chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: Atrial fibrillation; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a elderly patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included hyperlipidemia and cholelithiasis. Concurrent medical conditions included blood pressure high (HTN) and osteoarthritis. Additional patient notes included NKDA-patient had no known drug allergy. Concomitant products included amlodipine, atorvastatin and nortriptyline.   On an unknown date, the patient received Arexvy. On an unknown date, 7 days after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was resolved.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-NOV-2023 The patient self-reported this case. The patient received Arexvy shot and with 7 days interval he/she was found to be in new onset atrial fibrillation. The patient had no prior vaccinations for this reported event. The patient did not have any current illness. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain/ soreness at injection site; swelling at injection site; erythema at injection site; Headache; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-NOV-2023, the patient received Shingrix. On 02-NOV-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain/ soreness at injection site), injection site swelling (Verbatim: swelling at injection site), injection site erythema (Verbatim: erythema at injection site) and headache (Verbatim: Headache). The outcome of the injection site pain, injection site swelling, injection site erythema and headache were not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and headache to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling, injection site erythema and headache to be related to Shingrix.   Additional Information: GSK receipt date: 04-NOV-2023 The patient received a dose of Shingrix and had headache, pain, swelling, soreness, erythema at injection site. The symptoms were treated. The reporter consented to follow-up.
Sex: F
Vaccine: RSV
Symptoms: Gait disturbance, Weight bearing difficulty
Clinical narrative: could not put weight on knee; could not walk on her knee that has a spacer in the knee joint; This non-serious case was reported by a consumer and described the occurrence of walking difficulty in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included knee operation.   On 10-OCT-2023, the patient received Arexvy. In OCT-2023, 1 hr after receiving Arexvy, the patient experienced walking difficulty (Verbatim: could not walk on her knee that has a spacer in the knee joint). On an unknown date, the patient experienced weight bearing difficulty (Verbatim: could not put weight on knee). The outcome of the walking difficulty and weight bearing difficulty were not resolved.   It was unknown if the reporter considered the walking difficulty and weight bearing difficulty to be related to Arexvy.     It was unknown if the company considered the walking difficulty and weight bearing difficulty to be related to Arexvy.   Additional Information: GSK receipt date: 06-NOV-2023 It was reported that patient was walking on her knee and was ok but after the vaccine she could not put weight on the it. She had a spacer in the knee. Within one hour she could not walk on her knee that had a spacer in the knee joint. It was reported that the symptoms were treated.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she had her first dose of Shingrix administered in June 2019; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she had her first dose of Shingrix administered in June 2019). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-NOV-2023 The consumer was the reporter.   Stated she had her 1st dose of Shingrix administered in June 2019. No further information was known. Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got first dose a year and a half before 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st received a year and a half before).   On 06-NOV-2023, the patient received the 2nd dose of Shingrix. On 06-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: got first dose a year and a half before 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 06-NOV-2023 The pharmacist mentioned that a patient got first dose of Shingrix a year and a half before and 2nd dose. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter consented to follow up.
Age: 29.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix underage administration to a 29 year old immunocompetent patient.; Shingrix instead of a second dose of a varicella vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 29-year-old female patient who received Herpes zoster (Shingrix) (batch number 43D42, expiry date 16-SEP-2025) for prophylaxis.   Concurrent medical conditions included drug allergy (allergies to tramadol). Additional patient notes included immunocompetent .   On 06-NOV-2023, the patient received the 1st dose of Shingrix. On 06-NOV-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Shingrix underage administration to a 29 year old immunocompetent patient.) and wrong vaccine administered (Verbatim: Shingrix instead of a second dose of a varicella vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 06-NOV-2023 The practice manager reported that a 29 year old immunocompetent female patient received Shingrix first dose instead of the second dose of a varicella vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th December 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Longer than recommended interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-NOV-2023 The pharmacist contacted GSK via phone inquiring about Shingrix and what information was available about the administration of Shingrix after the recommended interval.  They gave partial information about the event, patient and vaccine. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 0.25
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: was inadvertently given a dose of Flulaval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number N4T5S, expiry date 30-JUN-2024) for prophylaxis.   On 06-NOV-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 06-NOV-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced inappropriate age at vaccine administration (Verbatim: was inadvertently given a dose of Flulaval). The outcome of the inappropriate age at vaccine administration 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: 6th November 2023 The HCP noted a 3 month and 27 day old baby was inadvertently given a dose of Flulaval, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This serious case was reported by a physician via sales rep and described the occurrence of shortness of breath in a 95-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included alzheimer's disease.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced shortness of breath (Verbatim: shortness of breath) (serious criteria hospitalization). The outcome of the shortness of breath was unknown.   It was unknown if the reporter considered the shortness of breath to be related to Arexvy.     It was unknown if the company considered the shortness of breath to be related to Arexvy.   Additional Information: GSK receipt date: 07-NOV-2023 The reporter was a physician who stated that a female patient with alzheimer who received Arexvy vaccine had to be admitted in the hospital due to shortness of breath. No other information provided regarding this event. The reporter did not want to be contacted by GlaxoSmithKline.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Exercise tolerance decreased, Giant cell arteritis, Loss of employment, Osteopenia
Clinical narrative: Polymyalgia rheumatica; Giant Cell Arteritis; chronic pain; Osteopenia; This serious case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included prednisone for product used for unknown indication.   Concurrent medical conditions included hashimoto's disease.   On 13-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient started prednisone. On an unknown date, an unknown time after receiving Shingrix, the patient experienced polymyalgia rheumatica (Verbatim: Polymyalgia rheumatica) (serious criteria GSK medically significant), giant cell arteritis (Verbatim: Giant Cell Arteritis), chronic pain (Verbatim: chronic pain) and osteopenia (Verbatim: Osteopenia). The action taken with prednisone was unknown. The outcome of the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Shingrix.     It was unknown if the company considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-NOV-2023 The patient stated that she had been diagnosed with two serious autoimmune diseases after vaccination with one dose of Shingrix.  The patient reported that she was diagnosed with Polymyalgia Rheumatica and Giant Cell Arteritis.  She had chronic pain.   The patient also reported that as a consequence of Prednisone usage she had developed osteopenia.   The patient reported that she had lost her job due to her diagnosis and she used to be a daily runner, and now she could not run anymore.   The patient stated that she was seeing a therapist for grief therapy for all that she had endured.   The patient stated that she was very angry that doctors were pushing patients to have the Shingrix vaccine.   The patient stated that due to her diagnosis of Hashimoto's disease she was not a good candidate to have the vaccine administered but that information was not given to her by her doctor. The patient was requesting a call back from the safety department at the phone number provided in account. It was unknown if the reporter considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Prednisone.  The reporter did not consent to follow-up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; Giant Cell Arteritis; chronic pain; Osteopenia; This serious case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included prednisone for product used for unknown indication.   Concurrent medical conditions included hashimoto's disease.   On 13-MAR-2023, the patient received the 1st dose of Shingrix. On an unknown date, the patient started prednisone. On an unknown date, an unknown time after receiving Shingrix, the patient experienced polymyalgia rheumatica (Verbatim: Polymyalgia rheumatica) (serious criteria GSK medically significant), giant cell arteritis (Verbatim: Giant Cell Arteritis), chronic pain (Verbatim: chronic pain) and osteopenia (Verbatim: Osteopenia). The action taken with prednisone was unknown. The outcome of the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia were unknown.   It was unknown if the reporter considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Shingrix.     It was unknown if the company considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-NOV-2023 The patient stated that she had been diagnosed with two serious autoimmune diseases after vaccination with one dose of Shingrix.  The patient reported that she was diagnosed with Polymyalgia Rheumatica and Giant Cell Arteritis.  She had chronic pain.   The patient also reported that as a consequence of Prednisone usage she had developed osteopenia.   The patient reported that she had lost her job due to her diagnosis and she used to be a daily runner, and now she could not run anymore.   The patient stated that she was seeing a therapist for grief therapy for all that she had endured.   The patient stated that she was very angry that doctors were pushing patients to have the Shingrix vaccine.   The patient stated that due to her diagnosis of Hashimoto's disease she was not a good candidate to have the vaccine administered but that information was not given to her by her doctor. The patient was requesting a call back from the safety department at the phone number provided in account. It was unknown if the reporter considered the polymyalgia rheumatica, giant cell arteritis, chronic pain and osteopenia to be related to Prednisone.  The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Concussion, Fall
Clinical narrative: she fell 3 weeks; small concussion; This spontaneous case was reported by a patient and describes the occurrence of FALL (she fell 3 weeks) and CONCUSSION (small concussion) in a 68-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In October 2023, the patient experienced FALL (she fell 3 weeks) and CONCUSSION (small concussion). The patient was treated with Wound care (needed some stitches) for Concussion. At the time of the report, FALL (she fell 3 weeks) and CONCUSSION (small concussion) outcome was unknown.            No concomitant medication was reported. Patient fell 3 weeks before and had a small concussion and needed some stitches.   This case was linked to MOD-2023-749081 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pericarditis
Clinical narrative: myocarditis; pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (myocarditis) and PERICARDITIS (pericarditis) in a 19-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocarditis) and PERICARDITIS (pericarditis) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  Company Comment: This is a Spontaneous case concerning a 19-year-old male patient with no medical history reported, who experienced the serious (per hospitalization and medically significant) expected events of pericarditis and myocarditis. The events occurred on an unknown onset date and latency with a dose of mRNA-1273.815 for COVID-19 Vaccination. The events had resolved. No further clinical information or diagnostic tests results were disclosed for analysis. No concomitant medication or treatment information was reported. The benefit-risk relationship of mRNA-1273.815 is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: arm is sore; chills; fatigued; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm is sore), CHILLS (chills) and FATIGUE (fatigued) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included RSV VACCINE and INFLUENZA VACCINE for an unknown indication.    On 09-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Nov-2023, the patient experienced PAIN IN EXTREMITY (arm is sore), CHILLS (chills) and FATIGUE (fatigued). At the time of the report, PAIN IN EXTREMITY (arm is sore), CHILLS (chills) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No medical history was reported. The dosage text was reported as unknown. This morning the arm was sore. During sleeping the patient also experienced chills this morning and feels fatigued.  No medications or treatments were given. The RX number.
Sex: M
Vaccine: COVID19
Symptoms: Visual acuity reduced
Clinical narrative: it worsened my 22 year old son's eye sight; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 22-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL ACUITY REDUCED (disability), outcome "unknown", described as "it worsened my 22 year old son's eye sight". Clinical course: Reporter believed it worsened both her 22 year old son's eye sight and her eye sight.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, patient's medical history and concomitant medications are not reported. However, a possible contributory role of suspect vaccine bnt162b2 to the reported event of Visual acuity reduced cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300356674 Same reporter/ SD/ AE, different patients.;US-PFIZER INC-202300360600 Same reporter, different patient/ AE (LOE);
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: they said it was a site reaction and they were just going to monitor her for cellulitis; Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction; Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction; Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation; for immunisation; bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 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: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset 2023, outcome "recovering" and all described as "Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction"; VACCINATION SITE CELLULITIS (non-serious) with onset 2023, outcome "recovering", described as "they said it was a site reaction and they were just going to monitor her for cellulitis". The events "they said it was a site reaction and they were just going to monitor her for cellulitis" and "her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction" required physician office visit. Therapeutic measures were not taken as a result of vaccination site cellulitis, vaccination site swelling, vaccination site erythema, vaccination site warmth.  Additional information: The patient had the Pfizer COVID Vaccine about 2 weeks before 02Nov2023 and about a week before 02Nov2023, received a Prevnar 20 at the same arm and had a reaction. Her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction and they were just going to monitor her for cellulitis.   Causality for "they said it was a site reaction and they were just going to monitor her for cellulitis" and "her arm was hot, red and swollen and she did go to the doctor, they said it was a site reaction" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht crm197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht crm197 protein), pneumococcal 20-val conj vac (dipht crm197 protein) , bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Ocular hyperaemia, Periorbital swelling, Rash macular
Clinical narrative: Red eyes, around eyes severe dark red, puffy, itchy, blotchy. Also blotchy severe red on neck.; Red eyes, around eyes severe dark red, puffy, itchy, blotchy. Also blotchy severe red on neck.; Red eyes, around eyes severe dark red, puffy, itchy, blotchy. Also blotchy severe red on neck.; Red eyes, around eyes severe dark red, puffy, itchy, blotchy. Also blotchy severe red on neck.; Red eyes, around eyes severe dark red, puffy, itchy, blotchy. Also blotchy severe red on neck.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TOPROL; MICROZIDE [GLICLAZIDE]; ESTRADIOL; ESCITALOPRAM. Past drug history included: Rocephin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster), manufacturer unknown), for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious), OCULAR HYPERAEMIA (non-serious), PERIORBITAL SWELLING (non-serious), EYE PRURITUS (non-serious), RASH MACULAR (non-serious) all with onset 18Oct2023 at 02:00, outcome "not recovered" and all described as "Red eyes, around eyes severe dark red, puffy, itchy, blotchy. Also blotchy severe red on neck.". Therapeutic measures were not taken as a result of erythema, ocular hyperaemia, periorbital swelling, eye pruritus, rash macular.  Additional information: Patient had Red eyes, around eyes severe dark red, puffy, itchy, blotchy. Also blotchy severe red on neck. Patient nit had covid prior to vaccination and not tested covid post vaccination. Patient had not received any other vaccine in four weeks.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 antibody test
Clinical narrative: COVID 19; COVID 19; Moderna Dose Number 1 and 2 / Pfizer, BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 27Nov2021 as dose 3 (initial pfizer dose), single (Lot number: FM8030) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2020 as dose 1, single (Lot number: 025J20A), in left arm and on 24Jan2021 as dose 2, single (Lot number: 28L20A) for covid-19 immunisation. The patient's relevant medical history included: "Non Hodgkin lymphoma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "DM-2" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Nov2021, outcome "unknown", described as "Moderna Dose Number 1 and 2 / Pfizer, BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measure taken as a result of the events included Zithromax from 23Oct2023 and Paxlovid from 25Oct2023 to 30Oct2023. The patient tested negative after Paxlovid ended but began feeling to have flu-like symptoms, cough, and fever 2 days later (02Nov2022). The patient did not have a cough with first round of COVID.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid started from  28Oct2023 to 01Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360284 same reporter/patient, different product/AE;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GJ2524), in left arm and on 28Apr2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 74 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9260), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 23Aug2021 as dose 3 (booster), single (Lot number: EC3080), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "saccular brochiectasis" (unspecified if ongoing); "Allergy: tomatoes" (unspecified if ongoing); "Allergy: Quinolones" (unspecified if ongoing); "Allergy: Hydroxychloroquine" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Oct2023 to 21Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360326 Same patient, different drug, different event.;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Treatment of COVID-19, Date of start of drug: 23Oct2023; Pfizer / BioNTech, Date: 20Oct2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 16:00 as dose 1, single (Lot number: HG2282) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative/Ulcerative Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset Oct2023, outcome "unknown", described as "Treatment of COVID-19, Date of start of drug: 23Oct2023; Pfizer / BioNTech, Date: 20Oct2023". Therapeutic measures were taken as a result of covid-19.  Additional information: Patient also received treatment with Paxlovid from 23Oct2023 to 27Oct2023 for Covid-19. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360488 same reporter/patient, different product/AE;
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion; was administered after this excursion; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Lot number: HG4589, Expiration Date: 31Dec2024) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 2023, outcome "unknown", described as "temperature excursion"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 2023, outcome "unknown", described as "was administered after this excursion".  Additional information: Had an excursion and is not sure when it happened. She was just going back to when they were last there, which was Friday evening. The last temperature they did on Friday was 8 degrees Celsius. On Monday morning, the place was hot. The temperature in the building was hot. They did a refrigerator temperature and the display showed 7 degrees Celsius. However, the high and low is what was different: High temperature was 10 degrees Celsius, Low temperature was 4 degrees Celsius. Time out of range: Assuming, since the staff was not there for the weekend, about 64 hours. Seeking viability information.  Clarifies only the Comirnaty was administered after this excursion. She had no patient information at time of call.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Fever of 102 degree fahrenheit; Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 40-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHILLS (non-serious) with onset 08Nov2023 at 03:00, outcome "recovering"; FATIGUE (non-serious) with onset 08Nov2023 at 03:00, outcome "recovering"; PYREXIA (non-serious) with onset 08Nov2023 at 03:00, outcome "recovering", described as "Fever of 102 degree fahrenheit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, fatigue.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300361224 same reporter/event, different patient/dose;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema
Clinical narrative: Patient mentioned redness / discoloration still remains at the vaccine injection site; Patient mentioned redness / discoloration still remains at the vaccine injection site; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in Oct2023 as dose 1, 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 (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE DISCOLOURATION (non-serious) all with onset Oct2023, outcome "not recovered" and all described as "Patient mentioned redness / discoloration still remains at the vaccine injection site". It was unknown if therapeutic measures were taken as a result of vaccination site erythema, vaccination site discolouration.  Additional information: Patient stated the reaction looks like a cupping therapy mark and that the same thing happened after their last booster (date unknown).  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Having problems in my left arm where I got my shot at; still paining; pain that was in shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Lot number: HD9876, Expiration Date: Oct2024), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2023, outcome "not recovered", described as "Having problems in my left arm where I got my shot at; still paining"; ARTHRALGIA (non-serious) with onset Nov2023, outcome "not recovered", described as "pain that was in shoulder". Additional information: consumer stated, "I got my COVID-19 shot on the 18th (18Oct2023) and that time I got my shot I did not have any problems. The first week of November, I have been having problems in my left arm where I got my shot at and I would like to know why or what I can do to stop this problem from time to time, by 6 to 7 times a day and that is left arm where I got the my COVID-19 shot, do you have any advise or what would be causing it or what?". Stated that it was still paining. Patient does not know what to do to get rid of the pain that was in his/her shoulder but he/she went to the Pharmacy. They told him/her to call because after 2 weeks, it should not be a problem but the patient was still having problem in his/her left arm.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Apr2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Drug Allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 11Oct2023 to 15Oct2023.  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: Linked Report(s) : US-PFIZER INC-202300360517 same patient, different drug/event;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: Aches and pain all over my body; it won't go away; where the shot, I have a massive red, kind of rash, discoloration on my arm; where the shot, I have a massive red, kind of rash, discoloration on my arm; where the shot, I have a massive red, kind of rash, discoloration on my arm; now I have all this discoloration on my arm and swelling; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Lot number: HG6396, Expiration Date: 31Dec2023) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 08Nov2023, outcome "unknown", described as "now I have all this discoloration on my arm and swelling"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 08Nov2023, outcome "unknown", VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), outcome "unknown" and all described as "where the shot, I have a massive red, kind of rash, discoloration on my arm"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovering", described as "Aches and pain all over my body; it won't go away". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain. Additional information: Consumer stated, "I got a COVID vaccine last Friday (03Nov2023) and I am still having issues with it. It may be very ill with fever and so forth, but it lasted much longer then they said and now I'm still at the point of where the shot, I have a massive red, kind of rash, discoloration on my arm." When paraphrased, consumer stated, "Yes, I had a lot of other symptoms too, I had a fever for 3 days. I had aches and pain all over my body, but it just continues, it won't go away, every day I can feel, I am better and then today as I wake up on Wednesday (08Nov2023) after now I have all this discoloration on my arm and swelling." The patient took 2 Advil for aches and pain and fever. She took Advil 400 milligram, 2 tablets, every 4 hours by mouth.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: Aches and pain all over my body; it won't go away; where the shot, I have a massive red, kind of rash, discoloration on my arm; where the shot, I have a massive red, kind of rash, discoloration on my arm; where the shot, I have a massive red, kind of rash, discoloration on my arm; now I have all this discoloration on my arm and swelling; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Lot number: HG6396, Expiration Date: 31Dec2023) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 08Nov2023, outcome "unknown", described as "now I have all this discoloration on my arm and swelling"; VACCINATION SITE DISCOLOURATION (non-serious) with onset 08Nov2023, outcome "unknown", VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), outcome "unknown" and all described as "where the shot, I have a massive red, kind of rash, discoloration on my arm"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; PAIN (non-serious), outcome "recovering", described as "Aches and pain all over my body; it won't go away". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain. Additional information: Consumer stated, "I got a COVID vaccine last Friday (03Nov2023) and I am still having issues with it. It may be very ill with fever and so forth, but it lasted much longer then they said and now I'm still at the point of where the shot, I have a massive red, kind of rash, discoloration on my arm." When paraphrased, consumer stated, "Yes, I had a lot of other symptoms too, I had a fever for 3 days. I had aches and pain all over my body, but it just continues, it won't go away, every day I can feel, I am better and then today as I wake up on Wednesday (08Nov2023) after now I have all this discoloration on my arm and swelling." The patient took 2 Advil for aches and pain and fever. She took Advil 400 milligram, 2 tablets, every 4 hours by mouth.