chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; Information has been received from the database (agency# not reported) on 12-JAN-2024.  This spontaneous report has been received from the database concerning to an elderly female patient between 70-74 years old.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) (strength, dose, frequency, route of administration, anatomical location, lot# and expiration date were not reported) as prophylaxis.  On an unspecified date in 2018, the patient experienced pneumococcal infection. At the reporting time, the outcome for the pneumococcal infection was not provided.  Causal relationship between the pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) and the event of pneumococcal infection was not provided. Upon internal review, the event of pneumococcal infection was considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; Information has been received from the database (agency# not reported) on 12-JAN-2024.  This spontaneous report has been received from the database concerning to an elderly male patient of more than 85-years-old.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with one dose of pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) (strength, dose, frequency, route of administration, anatomical location, lot# and expiration date were not reported) as prophylaxis.  On an unspecified date in 2018, the patient experienced pneumonia pneumococcal. At the reporting time, the outcome for the pneumonia pneumococcal was not provided.  Causal relationship between the pneumococcal 23v polysaccharide vaccine (PENUMOVAX23) and the event of pneumonia pneumococcal was not provided. Upon internal review, the event of pneumonia pneumococcal was considered to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection (other); Information has been received from Regulatory Authority (Agency # not provided) on 12-JAN-2024.   Information has been received from the Regulatory Authority, regarding an adult male patient of unknown age (age group: 60  64 years). The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) (dosage information, route of administration and lot number were not provided) for prophylaxis,   On an unknown date in 2018, the patient experienced pneumococcal infection (reported as: other).  The pneumococcal serotyping was reported as: not available.   The outcome of pneumococcal infection and the causality assessment with the suspect vaccine were not provided.   Upon internal review pneumococcal infection was considered to be a medically significant event.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Health Agency (agency number not provided) on 12-JAN-2024.  This spontaneous report was received from Regulatory Authority, regarding a elderly male  patient (reported as age group: between 75-79). The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of pneumococcal 23v polysaccharide vaccine as prophylaxis (PNEUMOVAX23), injection (strength, exact dose, route and site of administration, lot number, and expiration date were not provided).  On an unknown date in 2012, the patient experienced Pneumonia with streptococcus pneumoniae serotyping not available (streptococcus pneumoniae pneumonia). The outcome of the event was not provided.  The causal relationship between streptococcus pneumoniae pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event streptococcus pneumoniae pneumonia was considered as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from Health Agency (agency number not provided) on 12-JAN-2024.  This spontaneous report was received from Surveillance System (SS), regarding a elderly female  patient (reported as age group: more than 85). The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection  as prophylaxis (strength, exact dose, route and site of administration, lot number, indication, and expiration date were not provided).  On an unknown date in 2012, the patient experienced Pneumonia with streptococcus pneumoniae serotyping not available (streptococcus pneumoniae pneumonia). The outcome of the event was not provided.  The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event streptococcus pneumoniae pneumonia was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: pneumonia; Information has been received from Health Agency (agency number not provided) on 12-JAN-2024.  This spontaneous report was received from Surveillance System, regarding a elderly male  patient (reported as age group: between 70-74). The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection as prophylaxis (strength, exact dose, route and site of administration, lot number, and expiration date were not provided)  On an unknown date in 2012, the patient experienced pneumonia with streptococcus pneumoniae serotyping Not Available (streptococcus pneumoniae pneumonia). The outcome of the event was not provided.  The causal relationship between streptococcus pneumoniae pneumonia  and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event streptococcus pneumoniae pneumonia was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
Clinical narrative: pneumonia; Information has been received from Health Agency (agency number not provided) on 12-JAN-2024.  This spontaneous report was received from database, regarding a adult male  patient (reported as age group: between 30-34). The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection  as prophylaxis (strength, exact dose, route and site of administration, lot number, and expiration date were not provided)  On an unknown date in 2012, the patient experienced pneumonia with streptococcus pneumoniae serotyping Not Available (streptococcus pneumoniae pneumonia). The outcome of the event was not provided.  The causal relationship between streptococcus pneumoniae pneumonia  and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event streptococcus pneumoniae pneumonia was considered as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal bacteraemia
Clinical narrative: Bacteraemia; Information has been received from Health Agency (agency number not provided) on 12-JAN-2024.  This spontaneous report was received from Regulatory Authority, regarding a elderly female  patient (reported as age group: between 75-79). The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection as prophylaxis (strength, exact dose, route and site of administration, lot number, expiration date were not provided)  On an unknown date in 2012, the patient experienced Bacteraemia with streptococcus pneumoniae serotyping not available (Pneumococcal bacteraemia). The outcome of the event was not provided.  The causal relationship between Pneumococcal bacteraemia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event Pneumococcal bacteraemia was considered as medically significant.
Sex: F
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Other-Pneumococcal infection; Information has been received from Health Agency (agency number not provided) on 12-JAN-2024.  This spontaneous report was received from Health Agency, regarding a elderly female  patient (reported as age group: between 80-84). The patient's medical history, concurrent conditions, past drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection as prophylaxis (strength, exact dose, route and site of administration, lot number, expiration date were not provided)  On an unknown date in 2012, the patient experienced Other-Pneumococcal infection with streptococcus pneumoniae serotyping showed not available (Pneumococcal infection). The outcome of the event was not provided.  The causal relationship between Pneumococcal infection and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event Pneumococcal infection was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection, Streptococcus test positive
Clinical narrative: Pneumococcal infection; Information has been received from Health Authority (agency number not provided), on 12-JAN-2024.   This spontaneous report has been received from National Notifiable Diseases Surveillance System (NNDSS), regarding to an adult (also reported as an age between 20-24-year-old) male patient.   The patient's pertinent concurrent conditions, medical history, past drug reactions or allergies, and concomitant therapies were not provided.   On an unknown date, the patient was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), injection, (strength, exact dose, route and site of administration, lot number, and expiration date were not provided), for prophylaxis.   On an unknown date in 2011, streptococcus pneumoniae serotyping was not available. On that same date, the patient experienced Pneumococcal infection. At the time of reporting, the outcome of the event was not provided.  The causality assessment between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event Pneumococcal infection was considered as medically significant.      National Notifiable Diseases Surveillance System (NNDSS)   Streptococcus pneumoniae serotyping (??-???-20XX): 18C
Sex: F
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Pneumonia; Information has been received from regulatory authority (Agency number not provided) on 12-JAN-2024.  This spontaneous report has been received from the regulatory authority, regarding to an adult (reported as between 60-to-64-year-old) female patient. The patient's pertinent medical history, previous drug reactions or allergies, concurrent conditions, and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (strength, dosage, vaccination scheme frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis.  On an unspecified date in 2012, streptococcus pneumoniae serotyping was reported as not available. On the same date, the patient experienced streptococcus pneumoniae pneumonia (pneumonia pneumococcal). At the time of reporting, the outcome of the event and the causality assessment between the event with the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) were not reported.  Upon internal review, the pneumonia pneumococcal event was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal, Streptococcus test
Clinical narrative: Pneumonia; Information has been received from {HA} on 12-JAN-2024.  This spontaneous report has been received from the agency concerning a male patient between 50-54 year-old.   The patient's medical history, concurrent conditions and concomitant medication were not reported. Vaccines were given but not specified.   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). Total vaccinations: 1  On an unknown date in 2021, the patient experienced pneumonia.  On unknown date, a streptococcus pneumoniae serotyping (no results reported).  At the time of reporting, the outcome of the event Pneumococcal infection was not known.   The action taken with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23)  regarding Pneumococcal infection was reported as Not Applicable.    The causal relationship between pneumonia and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was unknown.  Upon internal review, the event of pneumonia was considered to be medically significant.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Patient who received first dose of GARDASIL 9 on 7/2022, second dose on 5/2023 and third dose on 7/2023.; This spontaneous report was received from a pharmacist and refers to a 24-year-old female patient. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On unknown date in July 2022, May 2023 and July 2023 respectively, the patient was vaccinated with a first, second and third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), for prophylaxis (quantity dose, lot #, expiration date and route were not reported) (inappropriate schedule of product administration). No additional adverse event and nor product quality complain were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who was inadvertently administered expired MMR-II (w/ no TEs) on 1/15/2024--SUPPORTED via post-expiry memo. No symptoms reported. Obtained consent to contact HCP. No additional AE/PQC.; This spontaneous report was received from other reporter and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-JAN-2024, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter/dose, administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) (lot number W017556 has been verified to be a valid lot number, expiration date reported and validated as 07-JAN-2024) (expired product administered). There were no symptoms or additional adverse event reported.
Age: 47.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product prescribing issue
Clinical narrative: No additional AE; it was recommended by the patients doctor even though patient is over 45 years old; Information was received from the pharmacist concerning a 47-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications and drug reactions or allergies were not reported.  On 26-OCT-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, frequency, route of administration, lot number, expiration date and anatomical location were not reported) for prophylaxis. The reporter stated it was recommended by the patient's doctor even though the patient was over 45 years old but the reporter did not know the reason for the recommendation (off label use). The reporter also stated the patient was late for her the second dose and had not yet received it. The patient had not reported any symptoms. No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP reports no issues or side effects; HCP called to report that an expired dose of MMR II was administered to a patient today 1/17/2024.; This spontaneous report has been received from a nurse, referring to patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 17-JAN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter once, lot #W009105, expiration date: 04-DEC-2023), therapy type rHA, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event and product quality complain (No adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported AE on behalf of a patient who received administration of expired dose of PNEUMOVAX23 (PFS) on 1/11/2024; No additional AE/PQC.; This spontaneous report has been received from a pharmacist, referring to patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-JAN-2024, the patient was vaccinated with an expired dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23 SYRINGE (DEVICE)) injection, 0.5 milliliter, (lot #W019533, expiration date: 30-SEP-2023), administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event and product quality complain (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported; Customer called and report that ROTATEQ involved in a temperature excursion was administered to a patient after the excursion.; This spontaneous report was received from a physician (conflicting information, also reported as a customer) referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.  On 16-JAN-2024, the patient was vaccinated with one dose of rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (lot#: 1979978, expiration date was not reported but upon internal validation indicated as 14-OCT-2024; strength was not provided) orally for prophylaxis. The vaccine administered experienced temperature excursion at 61.2F for 7 hours and 45 minutes before (product storage error). No other previous temperature excursion occurred. No patient symptoms have been reported (no adverse event).  This case was received from the same reporter with 2401USA008381, 2401USA008754, 2401USA009485, and 2401USA008919.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP reported an 18 year-old patient received their first dose of PROQUAD on 10JAN2024. Confirmed no symptoms or side effects reported. No additional AE/no PQC.; This spontaneous report was received from a nurse, referring to an 18-year-old patient of unknown gender..  The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On 10-JAN-2024, the patient was vaccinated with their first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (product administered to patient of inappropriate age) injection, at a dose of 0.5 milliliter, administered for prophylaxis (lot #x021759 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) expiration date was reported and upon internal validation has been established as: 23-FEB-2025; anatomical location of vaccination, strength, and route of administration were not provided); and also received sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). It was confirmed that no symptoms or side effects reported and no additional adverse event (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: Received both doses of Heplisav-B in series and did not seroconvert; Initial report received on 10-Nov-2023  A non-significant follow-up report received on 20-Nov-2023 that included the QA investigation results of the mixed product quality complaint: the investigation did not identify a potential lot-related issue, there was no trend.  No potential impact to the lots were identified.     A registered nurse reported that a 73-year-old male patient (race and ethnicity not provided) received both doses of HEPLISAV-B (hepatitis B vaccine) in the series for hepatitis B immunization and did not seroconvert.  Medical history was reported as pulmonary fibrosis, coronary artery calcification, benign prostatic hyperplasia, and high cholesterol. The patient had no known allergies or prior hepatitis B vaccines. There was no data on previous vaccine reactions. At the time of vaccination, the patient was about to undergo a lung transplant.   Concomitant mediations at the time of vaccination were reported as Lipitor (atorvastatin), prednisone, and Ofev (nintedanib).  On 08-Sep-2023, the patient received the first dose of HEPLISAV-B (Lot # 943007; expiration date and NDC # not available; and route of administration and injection site were not reported).   On 08-Oct-2023, 31 days after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 943186; expiration date and NDC # not available; and route of administration and injection site were not reported).  On 01-Nov-2023, 25 days after having been vaccinated with the second dose of HEPLISAV-B, serological laboratory testing results showed no immunity (less than a level of 5).   No additional information was available.  Company Comment: The company assessed the event as non-serious, and not immunologically confirmed for vaccine failure as no serological marker was reported and the time to serological testing was less than 4 weeks.; Sender's Comments: The company assessed the event as non-serious, and not immunologically confirmed for vaccine failure as no serological marker was reported and the time to serological testing was less than 4 weeks.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial report received on 11-Nov-2023  A patient's husband reported to the HEPLISAV-B Pregnancy Registry that a pregnant female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or concomitant medications were reported.   The last menstrual period date, pregnancy history, and pregnancy risk factors were not reported.   On an unspecified date in 2023, the pregnant patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported). She planned to have her baby "soon."  No further follow-up will be conducted by the Pregnancy Registry. The patient's husband did not provide permission for company to follow up.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Heplisav-B was Given to Three Patients Who Were Pregnant; Initial report received on 17-Nov-2023  A pharmacist reported that a pregnant female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history, allergies, or concomitant medications at the time of vaccination were reported.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On an unspecified date, the pregnant patient in her first trimester, received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported).   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Heplisav-B was Given to Three Patients Who Were Pregnant; Initial report received on 17-Nov-2023  A pharmacist reported that a pregnant female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history, allergies, or concomitant medications at the time of vaccination were reported.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On an unspecified date, the pregnant patient in her third trimester, received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported).   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Heplisav-B was Given to Three Patients Who Were Pregnant; Initial report received on 17-Nov-2023  A pharmacist reported that a pregnant female (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history, allergies, or concomitant medications at the time of vaccination were reported.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On an unspecified date, the pregnant patient in her third trimester, received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported).   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; Initial report received on 21-Nov-2023  A pharmacist reported that a 28-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and later reported that she was pregnant.  No medical history, allergies, or concomitant medications at the time of vaccination were reported.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported. Gestational age was unknown.  On an unspecified date in Nov-2023, the patient received a dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site were unknown).   Three days after having been vaccinated with HEPLISAV-B, the patient reported that she was pregnant.   No additional information was available.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure / Shingles; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / Shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 13-JAN-2024 This case was reported by a patient via interactive digital media. The patient got the shots of Shingles vaccine but two months after the second shot he/she still got shingles.  The patient stated that they were not too bad and with some medicine they passed fairly quick. Glad they were not a bad case and glad he/she got the shots. This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Insomnia, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in back; Severe pain in back and right side of neck; Severe pain in back and right side of neck, right hand; tingling in right foot; Clavicle also swelled up; trying to sleep is the most miserable time; drug used for unapproved indication; This non-serious case was reported by a consumer and described the occurrence of back pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix .5 ml. On 16-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: drug used for unapproved indication). On 24-OCT-2023, the patient experienced back pain (Verbatim: Severe pain in back), neck pain (Verbatim: Severe pain in back and right side of neck), pain in hand (Verbatim: Severe pain in back and right side of neck, right hand), tingling of extremity (Verbatim: tingling in right foot), bone swelling (Verbatim: Clavicle also swelled up) and difficulty sleeping (Verbatim: trying to sleep is the most miserable time). The outcome of the back pain, neck pain, pain in hand, tingling of extremity, bone swelling and difficulty sleeping were not resolved and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the back pain, neck pain, pain in hand, tingling of extremity, bone swelling and difficulty sleeping to be related to Shingrix.     It was unknown if the company considered the back pain, neck pain, pain in hand, tingling of extremity, bone swelling and difficulty sleeping to be related to Shingrix.   Additional Information: GSK receipt date:12-JAN-2024 The reporter reported that a patient received Shingrix vaccine on 16th august 2023 and experienced severe pain in back and right side of neck, right hand, tingling in right foot,clavicle also swelled up on 24th October 2023. The patient was always enjoyed excellent health and she was am very active, walk 2.5 miles every day and do other exercises and plenty of housework.  Did not taken medications.  The patient was distressed and go for the shingles vaccine and feel terrible pain at night and trying to sleep was the most miserable time.  The patient want second dose but afraid to get it. The patient would discuss with my primary doctor soon. Shingrix used for neuropathic pain indication which led to product use for unapproved indication. The reporter requested to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product use in unapproved indication, Swelling
Clinical narrative: Severe pain in back; Severe pain in back and right side of neck; Severe pain in back and right side of neck, right hand; tingling in right foot; Clavicle also swelled up; trying to sleep is the most miserable time; drug used for unapproved indication; This non-serious case was reported by a consumer and described the occurrence of back pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-AUG-2023, the patient received the 1st dose of Shingrix .5 ml. On 16-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: drug used for unapproved indication). On 24-OCT-2023, the patient experienced back pain (Verbatim: Severe pain in back), neck pain (Verbatim: Severe pain in back and right side of neck), pain in hand (Verbatim: Severe pain in back and right side of neck, right hand), tingling of extremity (Verbatim: tingling in right foot), bone swelling (Verbatim: Clavicle also swelled up) and difficulty sleeping (Verbatim: trying to sleep is the most miserable time). The outcome of the back pain, neck pain, pain in hand, tingling of extremity, bone swelling and difficulty sleeping were not resolved and the outcome of the drug use for unapproved indication was unknown.   It was unknown if the reporter considered the back pain, neck pain, pain in hand, tingling of extremity, bone swelling and difficulty sleeping to be related to Shingrix.     It was unknown if the company considered the back pain, neck pain, pain in hand, tingling of extremity, bone swelling and difficulty sleeping to be related to Shingrix.   Additional Information: GSK receipt date:12-JAN-2024 The reporter reported that a patient received Shingrix vaccine on 16th august 2023 and experienced severe pain in back and right side of neck, right hand, tingling in right foot,clavicle also swelled up on 24th October 2023. The patient was always enjoyed excellent health and she was am very active, walk 2.5 miles every day and do other exercises and plenty of housework.  Did not taken medications.  The patient was distressed and go for the shingles vaccine and feel terrible pain at night and trying to sleep was the most miserable time.  The patient want second dose but afraid to get it. The patient would discuss with my primary doctor soon. Shingrix used for neuropathic pain indication which led to product use for unapproved indication. The reporter requested to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: never followed up with getting a 2nd shot.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got the first Shingrix shot about 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never followed up with getting a 2nd shot.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-JAN-2024 The patient got the first Shingrix shot about 2 years ago but never followed up with getting a 2nd shot. The reporter asked if needed just one more shot at that point or needed to start over and get 2 shots within a few months of each other. Till the time of reporting the patient did not received the 2nd dose, which led to incomplete course of vaccination. The reporter requested consent to follow up.
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered yesterday an expired dose of Havrix to a 63 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 11-JAN-2024, the patient received Havrix. On 11-JAN-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Administered yesterday an expired dose of Havrix to a 63 year old patient). The outcome of the expired vaccine used 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: 12-JAN-2024 An healthcare professional (HCP) reported that one of the MAS in her facility administered yesterday (day before reporting date) an expired dose of Havrix to a patient. The reporter asked if the patient should be re-vaccinated. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix series for a patient who received 1st dose on 21AUG2023/ 2nd dose had not been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 21-AUG-2023, batch number:2PG39 and expiry date:19-Sep-2025).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: Twinrix series for a patient who received 1st dose on 21AUG2023/ 2nd dose had not been administered). The outcome of the incomplete course of vaccination 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: 12-JAN-2024 The reporter requested data on continuation of Twinrix series for a patient who return back for 2nd dose of Twinrix.  The 2nd dose of Twinrix had not been administered at time of call. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix adult, which led to incomplete course of vaccination.
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of an adult Engerix-B dose to a 3-year-old patient; administration of an adult Engerix-B dose to a 3-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 3-year-old female patient who received HBV (Engerix B adult) (batch number 79S54, expiry date 04-APR-2025) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: administration of an adult Engerix-B dose to a 3-year-old patient) and adult product administered to child (Verbatim: administration of an adult Engerix-B dose to a 3-year-old patient). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 16-JAN-2024 An Association called to report the administration of an adult Engerix-B dose to a 3-year-old patient, which led to overdose and adult use of a child product. The health care professional (HCP) asked for guidance on this situation. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First Shingrix dose in October of 2021/has not yet had the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: First Shingrix dose in October of 2021/has not yet had the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-JAN-2024 The patient was reporter. The patient reported that he had received his first Shingrix dose in October of 2021 and has not yet had the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 7.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix was given to a 7-year-old patient unintendedly instead of a boostrix dose; Wrong vaccine administered; 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 7-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2227K, expiry date 17-JAN-2026) for prophylaxis.   On 11-JAN-2023, the patient received Pediarix. On 11-JAN-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix was given to a 7-year-old patient unintendedly instead of a boostrix dose) and wrong vaccine administered (Verbatim: Wrong vaccine administered). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JAN-2024 The medical assistant called to report that Pediarix was given to a 7 year old patient unintendedly instead of a boostrix dose which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received their first dose of Shingrix in 2019 and 2nd dose in 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) (batch number 4G95T, expiry date 23-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (In 2019, received first dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient received their first dose of Shingrix in 2019 and 2nd dose in 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 17-JAN-2024 The reporter reported that a patient received their first dose in 2019 and second dose in 2023. The vaccine administration facility was the same as primary reporter. Reporter did not provide a patient date of birth or general age during call. The reporter consented to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: patient received a pediatric dose of Engerix B; patient received a pediatric dose of Engerix B; Engerix B was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 62-year-old female patient who received HBV (Engerix B 10 mcg) (batch number P49X7, expiry date 07-DEC-2023) for prophylaxis.   On 16-JAN-2024, the patient received Engerix B 10 mcg. On 16-JAN-2024, an unknown time after receiving Engerix B 10 mcg, the patient experienced adult use of a child product (Verbatim: patient received a pediatric dose of Engerix B), underdose (Verbatim: patient received a pediatric dose of Engerix B) and expired vaccine used (Verbatim: Engerix B was expired). The outcome of the adult use of a child product, underdose and expired vaccine used were unknown.   Additional Information: GSK Receipt Date: 17-JAN-2024 A healthcare professional (HCP). The HCP reported that an adult patient received a pediatric dose of Engerix B (10mcg) on January 16, 2024, which led to adult use of a child product and under dose. In addition, the Engerix B was expired, which led to expired vaccine used. The reporter consented to follow up.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: A pharmacist reported that a male patient received an incorrectly reconstituted dose of Menveo on 21Oct2023. The lyophilized portion was reconstituted with the diluent used for Merk MMR vaccine; A pharmacist reported that a male patient received an incorrectly reconstituted dose of Menveo on 21Oct2023. The lyophilized portion was reconstituted with the diluent used for Merk MMR vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 23-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA950A, expiry date 31-JUL-2024) for prophylaxis.   On 21-OCT-2023, the patient received Menveo. On 21-OCT-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: A pharmacist reported that a male patient received an incorrectly reconstituted dose of Menveo on 21Oct2023. The lyophilized portion was reconstituted with the diluent used for Merk MMR vaccine) and inappropriate dose of vaccine administered (Verbatim: A pharmacist reported that a male patient received an incorrectly reconstituted dose of Menveo on 21Oct2023. The lyophilized portion was reconstituted with the diluent used for Merk MMR vaccine). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-JAN-2024 The reporter reported that a patient received an incorrectly reconstituted dose of Menveo and the lyophilized portion was reconstituted with the diluent used for Merk MMR vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up via email.