chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2014, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
After the second in a series of three rabies vaccinations, I experienced fatigue, extreme motion sickness to the point that walking was difficult, debilitating nausea, pain in injection arm (left), injection arm numbness.  These symptoms lasted for three days, and afterwards I recovered with no lasting effects. The first and third shots caused no problems, and I told the vaccine administrator of the problem.
Patient started breathing heavy and advised EMT that he was feeling dizzy.  Patient was sweating heavily and stated he had not eaten anything.  EMT took vitals.  Everything normal. Patient is fine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a patient who received Flu Seasonal TIV Dresden (Flu trivalent vaccine) for prophylaxis.  Co-suspect products included bupropion hydrochloride (Wellbutrin) unknown for product used for unknown indication. Concurrent medical conditions included drug allergy (Chantix (Varenicline), Ciprofloxacin, Flagyl (Metronidazole Hcl), Zithromax Z-pak (Azithromycin), Paper tape).  On an unknown date, the patient received Flu trivalent vaccine at an unknown dose and Wellbutrin at an unknown dose and frequency. On an unknown date, unknown after receiving Flu trivalent vaccine and Wellbutrin, the patient experienced drug allergy, drug intolerance and psychological disorder nos. The action taken with Wellbutrin was unknown. On an unknown date, the outcome of the drug allergy, drug intolerance and psychological disorder nos were unknown. It was unknown if the reporter considered the drug allergy and drug intolerance to be related to Flu trivalent vaccine. It was unknown if the reporter considered the drug allergy and psychological disorder nos to be related to Wellbutrin. Additional details were provided as follows: The age at vaccination was not reported. The patient was allergic and intolerant to trivalent influenza virus vaccine and experienced allergy and psychological reactions due to Wellbutrin. The patient was also allergic to Chantix (Varenicline) and experienced gastro-intestinal distress; Ciprofloxacin, Flagyl (Metronidazole Hcl) and Zithromax Z-pak (Azithromycin) and experienced hives and due to paper tape, the patient experienced intolerance.
pt states that she developed a red, feverish, inflamed, itchy spot on her below the injection site and above the elbow of the left arm.  Pt had an appt w/ her oncologist which took a  look at it and told her it looked she had cellulitis.  She was prescribed Bactrim and prednisone.  She said she took it for 5 days and it has since cleared up.
Stillbirth. 11/18/09 and 11/19/09 DC summary and hospital records received for date 11/9/09 to 11/10/09. DX: fetal demise, stillbirth.  Pt. found to have no fetal cardiac activity via US. 36wk pregnant Pt. states felt movement in AM. Pt states received H1N1 vax on 11/6. Pt. had late PNC, GDM, AMA. At time of delivery, infant normal in appearance, but noted a tight nuchal cord, tight body cord at time of delivery.
Patient received vaccine, fainted in front of store while with father.  Brought her back to pharmacy where she sat for 15 minutes and regained her color.
Had a rash that started on her legs with intense itching.  The rash was very red and blotchy (she said it looked strange), somewhat raised.  It moved up to her neck and back.  She asked her boss, who is a physician and he gave her an allergy medication.  She did not know the name.  She did say it was not Benadryl.  She said she had the rash for a couple of days and continued to take the medication for that time.  She has no known allergies
The first dose of the vaccine I felt really bad; Strong headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "The first dose of the vaccine I felt really bad"; HEADACHE (non-serious), outcome "unknown", described as "Strong headache".  Additional information: Proprietary medicinal product name: Pfizer-BioNTech Covid-19 Vaccine. Patient got the Pfizer-BioNTech Covid-19 Vaccine last week and her husband too, Patient had a family member who got sick with the COVID 7 months ago, she got really sick and had trouble breathing, it was serious and asked whether she should get vaccinated or not. The first dose of the vaccine patient felt really bad, she had a really strong headache and other symptoms, but patient feels better now. It was reported that patient felt the first dose very strong. The report was non-serious  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
15 year old patient was inadvertently given  the Janssen/Johnson & Johnson vaccine in error. J&J is  currently not FDA approved for patients under 18 years of age.  Patient was monitored for 30 minutes and exhibited no adverse symptoms.  Patient's mother was advised of the administration error and provided contact numbers for follow-up, if necessary.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01May2021 as dose 1, single (Batch/Lot number: unknown), on 13Dec2021 as dose 2, single (Batch/Lot number: unknown), on 14May2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2012, stop date: 12Nov2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Negative, notes: Positive test 7 days after negative test. The negative test was taken 7 days after start of Paxlovid; (Nov2022) Positive, notes: Positive test 7 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 30Oct2022 to 04Nov2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax & 4hr later devel severe hives, a rash, heart palpitations & became lightheaded;tx w/DPH;
Uncontrolled hiccups; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 11Mar2021 at 10:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. The medical history included suspected COVID-19 in Jan2021 but rapid tested negative and became asymptomatic in Mar2020, asthmatic and Type 2 Diabetes mellitus (T2D). Concomitant medication included montpellier metformina clorhidrato (MANUFACTURER UNKNOWN) 500 mg per day for unknown indication. The patient was allergic to seasonal and pets. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. The patient had not tested positive for COVID-19 since vaccination. On 18Mar2021 at 06:00, the patient experienced uncontrolled hiccups after food ingest that stopped only under the following circumstances such as symptoms arose on 3/17 and had not ceased since high intensity while exercises and sleep. The patient did not receive treatment for the reported events. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event uncontrolled hiccups was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Parents describe "hives" locally on the left thigh where administered. Itching reported. After 5 days, red papules only left.
I woke up at 2 AM in the morning and  had unbearable pain in my legs, as if I had run a marathon, but laying down was not helping, nor was stretching etc. I almost went to the emergency room because it was so painful. I took Aleve and it eventually helped, but this morning my legs are still feeling weak down to my bones. I am afraid I have nerve damage.
Fussy: irritable within two hours of vaccine lasted around 12 hours. No fever. No V/D. CBC checked WNL. No treatment.
BlurrdVision, Headache, Myalgia, Fever, Loss of vision for several hours Narrative:
General aching, fever, fatigue on 10/14. Much of that resolved by abdominal rash appeared on 10/15. Not raised, no itching.  More on left than right, but then went to right side and then around to both blank areas, then chest, then side of neck. Spreading occurred over 6 hours. NP prescribed oral steroid (prednisone 20mg x5 doses, one daily). Rash began to resolve about 2-4 hours after first dose.  Rash totally gone by midday 10/16. No rash since.
Patient had vaccine administered at 10:11AM. Patient returned to pharmacy with parent (mom) visibly weak and incoherent approximately 15 minutes after receiving vaccine. Patient was moved to pharmacy waiting room and blood pressure was immediately taken. Patient did not report difficulty breathing, swelling of lips, tongue or throat. Just that she was very dizzy and could not hear. Blood pressure 75/30, Heart Rate 44 bpm. with first reading. Second reading 75/30, Heart Rate 50 bpm. EMS was activated immediately and arrived approximately 5-7 minutes. Patient was provided with bottle of water and remained under pharmacist observation until EMS arrived. Patient did not lose consciousness and reported feeling better after sitting down. EMS reported her blood pressure was 80/54 and patient was taken to the hospital for fluids and further observation.
Patient admitted with a positive COVID-19 breakthrough case. Presented with cough, fever, SOB. Nonverbal patient. Staff state that symptoms began on 9/28/21.
PT given influenza vaccine on 11/12/07.  Second influenza vaccination given on 11/14/07 due to miscommunication between physician and nurse.
itchy rash on arm, has increased in size; This case was reported by a consumer and described the occurrence of itchy rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number D9CB9, expiry date unknown) for prophylaxis.   On 29th September 2022, the patient received the 2nd dose of Shingrix. On 2nd October 2022, 3 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   The reporter considered the itchy rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The case was reported by the patient.  The patient had Shingrix shot.  As a result of 2nd shot, she had a rash on the underside of shot arm.  The patient was concerned as the rash as increased in size and was itchy.  This was not one of the side effects that was listed for this vaccine.
received the YF-VAX via intramuscular route; Initial information received on 16-Aug-2019 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to cases 2019SA233343, 2019SA233344 and 2019SA233345 (same reporter).  This case involves a 46 years old patient (gender not reported) who was vaccinated with a 0.5 ml  dose of vaccine YELLOW FEVER VACCINE - US [YF-VAX] lot U6288AB (Exp. Date not reported) via intramuscular route in the left deltoid on 13-Aug-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate route of vaccination. The vaccine must be vaccinated with subcutaneous route and not with intramuscular and intravenous route.  It was unknown whether the patient experienced any adverse event post 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 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.  List of documents held by sender: none.
Pt whose daughter was vaccinated with varicella virus vaccine live in August of 1999, was diagnosed with shingles that consisted of one little spot on his torso in September of 1999. Pt never received the varicella virus vaccine live. This may be a possible case of secondary transmission. Additional information has been requested.
Patient received 4yr immunizations on 03/31/08 and mother noticed redness on left thigh. Mother states the redness started half the size that the redness today. No complaints of pain, no fever. Mother applied warm compress to the site. Seen by physician today, advised warm compress and Advil PO.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 1:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.19 for dose administered on 11-Jan-2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11-Jan-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 02:00 PM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 11-Jan-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This case was reported by a nurse who experienced joint pain after she received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  At an unspecified time following an unspecified number of doses of Engerix-B, the pt experienced joint pain, neck stiffness and headache.  The events were unresolved as of 10/23/03.  Report received via manufacturer.
Right thigh has swelling and is hard to touch. It is red and blochy, hot to touch. Painful and itching.
Pericarditis: 4 days after vaccination classic symptoms/ EKG, positive rub on exam TX: anti-inflammatory.  11/27/07 Reviewed hospital ER medical records of 11/8/2007 which reveal patient experienced pleuritic chest pressure that increased when laying down, SOB, productive cough of clear sputum, indigestion, nausea, vomiting x 1 day.  Exam revealed (+) friction rub, abdominal tenderness.   Tx w/ASA & d/c home to f/u w/cardio in AM. FINAL DX: acute pericarditis.
Patient needed blood work and PPD and also a Gardasil 9. Pt tolerated blood work and the PPD but as when the Vaccine was given she started getting sick and passed out with nausea and headache. FNP and MA sat in the room with pt unti she started feeling better. 4 MG of Zofran was given to help with the nausea.
Bronchitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (Bronchitis) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (Bronchitis). At the time of the report, BRONCHITIS (Bronchitis) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  Treatment medications included unspecified antibiotics and a steroid pack.
sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for different patient. This is the first of two reports.  A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included egg allergy, bladder cancer and surgery.  There were no concomitant medications. It was reported that the patient had a sore arm after getting the shot. The outcome of the event was recovered on an unspecified date in Jan2021.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106756 same drug, same event and different patient
Sudden onset of unilateral sensorineural hearing loss with tinnitus, 6 days post injection. No other precipitating factors or prior history.
Sore Throat  This is a new problem. The current episode started yesterday. The problem has not changed since onset.There has been no fever. Associated symptoms include diarrhea (x3 over 24 hours, watery), trouble swallowing and cough (yellow production). Pertinent negatives include no congestion and no shortness of breath. She has tried nothing for the symptoms.  No loss of taste or smell.  COVID vaccinated x2
fever 104 that evening, screamed all next day then fever returned by 26JUL95 when seen in office, temp 97.9;
The patient presents with a complaint of palpitation while in observation area. Began feeling nauseated with lightheadedness and seen black spots no emesis. No chest pain. No respiratory distress. EMS on site. Patient agreeable to transfer to ED. Family on site. Supination PO fluids given and tolerated relaxation and deep breathing encourage throughout.
Left arm been hurting for weeks. Pain went up left side of neck and down left shoulder blade. Today is 4/13/2021 pain in next and shoulder blade nearly gone. Injection site still touchy.
Pt presented with anaphylactic symptoms (labored breathing, swollen/flushed face, sweating, dizziness, extreme pain in spinal area) within 60 to 90 seconds of receiving Fluad High-Dose for 65 yrs +. She was given Epipen IM within 1-2 minutes and EMS was called and responded within 5 minutes, by which time patient's symptoms were improving.