chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Pruritus, Throat irritation
Clinical narrative: Patient experienced an allergic reaction  (itching, throat scratchy) after the flu shot and was taken to the ED. she was treated and released uneventfully.  She is aware she she never consent to receiving the flu vaccine in the future.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Pruritus, Throat irritation
Clinical narrative: Patient immediately became itchy and throat became scratchy. 2 Benadryl tablets taken and symptoms improved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Fatigue, Memory impairment
Clinical narrative: I had the Moderna COVID-19 Vaccine for vaccines 1 and 2 and then the Pfizer COVID-19 Vaccine booster approximately 1 year after my second dose (My first vaccine was for sure in December of 2020 as a HealthCare worker I had early access to the vaccine) I am not sure if my symptoms are directly related to the vaccine but since my vaccinations I have had reoccurring brain fog, memory issues that is very uncommon for me, extreme fatigue and exhaustion. At this point I have no other confirmed diagnosis of any other health issues. Only reporting incase this information is useful if there is any link between the vaccine and these side effects.
Age: 56.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fluzone High Dose for over 65 yo was given to this pt who is 56yo
Age: 63.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Ascending flaccid paralysis, CSF protein increased, CSF white blood cell count negative, Coombs direct test negative, Endotracheal intubation
Clinical narrative: symptoms of Guillain-Barre  with paresthesias and difficulty walking began on 11/03/2023 and progressed to ascending paralysis. She was hospitalized 11/5/23 at Hospital, required intubation for respiratory failure. She was transferred to different Medical Center, 11/26/2023 where she remains hospitalized as of 12/10/202.
Age: 63.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Gait disturbance, Intervertebral disc degeneration, Intervertebral disc operation, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal
Clinical narrative: symptoms of Guillain-Barre  with paresthesias and difficulty walking began on 11/03/2023 and progressed to ascending paralysis. She was hospitalized 11/5/23 at Hospital, required intubation for respiratory failure. She was transferred to different Medical Center, 11/26/2023 where she remains hospitalized as of 12/10/202.
Age: 63.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Paraesthesia, Respiratory failure, Scan with contrast abnormal, Spinal stenosis, White matter lesion
Clinical narrative: symptoms of Guillain-Barre  with paresthesias and difficulty walking began on 11/03/2023 and progressed to ascending paralysis. She was hospitalized 11/5/23 at Hospital, required intubation for respiratory failure. She was transferred to different Medical Center, 11/26/2023 where she remains hospitalized as of 12/10/202.
Age: 1.42
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Full-body hives per mom. Mom gave her a warm bath and a dose of Benadryl and reports hives resolved after a few hours (2-3 hours) and did not return.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré syndrome
Age: 55.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Burning sensation, CSF test, Chest X-ray, Computerised tomogram head, Computerised tomogram spine
Clinical narrative: Feeling of "pins and needles" in hands and feet were first noticed on 01/10/2022 in the morning. The symptoms were getting worse every day.  Weakness in extremities were noticed the following day and by 01/13/2023 an abmulance had to be called because I could not walk or stand and had no arm strength.   When asked if there was anything events that occured recently (i.e, drugs, accident,etc), I informed staff that I had a pneumonia vaccine 2 weeks prior(Prevnar-20) and the neurologist on staff identified and diagnosed me with Guillain-Barre Syndrome. I recieved a 5-day treatment of IVIG and was moved to IP Rehab.  Most of the symptoms have diminished considerably.  However, neuropathy pain continues in toes on both feet.  I still cannot wear normal shoes for more than 20 minutes and walks with a cane to try to keep pressure off toes. I need to wear loose fitting slippers when I go out driving. Continuing to take Pregabalin for neurapathy pain.
Age: 55.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Culture, Full blood count, Guillain-Barre syndrome, Influenza virus test, Laboratory test
Clinical narrative: Feeling of "pins and needles" in hands and feet were first noticed on 01/10/2022 in the morning. The symptoms were getting worse every day.  Weakness in extremities were noticed the following day and by 01/13/2023 an abmulance had to be called because I could not walk or stand and had no arm strength.   When asked if there was anything events that occured recently (i.e, drugs, accident,etc), I informed staff that I had a pneumonia vaccine 2 weeks prior(Prevnar-20) and the neurologist on staff identified and diagnosed me with Guillain-Barre Syndrome. I recieved a 5-day treatment of IVIG and was moved to IP Rehab.  Most of the symptoms have diminished considerably.  However, neuropathy pain continues in toes on both feet.  I still cannot wear normal shoes for more than 20 minutes and walks with a cane to try to keep pressure off toes. I need to wear loose fitting slippers when I go out driving. Continuing to take Pregabalin for neurapathy pain.
Age: 55.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Lumbar puncture, Magnetic resonance imaging, Microscopy, Paraesthesia, Paralysis
Clinical narrative: Feeling of "pins and needles" in hands and feet were first noticed on 01/10/2022 in the morning. The symptoms were getting worse every day.  Weakness in extremities were noticed the following day and by 01/13/2023 an abmulance had to be called because I could not walk or stand and had no arm strength.   When asked if there was anything events that occured recently (i.e, drugs, accident,etc), I informed staff that I had a pneumonia vaccine 2 weeks prior(Prevnar-20) and the neurologist on staff identified and diagnosed me with Guillain-Barre Syndrome. I recieved a 5-day treatment of IVIG and was moved to IP Rehab.  Most of the symptoms have diminished considerably.  However, neuropathy pain continues in toes on both feet.  I still cannot wear normal shoes for more than 20 minutes and walks with a cane to try to keep pressure off toes. I need to wear loose fitting slippers when I go out driving. Continuing to take Pregabalin for neurapathy pain.
Age: 55.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: SARS-CoV-2 test, Tumour marker test, Vitamin B12
Clinical narrative: Feeling of "pins and needles" in hands and feet were first noticed on 01/10/2022 in the morning. The symptoms were getting worse every day.  Weakness in extremities were noticed the following day and by 01/13/2023 an abmulance had to be called because I could not walk or stand and had no arm strength.   When asked if there was anything events that occured recently (i.e, drugs, accident,etc), I informed staff that I had a pneumonia vaccine 2 weeks prior(Prevnar-20) and the neurologist on staff identified and diagnosed me with Guillain-Barre Syndrome. I recieved a 5-day treatment of IVIG and was moved to IP Rehab.  Most of the symptoms have diminished considerably.  However, neuropathy pain continues in toes on both feet.  I still cannot wear normal shoes for more than 20 minutes and walks with a cane to try to keep pressure off toes. I need to wear loose fitting slippers when I go out driving. Continuing to take Pregabalin for neurapathy pain.
Age: 55.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Asthenia, Blood test, CSF culture, CSF glucose, CSF protein
Clinical narrative: Feeling of "pins and needles" in hands and feet were first noticed on 01/10/2022 in the morning. The symptoms were getting worse every day.  Weakness in extremities were noticed the following day and by 01/13/2023 an abmulance had to be called because I could not walk or stand and had no arm strength.   When asked if there was anything events that occured recently (i.e, drugs, accident,etc), I informed staff that I had a pneumonia vaccine 2 weeks prior(Prevnar-20) and the neurologist on staff identified and diagnosed me with Guillain-Barre Syndrome. I recieved a 5-day treatment of IVIG and was moved to IP Rehab.  Most of the symptoms have diminished considerably.  However, neuropathy pain continues in toes on both feet.  I still cannot wear normal shoes for more than 20 minutes and walks with a cane to try to keep pressure off toes. I need to wear loose fitting slippers when I go out driving. Continuing to take Pregabalin for neurapathy pain.
Age: 55.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Dysstasia, Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging
Clinical narrative: Feeling of "pins and needles" in hands and feet were first noticed on 01/10/2022 in the morning. The symptoms were getting worse every day.  Weakness in extremities were noticed the following day and by 01/13/2023 an abmulance had to be called because I could not walk or stand and had no arm strength.   When asked if there was anything events that occured recently (i.e, drugs, accident,etc), I informed staff that I had a pneumonia vaccine 2 weeks prior(Prevnar-20) and the neurologist on staff identified and diagnosed me with Guillain-Barre Syndrome. I recieved a 5-day treatment of IVIG and was moved to IP Rehab.  Most of the symptoms have diminished considerably.  However, neuropathy pain continues in toes on both feet.  I still cannot wear normal shoes for more than 20 minutes and walks with a cane to try to keep pressure off toes. I need to wear loose fitting slippers when I go out driving. Continuing to take Pregabalin for neurapathy pain.
Age: 55.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Muscular weakness, Neuralgia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Feeling of "pins and needles" in hands and feet were first noticed on 01/10/2022 in the morning. The symptoms were getting worse every day.  Weakness in extremities were noticed the following day and by 01/13/2023 an abmulance had to be called because I could not walk or stand and had no arm strength.   When asked if there was anything events that occured recently (i.e, drugs, accident,etc), I informed staff that I had a pneumonia vaccine 2 weeks prior(Prevnar-20) and the neurologist on staff identified and diagnosed me with Guillain-Barre Syndrome. I recieved a 5-day treatment of IVIG and was moved to IP Rehab.  Most of the symptoms have diminished considerably.  However, neuropathy pain continues in toes on both feet.  I still cannot wear normal shoes for more than 20 minutes and walks with a cane to try to keep pressure off toes. I need to wear loose fitting slippers when I go out driving. Continuing to take Pregabalin for neurapathy pain.
Age: 55.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Walking aid user
Clinical narrative: Feeling of "pins and needles" in hands and feet were first noticed on 01/10/2022 in the morning. The symptoms were getting worse every day.  Weakness in extremities were noticed the following day and by 01/13/2023 an abmulance had to be called because I could not walk or stand and had no arm strength.   When asked if there was anything events that occured recently (i.e, drugs, accident,etc), I informed staff that I had a pneumonia vaccine 2 weeks prior(Prevnar-20) and the neurologist on staff identified and diagnosed me with Guillain-Barre Syndrome. I recieved a 5-day treatment of IVIG and was moved to IP Rehab.  Most of the symptoms have diminished considerably.  However, neuropathy pain continues in toes on both feet.  I still cannot wear normal shoes for more than 20 minutes and walks with a cane to try to keep pressure off toes. I need to wear loose fitting slippers when I go out driving. Continuing to take Pregabalin for neurapathy pain.
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with COVID
Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: COVID-19
Clinical narrative: Hospitalized with COVID
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Guillain-barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2705785-1 (VAERS ID).  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) subcutaneous for immunisation; for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "PVD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "S/P Stent placemnent" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LISINOPRIL; IMDUR; ASPRIN; CALCITROL [CALCITRIOL]. Past drug history included: Amoxicillin, reaction(s): "Allergies: Amoxicillin". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 28Oct2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: 2023). The event was not required emergency room and office visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (30Oct2023) Current illness: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Acute disseminated encephalomyelitis, CSF neutrophil count increased, CSF protein increased, CSF white blood cell count increased, Chest pain
Clinical narrative: Guillain-barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2705785-1 (VAERS ID).  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) subcutaneous for immunisation; for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "PVD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "S/P Stent placemnent" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LISINOPRIL; IMDUR; ASPRIN; CALCITROL [CALCITRIOL]. Past drug history included: Amoxicillin, reaction(s): "Allergies: Amoxicillin". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 28Oct2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: 2023). The event was not required emergency room and office visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (30Oct2023) Current illness: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Death, Endotracheal intubation, Gait disturbance, Heparin-induced thrombocytopenia test, Hypoaesthesia
Clinical narrative: Guillain-barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2705785-1 (VAERS ID).  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) subcutaneous for immunisation; for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "PVD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "S/P Stent placemnent" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LISINOPRIL; IMDUR; ASPRIN; CALCITROL [CALCITRIOL]. Past drug history included: Amoxicillin, reaction(s): "Allergies: Amoxicillin". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 28Oct2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: 2023). The event was not required emergency room and office visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (30Oct2023) Current illness: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Immunoglobulin therapy, Intensive care, Laboratory test normal, Leukoencephalopathy, Macrophage count
Clinical narrative: Guillain-barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2705785-1 (VAERS ID).  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) subcutaneous for immunisation; for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "PVD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "S/P Stent placemnent" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LISINOPRIL; IMDUR; ASPRIN; CALCITROL [CALCITRIOL]. Past drug history included: Amoxicillin, reaction(s): "Allergies: Amoxicillin". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 28Oct2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: 2023). The event was not required emergency room and office visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (30Oct2023) Current illness: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Meningioma, Neurological decompensation, Platelet count decreased
Clinical narrative: Guillain-barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2705785-1 (VAERS ID).  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) subcutaneous for immunisation; for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "PVD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "S/P Stent placemnent" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LISINOPRIL; IMDUR; ASPRIN; CALCITROL [CALCITRIOL]. Past drug history included: Amoxicillin, reaction(s): "Allergies: Amoxicillin". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 28Oct2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: 2023). The event was not required emergency room and office visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (30Oct2023) Current illness: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Thrombocytopenia
Clinical narrative: Guillain-barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2705785-1 (VAERS ID).  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) subcutaneous for immunisation; for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "PVD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "S/P Stent placemnent" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LISINOPRIL; IMDUR; ASPRIN; CALCITROL [CALCITRIOL]. Past drug history included: Amoxicillin, reaction(s): "Allergies: Amoxicillin". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 28Oct2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: 2023). The event was not required emergency room and office visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (30Oct2023) Current illness: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Guillain-barre syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. Regulatory number: 2705785-1 (VAERS ID).  A 79-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 01Oct2023 as dose 1, single (Batch/Lot number: unknown) subcutaneous for immunisation; for immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing); "PVD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "S/P Stent placemnent" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; LISINOPRIL; IMDUR; ASPRIN; CALCITROL [CALCITRIOL]. Past drug history included: Amoxicillin, reaction(s): "Allergies: Amoxicillin". The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization) with onset 28Oct2023, outcome "not recovered". The patient was hospitalized for guillain-barre syndrome (start date: 2023). The event was not required emergency room and office visit. The patient underwent the following laboratory tests and procedures: Lumbar puncture: (30Oct2023) Current illness: None.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Mobility decreased, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: pain at right shoulder; pains in right hip, left hip, left shoulder, left wrist, both hands; pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands; Pains so severe that use of hands was compromised; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 09:30 as dose 1, single (Lot number: GJ3277) at the age of 77 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; DOXAZOSIN; LEVOTHYROXINE. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "Pains so severe that use of hands was compromised"; ARTHRALGIA (medically significant) with onset 2022, outcome "unknown", described as "pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands"; PAIN IN EXTREMITY (medically significant) with onset 2022, outcome "unknown", described as "pains in right hip, left hip, left shoulder, left wrist, both hands"; ARTHRALGIA (medically significant) with onset 15Oct2022 at 04:30, outcome "not recovered", described as "pain at right shoulder". The events "pain at right shoulder", "pains in right hip, left hip, left shoulder, left wrist, both hands", "pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands" and "pains so severe that use of hands was compromised" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of arthralgia, pain in extremity, arthralgia, loss of personal independence in daily activities.  Clinical information: Relevant past drug history was no, reaction: Allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications the patient received within 2 weeks of vaccination: atenolol, atorvastatin, doxazosin, levothyroxine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. After 10 days, pain at right shoulder. In the next few weeks, additional pains in right hip, left hip, left shoulder, left wrist, both hands. The pain was so severe that use of hands was compromised. Consulted several doctors, and finally ended up with rheumatologist. The treatment received for the adverse event was prednisone and methotrexate.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Rheumatoid factor increased
Clinical narrative: pain at right shoulder; pains in right hip, left hip, left shoulder, left wrist, both hands; pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands; Pains so severe that use of hands was compromised; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 09:30 as dose 1, single (Lot number: GJ3277) at the age of 77 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; DOXAZOSIN; LEVOTHYROXINE. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "Pains so severe that use of hands was compromised"; ARTHRALGIA (medically significant) with onset 2022, outcome "unknown", described as "pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands"; PAIN IN EXTREMITY (medically significant) with onset 2022, outcome "unknown", described as "pains in right hip, left hip, left shoulder, left wrist, both hands"; ARTHRALGIA (medically significant) with onset 15Oct2022 at 04:30, outcome "not recovered", described as "pain at right shoulder". The events "pain at right shoulder", "pains in right hip, left hip, left shoulder, left wrist, both hands", "pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands" and "pains so severe that use of hands was compromised" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of arthralgia, pain in extremity, arthralgia, loss of personal independence in daily activities.  Clinical information: Relevant past drug history was no, reaction: Allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications the patient received within 2 weeks of vaccination: atenolol, atorvastatin, doxazosin, levothyroxine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. After 10 days, pain at right shoulder. In the next few weeks, additional pains in right hip, left hip, left shoulder, left wrist, both hands. The pain was so severe that use of hands was compromised. Consulted several doctors, and finally ended up with rheumatologist. The treatment received for the adverse event was prednisone and methotrexate.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity, SARS-CoV-2 test
Clinical narrative: pain at right shoulder; pains in right hip, left hip, left shoulder, left wrist, both hands; pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands; Pains so severe that use of hands was compromised; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 09:30 as dose 1, single (Lot number: GJ3277) at the age of 77 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATENOLOL; ATORVASTATIN; DOXAZOSIN; LEVOTHYROXINE. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "Pains so severe that use of hands was compromised"; ARTHRALGIA (medically significant) with onset 2022, outcome "unknown", described as "pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands"; PAIN IN EXTREMITY (medically significant) with onset 2022, outcome "unknown", described as "pains in right hip, left hip, left shoulder, left wrist, both hands"; ARTHRALGIA (medically significant) with onset 15Oct2022 at 04:30, outcome "not recovered", described as "pain at right shoulder". The events "pain at right shoulder", "pains in right hip, left hip, left shoulder, left wrist, both hands", "pain at right shoulder/pains in right hip, left hip, left shoulder, left wrist, both hands" and "pains so severe that use of hands was compromised" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Nov2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of arthralgia, pain in extremity, arthralgia, loss of personal independence in daily activities.  Clinical information: Relevant past drug history was no, reaction: Allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The other medications the patient received within 2 weeks of vaccination: atenolol, atorvastatin, doxazosin, levothyroxine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. After 10 days, pain at right shoulder. In the next few weeks, additional pains in right hip, left hip, left shoulder, left wrist, both hands. The pain was so severe that use of hands was compromised. Consulted several doctors, and finally ended up with rheumatologist. The treatment received for the adverse event was prednisone and methotrexate.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19, FLU4, RSV
Symptoms: Rash erythematous, Rash pruritic, Skin warm, Swelling
Clinical narrative: Patient reports that after receiving the vaccines her arm developed a red rash, it was swollen and warm to the touch.  She went to her doctor and was prescribed a steroid cream. She reported that it helped the swelling and warmth to the touch but the rash remained. She presented to the pharmacy on 12/7 there was a red circular rash on her arm. It did not appear swollen and patient said it was no longer warm to the touch. Patient states it did not itch.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19, FLU4, RSV
Symptoms: Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient reports that after receiving the vaccines her arm developed a red rash, it was swollen and warm to the touch.  She went to her doctor and was prescribed a steroid cream. She reported that it helped the swelling and warmth to the touch but the rash remained. She presented to the pharmacy on 12/7 there was a red circular rash on her arm. It did not appear swollen and patient said it was no longer warm to the touch. Patient states it did not itch.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/; improperly stored and administered GARDASIL 9.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 27-OCT-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (0.5 mL/ two or three dose series, lot number: 1965044, expiration date: 07-JAN-2026; strength and route of administration were not reported) for prophylaxis. The vaccine administered was improperly stored since October 2023 (product storage error). Their data logger for their refrigerator had discrepancy of the temperature output, in which it was unclear if the administered vaccine was stored outside the recommended temperature range. No reports of medical concerns or symptoms from patient involved. No additional adverse events (AE) were reported (no adverse event).
Age: 52.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: RPh reports a 52 year old patient received Arexvy.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 52-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9994M, expiry date 21-MAR-2025) for prophylaxis.   Concurrent medical conditions included diabetes and heart disorder.   On 28-NOV-2023, the patient received Arexvy. On 28-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: RPh reports a 52 year old patient received Arexvy.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt date: 01-DEC-2023 The reporter consented to follow up. The patient received Arexvy at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Sciatica
Clinical narrative: First dose was given on 07-Jan-2021 and second dose on 21-Feb-2021; The patient started to feel her left sciatic nerve hurting; This spontaneous case was reported by a patient and describes the occurrence of SCIATICA (The patient started to feel her left sciatic nerve hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 07-Jan-2021 and second dose on 21-Feb-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 013M20A, 026D21A and 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 07-Jan-2021 and second dose on 21-Feb-2021). In 2021, the patient experienced SCIATICA (The patient started to feel her left sciatic nerve hurting). At the time of the report, SCIATICA (The patient started to feel her left sciatic nerve hurting) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was given on 07-Jan-2021 and second dose on 21-Feb-2021) outcome was unknown.            No concomitant medication was reported. The patient had no adverse reactions after the first dose. After the second dose the patient started to feel the left sciatic nerve hurting. Then the received the third dose. After the third dose the patient really started noticing the pain in the sciatic nerve on the left side. The patient noticed sciatic nerve pain from the back to the back of the leg. The patient received her fourth Moderna Covid-19 vaccine dose. The patient started feeling that her sciatic nerve hurt even more. The pain was going away little by little. No treatment medication was reported.   This case was linked to MOD-2023-752664 (Patient Link).
Age: 45.0
Sex: M
Vaccine: TD
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillain barre syndrome; Initial information was received on 15-Nov-2023 regarding an unsolicited valid serious case received from a other health professional.  This case is linked to case 2023SA359298(CLUSTER).  This case involves 45 years old male patient who experienced guillain barre syndrome after receiving diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac].  The patient's past medical history, treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, MUMPS VACCINE, rubella vaccine (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and hepatitis b vaccine (HEP B VAX) for Immunisation.  On 03-Nov-2023, the patient received a dose of 0.5 ml of suspect diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT (Suspension for injection) lot U7920AA, Expiry date :25-Oct-2025, strength was unknown via intramuscular route in unknown administration site for immunization.  On an unknown date the patient developed  guillain barre syndrome (guillain-barre syndrome) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT.   Action taken with DIPHTHERIA and TETANUS TOXOIDS (Tenivac) was not applicable.  It was not reported if the patient received a corrective treatment for the event (guillain barre syndrome).  At time of reporting, the outcome was Unknown for the event guillain barre syndrome.  Seriousness criteria : This event was assessed as medically significant. The patient was hospitalized for this event. from 12-Nov-2023  Additional information was received on 01-Dec-2023 from : Case was upgraded from non case to valid. Texta mended accordingly.; Sender's Comments: Sanofi Company Comment dated 06-Dec-2023 : This case involves 45-year-old male patient who experienced guillain barre syndrome after receiving diphtheria-2/tetanus-5 adsorbed toxoids NO PRESERVATIVE ADULT [Tenivac].Further information regarding Past medical history, concurrent condition , allergic history, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of a vaccine cannot be assessed.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Contraindicated product administered, Medication error, No adverse event
Clinical narrative: PENTACEL and Pediarix are given at the same time, with no reported adverse event; Initial information received from Regulatory Authority on 29-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old male patient to whom Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and pediarix are given at the same time, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination.  On 24-Nov-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ858AA, strength and expiry date not reported) via intramuscular route in the left thigh as Immunization and at the same time patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number, strength, form, dose, expiry date not reported) via unknown route in unknown administration site as Prophylactic vaccination with no reported adverse event (contraindicated product administered) (Latency: same day).   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: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Drug hypersensitivity
Clinical narrative: Flu vaccines in the past but now have developed several drug allergies; Initial information received from on 04-Dec-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 67 years old female patient who experienced flu vaccines in the past but now have developed several drug allergies after Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Breast cancer, Diverticulitis and Allergy to antibiotic.   On an unknown date, the patient received an unknwon dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown strength, formulation, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed flu vaccines in the past but now have developed several drug allergies (allergy to vaccine) (unknown latency) following the administration of Influenza Vaccine.  It was reported,  I have allergy hx to certain antibiotics and am trying to get vaccinated with a Flu vaccine without antibiotic ingredients. I've called 5 different pharmacies and searched online for access to the Flublok Quadrivalent vaccine and I am unable to find it anywhere. Also I was told by chain pharmacies that they have no control or input into what vaccines are sent to their store. So how do I get Flu protection this year or in the future. I've had Flu vaccines in the past but now have developed several drug allergies. I've had Flu vaccines in the past but now have developed several drug allergies.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: Peripheral neuropathy  of the feet
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Oedema peripheral, Pain in extremity, Ultrasound Doppler normal
Clinical narrative: persistent left arm pain and diffuse arm edema
Age: 70.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: did not report any side effects; The medical assistant accidentally administered the pediatric dose (0.5 mL) to a 70 year old patient instead of the adult dose (1 mL).; This spontaneous report was received from a medical assistant referring to a 70-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 30-NOV-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (0.5 ml, lot#: W029899, expiration date: 16-MAY-2024; strength and route of administration were not reported) accidentally by the medical assistant for prophylaxis. The dose administered was the pediatric dose rather than an adult dose (1 ml) (incorrect dose administered). The patient did not report any side effects (no adverse event).
Age: 0.42
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: helicoba01-OCT-2004 and 05-MAY-2005, pt was vaccinated with Hepatitis B vaccine; helicoba01-OCT-2004 and 05-MAY-2005, pt was vaccinated with Hepatitis B vaccine; This case was split from a legal case (2310USA012197) via physician, referring to an 8-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were in 2310USA012197.  On 25-JUN-2004, 01-OCT-2004 (inappropriate schedule of product administration) and 05-MAY-2005 (inappropriate schedule of product administration), the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).; Sender's Comments:  US-009507513-2310USA012197:
Sex: U
Vaccine: RSV
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cold in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cold (Verbatim: Cold). The outcome of the cold was not reported.   It was unknown if the reporter considered the cold to be related to Arexvy.     It was unknown if the company considered the cold to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-DEC-2023 This case was reported by consumer via (Open field AE monitoring) interactive digital media. The reporter was a patient. Patient was not sure if he or she had a reaction or cold after vaccination.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Pain
Clinical narrative: patient is experiencing arm soreness in the arm she received Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 93PD7, expiry date 22-OCT-2024) for prophylaxis.   On 28-SEP-2023, the patient received Arexvy (intramuscular, unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: patient is experiencing arm soreness in the arm she received Arexvy). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Arexvy.     It was unknown if the company considered the pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date - 01-DEC-2023 The pharmacist reported that patient is experiencing arm soreness in the arm after she received Arexvy. The reporter consent to follow up. The reporter did not specify which arm is the affected arm