chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am having hives; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0161) via an unspecified route of administration on 21Apr2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0150) on 31-Mar-2021 at single dose for COVID-19 immunization. The patient had second vaccine about two weeks ago from the day of report and on the day of report, on an unspecified date in 2021, in the morning, the patient developed hives. The patient reported to have hives and then the patient called the doctor's office and they told to probably call someone connected with vaccine to see if it was caused by that and what should be done about it. The patient wanted to know whether to guess if it was connected to the vaccine or not. The patient reported that she was not sure if she called the right number because the sheet she received, it was confusing to her. She was trying to get a hold of a nurse or someone who could may be tell me if the symptoms she was having could be related to the COVID vaccine. In response to further probing, the patient stated that the patient would rather not do that right now. Further probing could not be initiated as consumer was unwilling to further answer the questions. Hence, further details were unknown and limited information was available over the call. Event seriousness was not specified. The clinical outcome of events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Discharge Provider: Unknown * Primary Care Provider: Private MD Admission Date: 10/1/2022 Discharge Date: Oct 13, 2022  PRESENTING PROBLEM: Fournier's gangrene [N49.3] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 52 y.o. male who present on 10/1 with fevers, chills, fatigue, and scrotal abscess. Pt. has a PMH of COPD, DM2, tobacco abuse, DVT no longer anticoagulated. Pt. reports for 1 week he had SOB and increased wheezing. He felt feverish on 9/28 and presented to his PCP office where he was diagnosed with a mild COPD exacerbation secondary to bronchitis. He was started on a prednisone taper and azithromycin. He also notes he had a small cyst on the left of his scrotum that he was able to get a small amount of pus out of. Over 2-3 days, it greatly increased in size with surrounding erythema and increasing pain.    Upon evaluation in the ED, labs with elevated glucose levels, WBC 23, Lactic acid 4.3 -> 0.8. Chest x-ray with mild basilar scarring or atelectasis. Scrotal U/S with right inguinal hernia, mild left variocele. CT abdomen pelvis with concerns for fournier's gangrene. He tested positive for COVID 19. He was admitted for further medical management of sepsis due to fournier's gangrene.   Urology was consulted and performed scrotal exploration, cystoscopy, left ureteral stent placement, scrotal resection and debridement on 10/01. Plastic surgery, Wound and Infectious disease were consulted. He was continue on IV antibiotics. He received ongoing wound care. He received analgesics as needed. Tissue cultures grew strep agalactiae as well as prevotella.  Eventually, Infectious Disease recommended 14 days of total therapy and he was able to switch to oral antibiotics in form of cefadroxil and metronidazole with plan for antibiotics through 10/15.   He received decadron and remdesivir for treatment of COVID 19. Oxygen was weaned as able he was eventually able to transition to room air with cessation of dexamethasone.       Assisted with management of blood sugars with insulin.   The patient had remain medically stable for several days and came out of enhanced isolation precautions. He was able to be transition to subacute rehab on 10/13/2022.  He will need outpatient follow up with Urology for outpatient left ureteroscopy in 3-4 weeks.
they have a patient who got their first dose in January of 2021 and have not gotten their 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (they have a patient who got their first dose in January of 2021 and have not gotten their 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (they have a patient who got their first dose in January of 2021 and have not gotten their 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (they have a patient who got their first dose in January of 2021 and have not gotten their 2nd dose) had resolved.        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.
Client was given a Pneumovax injection on 11/4/2003 and on 11/6/2003 came in and had a red swollen 4" area about 1/2" below the injection site
Client had reddened, itchy, puffy and nickel sized area on left cheek one hour after immunization. was given ice pack and instructed to call MD if any concerns. On 11-12-01, symptoms resolved.
Patient was given dose #2 COVID vaccine 7 days early (day #14 instead of day #21)
found not breathing by grandmother; taken to ER & revived; airlifted to hosp expired 12DEC94;
Patient ran a fever of over 103 degrees and had irritiblity for 7 hours after vaccine administration
9/21 Yellowish green diarrhea, no mucous or blood. Very watery. Now turned green. Possible reaction to Rotavirus.
This spontaneous report was received from an physician's assistant and refers to a 81 year old male patient. His concomitant therapy and medical history were not reported. On 14-OCT-2016 the patient was vaccinated with his first dose of PNEUMOVAX 23 (dose and strength were not reported, lot # M033086, expiration date 05-MAY-2018), intramuscularly in the left upper arm. On the same day, before the patient left the office, he complained of localized pain at the injection site. On 15-OCT-2016, the patient experienced left shoulder and elbow pain, which advanced to his left thumb over the next two days. On 18-OCT_2016 (reported as today), the patient experienced less left shoulder and elbow pain, but his left thumb was extremely tender to palpation and he was unable to move it. The outcome of injection site pain, pain in elbow, shoulder pain, pain in thumb, tenderness and mobility decreased was not reported. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Tested positive from covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive from covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced COVID-19 (Tested positive from covid-19). The patient was treated with Immunotherapy (Monoclonal antibodies) for COVID-19. At the time of the report, COVID-19 (Tested positive from covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient  has to wait 90 days before being able to get second dose.
This spontaneous report was received from a health care professional refers to 8 unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with PROQUAD (Merck) (Lot#L004006 and exp. 05-AUG-2016) (dose, route, dose # and frequency unspecified). Other suspect therapies included VARIVAX (Merck) (Lot# L012036 and exp. 07-APR-2017; Lot# K005183 and exp. 10-APR-2016) (dose, route, dose # and frequency unspecified). No concomitant medications were reported. The nurse reported that on an unknown date, 8 unspecified patients received a dose of VARIVAX (Merck) or PROQUAD (Merck) that at were improperly stored. No adverse effects reported. No further information was provided. Additional information has been requested.
p/pt recv vax exp nl stiffness in arm & legs; uncomfortable but nl until 4pm; gave motrin; high fever (102) w/motrin in system started 4pm & lasted all night; gave baths; c/o throat pain & abd pain; throat pain returned on day 2; pt fine no
extremely nauseous; short of breath; Very lightheaded/dizzy; feeling terrible; pain in her neck and jaw; pain in her neck and jaw; This is a spontaneous report received from a contactable consumer (patient).   A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on 08May2021 (age at vaccine 52-years-old) as dose 1, single for covid-19 immunization.The patient medical history and concomitant medications was not reported. On 09May2021, the patient experienced Very lightheaded/dizzy, very short of breath, extremely nauseous and on unknown date in 2021, the patient experienced pain in her neck and jaw, feeling terrible. It was reported that patient have been feeling terrible, extremely nauseous, short of breath, dizzy and reported pain in her neck and jaw. she was asking if she needs to go to the emergency room as she was not the type of person to seek medical attention even when she previously tore her ACL. she did not have a primary care provider. She referred to vaccination Provider or urgent care for additional guidance as caller stated she did not have a primary care provider she reported that she was one of those people that would like her death to be a surprise, so she doesn't go to the doctor or the emergency room. She stated that she does not know if this was something that was normal or if she should go to the doctor. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
8:40 Right arm/hand tingling, Left hand itching but mild. 9:10 Frontal headache- dull,achy. Ongoing left and right hand itching. 9:12 Benadryl administered( 25mg PO). 9:31 Hand itching about the same. Feels as if something is in throat. Tongue slightly itchy. 10:19 Stable tongue/facial itching.
Right after I received the vaccine, I was ill to the stomach and the next day I had a burning stabbing pain and leg (specifically, my left leg and calf area). I considered going to the ER. I went to a friend's house and the pain from my leg and calf was extremely bad and 4:00PM in the afternoon, I drove to my parents house. My parents helped me out of my vehicle and took care me. I waited to see if the symptoms would go away or if they continued to persist and finally went to a Doctor after 3 to 4 weeks to find out what was wrong with me.
RECEIVED FIRST VACCINE  MODERNA DOSE AT DR. OFFICE (HCPH) .DATE NOT LISTED FOR REPORT. RECEIVED 2ND DOSE PFIZER 3/20/21
Rash, maculopapular rash on extremities 1 week after vaccines.
- Persistent at the injection site after getting Vaccine. - No treatment for 2 months after injection. - 5 physical therapy after 2 months at Orthopedics - 1 physical therapy and prescription of anti-inflammatory medicine at department of pain medicine. - No improvement
No adverse event; HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7664B) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In August 2023, the patient experienced ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (HCP stated they accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage).    Concomitant medications were not reported.  They accidentally administered 25 booster doses of 0.25 mL of Moderna COVID-19 Vaccine Bivalent between 26AUG2023 and 27AUG2023 to adult patients, instead of the usual 0.5 mL dosage. No adverse event was reported for any of the patients.  Treatment medications were not reported.  This case contains information for patient 24 out of 25.   This case was linked to US-MODERNATX, INC.-MOD-2023-738766 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2023: Live significant follow-up received contains patient age, initials, gender and new references added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738766:master case
WITHIN 11 HOURS AFTER INJECTION - BEGAN EXPERIENCING SLIGHT RASH OVER MOST OF BODY- SORENESS AND INFLAMMATION AT INJECTION SIGHT (LEFT ARM), CHILLS, SHIVERING, ABDOMINAL PAIN, RISING TEMPERATURE (MAX 100.8) MUSCLE/JOINT PAIN, AND VERY SEVERE HEADACHES, LASTING NOW FOR THREE DAYS.
Soreness in both upper arms; soreness in the left arm where she got the injection; Dementia; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, NDC number: 000051971-02), via an unspecified route of administration on 19Apr2020 in left arm at a single dose for immunization. Medical history included swelling, and memory loss. Concomitant medication included spironolactone (SPIROLACTON) from an unspecified date and ongoing for at least 5 years for swelling, donepezil (strength: 15mg) from an unspecified date and ongoing for two years for memory loss; and also took some supplements. On 20Apr2020, the patient had soreness in the left arm where she got the injection, the patient had muscle soreness in the upper right arm; So she had soreness in both upper arms. The patient had dementia in an unspecified date in Apr2020. The patient underwent lab tests and procedures which included height: shrunk, 124.968 centigrade. The outcome of events was unknown. The report is not related to a study or programmer.  Information on the lot/batch number has been requested.; Sender's Comments: There is no reasonable possibility that the event dementia was related to pneumococcal 13-valent conjugate vaccine use. This is more likely associated with the history of memory loss, advanced age, or an intercurrent condition.
SOB and wheezing much improved and nausea subsided.  Pulse OX remained 96% or above. Team member allowed to leave and return to work. ,Team member had some brief nausea after vaccine given however it passed and she left the vaccine site after 15 minute, Team member rested on stretcher for 15 minutes Hr decreased to 90 SOB and wheezing much improved and nausea subsided. Pt had Shortness of Breath, Wheezing.
10-15min p/vax pt c/o nausea, dizzy, felt like was going to faint;pt was clammy, cold & diaphoretic;Bp 86/46, P96 10min later BP 110/70;
Patient states " I got Flu shot on Left shoulder on 10/2/17. Pain when I first received it, and pain until today (10/30/17) . Small lump felt on shoulder".
Generalized red, raised rash on both upper thighs with pimple-like appearance. Afebrile.
1 1/2 hr p/vax pt c/o blurred vision;cont for about 2 1/2hr;nurse advised pt to call pvt MD;did not call MD;nurse called pt next day, doing fine & w/o any sx;reporter states pt also exp dizziness;
Left arm bursitis; This spontaneous case was retrieved on 06-Sep-2022 from Reporting System (reference number 0901712-1), reported by other healthcare professional, and concerned a 30-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 05-Oct-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported). The batch number reported was 276551 (reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent).  On 10-Oct-2020, five days after receiving Flucelvax Quadrivalent, the patient experienced left arm bursitis.  On an unspecified date in 2020, the patient visited physician's office, however, further details were not reported. There was no laboratory data.  At the time of initial reporting, the patient was recovering from the event, as it was reported that bursitis was mostly resolved. There was a concern about long term issues.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 30-year-old male patient experienced left arm bursitis five days after being vaccinated with the suspect Flucelvax Quadrivalent vaccine (anatomical location - left arm). Information regarding relevant laboratory findings and diagnostic data was not provided. Due to biological and chronological plausibility, causality is assessed as possibly related.; Sender's Comments: A 30-year-old male patient experienced left arm bursitis five days after being vaccinated with the suspect Flucelvax Quadrivalent vaccine (anatomical location - left arm). Information regarding relevant laboratory findings and diagnostic data was not provided. Due to biological and chronological plausibility, causality is assessed as possibly related.
Dull headache for a day and a half Sore arm  Muscle aches for day
Employee Health notified several days after first vaccination that she had a sore throat, felt cold, "brief asthma attack" one hour after being vaccinated.  Did not seek medical care.  Inhaler used and symptoms went away 15-20 minutes later.
Achy body, lethargy, nausea, vomiting, loss of appetite, chills, fever, diarrhea. Lasted about 24 hours then needed a day to recover.
Patient had a seizure about 1 hour following vaccination.  Pt has hx of seizure dosorder.
A slight head cold; a ring worm on the right side of rib cage / pread to 90% of torso diagnosed as Granuloma Annulare; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01), administration date: 08Jan2021, for COVID-19 Immunization; BNT162b2 (Dose: 02), administration date: 28Jan2021, for COVID-19 Immunization. The following information was reported: GRANULOMA ANNULARE (non-serious) with onset Dec2021, outcome "not recovered", described as "a ring worm on the right side of rib cage / pread to 90% of torso diagnosed as Granuloma Annulare"; NASOPHARYNGITIS (non-serious) with onset 23Dec2021, outcome "recovered", described as "A slight head cold". The event "a ring worm on the right side of rib cage / pread to 90% of torso diagnosed as granuloma annulare" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nasopharyngitis, granuloma annulare.  Additional information: On 23Dec2021, patient developed a slight head cold which was treated and relieved with OTC pseudoephedrine (SUDAFED). Sometime before 27Dec2021, patient noticed what appeared to be a ring worm on the right side of rib cage. It was treated with OTC antifungal cream with no improvement that spread to 90% of torso. After seeking medical attention from numerous physicians, a biopsy was preformed and diagnosed as Granuloma Annulare.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Pain at Injection Site-Mild, Additional Details: Patients wife also had injury from injection being given to high. Patient just had mild pain at injection site that has since resolved. No medical treatment was required, and patient does not require a follow up.
After 12 days, I am still experiencing a lot of tenderness in my arm. It is slightly red and swollen at the injection site and I have overall felt rundown for 12 days now.
Excruciating migraine, neurological issues, confusion, chills, body aches, joint pain, and swelling.
Pt states that she had pain in her L arm radiating into her heck which began approx 2 hrs after receiving the vaccine on 10/19/01. It increased to the point of numbness in her  hand and pain radiating to her L eye, she had constant pain in arm and neck and experienced a low grade fever, 99.8-100F. She had difficulty lifting her arm She took anti-inflammatory medications (ES tylenol and on does of tylenol with codeine). She saw the doctor on 10/23/01. He felt a nerve was inflamed and prescribed Naproxen in the evening and during the day if necessary. She took on does Tuesday evening and on dose Wednesday AM but discontinued this after experiencing severe nausea. By this time she stated that the eye pain was much better and the numbness had subsided. She continued to self medicate with ES tylenol. 11/14/01 she stated she is back to normal. It got a little better each day without further treatment.
Ringing in ears; This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number G537F, expiry date 14th March 2022) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, 1 month after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was recovering/resolving.   The reporter considered the ringing in ears to be possibly related to Shingrix.  Additional details were provided as follows: The patient had the first dose of Shingrix right in left deltoid before Christmas day but could not provide exact date. 19th December 2019, was an estimated date of administration. About a month later in January of 2020, she developed ringing in her ears. She saw her doctor in March who said it could be a result of the vaccine. Consented to follow up. Emergency room visit required.