chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021 at 10:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment medication was provided  1 Vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2F) beyond 12 hours. The vial was first punctured at 1:01PM on 31-Jul-2021 and that is when it was first moved to the room temperature. Punctured Vial kept in room temperature beyond 12 hours.Total amount of time the punctured vial was exposed to room temperature range: 9 hours and 49 minutes at 67.2 Fahrenheit steady temperature   This case was linked to MOD-2021-273049 (Patient Link).
Syncope after dose 1, assisted to stretch, allowed to rest, patient's father refused further evaluation
Client received immunization of Tdap on 7/16/2007, on 7/22/2007, client noticed arm getting red between the elbow and below the injection site.
Exacerbation of joint pain; stiffness and body aches. I was already in PT for my joint pain and I was progressing until I received the vaccine. I have a follow up appointment on 11/18/2022.
Information has been received from a Registered Nurse concerning to multiple unspecified patients (ages and genders not reported) who on unknown dates were vaccinated with an improperly stored doses of GARDASIL 9 (Lot No. M016193, exp. 28-APR-2018) (route and dose not reported). The doses were part of an excursion with temperature of 35F for 1 hour. There was no previous temperature excursion. The reporter did not know if any adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
I have got poison ivy on both my arms and it is painful and it is blistering; It is possible that she might miss the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "I have got poison ivy on both my arms and it is painful and it is blistering; It is possible that she might miss the second dose".  Additional information: Caller reports pulling weeds on Saturday. On Sunday she broke out and became inflamed between her wrist and elbow. Caller voiced she must have touched some poison. Caller has appointment scheduled for Wednesday 19May2021 for her second Pfizer Covid 19 Vaccine. Caller asking if she will be able to receive her vaccine. Caller asking if she cannot receive the Pfizer Covid 19 Vaccine, what amount of timing will she have to receive the second vaccine. Reaction/event as reported by primary source was i have got poison ivy on both my arms and it is painful and it is blistering; It is possible that she might miss the second dose. Additional Context: Call was transferred from Pfizer by (Name)(CEP ID: Withheld) Transferring agent stated, I have a caller here. She received the first dose of the vaccine on 28Apr2021 and she is supposed to get the second dose on 19May2021 however the past weekend she got in contact with the poison ivy and right now she has blister on both arm. It is possible that she might miss the second dose. Consumer stated, I am book this Wednesday to get my second shot. I want to know if I miss it what happens. I have got poison ivy on both my arms and it is painful and it is blistering and as soon as I got off the phone, I have an appointment to go down to the drug store and he going to see if he can help me. So, I just want to know if I can still get my second Pfizer shot on Wednesday. (Vaccine name not clarified, hence suspect captured as Unspecified Vaccine and is this a Pfizer product tab Checked-Yes). Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number. Consumer further sated, can you give me any information or do I have to call this number. Consumer was informed that Pfizer medical information is the concerned department for all queries and advised to call on the number provided. Limited information was available over the call as consumer hung up abruptly. Hence, product details (LOT#, expiration date, NDC#, UPC#), purchase details and other details were unknown. QR Comment: AE filed conservatively.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt died at home after recently being hospitalized for acute on chronic hypercarbic respiratory failure and a recent COVID infection; pt required intubation with mechanical ventilation for a day, was extubated and weaned to O2 via NC; treated with steroids and antibiotics; dc'd to home with O2 and home health; per death certificate, pt died at home with cause of death being respiratory failure, pneumonia, COVID 19 infection, bronchiectasis
Drew up undiluted Pedi Pfizer Dose of 0.3ml and administered to client in Right deltoid IM.  Dose that should have been drawn up is Pfizer Adult 1st dose booster 0.3ml . Observed Client for 15minutes, client appears to have no adverse reactions, complications or distress noted. Entire staff notified of medication error. Client will be notified of Dr. recommendations of how to proceed with future COVID-19 vaccinations.
Information has been received from a licensed practical nurse concerning a 16 year old female with seasonal allergy who on 29-AUG-2006 was vaccinated intramuscularly with a first dose of Gardasil. On 06-NOV-2006, the patient was vaccinated intramuscularly with a second dose of Gardasil. It was reported that the patient received the first and second dose without incident. On 15-FEB-2007, the patient was vaccinated intramuscularly with a third dose of Gardasil. Concomitant therapy included Loratadine. On 16-FEB-2007, at midnight, the patient developed nausea and vomiting that lasted until 14:00 and the patient recovered. Unspecified medical attention was sought. Additional information has been requested.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL. Subsequently the patient fainted. The patient sought additional medical attention after fainting and saw another provider who referred the patient for a CT scan, result not reported. At the time of the report, the patient recovered on an unknown date. No further information is available.
PATIENT REPORTED LOW GRADE FEVER (100.1F), HEADACHE, CHEST TIGHTNESS, AND HIVES. PATIENT REPORTED THAT THE SYMPTOMS APPEARED AROUND 9PM THE EVENING OF THE VACCINATION. SHE DID NOT REPORT THE ADVERSE EVENT UNTIL 11/9/2020 AT 4:00PM. SHE REPORTED THE SYMPTOMS RESOLVED ON THEIR OWN BY THE TIME OF REPORTING. SHE WAS ADVISED TO STILL MAKE AN APPOINTMENT WITH HER PCP FOR A FOLLOW-UP.
No additional AE; syringe broke off at the base where you screw on the needle/ the entire luer lock snapped off.; Poor quality device used; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 28-FEB-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 ml, lot #W027250, expiration date: 09-JUL-2024, administered for prophylaxis (strength and route of administration were not provided). After administration the nurse attempted to put the safety on the needle and the entire luer lock snapped off (reported also as when I was giving a child one it broke off) (syringe issue) (poor quality device used). No adverse event reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2303USA000534:
Initial unsolicited report received from a non-healthcare professional on 27-Jul-2017. This case involves a female patient of unknown age who was vaccinated with a dose of DAPTACEL (batch number: C5157AA, expiry date: 23-Feb-2019), IPV (VERO) (IPOL) (batch number: N1A451M, expiry date: 05-Feb-2019) and MEASLES, MUMPS AND RUBELLA VACCINE (MMR), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient passed out. No further symptoms reported. The patient required ER/ doctor visit. The patient's laboratory data and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review the case was considered as serious because of important medical event: passed out. List of documents held by sender: none.; Sender's Comments: The patient passed out post vaccination with DAPTACEL and IPOL. Time to onset was not reported and the event is also not listed with the products. The patient was also vaccinated with MMR vaccine. Loss of consciousness could occur due to multiple reasons. No history of loss of consciousness has been reported in the patient along with any other medical history. Also, vaccination with multiple products also makes the assessment of causality in this case difficult. Additional information regarding latency, medical history and condition of the patient at the time of vaccination would be required to assess the case. Based upon reported information the role of the vaccine can not be assessed.
Soreness at site lasted a day; This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2023, outcome "recovered" (2023), described as "Soreness at site lasted a day".  Additional information: The COVID vaccine was painless to administer. Soreness at site lasted a day. Little or no side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a unknown source via company representative refers to a female patient of unknown age. The patient was vaccinated with third standard dose of GARDASIL (lot # was unknown) through injection in deltoid muscle for prevention of HPV on an unknown date. On an unknown date the patient experienced pain at the injection site. The outcome of the AE was unknown. Additional information is not expected.
Beginning two days after Fluvirin vaccination the patient reports having arm and neck pain. The patient went to his doctor for treatment. The patient states that he was given a cortisone injection from his doctor to help with his arm and neck pain.
Within days of the 2nd vaccine my husband became sick on his stomach with diarrhea.  After days of this going on he began to experience bloody diarrhea that later had blood clots in it.  This went on till he almost hemorrhaged to death.
Short of breath Narrative: Patient went to emergency room, was given Benadryl and Pepcid, had an unremarkable cardiac workup, and was sent home in stable condition.
Pt recv vax on 11/4/98; on same day pt exp hives x 30 min
Rash at injection site that grew to between 6-7 inches in diameter; Pain in the arm; Swelling in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), PERIPHERAL SWELLING (Swelling in the arm) and VACCINATION SITE RASH (Rash at injection site that grew to between 6-7 inches in diameter) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and PERIPHERAL SWELLING (Swelling in the arm). On 19-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site that grew to between 6-7 inches in diameter). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), PERIPHERAL SWELLING (Swelling in the arm) and VACCINATION SITE RASH (Rash at injection site that grew to between 6-7 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
Tasted very bad, appeared oily; Not able to swallow full dose; Not able to swallow full dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 14-APR-2023, the patient received Rotarix lyophilized formulation. On 14-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: Not able to swallow full dose) and accidental underdose (Verbatim: Not able to swallow full dose). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter
Tenderness; discharge; bloating; 2 weeks early period; Great deal of bleeding; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the arm left on 11May2021 at 15:30 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included IUD embedded which was ongoing. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the arm left on 27Apr2021 at 10:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks of vaccination. On 14May2021 at 21:00, 3 days after the Pfizer covid shot dose 2 , she had a great deal of bleeding, discharge, tenderness and bloating. Her period is also 2 weeks early. The patient had not experienced any of that in 9 years since the patient had started using IUDs. The patient had 2nd IUD and had been using for 9 years. Previously, the patient periods with an IUD had no bleeding and just spotting. The patient received the second dose of vaccination outside the scheduled window period (inappropriate schedule of vaccine administered). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events tenderness, discharge, bloating, irregular periods and menstruation increased were resolving. The clinical outcome of the event Inappropriate schedule of vaccine administered was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 13-MAR-2013, the patient was vaccinated with PNEUMOVAX23 (lot number H013399, expiration date: 07-MAR-2014) 0.5 ml in the arm. In March 2013, the patient experienced huge injection site reaction, swelling at least 6 inches to include the whole upper arm and redness,. The patients sought medical attention (office visit) and as prescribed steroids. The nurse also reported that she had not seen this type of reaction from PNEUMOVAX23 before. The outcome of all the reported events was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports from the same source. Additional information is not expected.
This is not an adverse reaction reporting but reporting of a deviation from approved manufacture's age requirement for Moderna COVID-19 Vaccine with parental consent. 17 yo male patient presented for Moderna Covid #2 on May 7, 2021.  Screening RN notified supervising physician of patient's age, which is below the approved age for the Moderna vaccine.  The FDA granted an EUA for the Moderna vaccine in patients age 18 years and older.  Upon further investigation it was noted that on April 8, 2021 when he presented to the vaccine clinic for shot #1, the MSA did initially turn the patient away, and subsequently notified the physician covering the clinic on that day that the patient was underage.  Since the patient will be 18, the physician approved  administration of the vaccine.
One day after receiving the vaccine, I developed a deep purple/blue bruise that extends from an inch above the injection site (shoulder of left arm) and extends to my elbow.  It is 4 inches wide.
Experienced excessive pain and swelling in arm where COVID vaccine was administered that occurred one week after shot was administered.
Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 (Body aches). At the time of the report, PAIN (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-403355, MOD-2021-403373 (Patient Link).
not feeling well for a couple days and then was ok; then about a week later felt unwell and fatigue was setting in; it has been a month of feeling unwell and well cycle./his mother is also experiencing this and hers is lasting longer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 90 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown, first vaccine dose on 7thMar). The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well for a couple days and then was ok"; FATIGUE (non-serious), outcome "unknown", described as "then about a week later felt unwell and fatigue was setting in"; DISEASE RECURRENCE (non-serious), outcome "unknown", described as "it has been a month of feeling unwell and well cycle./his mother is also experiencing this and hers is lasting longer".  Additional information: Stated last week he wasn't feeling well and has been feeling well the last 3 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021432691 same reporter/drug, similar event, different patient
72 hours after vaccine pinpoint dots then following day pinpoint puffy eyes, no sob, no fever, some pruritis spreading all over.
Client called for assistance feeling a cold sensation down his throat. Firefighters first responded.  Client stated he was feeling good.  Client was released to his home at 4:00pm.
Died after the 2nd dose; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient died after the 2nd dose on an unspecified date. The cause of death was not reported. It was not reported if an autopsy was performed.  Information on the batch/lot number has been requested.; Reported Cause(s) of Death: died after the 2nd dose
Vomiting, upset stomach, weird pains in stomach, back pain, joint pain, muscle pain, odd headaches, foul smelling urine, body aches, light numbness in a extremities, fatigue, slight burning sensation in back, pain in lower left back that's tender to the touch, restless legs, shoulder pain (injection site), congestion, stuffy nose, running nose, earaches, smelling odd smells, slight chills, slight shaking, neck pain, aching eyes, slightly puffy face, odd feeling in chest.
Pain, itchiness, redness, excessive swelling, hot around injection site and 3 inch perimeter.