chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: she has had smaller shingles outbreaks/suspected vaccination failure; shingles outbreak; did not feel well; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (chronic shingles infections in the past). Previously administered products included Dupixent.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: she has had smaller shingles outbreaks/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles outbreak) and feeling unwell (Verbatim: did not feel well). The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling unwell were resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JAN-2024 The reporter was the patient.  She stated that she received a shingles vaccine (unknown manufacturer) approximately 2 years ago.  She stated that after the first dose she did not feel well.  She also received a pneumonia vaccine (unknown manufacturer) at the same time, so she was not sure which vaccine caused her to feel this way or if it was just a combination.  She believed that she received 2 doses of the shingles vaccine.  She stated that since receiving the vaccine, she has had smaller shingles outbreaks but they did not last as long and were not as severe as they were before receiving the vaccine. The patient's doctor prescribed Nucala for her recently so she was inquiring about the risk of shingles while taking Nucala.  The patient had not started taking Nucala yet.  This report was received when speaking with the customer during an outbound call for the Patient Support Program. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. It was unknown if reporter considered feeling unwell to be related to Pneumonia vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: had achy body and pain after getting both doses of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: had achy body and pain after getting both doses of Shingrix). The outcome of the general body pain was resolved (duration 24 hrs).   It was unknown if the reporter considered the general body pain to be related to Shingrix.     It was unknown if the company considered the general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-JAN-2024 The patient self-reported this case for himself. The reporter received Shingrix years ago. The reporter reported that, he had achy body and pain after getting both doses of Shingrix that lasted for 12 to 24 hours. The reporter refused to provide demographics and did not provide the time of the events. The reporter did not recall enough regarding the events. The reporter denied consent to follow up. For tolerance of 2nd dose refer case US2024AMR007443, reported by same reporter. This case had been link with US2024007068, reported by same reporter; Sender's Comments:  US-GSK-US2024AMR007443:same patient / 2nd dose US-GSK-US2024007068:1 Of 2 patient case / female pt
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Only Diluent of Shingrix administered; Only Diluent of Shingrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number m34ds, expiry date 24-JAN-2026) for prophylaxis.   On 16-JAN-2024, the patient received the 1st dose of Shingrix. On 16-JAN-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only Diluent of Shingrix administered) and inappropriate dose of vaccine administered (Verbatim: Only Diluent of Shingrix administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-JAN-2024 The nurse reported patient administered only diluent of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No other data was available. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Gait disturbance, Heart rate increased, Hypertension
Clinical narrative: her heart rate increases; her blood pressure goes up; she becomes wobbly; and she has flushing of her face; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (her heart rate increases), HYPERTENSION (her blood pressure goes up), GAIT DISTURBANCE (she becomes wobbly) and FLUSHING (and she has flushing of her face) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A, 037B21A, S39901 and 027L21A) for COVID-19 prophylaxis.     The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (her heart rate increases), HYPERTENSION (her blood pressure goes up), GAIT DISTURBANCE (she becomes wobbly) and FLUSHING (and she has flushing of her face). At the time of the report, HEART RATE INCREASED (her heart rate increases), HYPERTENSION (her blood pressure goes up), GAIT DISTURBANCE (she becomes wobbly) and FLUSHING (and she has flushing of her face) outcome was unknown.            The concomitant medication was not reported by reporter.   The patient had vaccines and immediately after every dose (in 10-15 minutes), her heart rate increased, her blood pressure went up, she became wobbly, and she had flushing of her face. These pretty much fade within an hour or 2 tops. The 1st dose was given in a drive through immunization clinic through their health department. She consulted with her allergist after the 1st dose, and she was advised to have it administered in a hospital setting which she did for the next 4 doses. She still had the same reaction for after the next 4 doses. She was made to stay for observation but was not given any medication for the side symptoms.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-757179 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Pain
Clinical narrative: hurting a little stronger than it is normally; Joint pain especially in my shoulders, neck and hip; headaches; Joint pain especially in my shoulders, neck and hip; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of PAIN (hurting a little stronger than it is normally), NECK PAIN (Joint pain especially in my shoulders, neck and hip), HEADACHE (headaches) and ARTHRALGIA (Joint pain especially in my shoulders, neck and hip) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (hurting a little stronger than it is normally), NECK PAIN (Joint pain especially in my shoulders, neck and hip), HEADACHE (headaches) and ARTHRALGIA (Joint pain especially in my shoulders, neck and hip). At the time of the report, PAIN (hurting a little stronger than it is normally), NECK PAIN (Joint pain especially in my shoulders, neck and hip), HEADACHE (headaches) and ARTHRALGIA (Joint pain especially in my shoulders, neck and hip) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: It was reported the patient had chest pain after receiving the Moderna; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (It was reported the patient had chest pain after receiving the Moderna) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (It was reported the patient had chest pain after receiving the Moderna). At the time of the report, CHEST PAIN (It was reported the patient had chest pain after receiving the Moderna) outcome was unknown.            Concomitant medication information was not reported.  Patient took Moderna COVID-19 vaccine as an unspecified booster dose and experienced chest pain. The patient also reported that her cardiologist said that it was not related to the Moderna booster dose, but the reaction was too close for her.  Treatment medication information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: took it 2 years ago and since then has been sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (took it 2 years ago and since then has been sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (took it 2 years ago and since then has been sick). At the time of the report, ILLNESS (took it 2 years ago and since then has been sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Having constant and significant nerve pain from minor injuries or no injuries at all; This spontaneous case was reported by a patient and describes the occurrence of NEURALGIA (Having constant and significant nerve pain from minor injuries or no injuries at all) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 02-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NEURALGIA (Having constant and significant nerve pain from minor injuries or no injuries at all). At the time of the report, NEURALGIA (Having constant and significant nerve pain from minor injuries or no injuries at all) had not resolved.            Concomitant medication was not provided. Treatment information was not reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient received vaccine on 1/17. on 1/19 at approximately 6pm patient's daughter called the pharmacy stating that the patient was found deceased at his home on the evening of 1/18.  Daughter states that patient was otherwise  healthy. No report of  specifics on whether patient reported any symptoms of side effects before he was found deceased
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Within 15 minute observation lungs (burning sensation) were affected due to previous Tuberculosis, after Albuterol treatment lungs still affected (1st day of 5 day Quarantine)
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: GIVEN ADULT DOSE TO PEDIATRIC PATIENT. PATIENT DID NOT SUFFER ILL AFFECTS
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in both ears started in the morning of 1/1/2024. tinnitus for almost 3 weeks.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Metabolic function test, Muscle spasms, Ultrasound scan normal, Vitamin D decreased
Clinical narrative: I began experiencing cramps in my right hand, then left hand and toes, proceeding to my neck, and calves, then upper thigh over the course of several weeks.  Cramping in extremities became severe enough that I could not move normally without cramps occurring,  This is impacting my life as I normally walk 3 miles daily and downhill ski weekly.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Dermatitis contact, Erythema, Peripheral swelling, Platelet count decreased
Clinical narrative: To the best of my memory and looking up records: weight gain, starting at 6 month mark in 2021, significant, unexplainable; 2022 hair loss and tinea Infection of some sort; 2023 rosacea; 2023 blood work showed low white blood cell and low platelet count; 2023 finger swelling, redness, warmth diagnosed as likely contact dermatitis, and ongoing; and, most recently 2024 tinea pedis.  All of which can be autoimmune issues from what I've read.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rosacea, Tinea infection, Tinea pedis, Weight increased, White blood cell count decreased
Clinical narrative: To the best of my memory and looking up records: weight gain, starting at 6 month mark in 2021, significant, unexplainable; 2022 hair loss and tinea Infection of some sort; 2023 rosacea; 2023 blood work showed low white blood cell and low platelet count; 2023 finger swelling, redness, warmth diagnosed as likely contact dermatitis, and ongoing; and, most recently 2024 tinea pedis.  All of which can be autoimmune issues from what I've read.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Computerised tomogram head normal, Magnetic resonance imaging, Memory impairment, Mental status changes, Speech disorder
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Ammonia increased, Amnesia, Angiogram cerebral normal, Arteriogram carotid normal, Blood creatine phosphokinase
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Blood folate, Blood gases, Blood glucose, Blood grouping, Blood magnesium
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Blood phosphorus, C-reactive protein, Computerised tomogram, Computerised tomogram head normal, Culture urine
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Differential white blood cell count, Disorientation, Drug screen, Electrocardiogram, Electroencephalogram
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Full blood count, Glycosylated haemoglobin, International normalised ratio, Lipids, Magnetic resonance imaging head normal
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Memory impairment, Metabolic function test, Procalcitonin, Prothrombin time, Red blood cell sedimentation rate
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Repetitive speech, Toxicologic test, Transient global amnesia, Troponin I, Urine analysis
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 67.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Vitamin B12
Clinical narrative: Patient was vaccinated with Arexvy at approximately 2:00pm 1/18.  At approximately 5:00pm, family members report he experienced altered mental status, talking in circles, and unable to remember the past few months.  This became severe enough that they suspected a possible stroke and drove him to the nearest hospital at about 7:00pm.  At the hospital a CT scan was done which came back normal; ruling out stroke.  The relative who called to report this to the pharmacy stated an MRI had been ordered, but was not yet back.  He remembered the doctor coming in at 1:30 am to tell him the CT result, and seemed to be improving as of early afternoon 1/19, but still seemed to have lost 12 to 18 hours.  She also said that the hospital physicians had no idea how Arexvy could possibly cause such a reaction. but wanted to report it because it was the only thing different about his treatment.  This may be a duplicate report as it sounded like the patient's representative would be attempting to report to VAERS herself.
Age: 8.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Bilateral breast buds
Clinical narrative: Bilateral breast buds; This spontaneous case was retrieved on 10-Jan-2024 from the Vaccine Adverse Event Reporting System (VAERS) (reference number: 2722196-1), reported by other healthcare professional and concerned an 8-year-old, female patient.  The patient's concurrent conditions included viral upper respiratory tract infection (URI). The patient's concomitant medications included vitamin D and melatonin gummies, both used for an unreported indication.  On 16-Oct-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 370648. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, the patient was vaccinated with non-company co-suspect COVID-19 vaccine (reported as Moderna COVID-19 Vaccine, Bivalent (active ingredients not specified; dose: reported as '5', route of administration: intramuscular (IM), anatomical location: right arm (RA), indication: not reported). The batch number reported was AU5551B.  On 16-Nov-2023, one month after receiving Fluad Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced bilateral breast buds.  On an unspecified date in 2023, the patient visited physician's office, however, no further details were provided. It was reported that the patient will be seeing endocrinology soon.  At the time of the initial reporting, the patient had not recovered from the event.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 8-year-old female patient noticed bilateral breast buds one month after the vaccination with Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine. On an unspecified date, patient visited physician's office, however, no further details were provided. Reportedly, the patient will be seeing pediatric endocrinology soon. Relevant laboratory and diagnostic findings were also not provided. Causality is confounded by concurrently administered co-suspect vaccine. Due to biological implausibility, causality for the event of bilateral breast buds is assessed as not related.; Sender's Comments: A 8-year-old female patient noticed bilateral breast buds one month after the vaccination with Flucelvax Quadrivalent and non-company, co-suspect COVID-19 vaccine. On an unspecified date, patient visited physician's office, however, no further details were provided. Reportedly, the patient will be seeing endocrinology soon. Relevant laboratory and diagnostic findings were also not provided. Causality is confounded by concurrently administered co-suspect vaccine. Due to biological implausibility, causality for the event of bilateral breast buds is assessed as not related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Stress, Weight
Clinical narrative: She can't take paxlovid because she cannot swallow; She can't take paxlovid because she cannot swallow; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She can't take paxlovid because she cannot swallow".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011785 Same reporter, Patient / Different AE, Drug;
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She can't take paxlovid because she cannot swallow; She can't take paxlovid because she cannot swallow; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She can't take paxlovid because she cannot swallow".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400011785 Same reporter, Patient / Different AE, Drug;
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from Health Authority on 12-JAN-2024.  This spontaneous report was received from public data set 2009 to 2022 (data current as at 29-JUN-2023) about invasive pneumococcal disease (streptococcus pneumoniae) of Diseases Surveillance System (DSS) and referred to an elderly (age: 80-84 years) male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown date in 2017, the patient experienced Streptococcus pneumoniae pneumonia. Streptococcus pneumoniae serotyping was not available.  At the time of reporting, the outcome of the event was unknown. The causal relationship between the event and suspect vaccine was not provided.  Upon internal review, the event of Pneumonia pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Meningitis pneumococcal
Clinical narrative: Meningitis; Information has been received from Agency 12-JAN-2024.   This spontaneous report has been downloaded from National Notifiable Diseases Surveillance System (NNDSS) and referring to a Child (age: 02-04 years old) male patient. The patient's medical history included vaccines given (unspecified). The patient's concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated one time with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided). On unknown dates, the patient was vaccinated 3 times with a dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13)  injection (strength, exact dose, lot #, indication, expiry date, anatomical location and route of administration were not provided).  On an unknown date in 2014, the patient experienced meningitis (Streptococcus pneumoniae meningitis). The streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was unknown.   The action taken was not applicable.   The causal relationship between the event and suspect vaccines was not reported. Upon internal review, the event of meningitis was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Health Authority (Agency number not provided), on 12-JAN-2024.  This spontaneous report has been received from Diseases Surveillance System (DSS), regarding to a female patient with age reported as 70-74 years.  The patient's pertinent concurrent conditions, medical history, past drug reactions or allergies, and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection (strength, exact dose, route and site of administration, lot number, and expiration date were not provided), for prophylaxis. Then on an unspecified date, she received a second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection (strength, exact dose, route and site of administration, lot number, and expiration date were not provided),  On an unknown date in 2011, streptococcus pneumoniae serotyping was not available. On the same date, the patient developed Streptococcus pneumoniae pneumonia (pneumonia pneumococcal). At the time of reporting, the outcome of the event was unknown.   The causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.                                                                                      Upon internal review, the event pneumonia pneumococcal was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: pneumonia; Information has been received from {RA} Regulatory Authority (Diseases Surveillance System (DSS)) on 12-JAN-2024.  This spontaneous report was referring to an elderly male patient (age: 75-79). The patient's medical history, concurrent conditions, and concomitant drugs were not reported  On an unknown date, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis.   On an unknown date in 2009, the patient experienced streptococcus pneumoniae pneumonia. On an unknown date in 2009, streptococcus pneumoniae serotyping showed not available. At the time of reporting, the outcome of the event streptococcus pneumoniae pneumonia was unknown.   The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not provided.  Upon internal review, the event of streptococcus pneumoniae pneumonia was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Agency on 12-JAN-2024.  This spontaneous report has been downloaded from Surveillance System (SS) and referring to an elderly male patient (age: 80-84 years old). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2009, the patient experienced pneumonia pneumococcal. On an unknown date in 2009, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was not known.   The causal relationship between pneumonia pneumococcal and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of pneumonia pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from {HA} on 12-JAN-2024.  This spontaneous report was received from public data set 2009 to 2022 (data current as at 29-JUN-2023) about invasive pneumococcal disease (streptococcus pneumoniae) of Surveillance System (SS) and referred to an adult (60-64 years old) male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated 1 dose (time) of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, anatomical location and route of administration were not provided).  On an unknown date in 2016, the patient experienced streptococcus pneumoniae pneumonia (pneumonia pneumococcal). On an unknown date in 2016, streptococcus pneumoniae serotyping showed not available.   At the time of reporting, the outcome of the event was unknown. The action taken with the suspect vaccine was not applicable. The causal relationship between the event and suspect vaccine was not provided.  Upon internal review, the event pneumonia pneumococcal was determined as medically significant.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 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: BNT162b2 (DOSE 1, SINGLE, vaccine brand: Pfizer / BioNTech, vaccine administration date: 05Apr2021, vaccine lot unknown: True, vaccine lot unknown reason: Not  available/provided to reporter at the time of report completion, vaccine dose number: 1, vaccine_dose_number_unknown=False}]), administration date: 05Apr2021, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE, vaccine brand: Pfizer / BioNTech, vaccine administration date: 03May2021, vaccine lot unknown: True, vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number: 2, vaccine dose number unknown: False), administration date: 03May2021, for Covid-19 Immunization; BNT162b2 (vaccine brand: Pfizer / BioNTech, vaccine administration date: 02Nov2021, vaccine lot unknown: True, vaccine lot unknown reason: Not available/provided to reporter at the time of report completion, vaccine dose number: 3, vaccine dose number unknown: False), administration date: 02Nov2021, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jan2024) Negative; (14Jan2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included nirmatrelvir, ritonavir (PAXLOVID) from 30Dec2023 to 03Jan2024. After having tested negative on 07Jan2024, tested positive on 14Jan2024. Only symptom is runny nose  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 35.0
Sex: F
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 Consumer or other non HCP.  A 35-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pcos" (unspecified if ongoing); "adhd" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Welbutrine, reaction(s): "Drug allergy: Wellbutrin". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1;MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test today; Negative, notes: Just a rebound Covid after being negative before. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received other vaccine and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19  from 26Dec2023 till 01Jan2024  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown), 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 4, SINGLE), administration date: Aug2022, when the patient was 40 years old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE), administration date: Dec2021, when the patient was 39 years old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), administration date: Feb2021, when the patient was 38 years old, for Covid-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE), administration date: Jan2021, when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient used Paxlovid as treatment from 30Dec2023 to 04Jan2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure / COVID-19 cannot be ruled out
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Nov2023 at 11:00 as dose 1, single (Lot number: HG4677) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Restricted Lung Disease" (unspecified if ongoing); "Glaucoma" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1 , UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 2, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 3, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 4, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 5, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose number: 6, UNKNOWN MANUFACTURER), for covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included nirmatrelvir, ritonavir (PAXLOVID) from 01Jan2024 to 06Jan2024.  No follow-up attempts are possible.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 34-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from02Jan2024 to 06Jan2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.