chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No adverse event
Clinical narrative: Titer Drawn Showed No Immunity; Initial Report Received on 22-Mar-2023  A patient, and her pharmacist reported that she, a 47 year-old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient had a titer drawn and it showed no immunity, the surface antibody quantitative test was negative.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 07-Nov-2022, the patient received the first dose of HEPLISAV-B (Lot # 939672, expiration date 14-May-2024 and NDC # 43528-003-05) to the left arm from a pharmacy.   On 07-Dec-2022, the patient received the second dose of HEPLISAV-B (Lot # 939672, expiration date 14-May-2024 and NDC # 43528-003-05) to the left arm from a pharmacy.   On 01-Mar-2023, 115 days after having received the first dose, and 85 days after receiving the second dose of HEPLISAV-B, the patient had a titer drawn and it showed no immunity. The surface antibody quantitative test was negative.   The patient reported that she experienced no other adverse side effects. The pharmacist was contacted who reported that the patient was going to have repeat lab work to confirm if the results were accurate.  No additional information was reported.   Company Comment: The company assessed the event as non-serious and immunologically confirmed based on dosing schedule and titer drawn.; Sender's Comments: The company assessed the event as non-serious and immunologically confirmed based on dosing schedule and titer drawn.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Computerised tomogram normal, Discomfort
Clinical narrative: Severe abdominal pain / felt very uncomfortable; A spontaneous report was received from a physician on 20MAR2023 regarding a female patient (mid-30s) (patient 1) who experienced "severe abdominal pain / felt very uncomfortable" (PT: Abdominal pain) following the administration of VIVOTIF capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient did not take any medications concomitantly. The patient had no relevant allergies or medical history.  It was reported that on an unknown date in 2023, "last month", the patient experienced severe abdominal pain with no other symptoms due to Vivotif. The patient felt very uncomfortable for 2 to 3 days and had to go to the emergency room where she possibly underwent a computerised tomogram (CT) scan. Reportedly, the hospital did not find anything and thought it was a coincidence with the vaccine and had no reason to suspect anything else.   The outcome of the reported event was unknown, at the time of this report.   The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Based on the information available in the document three individual case safety reports 23000101 (patient 1), 23000102 (patient 2) and 23000103 (patient 3) were created and cross-linked into the database.  Company comment: A consumer took Vivotif for immunisation and experienced severe abdominal pain / felt very uncomfortable (abdominal pain). Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer took Vivotif for immunisation and experienced severe abdominal pain / felt very uncomfortable (abdominal pain). Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment. 23000102:Linked case (Patient 2) 23000103:Linked case (Patient 3)
Sex: U
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain; A spontaneous report was received from a physician on 20MAR2023 regarding a patient (patient 2) of unknown age and gender who experienced "abdominal pain" (PT: Abdominal pain) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that on an unknown date in 2023, "last month", the patient experienced abdominal pain with no other symptoms due to Vivotif.  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Based on the information available in the document three individual case safety reports 23000101 (patient 1), 23000102 (patient 2) and 23000103 (patient 3) were created and cross-linked into the database.  Company comment: A consumer took Vivotif for immunisation and experienced abdominal pain. Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer took Vivotif for immunisation and experienced abdominal pain. Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment. 23000103:Linked case (Patient 3) 23000101:Linked case (Patient 1)
Sex: U
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: Abdominal pain; A spontaneous report was received from a physician on 20MAR2023 regarding a patient (patient 3) of unknown age and gender who experienced "abdominal pain" (Abdominal pain) following the administration of Vivotif capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that on an unknown date in 2023, "last month", the patient experienced abdominal pain with no other symptoms due to Vivotif.  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Based on the information available in the document three individual case safety reports 23000101 (patient 1), 23000102 (patient 2) and 23000103 (patient 3) were created and cross-linked into the database.  Company comment: A consumer took Vivotif for immunisation and experienced abdominal pain. Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer took Vivotif for immunisation and experienced abdominal pain. Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment. 23000101:Linked case (Patient 1) 23000102:Linked case (Patient 2)
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Took vaccine and got shingles/suspected vaccination failure; Shingles; Very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Took vaccine and got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Very painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient's friend interactive digital media. The reporter stated that happened to his/her best friend.  The patient took the Shingles vaccine and two months later he had the shingles.  The patient said that it was very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and got shingles/suspected vaccination failure; Got Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot and in less than a year he/she got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shot and got shingles/Suspected vaccination failure; Got shingles, mild case; Were relentlessly painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot and got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles, mild case) and pain (Verbatim: Were relentlessly painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles shot and 3 months later got shingles.  The reporter stated that even though it was a mild case, holy cow they were relentlessly painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles shot, and got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles shot, and got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient received Shingles vaccine but experienced shingles from the latest dose of Covid vaccine. The patient stated that it was horrible, and shingles was not a joke. The reporter considered the adverse event to be related to Covid vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Got all the shots but got them/ suspected vaccination failure; Shingles; Postherpetic neuralgia; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (twice). Previously administered products included Covid vaccine (unknown dose received on an unknown date ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got all the shots but got them/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: Postherpetic neuralgia). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received all Shingles vaccines. The patient stated that the vaccines are 90 percentage effective and he or she is in the wrong 10 percentage. The patient tried so hard to not get shingles but experienced shingles anyway and now had post herpetic neuralgia. The patient received all doses of Covid vaccine and experienced corona twice so far. 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. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Neoplasm, Vaccination failure
Clinical narrative: Die 4 months after shingles shot; Had a break out after shingles shot/Suspected vaccination failure; Break out; Develop a tumor; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Die 4 months after shingles shot) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Had a break out after shingles shot/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Break out) and neoplasm (Verbatim: Develop a tumor). The outcome of the vaccination failure was unknown and the outcome of the shingles and neoplasm were not reported. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine.     It was unknown if the company considered the unknown cause of death, vaccination failure, shingles and neoplasm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 15-MAR-2023 This case was reported by a patient's friend via interactive digital media. The patient developed a tumor, break out and die 4 months after shingles shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case was 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR118387:Same reporter US-GLAXOSMITHKLINE-US2021AMR263783:Same reporter US-GSK-US2023AMR047859:Same reporter; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Shivering/chills; Ache; Tiredness; Painful arm; This non-serious case was reported by a consumer and described the occurrence of shivering in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 559H5) for prophylaxis.   Concurrent medical conditions included hiv positive. Concomitant products included cobicistat + elvitegravir + emtricitabine + tenofovir alafenamide fumarate (Genvoya).   On 14-MAR-2023, the patient received Shingrix .5 ml. On 14-MAR-2023, less than a day after receiving Shingrix, the patient experienced shivering (Verbatim: Shivering/chills), pain (Verbatim: Ache), tiredness (Verbatim: Tiredness) and pain in arm (Verbatim: Painful arm). On 17-MAR-2023, the outcome of the shivering and pain were recovered/resolved (duration 3 days). The outcome of the tiredness and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the shivering, pain, tiredness and pain in arm to be related to Shingrix.     It was unknown if the company considered the shivering, pain, tiredness and pain in arm to be related to Shingrix.   Additional Information: GSK receipt date:19-MAR-2023 The patient was the reporter. The symptoms were not treated. The reporter stated that he was frightened for second shot.  The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizzy spells; This non-serious case was reported by a consumer and described the occurrence of dizzy spells in a 72-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number D9CB9) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included losartan.   On 30-JAN-2023, the patient received Shingles vaccine. On 01-FEB-2023, 2 days after receiving Shingles vaccine, the patient experienced dizzy spells (Verbatim: Dizzy spells). The outcome of the dizzy spells was not recovered/not resolved.   It was unknown if the reporter considered the dizzy spells to be related to Shingles vaccine.     It was unknown if the company considered the dizzy spells to be related to Shingles vaccine.   Additional Information: GSK receipt date:19-MAR-2023 The Patient herself was a reporter. The vaccine details expiry date was unknown. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm sore; Headache; Joint aches; Fatigue; Muscle aches; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm sore), headache (Verbatim: Headache), joint pain (Verbatim: Joint aches), fatigue (Verbatim: Fatigue) and muscle pain (Verbatim: Muscle aches). The outcome of the pain in arm, headache, joint pain, fatigue and muscle pain were not reported.   It was unknown if the reporter considered the pain in arm, headache, joint pain, fatigue and muscle pain to be related to Shingrix.     It was unknown if the company considered the pain in arm, headache, joint pain, fatigue and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2023 The patient received dose of Shingrix The patient experienced arm sore, headache, joint aches, muscle aches and fatigue after the vaccination. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd 06Mar2023; 2nd Oct2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received HAB (Twinrix) for prophylaxis.  Co-suspect products included HAB (Twinrix) for prophylaxis and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) for prophylaxis.  On 06-MAR-2023, the patient received the 3rd dose of Twinrix. On 04-OCT-2022, the patient received the 2nd dose of Twinrix. On 03-AUG-2022, the patient received the 1st dose of TWINRIX. On 04-OCT-2022, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd Oct2022). On 06-MAR-2023, the patient experienced drug dose administration interval too long (Verbatim: 3rd 06Mar2023). The outcome of the drug dose administration interval too long and drug dose administration interval too long 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: 20-MAR-2023 The patient received 1st dose of Twinrix on 3rd August 2022. The patient had asked that he would like to know influenza have anything to do with the hepatitis shots. He went to get my third shot last week for hepatitis and they were trying to tell me that the influenza was part of the hepatitis. All they said was influenza and he had to figure it out so it does not mess me up so they could start the treatment on the liver. On Saturday 11th March the patient went to emergency room. The patient had received the second and third dose later than the recommended interval, which had led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Was really sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Was really sick). The outcome of the sickness was recovered/resolved (duration 4 days).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient's sister/brother interactive digital media. The reporter stated that his/her sister had it very bad. The patient got the Shingles booster last week and she was really sick for about 4 days. The reporter guessed that it was better than being in pain a few months as shingles was the worst  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: TTOX, VARZOS
Symptoms: Pain
Clinical narrative: Ouch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE for prophylaxis.   On 15-MAR-2023, the patient received Shingles vaccine (unknown arm) and TETANUS VACCINE (unknown arm). On 15-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: Ouch). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported he or she received Shingles vaccine and Tetanus vaccine in the other arm and experienced pain ouch. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Pain). The outcome of the pain was recovered/resolved (duration 2 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient got 1st Shingles shot and only 2 days he/she felt the pain. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had to wait a month between shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date). Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too short (Verbatim: Had to wait a month between shots). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient stated that he/she only had to wait a month between shots. The follow-up could not be possible as no contact details were available. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccination schedule. This case is linked with US2023AMR047845, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR047845:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had to wait a month between shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included SHINGLES VACCINE (NOS) (SHINGLES VACCINE).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too short (Verbatim: Had to wait a month between shots). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 15-MAR-2023 The case was received from the patient interactive digital media. The patient stated that he/she only had to wait a month between shots. The follow-up could not be possible as no contact details were available. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccination schedule. This case is linked with US2023AMR047839, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR047839:Same reporter
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Limb discomfort, Nervous system disorder, Pain in extremity, Uterine disorder
Clinical narrative: Extremely sore heavy arm. Dizziness for 24 hours. Apparent ?load? to nervous system which seemed to settle in uterus.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 2 year old was administered Kinrix; Kinrix dose instead of Pentacel; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 06-MAR-2023, the patient received Kinrix. On 06-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 year old was administered Kinrix) and wrong vaccine administered (Verbatim: Kinrix dose instead of Pentacel). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-MAR-2023 The licensed practical nurse (LPN) called to enquire, regarding any information on any harm to the patient. The reporter asked would the patient need another DTap or how to proceed. The LPN reported a 2 year old patient was inadvertently administered a Kinrix dose instead of Pentacel, at an alternate office listed on HCP account. The reporter consented to follow up.         The patient was inadvertently administered a Kinrix dose instead of Pentacel at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: administered subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 06-MAR-2023, the patient received Kinrix (subcutaneous). On 06-MAR-2023, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered subcutaneous). The outcome of the intramuscular formulation administered by other route 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: 13-MAR-2023 The pharmacist reported a patient was administered subcutaneous injection instead of intramuscular.  The health care professional (HCP) gave consent for safety team follow up. The patient received Kinrix subcutaneously, which led to intramuscular formulation administered by other route.
Sex: M
Vaccine: HEP, HEP
Symptoms: Hepatitis B antibody negative, Incomplete course of vaccination, Therapy non-responder
Clinical narrative: Got 1st on 28th Sep 2022, never got the 2nd; After hepatitis b vaccine, did titer and no antibodies were found; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Engerix-B (received first dose on 28-Sep-2022 with lot no. 9255P and expiry date 15-Feb-2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Hepatitis B vaccine. On an unknown date, an unknown time after receiving Engerix B and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: Got 1st on 28th Sep 2022, never got the 2nd) and therapy non-responder (Verbatim: After hepatitis b vaccine, did titer and no antibodies were found). The outcome of the incomplete course of vaccination and therapy non-responder were unknown.   Additional Information: GSK receipt date: 17-MAR-2023 The reporter reported that patient received hepatitis B vaccine (unknown when he was little) and then pulled titer on him did not have anything so they were making him do it again, so patient got first dose of Engerix-B on 28-Sep-2022 but never got the 2nd dose.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Red knot at the injection site; Circular red knot at  injection site; Injection site itchy; Injection site warm to touch; Arm was tender to touch; Throbbing Pain in arm; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included nasal polyp.   On 09-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 10-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Red knot at the injection site), injection site lump (Verbatim: Circular red knot at  injection site), injection site itching (Verbatim: Injection site itchy), injection site warmth (Verbatim: Injection site warm to touch), tenderness (Verbatim: Arm was tender to touch), pain in arm (Verbatim: Throbbing Pain in arm) and chills (Verbatim: Chills). The patient was treated with benadryl (nos) (Benadryl) and cefalexin (Cephalexin). The outcome of the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR044358   Additional Information: GSK Receipt Date: 17-MAR-2023 The patient reported that prior to starting nucala therapy for treatment of her nasal polyps, she received Shingrix. The next day she experienced throbbing pain in the left arm and the arm was tender to touch. There was a circular red knot at the injection site, and it was itchy and warm to touch and she experienced chills. She took Benadryl for the reaction, but after 2-3 days, there was not relief and she was prescribed cephalexin. After starting the antibiotic, the injection site returned to normal and the pain resolved. The patient consented to followup with the HCP (healthcare professional) and with herself. This case has been linked to the case US2023AMR044358 reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR044358:Same patient / Shingrix vaccine
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Red knot at the injection site; Circular red knot at  injection site; Injection site itchy; Injection site warm to touch; Arm was tender to touch; Throbbing Pain in arm; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included nasal polyp.   On 09-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 10-MAR-2023, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Red knot at the injection site), injection site lump (Verbatim: Circular red knot at  injection site), injection site itching (Verbatim: Injection site itchy), injection site warmth (Verbatim: Injection site warm to touch), tenderness (Verbatim: Arm was tender to touch), pain in arm (Verbatim: Throbbing Pain in arm) and chills (Verbatim: Chills). The patient was treated with benadryl (nos) (Benadryl) and cefalexin (Cephalexin). The outcome of the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site lump, injection site itching, injection site warmth, tenderness, pain in arm and chills to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR044358   Additional Information: GSK Receipt Date: 17-MAR-2023 The patient reported that prior to starting nucala therapy for treatment of her nasal polyps, she received Shingrix. The next day she experienced throbbing pain in the left arm and the arm was tender to touch. There was a circular red knot at the injection site, and it was itchy and warm to touch and she experienced chills. She took Benadryl for the reaction, but after 2-3 days, there was not relief and she was prescribed cephalexin. After starting the antibiotic, the injection site returned to normal and the pain resolved. The patient consented to followup with the HCP (healthcare professional) and with herself. This case has been linked to the case US2023AMR044358 reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR044358:Same patient / Shingrix vaccine
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: some of it leaked out; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number G3T43, expiry date 07-JUL-2024) for prophylaxis.   On 17-MAR-2023, the patient received the 1st dose of Shingrix. On 17-MAR-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: some of it leaked out). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 17-MAR-2023 A pharmacist reported that a patient received her 1st dose of Shingrix and some of it leaked out the needle during administration. The reporter did not mention whether it touched the skin or not. The reporter consented to follow up via email.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; 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 male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 02-FEB-2023, the patient received Havrix. On 02-FEB-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information:  GSK Receipt Date: 17-MAR-2023 The reporter was a supervisor public health. The reporter did consent to follow up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo  mixed with other diluent; Vx given mixed with other 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo  mixed with other diluent) and inappropriate dose of vaccine administered (Verbatim: Vx given mixed with other diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-MAR-2023 As per description in the case, it was stated that the clinic used an unapproved diluent when mixing with the powder portion of Menveo and administering to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Injection site pain
Clinical narrative: Weakness, slightly improved now; Episode of dizziness; Injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm). On 16-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). On 17-MAR-2023, the patient experienced weakness (Verbatim: Weakness, slightly improved now) and dizziness (Verbatim: Episode of dizziness). On 17-MAR-2023, the outcome of the dizziness was recovered/resolved. The outcome of the injection site pain was not recovered/not resolved and the outcome of the weakness was recovering/resolving.   It was unknown if the reporter considered the injection site pain, weakness and dizziness to be related to Shingrix.   It was unknown if the company considered the injection site pain, weakness and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date:17-MAR-2023 The reporter was the patient.  He received his Shingrix dose the day before reporting and experienced injection site arm pain.  At the time of reporting, about 10 hours after the injection, he experienced weakness and the weakness was slightly improved now.  He also had one episode of dizziness one day after receiving Shingrix. Nothing else was reported.  The reporter did not consent to follow-up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; 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 15-month-old female patient who received HAV (Havrix) (batch number 95EJ7, expiry date 06-FEB-2023) for prophylaxis.   On 15-MAR-2023, the patient received Havrix. On 15-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-MAR-2023 The reporter was office manager. The reporter consented to follow up. The reporter reported an expired dose of Havrix was administered to a patient, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult patient got pediatric dose instead of adult; Adult patient got pediatric dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number EM9E4, expiry date 17-FEB-2025) for prophylaxis.   On 17-MAR-2023, the patient received the 3rd dose of Engerix B pediatric. On 17-MAR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient got pediatric dose instead of adult) and adult use of a child product (Verbatim: Adult patient got pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 17-MAR-2023 A nurse informed that earlier that day, an adult patient came in to receive the 3rd dose of Engerix-B but received a pediatric dose instead. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  An adult patient received Engerix B pediatric, which led to underdose and adult use of a child product.