chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse drug reaction, Pain
Clinical narrative: Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; adverse drug reactions; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008730: 2US-009507513-107USA008732: US-009507513-2107USA008729: US-009507513-2107USA008733: US-009507513-2107USA008728: US-009507513-2107USA008727:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse drug reaction, Pain
Clinical narrative: Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008730: US-009507513-2107USA008731: US-009507513-2107USA008729: US-009507513-2107USA008733: US-009507513-2107USA008728: US-009507513-2107USA008727:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Adverse drug reaction, Pain
Clinical narrative: : Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; : Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008730: US-009507513-2107USA008731: US-009507513-2107USA008732: US-009507513-2107USA008729: US-009507513-2107USA008728: US-009507513-2107USA008727:
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Acute cardiac event, Anxiety, Balance disorder, Cardiac failure congestive, Cerebrovascular accident
Clinical narrative: congestive heart failure; Stroke; Herpes zoster ophthalmicus; Other serious neurological problems; Cardiovascular event; Anxiety; Balance issues; Depression; Postherpetic neuralgia; Vision problems; herpes zoster; Death; Information has been received from a lawyer regarding a case in litigation and concerning to a patient (pt.) of unknown gender, who would be approximately 80 years old. On 03-DEC-2008, the patient was vaccinated at a pharmacy with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for herpes zoster, post herpetic neuralgia, herpes zoster ophthalmicus (ophthalmic herpes zoster), stroke (cerebrovascular accident), cardiovascular event (cardiovascular disorder), congestive heart failure (cardiac failure congestive), vision problems (visual impairment), balance issues (balance disorder), anxiety, depression and other serious neurological problems (nervous system disorder). On 07-MAR-2018, the pt. died. It was not reported the cause of death and it was unknown if an autopsy was performed. Damages were claimed as a result of injury to the pt., wrongful death, loss of consortium, loss of services, and economic losses. The outcome of herpes zoster, postherpetic neuralgia, herpes zoster ophthalmicus, stroke, cardiovascular event, congestive heart failure, vision problems, balance issues, anxiety, depression and other serious neurological problems were not reported. The reporter considered the aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, ophthalmic herpes zoster, cerebrovascular accident, cardiac failure congestive and nervous system disorder were determined to be medically significant events.  Information regarding the events herpes zoster, post herpetic neuralgia, ophthalmic herpes zoster, cerebrovascular accident, cardiovascular disorder, cardiac failure congestive, visual impairment, balance disorder, anxiety, depression and nervous system disorder was already reported in MARRS#1812USA001687. But upon internal review it was determined that the information should be captured in MARRS#2107USA008942.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Death, Depression, Neurological symptom, Ophthalmic herpes zoster, Post herpetic neuralgia
Clinical narrative: congestive heart failure; Stroke; Herpes zoster ophthalmicus; Other serious neurological problems; Cardiovascular event; Anxiety; Balance issues; Depression; Postherpetic neuralgia; Vision problems; herpes zoster; Death; Information has been received from a lawyer regarding a case in litigation and concerning to a patient (pt.) of unknown gender, who would be approximately 80 years old. On 03-DEC-2008, the patient was vaccinated at a pharmacy with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for herpes zoster, post herpetic neuralgia, herpes zoster ophthalmicus (ophthalmic herpes zoster), stroke (cerebrovascular accident), cardiovascular event (cardiovascular disorder), congestive heart failure (cardiac failure congestive), vision problems (visual impairment), balance issues (balance disorder), anxiety, depression and other serious neurological problems (nervous system disorder). On 07-MAR-2018, the pt. died. It was not reported the cause of death and it was unknown if an autopsy was performed. Damages were claimed as a result of injury to the pt., wrongful death, loss of consortium, loss of services, and economic losses. The outcome of herpes zoster, postherpetic neuralgia, herpes zoster ophthalmicus, stroke, cardiovascular event, congestive heart failure, vision problems, balance issues, anxiety, depression and other serious neurological problems were not reported. The reporter considered the aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, ophthalmic herpes zoster, cerebrovascular accident, cardiac failure congestive and nervous system disorder were determined to be medically significant events.  Information regarding the events herpes zoster, post herpetic neuralgia, ophthalmic herpes zoster, cerebrovascular accident, cardiovascular disorder, cardiac failure congestive, visual impairment, balance disorder, anxiety, depression and nervous system disorder was already reported in MARRS#1812USA001687. But upon internal review it was determined that the information should be captured in MARRS#2107USA008942.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: congestive heart failure; Stroke; Herpes zoster ophthalmicus; Other serious neurological problems; Cardiovascular event; Anxiety; Balance issues; Depression; Postherpetic neuralgia; Vision problems; herpes zoster; Death; Information has been received from a lawyer regarding a case in litigation and concerning to a patient (pt.) of unknown gender, who would be approximately 80 years old. On 03-DEC-2008, the patient was vaccinated at a pharmacy with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, lot number, and expiration date were not reported). On an unknown date, reported as subsequent to the vaccination, the patient was treated for herpes zoster, post herpetic neuralgia, herpes zoster ophthalmicus (ophthalmic herpes zoster), stroke (cerebrovascular accident), cardiovascular event (cardiovascular disorder), congestive heart failure (cardiac failure congestive), vision problems (visual impairment), balance issues (balance disorder), anxiety, depression and other serious neurological problems (nervous system disorder). On 07-MAR-2018, the pt. died. It was not reported the cause of death and it was unknown if an autopsy was performed. Damages were claimed as a result of injury to the pt., wrongful death, loss of consortium, loss of services, and economic losses. The outcome of herpes zoster, postherpetic neuralgia, herpes zoster ophthalmicus, stroke, cardiovascular event, congestive heart failure, vision problems, balance issues, anxiety, depression and other serious neurological problems were not reported. The reporter considered the aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, ophthalmic herpes zoster, cerebrovascular accident, cardiac failure congestive and nervous system disorder were determined to be medically significant events.  Information regarding the events herpes zoster, post herpetic neuralgia, ophthalmic herpes zoster, cerebrovascular accident, cardiovascular disorder, cardiac failure congestive, visual impairment, balance disorder, anxiety, depression and nervous system disorder was already reported in MARRS#1812USA001687. But upon internal review it was determined that the information should be captured in MARRS#2107USA008942.
Sex: F
Vaccine: FLUN3
Symptoms: Drug ineffective
Clinical narrative: I GOT IT ONCE YEARS AGO AND I GOT SO SICK; LACK OF DRUG EFFECT; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza vaccine live reassort 3v) (batch number UNKNOWN), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST.    The report described lack of effect for Flumist. The reported term was "lack of drug effect" (Preferred term: Drug ineffective).     On an unknown date, the patient experienced i got it once years ago and i got so sick (preferred term: Illness).     It is unknown if any action was taken with Flumist (influenza vaccine live reassort 3v).     The outcome of the event(s) of i got it once years ago and i got so sick and lack of drug effect was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray  Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Vaccination site reaction
Clinical narrative: Drug dose administration interval too long; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on unknown date,for tolerance of 1st dose refer case US2021AMR089848).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported.   The patient received 2nd dose of Shingles vaccine, more than the recommended interval, which led to lengthening of vaccination schedule.. The case was linked with US2021AMR089848, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR089848:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: fever; tiredness; sore arm.; chili; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received Shingrix. On 26th July 2021, 3 days after receiving Shingrix, the patient experienced fever, tiredness, pain in arm and chills. On an unknown date, the outcome of the fever, tiredness, pain in arm and chills were unknown.   It was unknown if the reporter considered the fever, tiredness, pain in arm and chills to be related to Shingrix.  Additional details were reported as follows: The patient was the reporter. The age at vaccination was not reported. The patient received Shingrix and had fever, chills, tiredness and sore arm. The patient asked if this was this normal to be in 3rd day.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: How soon can I expect to feel better; This case was reported by a consumer via(Shingrix GSK Chatbot) interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient stated that, he or she received first dose of the Shingrix vaccine and am experiencing all the symptoms listed.  The patient asked how he or she soon could expect to feel better and would this happen again with his or her second dose. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had recurrent Shingles outbreaks even after receiving the Shingrex vaccine / has completed vaccine series in the past/Suspected vaccination failure; had recurrent Shingles outbreaks even after receiving the Shingrex vaccine / has completed vaccine series in the past; This case was reported by a physician and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. A patient who had recurrent Shingles outbreaks even after receiving the Shingrex vaccine.  The reporter had asked if she could receive the Shingrix vaccine again ( twice), if she had completed her vaccine series in the past. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting. Consent to follow up was granted.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: was vacinated and still got this horrible ick/suspected vaccination failure; got this horrible ick; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient was vaccinated and still got shingles horrible ick. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Sex: U
Vaccine: HEPAB
Symptoms: Hepatitis viral test, Incomplete course of vaccination
Clinical narrative: only recieved two of the doses /in 2007; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2007) and Twinrix (received 2nd dose in 2007).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The patient recieved only two doses of the Twinrix back  in 2007, which led to incomplete course of vaccination. The patient asked how effective could they be and how long did they last. The patient took a hepatitis test at the physicians office. No further information reported. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and then had shingles/ suspected vaccination failure; had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows; The age at vaccination was not reported. The reporter stated that, the patient had shot and then had shingles three after. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Reported a case of shingles in her groin area; This case was reported by a nurse via sales rep and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was in her 60s at the time of reporting. The age at vaccination was not reported. The patient received new Shingles vaccine, a year ago from the date of reporting. After receiving Shingles vaccine, the patient got shingles in her groin area. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. The reporter consented to follow up. This case has been linked with the case US2021AMR161208 (Nucala case), reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161208:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: very painful / area under the injection site; red / area under the injection site; hot / area under the injection site; hard / area under the injection site; This case was reported by a consumer via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 2nd dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site induration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and injection site induration were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth and injection site induration to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient. Age at vaccination was not reported. The patient had very painful, red, hot, hard area under the injection site after Shingrix dose number 2. It was day 3 and the edge of the reaction was still advancing, the reporter also asked what to do. No contact details were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: soreness; This case was reported by a consumer and described the occurrence of pain in a 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, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine when it came out, the patient thought she had soreness and she made sure to hydrated before and after each vaccine. The patient did believed hydration lessen and reaction symptoms. For tolerance in 2nd dose refer case US2021AMR162113.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR162113:same patient/reporter - 2nd dose
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: soreness; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date refer case US2021AMR162106).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 1st dose of Shingrix vaccine when it came out, the patient thought she had soreness and she made sure to hydrated before and after each vaccine. The patient did believed hydration lessen and reaction symptoms.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR162106:same patient/reporter - 1st dose
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Flatulence, Gastrointestinal sounds abnormal
Clinical narrative: my stomach is upset; my stomach is/bubbly; my stomach is/growling; This case was reported by a consumer via interactive digital media (Shingrix GSK Chatbot) and described the occurrence of upset stomach in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2021, the patient received Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced upset stomach, gas in stomach and abdominal noises. On an unknown date, the outcome of the upset stomach, gas in stomach and abdominal noises were unknown.   It was unknown if the reporter considered the upset stomach, gas in stomach and abdominal noises to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received Shingrix shot on Saturday before the day of reporting and his/her stomach was upset, bubbly and growling. The patient asked could this be a side effect of shot. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first/last august but never followed up with the second shot.; This case was reported by a other health professional via Shingrix GSK and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in last August from the date of reporting).  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient got the 1st Shingrix shot last August but never followed up with the 2nd shot.  The patient did not received the 2nd shot till the time of reporting which led to incomplete course of vaccination. The reporter asked did they start over with the series or just give 1 more shot. No contact details were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: just got the second shot/ first was Oct 2019; This case was reported by a consumer via interactive digital media 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 in October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of Shingrix in October 2019 and 2nd got just, which led to dose administration interval too long. The patient asked did he/she need a third dose.
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis, Feeling hot
Clinical narrative: Got vaccination and still get hot spots; This case was reported by a consumer via interactive digital media and described the occurrence of sensation of warmth in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got in his/her forties).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sensation of warmth. On an unknown date, the outcome of the sensation of warmth was unknown.   It was unknown if the reporter considered the sensation of warmth to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got shingles in his/her fortied and got shingles vaccination and still got hot spots, but no rash. The follow up would not be possible as no contact details were available
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: received / first dose of hepatitis B vaccine /in 2016 /now/ need a 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 17-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B (1st dose received in 2016).   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not applicable for this report. The member of public reported his daughter received her first dose of hepatitis B vaccine (brand unknown) elsewhere in 2016. They reside here now and need a 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Hepatitis B, which led to incomplete course of vaccination. No other details were available. The reporter consented to follow up.
Age: 7.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: received / 2nd dose / October 2014 / receiving "catch up doses" (16-JUN-2021); administration / to 7/o old; 1st dose / in August 2014, 2nd dose / October 2014 / receiving "catch up doses" (16-JUN-2021); This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 7-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa (Infanrix).   On 16th June 2021, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. In October 2014, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. In October 2014, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and an unknown time after receiving Infanrix, the patient experienced drug dose administration interval too long. On 16th June 2021, the patient experienced drug dose administration interval too long and inappropriate age at vaccine administration. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the drug dose administration interval too long, inappropriate age at vaccine administration 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 details were provided as follows: The reporter stated that, the patient received catch up doses. The patient received 1st dose of Infanrix in August 2014 and 2nd dose of Infanrix October 2014, which led to lengthening of vaccination schedule. The patient received 3rd dose late than the recommended time interval at the age of 7 years old, which led to drug dose administration interval too long, inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 months old patient / received / Boostrix (T-dap); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KN5ZR, expiry date 16th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 20th July 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported a 15-months-old patient received Boostrix (Tdap) instead of receiving D-tap, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose in October 2020) and Engerix B (received 2nd dose in December 2020).   On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not applicable to this report. Pharmacist reported that the patient had not receive the third dose yet, which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021157383:possible same patient
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Hypoaesthesia, Neurological symptom, Radiculitis brachial
Clinical narrative: numbness; back pain; brachial neuritis; neurological issues; This case was reported by a physician via call center representative and described the occurrence of numbness in a elderly female patient who received DTPa (Reduced antigen) (Boostrix) (batch number x2xj7, expiry date 8th August 2021) for prophylaxis.   On 4th November 2020, the patient received the 1st dose of Boostrix. On an unknown date, less than 9 months after receiving Boostrix, the patient experienced numbness, back pain, brachial neuritis and neurological symptom. On an unknown date, the outcome of the numbness, back pain, brachial neuritis and neurological symptom were unknown.   The reporter considered the numbness, back pain, brachial neuritis and neurological symptom to be possibly related to Boostrix.  Additional details provided were as follows: The doctor reported that the patient received first dose of Boostrix and shortly after the patient experienced neurological issues, back pain and numbness. The patient consulted a neurologist and doctor suspected it was from the vaccine and would like to report it.  The neurologist suspect it could be brachial neuritis. Doctor further would like to know about it. Reporter consented to follow-up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid component of Menveo  without the powder; administered only the liquid component of Menveo  without the powder; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA466A, expiry date 31st October 2022) for prophylaxis.   On 22nd July 2021, the patient received Menveo. On 22nd July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. Physician reported that they inadvertently administered only the liquid component of Menveo without the powder to a patient today (day of reporting), which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: administered/ only the liquid component /not /the lyophilized portion; administered/ only the liquid component /not /the lyophilized portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA39OA, expiry date 31st August 2021) for prophylaxis.   On 22nd July 2021, the patient received Menveo. On 22nd July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was administered with only the liquid component of Menveo, the vaccine was not reconstituted with the lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The quality personnel did not had the patient's date of birth. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Nausea, Pain
Clinical narrative: Pain; Nausea; stomach ache; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced stomach pain, pain and nausea. On an unknown date, the outcome of the stomach pain was recovered/resolved and the outcome of the pain and nausea were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, pain and nausea to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient himself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced stomach ache, pain and some nausea. The patient had contacted his HCP (health care professional) regarding the symptoms because he had experience the stomach ache and nausea for 3 days. No other information to report. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix late second dose / received one dose of Shingrix on July 2nd 2018 / never received Shingrix second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 2nd July 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided were as follows: Age at vaccination was not applicable for this report. The pharmacist was called to report about the patient who received 1st dose of shingrix and was late for the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up via phone.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered liquid portion only / not reconstituted with lyophilized portion.; administered liquid portion only / not reconstituted with lyophilized portion.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA438A, expiry date 31st October 2021) for prophylaxis.   On 30th June 2021, the patient received Menveo. On 30th June 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that, the patient was administered liquid portion only of Menveo, the vaccine was not reconstituted with lyophilized portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021160399, reported by same reporter for diferent patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160397:FU1 DELETED US-GLAXOSMITHKLINE-US2021160399:Same reporter US-GLAXOSMITHKLINE-US2021160399:Same reporter
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid portion of menveo, not the powder component; administered only the liquid portion of menveo, not the powder component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa465a, expiry date 20th September 2022) for prophylaxis.   On 26th July 2021, the patient received the 2nd dose of Menveo. On 26th July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that, 16 yrs old patient was administered only the liquid portion of menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: injection but did not reconstitute medicine first/only gave the "diluent"; injection but did not reconstitute medicine first/only gave the "diluent"; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a adult female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA438A, expiry date 31st October 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: This age at vaccination was not reported for this case. The nurse reported that a medical assistant administered a patient with Menveo injection but did not reconstitute the medicine first and only gave the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with US2021160396, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160396:Same reporter