chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Limb discomfort
Clinical narrative: I have COVID arm; I have COVID arm; 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), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), HYPERSENSITIVITY (non-serious), outcome "unknown" and all described as "I have COVID arm".  Additional information: Just wanted to thank you for all the COVID vaccines. Every time I have COVID arm. However, this time with the new booster my COVID arm red mark was in the shape of a heart. So even my body expresses it love. Would love to share a picture.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site injury
Clinical narrative: vaccine injury; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: VACCINATION SITE INJURY (non-serious) with onset Feb2021, outcome "unknown", described as "vaccine injury".  Additional information: Caller was calling regarding the mail she received about the vaccine injury that happened last Feb2021, she wanted to know the instructions to follow that. Upon asking if she could identify the color of the cap she mentioned she did not know. Did not ask if the vaccine was administered since it was a vaccine injury report instruction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Haematochezia, Inflammatory marker increased, Inflammatory marker test, Mucous stools
Clinical narrative: non-stop bloody, mucus filled stools; non-stop bloody, mucus filled stools; severely high inflammatory markers obtained in utero; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) was exposed to BNT162b2 (BNT162B2), transplacental, administration details for the mother: as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The mother was 28 weeks pregnant at the event onset. The mother's relevant medical history and concomitant medications were not reported. The following information was reported: HAEMATOCHEZIA (medically significant), MUCOUS STOOLS (non-serious), outcome "unknown" and all described as "non-stop bloody, mucus filled stools"; INFLAMMATORY MARKER INCREASED (non-serious), outcome "unknown", described as "severely high inflammatory markers obtained in utero". The patient underwent the following laboratory tests and procedures: Inflammatory marker test: High.  Clinical course: Mother had a vaginal delivery and her baby had nonstop bloody mucus filled stools. Infant was strictly breastfed. Baby was diagnosed with severely high inflammatory markers obtained in utero per her physician. Has this vaccine been tested on pregnant women, along with boosters and side effects on the infants post delivery?? I am assuming by the study where is now reconsidering of administration the vaccine to pregnant and lactating women that you as a company have not tested this on human studies. I know this women and this baby is suffering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201195695 Mother case;
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Gait inability, Lumbosacral radiculoplexus neuropathy, Weight decreased
Clinical narrative: autoimmune iatrogenic diabetic amyotrophic lumbar plexitis; I got a walker and my legs are now about 60 percent useless; big pain in my knee, then hip; knee kept getting thrown out from underneath me; weight loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 68-year-old patient received BNT162b2 (BNT162B2), 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: GAIT INABILITY (disability) with onset 2021, outcome "unknown", described as "I got a walker and my legs are now about 60 percent useless"; LUMBOSACRAL RADICULOPLEXUS NEUROPATHY (disability, medically significant) with onset 2021, outcome "unknown", described as "autoimmune iatrogenic diabetic amyotrophic lumbar plexitis"; ARTHRALGIA (disability) with onset 2021, outcome "unknown", described as "big pain in my knee, then hip"; ARTHROPATHY (disability) with onset 2021, outcome "unknown", described as "knee kept getting thrown out from underneath me"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "weight loss".  Clinical course: The patient reported, "I got the Pfizer booster when it first came out. That night I got a big pain in my knee, then hip, then my knee kept getting thrown out from underneath me. I got a walker and my legs are now about 60 percent useless. My neurologist said my weight loss contributed, but the booster triggered an autoimmune iatrogenic diabetic amyotrophic lumbar plexitis. It's been a year and I have gotten no help after being crippled. I am 68 years old, for God's sake help me. I did not get Covid though."  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: COVID-19, Drug ineffective
Clinical narrative: Contracted covid even though has received Bivalent vaccine; Contracted covid even though has received Bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history (No pMH). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted covid even though has received Bivalent vaccine".  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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: myocarditis; chest pain; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A male patient in his 60's received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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, Manufacturer unknown), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown". Clinical course: experienced chest pains after booster. Believes it was a result of myocarditis. Event took place after use of product.  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.; Sender's Comments: A possible contribution role of vaccines BNT162b2, BNT162b2 omi ba.4-5 to the onset of suspected myocarditis with chest pain cannot be excluded due to temporal relationship.  This case will be reassessed should additional information become available.  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.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Immunodeficiency, Off label use
Clinical narrative: she was fully vaccinated and had five shots.; she was fully vaccinated and had five shots.; has a rare immunodeficiency disease which she does weekly high center infusions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (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: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3), for COVID-19 immunization; Bnt162b2 (DOSE 4), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "she was fully vaccinated and had five shots."; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "has a rare immunodeficiency disease which she does weekly high center infusions". The event "has a rare immunodeficiency disease which she does weekly high center infusions" required physician office visit. Therapeutic measures were taken as a result of immunodeficiency.  Clinical course: Patient had a rare immunodeficiency disease which she did weekly high center infusions and her immunologist approved travel for her. She said she was fully vaccinated and had five shots. She was approved to travel in the Withheld and there was a shortage of Paxlovid there and they are getting it through shipment. Her doctor wrote a prescription for her and her doctor called the Pharmacy and was told that they wont let her have it unless she has a positive test for COVID.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My fathers death after he got it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: DEATH (death, medically significant), outcome "fatal", described as "My fathers death after he got it". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Reminds me of my passing from covid he was fully vac with pfizer; Reminds me of my passing from covid he was fully vac with pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (death, medically significant), SUSPECTED COVID-19 (death, medically significant), outcome "fatal" and all described as "Reminds me of my passing from covid he was fully vac with Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The patient date of death was unknown. Reported cause of death: "Reminds me of my passing from covid he was fully vac with Pfizer". It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Reminds me of my passing from covid he was fully vac with pfizer; Reminds me of my passing from covid he was fully vac with pfizer
Sex: F
Vaccine: FLUR3
Symptoms: Hypersensitivity, Injection site reaction, Pruritus
Clinical narrative: injection site reaction; full body itching; allergic reactions to the ingredients in Flublok; Initial information was received on 19-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age female patient who experienced injection site reaction, full body itching and allergic reactions to the ingredients in flublok while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (dose, formulation, strength, lot and expiry date: unknown) via intramuscular route in unknown administration site for prophylaxis vaccination.  On 19-OCT-2022 the patient developed a non-serious injection site reaction, full body itching (pruritus) and  allergic reactions to the ingredients in flublok (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK) was not applicable.  It was not reported if the patient received a corrective treatment for the events (injection site reaction, full body itching, allergic reactions to the ingredients in Flublok).  At time of reporting, the outcome was Unknown for all events
Age: 74.0
Sex: U
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: giving a 74 year old patient a dose of ActHib was out of indication with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 74 years old and unknown gender patient who had a dose of HIB (PRP/T) VACCINE [ACT-HIB] was out of indication with no reported adverse event.   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 20-Oct-2022, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection(strength, lot number and expiry date was unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 20-OCT-2022 the patient developed a non-serious event of giving a 74 year old patient a dose of acthib was out of indication with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day) following the administration of HIB (PRP/T) VACCINE.  Action taken : not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Malaise, Nausea
Clinical narrative: having problems with his nipples where he pushes them down and they get sore; stomach was upset; didn't feel like he wanted to eat; could have hit a nerve in his chest and ribs; nauseous; tired; Initial information received  on 19-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 78 years old male patient who experienced problems with his nipples where he pushes them down and they get sore, stomach was upset, didn't feel like he wanted to eat, could have hit a nerve in his chest and ribs, nauseous and tired while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included INFLUENZA VACCINE with he has been getting the same flu shot for 8-9 years. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UT7715BA) via unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient developed non-serious events of having problems with his nipples where he pushes them down and they get sore (nipple pain), stomach was upset (abdominal discomfort), didn't feel like he wanted to eat (decreased appetite), could have hit a nerve in his chest and ribs (vaccination site nerve damage), nauseous (nausea) and tired (fatigue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, 3 weeks ago he received the Fluzone HD QIV and he states that he has been sick for 3 weeks now. He states that he is having problems with his nipples where he pushes them down and they get sore. He states that he went to his doctor and his doctor told him that it could be caused by the flu shot that he got. He states that he has been getting the same flu shot for 8-9 years and he never had a problem before. He states that he was also nauseous, and his stomach was upset, and he didn't feel like he wanted to eat, and he was tired. He states that his doctor told him that everything he had seemed like the flu shot could have caused it and that it could have hit a nerve in his chest and ribs and that is why he is having trouble with his nipples. He states that it is a sharp pain when he pushes on them. He states that he "believes in the shot" and he "never got a cold from it", and it has always been good for him when he gets it in September or October.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Nipple pain
Clinical narrative: having problems with his nipples where he pushes them down and they get sore; stomach was upset; didn't feel like he wanted to eat; could have hit a nerve in his chest and ribs; nauseous; tired; Initial information received  on 19-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 78 years old male patient who experienced problems with his nipples where he pushes them down and they get sore, stomach was upset, didn't feel like he wanted to eat, could have hit a nerve in his chest and ribs, nauseous and tired while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included INFLUENZA VACCINE with he has been getting the same flu shot for 8-9 years. The patient's past medical history, medical treatment(s) and family history were not provided.   On an unknown date, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UT7715BA) via unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient developed non-serious events of having problems with his nipples where he pushes them down and they get sore (nipple pain), stomach was upset (abdominal discomfort), didn't feel like he wanted to eat (decreased appetite), could have hit a nerve in his chest and ribs (vaccination site nerve damage), nauseous (nausea) and tired (fatigue) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, 3 weeks ago he received the Fluzone HD QIV and he states that he has been sick for 3 weeks now. He states that he is having problems with his nipples where he pushes them down and they get sore. He states that he went to his doctor and his doctor told him that it could be caused by the flu shot that he got. He states that he has been getting the same flu shot for 8-9 years and he never had a problem before. He states that he was also nauseous, and his stomach was upset, and he didn't feel like he wanted to eat, and he was tired. He states that his doctor told him that everything he had seemed like the flu shot could have caused it and that it could have hit a nerve in his chest and ribs and that is why he is having trouble with his nipples. He states that it is a sharp pain when he pushes on them. He states that he "believes in the shot" and he "never got a cold from it", and it has always been good for him when he gets it in September or October.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Max/Low Temperature reached to 13.1° Farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event; administered with fluzone high-dose quadrivalent, which was exposed to a temperature excursion, with no reported adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient to whom administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], which was exposed to a temperature excursion, and max/low temperature reached to 13.1° farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Oct-2022, the patient received 0.7ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE strength: standard (formulation: unknown) (lot number: UT7733BA and expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for Immunization, on the same day patient was administered with fluzone high-dose quadrivalent, which was exposed to a temperature excursion, with no reported adverse event (poor quality product administered).  On an unknown date, a non-serious event of max/low temperature reached to 13.1° farheinheit and excursion last for 4 hours, 4 minutes, with no reported adverse event (product storage error).  Reportedly, Nurse inquiring if they need to revaccinate a patient that was administered with FLUZONE HIGH-DOSE QUADRIVALENT. Does extended stability data cover the excursion: YES And in case of negative advice: Was the product used by/ administered to the patient: YES. This situation is reported as a medication error due to the product administered after experiencing a temperature excursion in which the product was no longer viable  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  At time of reporting, the outcome was Unknown for both events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 64.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 64 year old patient given FLUZONE HIGH-DOSE QUADRIVALENT with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 64 years old male patient who was given fluzone high-dose quadrivalent with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE) for Immunisation.  On 19-Oct-2022, the patient received 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ919AD and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  On 19-Oct-2022, (latency: same day) the 64 year old patient was given fluzone high-dose quadrivalent with no reported adverse event (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported, two 64 year old patients were given FLUZONE HIGH-DOSE QUADRIVALENT per their request when they declined FLUZONE QIV.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2022SA439832:
Age: 64.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 64 year old patients were given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported ae; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 64 years old female patient who was given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported adverse event while receiving vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE).  On 19-Oct-2022, the patient received a dose of 0.7 ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ919AD) (Frequency: once ) (Strength: Fluzone HD ) (expiry date: 30-Jun-2023) (formulation was unknown) via intramuscular route in the right deltoid as prophylactic vaccination.  On 19-OCT-2022 the patient was given fluzone high-dose quadrivalent per their request when they declined fluzone qiv with no reported adverse event (Product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.08
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Nurse administered FLUZONE QUADRIVALENT in error to a 1 month old with no reported adverse event); Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 1 month old patient of an unknown gender whose nurse administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient's nurse administered INFLUENZA QUADRIVAL A-B VACCINE in error (product administered to patient of inappropriate age) (unknown latency) for Suspension for injection (dose, frequency, strength, lot number and expiry date: unknown) via unknown route in unknown administration site for immunization.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient under 6 months of age was administered Fluzone QIV with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 weeks (3 months and 5 days) old female patient who was under 6 months of age and administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2022, the patient received INFLUENZA QUADRIVAL A-B VACCINE  Suspension for injection (Frequency: once) (strength: standard) (dose, expiry date was unknown) (lot no. UT7689KA) via intramuscular route in the right thigh for Immunization.  On 20-OCT-2022 the patient under 6 months of age was administered fluzone qiv with no reported adverse event (Product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Redness and swelling where I got the shot, tired, muscle pain, a headache, shivering, fever, and stomach pain
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Redness and swelling where I got the shot, tired, muscle pain, a headache, shivering, fever, and stomach pain
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the shots, got them now/ Suspected vaccination failure; had the shots, got them now; pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient reported that he/she had the shots and man glad he/she did, got shingles now and not much pain Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: died from the shinglesvax; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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 unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-OCT-2022 Reporter's comment: This case was reported by the patient's friend via interactive digital media. The reporter stated that the patient recently died from the shingles vaccine, so be careful on what they put inside you. Additional supportive information: Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: received fluarix after being exposed at -2.1°C; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number JN7YG, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comment: A health care professional reported that a patient received dose of Fluarix , a box of vaccines exposed at  minus 2.1 degree Celsius. The reporter consented to follow-up. Additional Supportive Information: The patient received dose of Fluarix exposed at  minus 2.1 degree Celsius, which led to incorrect storage of drug.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Paraesthesia
Clinical narrative: woke up with tingling in his right hand which extended to his fingertips; intense shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a day after receiving Shingrix, the patient experienced shivering. On 19th October 2022, the patient experienced tingling of extremity. On an unknown date, the outcome of the shivering was recovered/resolved and the outcome of the tingling of extremity was not recovered/not resolved.   It was unknown if the reporter considered the shivering and tingling of extremity to be related to Shingrix.     Additional Information: GSK receipt date: 19-OCT-2022 Reporters comment: The reporter was the patient. The patient received the 2nd dose of shingrix and experienced intense shivering which eventually went away and today( the day reporting )he woked up with tingling in his right hand which extended to his fingertips. tingling was still present The reporter consent to follow-up.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Kinrix were exposed to 11°C for 35hs non consecutive hours (one dose) and 11°C for 37hs with no prior excursion and the administered to a patient; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The nurse called on 19th October 2022 and reported that on 2021 their Kinrix were exposed to 11 degree Celsius for 35 hours non consecutive hours (one dose) and 11 degree Celsius for 37 hours with no prior excursion and then administered to a patient.  The health-care professional was not aware of patient´s gender when asked.  The consent to follow-up was granted via email. The vaccine administration facility was the same as primary reporter. Additional supportive information: The patient received Kinrix vaccine which was exposed to 11 degree Celsius for 35 hours non consecutive hours (one dose) and 11 degree Celsius for 37 hours with no prior excursion, which led to incorrect storage of drug. This case is linked to the case US2022150628, US2022150629, US2022150631 and US2022150632 reported by the same reporter.; Sender's Comments:  GSK-US2022150628:Same reporter GSK-US2022150629:Same reporter GSK-US2022150631:Same reporter GSK-US2022150632:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: pain; Received at shoulder joint capsule; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain 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 injection site pain and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: Reporter stated that patient received her first Shingrix vaccine inadvertently in her shoulder joint capsule. Patient went to orthopedist due to pain and they confirmed Shingrix was improperly administered in the shoulder joint capsule. The patient was now due for her 6 month booster. Should this be considered the initial dose or second and final dose. HCP disconnected the chat after asked for patient demographics, therefore no additional information available. Follow up permission was not obtained due to this and unknown if address on file was correct. No additional details provided by HCP (ie, location of the injection (which arm), resolution, etc) as HCP was in a hurry to return back to awaiting patients in office. Additional supportive information: As patient received improper administration of vaccine which led to vaccine administered at inappropriate site. The case US2022150638 was identified as duplicate of US2022150639. The case US2022150639 would be voided, and all the future correspondence would be added in this case US2022150638 which stands as a case of record for this patient.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: only half of the volume  administered; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number kk3jm, expiry date 25th September 2023) for prophylaxis.   On 20th October 2022, the patient received the 1st dose of Shingrix. On 20th October 2022, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by pharmacist. Pharmacist reported that when administering the first dose of Shingrix to a patient, the needle leaked and only half of the volume was administered. Pharmacist does not think it was a product quality issue. The Vaccine Administration Facility is the same as Primary Reporter. Reporter consented to follow up. Additional supportive information: As patient received only partial dose of vaccine due to syringe leaked which led to accidental under dose.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Electrocardiogram, Fatigue, Pain in extremity
Clinical narrative: tolerable Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (tolerable Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tolerable Fatigue). At the time of the report, FATIGUE (tolerable Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662597 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662597:Dose 3
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tolerable Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (tolerable Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tolerable Fatigue). At the time of the report, FATIGUE (tolerable Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662597 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662597:Dose 3
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: tolerable Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (tolerable Fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tolerable Fatigue). At the time of the report, FATIGUE (tolerable Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-662597 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662597:Dose 3