chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to an approximately 56-year-old female patient (pt) who was 56 years old at the time of vaccination. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On 28-JUL-2016, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at physician's offices for the long-term prevention of shingles and zoster-related conditions. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer shingles in or about December 2016, including any and all of its sequelae (also reported as subsequently (date not provided), the pt was treated by a healthcare provider for shingles, resulting from the pt's use of zoster vaccine live (ZOSTAVAX)). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) defective design, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences (also reported as had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages). The pt had endured substantial pain and suffering. She had incurred significant expenses for medical care and treatment, and would continue to incur such expenses in the future. The pt had lost earnings and had suffered a loss of earning capacity. The pt had suffered and would continue to suffer economic loss, and had otherwise been physically, emotionally and economically injured. The pt's injuries and damages were permanent and would continue into the future. The outcome of the event was considered to be not recovered. The reported considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to an approximately 68-year-old female patient (pt) who was also 68-years-old at the time of vaccination. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 19-SEP-2011, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer shingles on or about 03-OCT-2011, including any and all of its sequelae (also reported as subsequently (date not provided), the pt was treated by a healthcare provider for shingles, resulting from the pt's use of zoster vaccine live (ZOSTAVAX)). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences (also reported as had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages). The pt had endured substantial pain and suffering. She had incurred significant expenses for medical care and treatment, and would continue to incur such expenses in the future. The pt had lost earnings and had suffered a loss of earning capacity. The pt had suffered and would continue to suffer economic loss, and had otherwise been physically, emotionally and economically injured. The pt's injuries and damages were permanent and would continue into the future. The outcome of the event was considered to be not recovered. The reported considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes ophthalmic, Herpes zoster
Clinical narrative: OCULAR HERPES; STROKE; shingles; Information has been received from a lawyer concerning a case in litigation and refers to a 67-year-old female patient. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On 30-JAN-2012, the pt was administered with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) at the physician office for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for injuries resulting from zoster vaccine live (ZOSTAVAX) use: ocular herpes and a stroke. As a result pf her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer shingles in or about October 2012, including and all of it sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX) , the pt has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences. The pt has endured substantial pain and suffering. The pt has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The pt has lost past earnings and has suffered a loss of earning capacity. The pt  has suffered and would continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The pt's injuries and damages ware permanent and would continue into the future.  The pt sought actual and punitive damages from the Company as alleged herein. the pt demanded judgment against Company for compensatory, treble, and punitive damages, together with interest, costs of suit, attorneys' fees, and all such other relief as the Court deems proper. The outcome of shingles was reported as not recovered. The outcome of ocular herpes and stroke was unknown. The causality was related.  The event of shingles was considered to be disabling. Upon internal review, the events of ocular herpes and stroke were determined to be medically significant.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 58-year-old male patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In August 2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On or about 30-DEC-2016, the patient presented Stroke. As a direct and proximate result, the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result, he suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences; additionally, he had incurred significant expenses for medical care and treatment, his injuries and damages were permanent and would continue into the future.   The reporter considered the event of Stroke to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of Stroke was considered as medically significant.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: an expired dose of PROQUAD that was given to a patient; This spontaneous report was received from a physician referring to a 3 years old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 06-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHA) (0.5 milliliter (ml), lot # S007075, expiration date reported as 06-AUG-2020, but upon internal validation established as 06-SEP-2020; strength, frequency and route of administration were not reported) for prophylaxis (expired product administered).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to an approximately 59-year-old female patient (pt) who was 59 years old at the time of vaccination (calculated based on the suspect vaccine start date; age at vaccination reported as 56 years old, conflicting information). No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 21-JUL-2010, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a county health department for the long-term prevention of shingles and zoster-related conditions. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer shingles in or about 2010, including any and all of its sequelae (also reported as subsequently (date not provided), the pt was treated by a healthcare provider for shingles, resulting from the pt's use of zoster vaccine live (ZOSTAVAX)). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences (also reported as had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages). The pt had endured substantial pain and suffering. She had incurred significant expenses for medical care and treatment, and would continue to incur such expenses in the future. The pt had lost earnings and had suffered a loss of earning capacity. The pt had suffered and would continue to suffer economic loss, and had otherwise been physically, emotionally and economically injured. The pt's injuries and damages were permanent and would continue into the future. The outcome of the event was considered to be not recovered. The reported considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer concerning a case in litigation and refers to a currently 69-year-old male patient. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. In or about 2012, the pt was administered with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) at the physician office for the long-term prevention of shingles and zoster-related conditions. As a result pf his receipt of zoster vaccine live (ZOSTAVAX), the pt was caused to suffer shingles in or about 2012, including and all of it sequelae and was subsequently treated by a provider. As a result of his receipt of zoster vaccine live (ZOSTAVAX) , the pt has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences. The pt has endured substantial pain and suffering. The pt has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The pt has lost past earnings and has suffered a loss of earning capacity. The pt has suffered and would continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The pt's injuries and damages ware permanent and would continue into the future. The pt sought actual and punitive damages from the Company as alleged herein. the pt demanded judgment against Company for compensatory, treble, and punitive damages, together with interest, costs of suit, attorneys' fees, and all such other relief as the Court deems proper. The outcome of shingles was reported as not recovered. The causality was related.  The event of shingles was considered to be disabling.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to an elderly male patient (pt) who at the time of vaccination was approximately 72 years old. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 06-OCT-2016, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. As a result of the said administration, the pt was caused to suffer shingles, including any and all of its sequelae (also reported as subsequently (date not provided), the pt was treated by a healthcare provider for shingles, resulting from the pt's use of zoster vaccine live (ZOSTAVAX)). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) manufacturing defect, the pt suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences (also reported as had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages). The pt had endured substantial pain and suffering. He had incurred significant expenses for medical care and treatment, and would continue to incur such expenses in the future. The pt had lost earnings and had suffered a loss of earning capacity. The pt had suffered and would continue to suffer economic loss, and had otherwise been physically, emotionally and economically injured. The pt's injuries and damages were permanent and would continue into the future. The outcome of the event was considered to be not recovered. The reported considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Products used after excursion. Two vials of PEDVAX HIB had already been administered to two different patients.; This spontaneous report was received from a registered nurse and refers to a 2-month-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history, drug reactions/allergies and historical drugs was not provided.  On 12-SEP-2020, the patient was vaccinated with an improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) first dose, 1 vial lot #S030967 and expiration date 15-APR-2022 administered as prophylaxis (route of administration was not reported)  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 1.14 degree Celsius (°C) for 2 hours and 20 minutes on, -0.99°C for 10 minutes, -1.23°C for 10 minutes, -0.44°C for 10 minutes on unknown dates; a previous temperature excursion was reported.  The call was made due to a digital data logger.  This is one of two reports from the same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: She said the patient had not experienced any adverse reactions; an expired ZOSTAVAX vaccine was administered to a patient; This spontaneous report was received from a health care professional (HCP) and refers to a 62 years old female patient of unknown ethnic.  The patient pertinent medical history, concurrent conditions, drug allergies and concomitant therapies were not provided.   On 11-SEP-2020, the patient was vaccinated with 0.65 ml of an expired vaccine live (ZOSTAVAX) lot # S016663 and expiration date 27-AUG-2020 (national drug code (NDC) 00006-4963-41) (route of administration not provided) for prophylaxis. The HCP said that the patient had not experienced any adverse reaction.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 57-year-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On 18-APR-2014, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On or about April 2014, the patient presented shingles. As a direct and proximate result, the patient had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result, he suffered severe and permanent physical injuries, including but not limited to shingles, as well as other severe and permanent health consequences; additionally, he had incurred significant expenses for medical care and treatment, his injuries and damages were permanent and would continue into the future.   The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The PROQUAD expired on 09/02/2020 and it did undergo a previous temperature excursion; No additional AE/PQC; patient in their office received and expired dose of PROQUAD roday in their office; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 15-SEP-2020, the patient was vaccinated with improperly stored and expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml injection, rHA, lot # S006830 has been verified to be a valid lot number, expiration date 02-SEP-2020 (frequency reported as "once", anatomical location and route of administration were not provided) for prophylaxis. On 20-AUG-2020, administered dose of vaccine experienced the temperature excursion of - 14.9 degrees Celsius (C) for 109 minutes. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Peripheral swelling, Rash
Clinical narrative: the patient developed a rash all over her body as well as swelling of the hands; the patient developed a rash all over her body as well as swelling of the hands; This spontaneous report was received from a medical assistant via company representative and refers to a 4-year-old female patient. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2020, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, vaccination site, route of administration, lot # and expiration date were not provided) for prophylaxis. On the same date, the patient was vaccinated with the fifth dose of diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (mrc-5), tetanus toxoid (QUADRACEL).  On an unknown date in 2020, the patient developed a rash all over her body as well as swelling of the hands. The patient sought medical attention. It was reported that no hospitalization was needed.The outcome of the events was unknown.  The causal relationship between the events and the suspect therapies was not reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: lhe patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an 08-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), rHA, lot # S031706 has been verified to be a valid lot number, expiration date 06-APR-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). Administered dose of vaccine experienced the temperature excursion of -11  degrees Celsiust (C) for 5 hours and 20 minutes. Data logger was not involved. There were no previous excursions reported.
Sex: M
Vaccine: HPV9
Symptoms: Concussion, Fall, Head injury, Syncope
Clinical narrative: fainted; suffered from a concussion; This spontaneous report was received from a physician via a company representative referring to a male patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.      On an unknown date (reported as several years ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date, the patient fainted, fell and hit his head. The patient had to go to the emergency room and suffered from a concussion for a few days following the fall.  It was unknown if treatment was given for the events. The outcome of all events was unknown. The causality assessment between all events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon interval review, fainted was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA006671:
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness
Clinical narrative: arm hurt a lot after shot; still a little tender to the touch; This case was reported by a consumer and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and tenderness. On an unknown date, the outcome of the pain in arm and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and tenderness to be related to Shingrix.  Additional details were provided as follows: The reporter reported the case for the father. The age at vaccination was not reported. The patient's arm hurt a lot after shot, arm still a little tender to the touch at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash macular
Clinical narrative: Red blotch area; Has been sore; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingles vaccine. On 13th September 2020, 3 days after receiving Shingles vaccine, the patient experienced red blotches. In September 2020, the patient experienced pain. On an unknown date, the outcome of the pain was recovering/resolving and the outcome of the red blotches was not recovered/not resolved.   It was unknown if the reporter considered the pain and red blotches to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient via interactive digital media. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The reporter stated that after receiving the vaccine, it had been sore but was better each day. The reporter noticed a red blotch area under the shot area on the day of reporting. The reporter had questioned if they were contagious from the shot. The follow-up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal behaviour
Clinical narrative: terrible reaction / pathetic sniveling; This case was reported by a consumer via interactive digital media and described the occurrence of behavior abnormal 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 behavior abnormal. On an unknown date, the outcome of the behavior abnormal was unknown.   It was unknown if the reporter considered the behavior abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the husband of the patient. The age at vaccination was not reported. The patient received Shingles vaccine and had terrible reaction pathetic sniveling.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a other health professional via other manufacturer and described the occurrence of allergic reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included urinary tract infection and drug allergy.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had allergy.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Ill-defined disorder
Clinical narrative: Bad reaction; Low back pain; This case was reported by a other health professional via interactive digital media and described the occurrence of ill-defined disorder in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced ill-defined disorder and low back pain. On an unknown date, the outcome of the ill-defined disorder and low back pain were unknown.   It was unknown if the reporter considered the ill-defined disorder and low back pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. HCP reported that he received the 2nd dose of shingrix on last thursday and experienced bad reaction and also low back pain with that. Patient was asking about if that was the concern or it will resolve.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: Low back pain; This case was reported by a consumer via interactive digital media and described the occurrence of low back pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced low back pain. On an unknown date, the outcome of the low back pain was unknown.   It was unknown if the reporter considered the low back pain to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer reported that after receiving the shingrix patient experienced low back pain. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Dizziness, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Numbness and tingling down to fingers; Tingling down to fingers; Severe dizziness; Nausia; Bedridden; This case was reported by a consumer and described the occurrence of numbness in fingers in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2020, the patient received the 1st dose of Shingrix. On 13th September 2020, 1 days after receiving Shingrix, the patient experienced numbness in fingers, tingling of extremity, dizziness, nausea and bedridden. On an unknown date, the outcome of the numbness in fingers, tingling of extremity, dizziness, nausea and bedridden were recovered/resolved.   It was unknown if the reporter considered the numbness in fingers, tingling of extremity, dizziness, nausea and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and awoke to numbness and tingling down to fingers in left arm and severe dizziness leading to nausea.  The symptoms lasted 1.5 days rendering the patient bedridden.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site stinging; This case was reported by a consumer via call center representative and described the occurrence of injection site stinging in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th February 2020, the patient received the 1st dose of Shingrix. On 7th February 2020, less than a day after receiving Shingrix, the patient experienced injection site stinging. On an unknown date, the outcome of the injection site stinging was not recovered/not resolved.   It was unknown if the reporter considered the injection site stinging to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 75 or 76 years. The patient reported injection site stinging with the 1st dose. For tolerance after 2nd dose of Shingrix, refer case US2020185507.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020185507:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Limb mass, Swelling
Clinical narrative: Lump on arm; Erythema on arm; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced local swelling and erythema of extremities. On an unknown date, the outcome of the local swelling and erythema of extremities were unknown.   It was unknown if the reporter considered the local swelling and erythema of extremities to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. It was reported by the patient that after receiving shingrix patient experienced that arm developed a dark red lump with size of tennis ball. The reporter did not consent to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: soreness at the injection site / pain; little swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-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, couple of hours after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm and experienced soreness at the injection site a couple of hours after the injection. The patient also had a little swelling at the injection site that lasted a couple of days before the pain and swelling resolved. The reporter consented to follow up. For tolerances of 2nd dose, refer case US2020187068, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187068:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: left arm became sore/soreness; "felt like" she was getting a fever/"felt like fever"; swollen, itchy left arm; itchy left arm; red, swollen, itchy left arm; soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 3AG4G, expiry date unknown) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On 8th September 2020, the patient received the 1st dose of Shingrix. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, swelling arm, pruritus, erythema of extremities and pain. On 9th September 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm, swelling arm and pruritus were not recovered/not resolved and the outcome of the erythema of extremities and pain were unknown.   It was unknown if the reporter considered the pain in arm, fever, swelling arm, pruritus, erythema of extremities and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was updated from 38G4G to 3AG4G, as per sales data sheet. The patient received Shingrix and her left arm became sore and felt like she was getting a fever.  The patient had red, swollen, itchy left arm.  The soreness, red, swollen, itchy left arm symptoms have improved, but all persist at the time of reporting. The reporter did not consent to follow up. The reporter declines to provide any additional information for this AE and did not consent to HCP follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: left arm became sore/soreness; "felt like" she was getting a fever/"felt like fever"; swollen, itchy left arm; itchy left arm; red, swollen, itchy left arm; soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number 3AG4G, expiry date unknown) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On 8th September 2020, the patient received the 1st dose of Shingrix. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, swelling arm, pruritus, erythema of extremities and pain. On 9th September 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm, swelling arm and pruritus were not recovered/not resolved and the outcome of the erythema of extremities and pain were unknown.   It was unknown if the reporter considered the pain in arm, fever, swelling arm, pruritus, erythema of extremities and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was updated from 38G4G to 3AG4G, as per sales data sheet. The patient received Shingrix and her left arm became sore and felt like she was getting a fever.  The patient had red, swollen, itchy left arm.  The soreness, red, swollen, itchy left arm symptoms have improved, but all persist at the time of reporting. The reporter did not consent to follow up. The reporter declines to provide any additional information for this AE and did not consent to HCP follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Injection site joint pain, Injection site pain, Pain of skin
Clinical narrative: headaches on the right side of his forehead/scalp/eye socket area; skin in the headache area is also sensitive.; headaches on the right side of his eye socket area; headaches on the right side of his scalp; injection site shoulder and muscle pain; injection site shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain and injection site joint pain. On 15th August 2020, the patient experienced headache, sensitive skin, aching eye socket and scalp pain. The patient was treated with ibuprofen and paracetamol (Tylenol). On 14th August 2020, the outcome of the injection site muscle pain and injection site joint pain were recovered/resolved. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the sensitive skin, aching eye socket and scalp pain were unknown.   It was unknown if the reporter considered the injection site muscle pain, injection site joint pain, headache, sensitive skin, aching eye socket and scalp pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and same day he developed injection site shoulder and muscle pain that lasted for less than 48 hours.  The patient started to get headaches on the right side of his forehead, scalp and eye socket area.  These headaches occur every 5-6 days and last for 3-4 hours.  The patient stated they resolve after treatment with tylenol or ibprofen.  The skin in the headache area was also sensitive. The consented to follow up and consents to HCP follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Sensitive skin
Clinical narrative: headaches on the right side of his forehead/scalp/eye socket area; skin in the headache area is also sensitive.; headaches on the right side of his eye socket area; headaches on the right side of his scalp; injection site shoulder and muscle pain; injection site shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2020, less than a day after receiving Shingrix, the patient experienced injection site muscle pain and injection site joint pain. On 15th August 2020, the patient experienced headache, sensitive skin, aching eye socket and scalp pain. The patient was treated with ibuprofen and paracetamol (Tylenol). On 14th August 2020, the outcome of the injection site muscle pain and injection site joint pain were recovered/resolved. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the sensitive skin, aching eye socket and scalp pain were unknown.   It was unknown if the reporter considered the injection site muscle pain, injection site joint pain, headache, sensitive skin, aching eye socket and scalp pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and same day he developed injection site shoulder and muscle pain that lasted for less than 48 hours.  The patient started to get headaches on the right side of his forehead, scalp and eye socket area.  These headaches occur every 5-6 days and last for 3-4 hours.  The patient stated they resolve after treatment with tylenol or ibprofen.  The skin in the headache area was also sensitive. The consented to follow up and consents to HCP follow up.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Headache, Injection site pain, Pain
Clinical narrative: received her first shingrix injection 5/2019 / second shingrix injection in 7/2019 / another shingrix vaccination on yesterday; Pain; Headache; injection site is sore; This case was reported by a consumer via call center representative and described the occurrence of pain in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019) and Shingrix (received 2nd dose in July 2019). Concurrent medical conditions included breast cancer.   On 10th September 2020, the patient received the 3rd dose of Shingrix (intramuscular). On 10th September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. In September 2020, the patient experienced pain, headache and injection site pain. On an unknown date, the outcome of the pain and headache were not recovered/not resolved and the outcome of the injection site pain and extra dose administered were unknown.   It was unknown if the reporter considered the pain, headache and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she received her first shingrix injection May 2019.  She then got the second shingrix injection in July 2019.  She said that she got another shingrix vaccination, extra dose.  Less than a week after vaccination patient experienced injection site was sore, pain, and she had a headache. The patient was uncomfortable because she did not get the injections from him.  The patient did not consent to follow-up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever was reported to be 101.2; fatigue; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number G4HX3, expiry date 13th May 2022) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix .5 ml. On 10th September 2020, 1 days after receiving Shingrix, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were unknown.   It was unknown if the reporter considered the fever and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient had fever 101.2 degree F. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: might be shingles/Blistering rash on right side of body that is  painful and itchy; blistering rash that was painful and itchy; blistering rash that was painful and itchy; This case was reported by a consumer via call center representative and described the occurrence of blistery rash in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 1st September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 3rd September 2020, 2 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced blistery rash, painful rash and itchy rash. On an unknown date, the outcome of the blistery rash, painful rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the blistery rash, painful rash and itchy rash to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received Shingrix and flu vaccine in left arm. 2 days later after receiving Shingrix and flu vaccine, the patient experienced a blistering rash that was painful and itchy and was concerned it might be shingles.  Till the time of reporting, the symptoms had not gotten any better.   The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: itching from neck down to knees; hives; soreness in the left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD VACCINE) for prophylaxis.   The patient's past medical history included hives (when she was younger). Previously administered products included Zostavax (received in 2013).   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD VACCINE (intramuscular). On 28th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 5th September 2020, the patient experienced pruritus and hives. The patient was treated with steroids nos (Steroid Shot (Nos)), prednisone, hydrocortisone (Hydrocortisone Cream) and atarax (nos) (Atarax). On 29th August 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pruritus and hives were recovering/resolving.   It was unknown if the reporter considered the pain in arm, pruritus and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported had hives when she was younger.  The patient reported received Zostavax vaccine in 2013. On 28th August 2020, the patient received first  dose of Shingrix vaccine and Fluad vaccine in left arm. The patient reported still has hives and itching currently but the Prednisone has helped with some improvement. The patient reported soreness in the left arm that happened later on the same day after receiving the vaccines and lasted up to 1 day and has resolved at this time.  On 5th September 2020, the patient developed hives and itching from neck down to knees. On 6th September 2020, the patient was seen by health care professional and received a steroid shot, oral Prednisone, hydrocortisone cream and Atarax as treatment.  On 8th September 2020, the patient reported went back to health care professional for a second time and the dosage of Prednisone was increased. The reporter consent to follow up.