chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2022 at 11:00 as dose 4 (booster), single (Lot number: FP7150) at the age of 69 years, in right 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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN, start date: 12Sep2022, stop date: 12Sep2022; MONTELUKAST; DULERA; PRESERVISION AREDS 2.  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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
There was a Vaccine Administration Error as the second dose was give on the 22nd day of receiving the first dose.   First dose of COVID19 ( Moderna) was administered 04-13-21 and the Second dose of COVID19 (Moderna) was administered 05-05-21
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. During 2015, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In or about May 2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pt passed out briefly about 7 minutes after vaccine was administered.  I followed company`s protocol and she was okay after about 2 to 5 minutes. Paramedics came but she refused going to ER with them because she was already feeling better by the time they arrived
MOTHER REFERS THAT THE NEXT DAY OF VACCINE ADMINISTRATION THE CHILD DEVELOPED A RASH IN THE ENTIRE BODY WITH A SLIGHT FEVER.
Employee nurse admistered vaccine SQ instead of IM. Adverse reaction included localized redness and pain. Swelling decreased by day 2 after using pain medications and ice packs. No anaphylaxis.
NONE, PATIENT RECIEVED VACCINE THAT WAS BEYOND USE DATE IN FRIDGE.  DAY 34 INSTEAD OF DAY 31
Pt has chronic kidney disease stage IV and diabetes mellitus type 2.  He comes to the hospital due to vomiting and is found to have COVID pneumonia.
First shot was 4/15/2021. About a week after the shot I developed tinnitus that lasted about a week and then went away. Second shot was 5/13/21. About a week after the shot I developed tinnitus that lasted about a week and then went away. Third shot was 12/23/21, and about a week after the shop I developed tinnitus that lasted about a week and then went away. It wasn't until this third shot that I made the connection between the tinnitus and the vaccine. I've never had tinnitus before. At the beginning of November, 2023, I suddenly developed severe ear pain and tinnitus again, with abosolutely nothing happening to cause it. The ear pain continued intermittently for about a month, and the tinnitus continued. It's now April 25, 2023, and I still have tinnitus every day, for the past six months now and no signs that it's dissipating.
ACUTE ST ELEVATION MI, ANTERIOR WALL 4/9/2023 ACUTE ST ELEVATION MI, ANTERIOR WALL ACUTE ST ELEVATION MI, UNSPECIFIED 4/21/2023 ACUTE ST ELEVATION MI, ANTERIOR WALL
Had a red rash below where the vaccine was given and also had severe arm pain that radiated into the shoulder. could not raise the shoulder for about 2 days and could not rub the skin as it was that sensitive to the pain
Information has been received from a nurse referring to unspecified patients of unknown age and gender. Since an unspecified date in May 2015, the patients had been administered with improperly stored doses of GARDASIL (lot number K023432, expiration date 18-JUN-2016, dose was unknown) intramuscularly. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Back pain, fatigue, injection site redness, swelling and pain Narrative:
Shingles rash; This is a spontaneous report from a non-contactable physician, the patient. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration on 26Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient was not allergic to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 05Mar2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient previously received varicella zoster vaccine (MANUFACTURER UNKNOWN) and was reported that the patient never had the chickenpox as a child; however, the patient did receive the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17May2021, the patient experienced shingles rash. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with valacyclovir (MANUFACTURER UNKNOWN) on 17May2021. The clinical outcome of the event shingles rash was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
onset 16JAN96 PM leg red, swollen, black bruising, t102 R since vax;pt does not move limb, keeps curled;21JAN96 taken to ER:dx bacterial infect given ATB;today 22JAN96 t102.6 R;
2+ weeks of increasing symptoms, including: dizziness, unequal equilibrium, increased cognitive difficulty with memory, processing, confusion, and retention, headaches, nauseous, fatigue, muscle tension, decreased appetite, low mood, hot/cold sweats, interrupted sleep, eye pain
Pt reported swelling and redness in right arm. Pt to use tylenol/ibuporfen asneeded, use ice pack and see dr if worse.
After vaccine I experienced a fever of 104+. I experienced chills, hallucinations, aches, headache
painful, itchy rash on the side of his chest; painful, itchy rash on the side of his chest; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 03-OCT-2023, 8 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: painful, itchy rash on the side of his chest) and pain (Verbatim: painful, itchy rash on the side of his chest).  The outcome of the itchy rash and pain were not resolved.   It was unknown if the reporter considered the itchy rash and pain to be related to Shingrix.     It was unknown if the company considered the itchy rash and pain to be related to Shingrix.   Additional Information: GSK receipt date: 03-OCT-2023 The reporter was the health care professional (pharmacist).  A patient developed a painful, itchy rash on the side of his chest.  Nothing else was reported. The reporter consented to follow up.
w/in 1 hrs of vax-felt burning across chest & throat & SOB-took Sudafed-sx eased but not relieved; w/in 2 hrs started getting fever 101, arm became red & swollen w/pain in lymph nodes under arms; area warm to touch; devel induration; dec MS
Patient has had chronic intermittent pain on her left lower leg for the past 5 years. However, she has noticed more pain on the left lower leg since having the COVID-19 Janssen vaccine on 3/19/2021. She is a chronic smoker. Thus, a left lower extremity arterial doppler was done on 5/20/2021 which incidentally revealed a DVT in the gastronemius vein of the left lower extremity. A subsequent bilateral US venous doppler of both lower extremities was done which revealed no DVT. Therefore, a repeat venous doppler of the left lower extremity was ordered for today, 5/21/2021, and remains pending at this time. Of note, patient was started on eliquis on 5/20/2021 (10 mg BID for the first 7 days with subsequent decrease to 5 mg BID thereafter). She will be referred to a hematologist for continued management.
This spontaneous report was received from a pharmacist via company representative, concerning a 64 year old female patient. The patient's medical history and concurrent conditions were not reported. In approximately 2014 (reported as "either 2014 or 2015"), the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU for prophylaxis (dose number, route, lot # and expiration date were unknown). Concomitant medications were not reported. On an unknown date, the patient experienced shingles. Then, on an unspecified date after that, the patient developed vision blurred. The patient saw an unspecified ophthalmologist and the ophthalmologist stated that "the blurred vision was most likely caused from receiving ZOSTAVAX and not from the shingles" because the ophthalmologist had a separate patient that developed blurred vision after receiving ZOSTAVAX, and the separate unspecified patient did not have shingles (captured in MARRS # 1807USA000847). At the time of reporting, the outcome of herpes zoster and vision blurred was unknown. The reporting pharmacist did not provided the causality assessment between the adverse events and ZOSTAVAX. Sender's Comments: US-009507513-1807USA000847.
her reaction was hard and warm to the touch; her reaction was hard and warm to the touch; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 8 years old female patient who experienced her reaction was hard and warm to the touch after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5ml (total) dose of suspect Influenza Quadrival A-B Vaccine (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization).  On an unknown date, the patient developed non-serious her reaction was hard and warm to the touch (vaccination site mass) (vaccination site warmth) (unknown latency) following the administration of Influenza Quadrival A-B Vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (her reaction was hard and warm to the touch).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event her reaction was hard and warm to the touch.
On July 16, 2022, I tested positive for COVID-19. I had a fever, sore throat, a headache, fatigue, aches and pains. I contacted my doctor the same day on July 16, 2022. They prescribe me Paxlovd .
Information has been received from a Registered Nurse concerning a 51 year old female patient with a history of cerebrovascular accident (CVA) and no known allergies, who on 25-JAN-2011 was vaccinated with 0.5 ml dose of PNEUMOVAX 23 (lot # not reported) intramuscularly into her left deltoid. Concomitant therapy included multiple unspecified medications. On approximately 25-JAN-2011 the patient experienced pain, redness, and warmth at the injection site. In addition, the patient had hard knot and swelling of 160 millimeters by 105. It was reported that "seems like swelling was bigger but less red and hard today" on 28-JAN-2011. At the time of reporting, the outcome of the events was not reported. The patient was not given treatment for the event and she was being observed. The patient sought unspecified medical attention. Additional information has been requested.
Individual reports pruritus at vaccination site for 2 weeks. Individual reports headaches not quite daily for 2 weeks. All symptoms now resolved.
Bad headache; Blurred vision; Tingling in the arm where the vaccine was administered (not at injection site but down the arm).; felt dizzy; This is a spontaneous report from a contactable pharmacist. An adult male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 19Jan2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 19Jan2021, within 15 minutes of vaccination, the patient experienced a bad headache, blurred vision, and tingling in the arm where the vaccine was administered (not at injection site but down the arm). The patient was asked to sit and rest for continued monitoring. After 20-30 minutes, the patient attempted to stand but felt dizzy. The events resulted in emergency room/department or urgent care for further evaluation. The clinical outcome of the events bad headache, blurred vision, tingling in the arm where the vaccine was administered (not at injection site but down the arm) and felt dizzy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
BRAIN ABSCESS; This spontaneous report received from a consumer via social media via company representative concerned a male of an unspecified age, race, and ethnic origin. 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, batch number and expiry date were not reported) dose was not reported, 01 total was administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced brain abscess and was hospitalized for a couple of months. The number of hospitalization days was not reported. The patient was discharged on an unspecified date. The patient did not had any seizures since returning to home and was taking medication. It was reported as, "I had the Pfizer shot and had no issues. My significant other got the Johnson & Johnson shot and wasn't so lucky. He ended up with an brain abscess and landed in the hospital for a couple of months. He is home now, and is still taking medication. He hasn't had any seizures since he came home. We are taking it one day at a time and thanking God that he is healing and functioning okay. We don't know for sure if the shots had anything to do with the brain abcess. His memory has a few holes in it, but he is functioning and thriving and that is what really counts." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from brain abscess. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221244141- brain abcess. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Patient reports immediate pain at site of PNEUMOVAX injection, which subsequently worsened within 10 minutes of injection.  Over the next few days, the site became red, hard, and warm and the area of involved tissue increased to a maximum size of about 6 inches around the injection site by 3/8.  About 24 hours after the injection, the patient developed joint pains (knees, elbows, back), chills (no documented fever) and nausea that resolved within 36 hours after the injection.  Patient denies rash otherwise, including lateral hands and feet.  On 3/9, the pain had somewhat improved, but the patient developed numbness and paresthesias in her left fingers and toes, which prompted her to seek medical attention at the NNMC ED.  She was given a prescription for septra and released.  She has been using ibuprofen as needed for the pain.  Patient reports last vaccine was about 20 years ago.  Contacted on 5/11/08 and this a.m. numbness and tingling had resolved.  Redness, warmth and tenderness has decreased to 70% of what was previously noted.  Edema at injection site > 120 mm not beyond elbow decreased ROM and pain.  Erythema extended about 6' surrounding vaccine site.  Tenderness at pneumonia vaccine site (not flu vaccine site).  Paresthesia primarily left pinky and thumb; resolved by 3/11/08.  Joint pain, multiple joints, knees, elbows, back.  Nausea without vomiting.  Chills. FOLLOW UP REPORT: Contacted patient on 4/21/08. She reports vaccine site of her left upper arm has returned to normal. The sensation has returned in her left pinky finger. She denies systemic symptoms.
COVID 19 Treatment; Covid 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster ), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE, start date: Dec2020. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered", described as "COVID 19 Treatment"; COVID-19 (medically significant), outcome "not recovered", described as "Covid 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (May2023) Positive, notes: Covid symptoms and positive test occurred 3 days after final dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2 weeks: Yes (pantoprazole). Anti-viral details product, COVID 19 Treatment, brand, Paxlovid, treatment start date 11May2023, treatment stop date: 15May2023, indication, Treatment of COVID-19. Covid symptoms and positive test occurred 3 days after final dose of Paxlovid on 18May2023 .  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.
The morning after the injection I woke up with chills and severe body aches, no appetite, no energy
Right leg bothering her; mind went blank and she was unable to think of her email address to provide; Arm soreness and arm soreness was getting worse/arm was sore; This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 21Feb2021 as single dose for covid-19 immunisation (at the age of 83 years). The patient medical history and concomitant medications were not reported.  The patient experienced right leg bothering her and mind went blank and she was unable to think of her email address to provide on an unspecified date, arm soreness and arm soreness was getting worse/arm was sore on 21Feb2021. The patient received her first dose of the Covid-19 vaccine on 21Feb2021, and her arm was sore on the 21Feb2021 (that night) and on the 22Feb2021 (next day) but went away. The pain came back  two and a half weeks later, and her 2nd shot was scheduled for this 13Mar2021 (Saturday). It seemed like it was okay after the first two days, but now it was back. Her arm had been sore, all week; on 10Mar2021 (today) it was really sore. She also mentioned her right leg was bothering her (start date: unspecified), but she didn't think that's related to the vaccine. She did not know if it was like just really dull before and she did not really notice it. It seemed like it was okay, and all of a sudden, each day she felt a little sore and today was really sore. She confirmed after the vaccine she had arm soreness and the arm soreness was getting worse. On 13Mar2021 (Saturday), it would be 3 weeks since she received the first dose. She took ADVIL as treat-ment, and but it didn't seem to help (Usually, ADVIL helps her). She did have TYLENOL and wanted to know if you can alternate TYLENOL and ADVIL. While attempting to provide email she commented her mind went blank and she was unable to think of her email address to provide (start date: unspecified). In concern to height, she thought she had shrunk. She wanted to know if it was normal for the pain to come back after about 2 and a half, almost 3 weeks and since this arm was sore, will she have to get it in her other arm. Therapeutic measures were taken as a result of arm soreness and arm soreness was getting worse/arm was sore. The outcome for arm soreness and arm soreness was getting worse/arm was sore was not recovered, and for another event was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
patient had facial angioedema wtihin minutes of receiving the first dose of Covid-19 dose. Patient was brought into an exam room, vitals were taken immediately. 120mgs of solumedrol was given to the patient within 10 minutes. Patient was observed for approximately 30 minutes in total, of which her sx of angioedema had resolved.
Initial unsolicited report received from a pharmacist on 22-FEB-2017. This case involves a 75 year old male patient who was vaccinated with an intramuscular dose of FLUZONE HD (batch number and expiry date were not reported) in right deltoid on an unspecified date in SEP-2016. The patient had a medical history of arthritis. Concomitant medication was not reported. On an unspecified date in SEP-2016, following the vaccination, the patient developed right arm soreness with difficulty lifting arm over head. It was reported that the patient has not seen physician. Patient's lab data and corrective treatment were not reported. The patient was not recovered from events. List of documents held by sender: none.