chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RSV
Symptoms: Areflexia, Asthenia, CSF protein increased, CSF white blood cell count negative, Cervical spinal stenosis
Clinical narrative: Acute demyelinating polyradiculoneuropathy after the novel RSV vaccination; This serious case was reported in a literature article and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Literature Reference.   Additional patient notes included Patient denied having any recent upper respiratory or gastrointestinal symptoms.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, 2 weeks after receiving Arexvy, the patient experienced acute inflammatory demyelinating polyradiculoneuropathy (Verbatim: Acute demyelinating polyradiculoneuropathy after the novel RSV vaccination) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins. The outcome of the acute inflammatory demyelinating polyradiculoneuropathy was resolving.   The reporter considered the acute inflammatory demyelinating polyradiculoneuropathy to be related to Arexvy.     The company considered the acute inflammatory demyelinating polyradiculoneuropathy to be unrelated to Arexvy.   Additional Information: GSK receipt date: 04-DEC-2024  Author reports 81-year-old male presented to the emergency department for generalized weakness. Patients weakness was painless, symmetrical, and ascending in nature. Symptoms began 2 weeks after receiving the Arexvy 120 mcg/0.5ml RSV vaccination. Physical exam revealed symmetric quadriparesis worse in the lower extremities compared to upper extremities with associated areflexia. Patient denied having any recent upper respiratory or gastrointestinal symptoms. CT scan of the head without contrast showed no acute intracranial process. Lumbar puncture revealed cytoalbuminologic dissociation. CT scan of the cervical spine showed chronic degenerative changes most significant at C5-C6 and C6-C7 levels. MRI of the cervical spine was done which showed spondylolytic changes with minimal spinal canal stenosis at C5-C6 and C6-C7 with central spinal cordimpingement, however, no cord signal change was found. MRI of the thoracic spine was unremarkable. Intravenous immunoglobulin (IVIG) was initiated at a dose of 0.4g/kg/day for 5 days. The patient experienced improvement in his symptoms and was transferred to an inpatient rehabilitation facility upon discharge.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: M
Vaccine: RSV
Symptoms: Computerised tomogram head normal, Computerised tomogram spine abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging spinal abnormal
Clinical narrative: Acute demyelinating polyradiculoneuropathy after the novel RSV vaccination; This serious case was reported in a literature article and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Literature Reference.   Additional patient notes included Patient denied having any recent upper respiratory or gastrointestinal symptoms.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, 2 weeks after receiving Arexvy, the patient experienced acute inflammatory demyelinating polyradiculoneuropathy (Verbatim: Acute demyelinating polyradiculoneuropathy after the novel RSV vaccination) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins. The outcome of the acute inflammatory demyelinating polyradiculoneuropathy was resolving.   The reporter considered the acute inflammatory demyelinating polyradiculoneuropathy to be related to Arexvy.     The company considered the acute inflammatory demyelinating polyradiculoneuropathy to be unrelated to Arexvy.   Additional Information: GSK receipt date: 04-DEC-2024  Author reports 81-year-old male presented to the emergency department for generalized weakness. Patients weakness was painless, symmetrical, and ascending in nature. Symptoms began 2 weeks after receiving the Arexvy 120 mcg/0.5ml RSV vaccination. Physical exam revealed symmetric quadriparesis worse in the lower extremities compared to upper extremities with associated areflexia. Patient denied having any recent upper respiratory or gastrointestinal symptoms. CT scan of the head without contrast showed no acute intracranial process. Lumbar puncture revealed cytoalbuminologic dissociation. CT scan of the cervical spine showed chronic degenerative changes most significant at C5-C6 and C6-C7 levels. MRI of the cervical spine was done which showed spondylolytic changes with minimal spinal canal stenosis at C5-C6 and C6-C7 with central spinal cordimpingement, however, no cord signal change was found. MRI of the thoracic spine was unremarkable. Intravenous immunoglobulin (IVIG) was initiated at a dose of 0.4g/kg/day for 5 days. The patient experienced improvement in his symptoms and was transferred to an inpatient rehabilitation facility upon discharge.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: M
Vaccine: RSV
Symptoms: Quadriparesis, Spinal cord compression, Spinal osteoarthritis
Clinical narrative: Acute demyelinating polyradiculoneuropathy after the novel RSV vaccination; This serious case was reported in a literature article and described the occurrence of acute inflammatory demyelinating polyradiculoneuropathy in a 81-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. Literature Reference.   Additional patient notes included Patient denied having any recent upper respiratory or gastrointestinal symptoms.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, 2 weeks after receiving Arexvy, the patient experienced acute inflammatory demyelinating polyradiculoneuropathy (Verbatim: Acute demyelinating polyradiculoneuropathy after the novel RSV vaccination) (serious criteria hospitalization and GSK medically significant). The patient was treated with immunoglobulins. The outcome of the acute inflammatory demyelinating polyradiculoneuropathy was resolving.   The reporter considered the acute inflammatory demyelinating polyradiculoneuropathy to be related to Arexvy.     The company considered the acute inflammatory demyelinating polyradiculoneuropathy to be unrelated to Arexvy.   Additional Information: GSK receipt date: 04-DEC-2024  Author reports 81-year-old male presented to the emergency department for generalized weakness. Patients weakness was painless, symmetrical, and ascending in nature. Symptoms began 2 weeks after receiving the Arexvy 120 mcg/0.5ml RSV vaccination. Physical exam revealed symmetric quadriparesis worse in the lower extremities compared to upper extremities with associated areflexia. Patient denied having any recent upper respiratory or gastrointestinal symptoms. CT scan of the head without contrast showed no acute intracranial process. Lumbar puncture revealed cytoalbuminologic dissociation. CT scan of the cervical spine showed chronic degenerative changes most significant at C5-C6 and C6-C7 levels. MRI of the cervical spine was done which showed spondylolytic changes with minimal spinal canal stenosis at C5-C6 and C6-C7 with central spinal cordimpingement, however, no cord signal change was found. MRI of the thoracic spine was unremarkable. Intravenous immunoglobulin (IVIG) was initiated at a dose of 0.4g/kg/day for 5 days. The patient experienced improvement in his symptoms and was transferred to an inpatient rehabilitation facility upon discharge.; Sender's Comments: Guillain-Barre syndrome is an unlisted event which is considered unrelated to GSK vaccine Arexvy.
Sex: U
Vaccine: MENB
Symptoms: Poor quality product administered, Product preparation issue
Clinical narrative: vaccine cloudier, color was different; withdrew medication from the PFS and put it in another syringe due to large air bubble in the syringe; Pharmaceutical product complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of poor quality vaccine administered in a patient who received Men B NVS (Bexsero) (batch number 52n4s, expiry date 30-NOV-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced poor quality vaccine administered (Verbatim: vaccine cloudier, color was different), inappropriate reconstitution technique (Verbatim: withdrew medication from the PFS and put it in another syringe due to large air bubble in the syringe) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the poor quality vaccine administered, inappropriate reconstitution technique and pharmaceutical product complaint were 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: 18-NOV-2024 HCP reported during preparation for administration 2 Bexsero PFS had a large air bubble in the syringe that stuck to the wall of the syringe and would not expel (solution 0050 Particles in product). HCP stated medication was able to be expelled but the air bubble stayed and medication was lost due to the air bubble and 2 PFS syringes were wasted. HCP stated this did occur with a third Bexsero PFS, however, the nurse withdrew medication from the PFS and put it in another syringe so the medication did not have to be wasted (related AE Inappropriate Reconstitution Technique). The questions were asked regarding description of approximate size, shape and color of vaccine. It was reported that it was very big bubble, vaccine cloudier, deposit more difficult to put in suspension, color was different, super big bubble that stuck to the wall and was not able to be expelled which led to poor quality vaccine administered, inappropriate reconstitution technique and pharmaceutical product complaint. There was no visible damage present on the syringe. No temperature excursions during storage was reported.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 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 patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on august 2024).   On 19-NOV-2024, the patient received the 2nd dose of Twinrix. On 19-NOV-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose.). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-NOV-2024 The pharmacist called to informed that a patient that received the 1st dose of Twinrix in August 2024 and received the 2nd dose of Twinrix on 19th November 2024 which led to drug dose administration interval too long.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received first shot of Shingrix on 9/29/2018 and second dose was given on 9/28/2020.; 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 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st shot on 29-SEP-2018).   On 28-SEP-2020, the patient received the 2nd dose of Shingrix. On 28-SEP-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received first shot of Shingrix on 9/29/2018 and second dose was given on 9/28/2020.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 20-NOV-2024 The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule The pharmacist asked if patient should be revaccinated with two additional doses. The reporter did not provided information about the Shingrix doses (lot number, expiration date). This case is linked with US2024AMR146332, reported by same reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac disorder, Pulmonary embolism, Pulmonary function test, SARS-CoV-2 test
Clinical narrative: emboli in my lungs; symptomatic covid; Cardiac event; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (emboli in my lungs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 06-Jun-2021, the patient experienced PULMONARY EMBOLISM (emboli in my lungs) (seriousness criterion medically significant) and COVID-19 (symptomatic covid). In 2021, the patient experienced CARDIAC DISORDER (Cardiac event). The patient was treated with Warfarin potassium (Warfarin) at an unspecified dose and frequency; Rivaroxaban (Xarelto) at an unspecified dose and frequency and Apixaban (Eliquis) at a dose of for 6 months. At the time of the report, PULMONARY EMBOLISM (emboli in my lungs), CARDIAC DISORDER (Cardiac event) and COVID-19 (symptomatic covid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pulmonary function test: which revealed a carbon exchange issue. In 2021, SARS-CoV-2 test: Negative. In 2021, Ultrasound Doppler: pneumonia and DVt never found in doppler.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that after the 3rd day she had shortness of breath and schedule 2/12 weeks later a pulmonary function test which revealed a carbon exchange issue. 3 days later went to her scheduled sleep study after her negative covid test. At around 4 am she had a cardiac event and started coughing and could not stop and they sent her home. Less than 72 hours later she ended up in the emergency having 3 diagnosis but never an exact in but finally being a symptomatic covid with emboli in her lungs. They first said she had pneumonia and then a dvt but never found that on a Doppler (just guessing). While remaining in the hospital she was on oxygen and her vein portals were filled with clots. It took 2 years to recover from the worst and still not good. It was unknown if the patient experienced any additional symptoms and events. Company comment: This spontaneous case concerns a 54-year-old female  patient who experienced unexpected serious (due to medically significant) event of AESI Pulmonary embolism and non serious events of Cardiac disorder and COVID-19. The events of pulmonary embolism and cardiac disorder are assessed as related to vaccination due to known safety profile. Pulmonary embolism may contribute to cardiac disorder. COVID-19 is assessed as not applicable. The benefit-risk relationship of product is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: emboli in my lungs; symptomatic covid; Cardiac event; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (emboli in my lungs) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 06-Jun-2021, the patient experienced PULMONARY EMBOLISM (emboli in my lungs) (seriousness criterion medically significant) and COVID-19 (symptomatic covid). In 2021, the patient experienced CARDIAC DISORDER (Cardiac event). The patient was treated with Warfarin potassium (Warfarin) at an unspecified dose and frequency; Rivaroxaban (Xarelto) at an unspecified dose and frequency and Apixaban (Eliquis) at a dose of for 6 months. At the time of the report, PULMONARY EMBOLISM (emboli in my lungs), CARDIAC DISORDER (Cardiac event) and COVID-19 (symptomatic covid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pulmonary function test: which revealed a carbon exchange issue. In 2021, SARS-CoV-2 test: Negative. In 2021, Ultrasound Doppler: pneumonia and DVt never found in doppler.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that after the 3rd day she had shortness of breath and schedule 2/12 weeks later a pulmonary function test which revealed a carbon exchange issue. 3 days later went to her scheduled sleep study after her negative covid test. At around 4 am she had a cardiac event and started coughing and could not stop and they sent her home. Less than 72 hours later she ended up in the emergency having 3 diagnosis but never an exact in but finally being a symptomatic covid with emboli in her lungs. They first said she had pneumonia and then a dvt but never found that on a Doppler (just guessing). While remaining in the hospital she was on oxygen and her vein portals were filled with clots. It took 2 years to recover from the worst and still not good. It was unknown if the patient experienced any additional symptoms and events. Company comment: This spontaneous case concerns a 54-year-old female  patient who experienced unexpected serious (due to medically significant) event of AESI Pulmonary embolism and non serious events of Cardiac disorder and COVID-19. The events of pulmonary embolism and cardiac disorder are assessed as related to vaccination due to known safety profile. Pulmonary embolism may contribute to cardiac disorder. COVID-19 is assessed as not applicable. The benefit-risk relationship of product is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypoaesthesia, Paraesthesia oral
Clinical narrative: tongue and then lips begin to tingle a little; I felt my tongue and then lips begin to tingle a little; felt a little hard to swallow; feel numb; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA ORAL (tongue and then lips begin to tingle a little), PARAESTHESIA ORAL (I felt my tongue and then lips begin to tingle a little), DYSPHAGIA (felt a little hard to swallow) and HYPOAESTHESIA (feel numb) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 02-Mar-2021, the patient experienced PARAESTHESIA ORAL (tongue and then lips begin to tingle a little), PARAESTHESIA ORAL (I felt my tongue and then lips begin to tingle a little), DYSPHAGIA (felt a little hard to swallow) and HYPOAESTHESIA (feel numb). On 02-Mar-2021, PARAESTHESIA ORAL (tongue and then lips begin to tingle a little), PARAESTHESIA ORAL (I felt my tongue and then lips begin to tingle a little) and HYPOAESTHESIA (feel numb) had resolved. At the time of the report, DYSPHAGIA (felt a little hard to swallow) had resolved.            Concomitant product use was not provided by the reporter.  It was unknown if the patient experienced any additional symptoms or events.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-778985 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-778985:same patient with different product
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema
Clinical narrative: one red mark on the back of the patient's arm subcutaneously; it was administered in the  posterior arm subcutaneously , like insulin into the fatty tissue; This is a spontaneous report received from a Nurse from medical information team, Program ID:.  A 60-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) subcutaneous, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE subcutaneous taken for immunisation as dose number unknown, siingle. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "one red mark on the back of the patient's arm subcutaneously"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "it was administered in the posterior arm subcutaneously , like insulin into the fatty tissue". Additional information: The patient went to the local pharmacy where the vaccine was administered by a technician not a pharmacist and they did not administer it correctly. COVID and Flu on the same day, very close together, no space between them, and it was administered in the posterior arm subcutaneously, like insulin into the fatty tissue.  It was 2 separate syringes, 2 punctures, but one red mark on the back of the patient's arm subcutaneously. She was not sure of the size of needle, so unsure if they used an IM or subcutaneous needle. She is a heavy girl. Her arms are huge, so she want to know if she received a benefit from this type of administration and what to do.  It was administered a couple of months ago.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Respiratory disorder
Clinical narrative: He does have upper respiratory problems; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "He does have upper respiratory problems".  Additional information: The patient's spouse called on behalf of the patient seeking assistance with the Abrysvo vaccine. During the call caller stated." He does have upper respiratory problems."  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Pruritus, Rash
Clinical narrative: Feel uncomfortable when he was trying to sleep; developed a total body rash, when he woke up on Saturday, he had rash on his chest and forearm; on Friday night he started to itch; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2024SA314595 (Sanofi).  A 70-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 09Oct2024 as dose number unknown, 0.5 ml single (Lot number: U8499CA) intramuscular, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious) with onset 11Oct2024, outcome "recovering", described as "Feel uncomfortable when he was trying to sleep"; RASH (non-serious) with onset 11Oct2024, outcome "recovering", described as "developed a total body rash, when he woke up on Saturday, he had rash on his chest and forearm"; PRURITUS (non-serious) with onset 11Oct2024, outcome "recovering", described as "on Friday night he started to itch".  Additional information: Patient presumed it was from the vaccine as there were no other changes with him, including his diet. He said he received the Sanofi flu vaccine last year and he did not had a reaction. He was wondering if there were any changes with the components of that year and last years vaccine. He also received his COVID Vaccine a week or two before he got his Fluzone HD shot', and was wondering what caused him to had a reaction. He wanted to know about if there was any change from the last year's vaccine to that year's one. He also wanted to know what to do next year as well. Caller mentioned his Symptoms were resolving.' It was not reported if the patient received a corrective treatment for all the events. On 11Oct2024 the patient felt uncomfortable when he was trying to sleep (discomfort), developed a total body rash, when he woke upon Saturday. He had rash on his chest and forearm (rash) and on Friday night he started to itch (pruritus).   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: extremely dizzy and any head movement caused me to lose my balance and nearly fall over (symptoms of vertigo); This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Dec2024 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: VERTIGO (non-serious) with onset 07Dec2024, outcome "recovering", described as "extremely dizzy and any head movement caused me to lose my balance and nearly fall over (symptoms of vertigo)".  Additional information: The patient received an updated COVID vaccine last Friday (06Dec2024). The following morning the patient was extremely dizzy and any head movement caused to lose balance and nearly fall over (symptoms of vertigo). Reported that 3 days later the patient then also have the symptoms but they were lessened.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had covid starting on the second week of November/covid lasted approximately 7 days; had covid starting on the second week of November/covid lasted approximately 7 days; This is a spontaneous report received from an Other HCP, Program ID:.  A 48-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, 30 ug, single (Batch/Lot number: unknown) intramuscular 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) all with onset Nov2024, outcome "recovered" (Nov2024) and all described as "had covid starting on the second week of November/covid lasted approximately 7 days".; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with COMIRNATY (2023-2024 FORMULA) can not be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Middle insomnia, Nausea, Syncope
Clinical narrative: fainted; Nauseated; middle of the night, patient was wake up really nauseated; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-778825 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 19Dec2021 as dose 3 (booster), single (Lot number: FE3594) and on 24Apr2022 as dose 4 (booster), single (Lot number: FM9992) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 19Oct2022 as dose 5 (booster), single (Lot number: 053D22A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE, Batch/Lot: 042L25A), administration date: 06Feb2021, for Covid-19 immunization, reaction(s): "No adverse event"; moderna COVID-19 vaccine (DOSE 2, SINGLE, Batch/Lot: 029A21A), administration date: 09Mar2021, for Covid-19 immunization, reaction(s): "No adverse event". The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "fainted"; NAUSEA (medically significant), outcome "unknown", described as "Nauseated"; MIDDLE INSOMNIA (medically significant), outcome "unknown", described as "middle of the night, patient was wake up really nauseated". Clinical course: On an unknown date, the patient experienced Syncope (fainted) (seriousness criterion medically significant) and Nausea (nauseated). At the time of the report, Syncope (fainted) and Nausea (nauseated) outcome was unknown. No Concomitant medication was reported. On last three boosters, patient ended up fainting 8 to 12 hours later. The middle of the night, patient was wake up really nauseated. patient got out of bed and one time was wrapped around the toilet, the other time fell on the floor. No treatment information was reported. Other Relevant History, Including Pre-existing Medical Conditions: Race: Unknown  Sender Comment: The benefit-risk relationship of product is not affected by this report.  No follow-up attempts are possible.
Sex: U
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: paralyzed the next day; Initial information received on 11-Dec-2024 regarding an unsolicited valid Social Media serious case received from a consumer/ Non-Healthcare Professional.  This case involves Adult and unknown gender patient who was paralyzed the next day after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization).   On an unknown date the patient was paralyzed the next day (paralysis) (latency- 1 day) following the administration of influenza vaccine.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-DEC-2024: This case involves Adult and unknown gender patient who was paralyzed the next day after receiving influenza vaccine. Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received adult dose vs pediatric dose
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Adult vaccine instead of Pediatric
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Redness, swelling, soreness, itching
Age: 34.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Pt was ok until came out of vaccination room and had syncope but without complete loss of conscious , he fell on ground but no injury to head , pt had no heart conditions and was responding ok saying he is ok but we called EMS -  they came checked vitals everything  was ok and went and pt went home by himself feeling ok
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: FROM LOT #, IT WAS DETERMINED AT INVENTORY THAT PATIENT WAS GIVEN PEDIATRIC MODERNA COVID-19, .25 ML IN ERROR. SHOULD HAVE BEEN .50 ML FOR THOSE 12+ (SPIKEVAX)
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash along her entire arm in which shot was given. patient did not apply anything, nor  did she take anything by mouth . occurred for 3 days
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pfizer Comirnaty 12+ given to an 11 year old. Should have been given Pfizer 5-11 y/o
Age: 63.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site rash
Clinical narrative: Patient stated she has had a rash on the injection site since the night of vaccine 12/10/24, and rash got bigger and still have rash today 12/17/24.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: No adverse reaction patient is currently 35 weeks and 6 days. EDD 01/15/2025
Age: 40.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Underdose
Clinical narrative: PATIENT WAS GIVEN PEDIATRIC MODERNA COVID-19 VACCINE 0.25 ML IN ERROR, DISCOVERED AT FINAL INVENTORY. PATIENT SHOULD HAVE RECEIVED MODERNA SPIKEVAX 0.50 ML
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Arthritis, Gait disturbance, Pain in extremity, X-ray abnormal
Clinical narrative: Beginning 6:00 a.m.,  Dec. 9, began having  extreme pain, mostly constant, but occasionally intermittent (off for a few minutes to half an hour) on my left leg, from knee to ankle. It was a new pain in my experience, so that I could not walk most of the time until December 13, day after Dr. had me given an anti-inflammatory steroid injection.
Age: 63.0
Sex: M
Vaccine: COVID19, PNC21, VARZOS
Symptoms: Injection site rash
Clinical narrative: DEVELOPED RASH AROUND INJECTION SITE OF SHINGRIX ON LEFT ARM. BEGAN DAY AFTER INJECTION, NOW IMPROVING ON DAY 5 POST INJECTION.
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Asthenia, Contusion, Disorientation, Fall, Injury
Clinical narrative: PATIENT GOT BOTH VACCINES AND LATER STARTED FEELING VERY WEEK, HIGH FEVER, TINGLING IN ARMS AND FEET, DESORIENTED, SHE FAINTED AND THAT CAUSED MINOR INJURIES AND BRUISES. SHE WAS TAKEN TO THE HOSPITAL AND WAS KEEPT FOR 1 DAY. DOCTORS PRESCRIBE MEDICATION S TO HELP WITH THE PAINED CAUSED BY THE FALL
Age: 73.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain, Paraesthesia, Pyrexia, Syncope
Clinical narrative: PATIENT GOT BOTH VACCINES AND LATER STARTED FEELING VERY WEEK, HIGH FEVER, TINGLING IN ARMS AND FEET, DESORIENTED, SHE FAINTED AND THAT CAUSED MINOR INJURIES AND BRUISES. SHE WAS TAKEN TO THE HOSPITAL AND WAS KEEPT FOR 1 DAY. DOCTORS PRESCRIBE MEDICATION S TO HELP WITH THE PAINED CAUSED BY THE FALL
Age: 51.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Underdose
Clinical narrative: PATIENT GIVEN MODERNIA COVID-19 IN PEDIATRIC FORMULA 0.25 ML IN ERROR. SHOULD HAVE BEEN MODERNA SPIKEVAX 0.50 ML. DISCOVERED BY LOT # AT FINAL INVENTORY
Age: 5.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given extra doses of COVID and Influenza vaccines. Received Covid and Influenza on 12/10/2024. Patient was observed 15 minutes post vaccination once error was discovered, and she had no adverse reaction at that time
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Chills, Diarrhoea, Fatigue
Clinical narrative: First 24 hours Friday feeling good, Saturday and Sunday headache, chills, swelling at injection site, large softball size redness at injection site, extreme tiredness, sore upper arm. itchy upper arm around site of injection,  Monday, day four, sore arm, still red and itchy, diarrhea, heart palpitations, low grade fever.  Tuesday, day five, less redness but still some around site of injection, still itchy, fever broke in night, diarrhea and upset stomach.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Palpitations
Clinical narrative: First 24 hours Friday feeling good, Saturday and Sunday headache, chills, swelling at injection site, large softball size redness at injection site, extreme tiredness, sore upper arm. itchy upper arm around site of injection,  Monday, day four, sore arm, still red and itchy, diarrhea, heart palpitations, low grade fever.  Tuesday, day five, less redness but still some around site of injection, still itchy, fever broke in night, diarrhea and upset stomach.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: First 24 hours Friday feeling good, Saturday and Sunday headache, chills, swelling at injection site, large softball size redness at injection site, extreme tiredness, sore upper arm. itchy upper arm around site of injection,  Monday, day four, sore arm, still red and itchy, diarrhea, heart palpitations, low grade fever.  Tuesday, day five, less redness but still some around site of injection, still itchy, fever broke in night, diarrhea and upset stomach.
Age: 79.0
Sex: F
Vaccine: COVID19, DF
Symptoms: Underdose
Clinical narrative: PEDIATRIC MODERNA COVID-19 0.25 ML GIVEN IN ERROR TO AN ADULT. SHOULD HAVE BEEN 0.50 ML MODERNA SPIKEVAX. DISCOVERED AT FINAL INVENTORY FROM LOT # RECORDED AT TIME OF VACCINATION.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Mobility decreased, Pain
Clinical narrative: Pain, weakness, poor range of motion
Age: 1.67
Sex: F
Vaccine: HEPA
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Patient developed diffuse mild rash to torso and extremities and tmax of 103 x 2 days, although rash has persisted x 5 days. Baby fussy but eating well, voiding well, no other symptoms.
Age: 68.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Eye swelling, Injection site rash, Mouth swelling
Clinical narrative: Rash at injection site that spread down the arm, swelling of the mouth and eyes.
Age: 41.0
Sex: F
Vaccine: COVID19, TDAP
Symptoms: Computerised tomogram abdomen abnormal, Mesenteric vein thrombosis, Mesenteric venous occlusion
Clinical narrative: Not sure if I have the right kind of Tdap listed. My chart says Tdap- adol/adult- Lot # X449Y. Reaction I believe is to the COVID vaccine. I receive imaging several times a year to monitor my liver disease. On September 26th, 2024 the ultrasound report reads: Color Doppler imaging demonstrates no portal vein thrombus. Then when I went to visit another clinic on 12/2/24 the CT Scan reads: complete occlusion of the cephalic end of the superior mesenteric vein. For the PVT to go from small to non existent to total clot in the superior mesenteric vein in not even 3 months time does not seem to be a coincidence.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Audiogram, Deafness unilateral, Vertigo, Vomiting
Clinical narrative: profound vertigo, vomiting, sudden complete hearing loss on right ear,  pt is taking steroid injection and oral tablet
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Dizziness, Fatigue, Nausea
Clinical narrative: Received vaccine 12/6/2024 @ 8:30 am. Symptoms started on 12/7/2024 @1:00 pm which includes abdominal pain, dizzy, weak, fatigued, nausea, pins and needles in hands and feet, projectile vomiting, fever 101F.  Symptoms resolved a week later.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Pyrexia, Vomiting projectile
Clinical narrative: Received vaccine 12/6/2024 @ 8:30 am. Symptoms started on 12/7/2024 @1:00 pm which includes abdominal pain, dizzy, weak, fatigued, nausea, pins and needles in hands and feet, projectile vomiting, fever 101F.  Symptoms resolved a week later.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Patient came into pharmacy with large welt at injection site that was painful as well as an additional red welt 2 inches below site. Reports pain and itching. referred to prescriber and advised I would make this report
Age: 2.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: LARGE ERYTHEMYTOUS AREA SURROUNDING INJECTION SITE EXTENDING COVERING MOST OF THE ENTIRE THIGH. TENDER TO TOUCH, VERY RED. MOTHER SHOWED ME PICTURE AS THE REACTION HAS MOSTLY DISSIPATED BY TODAY. STILL TENDER BUT NO MORE ERYTHEMA. STILL NOTE SKIN DISCOLORATION AND PT DOES NOT WANT LEG TOUCHED. NO MORE REDNESS TODAY (12/17/24) MOTHER STATES SHE DID NOT GIVE HIM ANY MEDICATION. APPLIED NO CREAMS. SHE DID NOT TAKE HIM TO ER OR URGENT CARE. MY CLINIC WAS CLOSED SATURDAY. AS HE WAS IMPROVING SHE DID NOT BRING HIM IN YESTERDAY, MONDAY WHEN CLINIC WAS OPENED, BUT WAITED UNTIL TODAY, TUESDAY TO BRING HIM IN.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Dysstasia, Exposure during pregnancy, Vomiting
Clinical narrative: Due date February 4th. After receiving vaccine today, within 45 mins I was extremely dizzy. Ten or so minutes went by feeling this way before I vomited three times. I wasn't able to stand unassisted so OB advised to triage at labor and delivery, where they administered Zofran.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Urticaria
Clinical narrative: Urticaria, occuring daily, since day following vaccination
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Cellulitis, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness and swelling at vaccination site. Tender. No systemic symptoms. Cellulitis
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash noted locally around injection site approximately 5 minutes following administration - monitored without spread of rash and advised on benadryl dose if additional spread. xl: stable
Sex: U
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: Pre-term birth due date 10/15/24 actual due date 10/15/24; delivery date; Gestation period when reaction/event was observed in the fetus: 36 weeks; This is a spontaneous report received from a Nurse from a sales representative.  This is a case for a fetus of a 28-year-old mother who, while pregnant, received RSV Vaccine Prot. Subunit Pref 2v (ABRYSVO) via an unspecified route of administration on 24Aug2024 as dose 1, single, for maternal immunization. The following information was reported: PREMATURE BABY (non-serious) with onset, outcome "unknown", described as "Pre-term birth due date 10/15/24 actual due date 10/15/24; delivery date; Gestation period when reaction/event was observed in the fetus: 36 weeks".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400324965 Mother case;
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; Customer calling to report temperature excursion. She states that the product was administered on 11/8/2024. No additional AE, no PQC. No additional information.          ?    Names of vaccines involved (including lot/exp) PROQUAD Y011215 12/18/202; This spontaneous report was received from a medical assistant and refers to a female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-NOV-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: recombinant Human albumin) (PROQUAD) injection, lot #Y011215, expiration date: 18-DEC-2025, administered for prophylaxis (strength, dose and route of administration were not provided) after temperature excursion with temperature at 18.4 F for 360 hours (Product storage error). There was no pervious temperature excursion. No additional adverse event (AE) (no adverse event).
Sex: F
Vaccine: TDAP
Symptoms: Anxiety, Attention deficit hyperactivity disorder, Pain
Clinical narrative: Severe pain; Anxiety ADHD; This non-serious case was reported by a consumer and described the occurrence of attention deficit hyperactivity disorder in a 33-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 3335k) for prophylaxis.   Concurrent medical conditions included inflammation. Concomitant products included prednisone.   On 12-NOV-2024, the patient received Tdap Vaccine .5 ml. On 12-NOV-2024, less than a day after receiving Tdap Vaccine, the patient experienced pain (Verbatim: Severe pain). In NOV-2024, the patient experienced attention deficit hyperactivity disorder (Verbatim: Anxiety ADHD). The outcome of the attention deficit hyperactivity disorder was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the attention deficit hyperactivity disorder and pain to be related to Tdap Vaccine.     It was unknown if the company considered the attention deficit hyperactivity disorder and pain to be related to Tdap Vaccine.   Additional Information: GSK Receipt Date: 19-NOV-2024 The patient had Anxiety ADHD (Attention deficit hyperactivity disorder).
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: patient probably received only the adjuvant portion of Shingrix. They got to the end of the box of Shingrix and there was one lyophilized portion left; patient probably received only the adjuvant portion of Shingrix.They got to the end of the box of Shingrix and there was one lyophilized portion left; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient probably received only the adjuvant portion of Shingrix. They got to the end of the box of Shingrix and there was one lyophilized portion left) and inappropriate dose of vaccine administered (Verbatim: patient probably received only the adjuvant portion of Shingrix.They got to the end of the box of Shingrix and there was one lyophilized portion left). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-NOV-2024 Practice manager reported that a patient probably received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They got to the end of the box of Shingrix and there was one lyophilized portion left. Only collected one patient's information for reporting purposes, the healthcare professional said she had narrowed it down to 3 patients the adjuvant was possibly administered to. The reporter consented to follow up.