chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immed somnolence cont for 24 hrs; hypotonic hyporesponsive episode @ 1 hr post vax; sz activity involving twitching of the fingers & eyebrow on th rt side @ 6 hrs post vax; irregular breathing patterns persisting for 30 days;
Allergic reaction to 2nd anthrax shot (symptoms-dyspnea, airway problems, chest tightness); Tx - Benadryl 50 mg IM right deltoid and O2 nonrebreather mask; transport to ER.
02/28 - On the night I received the vaccine, there was some minor pain in my lower right leg and, of course, soreness in the left arm. Some of the pain radiated from the upper arm to the lower arm. Ibuprofen was taken before bed 03/01 - Just continued soreness in the arm, fatigue and severe nausea later in the evening. 03/02 - Upon waking today, I have swollen lymph nodes and pain in the left armpit (the arm where the vaccine was administered)
Narrative:  fBreakthrough Delta Variant COVID infection requiring hospitalization; discharged 9/4/21
Patient has expired / died (9.28.21);  Hospitalized (9.15.21);  COVID positive (9.9.21);  fully vaccinated  Discharge Provider:  Admission Date: 9/15/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 virus infection [U07.1] COVID-19 [U07.1] Acute respiratory failure with hypoxia  [J96.01] Acute respiratory failure due to COVID-19 [U07.1, J96.00]   HOSPITAL COURSE: Patient is  a 57 year old with asthma, MS (ocrelizumab q 6 months), tobacco abuse (30pkyr), and congenitally absent left kidney.  He was COVID (+) 9/9 (was vaccinated in the spring).  He presented 9/15 with 10 days cough/SOB/fevers.  In the ED, he was hypoxemic and would desaturate with activity.  CXR showed patchy bilateral opacities.  He was admitted and treated with Decadron, remdesivir, and empiric antibiotics. On 9/18, he was transferred requiring HFNC/NRB.  On 9/19, he required intubation, NMB (until 9/22), and proning (until 9/21).  Doppler US 9/20 showed acute right IJ and right SC DVTs.  He was extubated 9/26 and initially tolerated low-flow NC oxygen but was profoundly weak.  He decompensated requiring BiPAP.  He had been made DNR by family then comfort measures.  He passed away on 9/28 while this attending was off service and at home Date of Death: 9/28/21 Time of Death:  8:07 PM Preliminary Cause of Death: Acute respiratory failure due to COVID-19
site of injection started itching and developed red mark (5 inches long); site of injection started itching and developed red mark (5 inches long); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (site of injection started itching and developed red mark (5 inches long)) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark (5 inches long)) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE PRURITUS (site of injection started itching and developed red mark (5 inches long)). 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark (5 inches long)). At the time of the report, INJECTION SITE PRURITUS (site of injection started itching and developed red mark (5 inches long)) and VACCINATION SITE ERYTHEMA (site of injection started itching and developed red mark (5 inches long)) had not resolved.            Treatment medicines include Cortozone-10 cream
Patient was given an additional booster dose inadvertently.  Patient requested booster and did not report that he already had a booster 10/11/2022 at an alternate provider.  Patient had no adverse events for that day at dialysis.  Patient went to ER and was admitted to the hospital on 11/17/2022 until 11/19/2022.  Admitting diagnosis weakness.  Discharge diagnosis Acute on Chronic Anemia s/p hemoclips. hx GI Bleed secondary to AVMs, ESRD on hemodialysis, Metastatic squamous lung cancer.
Rash developed on right side the day after the injection.  Over several days it expanded to a 14" long 3" wide Red Rash.  Dr Advised, NOT SHINGLES.  After applying prescripted cream - (Clotrim?Beta 1-0.05% CRE GLE - ) - Clotrimazole/Betamethasone Dipropinate 1% / 0.5% for 14 days.   Itching stopped immediately and rash started to heal after 3 days.  After 10 days almost gone.   Inaddition, Dr. wanted me to report that patient had the Bamlanivimab Intervenous Injection, January 22, after testing positive for  Covid-19 on January  13, 2021.
Severe chest pains and pressure; it 17 miles to the next exit before we could head to hospital - I was throwing up and sweating profusely. I don't remember a lot after that was happening and I woke up in the hospital. They said I had a heart attack. I had stents before  and they did an echo-cardiogram and an ultrasound - they said the aorta  (the aorta in the stomach) was 60% blocked and 5.5% aneurism - they said it was a 50/50 surgery as far as the risk. They found that my liver enzymes were up. But later on when a full panel was done they were okay. They also saw something in my stomach and did an emergency scope and found that I had Barrett's esophagus and put me on medicines for that - Pepcid and can't remember the other one. Because of the liver they did a colon thing at the same time and removed four 6 mm polyps and they did biopsies on those and on my stomach. Both were determined pre-cancerous. There was more meds ordered.  I didn't require another heart stent. They don't like to do it unless it is 70% blocked and 6.5-7 on the aneurism because of my age. Last Thursday - I have scoliosis and it had just gotten too bad - so they are burning the nerves in the L3,4,5 and the S1 - it's part of Osteoporosis.  Had back surgery on about a week and a half ago. It got really bad (the pain afterwards) so she put me on Oxycodone Acetophenazine  - last Thursday. A clinic  Pain Management Clinic - That was outpatient.  I have a fractured tibia - knee has mechanically failed. That is scheduled in September 27 - they will attempt to do a total revision from a previous revision from a previous injury. If they can't do a replacement they will have to put a pin in to work off a hinge.
Presented to the hospital for a knee replacement, but stay complicated by COVID pneumonia and respiratory failure. She was given supplemental Normal saline.
Her doctor thinks she has a damaged tendon / experienced tendon problem on her right arm / radiating into her neck; that went up into her neck; Her doctor mentioned / vaccine could be administered higher than normal, on the tendon; Had arm pain that went up into her neck / rolling around on the floor in severe pain / right arm has been hurting for 2 years; This case was reported by a nurse via call center representative and described the occurrence of tendon injury in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis.   On 1st March 2019, the patient received Shingrix (intramuscular). On 1st March 2019, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced tendon injury, pain in arm and neck pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the tendon injury and neck pain were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the tendon injury, pain in arm and neck pain to be related to Shingrix.  Additional details were provided as follows: The patient was reporting for herself. The age at vaccination was not reported. The patient received Shingrix in right arm. After receiving Shingrix, the patient had arm pain that went up into her neck and was rolling around on the floor in severe pain but did not go to the hospital, her doctor told her it would resolve.  The patient went back to get the 2nd dose in her left arm and did not have any complications from the 2nd dose in the left arm.  Her right arm had been hurting for 2 years. The patient stated her doctor thought she had a damaged tendon and she was taking Tylenol daily. The patient stated, her arm pain got worse in cold weather and she would like to know what she could take. At the time of reporting, the patient was experiencing this adverse event and symptoms were worsening. The patient said that, her doctor mentioned that, it could be due to vaccine injection site, that vaccine could be administered higher than normal, on the tendon which led to vaccine administered at inappropriate site was. No further information was provided.  The reporter consented to follow up not asked.  The batch number of Shingrix was reported as ER52B which was corrected to ER5ZB as per sales data sheet.
Patient developed pallor and given ammonia inhalant. He recovered immediately after inhaling the ammonia. Vitals: 110/73, 98, 18 and 100%. Patient stable and released from the vaccination site at 16:55. Escorted to exit.
sleeping up to 14 hours a day; pain in both arms but especially the left one; extreme fatigue; muscle weakness; difficulty getting out of chair; puffiness in her feet; hand tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (hand tremors), MUSCULAR WEAKNESS (muscle weakness), HYPOKINESIA (difficulty getting out of chair), OEDEMA PERIPHERAL (puffiness in her feet) and HYPERSOMNIA (sleeping up to 14 hours a day) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dementia (The patient suffers from dementia, Site is worsening) since 2013, Hyperlipidemia (no recent changes) and Arthritis (increased pain, stiffness, difficulty getting up from chair, hand tremors since covid vaccines given). Concomitant products included DONEPEZIL for Dementia, VITAMIN B12 [VITAMIN B12 NOS] for Memory disturbance and Nerve damage.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), HYPOKINESIA (difficulty getting out of chair) and FATIGUE (extreme fatigue). In 2021, the patient experienced TREMOR (hand tremors) and OEDEMA PERIPHERAL (puffiness in her feet). On an unknown date, the patient experienced HYPERSOMNIA (sleeping up to 14 hours a day) and PAIN IN EXTREMITY (pain in both arms but especially the left one). At the time of the report, TREMOR (hand tremors), HYPOKINESIA (difficulty getting out of chair), OEDEMA PERIPHERAL (puffiness in her feet), HYPERSOMNIA (sleeping up to 14 hours a day), PAIN IN EXTREMITY (pain in both arms but especially the left one) and FATIGUE (extreme fatigue) had not resolved and MUSCULAR WEAKNESS (muscle weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Vitamin B12 gummies of 500 mcg were also taken as concomitant medication for memory and nerve function from  March 2021 and still ongoing  The symptoms mentioned previously (extreme tiredness, weakness, hand tremors, difficulty getting out of a chair, sleeping up to 14 hours a day, pain in extremities-epecially the left arm all started after the patient received the moderna vaccine.  It started with the first vaccine and is ongoing and has not resolved.  She saw her primary care doctor on 4/27/2021 who only said that he had not heard of the covid vaccine causing such symptoms for an extended period of time.  He also did not know whether the vaccine triggered worsening of her dementia.  The puffiness in her feet started around the last week of April.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Significant:Additional AE, medical history, con med updated
Bilateral eye irritation, photophobia, increased lacrimation and conjunctivitis without discharge. Lasted 72 hours. Resolved with ophthalmologic steroid drops.
Site: Pain at Injection Site-Mild, Systemic: Right Jaw Pain-Medium, Systemic: Tinnitus-Medium, Additional Details: Adverse effects occured in the opposite side of the patients body from injection site.  Patient was moved to cooler location in the store, monitored but complained of jaw pain 10/10 and ringing in her ear (tinnitus).  Informed pt that tinnitus was possible side effect that could occur post injection, but was concerned about the jaw pain.  Checked on patient multiple times, applied ice pack wrapped in plastic bag to jaw, patient started to feel better after approximately 30 mins- 1 hour, 2/10 ps
minor irritation at injection site; chills; fever/febrile; chest pain; Heart Rate 120; Abnormal Laboratory Results; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site irritation in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number EN939, expiry date 31-OCT-2024) for prophylaxis.   On 13-JUL-2023 10:30, the patient received Bexsero (injection, left deltoid). On 13-JUL-2023, 3 hrs after receiving Bexsero, the patient experienced chills (Verbatim: chills), fever (Verbatim: fever/febrile), chest pain (Verbatim: chest pain), tachycardia (Verbatim: Heart Rate 120) and lab test abnormal (Verbatim: Abnormal Laboratory Results). On 14-JUL-2023, the patient experienced injection site irritation (Verbatim: minor irritation at injection site). The patient was treated with ibuprofen and paracetamol (Tylenol). The outcome of the injection site irritation and lab test abnormal were unknown and the outcome of the chills, fever, chest pain and tachycardia were resolved.   It was unknown if the reporter considered the injection site irritation, chills, fever, chest pain, tachycardia and lab test abnormal to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site irritation, chills, fever, chest pain, tachycardia and lab test abnormal to be related to Bexsero and Bexsero 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 Information: GSK Receipt Date: 14-JUL-2023 At approximately 1:00 pm patient's mother called at doctor's office and reported about chills, fever and chest pain, then gave patient Ibuprofen. Patient's mother was instructed to bring patient to office for assessment. Abnormal value reported by Physician Assistant as D-Dimer more than 5000. Patient given Tylenol at doctor's office. Symptoms resolved and patient was sent home in Mothers care.  On the reporting day, the patient complained of minor irritation at injection site during follow up call. The reporter consented to follow up.
I have an area around my collar bone on my left side close to the neck that is swollen and is tender to the touch and is about 3 inches long.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Additional Details: Patient has radiating pain from injection site up toward neck and down toward hand.  Patient has been unable to work and sleep.
Rash, burning, itching, bumps, blisters after 2nd shot and still continues. 2nd shot 2/13/21.
Case number PHEH2014US020158, is an initial spontaneous report from a pharmacist received on 06 Oct 2014. This report refers to a patient of unknown demographics. Concurrent conditions included latex allergy. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: not provided) intramuscularly on 06 Oct 2014 without any reports of patient harm. It was reported that severity of the latex allergy of the patient was unknown. No adverse event reported.
Lymph nodes became epically swollen after on my left collar bone and around my arm pit on the same arm .  This has resulted what presents as frozen shoulder.  My lymph nodes and/or bursa are still reactive.  I can't move my arm without sharp pain.  I can't put on a bra regularly.   It has dramatically limited my ability to exercise especially with yoga.   In addition my shoulder became so inflammed and tight a chiropractor was able to lessen the pain.  I have had headaches as a result several times a week that are severe that I didn't have prior to the injection.   Besides the chiropractor, no one seems to care and I am told it could take years to subside.
Tested positive for Covid 19.; Tested positive for Covid 19.; Other vaccine same date vaccine date 27Nov2021/Off label use; Other vaccine same date vaccine date 27Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation; influenza vaccine (FLU), administration date 27Nov2021 (Batch/Lot number: unknown) as unk, single for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination. Patient was tested positive post vaccination for COVID-19. Covid test type post vaccination was reported as Nasal Swab. Covid test name post vaccination was reported as BinaxNOW. Patient was tested as negative on 27Dec2021 and positive on 29Dec2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 21:30, outcome "recovering" and all described as "Tested positive for Covid 19."; OFF LABEL USE (non-serious) with onset 27Nov2021, outcome "unknown", described as "Other vaccine same date vaccine date 27Nov2021/Off label use"; PRODUCT USE ISSUE (non-serious) with onset 27Nov2021, outcome "unknown", described as "Other vaccine same date vaccine date 27Nov2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) negative, notes: Nasal swab; (29Dec2021) positive, notes: Nasal swab positive at 21:30. Adverse event was reported as Tested positive for Covid Virus. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Felt ill, vomiting, dizzy - looed pale. Had patient lay down and put cold towel on head.
itching behind ears and head on 07/01/2021, hives appeared on 07/02/2021 , swelling of lips 07/02/2021. went to hospital was given IV Benadryl and histamines, pepcid, and epi pen for emergency, discharged on 07/03/2021 with medrol dose pack and pepcid and OTC Benadryl, on 07/03/2021 evening rash intensified all over body, itching increased, woke up sunday 07/04/2021 both eyes swollen.  went back to the hospital was given more IV Benadryl and increased mg of prednisone at 60mg daily. woke up monday with rash still present. seen pcp on 07/06 and was referred to a allergist due to body being covered and prednisone not working.
One of twenty-one cases: A non-serious, spontaneous event of a half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
FEVER SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On an unspecified date, the subject experienced fever symptoms. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fever symptoms. This report was non-serious.
pt recvd vax;exp redness,swelling & pain at inject site;devel low grade fever,malaise & gen achiness about 12 hrs p/ vax;tx w/ Pen-Vee K as prophylaxis for subacute bacterial endocarditis due to pt hx of mitral valve prolapse;
Patient has 5" x 6" erythemic, swollen, warm. Painful area around injection site, entire (L) upper arm is swollen.
Sluggish; headache; Arm pain at site of injection; A spontaneous report was received from a nurse concerning a 43 year-old, female patient participating in the mRNA-1273 Program and experienced feeling sluggish, arm pain at site of injection, headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the same day as the onset of the events, the patient received their first of two planned doses of mRNA-1273 (025J20A) for prophylaxis of COVID-19 infection.   On 28 Dec 2020 the patient began to feel sluggish and experience arm pain at the site of injection. She also reported a headache that is improving with self-treatment. Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events feeling sluggish and arm pain at site of injection were unknown/not reported. The outcome of the event, headache, was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Patient received a booster dose prior to the five month waiting period after the second dose of COVID-19 vaccine. MA who administered vaccine asked the patient if five months passed since his last immunization. He said yes, but did not have his immunization card. Upon further investigation after the fact, RN checked the vaccine registry and found our electronic health record did not have both of his COVID-19 immunizations documented.
Rash under right underarm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH (Rash under right underarm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rash.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 22-Feb-2021, the patient experienced RASH (Rash under right underarm). At the time of the report, RASH (Rash under right underarm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided    This case was linked to US-MODERNATX, INC.-MOD-2021-062527 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062527:Crosslinked case