chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient with chronic undiagnosed illness felt to possibly be related to undiagnosed COVID-19 infection in 2020 or following COVID-19 vaccine series (Moderna) in Spring 2021. From my clinic note after his booster (Pfizer): "??patient is a 29M with h/o postconcussion syndrome (since resolved), anxiety, and episodic HSV who I've been following since fall 2021 for a constellation of symptoms with possible infectious etiology. See initial outpatient ID clinic visit note dated 9/7/2021 for initial details of HPI, and subsequent notes on 9/14, 9/21, 10/12, and 11/16 for additional details (latter includes Discharge Summary from admission to hospital from 10/21-27). Has seen multiple specialists and subspecialists with evaluation for cardiac arrhythmias, dysautonomia, and CNS infection among others across. Work up has occurred at a combination of Hospital, and various outpatient practices.  Infectious standpoint, patient most recently admitted to hospital from 12/5-8, during which he underwent EGD with GI for evaluation of throat/chest symptoms and also placement of PICC for purpose of initiating trial of acyclovir IV. See inpatient consult note dated 12/8 for details. Ultimately discharged with plans to complete acyclovir 10 mg/kg (7700 mg) IV Q8H x21 days.  Last seen in ID clinic on 12/22 towards the end of his course of acyclovir IV.  Plan at that time was completed the medication and then transition to famciclovir PO for HSV suppression.   Since last seen, has followed up with multiple providers (PCP, pulmonary).  Was feeling relatively well until just after he received COVID-19 booster (Pfizer) 1/4.  At 4 AM the next morning patient awoke with a migraine, burning behind the eyes/ears, and sore throat.  Felt like he been "run over by a truck again."  As the day wore on he had recurrence of his generalized weakness, shakiness, and convulsion symptoms.  He self managed with OTC medications and gradually improved slightly.  On 1/8 he began taking a 6-day course of dexamethasone that had previously been prescribed for headache management, but he was holding on starting until after vaccination.  Steroid did help with above-mentioned symptoms but did not take them away completely.  On 1/21 patient also had a short-lived GI illness in which he had nausea, vomiting, shortness of breath, and migraine that self resolved.   Most recently, over the past week patient has noted new oral ulcers in his mouth.  Seem to correlate with the flushing in his forehead/ears/face.  Described as circular flat ulcers of the tongue and inner lip.  Has about 5 in total, usually does not get this many weeks 3 sores at the same time, and they are usually smaller.  Set up care as a dentist yesterday, where he had the inner aspect of the front slightly right of midline ulcer on the lip biopsy.  Suture in place."
Day 7-8 canker sores on my tongue; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included ascorbic acid (VITAMIN C), magnesium (MANUFACTURER UNKNOWN) and ubidecarenone (COQ10); all from unknown date for unknown indications. Prior to the vaccination, the patient was not 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. On 15Apr2021, on day 7-8, the patient experienced canker sores on tongue. The clinical outcome of the event canker sores on tongue was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Schleraderma Morphea rash noted 1/2023 still not cleared up
Left leg felt numb after about 1 and half hour after the injection. Left leg skin felt burning and tingling for about two days. Called doctor's office, nurse said it is a normal reaction to the injection. Symptom went away after about two days and never came back.
Patient complained of swelling under arm pits, around toward back and shoulders. Had trouble sleeping because it was "uncomfortable" at first. Then it became painful to the touch all over shoulders, upper arms, under arms became swollen and he could not/and cannot raise arms above head without extreme pain/weakness set in also. He has been this way for the past 3 months. He goes to physical therapy so he does not become "frozen" as the neurologist describes. But the pain and weakness remain. Like his brother, he does not sleep well. And he does not go to school anymore because he cannot carry a backpack, and he fears some bumping into him. He will be redoing his 10th grade year (Hopefully).
Rash from waist up on torso. Not relieved by hydrocortisone 1% cream, benadryl tablets, benadryl cream, and hydroxyzine tablets.
The day after the vaccination  my legs felt weak, that feeling went away in a day I believe. At night my feet are usually cold but I noticed  An increased numbness in my toes and tingling. The tingling was daily not just at night . I saw Dr. the end of February for another issue and just mentioned in the past 2 weeks increased tingling in my feet and up to lower half of my legs. I was also having shooting pains in my feet which seems to be getting worse as of today. I?ll call Dr. to report this tomorrow. The pain keeps me awake at night and even wakes me up.
Jynneos was administered intramuscularly; Case reference number US-BN-2022-001865 is a spontaneous case report initially received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (sixth out of six).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided), at an unknown dose (5/8'' needle as reported) or site of administration, intramuscularly, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was *known that the patient did not experience any negative effects due to Jynneos vaccine.*  Additional information was received from Bavarian Nordic on 11-Aug-2022, included country of occurrence.  Additional information was received from the reporter on 12-Aug-2022, included confirmation about six patients and information about needle.  Additional information was received from Bavarian Nordic on 15-Aug-2022, included local BN case ID.  Follow up information received from a healthcare professional via Bavarian Nordic on 19-Sep-2022 included confirmation that the patient did not experience any negative effects.  This case is linked to cases no. US-BN-2022-001860, US-BN-2022-001861, US-BN-2022-001862, US-BN-2022-001863, and US-BN-2022-001864 concerning the same reporter.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. It was confirmed that the patient did not experience any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at an unknown dose (with 5/8" needle as reported) or site of administration, intramuscularly, which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. It was confirmed that the patient did not experience any adverse event. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
After the second dose on June 4,2021 I've been sick. It felt like I had the flu, I had to energy. Then on 6/26/2021 I felt a burning sensation in my leg then my last started swelling up. I went to the emergency room where they gave me an ultrasound in my leg and discovered that I had a blood clot.
I went to the eye doctor at the end of 04/27/2021 and when I returned on 05/12/2021 and my vision had deteriorated, and I had indications of Cataracts in both eyes. The evidence was not noted on the previous visit. I am not sure if it has anything to do with the vaccine. I developed a rash on 06/02/2021. It started on my elbow and then it moved to my thighs and it is mostly on my arms and legs. It has been there for 10 days so far. It has spread and it is red little bumps like a skin irritation and it is itchy. I have not taken any new medication recently.  I am planning on seeing a doctor for the rash.
Pt. C/O lightheaded dizzy/pale. PT. history and vitals obtained PT. monitored for 30 mins. PT. provided w/ juice + water per her request. PT. escorted to restroom by female staff. PT. stated she felt better and could drive home. Staff observed Pt. color had returned to normal. PT. released and advised to call 911 w/ any further problems. Vitals 5:33 BP 116/78 P 50 Resp 18 SPo2 100%. 5:45 BP 120/80 P 64 Resp 18 SPo2 99%. 5:55 BP 100/76 P 72 Resp 18 SPo2 100%.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "P.E. x2" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 22Aug2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Provider order vaccines for patient: Dtap-HIB-IPV, Hepatitis B, PCV13, and Rotavirus. I got vaccines from VFC fridge went over to RN to verify my vaccines, she gave the go ahead to proceed with vaccines. Patient waited in room with mom for 15 min, no reaction went home. Later that day around 3 PM I had the same order different patient got vaccines ready went to the Dr. to verify vaccines there Dr. identify I had KINRIX instead of PENTACEL. I went back to the fridge got the PENTACEL vaccine. Dr. verified the vaccines went ahead and did the administration of the vaccines. Once I was done with the vaccines I went back to the chart of my patient I administered vaccines and there I found I administered KINRIX on this patient instead of the PENTACEL. I informed my  lead, RN, Provider, supervisor. I called mother at 6 PM to inform her patient had received only DTAP-IPV only not with HIB; no reaction from patient per mother. RN was present when call was made. Mother scheduled to come in to clinic Monday. Monday morning appointment was cancelled. Called mother once again to schedule a follow up appointment was set and was a no-show. Next appointment set for patient now is 1/18/2019.
Fever of 101.6, Injection site red and very swollen. Fever breaks with tylenol but has returned.
First dose, extreme arm pain to the point I couldn't lift arm above my waist. Went on for three days. Second dose, extreme pain in upper body. Kidneys and liver pain included. Could not go to work on second day. Third day had heart issues, heart rate of 134 and BP of 170/90 which I have never been over 130/ 75 my entire life. Normal is 110/65 with an pulse of 60.
patient received COVID-19 Booster dose 2.5 mg ( recommended dose  0..25 mg). Patient was observed for 15 minutes after receiving dose without any adverse effects.  The increased dose received by the patient was discovered after the patient left the clinic. The patient was notified by phone; patient again reported no adverse effects.
PATIENT REPORTING CONTINUED ARM PAIN/DECREASED RANGE OF MOTION ON 8/13/2023 AFTER RECEIVING VACCINE ON 12/19/2022. HAS BEEN TO THE DOCTOR AND REPORTS SIRVA. PATIENT HAS HAD PHYSICAL THERAPY AND WILL BE HAVING AN MRI.
Generalized joint pain, fever of 100.5 WITH Aleve and Tylenol on board, malaise.  Chills and night sweats into Sunday, 2/26/2012 with resolution of all symptoms except malaise.
Mother notified public health of symptoms at 08:50 on 01/23/2013. Approx 1 hour following immunization reports client experienced left side to "give out" causing client to fall to the floor for no reason. After fall, client continued through her day. Mother reports raised welt like area at site of injection that is tender. No other welt-like/rash reported. Reports a more severe headache than usual the evening of receiving the shot. 01/23/2012: symptoms are not any worse. Advised to notify MD suggested ibuprofen, Benadryl and ice pack to site.
Patient developed warm red plaque on left upper arm around injection sites.  One site also had a small 0.75 x 0.75 in bruise.  The red plaque is irregular and 3.5" x 4.5" at its maximum.   There was also a small tender enlarged lymph node in his left axilla.  The initial arm pain had been decreasing and on the day of visit he had developed increased arm pain. He was treated for possible infection with Cephalexin 825 mg BID x 7-10 days.  12 hours later the arm was less tender but rash slightly larger at proximal side but less red at distal part.  By 5 days, his arm was nearly back to normal in appearance, just bruising persisited.   Never had fevers.
After the first shot I developed a rash around the injection site. After the second shot, two weeks later, I developed tinnitus
Intermittent pressure "headaches" beginning 2 hours after 1st Moderna dose and lasting 4 months. Bilateral joint pain in arms. Worst in CMC/MCP joints in thumbs, but affected all joints in fingers for 2 months after 1st dose. Intermittent joint pain in wrists, elbows and shoulders for 2 months after 1st dose.
red warm area that occurred over a week; vaccination site warmth; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (red warm area that occurred over a week) and VACCINATION SITE WARMTH (vaccination site warmth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red warm area that occurred over a week) and VACCINATION SITE WARMTH (vaccination site warmth). At the time of the report, ERYTHEMA (red warm area that occurred over a week) and VACCINATION SITE WARMTH (vaccination site warmth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications as provided by reporter was unknown.    Treatment for the events was unknown
Infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (Infection). At the time of the report, INFECTION (Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  Reportedly, the patient had infection and had to go to the hospital. No treatment information was provided..   This case was linked to MOD-2021-265605.
One week after I received the 1st dose of the Moderna  CoVid-19 vaccine, I developed a bright pink, hard, raised area of very itchy rash at the site of the injection. It was about 2"x3" in size, was very warm and painful to the touch. The size increased over the next couple of days to about 3" in diameter but decreased in symptoms (less pain, less itch, less hard, less raised and less warm). I still have the sensitive area today (Saturday, Feb 27, 12:33 pm) but it has continued to decrease in symptoms. The affected area is still about 3" in diameter but has faded in color (now pale pink).
Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition was not provided. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot# J011629 with expiration date of 20-SEP-2015, lot# K005958 with expiration date of 09-FEB-2017, lot# K010579 with expiration date of 12-FEB-2017, lot# reported as L007559 with expiration date of 01-JUN-2017)(dose strength and route unknown). No concomitant therapy was provided. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reprots received from the same reporter. Additional information has been requested.
Rash started@ site of injection approximately 24 hours afterward.  Today, 72 hours after injection right upper arm has rash approximately 7cm x 4 cm and feels hot to touch and is painful.   Patient was seen by her PCP Dr. and was prescribed Doxycycline.  She was advised to follow up with urgent care or ER if her symptoms worsened,
KINRIX given at 12:00 pm 2-15-13 at 12 wks 1 day old.
This spontaneous report was received from a registered nurse, referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not reported. From 01-MAY-2017 to 23-MAY-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M015698 and expiration date on 26-SEP-2017 (route and dose were not reported) for prophylaxis, which were diluted with a sterile diluent (MRK) injection lot number L007564 and expiration date on 19-NOV-2017, which was not improperly stored. The reporter stated that, the data logger registered that during 36 minutes, the temperature under the vaccine was stored was -14° Celsius degree to -10° Celsius degree, there was not prior temperature excursion and no adverse effects were reported. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA012139.
This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Lot number: ER8730) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 71 years old, for COVID-19 Immunization. The following information was reported: ARTHRALGIA (non-serious), BACK PAIN (non-serious), NECK PAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 28Apr2021, outcome "recovering" and all described as "I began having pain and tightness in my shoulder, back and neck"; PYREXIA (non-serious) with onset 28Apr2021, outcome "recovering", described as "running a low grad temperature"; PAIN (non-serious) with onset 23Apr2021, outcome "recovering", described as "had significant pain when inhaling"; PLEURAL EFFUSION (non-serious) with onset 28Apr2021, outcome "recovering", described as "I had an echo cardiogram which indicated a left plural effusion". The events "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "i began having pain and tightness in my shoulder, back and neck", "running a low grad temperature" and "had significant pain when inhaling" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, back pain, neck pain, muscle tightness, pyrexia, pain, pleural effusion. Additional information: The patient did not receive any other vaccine in 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and the patient was tested negative for COVID-19 post vaccination. The patient received recent COVID-19 vaccine at pharmacy or drug store. The patient began to having pain and tightness in her shoulder, back and neck and running a low grad temperature and had significant pain when inhaling around 23Apr2021. She went to the doctor's office on 28Apr2021 because she was concerned. The physician did an EKG which was negative but sent her to the ER as a precaution. She continued with the symptoms saw several doctors had numerous blood tests and scans. She had an echo cardiogram which indicated a left plural effusion. She was not certain if the problems were due to the vaccine, but everything else has been ruled out. Anti-inflammatory treatment medications were prescribed to patient due to events. Follow-up attempts are completed. No further information is expected.
Chills, hypothermia of 95, fever of 100, nausea, headache
Engerix B + pediatric dose administered to adult patient.; Engerix B + pediatric dose administered to adult patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22-DEC-2023) for prophylaxis.   On 26-SEP-2023, the patient received Engerix B pediatric. On 26-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix B + pediatric dose administered to adult patient.) and adult use of a child product (Verbatim: Engerix B + pediatric dose administered to adult patient.). The outcome of the underdose and adult use of a child product 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: 19-OCT-2023 Engerix B pediatric dose administered to adult patient, which led to underdose and adult use of a child product. Same lot number and expiration date for both vaccines. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. This case has been linked to the case US2023145302 reported by the same reporter.; Sender's Comments:  US-GSK-US2023145302:another adult patient.
I developed a very bad cough, so I went in to see the nurse practitioner. She indicated it might be a virus. It took about 3 to 4 weeks before the cough went away. I could cough for 10 minutes at a time. I have since completely recovered from my symptoms.