chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spondylitis ankylosing flare up; Memory issues; Pneumonia; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4339879-00 (Agency).  A 48-year-old female patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 20May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) and second regimen (ongoing) (Batch/Lot number: unknown), all subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PNEUMONIA (medically significant) with onset 2021, outcome "unknown"; ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing flare up"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "Memory issues". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "spondylitis ankylosing flare up" and "memory issues" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "pneumonia" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: Based on the available information in the case, the causal association between the event Spondylitis ankylosing aggravated, Pneumonia, Memory impaired and the suspect drug BNT162B2 cannot be excluded.  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.
Superficial vein thrombosis in left thigh that was reported to a primary care provider on 3/19, 6 days after the vaccine was given.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 26 years 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: "Known allergies: Amoxicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 16Oct2023 to 21Oct2023. 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.
Patient's mother notified the pharmacy that she had taken the patient to the doctor the following day of receiving the Flu shot because his arm was red and warm to touch. The provider told the mother that the flu shot had given him cellulitis and gave the patient an antibiotic, cephalexin. The
vaccine given to 13 year old; first dose is 29Jul2021.went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021.went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.) in a 13-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021.went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021.went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Patient called 6/13/22 and described very sore elbow starting day after vaccine (Wednesday). He stated that the vaccine site was not overly sore, but the elbow was somewhat swollen and extremely painful. The elbow pain and swelling then decreased and on Thursday his wrist hurt and was swollen, which then stayed sore until today (monday). He said his wrist is less sore today, but his thumb and parts of his hand hurt. He said he has not had a fever but has been feeling tired. I recommended that he go to urgent care to have it looked at. I also called his PCP who ordered the vaccine to report the issue. The PCP office stated that they would follow up with the patient. When asked if he had any problems with a tetanus shot in the past he said " I don't remember ever having one."
Subsequent to receiving vax, pt developed a local reaction that appeared to be infected. Additional information has been requested.
itching of all over body, started on arms and head the day following the vaccination. The second day following the vaccination I woke up with a swollen face and later on in the day my hands started swelling a lot. On the third day in my feet swell very little compared to my hands. I took benadryl which seemed to help. I have an appointment with my pcp tomorrow to get checked out. Today is day 5 and my hands are still swollen but the severity has lessened over the day today. I am very itchy all over my body.
C/O pain (R) deltoif. No reddness or swelling noted. Tender to the touvh upon palpation. Unable to raise arm above shoulder height without assistance from (L) arm. Pain disturbs sleep. TYLENOL ineffective. Level of pain has plateaued.
24DEC97 pt devel measles like rash, fever & conjunctivitis;pt seen by MD;also nasopharynx revealed white ulcerative spots on cheeks;had OM;microbiologic eval revealed positive combo of haemophilus, staph & neisseria;bulging red tympanic mem
After receiving SPIKEVAX, within 24 hours her symptoms subsided.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (After receiving SPIKEVAX, within 24 hours her symptoms subsided.) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine. Past adverse reactions to the above products included Vaccination adverse reaction with COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (After receiving SPIKEVAX, within 24 hours her symptoms subsided.). At the time of the report, IMMUNISATION REACTION (After receiving SPIKEVAX, within 24 hours her symptoms subsided.) had resolved.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-748676, MOD-2023-748677 (Patient Link).   Reporter did not allow further contact
This initial spontaneous report was received on 11-SEP-2018 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 16-APR-2012, the patient was inoculated with ZOSTAVAX at a physicians center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-NOV-2014, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. On or about 17-NOV-2014, the patient sought subsequent treatment at a physicians center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. 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.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Systemic: Tachycardia-Medium, Additional Details: family called pharmacy and stated reaction from covid vaccine, patient smoked a cigarette one hour after and passed out, pt is alert but informed family to seek medical attention since patient refuses, and does not have medical insurance
pt recvd vax & w/in 24 hrs of vax exp a flu-like illness w/n,v,d & aches; pt recovered 48 hrs later; reporter also stated pt failed to seroconvert;
This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No concomitant medications were reported. No medical history was provided. On unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (dosage schedule was not provided) (lot # L005298, expiration date: 17-FEB-2017; lot # K007783, expiration date: 28-MAY-2016). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
has COVID now and was pretty ill and in their ICU, positive COVID-19 test; has COVID now and was pretty ill and in their ICU, positive COVID-19 test; This is a spontaneous report from a contactable pharmacist.  A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unspecified date in Dec2020 at SINGLE DOSE for COVID-19 immunization. The patient developed positive COVID-19 test with symptoms on unknown date. The clinical course was as follows: the patient received the first dose of the vaccine 2 weeks ago and has COVID now and was pretty ill and in their ICU. Laboratory data included: SARS-CoV-2 test (unknown date): positive. The pharmacist was wondering if the participants in the trials received their second dose if they tested positive before the second dose and if there is any data on when to give the second dose of the vaccine for patients that test positive before the second dose. The outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
PT HAS PROLONGED LOCAL DISCOMFORT GREATER THAN 4 WEEKS. BEGAN MORNING FOLLOWING VACCINATION CONTINUING DAILY. ATTEMPTED MASSAGE AND ASPIRIN-BOTH INEFFECTIVE. ABLE TO DO FULL RANGE OF MOTION
Pain started at the injection spot in my left deltoid approximately 24 hours after injections. Approximately two weeks later, the pain had spread to the triceps brachii and upper brachioradial is muscles.  Over three months later, the pain has subsided somewhat, but definitely persists causing me to use my right hand/arm for any heavy lifting.
Extreme pain to site, back pain, breathing problems, fatigue. 60-day follow up on 01/06/04: "Shortness of breath, muscle pain, joint pain, ringing in ears, fatigue, mood changes, sleep apnea, periodic limb movement disorder, limb swelling, memory loss, muscle weakness." The medical records received on 1/12/04 confirms all the previously coded terms.
I experienced  a full red circle raised 1cm after receiving the shot, warm to the  touch but not itchy which grew to a total of 4inches in diameter 4 days after the shot. The tele-doctor described a a  well defined Erythema with no crusting or streaking and recommended using cold compresses, Ibuprofen/Tylenol for discomfort, and it went away after 7 days.
Patient presented to office with symptoms of vomiting, head hurting, rash all over that itches. Diagnosed by physician with varicella.
It started right before Christmas, I think around the 23rd. The symptoms were very much like the flu I had right before this. A lot of nasal congestion, and a cough that started to go from my throat to my lungs. My wife suggested I go and get a check up. I tested positive for COVID-19 at the Urgent Care and they prescribed Paxlovid, which I started that night. I basically was over my symptoms by the last dose. I didn't go out for about 10 days, so all of New Years and into the next week. If I had to describe it, it was like a very mild flu except for the cough. While I was sick I definitely had brain fog, and I was coughing a lot and sleeping a lot. After I was sick, about two weeks when I didn't have any other symptoms except for the brain fog.  I did feel winded a lot while I was sick too but it wasn't that bad, but I have experienced getting winded afterwards when doing normal stuff. I did go out to get a blood oximeter and that shows that I've been normal with that, but about a month afterwards I'm back to normal.
This spontaneous report was received from a physician (pediatrician) concerning a 15-year-old patient of unknown gender. The patients historical conditions, concurrent conditions, concomitant therapies, historical drugs, allergies and concomitant therapies were not reported. On 28-NOV-2018, the patient was vaccinated with VARIVAX reported lot number N028713, expiration date: 13-OCT-2019, for prophylaxis (strength, dose, and frequency were not reported); one dose was administered subcutaneously, and the other dose was administered intramuscularly (overdose, incorrect route of product administration). No adverse effects were reported.  No product quality complaint was filed.   At the time of reporting, the outcome of the events was unknown.
Patient fainted in the observation area about 5 minutes after receiving the vaccine. She was on the floor and we treated her for syncope. Her first blood pressure reading was not recorded but it was low around 100/60. Subsequent measurements were 128/78 then 145/87. She could respond to verbal commands but she felt weak and nausea. She recovered after about 5 minutes. We observed her for another 15 minutes before we released her.
thrombocytopenia  platelets 87K foot swelling, and pain petechial  rash
Tired; Very sick; Whole stomach was on fire adn into her esophagus; Weakness; No appetite; Achyness; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), DYSPEPSIA (Whole stomach was on fire adn into her esophagus), ASTHENIA (Weakness), DECREASED APPETITE (No appetite) and PAIN (Achyness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gastroesophageal reflux disease. Concomitant products included VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Weakness), DECREASED APPETITE (No appetite), PAIN (Achyness), HEADACHE (Headache) and CHILLS (Chills). On 28-Feb-2021, the patient experienced ILLNESS (Very sick) and DYSPEPSIA (Whole stomach was on fire adn into her esophagus). On an unknown date, the patient experienced FATIGUE (Tired). On 26-Feb-2021, ASTHENIA (Weakness), DECREASED APPETITE (No appetite) and CHILLS (Chills) had resolved. On 28-Feb-2021, ILLNESS (Very sick), DYSPEPSIA (Whole stomach was on fire adn into her esophagus) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (Achyness) and FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Blood pressure measurement: increased (High) recovered on 28-Feb-2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included:  blood pressure, cholesterol and for gastroesophageal reflux disease.  No treatment information was provided.
This spontaneous report as received from a 56 year old male patient refers to himself. The patient was unsure if he had ever had chickenpox in the past. On 25-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route and lot # not reported). The patient's physician prescribed him the vaccine since the patient's wife was diagnosed with shingles the same date. The patient reported the first week after receiving the vaccine he felt fine. On 01-SEP-2014 (estimated date, reported as "the Monday following receiving the vaccine"), the patient reported he began "feeling poorly with a fever". The patient also reported he developed an injection site reaction around the same time as he began to feel poorly in which the place of the injection became red with "small red dots circling the injection site." On an unknown date in September 2014 ("later in the week"), he began experiencing "a low grade fever, feeling crappy, and sweating". The patient sought medical attention by visiting his physician on 03-SEP-2014, his physician reported to the patient he was experiencing "an injection reaction". The patient and his wife went traveling on 05-SEP-2014. On 06-SEP-2014, he woke up with hives all over his face and neck, which the patient reported was "full blown chickenpox". On the same day, 06-SEP-2014, he went to a hospital (hospital unspecified and it unspecified if he was admitted to the hospital). The patient reported he spent four hours in the unspecified hospital where he had his blood taken  placed (result not provided). The patient reported he was treated with VALTREX which the patient reported he took one gram three times a day for seven days. The patient also reported he was treated with an unspecified topical oil which he places all over his face and body. The patient reported he was currently feeling "fine" by the time of this report. The patient recovered on an unknown date in 2014. Additional information has been requested.
The patient Got his 2 doses of Moderna vaccine on 05/20/2021 and 06/17/2021 but called the pharmacy on 09/03 to report a swollen left leg after receiving the 1st dose and swollen right leg after receiving the 2nd dose. Not sure if this is accurate since the patient didn't report anything right after getting the vaccines he waited until 09/03 to complain.
Case number PHEH2013US018853, is an initial spontaneous report received from a medical assistant on 29 Aug 2013: This case refers to a 12 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with expired MENVEO (batch number: A10054 and expiry date: Jan 2013) on 17 Jun 2013. No adverse reaction was reported following this administration error.
Numbness to the tip of the tongue, no loss of taste 2pm the day after vaccination 12/22/2020, resolved after 1 hour, but person took one dose each of prednisone 40mg/benadryl 25mg/pepcid 20mg.  Numbness recurred on the tip of tongue again at 11:50 pm the same day 12/22/2020.  same one dose of 3 meds as above taken, and the numbness subsided after 30 min.  no loss of taste.  no reports of recurrence on 12/23/2020 as of now (6:41 pm)
Patient was given the 2nd Pfizer vaccine 5 days before the recommended time between the 1st and 2nd dose.  Patient has been notified of the vaccine administration error.
Fever for about 4 hours; Aches; Chills; This is a spontaneous report from a contactable consumer, the patient. A 74-years-old non-pregnant elderly female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), dose number 2, via an unspecified route of administration in the left arm on 02Feb2021 at 09:45 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Past drug of the patient included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248), dose number 1, via an unspecified route of administration in the left arm on 12Jan2021 at 12:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient had no allergies to medication, food or other products. Concomitant medications of the patient included simvastatin (MANUFACTURER UNKNOWN) and Citrical (calcium) (MANUFACTURER UNKNOWN); all for unknown indication since unknown date and is unknown if ongoing. The patient had not received any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 02Feb2021 at 23:00, the patient experienced aches, chills and fever for about 4 hours. Some achiness lasted for about a total of 12 hours. No therapeutic medications were taken for the events. The clinical outcome of the events aches, chills and fever was recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
I had flu like symptoms with dizziness, fever, body aches. On the second day I was very dizzy and then I passed out. I woke up on the bathroom floor. I have no idea how long I was passed out for and I was alone. This was very scary for me. I felt exhaustion and muscle weakness. I did report this to my doctor. My Endocrinologists and he suggested that I not have another COVID-19 vaccine. My muscle pain and nerve issues remained the same after the 1st and 2nd dose of Moderna which was reported also.