chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. 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), 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 condition of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as 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.
pt revd vax & woke up w/hives-skin red, hands & feet & around eyes swollen; general puffiness all over; hive like eruption; urticaria w/itching; rx DPH;
The patient presented to the pharmacy with a swollen left arm and hand. She said that it started after receiving her second dose of the Shingrix vaccine. I suggested she saw a general practitioner. She was prescribed a course of prednisone and the following day 8/21/19 she said that she was significantly better. She said the Dr. told her she had a reaction to the Shingrix vaccine.  On 8/22/19, she said she tweaked her arm while putting on her seat-belt and had restricted range of motion.
Vaccine administered at 1727. Patient reported reaction to influenza vaccine in 2019. Patient advised to wait 30 minutes while being supervised. Reaction noted to start at 1736. Patient reported "Fire feeling" and "Tingling on my tongue." Blood pressure in right arm 190/78. Heart rate 85-90's, oxygen saturation level 98% on room air, and respirations 20 breaths per minute. Patient reported dry mouth and hot sensation. Cheeks and chest flush. Patient denied shortness of breath and swelling of the mouth and tongue. Patient reported "Could be a panic attack." Educated on importance of deep breathing. Exercise completed. Bottle of water provided. Benadryl offered and patient declined at this time.  1742: "Fire feeling" began to resolve.  1756: Blood pressure in right arm 160/80. Heart rate 81 and oxygen saturation level 97% on room air. Respirations 16 breaths per minute. Temporal temperature 98.6 degrees F. Patient reports headache in frontal region.
Breakthrough case after three vaccines Pfizer 3/10/21 Lot# EN6199;  Pfizer 3/31/21 Lot# EW0150;  Pfizer 12/14/21 Lot# FJ8757
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "isolated case of afib" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: CARTIA XT; ETODOLAC; VALSARTAN; PRILOSEC [OMEPRAZOLE]; CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]; CENTRUM B. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive tests. Therapeutic measures were taken as a result of vaccination failure, covid-19. Adverse event included Heavy cold symptoms: coughing, sneezing, chills, fever, positive tests, rebound. Ae treatment: Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness on lateral aspect of right arm of 6cm x 3cm. No vesicles, pustuals, crusted or oozing lesions where seen.
The patient had an elevated heart rate above 100 so a D-dimer was obtained because of persistent chest pain.  D-dimer was positive.  The patient received a CT PE of the chest.  The patient does not have a pulmonary embolism or other acute pathology that requires treatment in the emergency department on his CT PE.
colitis flare; had to miss my second shot; This case was reported by a consumer via call center representative and described the occurrence of colitis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced colitis and incomplete course of vaccination. The patient was treated with prednisone. On an unknown date, the outcome of the colitis and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the colitis to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix and had to miss 2nd dose of Shingrix because the patient was on Prednisone due to colitis flares which led to incomplete course of vaccination.  The reporter did not specify if the colitis was concurrent condition or experienced after receiving 1st dose of Shingrix. The patient asked if he/she should restart the series or just receive the 2nd dose. Follow-up would not be possible as no contact details available. Note: It was not clear if the colitis was the patients current condition and if it was aggravated after vaccination so the event coded as Colitis.
15 month patient received Kinrix; Kinrix administered instead of infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 20th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by nurse. Nurse reported that 15 month patient received Kinrix. Nurse was not sure if patient received 3 doses of Pediarix before or just 2.  Nurse thought the correct vaccine that should had being administered instead of Kinrix was Infanrix.  Reporter did not consent to follow up. Additional supportive information: As patient received vaccine at inappropriate age and received Kinrix instead of Pediarix which led to inappropriate age at vaccination and wrong vaccine administered.
8/21/13 Received IM FLUZONE at 1100 AM. Reported to ED at 1743 with reddened eyes, itching throat - felt like it was closing and states it was hard to breathe and face was swollen.
ACHINESS; VERY SLIGHT FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced achiness. On MAR-2021, the subject experienced very slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very slight fever on MAR-2021, and the outcome of achiness was not reported. This report was non-serious.
low grade fever; sore throat; Rash; headache; cold sore outbreak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Lot number: 7J8762) at the age of 29 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hodgkin's Lymphoma", start date: 01Oct2013, stop date: 01May2014; "ABVD treatment" (unspecified if ongoing), notes: ABVD treatment, 6 cycles; "Biopsy surgery", start date: Oct2013 (unspecified if ongoing); "port-a-cath surgery", start date: Oct2013 (unspecified if ongoing); "port-a-cath surgery", start date: May2014 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 2nd, Anatomical Site of injection: Left arm, Route of administration: Intramuscular (checked), Batch/Lot number: Pfizer ER8734), administration date: 07Apr2021, when the patient was 29-year-old, for COVID-19 immunization; BNT162b2 (Dose: 1st, Anatomical Site of injection: Left arm, Route of administration: Intramuscular (checked), Batch/Lot number: Pfizer EN6207), administration date: 11Mar2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 11May2022, outcome "recovering"; ORAL HERPES (non-serious) with onset 11May2022, outcome "recovering", described as "cold sore outbreak"; HEADACHE (non-serious) with onset 11May2022, outcome "recovering"; OROPHARYNGEAL PAIN (non-serious) with onset 12May2022, outcome "recovering", described as "sore throat"; PYREXIA (non-serious) with onset 13May2022, outcome "recovering", described as "low grade fever". Therapeutic measures were taken as a result of rash, headache, oral herpes, oropharyngeal pain, pyrexia.; Sender's Comments: Linked Report(s) :PFIZER INC-202200715001 same reporter, patient and suspect drug/different dose (3rd dose) and AE;
103.5 degree Fahrenheit fever while taking Acetaminophen every 6 hrs; extreme fatigue bedridden; chills; cold sweats; bone pain/aching; administration date=11Jan2021, dose number=2/administration date=30Dec2020, dose number=1; This is a spontaneous report from a contactable other health professional (patient). This 36-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 11Jan2021 11:15 AM at single dose for COVID-19 immunization. Medical history was unknown. The patient had no allergies to medications, food, or other products. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR). The patient previous received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 30Dec2020 09:15 AM at 36-year old for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 103.5 degree Fahrenheit fever while taking Tylenol every 6 hrs, extreme fatigue bedridden, chills and cold sweats, bone pain/aching on 12Jan2021 04:00 AM. No treatment was received for the adverse even. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequel. Seriousness criteria was reported as non-serious.   Information on the lot/batch number has been requested.
Acute kidney injury diagnosed in August 2021, many tests were performed and Nephrologist has not been able to determine a cause for the AKI.
pt presented to ED with SOB x 1wk, worsening; morbidly obese; cough, hypoxic; hx of CHF, chronic A Fib, DM2; positive for COVID; intubated on mechanical ventilation; condition worsened, pt died in the hospital
Patient is a 78 y.o. female patient of DO with history of COPD presented to a local Hospital with cough and dyspnea     Covid-19 Virus Infection Sepsis resolved Date of onset of symptoms: ~ 12/12/22 Date of covid positive test: 12/13/22 Vaccination status: unknown  Imaging: CXR  Prominence of the bronchovascular markings Oxygen requirements on admission: home 2L O2 Current oxygen requirements: Home 2L O2 Medical therapy: Remdesivir and Steroids started on admission but given rapid improvement can stop at discharge  Consultants following: none Anticipated special isolation end date: 12/22/22 DNR CC   COPD, with chronic resp failure On 2L at home On chronic prednisone, advair, incruse and albuterol  Resume home ARB in coming days   AKI Creat on admission 1.22, was 0.8 several months ago Improved with IV fluids   Dementia Moderate per history, stable Supportive care, delirium prevention measures (at high risk)   Afib HTN On crestor, labetolol, cozaar, amiodarone, eliquis
24 hours post injection - Shooting pain and numbness down arm, hands and fingers. 10/10 pain sharp shooting pain in head, teeth, gums, photophobia, dizziness. All on side of injection site.  Current and ongoing - numbness, tingling and pain on side on injection.
extreme swelling of LEFT arm bicep (below injection site), "puss" like area, fever, chills, sweating, blacking out, hearing loss in both ears, racing heart, impaired vision, horrific pain with fiery, stabbing sensation throughout body
Death. Narrative: Patient received Moderna COVID vaccine #1 on 3/1/21. On 3/17/21, he was admitted to a facility for a CABG. Per notes, after his CABG, he developed Pseudomonas pneumonia, AKI requiring dialysis and ultimately became oliguric. He required epinephrine, dobutamine, dopamine, amiodarone and went through two code blues prior to pronouncement of death on 3/25/21 at 2305. No autopsy reports available. 24 days from time of vaccine to date of death.
I felt fatigued and my arm hurt for about a day after receiving the vaccine.  I had a sore throat for two days prior. I tested positive with a home test for COVID-19 on 01/08/2023.  I had a high fever and my chest, so I contacted a nurse with my insurance company. I had a virtual visit with an urgent care clinic, and they provided a prescription for Paxlovid. I took it for two days and stopped because it was making me sicker and more nauseous. I still have congestion and dizziness.
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received SHINGRIX. In January 2019, less than a week after receiving SHINGRIX, the patient experienced feeling unwell, fever and fatigue. On an unknown date, the outcome of the feeling unwell, fever and fatigue were unknown.  It was unknown if the reporter considered the feeling unwell, fever and fatigue to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 68 or 69 years old. The day before reporting the patient received a dose of SHINGRIX and she was more concerned about the fever and fatigue. The patient asked about potential side effects. The reporter would not provide any details. The reporter disconnected abruptly.
Patient received COVID vaccine 3/23/2021.   The family called the vaccination clinic to inform that the patient died on 3/27/2021.   Family believes the vaccine caused the death.  I have no other information on this chart.
Pt c/o pain; soreness approximately 1 month after vaccination at Rt. deltoid.
This spontaneous report was received from a physician via two company representatives from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-SEP-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
I was having symptoms in the morning when I woke up on Wednesday morning. I was having a headache, with very severe sinus congestion, I was sneezing, coughing, with a runny nose, my eyes had that horrible pain behind them like it was sinus infection. I was exhausted and only wanted to sleep, and then my food started tasting weird. I took a COVID-19 home test Thursday night ad it was positive. I was achy all over, I had shortness of breath, and then I lost my appetite as well. I never had a fever, but I did have chills and severe sweating at night but was so cold that I had to bundle up with extra blankets but would be soaked from sweating all night. I did not get anything from my doctor for treatment and they advised that I keep taking the cold medications to help. I was able to manage the symptoms with the OTC medications. I still have some lingering fatigue, but it was only a few days after I tested positive that I was feeling better other than having to pause when I was talking to catch my breath.
Myocarditis; Troponins greater than 11,000; Mild Fever; Chills; Malaise; Chest pain; Body Aches; Cough; Headache; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported for a 18-year-old male patient that:  This is a spontaneous report from a contactable other hcp.   A 18-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  Medical history included ongoing attention deficit hyperactivity disorder (ADD) , ongoing autism. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose1 received on 10Mar2021, LOT: Unknown for COVID-19 Immunization. Concomitant medication(s) included risperidone (RISPERDAL) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; methylphenidate (METHYLPHENIDATE) taken for attention deficit hyperactivity disorder from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing.  The patient presented to the ER two days after receiving his second dose of the vaccine. The patient experienced myocarditis (hospitalization 01Apr2021 to 03Apr2021, medically significant) on 01Apr2021 with outcome of unknown, patient was post ICU admission, chest pain  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , body aches (hospitalization) on 30Mar2021 with outcome of unknown , cough (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , headache  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , nausea  (hospitalization 01Apr2021 to 03Apr2021) on 30Mar2021 with outcome of unknown , troponins greater than 11,000 (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , mild fever (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , chills (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown , malaise (hospitalization 01Apr2021 to 03Apr2021) on 01Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included echocardiogram: unknown result on  unknown date, electrocardiogram: no acute changes on 01Apr2021, electrocardiogram: abnormal with ST elevation  on 19Apr2021 and patient needed to consult with Cardiology, COVID-19 antigen test: negative   on unknown date. The patient was treated in the ICU, exact treatment unknown at this time.  Information about Lot/batch number is requested.; Sender's Comments: The contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported)  to reported events is probable.
Day 1: chills, body aches continued Day 4: vomiting Day 7: Hospitalized, discovered had severe bladder infection/kidney infection. Physician and Employee Health believe event was coincidental, but patient had concerns previous to hospitalization that illness was related to vaccination.
Patient was given Pfizer vaccine without diluting.  Was also given 0.5ml verses the 0.3ml ordered.
I got the flu shot last year and still got the flu a few months later; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who got the flu shot last year and still got the flu (influenza) a few months later, while the patient received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, route in administration site unknown) for prophylactic vaccination.  On an unknown date, the patient developed still got the flu a few months later (influenza), Unknown latency, following the administration of INFLUENZA VACCINE.  No laboratory test was reported.  It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown.  There will be no information available on the batch number for this case.
Normal pain in my right arm. Swelling at the site of injection with a 6 inch diameter of swelling and redness. I have severe itching all over my body but mostly on the left side of my torso... it seems to be under my skin not on the surface of my skin like as if my muscles itch. Headache on the first day.