chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022).    No concomitant medications were provided. It was reported that total 42 patients were affected. The vial size was 0.4 ml per vial . The vial was initially stored in the refrigerator on 23-Dec-2022. The vaccines were administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023 ,02-Feb-2023, 06-Feb-2023, 08-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 6th of 42 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient no- 1 out of 42 patients)
Body aches, Abdominal pain, diarrhea, nausea, headache, chills, low temp 99.8   Thurs 2/4 & continuing thru Thurs 2/11
Lupus Flared up; Chill; Body ache; Headache; Feeling weak; Fatigue; neck inflammation and Back Inflammation; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left arm on 07Mar2021 12:45 at a single dose for covid-19 immunization. Medical history included lupus, immunocompromise, asthma, and allergies to shellfish, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and there were no other medications that the patient received within 2 weeks. On 24Mar2021, the patient experienced chill after 30 minutes, body ache for 2 days, headache, feeling weak and fatigue or 2 days then disappeared, and reported after 2 weeks lupus flared up, had a neck inflammation and back Inflammation. Patient stated that one week after Covid vaccine, patient started taking lupus meds too. The events resulted in emergency room/department or urgent care and patient received prednisone as treatment and to reduce the inflammation. Since the vaccination (2021), has the patient been tested for COVID-19 which was a negative nasal swab. The patient was recovering from the reported events.  Information on the lot/ batch number has been requested.
Initial information received on 06-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two months old male patient who was vaccinated with a dose of 0.5 ml expired vaccine ACT-HIB (powder expired) lot UI820AA and Exp. Date 18 Nov 2018(for powder) via intramuscular route in the left thigh on 06-Dec-2018. It was reported that, Diluent lot U5962AA and Exp. date: 05 Jan 2019. The patients medical history not reported and concomitant medications included PREVNAR 13; ROTATEQ; DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and POLIO VACCINE INACT (IPV) for Immunization. It was an actual medication error case due to expired vaccine used. It was unknown whether the patient experienced 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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. List of documents held by sender: none.
This infant had a maculopapular rash on her trunk, face, and extremities. She was treated with Benadryl PRN itching.
Treatment of COVID-19; Treatment of COVID-19; antigen test showed faintest of pink line last Tuesday, 3 days after completion of paxlovid, next evening felt sick with return of head cold symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL3248), on 15Nov2021 as dose 2, single (Lot number: Fm9809) and on 25Oct2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15May2022 as dose 4 (booster), single (Lot number: 838A22a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "antigen test showed faintest of pink line last Tuesday, 3 days after completion of paxlovid, next evening felt sick with return of head cold symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) confirmed Covid, notes: Started Paxlovid on day 2 of symptoms with  antigen confirmed Covid; (30Aug2022) faintest of pink line, notes: antigen test showed faintest of pink line last Tuesday. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical course: Patient received lisinopril as other medication in 2 weeks. Anti-viral details: patient received antiviral as covid-19 treatment from 22Aug2022 to 27Aug2022 for Treatment of COVID-19. Patient Started Paxlovid on day 2 of symptoms with antigen confirmed Covid, stated to feel better each day antigen test showed faintest of pink line last Tuesday. 3 days after completion of paxlovid, next evening felt sick with return of head cold symptoms and cough headache tested bright red Wednesday am, felt a bit better. Thursday, now lingering with head cold and cough not improving. 14 days after onset of symptoms, 7 days after ending Paxlovid
2 month old found pulseless & unresponsive at home 7am 21 hrs after 2 month vaccines.
Client given HepB pediatric dose (no adverse events reported). (Gave 2nd dose of HepB pediatric dose).
missed 2nd dose and it's been 4 months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose and it's been 4 months) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd dose and it's been 4 months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose and it's been 4 months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Patient given adult Td instead of DTaP , returning to office for DTaP , had no reaction to vaccine.
5 minutes p/vax pt exp SOB episodes of apnea lasting 5 seconds-unresponsive-flacid responded to bright light but lethargic;
Psoriatic arthritis; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis) (seriousness criterion medically significant). At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient experienced psoriatic arthritis.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  Company comment  This spontaneous case reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that Patient experienced psoriatic arthritis and on an unknown date, patient also received RISANKIZUMAB (SKYRIZI) for moderate to severe chronic plaque Psoriasis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a consumer, concerns an adult female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, serious, medically significant event of PSORIATIC ARTHROPATHY (Psoriatic arthritis) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that Patient experienced psoriatic arthritis and on an unknown date, patient also received RISANKIZUMAB (SKYRIZI) for moderate to severe chronic plaque Psoriasis, which could be considered as a confounder. No further clinical information on other comorbidities, risk factors, symptoms, labs, diagnostics, concomitant medications and treatment details were available in the report. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
C/O dizziness, nausea, flushed. Seen by on-site EMT. Pt. released at 12:44 p.m. Recorded by RN.
Headache, Fever, Rash, body aches (unspecified) Narrative:
cold-like sx,dull h/a,swollen lip;stayed in urgent care from 635PM to 730PM;
pt called pharmacy on Monday March 1 and stated that she visited her orthopedic doctor who stated that she suffered a minor Bursa injury from the vaccine injection. Pt stated she "was fine though."
Two days following vaccine, returned to normal activities and legs felt extremely heavy. Within one week, began having painful leg episodes spanning both legs from groin to feet. Thought this was normal reaction and side effects. Pain was consistent and daily causing the need to take over-the-counter pain medication 2-3 times daily for nearly 3 months as the relief was temporary. Pain would wake me in the middle of the night. Side effects have now traveled to both arms and hands. Hands lock and get stuck in position. During those episodes very painful to move from those positions. Continue to take over-the-counter meds daily for pain.
redness and swelling in left deltoid after kinrix and VZV immunizations.  resolving after 48hrs.  No pain or limitation of movement.
all located at injection site: itching, swelling, soreness, rash, itching.  has lasted about 2 weeks.  No treatment taken.   (the soreness and itching were most prominent)  as of today's date: , itching has somewhat subsided; still some soreness (but not concerning to me); rash has gone;
Patient/vaccinator unable to state if vaccine was given due to needle retracted during administration of medication(vaccine). Medication noted oozing from syringe and on patient arm
In May 2022, My Fitbit alarmed that my heartbeat was beating fast, and I was in A-fib. I was experiencing shortness of breath, rapid heartbeat. I was hospitalized in May 2022 for Atrial Fibrillation. I was also diagnosed with Sleep Apnea. I was given medication for my A-Fib, and they have taken me off for now because my heart was beating too slow. I had an electrical Ablation twice. The last one was in February 2023, and I am scheduled for surgery on 06/06/2023.
Received vaccine at 14 weeks 3 days estimated gestational age. No heart tones heard at routine prenatal visit on 7/17/08, fetal death noted on ultrasound. Based on the ultrasound estimated fetal age at death 15 weeks, 3 days.
Migraines; A slight fever; Severe fatigue; This is a spontaneous report from a contactable consumer (patient's parent) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date in May2021 as 1st dose, single dose for covid-19 immunization. Medical history included a few immunity issues (currently being treated). Concomitant medications were not reported. It was reported that the patient had first vaccine last week, which left her with migraines, a slight fever with severe fatigue on an unspecified date in May2021. The reported also concerned that the second would be more harsh. The outcome of the events was unknown.  information about lot/batch number has been requested.
pt went to saudi nov98, sx of weight loss, dizziness & light headedness & joint soreness in lower back, elbows, hands & knees began; pt also very fatigued; has lost 30# since sx began; becomes nauseous if turns head too fast d/t dizziness
Moderna injection on Thursday 2/18/2021, Friday at 7 pm facial swelling and redness appeared. Eyes are swollen, whole face and welts all over, sore throat for 2 days, Denies fever. Mild wheezing/little winded. Welts over whole body, hips and ankle. Itching in unusual places. Denies swollen tongue.   Seen on 2/20/21 at urgent care.
patient stated she began to develop blurry vision as well as arm soreness. began to breathe heavily due to panic and stated there was numbness going down her left leg. 911 was called and symptoms began to resolve as ambulance arrived.
Headache, fever, chills - started about 3 hours after the vaccine and lasted about a day.
Erythematous painful rash on trunk with Bullae that ruptured, Macerats of areas under breasts and axilla . Treated with Prednisone and Atarax
my AFib kicked in and lasted for over a week; my AFib kicked in and lasted for over a week; This is a spontaneous report from a contactable consumer. A 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9269), via an unspecified route of administration from 08Feb2021 08:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 06:45 AM (also at age of 83 years old) on left arm for covid-19 immunization with lot number EK9231. The facility type vaccine was hospital. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation from an unknown date. Concomitant medication included apixaban (ELIQUIS). After the second dose, on 08Feb2021 08:45 AM, patient's AFib kicked in and lasted for over a week. Patient didn't received treatment for the event. The outcome of event was recovering.
Dizziness, BP 138/102 (pulse 98), BP 130/92. Given water and graham cracker.
Severe shivering with inability to walk for 20 minutes. Fever. Soreness at site. Shivering subsided after 30 minutes. Fever persisted for several hours. Took ibuprofen for soreness & fever with good outcome.
He had a headache, muscle ache, dizziness, nauseous, neck ache, "felt like some one was pinching his brain", sweats and chills, felt hot to the touch but did not register a fever. The symptoms lasted for about 12 hours. At approximately 9:00 PM he had 2 ADVIL after talking to the nurse at the Dr's office and that helped. He slept for about 18 hours.
Information has been received from a mother concerning her daughter who was vaccinated with GARDASIL vaccine (yeast) (Lot# not reported). Subsequently the patient experienced pain at injection site and swelling at injection site. The patient's outcome was unknown. No further information is available.
client stated she had cellulitis with previous Flublok vaccine in 2019 but PCP wanted to try once more to see if it wasn't an aberration or coincidence vs a true reaction/issue. vaccination was done at 10:41am on 10/12/2020.  advised client to call PCP and/or seek immediate medical attention should signs of cellulitis reoccur.   with clean hands and gloves cleaned site with circular motions going outward.  injected and placed clean bandage.  minimal bleeding evident after injection. client called me the next day stating that cellulitis did reappear post injection this year also and that client's PCP was aware and treating the issue. I did not get medications nor other treatment information at that time.
Allergic reaction; Shingles like lesions; Red rash, head to ankles all over her body; white blisters; painful rash; itchiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-MAR-2023, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Allergic reaction), vesicular rash (Verbatim: Shingles like lesions), red rash (Verbatim: Red rash, head to ankles all over her body), blister (Verbatim: white blisters), painful rash (Verbatim: painful rash) and itchy rash (Verbatim: itchiness). The outcome of the allergic reaction and vesicular rash were not reported and the outcome of the red rash, blister, painful rash and itchy rash were unknown.   It was unknown if the reporter considered the allergic reaction, vesicular rash, red rash, blister, painful rash and itchy rash to be related to Shingrix.     It was unknown if the company considered the allergic reaction, vesicular rash, red rash, blister, painful rash and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-MAY-2023 The case was self reported by the patient. The patient received second dose at the doctor's office and reported it was a shingles like lesions. The patient experienced red rash from head to ankles all over her body and had white blisters and it was painful rash and extremely itchy. The patient reported that she had to go several times to the urgent care. The patient reported that she eventually visited a dermatologist and stated it was an allergic reaction to the preservatives in the vaccine. The reporter stated that healthcare professional ruled out shingles. The reporter reported that not all information was available. Lot and expiry date were unknown. The patient was informed that there were no preservatives in Shingrix. The reporter consented to follow up.
pt recv vax 19MAY97 & 24JUN97 pt devel a varicella type rash w/a fever;
Onset tics, head jerk and blanking around two days after aDPT/MMR. (?Related to shots or illness or neither?)
7oct76 appeared nl & had no recent illness;fed & was placed in crib;2 hrs later,found dead;autopsy revealed no significant abnormalities;probable COD was SIDS;
Awoke in the middle of the night with my left upper arm swollen more than double in size at site of  RSV vaccine injection, reddened with a rash, sore at the injection site and painful to move left arm. Researched facility website for adverse reaction to RSV and followed instructions by taking antihistamine (extra dose of Allertec) & generic Pepcid and applying cold compress. Continued to do so for 3 days.
administrated with expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number d24g7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Kinrix and Kinrix 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: 26-JUL-2022 Reporter's comment: The nurse reported that the patient was administered a dose of Kinrix, which had an expiration date of 4th June 2022. No adverse event was reported. No patient's identifiers provided Permission to follow up was not requested. Additional supportive information: The patient had received an expired dose of Kinrix, which led to expired vaccine used.
Received flu vaccine (TIV) at noon. At approx 6pm client was ill with aches, fever, chills and diarrhea. Was feeling better by 5am and able to work.
Patient developed urticaria over body within 12 hours of vaccination. Patient is also complaining of lightheadedness.
I had extreme itching in all my extremities. The itching began in my hands, then quickly spread to my arms, legs, feet. I itched so much that I could not sleep for a week. Benedryl did not help at all. I finally took a week's course of prednisone, and the itching stopped.