chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 out of the 8 in the group have come down with COVID; 3 out of the 8 in the group have come down with COVID; This is a spontaneous report from a contactable consumer. This consumer (Daughter) reported for her mother. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and expiration date were unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. All of them took the Pfizer vaccine when it became available because they were over 75 years of age. Recently 3 out of the 8 in the group have come down with COVID. Their strain was unknown. Reporter believes all were over 75 years old with co morbidities. Event took place after use of product. The outcome of event was unknown. Follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021873318 Different patients, Same reporter, vaccine, event.;US-PFIZER INC-2021873299 Different patients, Same reporter, vaccine, event.
Pt had worsening altered mental status, tachypnea, and low-grade fever on 1/13/21. Pt considered terminal status previously and comfort-focus care pursued. Suspected pneumonia vs. TIA/CVA. PO meds D/C'ed as patient could no longer swallow.
I requested a flu vac, and  the tech told me I had'nt  yet had my 2nd pneumovax, and I wouldnt have immunity.  Told her I thought I had..she said it wasnt on the National Registry, and pharmacist said that meant it wasnt done.  I agreed to have it.  Later that night my arm began throbbing, so applied ice.  It was very painful all night with GI upset and chills for 45min.  Felt fatigued the next  day.  My arm felt some better.  My records showed I had Pneumoccal Polysaccharide vac 07012011, and Pnemococcal PCV13 12022016.
I had a sore throat, headache, mild fever of 100.5, nausea, fatigue. My sore throat lasted for over a week-close to 10 days. The other symptoms lasted about 4 days.
2 days after shot, arm was swollen and in pain. Had temperature of 102 degrees. Shot area felt warm and hard. Pt went to the ER Saturday. Was told had MRSA and cellulitis. Put on abx, got better by Tuesday.
Per provider notes, 26-year old male was brought to the emergency room after he had an out of the hospital cardiac arrest/seizure. Mother of patient provided initial history. Patient received his first COVID vaccine 2 days ago and the next day he started complaining of some chest pain.  Patient woke up on the 15th, mother made breakfast and acting normal. Mother went up to room and found him unresponsive foaming at the mouth and may have been shaking. Paramedics arrived and started CPR and noted he was in V fib and shocked once into an organized rhythm.  Patient experienced another seizure in the ED. Patient's family was positive for COVID in January. Patient was tested then and tested positive at hospital. Cycle threshold was  39.9. Patient was intubated initially yet extubated on 4/16/2021
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 18:00 as dose 4 (booster), single (Lot number: GH9693) at the age of 49 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "asthma" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: DOXYCYCLINE, start date: 03Oct2022; PANTOPRAZOLE; MONTELUKAST.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine within 2 weeks and received other medication within 2 weeks with Doxycycline and Pantoprazole, Montelucast, Flovent from 03Nov2022 to 12Nov2022. Patient received treatment for COVID-19 with Paxlovid from 03Nov2022 to 07Nov2022.
Second evening after getting 2nd dose Pfizer covid;  was reading when my vision went foggy for about 10 minutes.  The next day I saw there was blood around half the iris of my right eye.  The blood was not coming from the corner of my eye it appeared to only be pooled around half the iris.  It is still there just not as bright red.
Induration (3cm x 5cm), redness and swelling on left thigh noticed per mother two days after immunization.  Treated with Benadryl 10ml every 6 hours and ice on site.
Onset diffuse muscle twitching associated with occasional loss of balance shaking 12 hrs after flumist. Sib with similar sx (milder) also received flumist same day, Sib's symptoms started 15days after vacc. 11/10/2009 MD records from 9/14 and 9/17/2009. Patient with myoclonic jerks of the body.  Parents did take patient to ED on 9/14/2009. Neuro w/up was neg. Patient saw neurologist on 9/17/2009, neuro exam was normal, patient had developed red lesions. MD felt that lesions were post vaccine varicella and that the myoclonic jerks were subclinical and should resolve, therefore no tx was ordered.
R56.9 - Seizure (CMS/HCC) E87.1 - Hyponatremia
Elevated WBC; Body was red; Lips swelling; Itching; Allergic reaction; Migraine; Tachycardia; Hives/Red spots on skin; Myalgia; Chills; Vomits; Headache; Vaccination site pain; This spontaneous case was reported by a physician assistant and describes the occurrence of MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling) and WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: GARDASIL 9 (Dose 3/3 and Route i.m) on 03-Dec-2020. Concurrent medical conditions included Drug allergy (methimazole), Hives (Skin Allergy) since 22-Jan-2021 and Hypothyroidism (Recent changes: High levels, Medication increased) since 2016. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CONTRACEPTIVES and NORETHINDRONE ACETATE for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 20-Jan-2021, the patient experienced MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), MYALGIA (Myalgia), CHILLS (Chills), VOMITING (Vomits) and HEADACHE (Headache). On 22-Jan-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 01-Feb-2021, the patient experienced LIP SWELLING (Lips swelling) and PRURITUS (Itching). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) (oral) for Symptomatic treatment, at a dose of 4 mg. On 23-Dec-2020, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 31-Jan-2021, MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), MYALGIA (Myalgia), VOMITING (Vomits) and HEADACHE (Headache) had resolved, CHILLS (Chills) had resolved with sequelae. On 10-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling), WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red) outcome was unknown and HYPERSENSITIVITY (Allergic reaction) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021: updated reporter details, added patient details, medical history, Concomitant medications, treatment medication and event
Fatigue and malaise within 3 hours; chills, nausea and vomiting after 11 hours; headache, muscle aches, weakness and nausea/vomiting for 24 hours after the vaccine.
My arm where the injection was given is very itchy, red, and tender to the touch.  This started today approximately 9 days from when I received the 1st dose.  My skin has a burning sensation and the area feels hot to the touch (mainly all around the injection site.
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 14-OCT-2013, the patient was vaccinated with a expired dose of ROTATEQ (lot # H010696, expiry: 06-OCT-2013) 2 ml, orally. No adverse effect reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA sharp piercing headache at back of head onset at time of injection.  After 2-3 minutes the headache diminished but did not go away fully.  Patient took Tylenol 500mg to combat the headache.  Headache has lasted throughout the next few days and has finally gone away on day 7 post injection.  The headache was unusual in that when the patient moved their eyes or read or moved facial muscles the pain became stronger.  The patient's eyes were sore and tender for the duration of the timeframe mentioned. Also, the injection site was completely pain-free on the day of the injection.  However, the following 5 days after injection, the site became very sore and tender with no redness or swelling present.  Patient did contract the COVID virus and tested positive on day 4 post-injection
vaccine was kept in refrigrator  on 22/09/2021 and administered on 29/11/2021; 606 doses were given after expiration date/vaccine is given more than 30 days from storage and is expired.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/vaccine is given more than 30 days from storage and is expired.) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrator  on 22/09/2021 and administered on 29/11/2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/vaccine is given more than 30 days from storage and is expired.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was kept in refrigrator  on 22/09/2021 and administered on 29/11/2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/vaccine is given more than 30 days from storage and is expired.) and PRODUCT STORAGE ERROR (vaccine was kept in refrigrator  on 22/09/2021 and administered on 29/11/2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  The vial was placed in the refrigerator on 22-Sep-2021.Vial did not undergo any temperature excursion. No adverse event was reported.
patient experienced syncopal event with temporary LOC, regained spontaneously; HR bradycardic to 44 per pulse oximeter; pulse oximeter 95%, pupils dilated to 8 mm, skin diaphoretic, pale
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose pfizer12/30/20,Lot#ELO142 2nd dose: 01/20/21,Pfizer,Lot#  Diagnosed covid positive:07/22/21 Symptom onset:07/22/21 Exposure:Home exposure Symptoms:cough, loss of smell/taste,runny nose,sore throat
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter.; Sender's Comments: US-009507513-1901USA009536:
the patient received vaccine on 9/27/21, that evening he developed significant night sweats, shortness of breath and generalized fatigue, these symptoms continued and he presented to PCP office 9/30/21, he then had continued symptoms and was hopsitalized from 10/3/21 to 10/4/21 at which point his symptoms resolved
I received my shot at 5:45pm Thursday, 4/22/21 at the High School from Healthcare.   Friday morning I noticed a headache developing around 9am.  I laid down to rest at 10:30-12:30pm, when I woke up I had chills, took some acetaminophen, went back to sleep and woke up around 3-4pm, then went back to sleep.   I woke up around 6pm and had chills still, took more acetaminophen.  I also noticed major body aches through out my body, it was very difficult to move.   When I went to bed around 10 I had a fever of 100.3 and took Aleve.  I woke up around 1:30am Sat when my fever broke.  Saturday I got up around 9am and was feeling better but my right arm was grossly swollen, very hot and painful.   I took Aspirin, then later took Acetaminophen again and also wrapped an ice pack around my arm.  The redness and swelling traveled down my arm for the following 5 days along with itchiness.   I got a migraine on Wed, today Thursday.  Swelling is now gone and redness gone.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection, lot number M002053, expiration date 11-JUL-2017 (albumin status reported as rHA); M010475, expiration date 01-SEP-2017 (albumin status reported as HSA); L051102, expiration date 17-JUN-2017 (doses and routes were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 10 degrees Fahrenheit for 40 days (960 hours). There was no previous temperature excursion reported. No adverse effect were reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
a 22 month old received a Flublok Quadrivalent, no adverse event; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 22 months old female patient who received a dose of 0.5 ml of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV  lot QSAA1921/QSAA191, exp date: 30-Jun-2020 via unknown route in the left thigh on 11-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration.  The patient did not experience any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Headache, tired, achy, chills, nausea, felt like vomiting,  loss of appetite, arm pain and temperature increased to 99.7
flu like symptoms.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 047A21A) for COVID-19 vaccination.     Concomitant products included PREDNISONE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) and FAMOTIDINE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms.). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms.) outcome was unknown.            The patient received her first Moderna Covid-19 vaccine dose on 25-Mar-2021 and no adverse reactions reported. Patient did go to see her Physician and was prescribed Prednisone, Allegra and Famotidine. Famotidine gave the patient heart burn and indigestion.   This case was linked to MOD-2022-456661 (Patient Link).
Injection arm became swollen, red and painful in the upper section of the arm.  Patient went to her physician and the emergency room on 12/13/07.  Discharged with diagnosis:  "Local reaction".
1- MUSCULAR PAIN: DEVELOPED 1-2HR POST-INJECTION. MODERATELY SEVERE, INTERFERRED WITH DAILY ACTIVITIES. RESOLVED 24HR POST-INJECTION. 2- CHILLS: STARTED ABOUT 2HR POST-INJECTION, WITH INCREASING INTENSITY. ADDING CLOTHING LAYERS DID NOT HELP ME FEEL COMFORTABLE. RESOLVED 12H POST-INJECTION. 3- GENERAL FATIGUE: STARTED ABOUT 4HR POST-INJECTION. BY 6-7HR POST-INJECTION, STANDING UP WAS A STRUGGLE. WENT TO BED EARLY. RESOLVED BY NEXT MORNING. AFTER READING PACKAGE INSERT ON INTERNET, FOUND THAT AE'S ARE VERY COMMON. DID NOT CONSULT PCP OR ADMINISTERING PHARMACIST. I AM REPORTING THIS AE BECAUSE IT WAS VERY SEVERE. ALL VACCINE INFORMATION SHEETS LIST MANY POSSIBLE AE'S. THE SHINGRIX VIS SAID AE'S WERE COMMON BUT THE SEVERITY OF AE'S I EXPERIENCED SEEMED MORE THAN TYPICAL.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 53-year-old female. The patient's height, and weight were not reported. The patient's current conditions included penicillin allergy. The patient experienced drug allergy when treated with ciprofloxacin, and vancomycin.  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 0.5 ml, 1 total administered on 06-APR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2021, the patient experienced confirmed clinical vaccination failure  and confirmed COVID-19 infection. Laboratory data included: Rapid test and antibody testing for COVID-19 (NR: not provided) was positive for antibodies, and COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed clinical vaccination failure  and confirmed COVID-19 infection.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179016.  The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified.  Additional live follow up information was received from Product Quality Vigilance on 11-MAY-2021.; Sender's Comments: V0: 20210518529-covid-19 vaccine ad26.cov2.s-confirmed 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
sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore). At the time of the report, PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Face went numb on my left side, can not stay awake after 2 days, body hurt so bad couldnt move, and froze.  Benadryl, decatron steroid, fluids but still having effects
jerking & shaking noticed 24NOV w/fever; grand mal sz on 25NOV; lasted 4 mins, fever 102 @ ER in hosp;
patient complained of "flushed feeling"  within 7 min of receiving vaccine; 2 min later c/o "tongue feels funny".  Benadryl given, symptoms resolve
This case was reported by a physician via sales rep and described the occurrence of shivering in a 64-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on 23rd May 2018, for tolerance, refer case US2018215061). On 7th November 2018, the patient received the 2nd dose of SHINGRIX. On 8th November 2018, 1 days after receiving SHINGRIX, the patient experienced shivering, fever and bedridden. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shivering, fever and bedridden were recovered/resolved. It was unknown if the reporter considered the shivering, fever and bedridden to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a physician for himself. The age at vaccination was not reported but it could be 63 or 64 years. The second day after receiving SHINGRIX, the patient experienced shivering, rigor, fever and had to go to bed which lasted 8 hours. The physician consented to follow up.