chrisvoncsefalvay/vaers-outcomes huggingface dataset:
in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event; She mentioned that they received the vaccines with no adverse event; Initial information was received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA342573.  This case involves 6 patients an unknown age and gender patient who experienced in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event and mentioned that they received the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and was in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event (product storage error) and she mentioned that they received the vaccines with no adverse event (poor quality product administered) (unknown latency). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
On April 4th at approximately 8:00am, I blacked out while I was walking to use the restroom, and landed face first on the kitchen floor. When I came to, my nose was bleeding and my right arm was numb. My husband called my doctor (and spoke with the doctor on call) who told me to go to the ER. While at the ER, the doctor ran an EKG, CT, and labs. All tests came back fine. I have had a headache, neck pain, and have felt light headed ever since. I returned to the ER a week later with a severe headache. Another CT, EKG, and chest x-ray. All results were fine. I have also seen a neurologist and a cardiologists. All tests came back fine. I still have a constant headache and feel light headed.
On 10/27/21 I started with fever, chills and diaphoresis. On 10/30/21 I started with a cough, headache and intermittent fevers, chills and diaphroesis. These symptoms continued and on 11/17/21 I started becoming very dyspneic.
This spontaneous report as received from a healthcare worker refers to a patients of unknown age and gender. No medical history and concomitant medications were reported. The healthcare worker stated that the packaging of RECOMBIVAX HB and VAQTA were considerable close in appearance and errors may been made in administration. No concomitant medications were reported. The reporter also was requesting to work on changing the packaging of the 2 vaccines and enquired about the age range differences for the vaccines. Additional information has been requested.
On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness on the injection site) and INJECTION SITE SWELLING (swelling on the injection site). At the time of the report, INJECTION SITE ERYTHEMA (redness on the injection site) and INJECTION SITE SWELLING (swelling on the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Based on MSA comment, Injection site erythema coded to Vaccination site erythema. Injection site swelling coded to Vaccination site swelling
psoriasis; PRP; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had RA prior to all this" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "psoriasis"; PITYRIASIS RUBRA PILARIS (non-serious), outcome "unknown", described as "PRP". The events "psoriasis" and "prp" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional info: Patient stated, Mar of last year I received the two doses of vaccine. At that time I had two places on my face that were I saw my dermatologist about. Some cream was given. In Apr a month later saw the doctor again the places were spreading across my face. In Aug I got the booster. This dermatitis spread across my body like a fire. After testing, I had psoriasis , PRP. I believe the vaccines help push this on me.  The lot number for bnt162b2 was not provided and will be requested during follow up.
/Pt called to explain had seizure after second dose.  Was provided first dose on 5/12/21 (no reported incident).  Second dose provided on 6/9/21.  Patient reported seizure occurred on 6/11/21.
Patient experienced facial swelling around lips, eyes and nose around 10 o'clock. (Received shot around 5pm) also stated that she experienced shortness of breath and a headache. (Has had regular Flu shot without issue in the past) MD recommended BENADRYL only. No hospitalization.
patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:56 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:56 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant products were not provided.  Vials only punctured right before administration  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
Expired vaccine administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that some patients had reported flu like symptoms after receiving the vaccination, but reporter did not have details of that. No concomitant products were reported.  No treatment information was reported. Date the vial was initially stored in the refrigerator was on 01 Dec 2021.
Case Completed Covid vaccine series in January 2021, then contracted Covid and died of it in October 2021.  He was NOT hospitalized for Covid, rather tested positive and died the same day at his local health care facility.
Information has been received from a registered nurse concerning a patient who between 09-MAR-2010 and 18-MAR-2010 received a 0.5 ml IM dose PNEUMOVAX 23 (lot# 664476/1190Y). Between 09-MAR-2010 and 18-MAR-2010, 24 hours after vaccination with PNEUMOVAX 23, the patient developed cellulitis reaction on their arms. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for  the lot number 664476/1190Y were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. The nurse contacted during telephone follow-up could not supply the following information: patient names, dates of birth, dates of vaccination, dates of events and recovery status. Additional information has been requested.
The night after the vaccine I awoke with fever and chills. The next morning I awoke to severe pain in my scrotum. The Pain continued for several days. I went to the Emergency Room on February 5th. They conducted an ultrasound, gave me a prescription for antibiotic and pain, and released me. The condition continued to worsen and began bleeding. The condition continued to worsen. On February 18th. I went to hospital where they admitted me and performed an Orchiectomy.
Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vaccines were tend to store with 1 to 3 bottles in the fridge to thaw out and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  No treatment medication information was provided.
Irritation, itching, redness, slight swelling and heat in an area covering arm width at the shot site. The redness in the center of the area is not as red as the outer edges. The shot site is at the top edge of the area.  No doctor visit yet. I thought I was supposed to report this to you first.
He was feeling very dizzy and sick to his stomach.  He broke out in a rash all over his back.  He threw up and had diarrhea every day for 5 days.
28OCT93 vax recvd & mom noticed pt w/eyes rolled back in head, no loss of consciousness occurred x 3; taken to MD adm to hosp for observation; inject site of DPT red size of dime;
Patient is a 16 yo female, experienced syncopal episode immediately after receiving first dose of pfzier covid vaccine. Loss of conciousness noted for less than 60 seconds. Once patient regained consciousness, she presented Alert and oriented x4, verbal and able to make needs known. Respiration even and unlabored. Skin pink, warm dry and intact. No c/c of allergic reaction. No loss or altered level of consciousness noted. Patients mother reports patient has a history of anxiety, especially with medical procedures, reports prior near syncopal episodes but denies actual loss of concern, denies allergies or significant past medical HX. Patient reports feeling very nervous. Mother remained with patient and provided emotional support.  Patient was assisted to ground, placed supine with lower extremities elevated, past medical HX obtained from patient and physical assessment completed simultaneously. VS 137/82 HR 75 O2 97% RR 20. Encouraged patient to relax and breathe. Within 60 seconds, patient reported feeling better, although emotional. Once pt was OK, patient was assisted from sitting position and provided oral fluids. Patient denied dizziness or lightheadedness while in sitting position. Patient was then assited to standing positions and escorted to observation area, patient sat in chair while being observed for 30 mins. After observation period, pt denied any symptoms, no acute distress noted, patient went home with mother.
Health Network received telephone call at 7:55 am on 3-26-07. Mom stating child having symptoms of fever, swelling and redness to Left arm since 3-23-07 around 5pm wants to know what to do? Health Network recommended ice pack to Left deltoid as tolerated and Motrin (children's) as recommended by container. Mom already did that since 3-23-07. Nothing works. Health network recommended Primary medical doctor office or ER of choice since symptoms still occurring. Mom agreed.
Patient was given the J and J vaccine as the booster dose (third dose). 0.5 ml was given. Patient was persistent and still wanted to this vaccine. No side effects as of today.
Redness, warmth, raised area, itching 2 areas on left Deltoid one measuring 3 cm x 2.5 cm around injection area with a surrounding reddened area 17.6 cm x 13.2 cm,  Tylenol was used with minimal effectiveness
No additional adverse effect reported.; on 01/06/2020 a patient was administered an improperly stored dose of either VAQTA, PEDVAX HIB, or GARDASTL9; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications, previous drug reactions or allergies were not provided.  On 06-JAN-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe (lot # S010727, expiration date 26-JUL-2020); haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S006471, expiration date 22-JAN-2022) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot # 1621926, expiration date 28-NOV-2021) for prophylaxis (for all vaccines concentration, number of administered dose, route and anatomical location of vaccination were not reported) (product storage error). No adverse effects were reported for the patient. The medical assistant could not confirm which vaccine was administered to the patient.  Involved vaccines experienced temperature excursion of 34.9 degrees Fahrenheit (F) for 7 minutes and 48.2 F for 5 hours. There was no previous temperature excursion. Digital data logger was involved.
Patient had what appeared to be a vaso-vagal response 10-15 seconds after vaccines received.He became unconscious, lost bladder control and collapsed,was not responsive to verbal and physical stimulation.911 was activated. An assessment of his pulse and respirations was in progress when he regained consciousness. Pt responsive to verbal stimuli. Remained in resting state for 10min, drank water and was then able to stand. 911 call was cancelled. Pt ambulated from the clinic without assistance.
extreme tiredness beginning three hours after injection and lasting for five days total. Fever 24hours after injection and lasting for 2 days. Injection site swelling, redness, hotness, itching and lump beginning 24 hours after injection the redness, and swelling disappeared after seven day but the hotness, lump and itching are persisting and have not fully gone away two weeks after vaccination.  Sever body and muscle aches 24 hours after injection and lasting five days.
The day after the vaccine 10/06 I started experiencing a migraine and the worst body aches that I ever experienced. I went to the emergency room where they conducted several tests and was discharged shortly thereafter. I saw my Neurologist and he prescribed a course of steroids to take over 5 days.
Pt recv vax on 10/2/98; on 10/3/98 pt exp swollen,bruised &hot Rt arm; tx=ice packs.
first dose of Shingrix on 8/26/2020 and then the second dose was administered early on 9/27/2020; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 22N2D, expiry date 16-SEP-2022) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 27-SEP-2020, the patient received the 2nd dose of Shingrix. On 27-SEP-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first dose of Shingrix on 8/26/2020 and then the second dose was administered early on 9/27/2020). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 20-Jun-2023 The pharmacy manager called to inform that the patient received 1st dose and 2nd dose was administered early. The reporter asked if the patient needed with another dose. The patient received 2nd dose within one month from 1st dose, which lead to shortening of vaccinations schedule. The health care professional did not consent to follow up.
extreme pain; swelling; redness in knee joints; Great difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 12:00 (Lot number: pfizer3592) at the age of 70 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "10 year- old-knee replacements" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 26Feb2021, when the patient was 70 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9269, Vaccine Administration Time: 12:45 PM), administration date: 07Feb2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 03Oct2021 12:45, outcome "recovered", described as "extreme pain"; SWELLING (non-serious) with onset 03Oct2021 12:45, outcome "recovered", described as "swelling"; ERYTHEMA (non-serious) with onset 03Oct2021 12:45, outcome "recovered", described as "redness in knee joints"; GAIT DISTURBANCE (non-serious) with onset 03Oct2021 12:45, outcome "recovered", described as "Great difficulty walking". Therapeutic measures were not taken as a result of pain, swelling, erythema, gait disturbance.  Additional Information: Other vaccines within 4 weeks prior to COVID vaccine and post 2 weeks of vaccination, COVID prior and post vaccination, were reported to be none. There were no known allergies reported.  No follow-up attempts are possible. No further information is expected.
no aditional AE; patient ws vaccinated with VARIVAX that experienced a temperature excursion; This spontaneous report was received from medical assistant and refers to a 1 year-old male patient.  The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown).   On 18-AUG-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W003819, expiration date reported as 24-FEB-2004 but upon internal validation was set as  02-FEB-2024, administered subcutaneously on the left thigh as prophylaxis (strength was not provided) following a temperature excursion of  14 degrees Fahrenheit (F) up to 46 F for 1 hour 30 minutes data logger involved (product storage error), it was mentioned that no previous temperature excursion occurred. No additional adverse event was reported.; Sender's Comments:  US-009507513-2208USA008462: US-009507513-2209USA008834: US-009507513-2209USA008720: US-009507513-2209USA008838: US-009507513-2209USA008836: US-009507513-2209USA008837:
small rash on upper right arm at injection site. feels like pinpricks, itchy, bleeding, open sore. scabs over and then starts again. started 2/20/2022 and is still present. continues to feel like pinpricks, very itchy, reddish in color. took photos.
Hives starting two weeks after 3rd shot given on 12/11/21, namely on 12/25/21, persisting until today, 1/22/22
Narrative: Pt reported hives, a rash, and flu-like symptoms after getting first vaccine.