chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The patient was given a booster dose of primary pfizer vaccine when they were expecting a  booster dose of pfizer bivalent vaccine.  The patient was informed of the administration error and told that if they chose to receive the bivalent booster, they could after 60 days have past.  They had no further questions
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral disorder, Feeling abnormal, Hypertension, Tremor
Clinical narrative: ALMOST DEAD!!!!! YOU ALL SHOULD BE ASHAMED OF YOURSELF COMMITTING CRIMES AGAINST HUMANITY.  IT IS SICKENING WHAT YOU ALL ARE DOING - EVIL  MY BROTHER NOW HAS BRAIN ISSUES, HYPERTENSION AND THE SHAKES!!!!!  DEVILS!!!!!!    how can you be ok with hurting and harming innocent children?  I will NEVER EVER in my life take this mess   and yes he has recovered thanks to NATURAL HEALING PEOPLE OF OUR LAND WHO WAS HERE BEFORE YOU ALL COLONIZED EVERY COUNTRY
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperthermia, Hypothermia, Immunodeficiency, Inflammation, Lymphatic disorder
Clinical narrative: I WARNED MY HUSBAND NOT TO GET THIS EXPERIMENTAL TEHNOLOGICAL COMPUTER SYSTEM JUNK BUT HE DID ANYWAY BEHIND MY BACK, WE HAD INTERCOURSE AUGUST 2021 AND SOON AS WE FINISHED I, THE WIFE BLOOD CLOTTED FOR 3 MONTHS!!!!!! THIS IS INSANE. I WENT TO GET TESTED AND FOUND OUT I HAVE A COMPROMISED IMMUNE SYSTEM, HYPO AND HYPER THERMIA, INFLAMMATION ON CERVICAL, CONGESTED LYMPHATIC, ON THE VERGE OF DIABETES, ON THE VERGE OF AUTOIMMUNE DISORDER, ON THE VERGE OF REYNAUD'S SYNDROME...   HOW IN THE HECK CAN YOU ALL SLEEP AT NIGHT...   THE SPIRIT WORLD IS COMING
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: I WARNED MY HUSBAND NOT TO GET THIS EXPERIMENTAL TEHNOLOGICAL COMPUTER SYSTEM JUNK BUT HE DID ANYWAY BEHIND MY BACK, WE HAD INTERCOURSE AUGUST 2021 AND SOON AS WE FINISHED I, THE WIFE BLOOD CLOTTED FOR 3 MONTHS!!!!!! THIS IS INSANE. I WENT TO GET TESTED AND FOUND OUT I HAVE A COMPROMISED IMMUNE SYSTEM, HYPO AND HYPER THERMIA, INFLAMMATION ON CERVICAL, CONGESTED LYMPHATIC, ON THE VERGE OF DIABETES, ON THE VERGE OF AUTOIMMUNE DISORDER, ON THE VERGE OF REYNAUD'S SYNDROME...   HOW IN THE HECK CAN YOU ALL SLEEP AT NIGHT...   THE SPIRIT WORLD IS COMING
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: When I received my flu vaccine, my arm was sore for at least a week.  The initial soreness went away, but then I developed a shooting pain that radiates from the injection site down my arm. This occurs a couple of times a day, and is very painful. It is severe enough that I at times put a pain patch on the injection site.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paralysis, Pyrexia
Clinical narrative: I woke up around 11pm feeling paralyzed. I could not move one part of my body, only my eyes.  I thought it was because of the tremendous body ache and headache. I suffered helpless with fever,. I could not reach to a comforter or uncover myself. I could not go to the bathroom or reach for water.  I could not  call 911 or person for help.  I thought I could die that night of stroke alone. I had  only to  express a thought asking for help.  The fever subsided hours later, the strongest ever headache  continued. In the morning, around 7pm, I could move again.  It was my life time night!
Age: 2.58
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: HEP B was given with along with Pediarix (Dtap-IPV-Hep B) Child had 2 hep B on this date. Provider was notified. Parents was also made aware. No adverse reaction was noted.
Age: 0.83
Sex: U
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives, fever
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Joint range of motion decreased, Product administered at inappropriate site
Clinical narrative: Patient developed pain at injection site with decreased ROM of Rt shoulder. No swelling no redness no masses. Appears to be injection too high as apposed to adverse reaction.
Age: 2.92
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood test, Chest X-ray, Electroencephalogram, Encephalopathy, Febrile convulsion
Clinical narrative: High Fevers 105.1, complex Febrile seizures, cellulitis on injection site and a rash. encephalopathy
Age: 2.92
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count, Injection site cellulitis, Metabolic function test, Pyrexia, Rash
Clinical narrative: High Fevers 105.1, complex Febrile seizures, cellulitis on injection site and a rash. encephalopathy
Age: 2.92
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Viral test
Clinical narrative: High Fevers 105.1, complex Febrile seizures, cellulitis on injection site and a rash. encephalopathy
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Product administered to patient of inappropriate age
Clinical narrative: Patient's mom gave the wrong date of birth and so patient received vaccine at 11 years of age, which is too early. This was discovered by local DHS. Called mom to verify date of birth and advise that vaccine given too early.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Arthralgia, Chest pain, Fatigue, Haemorrhage
Clinical narrative: arrhythmias; abnormal bleeding and required surgery; chest pain; joint pain; feel sick; feel exhausted; it's hard to mobilize; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: ARRHYTHMIA (medically significant), outcome "unknown", described as "arrhythmias"; HAEMORRHAGE (medically significant), outcome "unknown", described as "abnormal bleeding and required surgery"; CHEST PAIN (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "feel sick"; FATIGUE (non-serious), outcome "unknown", described as "feel exhausted"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "it's hard to mobilize". Therapeutic measures were taken as a result of haemorrhage.  Clinical course: it was reported that patient understood the urgency of creating a vaccine for COVID and the good it did for many. Patient can only relay to you how it has made me feel everyday. Patient have arrhythmias, chest pain, joint pain, and feel sick every day. Patient feel exhausted everyday. Patient had abnormal bleeding and required surgery. Many of these problems were new, and one worsened to the point, it's hard to mobilize. Your vaccine ruined my life. Medical Information was forwarded to MI: N/A, no medical inquiry asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Malaise, Mobility decreased
Clinical narrative: arrhythmias; abnormal bleeding and required surgery; chest pain; joint pain; feel sick; feel exhausted; it's hard to mobilize; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: ARRHYTHMIA (medically significant), outcome "unknown", described as "arrhythmias"; HAEMORRHAGE (medically significant), outcome "unknown", described as "abnormal bleeding and required surgery"; CHEST PAIN (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "feel sick"; FATIGUE (non-serious), outcome "unknown", described as "feel exhausted"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "it's hard to mobilize". Therapeutic measures were taken as a result of haemorrhage.  Clinical course: it was reported that patient understood the urgency of creating a vaccine for COVID and the good it did for many. Patient can only relay to you how it has made me feel everyday. Patient have arrhythmias, chest pain, joint pain, and feel sick every day. Patient feel exhausted everyday. Patient had abnormal bleeding and required surgery. Many of these problems were new, and one worsened to the point, it's hard to mobilize. Your vaccine ruined my life. Medical Information was forwarded to MI: N/A, no medical inquiry asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Haemorrhage, Menometrorrhagia, Palpitations, Ventricular tachycardia
Clinical narrative: arrhythmias; abnormal bleeding and required surgery; chest pain; joint pain; feel sick; feel exhausted; it's hard to mobilize; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: ARRHYTHMIA (medically significant), outcome "unknown", described as "arrhythmias"; HAEMORRHAGE (medically significant), outcome "unknown", described as "abnormal bleeding and required surgery"; CHEST PAIN (non-serious), outcome "unknown"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain"; MALAISE (non-serious), outcome "unknown", described as "feel sick"; FATIGUE (non-serious), outcome "unknown", described as "feel exhausted"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "it's hard to mobilize". Therapeutic measures were taken as a result of haemorrhage.  Clinical course: it was reported that patient understood the urgency of creating a vaccine for COVID and the good it did for many. Patient can only relay to you how it has made me feel everyday. Patient have arrhythmias, chest pain, joint pain, and feel sick every day. Patient feel exhausted everyday. Patient had abnormal bleeding and required surgery. Many of these problems were new, and one worsened to the point, it's hard to mobilize. Your vaccine ruined my life. Medical Information was forwarded to MI: N/A, no medical inquiry asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No averse event, vaccine may have been expired
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse event, vaccine may have been expired
Sex: U
Vaccine: COVID19-2
Symptoms: Anxiety, Arthralgia, Cough, Joint swelling, Malaise
Clinical narrative: joint pain and swelling; joint pain and swelling; Cough; congestion; anxiety; malaise; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "joint pain and swelling"; COUGH (non-serious), outcome "not recovered"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "congestion"; ANXIETY (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown".  Additional Information: Reported as, patient had Booster on 10Dec2022. Since then, patient have developed joint pain and swelling. Cough and congestion off and on. Also, anxiety and malaise at times.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Nasal congestion
Clinical narrative: joint pain and swelling; joint pain and swelling; Cough; congestion; anxiety; malaise; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "joint pain and swelling"; COUGH (non-serious), outcome "not recovered"; NASAL CONGESTION (non-serious), outcome "not recovered", described as "congestion"; ANXIETY (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown".  Additional Information: Reported as, patient had Booster on 10Dec2022. Since then, patient have developed joint pain and swelling. Cough and congestion off and on. Also, anxiety and malaise at times.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: joint pain; swelling; seronegative inflammatory arthritis; fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Single, Lot# EL3247, ), administration date: 19Jan2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Lot# EL0140, ), administration date: 26Dec2020, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 06Nov2021, outcome "not recovered"; SERONEGATIVE ARTHRITIS (medically significant) with onset Mar2022, outcome "not recovered", described as "seronegative inflammatory arthritis"; ARTHRALGIA (non-serious) with onset Jul2022, outcome "not recovered", described as "joint pain"; SWELLING (non-serious) with onset Jul2022, outcome "not recovered". The events "seronegative inflammatory arthritis", "fatigue", "joint pain" and "swelling" required physician office visit. Therapeutic measures were taken as a result of seronegative arthritis, fatigue, arthralgia, swelling.  Clinical course: The Facility type vaccine was Hospital. The patient received no other vaccine in four weeks or other medications in two weeks. In Nov2021 developed severe fatigue, Jan2022 developed joint pain and swelling, Mar2022 diagnosed with seronegative inflammatory arthritis. Treatment included Plaquenil, Prednisone, methotrexate, Humira. The patient did not have covid prior vaccination. The patient had no known allergies or other medical history. Patient occupation was Nurse; Sender's Comments: The causal association between the event seronegative inflammatory arthritis and the suspect drug BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300048109 same patient, different vaccine dose/event;
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Seronegative arthritis, Swelling
Clinical narrative: joint pain; swelling; seronegative inflammatory arthritis; fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 49 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Single, Lot# EL3247, ), administration date: 19Jan2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (Dose 1, Single, Lot# EL0140, ), administration date: 26Dec2020, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 06Nov2021, outcome "not recovered"; SERONEGATIVE ARTHRITIS (medically significant) with onset Mar2022, outcome "not recovered", described as "seronegative inflammatory arthritis"; ARTHRALGIA (non-serious) with onset Jul2022, outcome "not recovered", described as "joint pain"; SWELLING (non-serious) with onset Jul2022, outcome "not recovered". The events "seronegative inflammatory arthritis", "fatigue", "joint pain" and "swelling" required physician office visit. Therapeutic measures were taken as a result of seronegative arthritis, fatigue, arthralgia, swelling.  Clinical course: The Facility type vaccine was Hospital. The patient received no other vaccine in four weeks or other medications in two weeks. In Nov2021 developed severe fatigue, Jan2022 developed joint pain and swelling, Mar2022 diagnosed with seronegative inflammatory arthritis. Treatment included Plaquenil, Prednisone, methotrexate, Humira. The patient did not have covid prior vaccination. The patient had no known allergies or other medical history. Patient occupation was Nurse; Sender's Comments: The causal association between the event seronegative inflammatory arthritis and the suspect drug BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300048109 same patient, different vaccine dose/event;
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Dr gave mmr intramusc instead of subcut.; This spontaneous report was received from a patient of unknown age and gender. Information of the patient's medical, concurrent condition and concomitant therapy was not reported.  On an unknown date, the patient was administrated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacture unknown) (strength, dose, frequency, lot #, and expiry date were not provided) intramuscularly for prophylaxis (incorrect route of product administration). The patient needed direction on what to do.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Temperature excursion 47.9 degrees Farenheit; This spontaneous report has been received from an office manager, regarding a 3-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 01-DEC-2022, a dose of Hepatitis A Vaccine, Inactivated (VAQTA) underwent a temperature excursion of 47.9 degrees Fahrenheit (F) (storage in clinical practice) for 47 minutes. Digital data logger was involved.  On 20-DEC-2022, the patient was vaccinated with the improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) Intramuscular Injection, intramuscularly at the right tight as prophylaxis (lot number: W017343, which was determined to be valid, with an expiration date on 13-DEC-2023) (product storage error) (dose was not reported).  The operator of the vaccine was a healthcare professional, and the vaccine was used according to the instruction leaflet. No adverse event was reported.  This is one of several reports received from the same reporter.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported; Tem excursion of 47.9 F for 47 min on Dec. 1st 2022/ VAQTA administered after a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a 6-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot number W023937 verified as valid, expiration date reported and upon internal review established as 06-DEC-2023, administered intramuscularly in the left thigh for prophylaxis (strength was not provided) after a temperature excursion that happened on 01-DEC-2022 at a temperature of 47.9 Fahrenheit degree for 47 minutes (product storage error). No additional adverse event reported.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:MSD
Age: 55.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of product administration, Underdose
Clinical narrative: today (01FEB2023) received 0.5 ml dose instead of 1 ml dose in error.; today (01FEB2023) received 0.5 ml dose; Caller said the patient had gotten antibody test a week ago and it showed non-immune to RECOMIBAX; This spontaneous report was received from a physician assistant, referring to a 55-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapy and drug reactions/allergies were unknown.  On an unknown date in 2014, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose, lot number, expiration date, route and anatomical location were not provided) for prophylaxis. On an unknown date in 2014, the patient was vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose, lot number, expiration date, route and anatomical location were not provided) for prophylaxis. On 01-FEB-2023 (reported as today), the patient was vaccinated with the third dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (thimerosal free) (0.5 milliliter (ml), lot number W022795 has been verified to be a valid lot number, expiration date was reported as 19-MAY-2025, route and anatomical location was not provided) instead of 1 ml dose in error for prophylaxis (incorrect dose administered and inappropriate schedule of product administration).  On 25-JAN-2023 (reported as a week ago), the patient had gotten antibody test and it showed non-immune to hepatitis B vaccine (recombinant) (RECOMBIVAX HB). The sought medical attention on patient was reported as unknown. The outcome of non-immune to hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was not provided. The causality between hepatitis B vaccine (recombinant) (RECOMBIVAX HB) and non-immune to hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was not provided.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE reported; temp excursion 47.9 degrees Fahrenheit; This spontaneous report has been received from a health care professional (HCP) concerning a 12-month-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 05-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, in left thigh, lot #W023937, expiration date: 06-DEC-2023, administered intramuscularly for prophylaxis.  The administered dose of the vaccine experienced a temperature excursion (product storage error temperature too high) on 01-DEC-2022. The vaccine administered were stored at temperatures of 47.9 degrees Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No additional adverse event reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175:
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a other health professional and described the occurrence of rash in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number 4S37J, expiry date 23rd November 2023) for prophylaxis.   Concurrent medical conditions included hypothyroidism. Concomitant products included levothyroxine.   On 5th January 2023, the patient received Shingrix (intramuscular). On 8th January 2023, 3 days after receiving Shingrix, the patient experienced rash (serious criteria clinically significant/intervention required). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Linked case(s) involving the same patient:US2023AMR017246   Additional Information: GSK Receipt Date: 31-JAN-2023 Reporter's comments: The reporter had reported that the patient had experienced rash after receiving the Shingrix vaccine. The reporter had reported the seriousness for rash as intervention required. The reporter had consented to follow-up.; Sender's Comments:  US-GSK-US2023AMR017246:Same report, Pharma case.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Know others who got the shots and got shingles / Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of  patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: This case was reported by a patient interactive digital media. The reporter had the shingles all over the front of her stomach and up and yes it was prickiy and itchy pain wise but was not to bad so not doing the shots. The other received shot and still had it. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR013560, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR013560:Same reporter. Husband's case.
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: got Shingles Vax & got shingles/suspected vaccination failure; shingles, so bad theywere in eyes, 4 times since; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and ophthalmic herpes zoster were unknown.   The reporter considered the vaccination failure and ophthalmic herpes zoster to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles vax and got shingles from it so had they were in her eye. The patient have had shingles 4 more times since. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Pain, Somnolence, Swelling
Clinical narrative: Itching at vaccine location; Severe soreness; Swelling; Redness; More sleepy during the day/Sleeping more at night; This case was reported by a consumer and described the occurrence of injection site itching in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included levothyroxine and topiramate (Topamax).   On 23rd January 2023, the patient received Shingrix. In January 2023, less than a week after receiving Shingrix, the patient experienced pain, swelling, erythema and sleepiness. On 26th January 2023, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved and the outcome of the pain, swelling and erythema were recovering/resolving and the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the injection site itching, pain, swelling, erythema and sleepiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix and experienced itching at vaccine location and it was ongoing.  The patient had sever soreness, swelling and redness which was going down but not gone completely yet 5 days after vaccine and reported that itching started 2 days ago and was quite bad.  The patient also had been more sleepy than normal during the day and sleeping more at night. The patient received Levothyroxine and Topamax which was ongoing. The symptoms were not treated.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received shot in 2021, in Aug 2022 started again; This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot (received the shot in January 2021) and Covid-19 vaccine  (received Covid-19 shot in the spring of 2021).   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 27-Jan-2023 Reporter's comment: The patient originally received the shot in January 2021 but failed to get the 2nd within 6 months. So in August of 2022, she started again and had planned to get the 2nd shot but ran into issues with the insurance not covering the cost. The patient went to pharmacy last night to get a 2nd (actually third) shingles shot and the pharmacist said she did not need a third shot.    The patient went to physicians and had a form that physician signed but still no luck. No further information was gathered.  Notified caller she would likely receive a letter from the safety department. Additional supportive information: The patient received the 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Small red patches (Rash erythematous); This case was reported by a consumer via other manufacturer and described the occurrence of red rash in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) solution for injection for chronic sinusitis and nasal polyp.   Concurrent medical conditions included chronic sinusitis, nasal polyp, drug allergy (allergic to aspirin), allergy to animal dander (Cat dander allergy), ragweed allergy, allergy to molds and pollen allergy. Additional patient notes included race: Chinese. Concomitant products included diphenhydramine hydrochloride (Benadryl (Diphenhydramine Hydrochloride)), fexofenadine hydrochloride (Allegra Allergy), metformin hydrochloride, semaglutide (Ozempic), losartan potassium and triamcinolone acetonide (Nasacort).   On an unknown date, the patient received the 1st dose of Shingrix. On 28th December 2021, the patient started Dupixent (subcutaneous) 150 mg/ml 300 mg at an unknown frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash. The patient was treated with cortisone (non-proprietary) (Cortisone Cream). Dupixent was continued with no change. On an unknown date, the outcome of the red rash was recovered/resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's comments: The Initial information was received regarding an unsolicited valid non-serious case.  The patient's age was reported as approximately 66 year old who received Shingrix (varicella zoster vaccine RGE (CHO)) and Dupixent via prefilled pen. In 2022, the patient had developed a non-serious event, small red patches (rash erythematous). It was reported that, when he got Shingrix vaccine last time it had caused a small red patches that did not last long with cortisone cream and had lasted a couple of days. It was not reported if the patient had received any corrective treatment for the event small red patches. The outcome was reported as recovered or resolved in 2022 for the event small red patches. The reporter had consented to follow-up. It was unknown reporter considered the red rash to be related to Dupixent.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: aching; sore arm.; side effects, Fever; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, pain in arm, fever and headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain, pain in arm, fever and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain, pain in arm, fever and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's comment: The reporter had stated that he/she had the side effects from the Shingles shot.  The reporter was wondering about how long he/she might be experiencing it. The side effect included fever, headache, aching, sore arm.  The reporter wanted to know if he/she Should do anything other than take Tylenol. The reporter had consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Illness, Injection site laceration, Skin warm
Clinical narrative: Cut where the needle went in; Got very ill; I still have a large warm red mark on my arm; I still have a large warm red mark on my arm; This case was reported by a consumer via interactive digital media and described the occurrence of injection site laceration in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site laceration, illness, skin warm and erythema. On an unknown date, the outcome of the injection site laceration, skin warm and erythema were not recovered/not resolved and the outcome of the illness was unknown.   It was unknown if the reporter considered the injection site laceration, illness, skin warm and erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's comments: This case was reported by the patient via interactive digital media. The reporter stated that the patient he/she had received the shingles vaccine and had got very ill. He/She still had a large warm red mark on his/her arm and cut where the needle went in at the time of reporting. Additional supportive information: As this was an RA case, the injection site laceration was captured conservatively. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Shoulder was a little sore; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 27-Jan-2023. Reporter's Comment: This case was reported by a consumer via interactive digital media. Patient stated that shoulder was a little sore for a couple of days. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: FLUX
Symptoms: Complication of pregnancy, Exposure during pregnancy, Live birth, Maternal condition affecting foetus, Premature labour
Clinical narrative: Had shot at 4th pregnancy; ended up having deliver her baby a month earlier; ended up having deliver her baby a month earlier; This retrospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Flu vaccine at an unknown time during the pregnancy. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccine exposure during pregnancy, premature labor and live birth. On an unknown date, the outcome of the vaccine exposure during pregnancy, premature labor and live birth were unknown. The pregnancy resulted in a live neonate with no apparent congenital anomaly.     See case US2023AMR014417 for details regarding the baby case.   Additional Information: GSK Receipt Date: 27-JAN-2023 Reporter's comment: This case was reported by the patient via interactive digital media.  The reporter stated that was your choice. She had regretted on her choice. She does not get the flu shot for 3 out of 4 of her pregnancies. during her pregnancy she had got the flu shot, she had extreme complications, and the baby started to had problems.  She ended up having deliver her baby a month earlier.  She also stated that, it was not a one size fits, all but she was just telling her story. Additional supportive information: Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR014417:Same reporter- Baby case
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm has been with pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JAN-2023 Reporter's comments: This case was reported by the patient via interactive digital media.  The reporter had stated that, the patient he/she had one of the 2 vaccines but his/her arm had been with pain.  The reporter had asked if your arm was hurt or not. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Bad rash; This case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment:The doctor mentioned that in the past that she had a patient that developed a bad rash post Shingrix immunization.  The reporter said it resolved and did not want to talk with medical about it. The reporter agreed to follow up from GlaxoSmithKline.