chrisvoncsefalvay/vaers-outcomes huggingface dataset:
child got his hands free and not all of the Havrix vaccine was injected; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 26-month-old male patient who received HAV (Havrix 720 Junior) (batch number 3397t, expiry date 30-NOV-2023) for prophylaxis.   On 12-SEP-2023, the patient received Havrix 720 Junior. On 12-SEP-2023, an unknown time after receiving Havrix 720 Junior, the patient experienced incomplete dose administered (Verbatim: child got his hands free and not all of the Havrix vaccine was injected).  The outcome of the incomplete dose administered 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:13-SEP-2023 The registered nurse reported that a child got his hands free and not all of the Havrix vaccine was injected, which led to incomplete dose administered. The reporter consented to follow up.
Patient (Guardian) received text to come in for second dose today. appointment was initially for December 1, 2021. Patient received 2nd dose of covid vaccine 1 week too soon. The Nurse and Registration clerk both stated that the date on the card looked like it said 11/1/2021 as oppose to 11/10/2021 which is when they were actually vaccinated. Patient was informed that they would need to get another dose in 21 days to complete the series
I21.4 ACUTE NON ST ELEVATION MI 4/23/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.A1 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 4/22/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 4/23/2023 ACUTE NON ST ELEVATION MI I21.A1 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 4/22/2023 ACUTE NON ST ELEVATION MI I21.4 ACUTE NON ST ELEVATION MI 4/23/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC I21.A1 ACUTE NON ST ELEVATION MI (NSTEMI), TYPE 2 MI (SUPPLY/DEMAND) 4/22/2023 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
A report was received from a regulatory authority on 1/6/03, indicating that a female vaccinee was hospitalized for a productive cough, increased SOB and sweating, after receiving Fluvirin on 10/31/2002. After vaccination (time of onset not provided) the vaccinee experienced a productive cough with clear sputum, increased SOB and sweating and was hospitalized (date not provided). The vaccinee recovered after 3 days on 11/3/02. There was insufficient information to determine the reporter's causality assessment.
Patient report swelling, redness, heat, pain and itching spreading to torso. PCP advised patient to take BENADRYL.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-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 EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Entire thigh became very swollen, hot, and red. Very painful. Swelling lasted approximately 72 hours, but blotchy red rash persists 9 days later.
Raised red rash 4 inches in circular diameter.  Patient was applying triamcinolone cream and the pharmacist instructed her to take Claritin 10mg once a day in addition.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 6 (booster), single (Lot number: GJ665) at the age of 52 years 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (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 "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid on 02May2023 for the treatment of Covid-19 and stopped treatment on 06May2023.
Pt recvd measles vax on 26MAY91 & 5 days p/vax arm remained tender @ inject site w/erythema, swelling & induration; Pt also had swollen lymph glands; dx DPH, Keftabs, Anaprox; Pt seen by MD 1JUN91 & 3JUN91;
JANSSEN COVID - 19 VACCINE EUA SEVERE CHILLS, HEADACHE, NAUSEA, FEVER, BODY ACHES, JOINT PAIN, EXTREME FATIGUE - INABILITY TO GO ABOUT MY NORMAL ACTIVITIES FOR ONE WEEK
Received March 6, 2021. Heavy rectal bleeding with clots, and multiple heart attacks 9 days after the Moderna booster vaccine.  Outcome was death on 3/15/22 at 12pm. Spoke to daughter.
Myocarditis-fast heart rate , shortness of breath and dizziness.  Was prescribed coreg for 6 months after my echo came back a little reduced.
student went thru full pre-exposure series last year; when exposed they did titer & was neg; completed sereis 26FEB91; exposed to rabid animal 3MAR92;
DEVELOPED A RAISED RASH IN AREA OF INJECTION IN DELTOID MUSCLE 8 DAYS FOLLOWING IMMUNIZATION.  RAISED RASH IS STILL PRESENT 4 DAY SINCE IT APPEARED ON ARM AND IS VERY RED, ITCHY, AND HOT TO TOUCH.
Seizure with a 2-3 minute episode of stiffening (body). Had a fixed upper gaze, then "lethargic". Onset 03:00 AM on 3/30/2000. A follow up report received 6/12/2000 adds: Nurse-reporter states pt seen in ER of local hospital then transferred to another hospital. Admission dx: R/O meningitis, right otitis media, seizure. Admitted 3/30/2000 and discharged 3/31. "Neuro-developmentally normal". No mention of anaphylaxis or difficulty breathing. Rectal temps ranged from 98.8 to 101.2. No family history of seizures.
At 11:50 am on Feb 9,2021,patient lost consciousness for 2-3 seconds and felt difficulty breathing, and was unable to move body such as turning around when lying on bed. Patient also felt dry in the upper jaw.  The above symptoms persisted till 12:20 pm. After short nap  to 2:30 pm, Patient recovered from the above symptoms.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection,  lot #W020540, expiration date: 28-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Sore arm at time of injection..sore shoulder blade for one week after. Severe right arm bicep pain eight days after followed by slight weakness to bilateral hands and inability to raise right arm. Affecting ability to drive, bathe etc. Went to walk in clinic, orthopedic, and two emergency rooms with no answers. 10/27/17 saw neurosurgeon and took a round of steroids and acyclovir. Primary care doctor started NEURONTIN for the nerve pain 10/20/17. Unable to raise arm for approximately one month and then able to do so with severe weakness. Began physical therapy after diagnosis of brachial neuritis on 11/03/17. Continue to do physical therapy and continued weakness to right arm with reaching and slight weakness to both hands. Currently on no medication and have no other health problems other than this event.
Vax given 1045 am, when got home pt was crying-screaming,Tylenol given,irritability &screaming con't-mom called SHC, crying persisted for hrs, more /w short breaks for naps while @ babysitter.T 101.6 am 5Feb91, Tylenol given.Recovered 08FEB
10 minutes after injection patient c/o itching at injection site. very slight redness at site. 1238 Benadryl 25 mg given. 1308 patient stated itching subsided. Denied adverse effects to Benadryl. Instructed to contact physician upon arrival to home to notify of event., and go to ER if itching returned.
Warm pink swelling at site of injection, extending around the entire upper arm, almost to the shoulder and almost to the elbow, but not touching either joint.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand: Other, vaccine brand other Moderna, vaccine brand unknown: False, vaccine administration date: 04Nov2021; This is a spontaneous report received from a 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 15Sep2022 as dose 4 (booster), single (Lot number: 0H9694) at the age of 67 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Jan2021 as dose 1, single (Lot number: 030L20A), on 25Feb2021 as dose 2, single (Lot number: 010A21A) and on 04Nov2021 as dose 3 (booster), single (Lot number: 033F21A) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Surgical Hypothyroidism" (unspecified if ongoing); "Osteoperosis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: Feb2015; AMLODIPINE, start date: Jan2011; ESCITALOPRAM, start date: May2022; LIOTHYRONINE, start date: Feb2017; RALOXIFENE, start date: Mar2021. Patient had no known allergies.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 15Sep2022, outcome "unknown", described as "vaccine brand: Other, vaccine brand other Moderna, vaccine brand unknown: False, vaccine administration date: 04Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (07Feb2023) Positive, notes: tested positive on day 6. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 01feb2023 to 06feb2023.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a six months old female patient who administered with an expired dose of 0.5 mL ACTHIB (Batch number: UI807AAA, expiration date: 01-OCT-2018) via unknown route in the left thigh on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine. It was actual medication error due to expired vaccine used. It was not reported that the patient had 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.
Patient is 65 Years Old Female presents with complaint saw skin rash at injection site after two days of injection.  Received PCV13 on   3/12/2019.
Localized erythema 3-4 cm surrounding the Tdap (R deltoid) vaccine site, well circumscribed, warm, & tender. Improving by 11/18.
16 month old child was administered Boostrix instead of Infanrix.; 16 month old child was administered Boostrix instead of Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 19-MAY-2023, the patient received Boostrix. On 19-MAY-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 16 month old child was administered Boostrix instead of Infanrix.) and inappropriate age at vaccine administration (Verbatim: 16 month old child was administered Boostrix instead of Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter reported that a 16 month old child was administered Boostrix instead of Infanrix. The vaccine administration facility was the same as primary reporter. The reporter declined to provide any additional adverse event details at this time, did give consent for safety team follow up. The reporter reported that a 16 month old child was administered Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
My daughter was screaming for 3.5-4 hours at a time. She would take a nap then wake up 15 minutes later and start the screaming process over and over again through about three days. While she was being nursed after the vaccination she started excessively vomiting for two minutes straight. Called doctors office and the nurse I spoke with told me it wasn't a true reaction because of no fever and I hung up on the woman and switched pediatrician's.
Hospitalized 04/23/2022-04/24/2022; COVID-19 positive 04/23/2022; fully vaccinated plus booste Admission Date: 4/23/2022 Discharge Date: 4/24/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Generalized weakness Pneumonia due to COVID-19 virus   HOSPITAL COURSE: Admission H and P : Patient is a 67 y.o. male past medical history schizoaffective disorder, bipolar 1, CKD stage 3, type 2 diabetes mellitus, chronic diastolic CHF who presents today with progressively worsening weakness, fever, cough.   History obtained from patient who has history of dementia as spouse/MD not at bedside and unable to reach by phone.  Patient endorses that yesterday a friend at his adult daycare was diagnosed with COVID.  He endorses cough, fatigue, nasal congestion, and not feeling too good.  He experiences pain on his left flank which started yesterday. He endorses no shortness of breath at rest of with exertion.   In the Emergency Department, patient with generalized weakness he was noted to desaturate with exertion to 80%.  COVID-19 PCR positive, influenza negative with abrupt symptom onset date of admission 04/23.  He has noted meet sepsis criteria with fever, tachycardia, tachypnea with normal lactic acid.  Serum studies with elevated creatinine at baseline with CKD stage 3. UA +, but not initiated on IV antibiotics in the emergency department.  Patient did not require supplemental oxygen.  He endorsed being too weak to return home for which hospitalist service was consulted for admission further evaluation.   Was evaluated by physical therapy with rec for dc home with assist. Testing positive for covid with exertional hypoxia on admit started with decadron tx. No further hypoxia over night. He will be assessed for home o2 needs for exertional hypoxia prior to dc. Will dc to complete x5 day course decadron and follow up with pcp . Urine with identified pyuria  , with hx dementia and of questionable historian will with x3 day cipro and rec op follow up ua to verify clearance . On day of dc tolerating oral diet ,ambulating at baseline
Report, chest pain HA, sore throat and hoarseness. Treatment: None. Outcome: refer for COVID-19 testing will follow-up with pcp.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 3:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 3:14 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 60.75 for dose administered on 14-FEB-2021 and 60.85 for dose administered on 21-MAR-2021.  No concomitant medication was reported.  Batch number 031L20A underwent temperature excursion on 14-FEB-2021 with temperature 32 degrees Fahrenheit at 09:00 AM to 11:00 AM and 35 degrees Fahrenheit at 02:00 PM to 03:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-JAN-2021. Batch number 003B21A underwent temperature excursion on 21-MAR-2021 with temperature 34 degrees Fahrenheit at 09:00 AM, 32 at 10.00 AM and 34 at 11.00 AM. This vial was moved to fridge on 16-MAR-2021 and beyond use date for the vial was reported as 15-APR -2021. Product moved to clinic on 21-MAR-2021  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medication was reported.
Pt with swelling (L) arm at site of immunization and fever within 24 hr, then developed hives, lip swelling on & off x 2 wk.
Temporarily experienced blurring; Unspecified amount ended up in patient's eye; Unspecified amount ended up in patient's eye; This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced blurred vision, occupational exposure while administering product and exposure via eye contact. On an unknown date, the outcome of the blurred vision, occupational exposure while administering product and exposure via eye contact were unknown.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.     Additional Information: GSK Receipt Date: 14th Apr 2022 Reporter's Comments: The pharmacist reported case for herself. The pharmacist reported that when they were drawing up Shingrix adjuvant, an unspecified amount ended up in their eye. The pharmacist was wearing contacts and temporarily experienced blurring. The pharmacist rinsed both their eyes and contacts. The vaccine was not administered to the patient. The reporter declined to provide additional information.  The reporter did not consent to follow-up. Additional Supportive Information: While drawing up Shingrix adjuvant, an unspecified amount ended up in the reporter's eye, which led to blurred vision, occupational exposure while administering product and exposure via eye contact.
Redness and swelling to right arm (itchy).  Tx: Augmentin.
Approximately 15 minutes after receiving vaccine patient had reddened area around injection site that extended down her upper arm to mid humeral area and extended up her arm over shoulder and across her chest to across midline in the front and upper back on her back.  Area was warm to touch.  Patient denied shortness of breath or any other symptoms.  Patient had bled with injection.  Area was marked with a pen and patient continued to be monitored.  NP views area at 30 minutes post injection.  Slight receding noted of redness in arm area.  patient continues to deny any other symptoms.  Patient instructed to return home and take Benadryl by NP.  1/15/21 patient contacted again by NP .  Reports redness receded and was gone the night of injection, no other symptoms noted.
Mother called clinic day after (11-17) vaccines were given to repot a 2 inch bump underneath the arm the vaccines were given. No fever at that time. Patient was scheduled to be seen in the office that day.  Evaluated by a provider and area of approx. 3cm in diameter of redness and swelling that was warm to touch noted.  Area is posterior area of R) arm.  Parent instructed to apply cool pack and observe.  Mother called back the next day (11-18) and patient is seen again by provider.  Redness has spread outside the area of a line drawn the day before.  Overall however there is less intense redness and the hardness int he middle and swelling seems improved.  No drainage or skin breakdown noted.  Area is more warm and tender than is was yesterday.  Patient was started on Amoxil the day of the immunizations due to an ear infection. Amoxil is stopped and patient is started on Augmentin.