chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number K003074 with expiration date of 13-MAR-2015 (route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 192 hours and at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for the sum of 1000 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 04-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
8 hours after injection: wakened feeling tightness in chest, as with panic/air hunger. 15 hours after injection:  abnormal hypertension (normal BP 118/77?post vaccine: 150/93). Irritable. Moderate headache.  Chest  tightness/heaviness continued all day.. at 23 hours: severe headache, severe nausea, dizziness, fatigue, exhaustion, feeling ?cold?.  At 25 hours: shaking chills, fever to 100.7 (normal for this patient=97.4).  Nausea precludes drinking and eating. Stomach pain, heaviness in chest, feeling of dyspnea, continuous severe headache.  On morning of 11/4: BP remains elevated?140/86.  HR=90 (normal =68-72). T=100.4. Mild headache. Irritable.  No further nausea; eat small amount; drinking well.  11/4 at 10am: Normal BP,. 112/77.   Continúe feeing exhausted.  Evening: dull headache.   11/5: still moderate fatigue, lack appetite, no nausea. Irritable.  Foggy? thinking. Slight soreness at injection site continues.  No headache. Moderately irritable.  Fever 100F at 5pm.  (Normal Temp=97.4)  Feeling of pressure in sinus forehead?Afebrile at 9:30pm
Varicella clinical diagnosis with fever and evolving papulovesicular pruritic rash.
Soreness and stiffness at and around injection site lasting greater than 30 days. Has received anti inflammatory treatment.
Headache; chills; muscle and joint pain; muscle and joint pain; tiredness; Dose Number: 3; This is a spontaneous report from a contactable consumer (patient) for herself via an agency. A 74-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: FH8028), via an unspecified route of administration, administered in left arm on 28Oct2021 14:30(at age of 74-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization in Doctor's office/urgent care. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies were tetracycline, most statins. The patient medical history and concomitant medications were not reported. On 19Feb2021 10:00 AM (at age of 73-year-old), the patient received bnt162b2(PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in right arm as dose 2, single for covid-19 immunization. On 29Jan2021 10:00 AM(at age of 73-year-old), the patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in right arm as dose 1, single for covid-19 immunization. The patient experienced headache, chills, muscle and joint pain, tiredness, all events started on 29Oct2021. The outcome of all the events were recovered in Oct2021 without treatment. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  Follow-up attempts are completed. No further information is expected.
trouble moving her legs; Chills; Fever; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISORDER (trouble moving her legs), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle soreness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MUSCULOSKELETAL DISORDER (trouble moving her legs), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle soreness). At the time of the report, MUSCULOSKELETAL DISORDER (trouble moving her legs), CHILLS (Chills), PYREXIA (Fever) and MYALGIA (muscle soreness) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Fever, chills, body aches, cough, headache - started within 12 hours and ended within 24 hours. Took Advil for symptoms.
Pink on the injection site; itching on the upper left arm./top down of the arm it was itchy; after receiving the vaccine the arm was hurting (when swiped on the left side and felt the pain); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (after receiving the vaccine the arm was hurting (when swiped on the left side and felt the pain)), VACCINATION SITE PRURITUS (itching on the upper left arm./top down of the arm it was itchy) and VACCINATION SITE ERYTHEMA (Pink on the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Finger injury. Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for Finger injury.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (after receiving the vaccine the arm was hurting (when swiped on the left side and felt the pain)). On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching on the upper left arm./top down of the arm it was itchy). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Pink on the injection site). In January 2021, VACCINATION SITE ERYTHEMA (Pink on the injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (after receiving the vaccine the arm was hurting (when swiped on the left side and felt the pain)) and VACCINATION SITE PRURITUS (itching on the upper left arm./top down of the arm it was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Information regarding patient initials, gender and address is updated
FEVER, NASAL CONGESTION, SORE THROAT, COUGH, DIARRHEA, FEVER
PATIENT HAD A YELLOWISH/GREY AREA ON THE RIGHT DELTOID MUSCLE WHERE THE SHOT WAS ADMINISTERED. SHE WENT TO SEE HER PCP ABOUT THE REACTION WHO ORDERED AN ANTIBIOTIC KEFLEX AND PREDNISONE.
Received vaccine on 4-21-2009. When awoke on 4/22 didn't notice rash. Got to school + noted rash> went to school nurse who stated she has' hives at the injection site. Rash (red, raised local reaction) got better with compresses (hot or cold)
Vaccine went into 2-8 Celsius thaw state on or about 24Dec2021 and administered on 12FEB2022; Vaccine went into 2-8 Celsius thaw state on or about 24Dec2021 and administered on 12FEB2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24Dec2021 and administered on 12FEB2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24Dec2021 and administered on 12FEB2022) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 1:04 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 12-Feb-2022 at 1:04 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24Dec2021 and administered on 12FEB2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24Dec2021 and administered on 12FEB2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24Dec2021 and administered on 12FEB2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24Dec2021 and administered on 12FEB2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine went into 2-8 °C thaw state on or about 24Dec2021, this vaccine was administered up until its manufacturing expiry date of 04Apr2022.   No treatment medication was reported by reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX (batch number C7B9P, expiry date 27th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 16th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In September 2018, 21 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 15th June 2018, the patient received the 1st dose of SHINGRIX with batch number TP5E5 and expiry date 15th November 2020. The patient received 2nd dose of SHINGRIX in left arm. The patient developed shingles following his 2nd dose of SHINGRIX. The reporter believed that, the shingles occurred 3 to 4 weeks following the 2nd dose. The reporter did not want to provide additional details regarding patient at the time of reporting. The reported batch number for the 2nd dose of SHINGRIX C789P was corrected to C7B9P as per sales data review. The reporter consented to follow up. This case has been linked to the case US2019003395, reported by same reporter.
SWELLING, REDNESS, ITCHING AT INJECTION SITE.    THEY REDNESS AND SWELLING BEGAN TO SPREAD ON MY ARM, HEADACHE      THE DOCTOR PUT ME ON PREDNISONE
Pt recv vax in 9/98; post vax pt exp temporomandibular joint dysfunction
I got out of bed at 1am because I felt sick to me stomach and I walked about 5 steps to cupboard. Once I found PEPTO BISMAL I tried to remove the cap. I very suddenly lost consciousness and struck the floor. Alerted to the noise my wife came to my aid. I have no memory for approximately the next hour or so. My wife called 911 and I was transported to Hospital. I was released about 13 hours later with a concussion as the back of my head struck the floor.
Initial information received on 26-Apr-2019 regarding an unsolicited valid non-serious case received from a Nurse by phone.  This case involves a eight months old male patient for whom it was reported that Dtap IPV part of Pentacel was mixed with Rotavirus by mistake instead of Acthib and gave the mixture to the patient.  The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.   On an unknown date the patient was vaccinated with a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] with Rotavirus without Acthib (Batch number: C5444AA and expiry date: 27-Oct-2019).   It was a case of actual medication error due to Wrong solution used in drug reconstitution and wrong vaccine administered.  No PTC.  It was unknown if any adverse event occurred or not following the vaccination.  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.   Documents held by the sender: none.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 16-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA003923: US-009507513-2102USA004059:
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 prophylaxis. No Medical History information was reported. In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture date of expiry). No concomitant medications were reported. It was reported that the date of the patient vaccine administration was not known, and it was also unknown whether patient took first, second or first and or second booster doses. The vaccine was expired on 01-Apr-2022 and vials were initially stored in the refrigerator on 07-Jun-2022, they had not undergone any temperature excursions. It was reported that the dates of vaccine administration were 01-Apr-2022, 05-Apr-2022,06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. No treatment medications were reported.
Gone 2 Days without Sleeping; Arms are in a lot of pain; Pain in his legs; has a big rash at the site of injection; suffering from a high fever; headaches; This is a spontaneous report from a contactable consumer (patient daughter). A48 year old male patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number:  EW0191) at 9-9:30 into arm left via an unspecified route of administration on 20Jul2021as dose 2, single for covid-19 immunization (age at vaccination: 48-year-old) at clinic. The patient medical history and concomitant medication was not reported. The patient had previously taken bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, lot number: EW0191) via an unspecified route of administration on 24Jun2021at 11:00 into arm left as DOSE 1, SINGLE for covid-19 immunization. The patient took Tylenol as a past drug event. It was reported that patient did not receive any vaccination within 4 weeks prior to vaccination.  On 20Jul2021at 20:00 the patient had experienced a lot of pain in arms, big rash at the site of injection, fever, headaches, pain in his legs and he has gone 2 days without sleeping. The clinical outcome of the events arms were in a lot of pain, headaches, big rash at the site of injection and Gone 2 Days without Sleeping were not recovered and outcome of events high fever are recovered and outcome of event pain in legs was unknown.  Follow-up attempts are completed. No further information is expected.
June 13, 2021 - Both bottoms of feet went numb and left eye hurt to look left & right and colors looked dim. Everyday for 4 weeks after that the numbness spread through my body. I then lost balance and was dizzy and was admitted into the hospital for 8 days.
Patient reports that her left arm has been painful since receiving her annual flu shot.  Immediately after receiving the vaccination patient felt painful arm.  Patient reports aches and pains night of receiving vaccine.  She states she tried to keep her arm moving and is still sore.  Everyday activities continue to cause soreness. Patient unable to sleep well because she cannot get comfortable from the arm pain.
patient "wiggled away" during MMR II administration. Caller assumes patient may have received about 95% of the dose; This spontaneous report was received from a medical assistant and refers to a 4 year old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 18-DEC-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S031483 with expiration date of 07-OCT-2021, for prophylaxis (route of administration and frequency were not reported).     It was reported that the patient "wiggled away" during measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administration, the reporter assumed that the patient might have received about 95% of the dose (underdose). No additional details available.
Since my Covid shot I have had pain in my right shoulder and arm.  My motion has been limited and painful.  I now have difficulty writing, carrying, lifting, and any activity which requires the use or my right arm.  It is even more painful at night when I am laying down.  I find it almost impossible to get comfortable - this interferes with my getting to sleep.
pt states her arm was hurting after getting the vaccine.  About two days later she broke out in a sweat about 2 AM in the morning.  She states she has no fever and had no other symptoms.
Small right thalamic ischemic stroke (proven on MRI) with left-sided total body numbness.
Hives -9-10 days after shots , Gone 4-5 days later. No Benadryl given
Customer c/o uncontrollable shaking after taking the second dose.  At customer was leaving the park at check point one customer pulled over to report shaking to staff.  EMS and nurse responded to call.  BP 149/82, HR 74, O2 99 and glucose 96.
10/20/23 had her shingrix vaccination.  On 10/21/23 just didn't feel well.  Went to the freezer and was looking for pork chops and then felt a little off and put head down on the freezer door and then in a few min woke on the floor and the table behind her was broken. Had scratches to her back.   Now is feeling fine.  No headache.  No memory loss.
Couldn't walk and was evaluated and told it was a "neuropathy"; Intermittent headaches; This is a spontaneous report from a contactable consumer. A female consumer (patient) of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications. The patient previously took bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on unspecified date in 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient had a reaction to the Pfizer Covid vaccine after the second dose, she couldn't walk and was evaluated and told it was a "neuropathy" (medically significant) on 04Jun2021. She had recovered somewhat, although she still had stabbing pain and intermittent headaches. And she says she had to get Hip MRIs done, although she did not say why. The clinical outcome of event was recovered with sequelae.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Injection site swelling, hyperkinesia, personality change,pt was very hyper injection site induration.