chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme asthenia; Dizziness; I had a fever over 102 degrees; Myalgias; Chills; Persistent cephalea; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0169) via an unspecified route of administration in the arm right on 22Apr2021 at 10:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension, depression, chronic rhinitis and mycotic allergy (allergy to penicillum), all on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8730) via an unspecified route of administration in the arm left on 31Mar2021 at 10:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:00, the patient experienced fever over 102 degrees, myalgias, chills, persistent cephalea, dizziness, and extreme asthenia. The cephalea remained still after four days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 22Apr2021 at 22:00, the patient underwent saliva test and the result was found to be negative and body temperature test and the result was found to be 102 degrees (unspecified units). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events extreme asthenia, dizziness, fever over 102 degrees, myalgias and chills were recovered with sequelae on an unknown date in Apr2021. The clinical outcome of the event persistent cephalea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the Government to Department of Health staff and then to Health System and the staff administering vaccine. Because of this delay, some monovalent vaccine throughout Health System was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Vaccine expired on 09/30/2022.  Per manufacture, efficacy is still valid until 10/19/2022
This case was reported by a nurse via sales rep and described the occurrence of redness in a adolescent patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced redness and pain. On an unknown date, the outcome of the redness and pain were recovered/resolved. It was unknown if the reporter considered the redness and pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness and soreness, but location of the redness and soreness was not specified. The specifics of the events were unknown, but the issues were believed to have resolved within a few days. This case has no been reported to VAERS. All questions were asked, but limited information was provided by the sales representative. This case has been linked to case US2016122905, reported by the same reporter.
Patient is a 66 y.o. female patient with history of HFpEF, chronic respiratory failure on 4 L O2 ATC, OSA/OHS, COPD, paroxysmal atrial fibrillation, CVA, gastric bypass s/p obesity, diverticulitis s/p colostomy then reversal and neuropathy who presented with shortness of breath.  On admission found to be COVID-positive and in respiratory failure.  Completed course of remdesivir and was treated with steroids.  Symptoms improved during admission.  Course complicated by anemia for which she was evaluated by GI with recommendation for outpatient EGD/colonoscopy.  To be transitioned back to ECF with outpatient follow-up   Acute on Chronic Respiratory Failure  Covid-19 Virus Infection with pneumonia Date of onset of symptoms: 12/6 Symptoms present on admission: dyspnea, fatigue Date of covid positive test: 12/7 Vaccination status: vaccinated Imaging: CXR with bibasilar left much worse than right infiltrates are seen Oxygen requirements on admission: BiPAP Current oxygen requirements: 4L (baseline home dose) wore nocturnal BiPAP  Medical therapy: Completed course of remdesivir while inpatient, to be discharged on short course of Decadron Anticipated special isolation end date: 12/16   Acute on chronic anemia Patient s baseline hemoglobin recently in Aug-Sept 22 has been between 8-9 n the setting of Eliquis use, previous RYGB and cirrhosis on previous CT scans Recent admission in 11/22 her hemoglobin was 6.5 on presentation when she underwent EGD 2 weeks ago. She was diagnosed with non bleeding esophageal ulcer. She was recommended to have follow up EGD in 3 months. Colonoscopy in 10/20: poor prep, 1 cm polyp in transverse colon (sessile serrated) patent end to end colonic anastomosis at 22 cm w/o stricture appreciated, diverticulosis descending colon. Ileum nl. I/E hemorrhoids She denies any bloody stools or BRBPR Occult stool is positive Patient  received 1 unit PRBC transfusion with minimal improvement in H&H. Continue PPI BID GI consulted-no further inpatient work-up recommended.  Will have follow-up EGD and colonoscopy as outpatient.   Received IV iron x1   Chronic HFpEF Chronic RH Failure TTE (8/2022) with RV failure and indeterminate DD Currently on Lasix 60 mg po bid  BNP chronically markedly elevated.    Paroxysmal Atrial Fibrillation EKG with atrial fibrillation (HR 90) on arrival Continue Eliquis  Chronic Hypoxic Respiratory Failure OSA/OHS Noncompliant with CPAP at home but wears  CPAP here and should go with her to SNF    Hx of CVAs IPH 10/2020 then embolic stroke 8/2022 without residual deficits   Seizure Disorder From 10/2020 IPH, continue Keppra 500 mg BID   Neuropathy Per history Gabapentin   Gout Stable, continue Allopurinol daily   Cirrhosis secondary to NASH   Morbid obesity BMI 65   Chronic metabolic alkalosis Chronic in setting of untreated obstructive sleep apnea and obesity hypoventilation syndrome.
Information has been received from a mother concerning her 12 year old daughter who on 09-May-2007 was vaccinated into the left arm with a first dose of Gardasil.  On 13-Nov-2007, the patient was vaccinated with a third dose of Gardasil.  Concomitant suspect vaccination on the same day included Vaqta.  On 14-Nov-2007 the patient fainted.  She "came out of it shaking or tremoring (whole body) and almost fell off the table".  She was given orange juice and was told to lie down.  The patient was in the office.  On 13-Nov-2007, the patient recovered.  The patient had no problems with the first and second dose of Gardasil.  Additional information has been requested.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ALBUTEROL [SALBUTAMOL]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: Testing positive again. Therapeutic measures were taken as a result of covid-19. Clinical course: Seriousness criteria-Results in death: No, Life threatening: No, Caused/prolonged hospitalization: No, Disabling/Incapacitating: No, Congenital anomaly/birth defect: No. Anti-viral details: COVID 19 Treatment, Pfizer Paxlovid, Treatment start date: 16May2022, Treatment stop date: 20May2022 AND indication: Treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Reported Event: Symptoms came back 1 week after treatment completed. Testing positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Within one hour began having vomiting and severe headaches. By the next day this has worsened further and was taken to the er which showed a bleed on the right frontal lobe. Admitted in neuro ICU at medical center.
BREAKTHROUGH OCCURRED AND BECAME INFECTED; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, dose number in series was 1, administered 1 in total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-NOV-2021, the patient took a business trip and on NOV-2021, patient became infected. The breakthrough occurred in a manner of two weeks. On the first day, patient experienced joint aches and lack of energy. By the second day, patient felt improved until the fevers started on the third day. The patient became little weaker each day until the fever broke on the eighth day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breakthrough occurred and became infected, and the outcome of Suspected Clinical Vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209763. This case, from the same reporter is linked to 20220100666.; Sender's Comments: V0:20220100988-Covid-19 vaccine ad26.cov2.s- Breakthrough occurred and became infected. This event(s) is considered unassessable. The event(s) 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(s). V0:20220100988-Covid-19 vaccine ad26.cov2.s-Suspected Clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Seizures recurrent 11/17/05, 12/05, 1/06, 3/06, 4/06. Apnea, Tx: phenobarbital, Keppra. 60 day Follow-up Information 24-JUL-2006: Still on seizure prophylaxis. He is doing well. We have discussed DTAP for now dft parent request.
Patient had COVID two weeks ago.  Patient reports swollen knot where vaccine was placed.  Arm is swollen, she is experiencing hot and cold flashes, and headache.  Patient reports that she had SOB earlier this morning but her inhaler resolved symptoms.  Patient denies any current SOB, wheezing, facial swelling or throat swelling.  Patient advised to monitor, use cool compress for knot and OTC pain reliever as needed for pain.  Patient given s/sx that warrant ER follow-up and given number for on-call provider if needing to be evaluated over weekend.
Initial onset of Parsonage Turner Syndrome began with weakness/heaviness of right arm, followed by pain, restricted ROM, scapular winging and dyskinesis.
Patient reports sore arm > greater than 3 days.  Says it went away but has come back. Says reported to primary md at physical and they advised get 2nd vaccine at late end of window( 6 mo).  RPH advised to ice and gently stretch and report back to us if any changes. Recommended 2nd shingrix vacc when ready.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EL9269) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022 Date(s) of administration of vaccine were -26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. Pharmacy staff reported that they inadvertently administered 51 doses of the monovalent vaccines. Lot number 004M21A, expiration date 13Jul2022 Date(s) of administration of vaccine were 26Jul2022 (40 doses), 04Aug2022 (1 dose), 19Aug2022 (1 dose), 30Sep2022 (1 dose). No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:master case
This initial spontaneous report was received from the patient's mother referring to her daughter; a female patient of unknown age. There was no pertinent medical history or drug allergies/drug reactions reported. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL injection (strength, dose, route, lot # and expiration date were not provided). There was no concomitant medication described. The reporter stated that since on an unknown date in September 2010, her daughter had been "out of school" due to developed unspecified symptoms after receiving GARDASIL. At the time of the report, the outcome of adverse event was not recovered. The relatedness between the adverse event to GARDASIL was not reported. Upon internal review adverse event was considered as disabling. Additional information has been requested.
On 12/4/21 (about 12 days after moderna booster vaccine) I started having itching in my scalp and back of neck, woke up next morning with continued itching that started spreading to other body parts with welts such as hives. I continue to have wide spread hives that improves with antihistamines but has not resolved.
12/29 Vaccine  12/31 soreness in arm. Redness. Started increasing in size to where there was hardening. I started getting chills, fever  (100.1, 102.3); ibuprofren / tylenol. Fever for 24 hours. Nausea, vomiting. *prescribed omeprazole.  *still feeling 'hot'
Vaccine expired 1 day prior to administration. Unable to contact patient as patient omitted his phone number on the consent form. Patient has not returned to the pharmacy since the administration to complain of any issues.
Received vaccine at 1:30 pm yesterday, noted onset of symptoms at 8:45 pm.  Numbness and tingling to mouth and bilateral upper and lower extremities, mild vision change, feeling of some swelling to bilateral eyelids.  Also swelling to lips.  She also did take zinc gluconate 50 mg last night and this morning.  Has never taken zinc 50 mg, but has taken zinc as component of multivitamin/pre-natal vitamins.   Patient was prescribed Pepcid 20 mg BID, Medrol 4 mg dose pack 21 pill taper until complete.  Also given Benadryl 25 mg - 50 mg every 4 - 6 hours for allergy symptoms.  And provided with an Epi-Pen for home.
Bloody nose - At least twice a day since getting the booster.  Takes about 20 minutes to stop.
Right eye red. Had rash on forehead on rt side and abdomen. c/o itching.  Denied any problems breathing.  Mom present.  Called Dr's office to report, states they have not seen her in a year.  Mom states she will take her home and give her Benadryl.  Instructed if condition worsens or does not improve to take child to emergency room.  Mom voiced understanding.
she also got a bad cough for 2 weeks after getting the second dose of the Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (she also got a bad cough for 2 weeks after getting the second dose of the Moderna vaccine) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (she also got a bad cough for 2 weeks after getting the second dose of the Moderna vaccine). At the time of the report, COUGH (she also got a bad cough for 2 weeks after getting the second dose of the Moderna vaccine) had resolved.            It was reported that patient had health issues.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-651282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651282:Daughter's case
bad ear pain; itching; swollen spot on the arm; ringing in the ear. swollen gland; ear infection; rash; with fever or 102.6; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.) and LYMPHADENOPATHY (swollen gland) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (over-react to certain medicine). Concomitant products included EPINEPHRINE (EPIPEN) for Drug allergy, VITAMIN D [VITAMIN D NOS] for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.), LYMPHADENOPATHY (swollen gland), EAR INFECTION (ear infection), RASH (rash) and PYREXIA (with fever or 102.6). At the time of the report, EAR PAIN (bad ear pain), PRURITUS (itching), PERIPHERAL SWELLING (swollen spot on the arm), TINNITUS (ringing in the ear.), LYMPHADENOPATHY (swollen gland), EAR INFECTION (ear infection), RASH (rash) and PYREXIA (with fever or 102.6) outcome was unknown.            Patient didn't take any treatment medications.  Patient went to the HCP and felt that there was ear infection. Patient believes it was from the vaccine.   This case was linked to MOD-2021-378337 (Patient Link).
felt miserable for several days after; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer via social media .  This case involves a 70 year old patient (unknown gender) who experienced felt miserable for several days (feeling abnormal), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious felt miserable for several days (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
A report has been received from a Health Professional concerning a 31 year old, female subject who had been receiving nasal FLUMIST Quadrivalent. Concomitant medications included Ascorbic acid, Biotin, minerals nos, Nicotine acid, Retinol , Tocopherol, Vitamin B nos, Vitamin D nos, and Calcium carbonate. FLUMIST Quadrivalent started on 06-OCT-2014. The patient experienced pregnant patient received FLUMIST Quadrivalent. The outcome of the event of pregnant patient received FLUMIST Quadrivalent was unknown. The report was considered to be non-serious. Follow-up  of insignificant information received on 11-MAY-2015 from a Health Professional. Pregnancy details were updated. Concomitant medications were added. Case narrative amended.
Sore arm, rash on arm, fever, chills, fatigue, body aches, lower back pain
Next day after the second dose of Moderna Covid 19 vaccine I experienced tiredness, dizziness and fatigue. The effects lasted for couple of days and ameliorated the third day.
Pt received vaccines 2/7/11 at 8:30 am. Around 8-8:30 p.m. she started hurting - "deep bone ache". Around 9:30pm started crying and c/o body aching from head to toe. Parents took to E.R. at 9:49 pm. Pt. was discharged home in "improved, stable" condition at 11:10 pm. Pt. did not run a temperature. Was given TYL #3 for discomfort. Had swelling in left arm. "Back to normal" in 3 days according to mother.
Second day after shot, fever began and has not subsided. Three and a half days later, seizures began.
Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient's wife called into the pharmacy about 3 hours after the patient recieved their vaccine. Patient's wife reported that the patient was experiencing blurred vision. No other symptoms were reported and patient's wife answered no when asked if the patient was experiencing trouble breathing, rash/hives, dizziness, nausea/vomiting etc.
Left leg DVT April 11, 2021. Johnson and Johnson vaccine on March 12, 2021