chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bad rash on body; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiry date: unknown) via unspecified route of administration on 04Jan2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiry date: unknown) via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that the patient got her second vaccine on 04Jan2021 and then next day she got a bad rash on her body and she still having it, it has cost her lot of money to go to the Doctors and want to get something about this rash. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: "I" have been throwing up a mixture of bile and mucous about 12 hours after "my" second shot; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06May2021 at 15:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to yeast. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant therapies included unspecified vitamins from an unknown date and indication and unknown whether ongoing at the time of reporting. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 15:30 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 03:00 (also reported as 12 hours after), the patient experienced throwing up a mixture of bile and mucous. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event throwing up a mixture of bile and mucous was resolving at the time of this report. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details; patient was admnistered her second dose of PNEUMOVAX 23 on 07-OCT-2021 that had expired on 01-OCT-2021; This spontaneous report was received from a pharmacist and refers to a 59 year old female patient. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.     The pharmacist reported that on 07-OCT-2021 (also reported as "today"), the patient was vaccinated with her second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot number T003597 that had expired on 01-OCT-2021, for prophylaxis (dosage, route of administration and anatomical location were not reported). No additional adverse event (AE) details.
Sex: U
Vaccine: MMRV, UNK, VARCEL
Symptoms: Incorrect product formulation administered
Clinical narrative: No additional AE; PROQUAD and VARlVAX instead of VARlVAX and MMR II.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 13-OCT-2021, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot# U010742, expiration date was reported as 03-OCT-2022, but upon internal validation established as 02-OCT-2022, 0.5 milliliter in the right thigh) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U002397, expiration date 22-JAN-2023, 0.5 ml into left thigh) (formulations, concentrations, dose numbers, frequencies and routes of administration were not reported) for prophylaxis. The measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was administered (instead of measles (+) mumps (+) rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II)) (overdose). Both of administered vaccines were dissolved in sterile diluent lot# T013004, expiration date 13-NOV-2022, 0.7 ml (formulation , strength, route of administration, frequency were not reported). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Injury
Clinical narrative: injury; This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, lot number and expiration date were not reported).         On an unknown date, the patient claimed that experienced injury.      The outcome of injury was unknown.     The reporter considered injury to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report was received from a lawyer and refers to a patient of currently 61 year-old of unknown gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster and was treated with unspecified medications.  The outcome of herpes zoster was unknown.     The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles/ herpes zoster; This spontaneous report was received from a lawyer and refers to a patient of currently 81 year-old of unknown gender concerning a case in litigation. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On or about 14-JUL-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced shingles/herpes zoster and was treated with unspecified medications.  The outcome of herpes zoster was unknown.  The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Dysarthria, Facial paralysis, Haemorrhagic stroke, Intraventricular haemorrhage
Clinical narrative: acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood; acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood; This spontaneous report as received from a lawyer refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 01-DEC-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         On an unknown date, the patient experienced slurring speech, development of facial droop and loss of consciousness and was later diagnosed with an acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect. The patient sustained severe and permanent personal injuries.  The outcome of haemorrhagic stroke and intraventricular haemorrhage was unknown.     The reporter considered haemorrhagic stroke and intraventricular haemorrhage to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the events of haemorrhagic stroke and intraventricular haemorrhage were considered medically significant and disabling events as its were permanent injuries.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood; acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood; This spontaneous report as received from a lawyer refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported.  On 01-DEC-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).         On an unknown date, the patient experienced slurring speech, development of facial droop and loss of consciousness and was later diagnosed with an acute stroke secondary to intraventricular bleed in left hypothalamus and intraventricular blood with no mass effect. The patient sustained severe and permanent personal injuries.  The outcome of haemorrhagic stroke and intraventricular haemorrhage was unknown.     The reporter considered haemorrhagic stroke and intraventricular haemorrhage to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, the events of haemorrhagic stroke and intraventricular haemorrhage were considered medically significant and disabling events as its were permanent injuries.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: A patient received improperly stored VARIVAX; No additional AEs were reported; This spontaneous report was received from a nurse referring to a patient an 11-year-old. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), at a dose of 0.5 milliliters (lot# U016065 with an expiration date on 20-MAY-2023) for prophylaxis (strength, anatomical location, and route of administration were not reported) (product storage error).       The dose of varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to a temperature excursion of 0.3 degrees Celsius (°C) during a time frame of 2 hours and 34 minutes. There was no prior temperature excursion and no adverse events were reported.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Influenza like illness, Myalgia, Pain in extremity, Pulmonary pain
Clinical narrative: flu like symptoms; pain in muscle arm area; coughing; pain from coughing in the upper left lung area; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 5th October 2021, the patient received the 2nd dose of Shingrix. On 6th October 2021, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, cough and pulmonary pain. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, cough and pulmonary pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, cough and pulmonary pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced flu like symptoms and pain in the muscle arm area, he developed pain from coughing in the upper left lung area. No further information reported.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Post herpetic neuralgia, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: shingles post vaccination series/ Suspected vaccination failure; 3-4 Breakthrough shingles/  7 breakthrough Shingles; uncomfortable with PHN; This case was reported by a pharmacist via sales rep and described the occurrence of suspected vaccination failure in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pneumonia bacterial. Previously administered products included Hizentra with an associated reaction of immunoglobulin therapy (received Hizentra on an unknown date), IVIG (received IVIG on an unknown date) and pneumovax with an associated reaction of pneumonia viral (received Pneumovax as late as July 2015 and experienced viral pneumonia twice.). Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix  Additional details were provided are as follows: The age at vaccination was not reported. The patient was having immunodeficiency. The patient received 2 doses of Shingrix in the fall of 2018. Since the vaccination, she had 7 breakthrough Shingles infections.  The patient's physician had her on a maintenance dose of 500mg Valacyclovir QD, increasing to BID and TID if improvement not seen. Last episode, about two weeks ago, she had to use valacyclovir 1g TID x1 week, then 500mg TID along with Prednisone, refer case US2021AMR217819. Given that these were happening so often, she wondered if a third dose of Shingrix would be advisable. She was quite uncomfortable with post-herpetic neuralgia. Her physician said the usual 2 shots was the maximum. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR217819:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pain, Vaccination failure
Clinical narrative: got shot and had shingles/suspected vaccination failure; shingles; pain from the shot; chills; 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), shingles, pain and chills. On an unknown date, the outcome of the vaccination failure, shingles, pain and chills were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had pain from the shot and also experienced chills. The patient also had shingles and it was a million times worse than the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: rash on rt arm; Shingles / symptoms of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included prednisone for rash.   On 8th October 2021, the patient received Shingrix. On an unknown date, the patient started prednisone at an unknown dose and frequency. On 15th October 2021, 7 days after receiving Shingrix, the patient experienced shingles. On 17th October 2021, the patient experienced rash. The action taken with prednisone was unknown. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got shingrix vaccine and developed symptoms of shingles. The patient also took prednisone and developed rash on right arm, confirmed diagnosed shingles. The follow up would not possible as contact details was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Herpes zoster, Illness, Vaccination failure
Clinical narrative: I am going through my third outbreak since having the vaccine/ suspected vaccination failure; third outbreak; extremely ill; stomach is raw; 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), shingles, illness and stomach discomfort. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, illness and stomach discomfort were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, illness and stomach discomfort to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had taken the shingles vaccine and was currently going through third outbreak since having the vaccine. The patient was extremely ill, and stomach was raw. The patient asked any advice. 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: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Shingrix; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date ) and Shingrix (2nd dose received on an unknown date ).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced Extra dose administered . On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to Extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: had Shingrix about 4 years ago, shingles/ suspected vaccination failure; shingles; 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 (Shingrix) for prophylaxis.  The patient's past medical history included shingles.  On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving 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.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the Shingrix vaccine about 4 years before the date of reporting and just had shingles again. The patient asked did he/she get another dose of it. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got both doses, have just had another case, shingles/ suspected vaccination failure; shingles; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 4 time).   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 details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received both the doses of Shingrix vaccine when it first came out and have just had another case of Shingles. The patient stated that when he/she got the vaccine, the patient was told it was for life, but the patient was reading now that it was good for 4 years or more. This case was considered to be a suspected vaccination failure case, as the details regarding completion of time to onset and laboratory confirmation for shingles were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: haven't taken 2nd dose yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2020).   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 provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to  incomplete course of vaccination. The patient asked could took the 2nd shot even though it was been.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: sister had shingles vaccine, a year passed, she got shingles/ suspected vaccination failure; shingles; no pain just a little itch; 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, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's sister. The age at vaccination was not reported. The patient got shingles vaccine and a year passed and she got shingles. The patient had no pain just a little itch. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: got both, little sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced sore arm, refer case US2021AMR218933).   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 pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got both the Shingles shot and had little sore arm and nothing else. This case is linked to the case US2021AMR218933, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR218933:2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot a year ago, never got 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago).   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 provided as follows: The reporter was the consumer. The age at vaccination was not applicable for this report. Till the time of reporting, the patient never get 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Nerve injury, Peripheral nerve operation
Clinical narrative: permanent nerve damage, had to go to a clinic to have nerves cut; This case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season and PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced nerve damage. On an unknown date, the outcome of the nerve damage was unknown.   It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details provided were as follows: The case was reported by the son/daughter for his/her mother. Age at vaccination was not reported. The patient received Shingles vaccine, Influenza vaccine and Pneumonia vaccine and had permanent permanent nerve damage nerve damage had to go to have nerve nerves cut. Follow-up would not be possible as no contact details available. It was unknown if the reporter considered the nerve damage to be related to PNEUMONIA VACCINE. The case was linked with case US2021AMR219050, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR219050:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity
Clinical narrative: still sore arm; feel chilly; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On 18th October 2021, the patient received the 2nd dose of Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced pain in arm and chills. On an unknown date, the outcome of the pain in arm and chills were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine yesterday (day before reporting) and still experienced sore arm and kinda felt chilly. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never returned for 2nd dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16 September 2020).   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 provided as follows: The age at vaccination was not applicable for this report. The patient never returned for 2nd dose after numerous attempts to reach them. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter needed to know if administered 2nd dose or restart series. The reporter consented to follow up. This case was linked with case US2021AMR219304, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR219304:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never returned for 2nd dose; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th September 2020).   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 provided as follows: The age at vaccination was not applicable for this report. The patient never returned for 2nd dose after numerous attempts to reach them. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter needed to know if administered 2nd dose or restart series. The reporter consented to follow up. This case was linked with case US2021AMR219304, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR219300:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, COVID-19
Clinical narrative: COVID-19; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2021, the patient received the 1st dose of Shingrix. On 8th September 2021, less than 2 months after receiving Shingrix, the patient experienced covid-19. The patient was treated with hyperimmune plasma covid-19 (Covid-19 Monoclonal Antibodies). On an unknown date, the outcome of the covid-19 was recovered/resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in July and had covid-19 in September. The reporter stated that the patient had received covid-19 monoclonal antibodies treatment on 08 September 2021. The reporter could not provide patient's information details as she only spoke to the nurse and not the patient himself/herself. she was not able to provide address when asked.  The reporter did not know the name of monoclonal antibody product the patient received and stated that she needed to assist a patient and would not be able to answer adverse event related questions at this time. The reporter stated that she would call back.  The reporter provided her personal phone number and was in rush to assist her patient. Follow-up consent was not obtained.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose in 2019, second dose on 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 1st February 2019) and Zostavax (received in January 2015).   On 22nd July 2021, the patient received the 2nd dose of Shingrix. On 22nd July 2021, 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: The patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Age: 77.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Product administered to patient of inappropriate age, Splenectomy
Clinical narrative: had an splenectomy; received 1st dose of  Menveo / DOB: 26-APR-1944; This case was reported by a pharmacist via call center representative and described the occurrence of splenectomy in a 77-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA440A, expiry date March 2022) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABXA95AA, expiry date February 2022) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2021, the patient received the 1st dose of Menveo, the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 16th September 2021, an unknown time after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced splenectomy. On an unknown date, the outcome of the splenectomy and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the splenectomy and inappropriate age at vaccine administration to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. 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 patient received 1st dose of Bexsero & Menveo at 77 years of age, which led to inappropriate age at vaccine administration. After first doses of both vaccines, the patient had an splenectomy and now they are wondering if there was a window time to administer 2nd dose or any guidelines on how to proceed with this patient 2nd doses. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Peripheral swelling, Vaccine breakthrough infection
Clinical narrative: Broke out in shingles; Red arm; Swollen arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GM34, expiry date 9th October 2022) for prophylaxis.   On 9th October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th October 2021, 1 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced erythema of extremities and swelling arm. On 14th October 2021, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex) and gabapentin. On 12th October 2021, the outcome of the erythema of extremities and swelling arm were recovered/resolved. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix. The reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced red and swollen arm and she broke out in shingles. The events red and swollen arm lasted for about 2 days and then resolved. The reporter saw her health care professional yesterday from the date of reporting and was now taking Valtrex and Gabapentin. The reporter declined to provide health care professional information. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the diluent portion was given; Only the diluent portion was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number AP545, expiry date 25th January 2023) for prophylaxis.   On 9th April 2021, the patient received the 1st dose of Shingrix. On 9th April 2021, unknown after receiving Shingrix, 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 received only the diluent portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter reported that, the diluent was not reconstituted with the powder and only the adjuvant was given. The reporter confirmed the correct batch number of Shingrix. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216670:Same reporter. US-GLAXOSMITHKLINE-US2021216677:Same reporter.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose July 2019/ second dose 18-OCT-2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2019).   On 18th October 2021, the patient received the 2nd dose of Shingrix. On 18th October 2021, 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 recovered/resolved.  Additional details were provided as follows: The patient self reported the case. The patient was out of the country and did not receive his second Shingrix dose until 18th October 2021, which led to lengthening of vaccination schedule. He had nothing else to report. The patient did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Dyspnoea, Head discomfort, Hyperhidrosis, Immediate post-injection reaction, Injection site erythema
Clinical narrative: redness at injection site; pain at injection site.; muscle pain all over body; She had to lower head between knees and deep breath for a few minutes; felt as if she were about to faint(almost fainted); felt blood rushing out of head; sweating; pain in arm and hand; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 5th October 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). On 5th October 2021, immediately after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced head discomfort, sweating, difficulty breathing and presyncope. On 6th October 2021, the patient experienced injection site erythema, injection site pain and generalized muscle aches. In October 2021, the patient experienced pain in hand. On an unknown date, the outcome of the injection site erythema, head discomfort, sweating, pain in hand, generalized muscle aches and presyncope were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the difficulty breathing was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, head discomfort, sweating, pain in hand, generalized muscle aches, difficulty breathing and presyncope to be related to Shingrix. It was unknown if the reporter considered the head discomfort, sweating, pain in hand, generalized muscle aches, difficulty breathing and presyncope to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was reported by patient herself. The patient received dose 1 of Shingrix in left arm and high dose Flu vaccine in right arm on same day. The patient received the flu shot first with no issues and then received Shingrix in left arm and within seconds felt the blood rush out of her head.  The patient was sweating, she felt as if she was about to faint.  She had to lower head between knees and deep breath for a few minutes.  She also mentioned the next day she had redness, and pain at the injection site (left arm) where she had the Shingrix shot.  The patient still had some pain in arm since then.  The patient had muscle pain all over body and less than 3 weeks after vaccination, had pain in hand.  The reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Myalgia, Pain in extremity, Presyncope, Sensation of blood flow
Clinical narrative: redness at injection site; pain at injection site.; muscle pain all over body; She had to lower head between knees and deep breath for a few minutes; felt as if she were about to faint(almost fainted); felt blood rushing out of head; sweating; pain in arm and hand; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 5th October 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season (intramuscular). On 5th October 2021, immediately after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced head discomfort, sweating, difficulty breathing and presyncope. On 6th October 2021, the patient experienced injection site erythema, injection site pain and generalized muscle aches. In October 2021, the patient experienced pain in hand. On an unknown date, the outcome of the injection site erythema, head discomfort, sweating, pain in hand, generalized muscle aches and presyncope were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the difficulty breathing was unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain, head discomfort, sweating, pain in hand, generalized muscle aches, difficulty breathing and presyncope to be related to Shingrix. It was unknown if the reporter considered the head discomfort, sweating, pain in hand, generalized muscle aches, difficulty breathing and presyncope to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The case was reported by patient herself. The patient received dose 1 of Shingrix in left arm and high dose Flu vaccine in right arm on same day. The patient received the flu shot first with no issues and then received Shingrix in left arm and within seconds felt the blood rush out of her head.  The patient was sweating, she felt as if she was about to faint.  She had to lower head between knees and deep breath for a few minutes.  She also mentioned the next day she had redness, and pain at the injection site (left arm) where she had the Shingrix shot.  The patient still had some pain in arm since then.  The patient had muscle pain all over body and less than 3 weeks after vaccination, had pain in hand.  The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose not yet given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th September 2020, batch number 3XR3X, expiry date 12th September 2022).   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 provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.