chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rheumatoid arthritis flare up; Drug effect decreased; 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-163-4255354-00 (RA).  A 58-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THERAPEUTIC PRODUCT EFFECT DECREASED (non-serious) with onset Dec2021, outcome "unknown", described as "Drug effect decreased"; RHEUMATOID ARTHRITIS (medically significant) with onset Dec2021, outcome "unknown", described as "Rheumatoid arthritis flare up". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" and "drug effect decreased" 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.  Additional Information: The reporter's causality for the event(s) of HUMIRA not effective anymore rheumatoid arthritis symptoms worsened/ Possible increase in arthritic issues following the COVID vaccine onset in Dec2021 and HUMIRA not effective anymore rheumatoid arthritis symptoms worsened/ Possible increase in arthritic issues following the COVID vaccine onset in Dec2021 was not provided. On 22Apr2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The event of HUMIRA not effective anymore rheumatoid arthritis symptoms worsened/ Possible increase in arthritic issues following the COVID vaccine.  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 reported information, the causal association between the events rheumatoid arthritis and therapeutic product effect decreased 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.
sore left arm for 24 hours after the second Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm for 24 hours after the second Covid-19 vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Spinal operation NOS (Cervical spine area surgery) in April 2021. Concomitant products included METHOCARBAMOL, PARACETAMOL (EXTRA STRENGTH TYLENOL BACK PAIN) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm for 24 hours after the second Covid-19 vaccine). In April 2021, VACCINATION SITE PAIN (sore left arm for 24 hours after the second Covid-19 vaccine) had resolved.            No treatment medication information was reported.   This case was linked to MOD-2021-409868, MOD-2021-409877 (Patient Link).
Arm pain at time of injection, continuing at pain scale grade 7 for 20 day. Limited range of motion.
DOSE 2 WAS GIVE 21 DAYS AFTER THE FIRST DOSE, WHICH IS PRIOR TO THE RECOMMENDED INTERVAL OF 28 DAYS
Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Additional Details: PT IS 6 YEAR OLD CHILD, HAD HER SECOND DOSE AND WAS TOLD TO SIT AND WAIT FOR HER OBSERVATOIN PERIOD. THE NEXT PATIENT WAS HER SISTER, AND WAS SCREAMING AND SCARED DURING HER APPOINTMENT. PT GOT UP AND WALKED OVER TO SEE, AND FELT DIZZY AND FAINTED AGAINST A STAND. SHE RECOVERED AND FELT DISORIENTED AND HAD STOMACH PAIN. PT RECOVERED AND WAS ABLE TO LEAVE AFTER HER OBSERVATION PERIOD WITH HER FATHER
Generalized pruritus and rash beginning approximately 24 hours after Varivax administration and resolving within the next 48 hrs.
carpal tunnel syndrome; 2 middle fingers cramped and closed on him and he could not open them without manually pulling on the fingers; pain in the whole left arm that radiated down to his fingers; 2 middle fingers cramped and closed on him and he could not open them without manually pulling on the fingers; This case was reported by a pharmacist via call center representative and described the occurrence of carpal tunnel syndrome in a 82-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4F99G, expiry date 19th August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th August 2020, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 17th August 2020, 1 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced carpal tunnel syndrome, finger cramps, radiating pain and mobility decreased. On an unknown date, the outcome of the carpal tunnel syndrome, finger cramps, radiating pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the carpal tunnel syndrome, finger cramps, radiating pain and mobility decreased to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the vaccine in the left arm. On 17th August 2020 the patient had pain in the whole left arm that radiated down to his fingers and the patient's 2 middle fingers cramped and closed on him and he could not open them without manually pulling on the fingers and this was ongoing at the time of reporting. The patient's physician diagnosed him with carpal tunnel syndrome and he had been going to physical therapy.  The patient did not consent to follow-up.
No adverse event happened. PT was given MMR at 2 months of age, which is early. The CDC recommended at the time that MMR be given at the age of 1 years old.
Itching, rashes, redness of skin and difficulty of breathing. They would be gone after a few minutes of taking Benadryl one tablet 25 mg.
Day after geting DTaP and Hep A - had swelling, pain, warmth on shoulder site of DTaP. Prompted visit and antibiotics - likely extreme local reaction.
This spontaneous report as received from a practice manager (other health professional) refers to multiple patients of unknown age. The practice manager reported to the field representative that multiple unspecified patients have been re-vaccine with PNEUMOVAX (lot/batch #, route and indication unknown) "every 5 years" regardless of their age. It was reported that the patients have potentially been given more than a single re-vaccination of PNEUMOVAX23. No adverse effects were reported. Additional information has been requested.
I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and; I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and; I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and; I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 15:15 (Lot number: FD8448) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "1 kidney" (unspecified if ongoing), notes: 1 kidney, No thyroid, Bipolar 2,, MTHFR C677T/A1298C,; "No thyroid" (unspecified if ongoing), notes: 1 kidney, No thyroid, Bipolar 2,, MTHFR C677T/A1298C,; "MTHFR" (unspecified if ongoing), notes: 1 kidney, No thyroid, Bipolar 2,, MTHFR C677T/A1298C,; "Bipolar 2" (unspecified if ongoing), notes: 1 kidney, No thyroid, Bipolar 2,, MTHFR C677T/A1298C,; "Penicillin" (unspecified if ongoing), notes: Penicillin, Sulfa, Codeine; "Sulfa" (unspecified if ongoing), notes: Penicillin, Sulfa, Codeine. Concomitant medication(s) included: SYNTHROID; CYTOMEL; TRILEPTAL; ATARAX [ALPRAZOLAM]; XANAX. Past drug history included: Codeine, reaction(s): "known allergies:Codeine", notes: Penicillin, Sulfa, Codeine. The following information was reported: ASTHENIA (non-serious), PALPITATIONS (non-serious), FEELING ABNORMAL (non-serious), DECREASED APPETITE (non-serious) all with onset 25Aug2021 05:00, outcome "recovered" (2021) and all described as "I have no thyroid. Removed Aug 2005 due to cancer. The morning after 1st vaccine, I felt just like I did before radiation treatment and being depleted of thyroid hormone. No energy, heart pounding and". Therapeutic measures were not taken as a result of asthenia, palpitations, feeling abnormal, decreased appetite.  Additional information: Patient did not receive any other vaccines within 4 weeks. Patient do not have covid prior to the vaccination.  Patient did not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Admitted to hospital with one day of chest pain in the setting of elevated troponin T level. Chest pain started three days after receiving second COVID-19 vaccine (Pfizer).
After vaccination patient complained of "a tingling sensation in the left side of tongue and like he could taste medication". Monitored for 25 minutes at which point symptoms had resolved.
Well like I said, I woke up and my arm after the shot was sore. The joint was bothering me, and I thought that it was a side effect of the shot and after about a week I had a little bit of movement but still pain. So later in May I finally called the orthopedic doctor. I got an MRI and he said it was a significant tear to the rotator cuff. I did not do anything so I do not know what or how it happened. I just figured it was the COVID vaccine, although the doctor thought it was highly unlikely. I had surgery to repair it on May the 20th 2021, at local hospital. I came home that night after the surgery. The doctor gave me tramadol for the pain as well. I will have another MRI next week, in mid-July 2021.
Increase heart rate. Started 5/5/21 at about 6:45PM and continued through the rest of the day. Leading up to the hear rate increasing I was fine and just enjoying my day. No drugs or alcohol or did not do any exercise that day. Felt uncomfortable and with some anxiety I visited a urgent care facility. The visit was about 45 minutes and left. As I am writing this, my heart rate is still a bit above normal but doing better.
shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 12:00 (Lot number: ew0196) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: ew0191, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 28Jul2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "I also contracted Covid", "I also contracted Covid/Lost of taste and smell". The following information was reported: HERPES ZOSTER (non-serious) with onset 28Aug2021, outcome "recovered with sequelae", described as "shingles". The event "shingles" was 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 herpes zoster.  Additional information: The patient had no Known allergies, had not taken other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had been tested for COVID-19. The patient did not receive if any other vaccine in four weeks. The patient received treatment with Valtrex. The patient stated that she developed shingles exactly 10 days after the second vaccine.  No follow-up attempts are possible. No further information is expected.
Post vaccination the pt experienced swelling, redness, and blotchy knot at injection site. She applied ice to the site and took Benadryl and the sx began to subside.
EXTREME PAIN IN RIGHT SHOULDER NEAR SITE OF INJECTION - LIMITED ROM REDUCING FUNCTIONAL CAPACITY WITH CONTINUED PAIN - STILL ONGOING 7+ DAYS.
This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. The reporter considered the injection site rash to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient went to get her 2nd SHINGRIX vaccination and she informed the reporter that she developed a rash at the injection site after her 1st vaccination.
p/vax pt exp slight swelling in lt arm, decreased movement. 7/16 swelling all way down to fingers. temp 99, began having rash on arms, legs, face, fine red rash w/itching. rash & itching continued saw md 7/19.
1st dose 2.5 years ago, 2nd not received; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received around 2.5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2.5 years ago, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-MAR-2023 The reporter stated that patient was told it was only 1 vaccine she needed. The reporter called the pharmacy to verify, and it was only one dose of Shingrix she received.  She did not remember the date or site of injection.   Phone number provided.  The patient was referred to health care professional (HCP).  Medical disclaimer and survey offered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
has Bexsero prescription, older than 25 years old; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 66-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a patient had a Bexsero prescription and was older than 25 years old, which led to intercepted drug prescribing error. The reporter did not clarify what was the patient condition. The reporter consented to follow-up.
fever was 100F; FATIGUE; muscle weakness is in both legs / legs are still weak / weakness in legs; headaches; walking is not right; severe chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2019, the patient received the 2nd dose of Shingrix. On 26th December 2019, less than a day after receiving Shingrix, the patient experienced chills. On 27th December 2019, the patient experienced fever, fatigue, muscle weakness lower limb, headache and gait disturbance. On 28th December 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the fatigue, muscle weakness lower limb, headache and gait disturbance were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, fatigue, muscle weakness lower limb, headache and gait disturbance to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe chills the evening of the vaccination.   All other symptoms presented the following day. The fever was 100 Fahrenheit and lasted one day.   The chills resolved after that one night.  The muscle weakness was in both legs and was still present.  The headaches was slight but still present.   She plays golf and tennis and her legs were still weak and her walking was not right. The patient had blood work done weeks after the vaccine and the tests did not show any issues. Follow up was received by the physician and was unable to provide vaccine details due to another pharmacy administration of vaccine to patient. Did not consent to follow-up.
My husband had it first and bad. 6 days after I got a really bad sore throat and tested negative. Next day I had the same symptom, tested and was positive. Headache and sore throat lasted 3-4 days. I had stupid dreams for 3 nights in a row that were very vivid for people I haven't seen in ages; and I don't dream. I had a low grade fever and head for 4 days. Then everything went away. I feel like I'm so tired since I had it which is really weird. My energy level now is 0 and I'm normally go go go.
Pain in muscle of same area of injection site that last 5 weeks and is still feeling a little sore.
Person reports since last Monday can't raise arm (left) above shoulder b/c of pain. Reports he went to school nurse for ice, can shrug shoulders, can move arm below elbow. Pain is 7/10, has not taken anything for pain, can move one finger& wrists, bilat, is able to perform ADLs/dress self. Drd not call PCP.
Painful and swollen lymph nodes in injection arm. Starting in underarm nodes and spreading up the left side of neck.
Swollen, itchy hands, redness and swelling around hand joints. Pain in left shoulder muscles.
I notice I had pulsatile tinnitus and I also had a loss of vision between February and April.  So I first went to an ENT who sent me to get an MRA and MRI head, neck and brain with and without contrast. They found probably Dural arteriovenous fistula .The doctor  found pressure on my optic nerve. Then I went to see Doctor,  neurosurgeon,  about the the arteriovenous fistula which can cause pressure on the optic nerve. He looked at the scan . Very rare and not something your born with and the doctor said he's been seeing more common  of this after the vaccine and with COVID-19. I will be getting an angiogram 07/13/2021 @ 12:00 PM.  They will figure out my treatments after the angiogram. After the angiogram, I don't know if they will get the visual to get the pressure off the optic nerve.
On 11/11/09 patient received H1N1 nasal spray (LAIV). His mother requested that he also receive the seasonal flu vaccine. Nurse reached for wrong vial of vaccine and patient received H1N1 injection instead.
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the RN inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The nurse then alerted the APRN, who escalated the situation to the manager. The operations manager then contacted Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL. After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of care.
Not adverse just soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 15:15 (Lot number: FD0809) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CELEXA [CELECOXIB]; ADDERALL. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot No: Er8736, Anatomical location: Left Arm, Vaccine Administration Time: 12:00 PM), administration date: 16May2021, when the patient was 30 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, single, Batch/Lot No: Ew968, Anatomical location: Left Arm, Vaccine Administration Time: 12:00 PM), administration date: 13Jun2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 14Oct2021 10:00, outcome "recovering", described as "Not adverse just soreness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. patient received Celexa, adderall within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The vaccine was administered at Public Health Clinic.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101374795 similar report from same reporter
AFLURIA given 11/10/2008 slight itching that night next AM rash generalizes itching took Benadryl 50mg 11/12/2008 AM had severe itching hives all over welts. MD Rx Epi 13 at Decadron 1.5ml.