chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC20, RSV, PNC20, RSV
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Injection site warmth, Urticaria
Clinical narrative: golf sized lump at injection site; Fever/temp 100.5/felt hot; chills; itching at injection site; redness at injection site and spreading- encompassing all upper arm; pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for prophylaxis.   On 01-DEC-2023, the patient received Arexvy (right arm) and Prevnar 20 (right arm). On 01-DEC-2023, less than a day after receiving Arexvy, the patient experienced fever (Verbatim: Fever/temp 100.5/felt hot) and chills (Verbatim: chills). In DEC-2023, the patient experienced injection site pain (Verbatim: pain at injection site), injection site lump (Verbatim: golf sized lump at injection site), injection site itching (Verbatim: itching at injection site) and injection site erythema (Verbatim: redness at injection site and spreading- encompassing all upper arm). The patient was treated with diphenhydramine hydrochloride (Benadryl). In DEC-2023, the outcome of the injection site lump was resolved. The outcome of the injection site pain, injection site itching and injection site erythema were not resolved and the outcome of the fever and chills were resolved.   It was unknown if the reporter considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Arexvy.     It was unknown if the company considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Arexvy.   Additional Information: GSK receipt date: 15-DEC-2023 The reporter reported that patient received Arexvy and Prevnar 20 vaccines in right arm.  The patient was experienced felt hot and chills.  The patient took her temperature, and it was 100.5.  The patient also experienced redness, pain and itching at injection sites. The redness spread to encompass all upper arm area. And golf size lump at injection sites.  The patient was called health care professional  who recommended Benadryl.  The patient still had redness, pain and itchiness at injection site.  It was unknown if the reporter considered the injection site pain, injection site lump, injection site itching, injection site erythema, fever and chills to be related to Prevenar 20. The reporter did not consent to follow-up.
Age: 4.0
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 4 year old was administered BEXSERO by accident; This non-serious case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-year-old 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 inappropriate age at vaccine administration (Verbatim: a 4 year old was administered BEXSERO by accident). 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: 15-DEC-2023 The reporter stated that she was informed that a 4 year old was administered Bexsero by accident (Wrong Vaccine Administered), which led to inappropriate age at vaccine administration. No further information was known.  The reporter consented to follow up.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 month old male patient received a dose of Kinrix; 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 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 14-DEC-2023, the patient received Kinrix. On 14-DEC-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 5 month old male patient received a dose of Kinrix). 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: 15-DEC-2023 A medical assistant reported that a 5 month old male patient received a dose of Kinrix which led to inappropriate age at vaccine administration. No symptoms reported. The reporter consented to follow up via email. This case is of patient 1 of 2.; Sender's Comments:  US-GSK-US2023175975:patient 1
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Underdose
Clinical narrative: administration of less than the recommended volume of Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 78-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number dd372, expiry date 24-FEB-2025) for prophylaxis.   On 15-DEC-2023, the patient received the 1st dose of Arexvy. On 15-DEC-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: administration of less than the recommended volume of Arexvy). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2023 The pharmacist was inquiring about Arexvy and what information was available about the administration of less than the recommended volume of Arexvy, which led to incomplete dose administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Nurse stated that a patient received the first dose of Arexvy in October and the second dose today; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G479Y) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 15-DEC-2023, the patient received the 2nd dose of Arexvy. On 15-DEC-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Nurse stated that a patient received the first dose of Arexvy in October and the second dose today). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 15-DEC-2023 A nurse reported that a patient received the first dose of Arexvy in October and the second dose on the reporting day, which led to extra dose administered.  No side effects were noted by the reporter.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles rash for 30 days in his right hip, then in left chest area; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles rash for 30 days in his right hip, then in left chest area). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date:18-DEC-2023 The reporter was patient. The patient reported that, she received 2 shots Shingrix a couple or years ago. The patient developed rash for 30 days in his right hip then in left chest area that had not resolved at the time of reporting. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: chronic hives; This non-serious case was reported by a consumer and described the occurrence of hives in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure. Concomitant products included amlodipine and lisinopril.   On 08-SEP-2023, the patient received Shingrix. On 11-DEC-2023, 94 days after receiving Shingrix, the patient experienced hives (Verbatim: chronic hives). The patient was treated with cetirizine hydrochloride (Cetrizine). The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK receipt date: 15-DEC-2023 The reporter was the patient. The reporter reported that he had received the Shingrix vaccine. The reporter stated that he had experienced chronic hives after the Shingrix vaccine. The reporter stated that he had also received the Cetrizine 20mg per day for had little effect. The reporter did not consented to follow up.
Age: 56.0
Sex: M
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Rash vesicular
Clinical narrative: These appear to be shingles-type rashes on my right front trunk and left back; This non-serious case was reported by a consumer and described the occurrence of vesicular rash in a 56-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Elasomeran (Moderna COVID-19 vaccine) for prophylaxis and Influenza vaccine for prophylaxis.   On 17-DEC-2023, the patient received the 2nd dose of Shingles vaccine, Moderna COVID-19 vaccine and Influenza vaccine. On 17-DEC-2023, less than a day after receiving Shingles vaccine, the patient experienced vesicular rash (Verbatim: These appear to be shingles-type rashes on my right front trunk and left back). The outcome of the vesicular rash was not resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingles vaccine.     It was unknown if the company considered the vesicular rash to be related to Shingles vaccine.   Additional Information: RA Receipt Date: 17-DEC-2023 This report was submitted via the online direct entry reporting system. The patient self-reported this case. The patient had rash on trunk, these appeared to be shingles-type rashes on right front trunk and left back. The patient received the Shingrix vaccine,  Moderna Covid vaccine and Flu vaccine at the same time. The patient was healthy and no chronic conditions. The symptoms were not treated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Migraine, Pain, Pyrexia, Vomiting
Clinical narrative: Migraine; Vomitting; Fever; Body aches; she was out of work for 1 week; This non-serious case was reported by a consumer via call center representative and described the occurrence of migraine in a female patient who received Herpes zoster (Shingrix) (batch number J3CD5) for prophylaxis.   On 23-SEP-2023, the patient received the 1st dose of Shingrix (left deltoid). In SEP-2023, 12 hrs after receiving Shingrix, the patient experienced migraine (Verbatim: Migraine), vomiting (Verbatim: Vomitting), fever (Verbatim: Fever) and general body pain (Verbatim: Body aches). On an unknown date, the patient experienced inability to work (Verbatim: she was out of work for 1 week). In SEP-2023, the outcome of the migraine, vomiting and general body pain were resolved (duration 2 days) and the outcome of the fever was resolved (duration 4 days). The outcome of the inability to work was resolved (duration 1 week).   It was unknown if the reporter considered the migraine, vomiting, fever, general body pain and inability to work to be related to Shingrix.     It was unknown if the company considered the migraine, vomiting, fever, general body pain and inability to work to be related to Shingrix.   Additional Information: GSK receipt date: 13-DEC-2023 Customer stated that she received her first dose of Shingrix and reported that she was out of work for 1 week after getting her first dose of Shingrix due to symptoms experienced. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Syringe issue, Underdose
Clinical narrative: a patient received Arexvy half of the dose due a syringe malfunction; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number XP24G, expiry date 29-MAR-2025) for prophylaxis.   On 15-DEC-2023, the patient received Arexvy (intramuscular). On 15-DEC-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: a patient received Arexvy half of the dose due a syringe malfunction). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2023 The pharmacist reported that the patient received Arexvy half of the dose due a syringe malfunction which led to accidental underdose and pharmaceutical product complaint. The reporter did not consent to follow-up.  The reported that permission to storage personal information within Medical information database declined.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Shingrix on September 27th after receiving her first dose on September 22nd of the same year; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number TF3A9, expiry date 08-OCT-2024) for prophylaxis.   Co-suspect products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of SHINGRIX. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: second dose of Shingrix on September 27th after receiving her first dose on September 22nd of the same year). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2023 The reporter was pharmacy student called stating patient received her second dose of Shingrix on September 27th after receiving her first dose on September 22nd of the same year.  The reporter stated that she had no information on how patient responded since she was not able to speak to her but assumes ok since the patient wanted another shot. The reporter consented to follow up. The year of vaccination not collected so did not want to assume it was 2023. The reporter stated that she might not be at the pharmacy should safety follow up since she was a pharmacy student but provided postal address for follow up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MA reports a 6 month old patient received Kinrix today; 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 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number mz379, expiry date 25-JAN-2025) for prophylaxis.   On 15-DEC-2023, the patient received Kinrix. On 15-DEC-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: MA reports a 6 month old patient received Kinrix today). 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: 15-DEC-2023 A medical assistant reported a 6-month-old patient received Kinrix on the day of reporting, which led to inappropriate age at vaccine administration. The reporter mentioned that the patient was off schedule with DTaP and IPV vaccination and that was his 2nd DTaP and Polio. Brand of previous vaccine of each was unknown. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: the administration of Shingrx vaccine reconstituted with Varivax diluent; the administration of Shingrx vaccine reconstituted with Varivax diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 47PH9, expiry date 23-SEP-2025) for prophylaxis.   On 13-DEC-2023, the patient received Shingrix. On 13-DEC-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: the administration of Shingrx vaccine reconstituted with Varivax diluent) and inappropriate dose of vaccine administered (Verbatim: the administration of Shingrx vaccine reconstituted with Varivax diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date:15-DEC-2023 The healthcare professional called to report the administration of Shingrx vaccine reconstituted with Varivax diluent. The healthcare professional asked if the dose was valid or if it should be repeated. The reporter consented to follow up. The patient was given the Shingrix vaccine reconstituted with Varivax diluent, which led to Wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: wrote prescription for AREXVY for an immunocompromised patient under 60yoa; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in unapproved age group in a 55-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced off label use in unapproved age group (Verbatim: wrote prescription for AREXVY for an immunocompromised patient under 60yoa). The outcome of the off label use in unapproved age group was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2023 A Doctor of Medicine wrote prescription for Arexvy for an immunocompromised patient under 60 years of age, which led to off label use in an unapproved age group. The reporter did not consent to follow-up.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 5 month old female patient received a dose of Kinrix on 14Dec2023; 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 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   On 14-DEC-2023, the patient received Kinrix. On 14-DEC-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 5 month old female patient received a dose of Kinrix on 14Dec2023). 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: 15-DEC-2023 The reporter was a medical assistant. The reporter reported that a 5-month-old female patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. No symptoms were reported. This was 1 of 2 linked cases, reported by the same reporter. The reporter consented to follow up via email.; Sender's Comments:  US-GSK-US2023175974:patient 1
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7MH39, expiry date 18-NOV-2023) for prophylaxis.   On 08-DEC-2023, the patient received Boostrix. On 08-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired vaccine administration). 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: 17-DEC-2023 The reporter had an inquiry regarding some excursion data for Boostrix. The reporter stated that he/he was a retail pharmacist who had a patient who received the Boostrix vaccine, but the expiration date had not been checked prior to vaccine administration, and the vaccine had expired which led to expired vaccine used. The vaccine had been kept with our stock in the fridge at stable temperatures, and the reporter just wanted to know whether this should be a cause for concern. The vaccine administration facility is the same as primary reporter.
Age: 38.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product label confusion, Product use issue
Clinical narrative: At the time when Pfizer vaccine was approved for pregnant patients,; This patient already gave birth and it was a normal birth; Underage; This non-serious retrospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 38-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number gx45d, expiry date 19-OCT-2024) for prophylaxis.   On 24-OCT-2023, the patient received Arexvy. On 24-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: At the time when Pfizer vaccine was approved for pregnant patients,) and live birth (Verbatim: This patient already gave birth and it was a normal birth). The outcome of the inappropriate age at vaccine administration, vaccine exposure during pregnancy and live birth were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Live neonate with no apparent congenital anomaly   Additional Information: GSK receipt date: 18-DEC-2023 This patient already gave birth and it was a normal birth.  Med Tech stated there was confusion work wise.  They went off standing orders but have no standing order for RSV vaccines and that the script comes in from the provider.   There was lots of back and forth with who can give which vaccines.  At the time when Pfizer vaccine was approved for pregnant patients, they thought the 2 vaccines were interchangeable.  She stated the FDA website stated there were 2 separate RSV vaccines approved and ACIP recommendations sounded like you can use either one. The 38 year old pregnant patient received Arexvy, which led to inappropriate age at vaccine administration and vaccine exposure during pregnancy. The reporter consented to follow up. The case is link with US2023176718, US2023176724, by same reporter.; Sender's Comments:  US-GSK-US2023176718:Different patient US-GSK-US2023176724:Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she had dose 1 Shingrix about 2 yeas ago. She asks if she should get dose 2.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had dose 1 Shingrix about 2 yeas 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: she had dose 1 Shingrix about 2 yeas ago. She asks if she should get dose 2.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-DEC-2023 The caller mentions that she had dose 1 Shingrix about 2 yeas ago.  She asked if she should get dose 2. Education provided.  Till the time of reporting the patient did not received 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Pharmacist reports a 17 year old patient received an expired dose of the menveo vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva748a, expiry date 23-NOV-2023) for prophylaxis.   On 15-DEC-2023, the patient received the 1st dose of Menveo (left arm). On 15-DEC-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Pharmacist reports a 17 year old patient received an expired dose of the menveo vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-DEC-2023 The reporter reported that a patient received an expired dose of the Menveo vaccine, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: administration of pediatric Engerix-B dose to a 32 year old patient; administration of pediatric Engerix-B dose to a 32 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 32-year-old male patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 18-DEC-2023, the patient received the 3rd dose of Engerix B pediatric. On 18-DEC-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administration of pediatric Engerix-B dose to a 32 year old patient) and adult use of a child product (Verbatim: administration of pediatric Engerix-B dose to a 32 year old patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 18-DEC-2023 The reporter called to ask for information about the administration of pediatric Engerix B dose to a 32 year old patient which led to underdose and adult use of a child product. The Healthcare professional asked if they need to administered another pediatric dose in order to complete a full dose This should be the 3rd dose of the Engerix B series. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: they could store Shingrix in the freezer or the refrigerator; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted product storage error (Verbatim: they could store Shingrix in the freezer or the refrigerator). The outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt Date: 18-DEC-2023 The clinical supervisor stated that they were informed that they could store Shingrix in the freezer or the refrigerator, but had been storing it in the freezer which led to intercepted product storage error. The reporter consented to follow up via postal The vaccine administration facility is the same as primary reporter.
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 67 year old patient received a pediatric dose of Havrix; 67 year old patient received a pediatric dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 67-year-old female patient who received HAV (Havrix pediatric) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis.   On 18-DEC-2023, the patient received Havrix pediatric. On 18-DEC-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: 67 year old patient received a pediatric dose of Havrix) and adult use of a child product (Verbatim: 67 year old patient received a pediatric dose of Havrix). The outcome of the underdose and adult use of a child product 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: 19-DEC-2023 The nurse called to inform that a 67 year old patient received a pediatric dose of Havrix which led to adult use of a child product and underdose. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; 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 68-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 19-DEC-2023, the patient received the 4th dose of Boostrix. On 19-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administration of an expired dose). 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: 19-DEC-2023 A Healthcare Professional contacted GlaxoSmithKline via phone inquiring about Boostrix and what information was available about the administration of an expired dose which led to expired vaccine used. They asked to not be contacted and be kept anonymous. The reporter did not consent to follow-up. The vaccine administration facility is the same as primary reporter.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of BOOSTRIX; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 23-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-DEC-2023) for prophylaxis.   On 19-DEC-2023, the patient received Boostrix. On 19-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of BOOSTRIX). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-DEC-2023 The patient received an expired dose of Boostrix, which led to expired vaccine used. The reporter did not consent to follow-up.
Sex: U
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity, Psoriasis
Clinical narrative: psoriasis in the scalp, neck and upper back/shoulder blades which has now persisted for 5 weeks; within 12 hrs, extreme pain in the arms and hands, like glass shards poking me; Initial information received on 15-Dec-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This was a courtesy case received from Pfizer.  This case involves an unknown age and unknown gender patient who experienced psoriasis in the scalp, neck and upper back/shoulder blades which has now persisted for 5 weeks and within 12 hrs, extreme pain in the arms and hands, like glass shards poking me after receiving Covid-19 vaccine and influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 18-Oct-2023, the patient received a dose 1 of suspect covid-19 vaccine not produced by Sanofi Pasteur lot hf9300 via unknown route in the left arm (formulation, strength and expiration date: not provided) for immunisation.  On 28-Oct-2023, the patient received a dose 1 of suspect influenza quadrival a-b vaccine Suspension for injection lot 49281-423-88/U8201EA via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On Oct-2023 the patient developed a non-serious within 12 hrs, extreme pain in the arms and hands, like glass shards poking me (pain in extremity) (latency- 12 hours) following the administration of influenza quadrival a-b vaccine and covid-19 vaccine.  On 05-Nov-2023 the patient developed a non-serious psoriasis in the scalp, neck and upper back/shoulder blades which has now persisted for 5 weeks (psoriasis) 8 days following the administration of influenza quadrival a-b vaccine and 18 days following the administration of covid-19 vaccine.  Action taken- not applicable.  An unknown corrective treatment was received for the events.  At time of reporting, the outcome was Unknown for the event within 12 hrs, extreme pain in the arms and hands, like glass shards poking me and was Not Recovered / Not Resolved for the event psoriasis in the scalp, neck and upper back/shoulder blades which has now persisted for 5 weeks.
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was given only the DTaP-IPV portion of the vaccine. The ActHIB was not reconstituted and was not given with no reported adverse event; Initial information received on 14-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was given only the dtap-ipv portion of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] the acthib was not reconstituted and was not given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received am unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, expiry date and lot number) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was given only the dtap-ipv portion of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] the acthib was not reconstituted and was not given with no reported adverse event (product preparation error) (latency: same day).  It was reported, Recently a patient was given only the DTaP-IPV portion of the vaccine. The ActHIB was not reconstituted and was not given. What is the best way to catchup. Re-vaccinate w/ complete Pentacel or administer HIB only. Information from web/email communication. No additional information available from this first contact. Follow-up to be defined  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Age: 0.17
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave Fluzone QIV-NP to a patient who is 2 months old with no reported adverse event; gave Fluzone QIV-NP to a patient who is 2 months old thinking that it was a pneumonia vaccine with no reported adverse event; Initial information received on 14-Dec-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old and unknown gender patient who was given influenza quadrival A-B vaccine [Fluzone Quadrivalent] thinking that it was a pneumonia vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Dec-2023, a 2 months old patient received a dose of 0.5 ml once of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT8040JA; expiry date: 30-Jun-2024; strength: standard) via unknown route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day) thinking that it was a pneumonia vaccine with no reported adverse event (wrong product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: Now they have come to realize that one of those children received the diluent only rather than the actual vaccine. They are not sure which of the children received the diluent only with no reported adverse event; Initial information received on 15-Dec-2023 from country regarding an unsolicited valid non-serious case received from other health professional.  This case involves a Child and unknown gender patient who received the diluent only rather than the actual vaccine, they are not sure which of the children received the diluent only with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in Dec-2023, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (Frequency: once; Strength: standard) (lot number: UJ835AB; expiry date: unknown) via intramuscular route in unknown administration site for Immunization; patient received the diluent only (diluent is 0.4% saline) rather than the actual vaccine, they are not sure which of the children received the diluent only with no reported adverse event (product preparation error) (same day latency).  Treatment- vaccines will be repeated  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 positive; This spontaneous case was received on 06-Dec-2023 from Seqirus via Pfizer (reference number 202300414609), reported by a nurse and concerned a patient of an unreported age and gender.   The patient's medical history included COVID-19. The patient's concomitant medications were not reported. The patient's historical vaccines included an unspecified COVID-19 vaccine, after which the patient experienced allergy.    On 14-Sep-2023, the patient was vaccinated with influenza virus vaccine (reported as 'Seqirus') (brand not specified; anatomical location: left deltoid, dose, route of administration and indication: not reported). The batch number reported was 94447 (Batch number unable to be matched).  On 11-Oct-2023, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as '5', route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was HF9275.  On an unspecified date in Nov-2023, the patient was exposed to someone who was sick, and the patient first felt head cold and had a SARS-CoV-2 antigen test (reported as 'AG') which was negative.  On 18-Nov-2023, two months after receiving influenza virus vaccine and more than one month after receiving non-company, co-suspect COVID-19 vaccine and after exposure to someone who was sick, the patient started feeling ill, fatigue, myalgia, cold-like symptoms and head cold. The patient had no smell.  On 21-Nov-2023, the patient was tested with SARS-CoV-2 antigen test (reported as 'AG') and the nasal swab was positive.  At the time of initial reporting, the patient was recovering from the event of COVID-19.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A patient of unreported age developed COVID-19 approximately two months after receiving influenza virus vaccine and more than one month after receiving non-company, co-suspect COVID-19 vaccine. Based on biological implausibility, causal role of the suspect vaccine is assessed as not related.; Sender's Comments: A patient of unreported age developed COVID-19 approximately two months after receiving influenza virus vaccine and more than one month after receiving non-company, co-suspect COVID-19 vaccine. Based on biological implausibility, causal role of the suspect vaccine is assessed as not related.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Temporary loss of hearing in left ear (12 hours) with significant increase in perceived volume of tinnitus (permanent).
Sex: U
Vaccine: COVID19
Symptoms: Capillary permeability increased, Dizziness, Dyspnoea, Haemorrhage subcutaneous, Injection site haemorrhage
Clinical narrative: Acute:   Tachycardia up to 130 / min Lightheadedness Short of Breath Palpitation Body Itchiness Increased vascular permeability with visible small amount of subcutaneous bleeding at the site after measuring blood pressure  Administered liquid Xyzal 7.5mg which seems to gradually help
Sex: U
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Tachycardia
Clinical narrative: Acute:   Tachycardia up to 130 / min Lightheadedness Short of Breath Palpitation Body Itchiness Increased vascular permeability with visible small amount of subcutaneous bleeding at the site after measuring blood pressure  Administered liquid Xyzal 7.5mg which seems to gradually help
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Arthralgia, Gait disturbance, Joint swelling, Laboratory test abnormal
Clinical narrative: I noticed severe pain in all my smaller joints (hands) around April 15, 2023, and there was swelling in the small joints. I took painkillers and reported to my PCP. To my surprise, I was diagnosed with rheumatoid arthritis (autoimmune disease). I do not have any family history of autoimmune disease in my family. Now I am taking the highest doses of methotrexate and the pain is not completely gone yet after 6 months of continuous treatments. My day-to-day life is severely limited. I cannot go for walking anymore. I also took prednisone and had an episode of acute abdominal pain and I ended up in the emergency.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Rheumatoid arthritis
Clinical narrative: I noticed severe pain in all my smaller joints (hands) around April 15, 2023, and there was swelling in the small joints. I took painkillers and reported to my PCP. To my surprise, I was diagnosed with rheumatoid arthritis (autoimmune disease). I do not have any family history of autoimmune disease in my family. Now I am taking the highest doses of methotrexate and the pain is not completely gone yet after 6 months of continuous treatments. My day-to-day life is severely limited. I cannot go for walking anymore. I also took prednisone and had an episode of acute abdominal pain and I ended up in the emergency.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram normal, Injection site erythema, Injection site pain
Clinical narrative: Per pt "woozyness". Pt dizzy, especially when looking down.  Postural blood pressures are normal. EKG is normal.  No ear infection. Pt also had normal reaction of soreness and redness at injection site. Pt's blood pressure was elevated 165/93. 2 days prior her blood pressure was 129/77 and that is more of her normal BP. Pt prescribed meclizine 25 mg.
Age: 71.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Injection site paraesthesia, Paraesthesia
Clinical narrative: Approximately one week after receiving the Shingrix vaccine, I have started getting shooting, tingling sensations that start in my left shoulder and goes all the way down to my fingers.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Balance disorder, Dizziness, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Ears ringing, dizziness. Trouble standing, sitting, lying down due to lack of balance.   Had similar ears ringing and dizziness from last year's booster. Last year, I was prescribed a medication to help with balance and resolve dizziness. Last year, had MRI, Hearing Test and results were to return for hearing test in one year. I have not contacted my doctor yet about these most recent symptoms that are very similar to last year's.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears ringing, dizziness. Trouble standing, sitting, lying down due to lack of balance.   Had similar ears ringing and dizziness from last year's booster. Last year, I was prescribed a medication to help with balance and resolve dizziness. Last year, had MRI, Hearing Test and results were to return for hearing test in one year. I have not contacted my doctor yet about these most recent symptoms that are very similar to last year's.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test, Sinus congestion
Clinical narrative: Chest congestion, sinus congestion