chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wegener's granulomatosis; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) (seriousness criterion medically significant). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Wegener's granulomatosis) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  No treatment information was provided. Company Comment: 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.   This case was linked (Dose 2) (Patient Link).
vision loss; hearing loss; neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On an unknown date in or around October 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered vision loss, hearing loss and neuropathy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of vision loss, hearing loss and neuropathy was considered to be not recovered/not resolved. The reporter considered all of the events to be related to zoster vaccine live (ZOSTAVAX).  The events of vision loss, hearing loss and neuropathy were considered to be disabling.  Upon internal review, the events of vision loss, hearing loss, neuropathy were determined to be medically significant.
Fatigue x 1 week and ongoing nausea vomiting diarrhea 2 days pruritus rash x1 week and ongoing
On 8/17/2022 I started having sore throat and fever. Then fatigue, muscle aches, and nausea, and chills, the worse chills ever.  Eventually my nose started running. On 8/17/2022 I took the COVID-19 home test and the results were positive. I called the doctor's office and they said to take ibuprofen, and if it got worse to call back. I just took Tylenol and at some point, I started taking antihistamines. It took like 12 days for my symptoms to resolve. By the 12th day I tested negative. Weeks later, 9/8/2022, I had low blood pressure and I felt lightheadedness. It lasted a week and a half. I called my doctor and he said to eat more salt and drink my liquids and it eventually went away after a week and a half. There was no obvious explanation.  I felt fully recovered from COVID-19 and then that happened.
Started with post-nasal drip and coughing.  Turned into a cold. Sore throat. Nasal and chest congestion. Sore eyes. Sore ear.
PATIENT RECEIVED PFIZER MONOVALENT VACCINE INSTEAD OF PFIZER BIVALENT VACCINE BOOSTER
Patient was nervous about getting this vaccination specifically  and additionally did not like needles. Husband reported that it was normal for patient to faint with vaccinations. Vaccine was administered and patient remained sitting in chair with husband and myself by her side. She stated that she was getting very warm so I provided her with some air (by opening door). Patiently fainted momentarily in chair and then recovered quickly. This happened twice with approximately 1-2 minutes in between fainting episodes. Patient was alert upon recovery. Patient fainted a third time (approximately 1-3 minutes after episode 2) however when she fainted a third time, the patient went rigid in the chair and seemed to seize a few times. Emergency services were contacted and arrived on scene. Patient was alert and had recovered. Patient did not remember the events that had occurred other than the fact that she told her husband and I that she was getting very warm. Patient was taken via ambulance to ensure stable status.
received the original 2 shots in Mar2021 and was boosted 01Nov2021 (all Pfizer)/ tested Covid; received the original 2 shots in Mar2021 and was boosted 01Nov2021 (all Pfizer)/ tested Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown), on 01Nov2021 as dose 3 (booster) single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21May2022, outcome "unknown" and all described as "received the original 2 shots in Mar2021 and was boosted 01Nov2021 (all Pfizer)/ tested Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Negative; (21May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  Clinical Course: Reported as, Patient received the original 2 shots in Mar2021 and was boosted 01Nov2021 (all Pfizer). Thursday 19May2022 patient had a tickle in throat and performed an at home test (negative result). Patient set a 2nd booster appointment for 20May2022, informed that patient had a tickle but a negative test result. They said it was ok and received the 2nd booster (Pfizer). On Saturday 21May tested Covid and contacted the local Doctor who prescribed Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Subconjunctival hemorrhage; This is a spontaneous report from a contactable nurse (patient herself).  This 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on 19Aug2021 16:00 at single dose for COVID-19 immunisation, administered at pharmacy/drug store.  No other vaccine was received in four weeks. Relevant medical history included colitis ulcerative. No known allergies. The patient was taking concomitant medications (no details provided). On 19Aug2021, the patient developed subconjunctival hemorrhage. No seriousness criterion was provided by the reporter. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the event. The patient had not recovered from the event.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relation, the association between the event of subconjunctival haemorrhage and the suspect product of BNT162B2 cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Anaphylaxis; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Pt. given DTAP (L) arm on 4/20/10, along with MMR, VZV, IPV. On 4/21/10 pt returned to clinic with (L) deltoid area erythema, heat and indurated area of 7 cm - 8 cm in size with central area of sm. papular lesions in clump.
This spontaneous case reported by a pharmacist, describes the occurrence of COVID-19 (patient diagnosed with COVID-19 five days after 1st dose) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced COVID-19 (patient diagnosed with COVID-19 five days after 1st dose). At the time of the report, COVID-19 (patient diagnosed with COVID-19 five days after 1st dose) outcome: unknown. Diagnostic results: On an unknown date, SARS-CoV-2 test: positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant product use, treatment information or lab details.
Initial information has been received from a registered nurse and follow up information was received from the physician concerning a 12 month old female with no pertinent medical history and no known drug reactions/allergies who on 09-JUN-2008 at 09:00AM was vaccinated subcutaneously in her right anterior thigh with the first dose of VARIVAX (Oka/Merck) (LOT# 660659/0174X). Suspect vaccination included MMR II (MSD) (LOT# 658581/0264X). Concomitant vaccination included HAVRIX (LOT# AHAVB3S5BA). There was no illness at time of vaccination. On 11-JUN-2008 the patient's mother reported that the patient started with a couple of red spots (reported to be chickenpox) around the right leg. Within 1 day the red spots became yellow fluid filled and were crusted over. On 17-JUN-2008 (2 days ago), clusters of red spots appeared on the left thigh and right leg and 1 spot on the knee which were fluid filled. On 18-JUN-2008 the patient also had a low grade temperature of 99-100 deg F. The patient was more sleepy, "not herself" and appetite had decreased slightly but she was still drinking fine. On 19-JUN-2008, there was a red spot that appeared on the right knee which was red and raised. subsequently, the patient recovered. Medical attention was sought by phone. Additional information is not expected.
Patient received vaccine on 1/12/22 and was hospitalized  on 1/25  after testing positive for  covid-19 on 1/24/22. Patient had SOB and developed pneumonia  and ARDS, after an abnormal chest X-ray.
Initial unsolicited report received from a nurse on 18-Jul-2018. This case involves a 4-years-old male patient who was vaccinated with a fifth dose of suspect 0.5 ml IMOVAX POLIO (batch number: N1K921M, expiration date: 14-Nov-2019, frequency: once) via subcutaneous in upper left arm on 16-Jul-2018 and this dose was involved in a temperature excursion (opened vial 55.2 F for 4 hours). The patient's medical history was not reported. Concomitant medications included DAPTACEL for Immunisation. It was an actual medication error due to extra dose administered and incorrect product storage. The patient had no signs of any adverse reaction at the time of report. 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.
Bladder infection; dizziness; This is a spontaneous report received from a contactable consumer. A 70-year-old female patient 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. Medical history and concomitant medications were not reported. The reporter stated that her sister, who was 70 years old, was scheduled to receive the second dose of BNT162B2 today (as of 23Mar2021). She reported the patient had a bladder infection that was current and had not resolved even after trying two different antibiotics. The patient also experienced severe dizziness and didn't even feel safe to drive her car. The reporter inquired if infections were a common adverse event after receiving the first dose of the vaccine and if her sister should delay receiving the second dose due to her symptoms. The clinical outcome of bladder infection was not recovered, and the outcome of dizziness was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
04/30/2021- Arm swelling, headache, lethargy 06/02/2021- I began experiencing headaches, I had difficulty focusing when reading, it has started getting worse. My left index finger is now stiff and I cannot bend it fully anymore. Then I have loss of appetite and loss of interest in flavor, I cannot differentiate between flavors, all things taste the same and they are bland.
Irritation noted to both sides of mouth with several read ulcers noted; Irritation noted to both sides of mouth; administration date of dose 1 was 01Feb2021/administration date of dose 2 was 05Apr2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 11:45 (Lot number: EP7533) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Pan Strawberries.; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: VITAMIN D NOS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3247; Administration time: 12:00; Anatomical Location: Right arm, First dose 3 red ulcers noted inside mouth next day), administration date: 01Feb2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "red ulcers". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Apr2021 11:45, outcome "unknown", described as "administration date of dose 1 was 01Feb2021/administration date of dose 2 was 05Apr2021"; MOUTH ULCERATION (non-serious) with onset 05Apr2021 17:00, outcome "not recovered", described as "Irritation noted to both sides of mouth with several read ulcers noted"; STOMATITIS (non-serious) with onset 05Apr2021 17:00, outcome "not recovered", described as "Irritation noted to both sides of mouth". Therapeutic measures were not taken as a result of mouth ulceration, stomatitis.  Additional information: Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
14 year old patient refers to EMT feeling dizzy 20 minutes after second Pfizer dose. The EMT proceed by taking him to observation area to measure his vital signs: 70/40 mmHg b/P, P-59 beats/minute Oxygen98% and DXT 135mg/DL. Patient is instructed to lay down on table with feet elevated (trendelenburg position) for the return of the volume in his blood. He is in observation for 15 minutes. At 4:57 his vitals are taken again: 80/50 mmHg B/P, P-70 beats/minute and Oxygen 99%. At 5:15pm he is discharge with stable condition by Doctor.
Swelling in elbows and left foot toes told Dr about it but said it's nothing
After receiving COVID19 Pfizer vaccine on 05/11/2022, on 05/12/2022, developed multiple hypopigmented 1 x 1 cm circular patches on frontal forehead with associated swelling and pruritus. Also developed 1 x 1 cm hyperpigmented lesion of inferolateral orbital/R buccal region. The swelling subsequently improved but the discoloration remained. After receiving COVID Pfizer vaccine dose #2 on 06/01/2022 (FL8095), noted to have recurrent swelling.
This spontaneous report as received from a parent consumers refers to their 9 months old daughter with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated IM with RECOMBIVAX HB (lot# was unspecified) on 16-JUL-2012. No other co-suspects were reported. Concomitant medications included generic ZANTAC (manufacturer unknown). No lab diagnostic studies performed. On 19-JUL-2012 the patient experienced fever 100.9 degrees, 4 days after onset of therapy. No treatment information was reported. The outcome of fever 100.9 degrees was reported as recovered/resolved on 20-JUL-2012. The patient did not seek medical attention. Additional information is not expected.
Initial report received from a healthcare professional on 12 November 2012. A 78-year-old female patient had no relevant medical history and no illness at the time of vaccination, received intramuscular dose of FLUZONE HD in left deltoid (Lot number U4537AA) on 21 October 2012. On 22 October 2012, the patient had presented bilateral ankle, figure and thumb swelling and painful to walk. Corrective medications were not reported and relevant Laboratory test were reported as none. The patient's outcome was not reported. Documents held by sender: None. Follow-up information was received from a healthcare professional on 01 April 2013. Based on the new information, this case has been upgraded to serious. The events were not related, the patient was diagnosed with rheumatoid arthritis. Outcome was recovered.
Vein bruise can still be seen 2 weeks later. Tender to touch. Can still locate needle injection site. Was initially taking Tylenol. Now just using heating pad.   Also had multi day headache and left armpit lymph nodes were sore. But those both only last a couple days.
first dose:  at 60 hours after shot went into Atrial Fib.  Heart Beat up to 150 plus.  Had paramedics come.  Took a Flecanide.   They ran heart test and it doing okay.  Delined hospital emergency room transpoort as heart beat came down.    Had not had an AFIB event since I had been carioverted a year and a half previously.  Second dose was 2/19/21  Same lot.  At approximately 81 hours after shot haI d another fib EVENT.  aLTHOUGH FOR 24 HOURS BEFORE HAD ERRACTIC and higher thannormal poulse.  Highest was 110 beats .  Tookm FlecNIDE.sINCE that time have had increased symptomology
Day 7 (12/29) after Moderna Vaccine I began experiencing severe itching to left upper arm. I did not think it was related to the vaccine..however: The next day Day 8.. I spoke to the woman who was in vaccination line behind me..she stated she awoke that am (12/30) with severe itching in the inoculated arm. Hours later I spoke to coworker who also had Moderna the day after us (12/23) and she had just returned from the ER (12/30). She had cellulitis over 1/2 of her upper arm. She was prescribed Keflex. Her itching began on her day 6. (12/29). I went to the ER and was also given a diagnosis of cellulitis and prescribed 10 days of Keflex. Infection control at the hospital was notified. We are all healthcare workers.
days after receiving vaccine, pt developed achy joints, rash all over, as well as welts.  patient discussed with rph prior to express desire to receive second dose to complete series. rph informed pt that pt should further discuss with md second dose (pt already discussed side effects but not risks vs benefit of second dose).
Description: Headache, arthralgias, memory loss, fatigue, visual change, fever after anthrax vaccine #2. Symptom: Head, general; Symptom: Joint Pain, multiple joints; Symptom: Fever; Symptom: Alopecia (hair loss); Symptom: Fatigue, Malaise > 60 Days ; Symptom: Memory loss, short term; Symptom: Blurred Vision.
This case was reported by a physician and described the occurrence of an injection site reaction in a 5 year old female pt who received Infanrix. On 8/4/04, the pt received the 5th dose of Infanrix in the left thigh (lot DTPA634A2). On 8/4/04, the pt also received an injection of MMRII in the right thigh. Approximately 2 days following administration of Infanrix, on 8/6/04, the pt experienced an injection site reaction on the left thigh that was characterized as inflammation, redness and was "warm to touch". The pt was seen at a physician's office and was treated with unspecified anti-inflammatories and antihistamines. The event resolved on an unspecified date in 8/04. The reporting physician considered the injection site reaction to probably be related to the lot of Infanrix administered.
No adverse reaction or event. Patient came in for first dose Pfizer monovalent vaccine (5-11Y) but received the Pfizer Bivalent-booster vaccine (5-11Y) instead. Patient was monitored for 30 minutes with no adverse effects. Mom was instructed to call the office if she had any questions or concerns.
immed p/vax pt c/o severe pain in lt arm (shoulder to fingers tips); c/o dizziness; pt placed on floor; did not lose consciousness; exp weakness;
68 yo male with Hx HTN, alcohol pancreatitis and gout who presented as a level 2 trauma after MVA. Per EMS, pt was traveling on the hwy at hwy speeds when he rear ended another slower vehicle. Patient was tested for COVID-19 and found to be positive, then treated for pneumonia.
Administered flu vaccine at approximately 11 am. By 2:30 pt noticed soreness at the site. By the time she got home at 4:15 her right arm was reddened, hot, swollen and she could not move it without pain. At that time she also started having a headache and her eyes were red, burning, teary and hurt. This morning she still complains of all of the above, although, not as severe. She was referred to her PMD, but her PMD is unavailable until next week.
Pt. phoned health unit to report that feeling ill after receiving the flu vaccine. Pt. report that she was nauseated, diaphoretic, weak, and general body aches. Instructed to report to ER for evaluation.