chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles/Psoriatic arthritis aggravated; Elevated liver enzyme levels; Sleep impacted/changed sleep pattern /Sleep disturbed; Blood pressure high; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4308595-00.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis breakouts on front of hand/sides of fingers/knuckles/Psoriatic arthritis aggravated"; HEPATIC ENZYME INCREASED (non-serious), outcome "unknown", described as "Elevated liver enzyme levels"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Sleep impacted/changed sleep pattern /Sleep disturbed"; HYPERTENSION (non-serious), outcome "unknown", described as "Blood pressure high". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high; blood test: elevated liver enzymes. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles, elevated liver enzyme levels, sleep impacted/changed sleep pattern and high blood pressure was not provided.   Causality for Pfizer BioNTech COVID-19 Vaccine: The reporter's causality for the event(s) of Psoriatic arthritis break outs on front of hand/sides of fingers/knuckles, elevated liver enzyme levels, sleep impacted/changed sleep pattern and high blood pressure was possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
PATIENT WAS TO HAVE RECEIVED A BOOSTER DOSE OF MODERNA COVID-19 VACCINE (0.25ML) BUT PATIENT RECEIVED FULL DOSE (0.5ML).  PATIENT STATES NO ADVERSE EVENT AFTER RECEIVING VACCINE.
pt recv vax 28JUL97 & 11AUG97 pt exp chickenpox;pt had a papular rash over complete body in mouth;presented to a clinic on approx 3SEP97;
Pt was given MMR#1 in (L) anterior lateral thigh on 3/17/14. Was seen in office on 3/26/14 for localized itchy rash in this area. Returned to office on 3/27/14 with full body rash. Pt prescribed BENADRYL orally and cortisone cream.
3rd Booster on 10Sep2021; never felt right / felt bad continuously; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 10Sep2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Multiple Sclerosis (ongoing); anxiety (unspecified if ongoing); migraines (unspecified if ongoing); pain (unspecified if ongoing); urinary incontinence (unspecified if ongoing); nephrolithiasis (unspecified if ongoing); degenerative disc disease (unspecified if ongoing); spasms (unspecified if ongoing); dizziness (unspecified if ongoing). Concomitant medication(s) included OCREVUS; DIAZEPAM; NEURONTIN; FLEXERIL; DETROL; ADDERALL; HYDROCODONE; MECLIZINE; ROBAXIN; TIZANIDINE; ESTRACE VAGINAL; LEVOFLOXACIN. Vaccination history included: Bnt162b2 (Dose: 2), administration date: 22Jul2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1), administration date: 30Jun2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported FEELING ABNORMAL (non-serious) with onset 2021, outcome unknown; IMMUNISATION (non-serious) with onset 10Sep2021, outcome unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a physician concerning a 13 year old male who was vaccinated with the first and the second dose of MMR II (lot # not provided) on 18-NOV-1997 and 20-JUL-2000 respectively. On 18-JAN-2010 the patient experienced mumps and it was swelling. On 20-JAN-2010, the first blood work revealed IgM<1:10, IgG was 7.92 and serum amylase was 562. On 20-JAN-2010, the patient was diagnosed with mumps. Parotitis was on the right. It was unspecified if the patient sought medical attention. Additional information has been requested.
For about 3 days soon after the vaccine  High fever  Body aches Migraines  Weak
Injection site pain Swelling around injection site Rash/hives on arms Headache  Fever
My son suffered adverse reactions the day after and everyday after receiving the MMR vaccination. This included : difficulty concentrating, restlessness and psychosis. He had to leave his academic undergraduate " 4.0" standing and  stop his studies to come home. He endured multiple hospitalizations . 40 days total. Discharged with anti psychotic medications.
Swelling in lymph nodes on left side between armpit and breast.  Mammogram and ultrasound confirmed not cancerous, but rather likely enlarged lymph node.  Aches, headache, fatigue.
I knew when the needle hit my body, it was in the wrong place-it had entered my shoulder joint, instead of my deltoid muscle! Within just a few moments, I had severe pain in my shoulder such that I couldn't even lift my arm to do simple tasks-to put on my seatbelt to drive home, for example. Since then, it has been extremely difficult even to sleep, as I cannot even pull a sheet up over my body because I cannot lift my arm at all. I have been taking Aleve all day long but it doesn't even make the pain bearable. Even putting on deodorant is beyond painful and brings tears to my eyes. I am going to see a doctor tomorrow because I haven't been able to sleep through the night since this happened and my daytime life activities are so painful and impaired.
Patient: Female, Per RN notes: "1610 vaccinated L deltoid, Reaction time: 1611 Fainted, Chin lift and head support, Patient recovered BP 82/55, HR 73 at 1614. Slight nausea. After vaccine administered, patient stated she "didn't feel good". Encouraged patient to deep breathe and wiggle toes. Noted pale in color and she lost consciousness. Noted breathing, still rapid response called. Patient awake, alert, transferred patient to gurney. Patient agreed to go/be transferred to the ER with security and ER nurse. "
On 09/01/2021 A Moderna vial was opened at approximately 05:30 PM, at closing of the business day (7pm) the Moderna vial was not removed from the refrigerator and discarded. Subsequently the vial was used the next day on 09/02/2021 at 05:29 PM to vaccinate the patient, approximately  12 hours past its 12 hour refrigerated expiration. The moderna vial was always kept refrigerated.
This case was reported by a pharmacist and described the occurrence of swelling injection site in a 75-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medications included Pioglitazone, Glimepiride, Omeprazole, Atorvastatin calcium, Metformin hydrochloride, Lisinopril+Hydrochlorothiazide. On 4 November 2013 at 10:00 the subject received a dose of BOOSTRIX (unknown, left arm). On an unspecified date in November 2013, within a couple of days after vaccination with BOOSTRIX, the subject experienced swelling injection site and injection site redness. In November 2013, one to two weeks after vaccination with BOOSTRIX, the subject experienced injection site lump. The subject was administered BOOSTRIX, about one week after the injection, the subject returned to the pharmacy with redness and swelling at the injection site. The pharmacist stated that the redness and swelling was about two inches in diameter. She counseled the subject that this can occur and would resolve. The subject returned home. The subject returned to the pharmacy again after another week and the redness and swelling at injection had resolved, but she now had a lump that could be felt at the injection site (injection site lump). The reporter did not know the exact timeline of events, but the redness and swelling started a couple days after the injection and resolved sometime between one to two weeks after the injection. The pharmacist did know if the subject had sought medical attention beyond speaking with the pharmacy. At the time of reporting the swelling injection  site and injection site redness resolved; injection site lump was unresolved. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. Follow up received from pharmacist on 22 January 2014. The pharmacist reported that they "contacted the CDC for adverse reaction information but no official report was made." The pharmacist provided no additional details.
This spontaneous report as received from a nurse refers to a 62 years old male patient with thyroid disease, hypertension and diabetes. The patient was vaccinated with ZOSTAVAX (lot number, expired date, dose and injection site were not reported) (subcutaneous injection) for prevention of shingles on 29-OCT-2012. No other co-suspects were reported. Concomitant medications included: TDAP. The patient came back in the office for medical attention on 01-NOV-2012 sick where he was diagnosed having jaundice. The adverse event onset date was 29-OCT-2012. The outcome was unknown at the time of report. Additional information has been requested.
had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (had their 1st dose of the Moderna vaccine on 21Jun2022 and no 2nd dose yet).    No concomitant medication were reported.  Pharmacist states that they have a patient who had their 1st dose of the Moderna vaccine on 21Jun2022 and is now at their store for the 2nd dose. Pharmacist wanted to know if they can give them the 2nd dose. No treatment information was provided by the reporter.   Reporter did not allow further contact
OBSTRUCTIVE SLEEP APNEA ANGIOEDEMA, INIT 11/18/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I incurred Lymphedema which caused swelling and pain required to see an occupational therapist and massage to reduce the swelling was going 2-3 times weekly.
2 days after receiving immunization patients arm had a rash at site of injection warm to the touch.
Information has been received from a physician assistant concerning a male patient who on 17-NOV-2008 was vaccinated with VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck). No symptoms was reported. Further information has been requested.
I got shot on Friday and the next morning at 2 am i got a really bad head ache that last about half hr. It started getting better after i took a 650 mg Tylenol. Worse when i lay down.  Saturday it happened again at 2:30 am it was not a bad pain more like an ache to a pain but nothing like the 1st night. Sunday i had no pain.  Then Monday at 3 Am it was a really bad pain again. Today i was sleeping and at 7:30 Am I woke up with headache that was very uncomfortable. Got out of bed and took my Tylenol about 30 mins later the pain went away.  Today it went away much quicker then the 1st couple of nights.
Menstrual cycle was 12 days late according to regular tracking for 3 years. Onset of menstrual cycle was accompanied by more severe cramping and heavier bleeding than is normally experienced.
Couldn't stand,walk feel feet.Headache, fever. became paralized from head to toes.Had a trach,on resporator for 33days,couldn't walk,stand for months.Treated in hospital on machines and then home with pain meds. and had to be rehabilatated for months.
Information has been received from a 60 year old Registered Nurse with no known allergies, "osteomylasia" and hypothyroidism who on 19-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included ezetimibe (+) simvastatin (MDS), SYNTHROID, LEXAPRO, EXCEDRIN and FORTEO. On 23-FEB-2008, the patient experienced a headache that was being treated with EXCEDRIN. The patient also developed a lump, bruise, erythema and pruritus at the site of injection. There was no medical attention sought. At the time of the report the patient was not recovered. There was no product quality complaint involved. Follow-up information from the physician indicated she did not administer the vaccine to the patient nor was she aware of any complaints. Follow-up information from the registered nurse indicated that the headache she experienced after the vaccination was probably not due to the vaccine. It was noted that the headache was thought to be due to environmental consequences. Additional information is not expected.
NECK PAIN; HEADACHE/PAIN RADIATING FROM NECK TO POSTERIOR SKULL; NAUSEA; This spontaneous report received from a health care professional concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, and hormonal change, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced neck pain. On 08-APR-2021, the subject experienced headache/pain radiating from neck to posterior skull. On 08-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache/pain radiating from neck to posterior skull, neck pain, and nausea. This report was non-serious.
Rapid heartbeat-between 20-24 beats faster than normal for me-lasted until after I feel asleep.  In AM, rate was back to normal.  Arm sore from injection, which I considered not to be important. I have had the high dose flu vaccine -Fluzone- before and never had any problems. I felt quite uncomfortable, but had no chest pain and did not need to go to the ER.
Systemic: claims shoulder pain 2 months after shot-Mild, Additional Details: Patient received shot on 10/21/22, recently had a doctors appointment and is having shoulder discomfort. Doctor told her "dont know" what shoulder issue is from. Call the pharmacy" Over 2 months after shot, its being reported to us.
My reaction was not life threatening, but I wasn't able to report the first couple days via the CDC app, so I'm providing the dat here. Fever, chills devere fatigue, localized pain and swelling at vaccination site started about 8 hours after my injection and worsened until about 36 hours then symptoms abated after another 24 hr.
Increased appetite; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 28Mar2021 at 14:15 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The facility where the patient received the vaccine was at a pharmacy or drug store. On 28Mar2021 at 15:00, the patient experienced increased appetite for 12 hours. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event increased appetite was recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I received my second Pfizer booster for COVID-19 on 4/8/2022. On 8/14/2022, I had a prickly feeling in my throat. I didn't have a fever and it was a mild symptom, but it was different from any other sore throat I've ever had. On 8/15/2022, I continued to have the sore throat. I took a home COVID-19 test and got a negative result. Not only did I still have the sore throat, but I also felt fatigued. Even though I got a negative result on the test, I felt like I was coming down with something. On 8/16/2022, I still had the sore throat and fatigue. I took another home test and got a positive result. I called my doctor's office to let them know, and I was instructed to go to a local hospital to get a bebtelovimab infusion. When I got to the ER, I underwent a chest X-ray and a rapid test for COVID-19, and I got another positive result. I went home immediately after getting the infusion. At this point, I didn't really feel too bad. However, by about 8/19/2022, I was short of breath, so I called my PCP, who then consulted with my pulmonologist. They decided that I should be given a 6-day pack of methylprednisone. After taking the methylprednisone, I felt better. On 8/22/2022, I tested negative and I felt better. However, on 8/24/2022, I was again out of breath; when I took another test, I got a positive result. On 8/26/2022, I tested negative again, but the shortness of breath probably lasted 6 weeks after the initial diagnosis. I felt better for a while, but at the time of this writing, my oxygen saturation level is now a little lower. I don't know if that is related to my bout with COVID-19 or with my anemia.
Left little finger is numbed up real good and is going down to the palm; he felt like he was stuck in an elevator and couldn't get out; he was real nervous.; At one point, was real anxious and aggravated; This is a spontaneous received from a contactable consumer (patient). A male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expire date: 30Jun2021) via unspecified route on left shoulder single dose for COVID-19 immunization on 05Mar2021, . Relevant medical history included: ongoing chronic obstructive pulmonary disease (COPD), ongoing depression. Concomitant medications included: lisinopril 20mg tablet once a day for blood pressure for 4 or 5 months; amlodipine 10mg once a day for blood pressure; carvedilol 6.25 mg tablet for blood pressure; budesonide, formoterol fumarate (SYMBICORT) inhaler twice daily for COPD for 6 years; salbutamol sulfate (ALBUTEROL SULFATE) inhaler blue every four hours for COPD about 6 years; all ongoing. Left little finger was numbed up real good and was going down to the palm now. This started 05Mar2021 when he got the vaccination, that night (05Mar2021), he felt like he was stuck in an elevator and couldn't get out. He was really nervous. At one point, the patient was real anxious and aggravated. Numbness was still lingering. Treatment not until 15Apr2021. The most he had been taking was acetylsalicylic acid (ASPIRIN). Emergency room or physician's office not visited. Outcome of the event numbness was not resolved; outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
After my previous vaccines, I began to feel progressively worse and started to experience a slow decline.  I had bouts of dizziness, unsteadiness on my feet at times and at times I would have to lay down.  I would get heart palpitations and it would take a minute to catch my breath after a heart palpitation.  The more pervasive symptom was I had a tremendous amount of fatigue throughout my day.  I had an event of vasovagal syncope during a biopsy procedure on May 3rd, 2022.  The same thing happened to me when I was in the emergency room in which my heart paused and this is when I went into cardiac arrest on September 10th, 2022.  Received pacemaker on 9/11/2022
c/o itching & redness on feet, ankles, hands, forehead & behind neck; Seen by MD dx allergy to Td; given meds; Pt noticed palm of hands & bottom of feet around joints occasionally devel red area & became sore;
very sudden and dramatic breakthrough/period-like bleeding around about the time I ought to be ovulating.(14days after shot); This is a spontaneous report from a contactable consumer. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated,"I had my second dose of your covid vaccine on the 22nd (the day after I got my period). I'm still experiencing side effects, I probably won't be out of bed for at least another couple of days. The most recent one is I got very sudden and dramatic breakthrough/period-like bleeding around about the time I ought to be ovulating.(14 days after shot; May2021) Do you have a link or number to call to report all the side effects?". The outcome of event was unknown.