chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient received the first dose of Shingrix in 2020 and didn't return for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: a patient received the first dose of Shingrix in 2020 and didn't return for the second dose). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 29-APR-2024 The reporter called to report a patient received the first dose of Shingrix in 2020 and did not return for the second dose because of the pandemic, which led to social problem. The Vaccine Administration Facility was the same as Primary Reporter. No lot number or specific vaccination date reported. Second dose of Shingrix had not been administered yet. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received only one dose of Hep A vaccine at the end of 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 43-year-old male patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A (received only one dose of Hep A vaccine at the end of 2020).   On an unknown date, the patient did not received Hepatitis A vaccine. On an unknown date, an unknown time after receiving Hepatitis A vaccine, the patient experienced incomplete course of vaccination (Verbatim: patient received only one dose of Hep A vaccine at the end of 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-APR-2024 The reporter stated that a patient received only one dose of Hepatitis A vaccine at the end of 2020 (brand unknown). The health care professional only had Twinrix in stock and wanted to know if she could restarted with that or did the patient need to get a Hepatitis A vaccine. The reporter did not consent to follow up.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arm is killing me with soreness; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced pain in arm (Verbatim: Arm is killing me with soreness). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 30-APR-2024 Field Representative reported on behalf of vaccine coordinator at the HCP office. The reporter stated the vaccine coordinator said to him that her nephew received the Bexsero vaccine and the patient told her that arm was killing him with soreness. No other information was given at that time. The adverse events filed with minimal information. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: she had gotten shingles/lack of effect; second dose of Shingrix was administered in January 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In JAN-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: second dose of Shingrix was administered in January 2024). On an unknown date, the patient experienced shingles (Verbatim: she had gotten shingles/lack of effect ). The outcome of the shingles was not reported and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2024 The reporter called to inform that a patient got the first dose of Shingrix back in 2017 and after that the patient had gotten shingles, and then the patient got another dose like 5 years later.  Now the patient was under the impression that she wanted to restart the series. According to the reporter, the patient's doctor advised the patient to get the series of Shingrix restarted.  The vaccine administration facility was the same as primary reporter. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received Menveo one vial presentation expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 09-APR-2024, the patient received Menveo. On 09-APR-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received Menveo one vial presentation expired dose ). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 30-APR-2024 This was 1 of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024055469:another patient/ same reporter US-GSK-US2024055470:another patient/ same reporter
Sex: F
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: 69 year old female patient came in to pharmacy with a prescription from her doctor to receive; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 69-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Ravulizumab (Ultomiris).   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: 69 year old female patient came in to pharmacy with a prescription from her doctor to receive). The outcome of the intercepted drug prescribing error 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: 30-APR-2024 Pharmacist stated that a patient came in to pharmacy with a prescription from her doctor to receive Bexsero vaccine since she was on Ultomiris (biologic) infusion therapy, which led to intercepted product prescribing error. The prescription did specifically say Bexsero, not just meningococcal B vaccine.  At the time of reporting, the vaccine has not been administered. The Vaccine Administration Facility was the same as Primary Reporter,
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate Age at Vaccine Administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   On 15-APR-2024, the patient received Kinrix. On 15-APR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate Age at Vaccine Administration). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 30-APR-2024 The reporter stated that a patient received Kinrix who was not at the appropriate age, which led to inappropriate age at vaccine administration. She assumed that the patient was supposed to get separate Dtap and Polio vaccines because of the age. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Faeces discoloured, Haematochezia, Occult blood positive, Rotavirus test positive, Ultrasound abdomen normal
Clinical narrative: Positive Stool Hemoccult; stool today was greenish; Streaky blood in Stool; Positive rotavirus on stool panel; This serious case was reported by a physician via call center representative and described the occurrence of blood in stool in a 4-month-old female patient who received Rota (Rotarix liquid formulation) (batch number 737J5, expiry date 05-OCT-2025) for prophylaxis.   Concomitant products included Rotavirus vaccine live oral 1v (Rotarix).   On 19-APR-2024, the patient received the 2nd dose of Rotarix liquid formulation (oral). On 26-APR-2024, 7 days after receiving Rotarix liquid formulation, the patient experienced blood in stool (Verbatim: Streaky blood in Stool) (serious criteria GSK medically significant) and rotavirus test positive (Verbatim: Positive rotavirus on stool panel). On 01-MAY-2024, the patient experienced fecal occult blood positive (Verbatim: Positive Stool Hemoccult) and greenish stool (Verbatim: stool today was greenish). The outcome of the blood in stool was resolved and the outcome of the fecal occult blood positive and rotavirus test positive were unknown and the outcome of the greenish stool was not reported.   It was unknown if the reporter considered the blood in stool, fecal occult blood positive, rotavirus test positive and greenish stool to be related to Rotarix liquid formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the blood in stool, fecal occult blood positive, rotavirus test positive and greenish stool to be related to Rotarix liquid formulation and Rotarix Oral Applicator Device.   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: 01-MAY-2024 The reporter reported that, the patient received 1st dose of Rotarix on 21st February 2024 and 2nd dose on 19th April 2024.  Both doses were administered orally. The patient was reported to have streaky blood in stool and was taken to the emergency room.  The patient had an ultrasound that was negative for intussusception.  The viral panel on stool was positive for rotavirus.  The patient was not admitted to the hospital.  The physician reported that, the patient was saw back in office on 1st May 2024.  The physician reported the baby was breastfeed and was feeding fine and acting normal.  The stool on the day of reporting (today) was greenish, normal looking, no visible blood, however hemoccult performed on the day of reporting (today) was positive. The vaccine administration facility was the same as primary reporter The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 2 doses of Arexvy administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number b33d2, expiry date 02-FEB-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 11-NOV-2023, the patient received the 2nd dose of Arexvy. On 11-NOV-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 2 doses of Arexvy administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 02-MAY-2024 2 doses of Arexvy administered which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Malaise
Clinical narrative: Passed out; she didn't feel well; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 74-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2024, the patient received the 1st dose of Shingles vaccine. In APR-2024, 3 hrs after receiving Shingles vaccine, the patient experienced passed out (Verbatim: Passed out) (serious criteria hospitalization and GSK medically significant) and feeling unwell (Verbatim: she didn't feel well) (serious criteria hospitalization). The outcome of the passed out was resolved and the outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the passed out and feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the passed out and feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAY-2024 The reporter was the husband of the patient. He reported that he and his wife (patient) both received the Shingles vaccine about a Month ago. After the vaccination they went for shopping when the patient told him she did not feel well and when they arrived at home she passed out. 911 was called and she was transported to the hospital where she was admitted for 5 days. The reporter did not know what her official diagnosis was. The reporter requested to consent the follow up. This case has been linked to the case US2024056865 reported by the same reporter.; Sender's Comments:  US-GSK-US2024056865:Same reporter,Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: friend of the wife who received Shingrix and was hospitalized; This serious case was reported by a consumer via call center representative and described the occurrence of hospitalization 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 hospitalization (Verbatim: friend of the wife who received Shingrix and was hospitalized) (serious criteria hospitalization). The outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Shingrix.     It was unknown if the company considered the hospitalization to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2024 The reporter while reporting on his own and his wife's adverse events for Shingrix, the caller mentioned a friend of the wife who received Shingrix and was hospitalized. No other details were known. This case had been linked to the cases US2024056867, US2024056862 and US2024056863 reported by the same reporter. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2024056867:Same reporter,Different patient US-GSK-US2024056863:Same reporter,Different patient US-GSK-US2024056862:Same reporter,Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Bronchial hyperreactivity, Condition aggravated, Deafness unilateral, Labyrinthitis, Pharyngitis
Clinical narrative: hearing loss left ear; tinnitus; Reactive airway disease; pharyngitis; sinusitis; vestibulitis of the left ear; This serious case was reported by a physician via call center representative and described the occurrence of hearing loss unilateral in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hearing loss unilateral (in 2008), tinnitus (in 2008), reactive airways disease (in 2008), pharyngitis (in 2008), sinusitis (in 2008) and ear vestibulitis (in 2008). Previously administered products included shingrix (1st dose received in February 2018) and zostavax (Received a dose in 2007 and experienced similar symptoms but not as severe that were treated and responsive to nasal steroids). Concurrent medical conditions included hearing loss (left orbital hearing loss).   In MAY-2018, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hearing loss unilateral (Verbatim: hearing loss left ear) (serious criteria GSK medically significant), tinnitus (Verbatim: tinnitus), reactive airways disease (Verbatim: Reactive airway disease), pharyngitis (Verbatim: pharyngitis), sinusitis (Verbatim: sinusitis) and ear vestibulitis (Verbatim: vestibulitis of the left ear). The patient was treated with valaciclovir (Valacyclovir). The outcome of the hearing loss unilateral, tinnitus, reactive airways disease, pharyngitis, sinusitis and ear vestibulitis were resolved (duration 2 years).   It was unknown if the reporter considered the hearing loss unilateral, tinnitus, reactive airways disease, pharyngitis, sinusitis and ear vestibulitis to be related to Shingrix.   It was unknown if the company considered the hearing loss unilateral, tinnitus, reactive airways disease, pharyngitis, sinusitis and ear vestibulitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2024 A physician mentioned he had the zostavax in 2007 and a year later experienced similar symptoms but not as severe that were treated and responsive to nasal steroids. The patient stated he received Shingrix and experienced reactive airway disease, pharyngitis, sinusitis and vestibulitis of the left ear.  He also stated he experienced tinnitus and severe hearing loss of left ear.  This continued for 2 years until he started taking valacyclovir. When he tapered off the valacyclovir the symptoms would come back and he would take the valacyclovir again.  The medical information (MI) phone number and transfer were provided. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Sinusitis, Tinnitus
Clinical narrative: hearing loss left ear; tinnitus; Reactive airway disease; pharyngitis; sinusitis; vestibulitis of the left ear; This serious case was reported by a physician via call center representative and described the occurrence of hearing loss unilateral in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hearing loss unilateral (in 2008), tinnitus (in 2008), reactive airways disease (in 2008), pharyngitis (in 2008), sinusitis (in 2008) and ear vestibulitis (in 2008). Previously administered products included shingrix (1st dose received in February 2018) and zostavax (Received a dose in 2007 and experienced similar symptoms but not as severe that were treated and responsive to nasal steroids). Concurrent medical conditions included hearing loss (left orbital hearing loss).   In MAY-2018, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hearing loss unilateral (Verbatim: hearing loss left ear) (serious criteria GSK medically significant), tinnitus (Verbatim: tinnitus), reactive airways disease (Verbatim: Reactive airway disease), pharyngitis (Verbatim: pharyngitis), sinusitis (Verbatim: sinusitis) and ear vestibulitis (Verbatim: vestibulitis of the left ear). The patient was treated with valaciclovir (Valacyclovir). The outcome of the hearing loss unilateral, tinnitus, reactive airways disease, pharyngitis, sinusitis and ear vestibulitis were resolved (duration 2 years).   It was unknown if the reporter considered the hearing loss unilateral, tinnitus, reactive airways disease, pharyngitis, sinusitis and ear vestibulitis to be related to Shingrix.   It was unknown if the company considered the hearing loss unilateral, tinnitus, reactive airways disease, pharyngitis, sinusitis and ear vestibulitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2024 A physician mentioned he had the zostavax in 2007 and a year later experienced similar symptoms but not as severe that were treated and responsive to nasal steroids. The patient stated he received Shingrix and experienced reactive airway disease, pharyngitis, sinusitis and vestibulitis of the left ear.  He also stated he experienced tinnitus and severe hearing loss of left ear.  This continued for 2 years until he started taking valacyclovir. When he tapered off the valacyclovir the symptoms would come back and he would take the valacyclovir again.  The medical information (MI) phone number and transfer were provided. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: A big white circle appeared around the vaccination spot after getting SPIKEVAX; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (A big white circle appeared around the vaccination spot after getting SPIKEVAX) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (A big white circle appeared around the vaccination spot after getting SPIKEVAX). At the time of the report, VACCINATION SITE REACTION (A big white circle appeared around the vaccination spot after getting SPIKEVAX) outcome was unknown.            It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. It was reported that patient had a big white circle appeared around the vaccination spot after getting SPIKEVAX. Patient got SPIKEVAX twice and this happened after both doses.  The treatment medication was not reported by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Pyrexia
Clinical narrative: chills; fever; administered a dose of Spikevax on Saturday, 04MAY2024 which was past 30 day BUD of 27APR2024; This spontaneous case was reported by a pharmacist and describes the occurrence of CHILLS (chills), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (administered a dose of Spikevax on Saturday, 04MAY2024 which was past 30 day BUD of 27APR2024) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032713) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-May-2024, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 04-May-2024, the patient experienced CHILLS (chills), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (administered a dose of Spikevax on Saturday, 04MAY2024 which was past 30 day BUD of 27APR2024). At the time of the report, CHILLS (chills), PYREXIA (fever) and EXPIRED PRODUCT ADMINISTERED (administered a dose of Spikevax on Saturday, 04MAY2024 which was past 30 day BUD of 27APR2024) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter thought patient was 55 but she was not 100% sure, but reporter thought patient was in that range. The reporter stated that the vaccine did not undergo any temperature excursions. Reporter added that she thought this was the patient's first dose of Spikevax and that patient possibly had Pfizer before in 2022 or 2021. No treatment information was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Patient stated he has a little pain; Patient also added up "double the fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Patient stated he has a little pain) and FATIGUE (Patient also added up "double the fatigue) in a 76-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-May-2024 at 10:00 AM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Patient stated he has a little pain) and FATIGUE (Patient also added up "double the fatigue). At the time of the report, PAIN (Patient stated he has a little pain) and FATIGUE (Patient also added up "double the fatigue) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient called to asked if how soon he can take a pain killer after having the vaccine. Patient stated that he got his second booster yesterday 06-MAY-2024 at 10 in the morning and experienced the usual side effects. Patient stated he had a little pain, and that tomorrow patient was going out and engage in a physical activity for which he usually took a pain reliever before engaging in the activity. Patient stated that he wanted to know if he could take or if he had to take Tylenol rather than take Aleve. Patient also added up "double the fatigue". Patient reiterated that he knows eventually that he can take Tylenol after a vaccine.
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin E decreased, Blood immunoglobulin G decreased, Blood immunoglobulin M normal, Full blood count normal
Clinical narrative: Pneumococcal vaccine responses were nearly absent; Pneumococcal vaccine responses were nearly absent; Literature report.  Information has been received from the authors in a published literature article entitled as stated above concerning a 11-year-old female patient who had treatment-resistant parotitis and was found to have hypogammaglobinemia. She had a history of chronic nasal congestion, distant history of recurrent ear infections, and a group A streptococcal peritonsillar abscess at age 2 years (approximately on 2015) but was otherwise healthy with normal growth and development. She had no history of pneumonia or chronic diarrhea.  At age 9, she developed recurrent left-sided parotitis which did not respond to an initial course of antibiotics. Treatment with systemic steroids and sialo endoscopy with insufflation of steroids resulted in improvement but not full resolution of her symptoms.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  Laboratory evaluation revealed decreased Immunoglobulin G (IgG) of 203 mg/dL (lower limit 586 mg/dL), low Immunoglobulin M (IgM) of 45 mg/dL (lower limit 47 mg/dL), and absent Immunoglobulin A (IgA) and Immunoglobulin E (IgE). CBC and total counts of T, B, and NK cells were normal. B cell phenotyping showed a decrease in total memory B cells (CD27+) at 1.5%, (normal 4.6% to 49.1%), switched memory B cells (CD27+IgD-IgM-) at 0.2% (normal 1.9% to 30.4%), and IgM-only memory B cells (CD27+IgD-IgM +) at 0.1%, (normal 0.3% to 13.1%).  It was reported that pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) responses were nearly absent (vaccine response impaired and vaccination failure). She was treated with intravenous Immunoglobulin (IVIG) and her parotid swelling resolved. Ongoing IgG replacement therapy was given subcutaneously, and she had no recurrence of parotitis for several months.  The outcome of vaccine response impaired and vaccination failure was not known.  The authors considered the events to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  A copy of the published article has been requested.
Sex: F
Vaccine: PPV
Symptoms: Immunoglobulin therapy, Laboratory test abnormal, Parotid gland enlargement, Vaccination failure
Clinical narrative: Pneumococcal vaccine responses were nearly absent; Pneumococcal vaccine responses were nearly absent; Literature report.  Information has been received from the authors in a published literature article entitled as stated above concerning a 11-year-old female patient who had treatment-resistant parotitis and was found to have hypogammaglobinemia. She had a history of chronic nasal congestion, distant history of recurrent ear infections, and a group A streptococcal peritonsillar abscess at age 2 years (approximately on 2015) but was otherwise healthy with normal growth and development. She had no history of pneumonia or chronic diarrhea.  At age 9, she developed recurrent left-sided parotitis which did not respond to an initial course of antibiotics. Treatment with systemic steroids and sialo endoscopy with insufflation of steroids resulted in improvement but not full resolution of her symptoms.  On an unknown date, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).  Laboratory evaluation revealed decreased Immunoglobulin G (IgG) of 203 mg/dL (lower limit 586 mg/dL), low Immunoglobulin M (IgM) of 45 mg/dL (lower limit 47 mg/dL), and absent Immunoglobulin A (IgA) and Immunoglobulin E (IgE). CBC and total counts of T, B, and NK cells were normal. B cell phenotyping showed a decrease in total memory B cells (CD27+) at 1.5%, (normal 4.6% to 49.1%), switched memory B cells (CD27+IgD-IgM-) at 0.2% (normal 1.9% to 30.4%), and IgM-only memory B cells (CD27+IgD-IgM +) at 0.1%, (normal 0.3% to 13.1%).  It was reported that pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) responses were nearly absent (vaccine response impaired and vaccination failure). She was treated with intravenous Immunoglobulin (IVIG) and her parotid swelling resolved. Ongoing IgG replacement therapy was given subcutaneously, and she had no recurrence of parotitis for several months.  The outcome of vaccine response impaired and vaccination failure was not known.  The authors considered the events to be related to pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23).  A copy of the published article has been requested.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC/It was confirmed that no symptoms or side effects were reported; 18 year old female who was administered PROQUAD/and second dose on 4/8/2024; 18 year old female who was administered PROQUAD/Patient received their first PROQUAD dose on 3/6/2024; This spontaneous report was received from an administrator and refers to an 18-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 06-MAR-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #x018570, expiration date: 05-JAN-2025, administered subcutaneously for prophylaxis (strength and anatomical location were not provided) (Product administered to patient of inappropriate age). On 08-APR-2024, she received the second 0.5 ml dose subcutaneously lot #x018570, expiration date: 05-JAN-2025 for prophylaxis (strength and anatomical location were not provided) (Product administered to patient of inappropriate age). It was confirmed that no symptoms or side effects were reported. No additional adverse event. The reporter inquired if patient required revaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; she had Herpes Zoster dermatitis; server PHN; suspect vaccine is expired; suspect vaccine is expired; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) (batch number 2G217) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number GH455) for prophylaxis.   On 26-AUG-2019, the patient received the 1st dose of Shingrix. On 18-NOV-2019, the patient received the 2nd dose of Shingrix. On 26-AUG-2019, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: suspect vaccine is expired). On 18-NOV-2019, the patient experienced expired vaccine used (Verbatim: suspect vaccine is expired). In MAR-2024, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster dermatitis (Verbatim: she had Herpes Zoster dermatitis) and post herpetic neuralgia (Verbatim: server PHN). The outcome of the vaccination failure, herpes zoster dermatitis, post herpetic neuralgia, expired vaccine used and expired vaccine used were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster dermatitis and post herpetic neuralgia to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, herpes zoster dermatitis and post herpetic neuralgia to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2024, 02-MAY-2024 and 03-MAY-2024 The patient was not immunocompromised. The physician reported that the patient had Shingrix vaccination in 2019 and she had herpes zoster dermatitis with server post herpetic neuralgia in March 2024.  The physician reported it looked like that her vaccination was not effective.  The physician asked should she repeat vaccination, what was the problem with her vaccination, counterfeit drug. The physician indicated that the patient's shingles outbreak was getting worse and that the patient had to go to the emergency room.  No product quality complaint would be filed because prescriber withdrew the request for product quality complaint and also the suspect vaccine was expired, which led to expired vaccine used.  GlaxoSmithKline did not file product quality complaints on expired medications. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding herpes zoster were unknown at the time of reporting The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: The First booster was Moderna Covid Booster/ BNT162B2 DOSE 4 (BOOSTER); 7-10 days after getting the Pfizer Covid Booster she got covid/The first time she got covid was May2022; 7-10 days after getting the Pfizer Covid Booster she got covid/The first time she got covid was May2022; This is a spontaneous report received from a Nurse from product quality group.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 09May2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 54 years, in left deltoid for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Sep2021 as dose 1, single), in Sep2021 as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 1971 (ongoing), notes: Asthma, Start-Age 3. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09May2022, outcome "unknown", described as "The First booster was Moderna Covid Booster/ BNT162B2 DOSE 4 (BOOSTER)"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "7-10 days after getting the Pfizer Covid Booster she got covid/The first time she got covid was May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative, notes: Got Covid May2022- It took roughly 7-10 days for a negative test; (06May2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Vaccination Facility Type was Pharmacy or Drug Store and vaccine was not administered at Facility. The patient had no prior vaccinations (within 4 weeks). The patient had a positive test for SARS-CoV2. The patient was not hospitalized. The patient did not require supplemental oxygen. The patient is not a smoker/former smoker.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile and temporal association.
Sex: U
Vaccine: PNC20
Symptoms: Product container issue
Clinical narrative: 1 vial that was broken/one was damaged; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HH9323, Expiration Date: May2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "1 vial that was broken/one was damaged".  Additional information: there was no patient involvement with report, still had the broken vial, to be sent back if requested.
Sex: F
Vaccine: COVID19
Symptoms: Anti-GAD antibody, Blood ketone body, Body mass index, Glycosylated haemoglobin, Insulin C-peptide
Clinical narrative: Latent autoimmune diabetes in adults; This is a literature report for the following literature source(s).  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "progressive weakness" (unspecified if ongoing); "polyuria" (unspecified if ongoing); "worsening confusion" (unspecified if ongoing); "Type 2 DM" (ongoing), notes: in her mother. The patient's family history included: "positive for suspected Type 1 DM" (unspecified if ongoing), notes: in her father. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer unknown), for Covid-19 immunisation. The following information was reported: LATENT AUTOIMMUNE DIABETES IN ADULTS (hospitalization, medically significant, life threatening), 1 week after the suspect product(s) administration, outcome "unknown".  Clinical course: The patient presented with progressive weakness, polyuria, and worsening confusion. Patient was administered the second dose of Pfizer-BioNTech COVID-19 vaccine dose one week before her symptoms began. No sources of infection. Her family history is positive for suspected Type 1 DM in her father and Type 2 DM in her mother. On arrival, the patient was confused and only oriented to person. BMI was 35.4. Initial laboratory results signified DKA. The patient was eventually admitted to the medical ICU for management. Endocrinology was consulted. Other labs revealed a hemoglobin A1C of 15.1% (baseline A1C was 6.0), and increased glutamic acid decarboxylase antibodies (GAD) to > 250 with corresponding low C peptide levels suggesting Type 1 DM. Beta-hydroxybutyrate was >8. Follow-up labs post-admission revealed persistent elevated GAD levels, and C peptide remained low, further confirming LADA.  Follow-up (09May2024): This is a literature report for the following literature source. This is a follow-up report based on the receipt of the Full publication; the case has been updated to include additional information identified in the publication. Updated information included: Second reporter. Literature information (Journal name, DOI, pgs). Patient details (age, gender). Relevant medica history and lab data. Vaccine history. Suspect details (dose number)
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Latent autoimmune diabetes in adults
Clinical narrative: Latent autoimmune diabetes in adults; This is a literature report for the following literature source(s).  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "progressive weakness" (unspecified if ongoing); "polyuria" (unspecified if ongoing); "worsening confusion" (unspecified if ongoing); "Type 2 DM" (ongoing), notes: in her mother. The patient's family history included: "positive for suspected Type 1 DM" (unspecified if ongoing), notes: in her father. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single, manufacturer unknown), for Covid-19 immunisation. The following information was reported: LATENT AUTOIMMUNE DIABETES IN ADULTS (hospitalization, medically significant, life threatening), 1 week after the suspect product(s) administration, outcome "unknown".  Clinical course: The patient presented with progressive weakness, polyuria, and worsening confusion. Patient was administered the second dose of Pfizer-BioNTech COVID-19 vaccine dose one week before her symptoms began. No sources of infection. Her family history is positive for suspected Type 1 DM in her father and Type 2 DM in her mother. On arrival, the patient was confused and only oriented to person. BMI was 35.4. Initial laboratory results signified DKA. The patient was eventually admitted to the medical ICU for management. Endocrinology was consulted. Other labs revealed a hemoglobin A1C of 15.1% (baseline A1C was 6.0), and increased glutamic acid decarboxylase antibodies (GAD) to > 250 with corresponding low C peptide levels suggesting Type 1 DM. Beta-hydroxybutyrate was >8. Follow-up labs post-admission revealed persistent elevated GAD levels, and C peptide remained low, further confirming LADA.  Follow-up (09May2024): This is a literature report for the following literature source. This is a follow-up report based on the receipt of the Full publication; the case has been updated to include additional information identified in the publication. Updated information included: Second reporter. Literature information (Journal name, DOI, pgs). Patient details (age, gender). Relevant medica history and lab data. Vaccine history. Suspect details (dose number)
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Maternal exposure timing unspecified, SARS-CoV-2 test, Serology test
Clinical narrative: Pregnant; tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 46-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Sep2023 as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Preganancies" (unspecified if ongoing), notes: Number of previous pregnancies: 3; "IVF" (unspecified if ongoing); "Miscarriages" (unspecified if ongoing); "POTS", start date: Mar2020 (unspecified if ongoing); "concussion" (unspecified if ongoing); "gestational diabetes" (unspecified if ongoing). Date of last menstrual period: Jun2023. The patient was 7 months pregnant at the event onset. The patient is expected to deliver one baby(s). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jan2024, outcome "unknown" and all described as "tested positive for COVID"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "Pregnant". The baby was delivered full-term, via cesarean route. The baby weighed 6 lbs,10 ozs. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jan2024) Positive; (Jan2024) Negative, notes: tested negative about 5-7 days later; (27Jan2024) Positive; Serology test: (unspecified date) Normal. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was vaccinated twice with the Pfizer vaccine and the third time in Sep2023 with the Moderna vaccine. Patient was tested positive for COVID the first time on or around 13Jan2024. She was in her third trimester of pregnancy, delivered at 38 weeks. Patient did have gestational diabetes while pregnant. Patient also have had since Mar2020, POTS which got from a concussion and was diagnosed with in Oct2021 by OBGYN. Now that she was not pregnant, she no longer have diabetes and she did not have it prior to being pregnant. The mother did not smoke or drink alcohol or use illicit drugs during this pregnancy. She did IVF with her frozen eggs from 37 so the risk factors of age were long with the fetus.
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Insomnia, Overdose
Clinical narrative: insomnia exacerbated; given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml. [vaccine overdose]; Initial information was received on 26-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age child and unknown gender patient who experienced insomnia exacerbated and given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml. [vaccine overdose] while receiving vaccines MODERNA COVID-19 VACCINE and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Insomnia and Premature baby.   On 09-Feb-2024, the patient received a 1 dosage form (DF) of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT8109LA via intramuscular route in unknown administration site for Immunisation On 09-Feb-2024, the patient received a 0.5 ml dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur lot AU5556B via intramuscular route in unknown administration site for Covid-19 Immunistaion.  On 09-FEB-2024 the patient had insomnia exacerbated (insomnia) and given the 6-11 year old vaccine, however, each child was given (drawn up) the entire contents of the vial which came out to 0.5 ml. [vaccine overdose] (overdose) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE and following the administration of MODERNA COVID-19 VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.