chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Pfizer/ Dose 4: Pfizer/ Dose 5: Pfizer.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 67 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FH8020), in left arm and on 04Apr2022 at 15:00 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jan2021 at 14:00 as dose 1, single (Lot number: 042L20A), in left arm and on 24Feb2021 at 11:30 as dose 2, single (Lot number: 030M26A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing); "dematitis herpetiformis" (unspecified if ongoing); "Sjogrens Syndrome" (unspecified if ongoing); "GERD" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "Known allergires: gluten" (unspecified if ongoing); "Known allergires: wheat" (unspecified if ongoing); "Known allergires: oats" (unspecified if ongoing); "Known allergires: flax, caragheenan" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing); "Known allergies: dander" (unspecified if ongoing); "Known allergies: pollen" (unspecified if ongoing); "Known allergies: dust" (unspecified if ongoing); "Known allergies: feather" (unspecified if ongoing); "Known allergies: NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies"; Demerol, reaction(s): "known allergies". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Oct2021 at 10:00, outcome "unknown", described as "Dose 1: Moderna/ Dose 2: Moderna/ Dose 3: Pfizer/ Dose 4: Pfizer/ Dose 5: Pfizer."; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Sep2023 to 20Sep2023.
DELIRIOUS; LEG CRAMPS; STOMACH KILLING; EXPLOSIVE DIARRHEA; SWEATS; SOUNDED LIKE MOANING; CHILLS; FEVER 101 F/BURNING UP; This spontaneous report received from a parent concerned a 34 year old female. The patient's height, and weight were not reported. The patient's past medical history included endometriosis (reporter thought the patient may had endometriosis), and other pre-existing medical conditions included no known allergies. The patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 06-APR-2021 13:30 to right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021, the patient woke with diarrhea during night (unsure if before or after midnight). Patient also experienced leg cramps, fever (101 F), chills, stomach killing the patient, explosive diarrhea, sweats, and burning up. The patient had drank Gatorade, but did not eat anything else. Patients mother thought that the patient was delirious as she was talking out of her head. The patient was making sounds that sounded like moaning. The patient did not received any treatment at the time of reporting. She was fine on vaccination day. Laboratory data included body temperature 101 F on APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramps, fever 101 F/burning up, chills, stomach killing, explosive diarrhea, sweats, sounded like moaning and delirious. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210414111- Covid-19 vaccine ad26.cov2.s-delirious. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
The next day after the vaccine I developed fever and chills. My entire skeletal system felt as if it hurts all the way down to my bones. I performed no treatment and after about 12hrs later I fell asleep, woke up as if nothing had ever even happened, but on 8/16 I woke up and my left ear was muffled and began to ring. I went to the urgent care and was given antibiotics and advised to see an ENT if the symptoms didn't clear within 3 days. I made an appointment with the ENT who prescribed steroids for 10 days and is still under his care with an appointment scheduled for Friday to further check status, but my left ear is still ringing to date.
Initial report received from a healthcare professional on 21 October 2014. This case is linked to the case 2014SA149860 for adverse event following ADACEL vaccine. A 59 year old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE TIV (Batch number UI198AB and expiry date not reported) in the right deltoid, on 17-OCT-2014. It was reported that the patient had received an ADACEL injection about 6 weeks ago she had a similar reaction which occurred after FLUZONE vaccine. It was reported that on 18-OCT-2014 the patient had tightness and swelling on the right side of neck she described it as about twice the size of the noodle. The patient had a 3 half mm nodule on her subclavicular notch without lymph involvement. The patient had no illness at the time of vaccination, no known allergies, birth defects and medical conditions were not reported. Corrective treatment was not reported and Laboratory data were reported as none. At the time of this report the outcome of the event was unknown. List of documents held by sender: none.
About 10 minutes after receiving the vaccine, patient became dizzy.  Symptoms then progressed to increased heart rate (104), increased blood pressure (~180/120), tremors, and blurred vision.  Patient stated he was diabetic, glucose was checked (198 - was ~4 hours after eating a bagel - had taken lantus the night before and victoza that morning).  Oxygen was good, no trouble breathing.  Pupils dilated.
Nausea; Vomiting; Headache; This case was reported by a physician via sales rep and described the occurrence of nausea in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced nausea, vomiting and headache. On an unknown date, the outcome of the nausea, vomiting and headache were unknown.   It was unknown if the reporter considered the nausea, vomiting and headache to be related to Bexsero.  Additional details were provided as follows: The age at administration was not reported. The patient received Bexsero and experienced nausea, vomiting and headache. The reporter wants to know if he should give the second dose
Small red rash at injection site with more redness & slight swelling ~ 3 inches below injection site. Pt reported no other effects other than rash area feeling hot. Told pt to see doctor if rash worsens.
Pt's mom called clinic on 7/24/08. Stated pt's arm where DTaP was given was red, not pink, red, from deltoid to elbow and swollen up - painful to touch. Had fever noted at 101. I told Mom to bring pt to doctor.
Generalized raised red rash began approx 24hrs after vaccination. Personal physician administrated steroid injections.
Few scattered hives around the site of injection, low grade fever. Fever resolved with TYENOL. Hives disappeared in the morning.
Received first dose of Pfizer COVID-19 vaccine on 12/28/20 and 2nd dose on 1/18/21, individual tolerated well.  Traveled on 3/5/21-3/7/21. Individual is asymptomatic and tested positive for COVID-19 PCR on 3/8/21 during a routine screening test.
I received a Pneumococcal Polysaccharide Vaccine injection in my left arm about 4 inches above my elbow. I experienced pain with limited mobility of my left arm, swelling around my elbow and a red streak that extended my elbow to my axillary area and my arm was warm to touch. I also had a low grade temperature of 99.4.
Vaccine administered at 10:30 am. Child went to daycare. When daycare providers applied sunscreen to child's face, he immediately developed swelling in his eyes/eyelids. The sunscreen brand had been applied previously to this child with no adverse reaction. Mother called clinic at 1 pm to report swelling of eyes and nasal congestion in her son. He was having no difficulty breathing. Recommended that mother administer Benedryl to the child and visit physician immediately if symptoms worsen or fever, dizziness, hives, or respiratory difficulty occur.
acute corneal epithelial rejection of LR-CLAL; This is a literature report.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "living-related conjunctival limbal allograft" (unspecified if ongoing), notes: 4 years and 7 months previously. The patient's concomitant medications were not reported. The following information was reported: CORNEAL GRAFT REJECTION (medically significant), outcome "unknown", described as "acute corneal epithelial rejection of LR-CLAL". The patient underwent the following laboratory tests and procedures: blood grouping: abo.  Abstract: PURPOSE: The purpose of this study was to report a case of acute corneal epithelial rejection of living-related conjunctival limbal allograft (LR-CLAL) after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. OBSERVATIONS: A 27-year-old woman developed acute epithelial rejection of LRCLAL 2 weeks after receiving the SARS-CoV-2 vaccine. She received the LR-CLAL transplant 4 years and 7 months previously and had a stable clinical course with no history of rejection. She had an ABO blood group and human leukocyte antigen compatible donor, no systemic comorbidities, and no rejection risk factors. CONCLUSIONS: The novel SARS-CoV-2 vaccine upregulates the immune system to produce an adaptive immune response. The SARS-CoV-2 vaccine may potentially be associated with increased risk of rejection in those with ocular surface transplants.  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 information provide and plausible temporal association, the causality between BNT162B2 and CORNEAL GRAFT REJECTION  cannot be completely 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.
A report has been received from a Physician concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced nurse gave FLUMIST to 13 month old child which started on 29-Nov-2012. The outcome of the event of nurse gave FLUMIST to 13 month old child is unknown. The report was considered to be non-serious by the reporter.
RIGHT ARM CANNOT PICK UP ANYTHING, CAN ONLY LIFT ARM UP TO ABDOMINAL LEVEL.  STATIONARY MOVEMENT IS OK. RIGHT ARM TENDER TO TOUCH. EXPERIENCING FATIGUE, NASEA WITHOUT VOMITING, LOW GRADE FEVER AND CHILLS.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 8/11/21 (ew0179) Pfizer Dose 2 9/2/21 (EW0170) COVID Positive 11/27/21  11/27/21: Patient is a 73 year old female who presented to ED via EMS for altered mental status come possible fall.  Patient is somewhat of a poor historian. History was obtained per chart review, ER staff and from the patient herself. Patient lives at home at baseline with her son. EMS reported the patient was found hypoxic on room air at 80% on arrival. She has a past medical history of paroxysmal atrial fibrillation not on anticoagulation secondary to GI bleed, type 2 diabetes mellitus, hypertension, hyperlipidemia, mixed Alzheimer's and vascular dementia, history of CVA with mild left-sided deficits, CKD stage G4, anemia CKD and asthma. She has decubitus ulcers noted on her coccyx which she has been following wound care for, the patient had a wound VAC in place stopped working approximately 4 days ago.  She has not been on any recent antibiotic therapy for her wounds.   On arrival to ED the patient was febrile and hypoxic on room air at 80%, 2 L supplemental oxygen was applied with improvement oxygen saturation to 95%. Laboratory findings were significant for hypokalemia 3.2. CKD stage G4 Bun 51 and creatinine 2.90.  Hypomagnesemia 1.4.  Leukocytosis 20.62.  Anemia 9.8.  Rapid COVID positive.  D-dimer 1.08. Chest x-ray unremarkable.  CT head no acute findings.  CT abdomen no acute intra-abdominal findings.  No acute inflammatory changes or bowel obstruction.  Small sacrococcygeal decubitus ulcer, no evidence of abscess formation.  Ceftriaxone, vancomycin and Flagyl initiated in ED.  Potassium chloride 20 mEq IV and magnesium 1 g IV given.  12/4/21: 73-year-old woman who was brought in from home by EMS on account of altered mental status.  She was found to be febrile and hypoxic, labs remarkable for leukocytosis and acute kidney injury.  She has a known history of coccygeal decubitus ulcers undergoing wound VAC therapy and wound care as outpatient.  She was admitted to the hospitalist service and started on empiric broad-spectrum antibiotic therapy, blood per cultures were subsequently positive to Streptococcus pyogenes.  She was started on treatment with IV ceftriaxone in keeping with blood culture susceptibility results with good effect, mental status improved to her previous baseline.  IV fluid hydration was initiated with resolution of initial acute kidney injury, electrolyte repleted as indicated.  She was evaluated by Physical and Occupational therapy and recommended for skilled placement, however patient and family declined and preferred to be discharged home with home health services.  She is in stable medical condition at the time of discharge.
Case number PHEH2014US003955 is an initial spontaneous report received from a pharmacist on 24 FEB 2014. This report refers to an 11 years-old patient whose gender was not reported. The patient's medical history and concomitant medications were not reported. It was reported that this patient under 18 years of age was vaccinated with an intramuscular dose of FLUCELVAX (batch number: not reported) on an unknown date. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 24 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult provide administered to child".
FEVER, LYMPH NODE INFLAMMATION,  PAIN IN  THE ARM, LETHARGICNO
extreme difficulty breathing w/in 1/2hr of receiving vax;nose burning, began breaking out in rash-taken to ER, given meds;
Skin: maculopapular eryth lesions back, and vesicles in all stages compatible with varicella; few on abdomen, Cluster on right testis, which it scratches often. No lesions mucosa. Neuro:  Normal strength and tone.  No meningeal signs.  ALLERGIC REACTION TO VARIVAX Suspected 2ry to Varivax, as there's no cluster of varicella going on anecdotally. Due to timing , more likely than not it was caused by vaccine. Advice parents course is usually mildly and less or not contagious.
Screaming 7 hours mom says, Stops, smiles when talked to, otherwise irritable, Temp 99.4, Red slightly swollen right leg where PV + HIB were given. Appetite decreased.
Fatigue. Covid-19 arm-rashes that spread to my chest- started the third day after vaccination. Migraines to the point her my eyes hurt badly. Muscle aches. Numbness of the left side of my face.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age. Concurrent conditions and medical history of the patient were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored MMR II (lot# K006141 (rHA), expiry date 29-APR-2016; lot# K006396 (rHA), expiry date 04-MAY-2016, lot# K014833 (rHA), expiry date 17-FEB-2017, lot# L012479 (rHA), expiry date 10-APR-2017) (dose, route unspecified). Concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Initial unsolicited report received from a consumer on 27-Feb-2017. This case involves a 57 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu Shot) and LYRICA (dose, dose in series, batch number, expiry date, site, route of administration were not reported for both) on an unknown date. Medical history was reported as arthritis, Surgery, Gastritis (2015). It was also reported that vomiting, diarrhea and fever was there in Dec-2015. Concomitant medications were not reported. On an unknown date of Oct-2016, following the vaccination, the patient experienced flu, fever 100 degrees, vomiting, and diarrhea. On an unknown date following vaccination, patient could not eat much, did not have an appetite and felt very tired and worn out. It was reported patient was previously vaccinated with INFLUENZA VACCINE in Dec-2015. Laboratory investigations and corrective treatment were not reported. The outcome of the event flu and vomiting was reported as recovered on an unknown date. Outcome of the event tiredness reported as not recovered. Outcome of the event fever and diarrhea reported as recovering. Outcome of the event appetite absent was not reported. List of documents held by sender: none.
The day after receiving my second dose, I noticed a loss of taste and smell. Soon after that I noticed a ringing in my right ear. I self-diagnosed tinnitus. This lasted for about 3-4 weeks. I called and scheduled an appointment with my doctor, and he told me that the COVID virus can be very unpredictable. He was hinting that I may have COVID. I took 2 tests, and both were negative. As of today, I still cannot taste, or smell and I still have the ringing in my right ear.
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old female patient who received HAV (Havrix 1440 adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received the 1st dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comments:  The pharmacist reported that a patient received an expired dose Havrix.   The Havrix expired on 18th June 2022.   The date of vaccination was 6th October 2022 and this was the patients first dose. Additional Supportive Information: The patient received an expired dose Havrix which lead to Expired vaccine used.
He had to re-do his primary series,had two of the three shots; The Moderna Monovalent expires a couple of days before his third shot; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (He had to re-do his primary series,had two of the three shots), EXPIRED PRODUCT ADMINISTERED (The Moderna Monovalent expires a couple of days before his third shot), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Stem cell transplant.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (He had to re-do his primary series,had two of the three shots), EXPIRED PRODUCT ADMINISTERED (The Moderna Monovalent expires a couple of days before his third shot), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (He had to re-do his primary series, had two of the three shots), EXPIRED PRODUCT ADMINISTERED (The Moderna Monovalent expires a couple of days before his third shot), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) 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 assessments were provided for EXTRA DOSE ADMINISTERED (He had to re-do his primary series, had two of the three shots), EXPIRED PRODUCT ADMINISTERED (The Moderna Monovalent expires a couple of days before his third shot) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    Concomitant medication was not provided.   Treatment information was not provided.
CDC reports: 5 yo child developed fever to 101, redness, pain & swelling @ inject site & wheezing following DTP/OPV immun. On Ventolin for 4 days; given Epinephrine inject twice in ER; Recovered in 10 days.