chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The healthcare professional stated that he experienced little bit of sore arm lasting a day or two days after the dose of SHINGRIX. This case is one of the four linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported.  This case was reported by the patient's husband. The healthcare professional stated that the patient experienced little bit of sore arm lasting a day or two days after the dose of SHINGRIX. The healthcare professional did not want to provide details about the patient (reporter's wife). This case is one of the four linked cases, reported by the same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 74-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in April 2018). On 14th August 2018 18:00, the patient received the 2nd dose of Shingrix. On 14th August 2018 23:00, 5 hrs after receiving Shingrix, the patient experienced chills, nausea, pain and viral infection. On 15th August 2018, the patient experienced fever. The patient was treated with Aspirin. On an unknown date, the outcome of the chills, nausea, pain, fever and viral infection were not recovered/not resolved. It was unknown if the reporter considered the chills, nausea, pain, fever and viral infection to be related to Shingrix. Additional information was received as follows: The healthcare professional stated that all night he felt like he had a virus. At the time of reporting, the reporter stated that he had chills, nauseous, and achy. The reporter thought that he would feel better at morning of the reporting day and took couple aspirins, but at the time of reporting, he was experiencing symptoms again. The reporter also stated that at the time of reporting, he had the fever. This case is one of the four linked cases, reported by the same reporter.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 74-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in April 2018). On 14th August 2018 18:00, the patient received the 2nd dose of Shingrix. On 14th August 2018 23:00, 5 hrs after receiving Shingrix, the patient experienced chills, nausea, pain and viral infection. On 15th August 2018, the patient experienced fever. The patient was treated with Aspirin. On an unknown date, the outcome of the chills, nausea, pain, fever and viral infection were not recovered/not resolved. It was unknown if the reporter considered the chills, nausea, pain, fever and viral infection to be related to Shingrix. Additional information was received as follows: The healthcare professional stated that all night he felt like he had a virus. At the time of reporting, the reporter stated that he had chills, nauseous, and achy. The reporter thought that he would feel better at morning of the reporting day and took couple aspirins, but at the time of reporting, he was experiencing symptoms again. The reporter also stated that at the time of reporting, he had the fever. This case is one of the four linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in April 2018).  On 14th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills, nausea, pain, fever and viral infection. On an unknown date, the outcome of the chills, nausea, pain, fever and viral infection were not recovered/not resolved. It was unknown if the reporter considered the chills, nausea, pain, fever and viral infection to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The healthcare professional stated that all night the patient felt like she had a virus. The healthcare professional did not want to provide details about the patient (reporter's wife). This case is one of the four linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received in April 2018).  On 14th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced chills, nausea, pain, fever and viral infection. On an unknown date, the outcome of the chills, nausea, pain, fever and viral infection were not recovered/not resolved. It was unknown if the reporter considered the chills, nausea, pain, fever and viral infection to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The healthcare professional stated that all night the patient felt like she had a virus. The healthcare professional did not want to provide details about the patient (reporter's wife). This case is one of the four linked cases, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Condition aggravated, Musculoskeletal pain, Off label use
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of viral infection in a female patient who received Shingrix for prophylaxis. The patient's past medical history included viral infection (frequently experienced viral infections for a long time). On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced viral infection, tingling, back pain, viral rash, shoulder pain, abdominal pain, off label use and drug use for unapproved indication. On an unknown date, the outcome of the viral infection, tingling, back pain, viral rash, shoulder pain, abdominal pain, off label use and drug use for unapproved indication were unknown. It was unknown if the reporter considered the viral infection, tingling, back pain, viral rash, shoulder pain and abdominal pain to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced a flare up of viral infection after vaccination. The patient experienced more intense viral sensations such as rash, tingling, and pain on the back, shoulder and abdomen. The patient had frequently experienced viral infections for a long time in the past too, but te symptoms seemed to be worse after vaccination with Shingrix. The patient's doctor had prescribed Shingrix to decrease the frequency of viral infections, which led to off label use and drug use for unapproved indication. The patient was vaccinated with Shingrix at a different location.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Product use in unapproved indication, Viral infection, Viral rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of viral infection in a female patient who received Shingrix for prophylaxis. The patient's past medical history included viral infection (frequently experienced viral infections for a long time). On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced viral infection, tingling, back pain, viral rash, shoulder pain, abdominal pain, off label use and drug use for unapproved indication. On an unknown date, the outcome of the viral infection, tingling, back pain, viral rash, shoulder pain, abdominal pain, off label use and drug use for unapproved indication were unknown. It was unknown if the reporter considered the viral infection, tingling, back pain, viral rash, shoulder pain and abdominal pain to be related to Shingrix. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced a flare up of viral infection after vaccination. The patient experienced more intense viral sensations such as rash, tingling, and pain on the back, shoulder and abdomen. The patient had frequently experienced viral infections for a long time in the past too, but te symptoms seemed to be worse after vaccination with Shingrix. The patient's doctor had prescribed Shingrix to decrease the frequency of viral infections, which led to off label use and drug use for unapproved indication. The patient was vaccinated with Shingrix at a different location.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 73-year-old female patient who received Shingrix (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. On 7th August 2018, the patient received Shingrix .5 ml. In August 2018, less than a month after receiving Shingrix, the patient experienced rash and pruritus. On an unknown date, the outcome of the rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the rash and pruritus to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix vaccine on right arm. The patient reported a rash on both arms and legs with an itchy feeling. The onset date was unknown. The dose number in series was unknown. The pharmacist said he did not have a record of her receiving another dose but could not confirm this one as the first dose. The vaccine was given in the afternoon. Upon call back to health care professional, health care professional stated he found out patient had a computed tomography scan on Monday and received IV contrast medium. He thought  the adverse event could be related to the IV contrast medium.
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fatigue in a adult female patient who received Bexsero for prophylaxis. In July 2018, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. In July 2018, 1 day after receiving Bexsero, the patient experienced fatigue, fever and nausea. On an unknown date, the outcome of the fatigue, fever and nausea were recovered/resolved. It was unknown if the reporter considered the fatigue, fever and nausea to be related to Bexsero. Additional details were provided as follows: The age at vaccination was not reported. Limited information was provided by the sales representative from the physician.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injected limb mobility decreased, Malaise, Pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included allergic reaction. Previously administered products included shingles vaccine. On 10th August 2018, the patient received the 1st dose of Shingrix 50 mcg/mg. In August 2018, less than a week after receiving Shingrix, the patient experienced headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased. On an unknown date, the outcome of the headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased were unknown. It was unknown if the reporter considered the headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The caller noted she had the previous shingles vaccine on the market a few years back. The caller reported she had a history of allergic reactions and that was expressed to the pharmacist, but the pharmacist insisted and gave her the first shingrix shot last Friday from the reporting date. She calls the day of reporting the events noted above, feeling like she could have died from them. She noted the bumps were fine and located on her arm and appeared like chicken pox. She stated she was taking a medication for the headache but she continued to experience all the events. The description section of the prescribing information was reviewed with the caller and it was also being mailed to her. The healthcare professional note asked as caller hung-up abruptly. The caller was upset GlaxoSmithKline could not provide any recommendation on treatment. The caller was referred to her physician and medical advice statement given.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included allergic reaction. Previously administered products included shingles vaccine. On 10th August 2018, the patient received the 1st dose of Shingrix 50 mcg/mg. In August 2018, less than a week after receiving Shingrix, the patient experienced headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased. On an unknown date, the outcome of the headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased were unknown. It was unknown if the reporter considered the headache, pain, varicella-like rash, swelling arm, sickness, pruritus and injected limb mobility decreased to be related to Shingrix. Additional details were provided as follows: The caller noted she had the previous shingles vaccine on the market a few years back. The caller reported she had a history of allergic reactions and that was expressed to the pharmacist, but the pharmacist insisted and gave her the first shingrix shot last Friday from the reporting date. She calls the day of reporting the events noted above, feeling like she could have died from them. She noted the bumps were fine and located on her arm and appeared like chicken pox. She stated she was taking a medication for the headache but she continued to experience all the events. The description section of the prescribing information was reviewed with the caller and it was also being mailed to her. The healthcare professional note asked as caller hung-up abruptly. The caller was upset GlaxoSmithKline could not provide any recommendation on treatment. The caller was referred to her physician and medical advice statement given.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 18-year-old female patient who received Bexsero for prophylaxis. On 13th August 2018, the patient received Bexsero. In August 2018, less than a week after receiving Bexsero, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to Bexsero. Additional details were provided as follows: The nurse told GSK representative that one of their patients received the Bexsero prefilled syringe on Monday. The patient experienced swelling at the injection site. She had to go to the hospital for that but reporter did not know if the patient stayed overnight.
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in an adult female patient who received Influenza vaccine Quadrivalent for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: This case was not reported previously to anyone. The age at vaccination was not reported. In 1995, 25 years or so before the reporting date, the patient received unspecified flu shot. The patient had an unspecified bad reaction after vaccination. The patient's physician told her never to get a flu shot ever again.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received BOOSTRIX (batch number X9YP3, expiry date 2nd October 2020) for prophylaxis. On 26th July 2018, the patient received BOOSTRIX. On 31st July 2018, 5 days after receiving BOOSTRIX, the patient experienced pain in arm, injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the pain in arm, injection site swelling, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the pain in arm, injection site swelling, injection site warmth and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: The patient reported feeling pain in her arm approximately 5 days after receiving a BOOSTRIX injection in the right arm. The patient also reported that the injection site was warm, red, and swollen.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles (four times in the past). On 13th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th August 2018, 1 days after receiving Shingrix, the patient experienced injection site swelling, joint pain and fever. On an unknown date, the outcome of the injection site swelling, joint pain and fever were recovered/resolved. It was unknown if the reporter considered the injection site swelling, joint pain and fever to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the left arm. The patient reported that she experienced shingles four times in the past, and planned to get her second injection.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old patient who received Shingrix for prophylaxis. On 2nd August 2018, the patient received Shingrix. On 3rd August 2018, 1 days after receiving Shingrix, the patient experienced pain in arm. On 4th August 2018, the patient experienced injection site warmth and erythema of extremities. On an unknown date, the outcome of the pain in arm, injection site warmth and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the pain in arm, injection site warmth and erythema of extremities to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in the right arm. One day after receiving Shingrix, the patient experienced a sore arm. Two days after receiving Shingrix, the patient experienced redness and an injection site that was hot to the touch. On the day after that, the redness increased to a size described as about 5 by 3 inches in size. At the time of report, all symptoms were resolved.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain upon movement in a 70-year-old female patient who received BOOSTRIX for prophylaxis. The patient's past medical history included mastectomy. On 12th July 2018, the patient received the 1st dose of BOOSTRIX (intramuscular) .5 ml. On 13th July 2018, 1 days after receiving BOOSTRIX, the patient experienced injection site pain and injection site swelling. On 19th July 2018, the patient experienced pain upon movement. On an unknown date, the outcome of the pain upon movement was not recovered/not resolved and the outcome of the injection site pain and injection site swelling were recovered/resolved. It was unknown if the reporter considered the pain upon movement, injection site pain and injection site swelling to be related to BOOSTRIX. Additional information was received as follows: The patient received BOOSTRIX on the left arm. Seven days after receiving BOOSTRIX, the patient experienced arm pain with movement. The patient had denied permission to contact their physician.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 51-year-old female patient who received Shingrix (batch number Y24KE, expiry date 11th October 2020) for prophylaxis. On 13th August 2018, the patient received the 1st dose of Shingrix. In August 2018, less than a week after receiving Shingrix, the patient experienced local swelling, induration and erythema. On an unknown date, the outcome of the local swelling, induration and erythema were unknown. It was unknown if the reporter considered the local swelling, induration and erythema to be related to Shingrix. Additional details were provided as follows: The patient presented to the pharmacy with a fist sized hard really red lump.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old male patient who received Shingrix for prophylaxis. On 20th June 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced fever, chills and tremor. On an unknown date, the outcome of the fever, chills and tremor were unknown. It was unknown if the reporter considered the fever, chills and tremor to be related to Shingrix. Additional details were provided as follows: This case was not previously reported to any one. The age at vaccination was not reported. The patient reported that he experienced fever and chills to the point he was shaking uncontrollably and had to get into warm bath to help stabilize his temperature. The patient stated that he had no primary care physician at the time of reporting.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Movement disorder, Pain, Rash, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles (experienced 12 times previously). Previously administered products included Zostavax (received 10 years before the date of reporting). On 14th May 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th August 2018, 89 days after receiving Shingrix, the patient experienced shingles, painful rash and erythematous rash. On 13th August 2018, the patient experienced local swelling, movement disorder, pain and tenderness. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the local swelling was recovered/resolved and the outcome of the movement disorder and pain were recovering/resolving and the outcome of the painful rash, erythematous rash and tenderness were unknown. It was unknown if the reporter considered the shingles, local swelling, movement disorder, pain, painful rash, erythematous rash and tenderness to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix in the left deltoid. The patient experienced a rash on the nerve line and there was a red line up the nerve line and she was in horrible pain. The patient was diagnosed with Shingles. After 91 days of vaccination, the patient had a knot in her back on the right side which was sore until it went up her back. The patient could not move and it was tender and the pain shooted every once in a while but she was taking medication (unspecified) at the time of reporting. At the time of reporting, the patient still had trouble moving and initially she could not move her arm. The contact details of the physician was provided.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles (experienced 12 times previously). Previously administered products included Zostavax (received 10 years before the date of reporting). On 14th May 2018, the patient received the 1st dose of Shingrix (intramuscular). On 11th August 2018, 89 days after receiving Shingrix, the patient experienced shingles, painful rash and erythematous rash. On 13th August 2018, the patient experienced local swelling, movement disorder, pain and tenderness. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the local swelling was recovered/resolved and the outcome of the movement disorder and pain were recovering/resolving and the outcome of the painful rash, erythematous rash and tenderness were unknown. It was unknown if the reporter considered the shingles, local swelling, movement disorder, pain, painful rash, erythematous rash and tenderness to be related to Shingrix. Additional details were reported as follows: The patient received Shingrix in the left deltoid. The patient experienced a rash on the nerve line and there was a red line up the nerve line and she was in horrible pain. The patient was diagnosed with Shingles. After 91 days of vaccination, the patient had a knot in her back on the right side which was sore until it went up her back. The patient could not move and it was tender and the pain shooted every once in a while but she was taking medication (unspecified) at the time of reporting. At the time of reporting, the patient still had trouble moving and initially she could not move her arm. The contact details of the physician was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a elderly female patient who received Shingrix (batch number BN9L9, expiry date 30th March 2020) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to Shingrix. Additional details were provided as follows: The age at vaccinationwas not reported. The patient developed a fine and pronounced rash from the elbow to the shoulder after receiving a dose of the Shingrix vaccine.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site rash, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 84-year-old female patient who received Shingrix (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 10th August 2018, the patient received Shingrix (intramuscular). On 10th August 2018, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On 11th August 2018, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the injection site rash to be related to Shingrix. Additional information was received as follows: The healthcare professional reported that she mixed 2 adjuvant of Shingrix and administered it to the patient, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. The patient experienced the rash at injection site. On 12th August 2018, the patient did receive the properly reconstituted dose of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. In July 2018, 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 pharmacy student. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The health care professional did not have any further information. The health care professional reported that, this happened at a different pharmacy location and that the other location would probably call in regards to this as well.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure diastolic increased, Blood pressure systolic increased, Fatigue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of diastolic blood pressure increased in a elderly female patient who received Shingrix for prophylaxis. Concomitant products included Norvasc and hydrochlorothiazide. On 19th June 2018, the patient received the 1st dose of Shingrix (intramuscular). In June 2018, 5 days after receiving Shingrix, the patient experienced tiredness. On an unknown date, the patient experienced diastolic blood pressure increased and blood pressure systolic increased. The patient was treated with Cozaar. On an unknown date, the outcome of the diastolic blood pressure increased was not reported and the outcome of the tiredness was recovering/resolving and the outcome of the blood pressure systolic increased was unknown. It was unknown if the reporter considered the diastolic blood pressure increased, tiredness and blood pressure systolic increased to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on left deltoid. The health care professional stated that she experienced extreme tiredness. Less than a month after receiving Shingrix, the patient was experiencing very high blood pressure specially diastolic ranging 100 to 111 mm Hg. The health care professional noticed increase in blood pressure when she went to her podiatrist for work on her foot 5 to 6 weeks ago. Upon escalation, the health care professional also stated that her systolic blood pressure was up to 158 mm Hg about 7 weeks ago from the date of reporting and was 100 mm Hg one day before the date of reporting. The health care professional stated that she went to her attending back in May and blood pressure was normal. The health care professional went back to her attending and was put on Cozaar and started taking Cozaar in morning on the day of reporting.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling abnormal, Influenza, Muscle spasms
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cramp in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose refer case: US2018GSK153743). On 14th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced cramp and diarrhea. On 15th August 2018, the patient experienced influenza, chills, fever and general body pain. On an unknown date, the outcome of the cramp, chills, diarrhea and general body pain were recovered/resolved and the outcome of the influenza and fever were not recovered/not resolved.  It was unknown if the reporter considered the cramp, influenza, chills, fever, diarrhea and general body pain to be related to SHINGRIX. Additional information was reported as follows: On 14th August 2018, Tuesday night before 6 pm, the patient was vaccinated with the 2nd dose of SHINGRIX. On the same evening of the vaccination, later the patient experienced diarrhea and feeling crampy. One day after the vaccination and a day before the date of reporting the patient felt achy all over, chills and was running a fever. Last night before the date of reporting, the fever was 3.3 degrees higher than the normal body temperature. The patient felt like he had flu. The patient did not feel as bad as the day before reporting, but still till the date of reporting he was running a low grade fever.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of cramp in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose refer case: US2018GSK153743). On 14th August 2018, the patient received the 2nd dose of SHINGRIX. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced cramp and diarrhea. On 15th August 2018, the patient experienced influenza, chills, fever and general body pain. On an unknown date, the outcome of the cramp, chills, diarrhea and general body pain were recovered/resolved and the outcome of the influenza and fever were not recovered/not resolved.  It was unknown if the reporter considered the cramp, influenza, chills, fever, diarrhea and general body pain to be related to SHINGRIX. Additional information was reported as follows: On 14th August 2018, Tuesday night before 6 pm, the patient was vaccinated with the 2nd dose of SHINGRIX. On the same evening of the vaccination, later the patient experienced diarrhea and feeling crampy. One day after the vaccination and a day before the date of reporting the patient felt achy all over, chills and was running a fever. Last night before the date of reporting, the fever was 3.3 degrees higher than the normal body temperature. The patient felt like he had flu. The patient did not feel as bad as the day before reporting, but still till the date of reporting he was running a low grade fever.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 50-year-old female patient who received Shingrix (batch number ZG47A, expiry date 12th February 2021) for prophylaxis. On 12th August 2018, the patient received Shingrix (intramuscular) .5 ml. On 13th August 2018, 1 days after receiving Shingrix, the patient experienced injection site rash and axillary lymph nodes enlarged. On an unknown date, the outcome of the injection site rash and axillary lymph nodes enlarged were unknown. It was unknown if the reporter considered the injection site rash and axillary lymph nodes enlarged to be related to Shingrix. Additional details reported as follows: The pharmacist reported that, the patient developed a rash on her arm where she got Shingrix, and also had a swollen lymph node under her arm.
Sex: U
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 patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 91 days 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 information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that the patient developed shingles about 3 months after receiving the first dose of the Shingrix series. The healthcare professional did not have any patient or vaccine information because the vaccine was given at a different pharmacy location.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in an unspecified number of adult patients who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced headache, feeling bad and general body pain. On an unknown date, the outcome of the headache, feeling bad and general body pain were unknown. It was unknown if the reporter considered the headache, feeling bad and general body pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional stated that 5 to 10 of his patients experienced headache and body ache after receiving Shingrix. No further details available from health care professional.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Injection site pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Zostavax. On 1st August 2018, the patient received the 1st dose of Shingrix (intramuscular). In August 2018, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and shingles were recovered/resolved. It was unknown if the reporter considered the injection site pain and shingles to be related to Shingrix. Additional details reported as follows: The reporter was the patient's wife. The patient received Shingrix on left arm. The reporter stated the patient experienced sore arm and flu like symptoms which lasted for total of 3 to 4 days. No further details were provided by the reporter. This case has been linked with US2018149412, reported by same reporter for herself.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, 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 76-year-old male patient who received Shingrix for prophylaxis. Previously administered products included Zostavax. On 1st August 2018, the patient received the 1st dose of Shingrix (intramuscular). In August 2018, less than a month after receiving Shingrix, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to Shingrix. Additional details reported as follows: The reporter was the patient's wife. The patient received Shingrix on left arm. The reporter stated the patient experienced sore arm and flu like symptoms which lasted for total of 3 to 4 days. No further details were provided by the reporter. This case has been linked with US2018149412, reported by same reporter for herself.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Chills, Fatigue, Feeling cold, Feeling of body temperature change, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and 10PN-PD-Dit (Pneumococcal vaccine). On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness, feeling hot and cold, nausea, shivers, pain and feeling cold. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the tiredness, feeling hot and cold, shivers, pain and feeling cold were unknown and the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the muscle pain, tiredness, feeling hot and cold, nausea, shivers, pain and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX 2.5 months before the date of reporting and she did not feel sick after the 1st dose. The patient received her 2nd dose of SHINGRIX and a pneumococcal vaccine on 15th August 2018, but on 16th August 2018 she felt achy, nauseated, shivery and tired, every muscle in her body ached. The patient felt like she could not stay awake she was so tired, She would feel hot for a few seconds, and then feel very cold, she had not taken her temperature.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Nausea, Pain, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and 10PN-PD-Dit (Pneumococcal vaccine). On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness, feeling hot and cold, nausea, shivers, pain and feeling cold. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the tiredness, feeling hot and cold, shivers, pain and feeling cold were unknown and the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the muscle pain, tiredness, feeling hot and cold, nausea, shivers, pain and feeling cold to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX 2.5 months before the date of reporting and she did not feel sick after the 1st dose. The patient received her 2nd dose of SHINGRIX and a pneumococcal vaccine on 15th August 2018, but on 16th August 2018 she felt achy, nauseated, shivery and tired, every muscle in her body ached. The patient felt like she could not stay awake she was so tired, She would feel hot for a few seconds, and then feel very cold, she had not taken her temperature.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 52-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 14th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 14th August 2018, less than a day after receiving SHINGRIX, the patient experienced sleeplessness and pain. On 15th August 2018, the patient experienced rash, swelling, erythematous rash, fever and skin warm. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the rash, swelling, erythematous rash and fever were not recovered/not resolved and the outcome of the sleeplessness and skin warm were unknown and the outcome of the pain was recovering/resolving.  It was unknown if the reporter considered the rash, sleeplessness, swelling, erythematous rash, pain, fever and skin warm to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient herself. At evening, the patient had SHINGRIX vaccine. The patient could not sleep that night because of the pain which made her twist and turn all night. The next morning, she noticed a rash about 3 to 2 inches in width which appeared about 2 inches below the injection site. It was a bit swollen and was red and warm to the touch. She took Motrin at morning and at evening, the day before reporting day, so the pain has improved a little but the rash seems to be worsening. The patient was transferred for additional assistance.