chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Ocular hyperaemia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLULAVAL QUADRIVALENT (batch number PP732, expiry date 30th June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, 1 day after receiving FLUALVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The day after vaccination, the patient experienced bull's eye redness, swelling, pain and heat all around the injection site. The reporter did not have date of birth. This case has been linked with case US2018180227 and US2018180228, reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Ocular hyperaemia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number PP732, expiry date 30th June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, 1 day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were recovering/resolving. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The day after vaccination, the patient experienced bull's eye redness, swelling, pain and heat all around the injection site. This case has been linked with case US2018180225 and US2018180228, reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number PP732, expiry date 30th June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season. In October 2018, 1 day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site erythema, injection site pain, injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain, injection site warmth and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, injection site warmth and injection site swelling to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were reported as follows: The age at vaccination was not reported. The day after vaccination, the patient experienced bull's eye redness, swelling, pain and heat all around the injection site. The reporter stated that, symptoms of the patient's might be worsened. This case has been linked with case US2018180227 and US2018180225, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test, Burning sensation, Immunoglobulins increased, Pain, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 64-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 6 hrs after receiving SHINGRIX, the patient experienced burning sensation, generalized pruritus and general body pain. On an unknown date, the patient experienced immunoglobulins increased. On an unknown date, the outcome of the burning sensation, generalized pruritus, general body pain and immunoglobulins increased were unknown. It was unknown if the reporter considered the burning sensation, generalized pruritus, general body pain and immunoglobulins increased to be related to SHINGRIX. Additional details were provided as follows: The reporter reported through online chat that, she had already reported it to the Center for disease control and prevention (CDC). Since the shot approximately 6 to 7 hours after, the patient began itchy and the itching continued and gotten worse and then a burning like a bad pair shoes. This was all over her body. Less than a month after receiving SHINGRIX, the patient did not had the rash but her antibodies were over 3000 since getting the shot. The patient would like to know what remedy was suggested for it. The patient had been dealing with this for almost over a month. The patient was seeing a neurologist at the time of reporting because she also got little shooting pains randomly throughout her body like little needles poking. The patient did not have rash though. Lab Comments: Lab test was done on an unknown date.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 64-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 6 hrs after receiving SHINGRIX, the patient experienced burning sensation, generalized pruritus and general body pain. On an unknown date, the patient experienced immunoglobulins increased. On an unknown date, the outcome of the burning sensation, generalized pruritus, general body pain and immunoglobulins increased were unknown. It was unknown if the reporter considered the burning sensation, generalized pruritus, general body pain and immunoglobulins increased to be related to SHINGRIX. Additional details were provided as follows: The reporter reported through online chat that, she had already reported it to the Center for disease control and prevention (CDC). Since the shot approximately 6 to 7 hours after, the patient began itchy and the itching continued and gotten worse and then a burning like a bad pair shoes. This was all over her body. Less than a month after receiving SHINGRIX, the patient did not had the rash but her antibodies were over 3000 since getting the shot. The patient would like to know what remedy was suggested for it. The patient had been dealing with this for almost over a month. The patient was seeing a neurologist at the time of reporting because she also got little shooting pains randomly throughout her body like little needles poking. The patient did not have rash though. Lab Comments: Lab test was done on an unknown date.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Antibody test abnormal, Burning sensation, Eye pruritus, Injection site pain, Injection site pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 64-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 6 hrs after receiving SHINGRIX, the patient experienced burning sensation, generalized pruritus and general body pain. On an unknown date, the patient experienced immunoglobulins increased. On an unknown date, the outcome of the burning sensation, generalized pruritus, general body pain and immunoglobulins increased were unknown. It was unknown if the reporter considered the burning sensation, generalized pruritus, general body pain and immunoglobulins increased to be related to SHINGRIX. Additional details were provided as follows: The reporter reported through online chat that, she had already reported it to the Center for disease control and prevention (CDC). Since the shot approximately 6 to 7 hours after, the patient began itchy and the itching continued and gotten worse and then a burning like a bad pair shoes. This was all over her body. Less than a month after receiving SHINGRIX, the patient did not had the rash but her antibodies were over 3000 since getting the shot. The patient would like to know what remedy was suggested for it. The patient had been dealing with this for almost over a month. The patient was seeing a neurologist at the time of reporting because she also got little shooting pains randomly throughout her body like little needles poking. The patient did not have rash though. Lab Comments: Lab test was done on an unknown date.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Pain, Paraesthesia, Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 64-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, 6 hrs after receiving SHINGRIX, the patient experienced burning sensation, generalized pruritus and general body pain. On an unknown date, the patient experienced immunoglobulins increased. On an unknown date, the outcome of the burning sensation, generalized pruritus, general body pain and immunoglobulins increased were unknown. It was unknown if the reporter considered the burning sensation, generalized pruritus, general body pain and immunoglobulins increased to be related to SHINGRIX. Additional details were provided as follows: The reporter reported through online chat that, she had already reported it to the Center for disease control and prevention (CDC). Since the shot approximately 6 to 7 hours after, the patient began itchy and the itching continued and gotten worse and then a burning like a bad pair shoes. This was all over her body. Less than a month after receiving SHINGRIX, the patient did not had the rash but her antibodies were over 3000 since getting the shot. The patient would like to know what remedy was suggested for it. The patient had been dealing with this for almost over a month. The patient was seeing a neurologist at the time of reporting because she also got little shooting pains randomly throughout her body like little needles poking. The patient did not have rash though. Lab Comments: Lab test was done on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and radiating pain. On an unknown date, the outcome of the muscle pain and radiating pain were unknown. It was unknown if the reporter considered the muscle pain and radiating pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 62 or 63 years old. The healthcare professional (HCP) had a patient who complained of muscle pain from SHINGRIX injection, radiated down her arm pit and her back shoulder after her shot. The HCP asked, should the patient get the 2nd dose of SHINGRIX.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.  On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The every year the patient gets the flu vaccine and she gets a sore arm. This case was linked with case US2018180124, reported by same reporter and having same patient.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a 60-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis. The patient's past medical history included menopause and headache (10 years before the date of reporting). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. 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 Flu vaccine. Additional details were provided as follows; The age at vaccination was not reported. The patient experienced just a little sore arm. For tolerance of 1st dose of SHINGRIX, refer case US2018077610. For tolerance of 2nd dose of SHINGRIX, refer case US2018GSK080935. This case has been linked to US2018GSK186361, reported by the same reporter for the patients husband.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness, tenderness, swelling, and warm on site of vaccine.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction
Clinical narrative: "Localized reaction" (L) UE/(L) Deltoid.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Bruising around injection site. Muscle soreness and stiffness. Shoulder pain.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Patient received ADACEL and FLUARIX in the right arm and came down with a cellulitis infection. Patient's dr says site of infection was too far down in the arm. Patient's arm was swollen and had to go to have a dr visit resulting in a prescription for BACTRIM DS.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Patient developed surrounding erythema with localized wheal around his injection site within 24 hours of vaccine administration. He had no other constitutional symptoms, ie no fever, no nausea/ vomiting, no fatigue or weakness. Erythema had improved notably by the time of follow-up assessment.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal discomfort, Chills, Dizziness, Muscular weakness
Clinical narrative: Pt c/o: dizziness, weakness of muscles in both legs, stomach upset, and chills 1 day after vaccine.  Pt was advised to go to ER.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Patient states woke up Sunday morning and his hand was numb. He was fine before then. The numbness has been improving but currently 4 days out he still has some hand weakness/numbness.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event
Clinical narrative: He was not due for this shot - he should have waited till he was 65 to get this shot to start his pneumonia series - no adverse effects. Reported by patient
Age: 59.0
Sex: M
Vaccine: FLUR4
Symptoms: Chills, Dizziness, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Fever, vomiting, pain, sweating/chills, dizzy when standing since 5:00pm yesterday.
Age: 59.0
Sex: M
Vaccine: FLUR4
Symptoms: Vomiting
Clinical narrative: Fever, vomiting, pain, sweating/chills, dizzy when standing since 5:00pm yesterday.
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site swelling, Pain, Paraesthesia
Clinical narrative: 21-22 Sep 2018: Numbness/tingling in left arm; Body aches; Couldn't lift left arm; Swelling noted in upper left arm.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pruritus generalised, Rash erythematous, Throat irritation, Throat tightness
Clinical narrative: Within 5 minutes of IM flu vaccine developed generalized itching with some mild red rash, tightness in throat. Tightness in throat worsened for several minutes. Took 50 mg diphenhydramine. Then took ZANTAC 75 mg approx. 2 hours later. Still had some scalp itching and some throat sensation. Took ZYRTEC 10 mg later that evening and another ZANTAC 75 mg at bedtime.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chest discomfort, Fatigue, Headache, Impaired work ability
Clinical narrative: Ninety minutes after the dose, mild tightness  in chest noted, remained stable. At 15 hours after the dose, awakened with marked body and joint aches, headache, fever; felt too sick to arise to check temperature. This persisted; at 30 hours when feeling somewhat better, temperature was 38.2. Fever and aches resolved by 48 hrs, fatigue and headache persist another several days. Sister (an RN) has anaphylaxis with the flu vaccine. This was my first ever flu vaccine, which I reluctantly received as it became a requirement for hospital staff. Previous history of unexpected response to and infection with (rubeola and rubella) when living overseas in the 80s.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Ninety minutes after the dose, mild tightness  in chest noted, remained stable. At 15 hours after the dose, awakened with marked body and joint aches, headache, fever; felt too sick to arise to check temperature. This persisted; at 30 hours when feeling somewhat better, temperature was 38.2. Fever and aches resolved by 48 hrs, fatigue and headache persist another several days. Sister (an RN) has anaphylaxis with the flu vaccine. This was my first ever flu vaccine, which I reluctantly received as it became a requirement for hospital staff. Previous history of unexpected response to and infection with (rubeola and rubella) when living overseas in the 80s.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Joint noise, Joint range of motion decreased, Muscular weakness, Musculoskeletal pain
Clinical narrative: Shoulder pain, Shoulder range of motion limited, Can be force, pops very painfully, full range is restored without pain for a short period of time. Injection site is tender when moving arm. Reduced strength in arm. ~30% Peak of pain was about 1 week post shot. Issues are slowly subsiding after two week, but persists. Number of times my shoulder gets stuck/ hurts or pops while in use has been reduced to under a 10 times a day from a peak of over 20. Ibuprofen, stretching and ice.
Age: 37.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: Shoulder pain, Shoulder range of motion limited, Can be force, pops very painfully, full range is restored without pain for a short period of time. Injection site is tender when moving arm. Reduced strength in arm. ~30% Peak of pain was about 1 week post shot. Issues are slowly subsiding after two week, but persists. Number of times my shoulder gets stuck/ hurts or pops while in use has been reduced to under a 10 times a day from a peak of over 20. Ibuprofen, stretching and ice.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23(lot # R009408, expiration date 07-MAR-2020) (dose, frequency, route of administration were not reported) for prophylaxis (product storage error). The product was stored in an unmonitored refrigerator (temperature was unknown by reporter) for 7 hours. No adverse symptoms reported. Follow up information was received on 04-OCT-2018: This spontaneous report was received from a registered nurse refers to a 56-year-old female patient. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R009408, expiration date 07-MAR-2020) (dose and frequency not reported) intramuscularly for prophylaxis. It was reported that temperature monitor was not tracking the temperatures. There was no reason to believe the temperatures were out of normal range. No temperature excursion was suspected. The call was due to protocol.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-NOV-2013, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long-term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 30-AUG-2016, the patient was treated for a vesicular outbreak, which was diagnosed as or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX), prednisone and neosporin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-JUN-2011, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long-term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 20-AUG-2016, the patient was treated for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 18-OCT-2013, the patient was inoculated with ZOSTAVAX at Pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-DEC-2014, the patient was treated a physician office for the onset of Rash, which was diagnosed as herpes zoster. She was prescribed Val Acyclovir and VICODIN (acetaminophen, hydrocodone bitartrate) for management of her painful symptoms and excruciating pain. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX at a clinic as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. On or about 17-JAN-2012, the patient was treated in a clinic for the diagnosis as of post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. She was prescribed Acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer via poison and drug center regarding an 82 year old female patient. The patient's medical history includes pneumonia and seasonal flu vaccinations. The patient's concomitant medications include a long list including FLUAD vaccination received on 13-OCT-2018. On the same day, the patient was vaccinated with PNEUMOVAX 23 once in the left deltoid for prophylaxis (dose and lot# were not reported). On the same day, after receiving the vaccination, the patient experienced pain at the injection site (vaccination site pain) and swelling from left elbow to left armpit (peripheral swelling). She had no relevant laboratory test. As of 14-OCT-2018, it was unknown if she would continue PNEUMOVAX 23 and the outcome of the events was unknown. Causality assessment was not provided.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of headache in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number M73CE, expiry date 30th June 2019) for prophylaxis. On 26th September 2018, the patient received FLUARIX QUADRIVALENT. On 27th September 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced headache and vomiting. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the vomiting was recovering/resolving. It was unknown if the reporter considered the headache and vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported that she experienced headache, one day after receiving the injection. The event, at time of report, was unresolved. The patient also experienced vomiting, which had improved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Injection site mass, Injection site swelling, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received original shingles vaccine and experienced shingles). On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd August 2018, 113 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced influenza-like symptoms, injection site lump, feeling unwell and injection site swelling. On 17th September 2018, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms, injection site lump, feeling unwell and injection site swelling were recovered/resolved. It was unknown if the reporter considered the shingles, influenza-like symptoms, injection site lump, feeling unwell and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. In August, the patient got shingles which lasted for several weeks but was gone by 17th September 2018. The patient also said when she had the original vaccination, less than a year after receiving SHINGRIX, the patient experienced a golf ball (lump/swelling) at the site and she felt ill for 3 days. All symptoms were resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site swelling, Injection site warmth, Skin warm, Swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 1st October 2018, the patient received SHINGRIX .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid. After receiving SHINGRIX, the patient experienced large swelling at injection site that went up to the patient's clavicle and it was warm to touch. This case has been linked with the case US2018182677, reported by same reporter.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received SHINGRIX .5 ml. In October 2018, less than a week after receiving SHINGRIX, the patient experienced injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right deltoid. After receiving SHINGRIX, the patient experienced large swelling at injection site that was warm to touch. This case has been linked with the case US2018182676, reported by same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received SHINGRIX (batch number FZ3ND, expiry date 2nd February 2021) for prophylaxis. On 21st September 2018 16:38, the patient received the 1st dose of SHINGRIX 5 ml. On 21st September 2018, less than a day after receiving SHINGRIX the patient experienced injection site pain, injection site erythema, injection site warmth and injection site itching. The patient was treated with hydrocortisone. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and injection site itching were recovering/resolving. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The patient reported pain and soreness at the injection site the evening of the injection. The patient also described it as tender. Over time the injection site area became red, itchy and warm. The affected area was described to be the size of a nickel. The second red, itchy and warm area presented located an inch below the injection site area. This patch measured either 4 by 4 inches or 5 by 3 inches. The exact measurement was unclear. The time frame of presentation was also unclear. It was started on 21st September 18 and continued through 4th October 2018 when the patient visited the pharmacist who treated the areas with hydrocortisone cream. The patient then sought medical attention at her physician's office and was offered medication which she refused. The patient called the pharmacist on Saturday (6th October 2018) and told her that the redness and itching had decreased following the hydrocortisone cream treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site swelling, Muscular weakness, Myalgia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 3 days after receiving SHINGRIX, the patient experienced shoulder pain and pain in elbow. On 27th August 2018, the patient experienced pain in arm, tingling, weakness of arms, injection site swelling and injected limb mobility decreased. On 28th August 2018, the patient experienced fever and pain. On an unknown date, the patient experienced tenderness muscle. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm, fever, pain, injection site swelling and injected limb mobility decreased were recovering/resolving and the outcome of the shoulder pain, tingling, weakness of arms and pain in elbow were not recovered/not resolved and the outcome of the tenderness muscle was unknown. It was unknown if the reporter considered the pain in arm, shoulder pain, tingling, fever, pain, weakness of arms, pain in elbow, injection site swelling, injected limb mobility decreased and tenderness muscle to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. About an hour later after receiving SHINGRIX, the patient's arm hurt at the injection site and was a little swollen. About 4 hours later, at bedtime, the pain in the arm became worse, and the patient could barely move her arm. The next day after receiving SHINGRIX, the patient felt achy and feverish. The arm pain increased. On the third day after receiving SHINGRIX, the pain spread to the elbow and shoulder. The patient experienced muscle tenderness in the right arm. The patient also reported that the thumb on the injection side feels like an electric charge and tingling was going through it. The patient took ADVIL, and it did not help. The patient saw her physician, but was just advised to wait and see. Clarification raised regarding event onset date.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 27th August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 3 days after receiving SHINGRIX, the patient experienced shoulder pain and pain in elbow. On 27th August 2018, the patient experienced pain in arm, tingling, weakness of arms, injection site swelling and injected limb mobility decreased. On 28th August 2018, the patient experienced fever and pain. On an unknown date, the patient experienced tenderness muscle. The patient was treated with ADVIL. On an unknown date, the outcome of the pain in arm, fever, pain, injection site swelling and injected limb mobility decreased were recovering/resolving and the outcome of the shoulder pain, tingling, weakness of arms and pain in elbow were not recovered/not resolved and the outcome of the tenderness muscle was unknown. It was unknown if the reporter considered the pain in arm, shoulder pain, tingling, fever, pain, weakness of arms, pain in elbow, injection site swelling, injected limb mobility decreased and tenderness muscle to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. About an hour later after receiving SHINGRIX, the patient's arm hurt at the injection site and was a little swollen. About 4 hours later, at bedtime, the pain in the arm became worse, and the patient could barely move her arm. The next day after receiving SHINGRIX, the patient felt achy and feverish. The arm pain increased. On the third day after receiving SHINGRIX, the pain spread to the elbow and shoulder. The patient experienced muscle tenderness in the right arm. The patient also reported that the thumb on the injection side feels like an electric charge and tingling was going through it. The patient took ADVIL, and it did not help. The patient saw her physician, but was just advised to wait and see. Clarification raised regarding event onset date.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pruritus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site itching in a 58-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On 9th October 2018 10:00, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 9th October 2018, less than an hour after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced injection site itching. On 9th October 2018, the outcome of the injection site itching was recovered/resolved. It was unknown if the reporter considered the injection site itching to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: This case was reported by physician for himself. On the day of reporting, the patient received the flu vaccination on left deltoid. Within an hour after receiving Flu vaccine, the patient experienced itching at the injection. Once the patient removed the band aid from the injection site, the itching resolved. The patient knows it was a GSK product but was unable to provide the name or any other information at the time of the call. The staff member would call back to provide additional information. This case was transferred to medical information. This case has been linked with the case US2018183712, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacist via online chat. The age at vaccination was not reported. After receiving SHINGRIX, the patient developed shingles.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 82-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 7th August 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: This reporter is in risk management department at the reporting pharmacy. The patient received the vaccine in the right arm. The reporter's daughter told him that she called GSK to report and no one called her back. The reporter also said he sent a letter to GSK. It was sent certified mail. The reporter was given the fax number to fax the letter he had originally sent. He had also reported this to VAERS.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter thought the patient was 58 years old. This case was reported by physician assistant (PA) via online chat. The PA reported that the patient received a dose of SHINGRIX subcutaneously instead of intramuscular route, which led to inappropriate route of vaccination. The vaccination took place in the reporter's clinic. The reporter asked for recommendation at that point of time. The reporter was at home at the reporting time and the patient just text her a picture of the injection site reaction erythema and minor swelling. The reporter found this 45 seconds before the reporting time. The lot number and expiration was not available. The healthcare professional did not provided in chat, but there was an address in system for him which matched the city and state he provided.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Muscular weakness, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 4th October 2018, the patient received SHINGRIX. On 6th October 2018, 2 days after receiving SHINGRIX, the patient experienced headache, fatigue, muscle weakness, joint pain and tingling feet/hands. On an unknown date, the outcome of the headache, fatigue, muscle weakness, joint pain and tingling feet/hands were unknown. It was unknown if the reporter considered the headache, fatigue, muscle weakness, joint pain and tingling feet/hands to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX on Thursday. The patient woke up on Saturday with severe headache, joint pain, tingling in her fingers and toes, loss of muscle strength and severe fatigue. The patient was in bed since Saturday. The patient described these adverse events as grade 3. The patient was basically bed-bound. No additional information could be obtained because the physician was in a rush.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of forehead swelling in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 1st September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th September 2018, 7 days after receiving SHINGRIX, the patient experienced forehead swelling, welts and rash. On an unknown date, the outcome of the forehead swelling, welts and rash were not recovered/not resolved. It was unknown if the reporter considered the forehead swelling, welts and rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, however it could be 64 or 65 years. The patient received SHINGRIX on left arm. The patient experienced swelling, rash, and welts on her forehead and face. On 10th August 2018, the patient was seen by her physician. The patient planned to continue follow-up with her physician on an unknown date. The patient wanted to remain anonymous.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood iron normal, Haematocrit decreased, Haemoglobin normal, Reticulocyte count normal
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of hematocrit decreased in a 86-year-old male patient who received SHINGRIX for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX. On 25th July 2018, 28 days after receiving SHINGRIX, the patient experienced hematocrit decreased and hemoglobin decreased. On an unknown date, the outcome of the hematocrit decreased and hemoglobin decreased were unchanged. It was unknown if the reporter considered the hematocrit decreased and hemoglobin decreased to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported the case for the patient. The patient had routine CBC labs (complete blood count) taken on 25th July 2018. The patient's hematocrit was at 38 and hemoglobin count was 14. A repeat laboratory was done on 5th October 2018 and the hematocrit went to 36. Iron levels and reticulocyte counts were normal. The reporter agreed to have a letter from Safety sent to her for physician information.