chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Lung opacity, Nausea, Pneumonia, Procalcitonin normal, SARS-CoV-2 test positive
Clinical narrative: BRIEF OVERVIEW: Admission Date: 7/10/2023 Discharge Date: 7/15/2023 Discharge Disposition:  home health care svc   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1]   HOSPITAL COURSE:  Patient is 87-year-old female PMH significant for CKD stage 4, chronic diastolic HF, paroxysmal AFib, hypertension--presents to the hospital 7/10 with complaints of dyspnea.  Patient had flu-like symptoms, nausea, vomiting, diarrhea and cough about 11 days prior to admit and tested positive for COVID-19.  She tried to nurse herself at home but did not notice any improvement over several days.  She continued to have progressive dyspnea, especially about 5 days prior to presentation, ongoing poor oral intake. Patient was noted to be hypoxic in ER and was placed on supplemental oxygen, along with sodium of 125.  Chest x-ray showed right lung pneumonia in left lung streaky opacity.  Film array confirmed positive COVID-19.  Patient was placed on supplemental oxygen given hypoxia and admitted to the hospital for further management of COVID infection. Patient does not qualify for remdesivir due to duration of her illness, was started on dexamethasone at 6 mg daily along with encouragement for pulmonary toilet, deep breathing/coughing, increased out of bed mobility and maintaining adequate nutrition.  She was maintained on her home dose apixaban for DVT prophylaxis.  Patient's hypoxia worsened to need Ventimask, CT thorax was obtained which was negative for any lobar consolidations and hence was not started any antibiotics.  Her procalcitonin was negative as well.  Since no clinical improvement was noted, pulmonary consultation was requested, recommended to continue with present management, possibly consideration for high-flow nasal cannula if FiO2 need> 50%/or oxygen pendant if FiO2 requirement < 40%, instead of Ventimask.  Will need outpatient repeat CT for follow-up in 2-3 months.  Commented on other available therapies including remdesivir (if patient gets worse), baricitinib, antibiotics, diuretics etc..  Oxygen needs however started to improve by 7/14, pulmonary rehab consulted and recommended d/c home with 3L at rest and 6L with activity. Portable O2 tank dropped off too room and pt discharged home in stable condition on 7/15. HHC was arranged for her ongoing home therapy.   Her presenting symptoms of nausea, vomiting and diarrhea mostly resolved. Renal function consistent with her stage IV CKD, remained stable. Atrial fibrillation also states stable, maintained on anticoagulation
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BRIEF OVERVIEW: Admission Date: 7/10/2023 Discharge Date: 7/15/2023 Discharge Disposition:  home health care svc   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] COVID-19 [U07.1]   HOSPITAL COURSE:  Patient is 87-year-old female PMH significant for CKD stage 4, chronic diastolic HF, paroxysmal AFib, hypertension--presents to the hospital 7/10 with complaints of dyspnea.  Patient had flu-like symptoms, nausea, vomiting, diarrhea and cough about 11 days prior to admit and tested positive for COVID-19.  She tried to nurse herself at home but did not notice any improvement over several days.  She continued to have progressive dyspnea, especially about 5 days prior to presentation, ongoing poor oral intake. Patient was noted to be hypoxic in ER and was placed on supplemental oxygen, along with sodium of 125.  Chest x-ray showed right lung pneumonia in left lung streaky opacity.  Film array confirmed positive COVID-19.  Patient was placed on supplemental oxygen given hypoxia and admitted to the hospital for further management of COVID infection. Patient does not qualify for remdesivir due to duration of her illness, was started on dexamethasone at 6 mg daily along with encouragement for pulmonary toilet, deep breathing/coughing, increased out of bed mobility and maintaining adequate nutrition.  She was maintained on her home dose apixaban for DVT prophylaxis.  Patient's hypoxia worsened to need Ventimask, CT thorax was obtained which was negative for any lobar consolidations and hence was not started any antibiotics.  Her procalcitonin was negative as well.  Since no clinical improvement was noted, pulmonary consultation was requested, recommended to continue with present management, possibly consideration for high-flow nasal cannula if FiO2 need> 50%/or oxygen pendant if FiO2 requirement < 40%, instead of Ventimask.  Will need outpatient repeat CT for follow-up in 2-3 months.  Commented on other available therapies including remdesivir (if patient gets worse), baricitinib, antibiotics, diuretics etc..  Oxygen needs however started to improve by 7/14, pulmonary rehab consulted and recommended d/c home with 3L at rest and 6L with activity. Portable O2 tank dropped off too room and pt discharged home in stable condition on 7/15. HHC was arranged for her ongoing home therapy.   Her presenting symptoms of nausea, vomiting and diarrhea mostly resolved. Renal function consistent with her stage IV CKD, remained stable. Atrial fibrillation also states stable, maintained on anticoagulation
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Delivery, Exposure during pregnancy
Clinical narrative: I am unsure if this was caused by the vaccine, but my daughter was born with a congenital cleft ear. NO ONE on her dad, or my dad has this or ANY type of birth defect at all. It didn?t happen during delivery because there was no blood or trauma at her ear?it was already formed. I just can?t understand why she was born with a birth defect, and now we have to worry about surgery in the future. I?ve been researching and wondering if my second dose of the vaccine, while I was in my early stages of pregnancy, could have caused this.
Age: 82.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blindness unilateral
Clinical narrative: 4th dose wasModerna and was on 17May2022 and had lot 056A22A and then she got the Pfizer one; became blind in one eye/it was in the right eye; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 on 08Nov2022 sometime in afternoon as dose 5 (booster), single (Lot number: GL0446) at the age of 82 years, in right arm for covid-19 immunisation. The patient had no relevant medical history and no family medical history relevant to adverse events. Concomitant medication included: INFLUENZA VACCINE taken for immunisation as unk, single probably 2 weeks before that in the other arm with no name, manufacturer name. There was no lot or other information to provide for the flu shot but it was the regular flu shot patient gets every year and she never had any kind of reaction to any shot except for the Pfizer. Patient did not have any other concomitant products. Vaccination history included: moderna covid-19 vaccine (Dose 1, single, lot number 031LZ0A), administration date: 11Feb2021, when the patient was 80-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 2, single, lot number 031A21A), administration date: 11Mar2021, when the patient was 80-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 3, single, lot number 040D21A), administration date: 22Oct2021, when the patient was 81-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 4, single,  lot number 056A22A), administration date: 17May2022, when the patient was 81-year-old, for COVID-19 immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 08Nov2022, outcome "unknown", described as "4th dose wasModerna and was on 17May2022 and had lot 056A22A and then she got the Pfizer one"; BLINDNESS UNILATERAL (hospitalization) with onset 08Nov2022, outcome "unknown", described as "became blind in one eye/it was in the right eye". The patient was hospitalized for interchange of vaccine products, blindness unilateral (start date: 09Nov2022, discharge date: 10Nov2022, hospitalization duration: 2 days). The event "became blind in one eye/it was in the right eye" required emergency room visit. After she got blind, she was ambulanced to the hospital and admitted and they did all sorts of tests; caller was asked for dates of tests or results and did not provide this information. There was nothing else wrong and she had no stroke and had no paralysis and nothing else but it was just the blindness in one eye; she got the shot and went to bed and woke up in the middle of the night and was blind. Therapeutic measures were taken as a result of blindness unilateral. She got into a chamber so she had four treatments in the chamber to try to reverse the eye thing and the hyperbaric chamber treatments were on 09Nov2022. She went right to the emergency room and got right into the chamber.
Age: 82.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Blindness unilateral, Interchange of vaccine products
Clinical narrative: 4th dose wasModerna and was on 17May2022 and had lot 056A22A and then she got the Pfizer one; became blind in one eye/it was in the right eye; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 on 08Nov2022 sometime in afternoon as dose 5 (booster), single (Lot number: GL0446) at the age of 82 years, in right arm for covid-19 immunisation. The patient had no relevant medical history and no family medical history relevant to adverse events. Concomitant medication included: INFLUENZA VACCINE taken for immunisation as unk, single probably 2 weeks before that in the other arm with no name, manufacturer name. There was no lot or other information to provide for the flu shot but it was the regular flu shot patient gets every year and she never had any kind of reaction to any shot except for the Pfizer. Patient did not have any other concomitant products. Vaccination history included: moderna covid-19 vaccine (Dose 1, single, lot number 031LZ0A), administration date: 11Feb2021, when the patient was 80-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 2, single, lot number 031A21A), administration date: 11Mar2021, when the patient was 80-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 3, single, lot number 040D21A), administration date: 22Oct2021, when the patient was 81-year-old, for COVID-19 immunization; moderna covid-19 vaccine (Dose 4, single,  lot number 056A22A), administration date: 17May2022, when the patient was 81-year-old, for COVID-19 immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization) with onset 08Nov2022, outcome "unknown", described as "4th dose wasModerna and was on 17May2022 and had lot 056A22A and then she got the Pfizer one"; BLINDNESS UNILATERAL (hospitalization) with onset 08Nov2022, outcome "unknown", described as "became blind in one eye/it was in the right eye". The patient was hospitalized for interchange of vaccine products, blindness unilateral (start date: 09Nov2022, discharge date: 10Nov2022, hospitalization duration: 2 days). The event "became blind in one eye/it was in the right eye" required emergency room visit. After she got blind, she was ambulanced to the hospital and admitted and they did all sorts of tests; caller was asked for dates of tests or results and did not provide this information. There was nothing else wrong and she had no stroke and had no paralysis and nothing else but it was just the blindness in one eye; she got the shot and went to bed and woke up in the middle of the night and was blind. Therapeutic measures were taken as a result of blindness unilateral. She got into a chamber so she had four treatments in the chamber to try to reverse the eye thing and the hyperbaric chamber treatments were on 09Nov2022. She went right to the emergency room and got right into the chamber.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 63.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: The patient called four days after receiving the vaccine and reported that the injection site is sensitive to touch, small bump, and feels itchy. The patient was advised to report the incident to her family doctor and call for emergency services if there were any signs of breathing problems, rash, or swelling. The patient was also advised to take Benadryl if the symptoms were minor and to call GSK to report the event immediately.  We followed up with the patient to make sure the symptoms were improving.
Age: 63.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The patient called four days after receiving the vaccine and reported that the injection site is sensitive to touch, small bump, and feels itchy. The patient was advised to report the incident to her family doctor and call for emergency services if there were any signs of breathing problems, rash, or swelling. The patient was also advised to take Benadryl if the symptoms were minor and to call GSK to report the event immediately.  We followed up with the patient to make sure the symptoms were improving.
Age: 0.42
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Proquad administration was administered to a 4 month old baby. After a week of administration patient developed a rash,
Age: 0.42
Sex: F
Vaccine: MMRV, DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: Proquad administration was administered to a 4 month old baby. After a week of administration patient developed a rash,
Sex: F
Vaccine: RSV, RSV
Symptoms: Pyrexia
Clinical narrative: 41-year-old pregnant patient received a dose of Arexvy; 41-year-old pregnant patient received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 41-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 34HY5, expiry date 02-FEB-2025) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy. On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 41-year-old pregnant patient received a dose of Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 41-year-old pregnant patient received a dose of Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 31-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist called to inform that a 41-year-old pregnant patient received a dose of Arexvy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: 41-year-old pregnant patient received a dose of Arexvy; 41-year-old pregnant patient received a dose of Arexvy; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 41-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 34HY5, expiry date 02-FEB-2025) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy. On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 41-year-old pregnant patient received a dose of Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: 41-year-old pregnant patient received a dose of Arexvy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 31-OCT-2023 The vaccine administration facility was the same as primary reporter The pharmacist called to inform that a 41-year-old pregnant patient received a dose of Arexvy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 91.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19-2, FLU4, RSV
Symptoms: Amnesia, Aphasia, Blood test, Bradykinesia, Cerebrovascular accident
Clinical narrative: Patient had stroke a few days after vaccines were administered
Age: 91.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19-2, FLU4, RSV
Symptoms: Cognitive disorder, Computerised tomogram abnormal, Dysstasia, Fall, Gait disturbance
Clinical narrative: Patient had stroke a few days after vaccines were administered
Age: 91.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19-2, FLU4, RSV
Symptoms: Incoherent, Intensive care, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Speech disorder
Clinical narrative: Patient had stroke a few days after vaccines were administered
Age: 91.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19-2, FLU4, RSV
Symptoms: Walking aid user
Clinical narrative: Patient had stroke a few days after vaccines were administered
Age: 91.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19-2, FLU4, RSV
Symptoms: Cerebrovascular accident
Clinical narrative: Patient had stroke a few days after vaccines were administered
Age: 33.0
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: Arexvy administered to 34 week old pregnant women; increased blood pressure; Arexvy administered to 33 year old pregnant women; Arexvy administered instead of RSV pfizer vaccine; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 01-NOV-2023, the patient received the 1st dose of Arexvy (right deltoid). On 01-NOV-2023, less than a day after receiving Arexvy, the patient experienced increased blood pressure (Verbatim: increased blood pressure), inappropriate age at vaccine administration (Verbatim: Arexvy administered to 33 year old pregnant women) and wrong vaccine administered (Verbatim: Arexvy administered instead of RSV pfizer vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered to 34 week old pregnant women). The outcome of the increased blood pressure was not resolved and the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Arexvy.     It was unknown if the company considered the increased blood pressure to be related to Arexvy.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter was the husband of a 33 year old woman who was pregnant at 34 weeks gestation.  The reporter stated that pharmacist gave the wrong vaccine to his wife.  The wife went to the pharmacy and requested the Pfizer RSV vaccine and was given Arexvy which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. Arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.  The reporter stated that his wife had increased blood pressure since getting the vaccine yesterday that had not resolved.  (Increased Blood Pressure / Symptomatic). The reporter stated that pharmacist did not give any paperwork to his wife.  The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Arexvy administered to 34 week old pregnant women; increased blood pressure; Arexvy administered to 33 year old pregnant women; Arexvy administered instead of RSV pfizer vaccine; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 01-NOV-2023, the patient received the 1st dose of Arexvy (right deltoid). On 01-NOV-2023, less than a day after receiving Arexvy, the patient experienced increased blood pressure (Verbatim: increased blood pressure), inappropriate age at vaccine administration (Verbatim: Arexvy administered to 33 year old pregnant women) and wrong vaccine administered (Verbatim: Arexvy administered instead of RSV pfizer vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered to 34 week old pregnant women). The outcome of the increased blood pressure was not resolved and the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Arexvy.     It was unknown if the company considered the increased blood pressure to be related to Arexvy.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter was the husband of a 33 year old woman who was pregnant at 34 weeks gestation.  The reporter stated that pharmacist gave the wrong vaccine to his wife.  The wife went to the pharmacy and requested the Pfizer RSV vaccine and was given Arexvy which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. Arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.  The reporter stated that his wife had increased blood pressure since getting the vaccine yesterday that had not resolved.  (Increased Blood Pressure / Symptomatic). The reporter stated that pharmacist did not give any paperwork to his wife.  The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Blood pressure increased, Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: Arexvy administered to 34 week old pregnant women; increased blood pressure; Arexvy administered to 33 year old pregnant women; Arexvy administered instead of RSV pfizer vaccine; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 01-NOV-2023, the patient received the 1st dose of Arexvy (right deltoid). On 01-NOV-2023, less than a day after receiving Arexvy, the patient experienced increased blood pressure (Verbatim: increased blood pressure), inappropriate age at vaccine administration (Verbatim: Arexvy administered to 33 year old pregnant women) and wrong vaccine administered (Verbatim: Arexvy administered instead of RSV pfizer vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered to 34 week old pregnant women). The outcome of the increased blood pressure was not resolved and the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Arexvy.     It was unknown if the company considered the increased blood pressure to be related to Arexvy.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter was the husband of a 33 year old woman who was pregnant at 34 weeks gestation.  The reporter stated that pharmacist gave the wrong vaccine to his wife.  The wife went to the pharmacy and requested the Pfizer RSV vaccine and was given Arexvy which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. Arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.  The reporter stated that his wife had increased blood pressure since getting the vaccine yesterday that had not resolved.  (Increased Blood Pressure / Symptomatic). The reporter stated that pharmacist did not give any paperwork to his wife.  The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: RSV, RSV, RSV, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: Arexvy administered to 34 week old pregnant women; increased blood pressure; Arexvy administered to 33 year old pregnant women; Arexvy administered instead of RSV pfizer vaccine; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 01-NOV-2023, the patient received the 1st dose of Arexvy (right deltoid). On 01-NOV-2023, less than a day after receiving Arexvy, the patient experienced increased blood pressure (Verbatim: increased blood pressure), inappropriate age at vaccine administration (Verbatim: Arexvy administered to 33 year old pregnant women) and wrong vaccine administered (Verbatim: Arexvy administered instead of RSV pfizer vaccine). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy administered to 34 week old pregnant women). The outcome of the increased blood pressure was not resolved and the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Arexvy.     It was unknown if the company considered the increased blood pressure to be related to Arexvy.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 34 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter was the husband of a 33 year old woman who was pregnant at 34 weeks gestation.  The reporter stated that pharmacist gave the wrong vaccine to his wife.  The wife went to the pharmacy and requested the Pfizer RSV vaccine and was given Arexvy which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. Arexvy is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older.  The reporter stated that his wife had increased blood pressure since getting the vaccine yesterday that had not resolved.  (Increased Blood Pressure / Symptomatic). The reporter stated that pharmacist did not give any paperwork to his wife.  The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Limb mass, Muscle mass
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 70 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Oct2022 (as reported) as dose 3 (booster), single (Lot number: FM0173) at the age of 70 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naprosin, reaction(s): "Drug Allergy: Naproxen". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2023, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (09Jan2023) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354231 same patient/drug, different dose/event;
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngeal swab
Clinical narrative: covid test result=Positive; covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 70 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Oct2022 (as reported) as dose 3 (booster), single (Lot number: FM0173) at the age of 70 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naprosin, reaction(s): "Drug Allergy: Naproxen". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2023, outcome "unknown" and all described as "covid test result=Positive". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (09Jan2023) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354231 same patient/drug, different dose/event;
Sex: M
Vaccine: HEP
Symptoms: Anaemia, Foetal exposure during pregnancy
Clinical narrative: Diagnosed with anemia in hospital; Foetal exposure during pregnancy; This spontaneous report was received from nurse and refers to an 1-day-old male patient.  The patient's medical history, concurrent conditions included were not reported. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), minerals nos (+) vitamins nos (PRENATAL VITAMINS) and acetylsalicylic acid (ASPIRINE).  On 14-FEB-2023, the patient mother was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular (lot # W036194 has been verified to be a valid lot number of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), expiration date reported as 23-MAY-2025, but upon internal validation established as 29-SEP-2025), in the left deltoid for prophylaxis (foetal exposure during pregnancy).  On 17-APR-2023, the patient was diagnosed with anemia at the hospital and was treated with iron at home. At the time of reporting, the outcome of the event anemia was unknown.  The causal relationship between anemia and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored VARIVAX administered to the patient; no additional adverse events were reported; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitants medication were not provided.  On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (lot # W039294 has been verified to be a valid lot number, expiration date: 11-DEC-2024: strength, dose and route of administration were not reported), administered by a health professional (product storage error). The vaccine had been stored under 17.4 degrees Fahrenheit (F) for 2 hours. There was no previous temperature excursion. No additional adverse events were reported.
Age: 37.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administration error, Product use issue, Wrong product administered
Clinical narrative: No AE; Nurse reported that a 37 years old male patient received PROQUAD instead of MMR II and VARIVAX due to a human error.; Nurse reported that a 37 years old male patient received PROQUAD instead of MMR II and VARIVAX due to a human error.; This spontaneous report was received from a nurse and refers to a 37-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-OCT-2023, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, therapy type: rHA, 1 dose, valid lot #X009731, expiration date: 30-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product use issue)  instead of varicella virus vaccine live (OKA/MERCK) (VARIVAX) injection, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, due to a human error (Wrong product administered). No additional adverse events were reported (No adverse event).
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; HCP called to report administering VARIVAX and MMR-II to a patient a few days apart from each other.; This spontaneous report has been received from a pharmacist concerning to a 5-year-old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 27-OCT-2023, the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection. Then, on 30-OCT-2023, the patient was vaccinated with the first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) injection (for both: strengths, doses, anatomical locations, routes of administration, lot numbers and expiration dates were not provided). Both vaccines administered as prophylaxis.   On an unspecified date in October 2023 (also reported as "a few apart from each other"), it was administered to the patient varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of product administration).  No additional details were known by reporter. Limited patient demographics provided.   No additional adverse events (AE).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No further adverse event; TE was supported; one dose was administered; This spontaneous report was received from a nurse, regarding to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, allergies and drug reactions were not reported.  On 19-OCT-2023, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (lot #X009734 has been confirmed as valid, expiration date was reported and confirmed on 30-SEP-2024, therapy type rHA, vaccination scheme, strength, and route of administration were not provided), that vaccine was involved in a temperature excursion (Product storage error) for a time frame of 3 hours 41 minutes, with a temperature of -14.3 degree Celsius (°C). There were previous temperature excursions from a temperature of -14 °C to -10°C for 3 minutes. Other temperature excursion were reported as follows: 14°C to -10°C(-14.6C) for 2 Hours 12 Minutes 0 Seconds; -14°C to -10°C(-14.6C) for 5 Hours 43 Minutes 0 Seconds; -14°C to -10°C(-14.6C) for 4 Hours 49 Minutes 0 Seconds; -14°C to -10°C(-14.3C) for 6 Hours 3 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 6 Hours 59 Minutes 0 Seconds; -14°C to -10°C(-14.3C) for 2 Hours 33 Minutes 0 Seconds; -14°C to -10°C(-14.6C) for 0 Hours 45 Minutes 0 Seconds; -14°C to -10°C(-14.6C) for 2 Hours 7 Minutes 0 Seconds; -14°C to -10°C(-14.8C) for 0 Hours 34 Minutes 0 Seconds; -14°C to -10°C(-14.5C) for 1 Hour 25 Minutes 0 Seconds; -14°C to -10°C(-14.8C) for 0 Hours 26 Minutes 0 Seconds; -14°C to -10°C(-14.8C) for 0 Hours 24 Minutes 0 Seconds; -14°C to -10°C(-14.8C) for 0 Hours 15 Minutes 0 Seconds; -14°C to -10°C(-14.5C) for 4 Hours 23 Minutes 0 Seconds; -14°C to -10°C(-14.1C) for 9 Hours 24 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 8 Hours 10 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 8 Hours 5 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 8 Hours 31 Minutes 0 Seconds; -14°C to -10°C(-14.2C) for 6 Hours 37 Minutes 0 Seconds. No further adverse event (AE) (No adverse) details were reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Post-acute COVID-19 syndrome, Pulmonary fibrosis
Clinical narrative: Pulmonary fibrosis; Did not help us one bit, hurt us actually; still got Covid; long term COVID; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY FIBROSIS (Pulmonary fibrosis) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criterion medically significant) and POST-ACUTE COVID-19 SYNDROME (Did not help us one bit, hurt us actually; still got Covid; long term COVID). At the time of the report, PULMONARY FIBROSIS (Pulmonary fibrosis) and POST-ACUTE COVID-19 SYNDROME (Did not help us one bit, hurt us actually; still got Covid; long term COVID) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  On 02-Feb-2021, the patient had first dose, lot: 012M20A. Patient took all vaccines of Moderna.  Patient visited pulmonologist since his case was severe.  No treatment medication was reported.  Company Comment This spontaneous case concerns a male patient of an unknown age with no medical history reported who experienced the unexpected medically significant seriousness criteria event of Pulmonary fibrosis and the unexpected event of post-acute Covid-19 syndrome unknown days after a. dose of mRNA-1273 BIVALENT .222 vaccine. Concomitant medication details nor Treatment details were reported At the time of the report, the outcome of the events were unknown.    The benefit-risk relationship of mRNA-1273 BIVALENT .222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-748042, US-MODERNATX, INC.-MOD-2023-747954 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748042:Case for Wife US-MODERNATX, INC.-MOD-2023-747954:Invalid case
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Three months of arrhythmia; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Three months of arrhythmia) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Three months of arrhythmia) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Three months of arrhythmia) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant and treatment medications were not reported.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Arrhythmia. Latency is unknown but it is reported that after the administration of SPIKEVAX 2023-2024 vaccine the patient developed three months of arrhythmia. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Gait inability
Clinical narrative: He tried to get out of bed and put his feet down. He was unable to walk; Dizzy; Unbalanced; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (He tried to get out of bed and put his feet down. He was unable to walk), DIZZINESS (Dizzy) and BALANCE DISORDER (Unbalanced) in an elderly male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (He tried to get out of bed and put his feet down. He was unable to walk) (seriousness criterion hospitalization), DIZZINESS (Dizzy) (seriousness criterion hospitalization) and BALANCE DISORDER (Unbalanced) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to BALANCE DISORDER, DIZZINESS and GAIT INABILITY. At the time of the report, GAIT INABILITY (He tried to get out of bed and put his feet down. He was unable to walk), DIZZINESS (Dizzy) and BALANCE DISORDER (Unbalanced) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. About 3 weeks ago on a Thursday, patient took the Moderna vaccine. 10 days after, on a Monday, he tried to get out of bed and put his feet down, but he was unable to walk, felt dizzy, and unbalanced. He then went by ambulance to the hospital. Spent 5 days in the hospital. He was working with a physical therapist but did not take any medications or treatments. He then started to walk 2 days after being admitted and was discharged 2 days after that. Treatment information was not reported.  Company comment: This spontaneous case concerns an elderly male patient, with no medical history reported, who experienced the unexpected, serious (hospitalization) events of gait inability, dizziness, and balance disorder. The events occurred approximately 10 days after a dose of Spikevax 2023-2024 vaccine (Andusomeran); no information about previous immunisation schedule was provided. The report stated that when the patient tried to get out of bed and put his feet down, but he was unable to walk, dizzy, and unbalanced. He was hospitalized for 5 days and had a physical therapist, but he did not require any medications or treatments. He was able to walk after 2 days after being admitted. No further clinical details were provided for medical reviewing. The benefit-risk relationship of Spikevax 2023-2024 vaccine (Andusomeran) is not affected by this report.   This case was linked to MOD-2023-748396 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received and added references.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: lot of discomfort in my left arm/recently received the Moderna vaccine, and now (five days later) have a lot of discomfort in my left arm; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (lot of discomfort in my left arm/recently received the Moderna vaccine, and now (five days later) have a lot of discomfort in my left arm) in an elderly patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (lot of discomfort in my left arm/recently received the Moderna vaccine, and now (five days later) have a lot of discomfort in my left arm). At the time of the report, LIMB DISCOMFORT (lot of discomfort in my left arm/recently received the Moderna vaccine, and now (five days later) have a lot of discomfort in my left arm) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not reported.  The patient had lot of discomfort in left arm. The patient was wondered if the patient was having heart issues, so the patient took aspirin during the night.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2023: Live follow-up received, contains significant information: reporter information added.