chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Potential Extra Dose/patient and his wife think that he might have had the series maybe 5 years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 29GB3, expiry date 16-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (received series on an unknown date).   On 28-OCT-2023, the patient received the 3rd dose of Shingrix. On 28-OCT-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Potential Extra Dose/patient and his wife think that he might have had the series maybe 5 years ago). The outcome of the extra dose administered was unknown.   Additional Information: Pharmacist reported 72 year old patient was administered a 3rd dose of Shingrix which led to extra dose administered. The patient and his wife think that he might have already had the series maybe 5 years ago, but there was no record of that in the patient's medical record or with his insurance company. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. The reporter gave permission for follow-up
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: Only adjuvant administered; patient received only Arexvy adjuvant today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 59K92, expiry date 26-MAR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy. On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Only adjuvant administered) and inappropriate dose of vaccine administered (Verbatim: patient received only Arexvy adjuvant today). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 30-OCT-2023 The pharmacist called stating patient received only Arexvy adjuvant today (on the day of reporting), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix diluted with incorrect diluent; Shingrix diluted with incorrect diluent and was administered to patient; 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 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis.   On 30-OCT-2023, the patient received Shingrix. On 30-OCT-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix diluted with incorrect diluent) and inappropriate dose of vaccine administered (Verbatim: Shingrix diluted with incorrect diluent and was administered to patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 The pharmacist stated that he/she needed to speak with someone about Shingrix which was mixed with sterile diluent, not the adjuvent suspension component provided with product. The reporter had a situation where a healthcare professional diluted Shingrix with incorrect diluent and was administered to patient which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Malaise, Pain, Pain in extremity
Clinical narrative: overall not feeling well; shoulder pain radiating down arm/ Shoulder pain; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of feeling unwell in an unspecified number of patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced feeling unwell (Verbatim: overall not feeling well) and shoulder pain (Verbatim: shoulder pain radiating down arm/ Shoulder pain). The outcome of the feeling unwell was resolved and the outcome of the shoulder pain was unknown.   It was unknown if the reporter considered the feeling unwell and shoulder pain to be related to Arexvy.     It was unknown if the company considered the feeling unwell and shoulder pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 The field representative from Syneos reports speaking with a pharmacist.  The pharmacist reported to her that they had administered approximately 270 Arexvy vaccinations, all to patients over the age of 60.   He told her that about half of those 270 patients reported shoulder pain, with some reporting the pain radiating down their arm, and overall just not feeling well for a day or two. The reporter consented to follow up.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: patients were inadvertently administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 11-OCT-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: patients were inadvertently administered). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacy operations manager called to report three patients were inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days.  Manager mentioned the Boostrix was left in the stock room and three patients received it during that time. The HCP unable to provide vaccine details of lot and expiration. The patient received temperature excursed product, which led incorrect storage of drug. The reporter did not consent to follow-up from safety. The case is linked with case US2023151105 and US2023151106, reported by the same reporter, for different patients.; Sender's Comments:  US-GSK-US2023151106:same reporter US-GSK-US2023151105:Same reporter
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 18-OCT-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacy operations manager called to report three patients were inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days which led to incorrect storage of drug. The manager mentioned the Boostrix was left in the stock room and three patients received it during that time. Manager unable to provide vaccine details of Lot and expiration. The reporter did not consent to follow up. This case is linked with US2023151106 and US2023151104, same reporter.; Sender's Comments:  US-GSK-US2023151106:Same reporter US-GSK-US2023151104:Same reporter
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix that was exposed to 70 Fahrenheit for up to 32 days.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 20-OCT-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix that was exposed to 70 Fahrenheit for up to 32 days.). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2023 The pharmacy operations manager called to report three patients were inadvertently administered Boostrix that was exposed to 70 Fahrenheit for up to 32 days.  Manager mentioned the Boostrix was left in the stock room and three patients received it during that time. The HCP unable to provide vaccine details of lot and expiration. The patient received temperature excursed product, which led incorrect storage of drug. The reporter did not consent to follow-up from safety. The case is link with US2023151105, US2023151104, by same reporter.; Sender's Comments:  US-GSK-US2023151105:Same reporter US-GSK-US2023151104:same reporter
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a patient received their 2nd dose of Havrix one month after the first dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 34-year-old male patient who received HAV (Havrix 1440) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 1440).   On 30-OCT-2023, the patient received the 2nd dose of Havrix 1440. On 30-OCT-2023, an unknown time after receiving Havrix 1440, the patient experienced drug dose administration interval too short (Verbatim: a patient received their 2nd dose of Havrix one month after the first dose.). The outcome of the drug dose administration interval too short 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: 31-OCT-2023 The pharmacist called stating a patient received their 2nd dose of Havrix one month after the first dose. The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. (Drug dose administration interval too short) minus 4 days. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Fatigue, Headache, Lymph node pain, Pyrexia
Clinical narrative: tenderness in left underarm/axillary area; lymph nodes tender; feeling tried; fever; having a headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of axillary pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-OCT-2023, the patient received the 2nd dose of Shingrix (left deltoid). In OCT-2023, 2 days after receiving Shingrix, the patient experienced lymph node tenderness (Verbatim: lymph nodes tender), tiredness (Verbatim: feeling tried), fever (Verbatim: fever) and headache (Verbatim: having a headache). On 29-OCT-2023, the patient experienced axillary pain (Verbatim: tenderness in left underarm/axillary area). The outcome of the axillary pain, lymph node tenderness, tiredness, fever and headache were not resolved.   It was unknown if the reporter considered the axillary pain, tiredness, fever and headache to be related to Shingrix. The reporter considered the lymph node tenderness to be related to Shingrix.     It was unknown if the company considered the axillary pain, tiredness, fever and headache to be related to Shingrix. The company considered the lymph node tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-OCT-2023 The reporter received her 2nd Shingrix vaccine and one day later she developed tenderness in her left underarm / axillary area.  The reporter believed her lymph nodes are tender due to the Shingrix Vaccine.  And also reports being feeling tired, having a fever, and having a headache 2 days after receiving her 2nd dose of Shingrix.  All symptoms are not resolved. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: administered Kinrix as the 4th dose for DTAP series, following 3 doses of Pediarix; administered Kinrix at 3 years; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5AY2J, expiry date 10-JUN-2024) for prophylaxis.   Previously administered products included Pediarix (received 3 doses of Pediarix on an unknown date).   On 11-AUG-2023, the patient received Kinrix. On 11-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: administered Kinrix as the 4th dose for DTAP series, following 3 doses of Pediarix) and inappropriate age at vaccine administration (Verbatim: administered Kinrix at 3 years). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration 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: 31-Oct-2023 Medical assistant reported that Kinrix as the 4th dose for DTAP series, following 3 doses of Pediarix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received a dose of Kinrix as 4th dose for DTAP series at an inappropriate age, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: body-wide rash; This non-serious case was reported by a physician via sales rep and described the occurrence of generalized rash in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-OCT-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced generalized rash (Verbatim: body-wide rash). In OCT-2023, the outcome of the generalized rash was resolved (duration 6 days).   It was unknown if the reporter considered the generalized rash to be related to Shingrix.     It was unknown if the company considered the generalized rash to be related to Shingrix.   Additional Information: GSK Receipt Date - 31-OCT-2023 The reporter reported after Shingrix vaccination, the patient developed a non-painful, non-pruritic, body-wide rash that resolved after 6 days. Nothing else was reported.  The reporter consented to follow up
Age: 13.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Extra dose administered
Clinical narrative: Havrix Extra dose administration; administration of an extra dose of Engerix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number ZP72X, expiry date 15-DEC-2024) for prophylaxis.   On 17-OCT-2023, the patient received the 3rd dose of Havrix and the 4th dose of Engerix B. On 17-OCT-2023, an unknown time after receiving Havrix and not applicable after receiving Engerix B, the patient experienced extra dose administered (Verbatim: Havrix Extra dose administration) and extra dose administered (Verbatim: administration of an extra dose of Engerix vaccine). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date - 31-OCT-2023 The heath care professional called to report the administration of an extra dose of both Havrix and Engerix vaccines. The patient received the third dose of Havrix and the fourth dose of Engerix-B which led to extra dose administered. The heath care professional asked for guidance on this situation.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: inappropriate schedule of vaccine 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 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 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: inappropriate schedule of vaccine administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The patient had not received 2nd dose of Shingrix yet. The reporter forgot to ask about follow up, pharmacy address in health care professional (HCP) details. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Occupational exposure to product
Clinical narrative: while drawing it out the pressure squirted the vaccine in their eye; while drawing it out the pressure squirted the vaccine in their eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 25-year-old female patient who received Herpes zoster (Shingrix) (batch number 7l777, expiry date 22-AUG-2025) for prophylaxis.   On 01-NOV-2023, the patient received Shingrix. On 01-NOV-2023, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: while drawing it out the pressure squirted the vaccine in their eye) and exposure via eye contact (Verbatim: while drawing it out the pressure squirted the vaccine in their eye). The outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 Pharmacist reported that a student was mixing Shingrix and while drawing it out the pressure squirted the vaccine in their eye, and they already washed their eye, which led to exposure via eye contact and occupational exposure while preparing product for administration. The pharmacist inquired any information available, what were the next steps, any side effects/problems that might occur from this. The reporter did not consent to contact.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 50-year-old patient received a pediatric dose of Engerix-B; 50-year-old patient received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 50-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on 10th March 2023) and Engerix-B (2nd dose received on 14th April 2023).   On 22-SEP-2023, the patient received the 3rd dose of Engerix B pediatric. On 22-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 50-year-old patient received a pediatric dose of Engerix-B). On an unknown date, the patient experienced adult use of a child product (Verbatim: 50-year-old patient received a pediatric dose of Engerix-B). 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: 01-NOV-2023 The nurse via call centre representative reported that a 50-year-old patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter did not consent to follow-up. .
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Pain in extremity
Clinical narrative: she had a very sore arm; she had fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy (left arm). On 30-OCT-2023, less than a day after receiving Arexvy, the patient experienced pain in arm (Verbatim: she had a very sore arm) and fatigue (Verbatim: she had fatigue). The outcome of the pain in arm and fatigue were unknown.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Arexvy.     It was unknown if the company considered the pain in arm and fatigue to be related to Arexvy.   Additional Information: GSK receipt date: 01-NOV-2023 The patient self-reported this case. The patient stated that she had the Arexvy vaccination and later that day the consumer reported she had a very sore arm and fatigue. No further information was known. The reporter did not consent to follow-up.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Injected limb mobility decreased, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: shoulder muscles were stiff; Arm pain; diarrhea; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder muscle stiffness in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included skin cancer (had history of skin cancer) and cancer surgery (had outpatient surgery ).   On 30-OCT-2023 16:00, the patient received Arexvy (intramuscular, right arm). On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced diarrhea (Verbatim: diarrhea) and fever (Verbatim: fever). On 30-OCT-2023 18:00, the patient experienced shoulder muscle stiffness (Verbatim: shoulder muscles were stiff) and pain in arm (Verbatim: Arm pain). The patient was treated with non-drug therapy (Cold Compress). The outcome of the shoulder muscle stiffness, pain in arm, diarrhea and fever were resolving.   The reporter considered the shoulder muscle stiffness, pain in arm, diarrhea and fever to be unrelated to Arexvy.   The company considered the shoulder muscle stiffness, pain in arm, diarrhea and fever to be unrelated to Arexvy.   Additional Information: GSK receipt date: 01-NOV-2023 The patient was administered vaccine, injection site did not bleed, so band aid was not put on vaccine site.  The patient could not reach for phone, both shoulder muscles were stiff, put icepacks on vaccine arm, no swelling but the arm pain continued, administered more ice, made no difference.  The patient had one bout of diarrhea, possibly a fever (did not gauge temp) the night of the vaccine administration.  The patient slept better the night after vaccine.  The patient did not had history of vaccination reactions prior to Arexvy vaccine. The reporter consented to follow up with pharmacist.
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia
Clinical narrative: shoulder muscles were stiff; Arm pain; diarrhea; fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder muscle stiffness in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included skin cancer (had history of skin cancer) and cancer surgery (had outpatient surgery ).   On 30-OCT-2023 16:00, the patient received Arexvy (intramuscular, right arm). On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced diarrhea (Verbatim: diarrhea) and fever (Verbatim: fever). On 30-OCT-2023 18:00, the patient experienced shoulder muscle stiffness (Verbatim: shoulder muscles were stiff) and pain in arm (Verbatim: Arm pain). The patient was treated with non-drug therapy (Cold Compress). The outcome of the shoulder muscle stiffness, pain in arm, diarrhea and fever were resolving.   The reporter considered the shoulder muscle stiffness, pain in arm, diarrhea and fever to be unrelated to Arexvy.   The company considered the shoulder muscle stiffness, pain in arm, diarrhea and fever to be unrelated to Arexvy.   Additional Information: GSK receipt date: 01-NOV-2023 The patient was administered vaccine, injection site did not bleed, so band aid was not put on vaccine site.  The patient could not reach for phone, both shoulder muscles were stiff, put icepacks on vaccine arm, no swelling but the arm pain continued, administered more ice, made no difference.  The patient had one bout of diarrhea, possibly a fever (did not gauge temp) the night of the vaccine administration.  The patient slept better the night after vaccine.  The patient did not had history of vaccination reactions prior to Arexvy vaccine. The reporter consented to follow up with pharmacist.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality product administered, Product container issue, Product contamination physical
Clinical narrative: glass vial broke and was inside vaccine before reconstitution and was administered; glass vial broke and was inside vaccine before reconstitution and was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product contamination glass in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 2TL27, expiry date 23-AUG-2025) for prophylaxis.   On 25-OCT-2023, the patient received Shingrix (intramuscular, left deltoid). On 25-OCT-2023, an unknown time after receiving Shingrix, the patient experienced product contamination glass (Verbatim: glass vial broke and was inside vaccine before reconstitution and was administered) and poor quality vaccine administered (Verbatim: glass vial broke and was inside vaccine before reconstitution and was administered). The outcome of the product contamination glass and poor quality vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist reported that a 62 year old female patient reached out to her because she was concerned that when she was getting Shingrix vaccine last week, a vial rolled off counter and fell prior to the pharmacist removing cap to reconstitute. The patient stated that she heard sound like glass shattering. She was concerned that glass from vial broke and was inside vaccine before reconstitution which led to product contamination glass and poor quality vaccine administered. The Pharmacist stated that the vial did not shatter. The dose was administered in the patient's left deltoid muscle. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago in 2021).   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: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 01-NOV-2023 The pharmacist informed that a patient had just received the 2nd dose of Shingrix. The health care professional (HCP) did not specified dates of administration. No more details could be obtained since call disconnected. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a pharmacist 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 (1st dose received on 14 February 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: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist called to inquired did the patient need to repeat the series as the patient received the Shingrix first dose back 14 February 2021 and never came back for the second dose. The reporter asked how to proceed. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: only the adjuvant of Arexvy was administered to a patient; the adjuvant of Arexvy was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: only the adjuvant of Arexvy was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: the adjuvant of Arexvy was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist reported only the adjuvant of Arexvy was administered to a patient which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 8.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received adult dose of Havrix; pediatric patient received adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 8-year-old male patient who received HAV (Havrix 1440 adult) (batch number GSK95, expiry date 13-DEC-2024) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Havrix 1440 adult. On 31-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: pediatric patient received adult dose of Havrix) and adult product administered to child (Verbatim: pediatric patient received adult dose of Havrix). The outcome of the overdose and adult product administered to child 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: 02-NOV-2023 It was reported that male pediatric patient received adult dose of Havrix which led to overdose and adult product administered to child. The reporter consented to follow up. This case is linked to US2023152358, same reporter.; Sender's Comments:  US-GSK-US2023152358:Same reporter
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received adult dose of Havrix; pediatric patient received adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 13-year-old male patient who received HAV (Havrix 1440 adult) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Havrix 1440 adult. On 31-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: pediatric patient received adult dose of Havrix) and adult product administered to child (Verbatim: pediatric patient received adult dose of Havrix). The outcome of the overdose and adult product administered to child 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: 02-NOV-2023 It was reported that male pediatric patient received adult dose of Havrix which led to overdose and adult product administered to child. The reporter consented to follow up. This case is linked to US2023152355, same reporter.; Sender's Comments:  US-GSK-US2023152355:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Nasopharyngitis
Clinical narrative: cold; tired; Shivering; Severe headache; posterior neck pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (Breast Cancer Survivor) and neck pain (little bit of a neck ache on 29-Oct-2023). Previously administered products included Covid 19 shot (unspecified "reaction" to second Covid-19 shot (historical event)).   On 30-OCT-2023 15:30, the patient received the 1st dose of Shingrix. On 31-OCT-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Severe headache) and neck pain (Verbatim: posterior neck pain). On an unknown date, the patient experienced cold (Verbatim: cold), tiredness (Verbatim: tired) and shivering (Verbatim: Shivering). The patient was treated with ibuprofen (Advil). The outcome of the headache and neck pain were not resolved and the outcome of the cold and tiredness were unknown and the outcome of the shivering was not reported.   It was unknown if the reporter considered the headache, neck pain, cold, tiredness and shivering to be related to Shingrix.     It was unknown if the company considered the headache, neck pain, cold, tiredness and shivering to be related to Shingrix.   Additional Information: GSK receipt date: 02-NOV-2023 The reporter was the patient and she was a retired nurse.  She did not want to provide her exact date of birth.  She reported that on Monday 30-Oct-2023 she had Shingrix shot #1 administered at a pharmacy at around 3:30 pm.  She did not have the lot number for the vaccine but did provide her pharmacy's contact information who should have that information on file. She gave permission for GSK to contact her pharmacy.  She reported that she was not sure if she was having a reaction to Shingrix or if something else could be going on. [She was not sure if she should go to the emergency room or not to make sure she did not had meningitis].  She said, of having some reactions to it.  The patient did not knew whether it from that or something else. She reported of Severe headache and posterior neck pain, shivering last night, cold tired On Sunday [Pre-existing condition] the patient had a little bit of neck-ache, thought that was on the couch in the wrong position watching TV so one side of the neck was stiff. On Monday got the [Shingrix] shot. On Tuesday, was walking around with the grandkids for Halloween with a neckache, It was there a little bit but not bad. She took some Advil. On Wednesday she indicated that yesterday her headache was so bad she felt like someone hit her in the head with a baseball bat. On Thursday she said she was in too much pain to get out of bed right now.  She said only her head and neck hurt, no other part of her body hurts for example her legs did not hurt. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain
Clinical narrative: cold; tired; Shivering; Severe headache; posterior neck pain; This non-serious case was reported by a nurse via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (Breast Cancer Survivor) and neck pain (little bit of a neck ache on 29-Oct-2023). Previously administered products included Covid 19 shot (unspecified "reaction" to second Covid-19 shot (historical event)).   On 30-OCT-2023 15:30, the patient received the 1st dose of Shingrix. On 31-OCT-2023, 1 days after receiving Shingrix, the patient experienced headache (Verbatim: Severe headache) and neck pain (Verbatim: posterior neck pain). On an unknown date, the patient experienced cold (Verbatim: cold), tiredness (Verbatim: tired) and shivering (Verbatim: Shivering). The patient was treated with ibuprofen (Advil). The outcome of the headache and neck pain were not resolved and the outcome of the cold and tiredness were unknown and the outcome of the shivering was not reported.   It was unknown if the reporter considered the headache, neck pain, cold, tiredness and shivering to be related to Shingrix.     It was unknown if the company considered the headache, neck pain, cold, tiredness and shivering to be related to Shingrix.   Additional Information: GSK receipt date: 02-NOV-2023 The reporter was the patient and she was a retired nurse.  She did not want to provide her exact date of birth.  She reported that on Monday 30-Oct-2023 she had Shingrix shot #1 administered at a pharmacy at around 3:30 pm.  She did not have the lot number for the vaccine but did provide her pharmacy's contact information who should have that information on file. She gave permission for GSK to contact her pharmacy.  She reported that she was not sure if she was having a reaction to Shingrix or if something else could be going on. [She was not sure if she should go to the emergency room or not to make sure she did not had meningitis].  She said, of having some reactions to it.  The patient did not knew whether it from that or something else. She reported of Severe headache and posterior neck pain, shivering last night, cold tired On Sunday [Pre-existing condition] the patient had a little bit of neck-ache, thought that was on the couch in the wrong position watching TV so one side of the neck was stiff. On Monday got the [Shingrix] shot. On Tuesday, was walking around with the grandkids for Halloween with a neckache, It was there a little bit but not bad. She took some Advil. On Wednesday she indicated that yesterday her headache was so bad she felt like someone hit her in the head with a baseball bat. On Thursday she said she was in too much pain to get out of bed right now.  She said only her head and neck hurt, no other part of her body hurts for example her legs did not hurt. The reporter did not consent to follow-up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstitution with another manufacturer sterile water.; patient was potentially vaccinated with a dose of Hiberix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 4R9T4) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstitution with another manufacturer sterile water.) and inappropriate dose of vaccine administered (Verbatim: patient was potentially vaccinated with a dose of Hiberix). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 02-NOV-2023 The nurse called to inform that a patient was potentially vaccinated with a dose of Hiberix that was reconstituted using sterile water from another manufacturer (Merck), which led wrong solution used and inappropriate dose administered. The reporter did not consent to follow-up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: an adult dose of Havrix was administered to a child; an adult dose of Havrix was administered to a child; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-month-old male patient who received HAV (Havrix 1440 adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Havrix 1440 adult. On 31-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: an adult dose of Havrix was administered to a child) and adult product administered to child (Verbatim: an adult dose of Havrix was administered to a child). The outcome of the overdose and adult product administered to child 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: 02-NOV-2023 Nurse reported that an adult dose of Havrix was administered to a child, which led to overdose and adult product administered to child. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: an adult dose of Havrix was administered to a child; an adult dose of Havrix was administered to a child; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 3-year-old male patient who received HAV (Havrix 1440 adult) for prophylaxis.   On 18-OCT-2023, the patient received Havrix 1440 adult. On 18-OCT-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: an adult dose of Havrix was administered to a child) and adult product administered to child (Verbatim: an adult dose of Havrix was administered to a child). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The patient age was 3 years 1 month. Nurse reported that an adult dose of Havrix was administered to a child, which led to overdose and adult product administered to child. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: inadvertently gave Arexvy to a pregnant patient; Given to patient under 60 years of age; inadvertently gave Arexvy to a pregnant patient instead of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: inadvertently gave Arexvy to a pregnant patient), inappropriate age at vaccine administration (Verbatim: Given to patient under 60 years of age) and wrong vaccine administered (Verbatim: inadvertently gave Arexvy to a pregnant patient instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt date: 02-NOV-2023 The pharmacist stated patient was around 45 years old.  The pharmacist stated a colleague inadvertently gave Arexvy to a pregnant patient instead of Abrysvo, which led to inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy. The pharmacist was not at work at the time of this call and did not had access to the patient chart, so details such as patient date of birth, vaccine information such as lot, and date of administration were not available.  The pharmacist consented to follow up from safety via postal.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: some of the medicine leaked out of the syringe; she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm).; she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9994M, expiry date 21-MAR-2025) for prophylaxis.   On 02-NOV-2023, the patient received Arexvy. On 02-NOV-2023, an unknown time after receiving Arexvy, the patient experienced accidental underdose (Verbatim: some of the medicine leaked out of the syringe), inadvertent exposure to vaccine (Verbatim: she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm).) and exposure via skin contact (Verbatim: she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm)). The outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt date: 02-NOV-2023 The pharmacist stated that when she was administering Arexvy, some of the medicine leaked out of the syringe (and also went onto the patient's arm), which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow up via postal.