reported this to his doctor as well.
After receiving the vaccine, patient claims her was sore and she could not move it very well without pain. She thought it would go away, but after a little over a week and no improvement, she came to the pharmacy to report it. I told her to go to her PCP and have them examine her. Her PCP could find neither infection nor inflammation and recommended the patient get an MRI to see if there was nerve damage. Have not heard any further from the patient.
This is a spontaneous report received from contactable consumer or other non-HCP (the patient). A 63-year-old male patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FH8030), at the age of 62, in left arm, Nov 16, 2021, at 18:45, single dose, for COVID-19 immunization. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot# unknown) for immunization. No medical history or concomitant medications. The patient experienced COVID-19 (medically significant), onset 2022, with outcome of not recovered; and ineffective drug/vaccine brand: Pfizer BioNTech/product: COVID-19 treatment (medically significant), onset 2022, with outcome of unknown. Therapeutic measures were taken as a result of COVID-19 and ineffective drug. Additional information: No other medication in 2 weeks.  No follow-up attempts possible. No further information expected.
Initial misuse report received from a nurse on 11 November 2013. The patient had received only DTaP/IPV component of PENTACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
After the fourth dose of rabies vaccine administered to this client (Immune Globulin and Imovax Rabies vaccine doses on days 0, 3, and 7 having been given without incident), this patient developed soreness and redness at the area of injection in the left deltoid muscle within a few hours.  Family physician was unable to determine if this was a hypersensitivity reaction or possible cellulitis, so prescribed antibiotic.  Retrospectively she mentioned that the 3rd dose "had been sore and a little red" as well.  The 5th dose scheduled for day 28 was witheld per order of the Health Department Medical Dlirector and corroborated by the Deparatment of Health, the risk for vaccination reaction being considered greater than that for rabies, as contact with the animal (a bat that was not available for testing) was not verifiable.  (It had been in her home for an undetermined amount of time, possible during sleep hours.)
Redness in arm and tenderness in arm for 2 weeks after - Miscarriage happened in pregnancy.
Covid-19; Covid-19; This was a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter was the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), on 05Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 22Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CLL" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "BPH" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM DS; LOVASTATIN, stop date: 09Apr2022; DULERA; LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
exposed to covid and symptomatic; Congestion; cough; runny nose; fatigue; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included glaucoma, OAB (hypertonic bladder), osteoarthritis all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced exposed to covid and symptomatic, congestion, cough, runny nose and fatigue. The patient underwent lab tests and procedures which included Covid rapid test (sars-cov-2 test): negative on 03Aug2021. Reportedly, event took place after use of product. Outcome of the events were unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Red, slightly swollen arm where the shot was given. Strength loss in arm and fingers felt numb.
01/28/22 presents to ED for "dyspnea and cough". PMHx of " CAD s/p MI and stents 2009"
Site: Pain at Injection Site-Medium, Additional Details: Per pt, had soreness at the site of injection the day of the shot, but expected it to fade after 24 hours,  unfortunately the pain  has not subsided even after 2 weeks. The pain spreads down arm when pt moves. Range of motion is limited. Contacted patient to follow up, however, pt refuesed to give any information.
Both my sons had the GARDASIL vaccines, my one son has been permanently changed by it. He experiences anxiety, mood swings, depression, trouble sleeping ever since he was given vaccines.
Information has been received from a medical assistant referring to multiple patients of unknown ages and genders. The patients' medical histories and concurrent conditions were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of M-M-R II (lot # L027591, expiration date 23-JUL-2017) subcutaneously. Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vertigo - dizziness from 12/2-12/6 (not yet resolved) Headache 12/1/21 - 12/6 not yet resolved Chills - 11/30 - 12/6 on and off throughout the days
nursing mother; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (nursing mother) in a  child of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the child was diagnosed with EXPOSURE VIA BREAST MILK (nursing mother). At the time of the report, EXPOSURE VIA BREAST MILK (nursing mother) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned.
Felt very dizzy and like she was going to throw up. She was then unconscious for about a minute.
PATIENT REPORTED CLASSIC SYMPTOMS OF BRUSITIS - UNABLE TO LIFT LEFT ARM & SHOULDER ABOVE HEAD FOR ABOUT 5-7 DAYS AFTER IMMUNIZATION. HAS BETTER RANGE OF  MOVEMENT NOW BUT STILL SORE AT SHOULDER
Pt reports that about a week after his vaccination he was reporting to his infectious disease doctor and his blood pressure was so elevated to the point of hypertensive crisis and they debated sending him to the ER.   He also had he blood pressure tested by a relative who is a dental hygienist and he trusts is medically competent to test blood pressure, and was found to still be elevated days later.  He was advised to test his blood pressure to verify it was not White Coat Hypertension, and it is still remaining elevated, as is his girlfriends, weeks later.  He reports that this is consistent with information he has, "read online."  and wants this reported as an adverse effect of the vaccine, as does his girlfriend.  He reports no lifestyle changes or medication changes since the vaccination and will follow up with pcp.
Began to experience constant exhaustion and dizziness 2 days after receiving the 2nd dose of the vaccine. Daily life is difficult and been unable to return to work due to the effects of the vaccine. The symptoms persist as of the writing of this report.
Information has been received from a physician concerning a 38 year old healthy female who was vaccinated with 2 doses of varicella virus vaccine live, four weeks apart.  One month after the second dose the patient had a negative titer.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
SORE ARM LOCALLY, OVERALL WEAKNESS AND LETHARGY FOR 2 DAYS.
This is a spontaneous report from a Pfizer-sponsored program SNOW Patient Testimonial Recruitment . A non-contactable consumer reported for himself. This male patent received PREVNAR 13 via an unspecified route at single dose for immunization in Mar2017. The patient reported that his cough has come back and worse. No follow up attempts are possible. No further information is expected.
FLUCELVAX was administered to the patient. She sat for a few seconds, then passed out upon standing up. Mom was there to catch her and lowered her to the floor. She woke up after a few seconds and said she just felt lightheaded after getting the vaccine. Pharmacy staff offered her water and candy. She perked up and said she thought she has "psyched herself out" before getting the vaccine.
pt recv vax 19MAR98 & soon after exp a wiped-out feeling, lightheadedness, soreness @ the inj site, sore locally & travels up to neck, pain down the arm & a sl h/a;