chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX. Previously administered products included small pox vaccine (received 4 years ago), yellow fever vaccine, tetanus vaccine (every year), cholera vaccine, typhoid vaccine and shingles vaccine (had first shingles vaccine shot a few years ago). 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 injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, tiredness, headache, shivering, fever and upset stomach to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Four years ago and the patient probably had every shot known to man that was like small pox-every six months-insisted on by crew doing small pox eradication, yellow fever, gamma globulin, tetanus every year, cholera, typhoid, and others vaccines that he did not remember. The patient had first shingles vaccine shot a few years ago. The patient had side effects like Pain, redness, and swelling at the injection site, Muscle pain, Tiredness, Headache, Shivering, fever and upset stomach with new SHINGRIX. The patient stated that, warn the physicians to tell patients to take aspirin or TYLENOL in good doses before getting each of the two SHINGRIX shots, because SHINGRIX is goofy to him.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received SHINGRIX (batch number UNK, expiry date unknown). On 11th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On 11th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the pharmacist and by the patient himself. On 31st May 2018, an health care professional reported that patient's pain remained ongoing, was worsening, and woke the patient from his sleep. No hospitalization, emergency room or physician visit was required, and the patient's symptoms were not considered to be life threatening or disabling. The patient stated he had the vaccine over a month ago and he was still experiencing pain at the site of the injection. While gathering information the patient stated that his pharmacist had already report this. The patient want a medical advice and was upset when representative could not provide any so no more details was available.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse event in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The field representative called to report adverse events that three different patients experienced on SHINGRIX as reported to her by the nurse. The field representative did not know any information in regards to demographics and what adverse events patient experienced, but knew that the patient experienced side effects from SHINGRIX vaccine. No further details were provided as far as what kind of adverse event the patient experienced. The field representative had very limited information. Attempted to call nurse twice to get further information on the events but was not able to reach her. She also stated that nurse had reported the event to VAERS. This was 1 of 3 cases, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included SHINGRIX with an associated reaction of injection site pain (along with injection site redness after receiving 1st dose received on 1st March 2018, refer case US2018GSK102761). On 30th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, 1 hr after receiving SHINGRIX, the patient experienced red blotches. On 30th May 2018, the patient experienced injection site pain, injection site erythema and shivering. The patient was treated with BENADRYL and MEDROL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, shivering and red blotches were unchanged. It was unknown if the reporter considered the injection site pain, injection site erythema, shivering and red blotches to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX on the left arm. One hour after receiving vaccination, the patient developed pain, redness at injection site about 4 inches in diameter along with shivering and red blotchiness above knees (in which appeared with applied pressure). The patient reported taking BENADRYL, applied CBD oil and started a MEDROL DOSE PACK for treatment of symptoms. The health care professional stated this was the first report submitted for both the initial and secondary doses received which brought about the reported adverse reactions. This case was also linked to case US2018GSK102761 and US2018GSK102762, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). Previously administered products included SHINGRIX with an associated reaction of injection site pain (along with injection site redness after receiving 1st dose received on 1st March 2018, refer case US2018GSK102761). On 30th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, 1 hr after receiving SHINGRIX, the patient experienced red blotches. On 30th May 2018, the patient experienced injection site pain, injection site erythema and shivering. The patient was treated with BENADRYL and MEDROL. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, shivering and red blotches were unchanged. It was unknown if the reporter considered the injection site pain, injection site erythema, shivering and red blotches to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX on the left arm. One hour after receiving vaccination, the patient developed pain, redness at injection site about 4 inches in diameter along with shivering and red blotchiness above knees (in which appeared with applied pressure). The patient reported taking BENADRYL, applied CBD oil and started a MEDROL DOSE PACK for treatment of symptoms. The health care professional stated this was the first report submitted for both the initial and secondary doses received which brought about the reported adverse reactions. This case was also linked to case US2018GSK102761 and US2018GSK102762, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Rash macular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX. On 1st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient developed redness and pain at injection site. The patient stated this was the first report submitted for both the initial and secondary doses received which brought about the reported adverse reactions. For tolerance to the 2nd dose refer case US2018097725.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX. On 1st March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient developed redness and pain at injection site. The patient stated this was the first report submitted for both the initial and secondary doses received which brought about the reported adverse reactions. For tolerance to the 2nd dose refer case US2018097725.
Sex: M
Vaccine: MENB
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old male patient who received BEXSERO. On 24th May 2018, the patient received the 2nd dose of BEXSERO. On 24th May 2018, 3 hrs after receiving BEXSERO, the patient experienced fever, general body pain and headache. On an unknown date, the outcome of the fever, general body pain and headache were recovered/resolved. It was unknown if the reporter considered the fever, general body pain and headache to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was recorded as 102 Degree F. The events were lasted for 2 days.
Sex: U
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a neonate patient who received ENGERIX B. On an unknown date, the patient received ENGERIX B. On an unknown date, unknown after receiving ENGERIX B, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to ENGERIX B. Additional details were provided as follows: The patient was 4 years old at the time of reporting. The patient received a dose of ENGERIX B vaccine at birth. On an unknown date, the patient might had an allergic reaction to the ENGERIX B. The healthcare professional (HCP) was unable to clarify what specific reaction did the patient experience. The HCP was unsure if the report was previously reported.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via other and described the occurrence of fever in a female patient who received SHINGRIX. 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 fever, swelling arm, erythema and fatigue. On an unknown date, the outcome of the fever, swelling arm, erythema and fatigue were recovered/resolved. The reporter considered the fever, swelling arm, erythema and fatigue to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. The age at vaccination was not reported. This case was reported by the physician assistant. The reporter did not specify when they received the dose. It was unknown if the events caused the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in  persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. This case is 1 of 4 cases reported by the same reporter.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a 80-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Concomitant products included Losartan, metoprolol and ZYRTEC. On 30th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 6th April 2018, 7 days after receiving SHINGRIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was not recovered/not resolved. It was unknown if the reporter considered the diarrhea to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving Tartrate. The reporter reported that the patient followed up with his physician on 31st May 2018.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via other and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX. 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the influenza-like symptoms to be probably related to SHINGRIX. Additional details were provided as follows: This case was reported by an attendee (physician) at Conference. The age at vaccination was not reported. The reporter did not specify when they received the dose. The patient had flu like symptoms for 3 to 4 days. The event did not cause the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. This case is 1 of 4 cases reported by the same reporter.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 54-year-old male patient who received SHINGRIX (batch number 79N59, expiry date 30th January 2019). On 8th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. The reporter considered the injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient's wife reported to the pharmacist that the day after the vaccination, a red line formed about 3 to 4 inches below the injection site. It was not painful and there was no swelling. It went away about 2 to 3 days later.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Fatigue, Hypotension, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in 17-year-old female patient who received BEXSERO (batch number 169701, expiry date 31st January 2019). The patient's past medical history included blood pressure decreased (Patient's BP was low once previously). On 29th May 2018, the patient received the 2nd dose of BEXSERO. On 29th May 2018, less than a day after receiving BEXSERO, the patient experienced injection site pain and injection site erythema. On 30th May 2018, the patient experienced general body pain, nausea, dizziness, fatigue and injection site swelling. On 31st May 2018, the patient experienced low blood pressure. On an unknown date, the outcome of the general body pain, nausea, dizziness, injection site pain, injection site erythema, fatigue and injection site swelling were recovering/resolving and the outcome of the low blood pressure was unknown. It was unknown if the reporter considered the general body pain, nausea, low blood pressure and dizziness to be related to BEXSERO. The reporter considered the injection site pain, injection site erythema, fatigue and injection site swelling to be probably related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on left arm. On 30th May 2018, the patient began to experience body aches, dizziness, and nausea which were improving but not resolved at the time of the report. The health care professional additionally reported that the patient's blood pressure was on the lower end, 98/60. On 31st May 2018, the patient returned to the primary care practice for the symptoms, but no emergency room visit, intervention or hospitalization was required at the time of the report. Did not verify patient's usual blood pressure. The reporting health care professional was the patient's primary care physician. Upon escalation, as follow up to case US-CRC-0060888, the health care professional stated that patient also experienced pain at the injection site (still tenderness today), minimal swelling at the injection site, erythema at injection site, fatigue and feeling tired. The patient was feeling better on the day of reporting, the symptoms were resolving.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Nausea, Pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of general body pain in 17-year-old female patient who received BEXSERO (batch number 169701, expiry date 31st January 2019). The patient's past medical history included blood pressure decreased (Patient's BP was low once previously). On 29th May 2018, the patient received the 2nd dose of BEXSERO. On 29th May 2018, less than a day after receiving BEXSERO, the patient experienced injection site pain and injection site erythema. On 30th May 2018, the patient experienced general body pain, nausea, dizziness, fatigue and injection site swelling. On 31st May 2018, the patient experienced low blood pressure. On an unknown date, the outcome of the general body pain, nausea, dizziness, injection site pain, injection site erythema, fatigue and injection site swelling were recovering/resolving and the outcome of the low blood pressure was unknown. It was unknown if the reporter considered the general body pain, nausea, low blood pressure and dizziness to be related to BEXSERO. The reporter considered the injection site pain, injection site erythema, fatigue and injection site swelling to be probably related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on left arm. On 30th May 2018, the patient began to experience body aches, dizziness, and nausea which were improving but not resolved at the time of the report. The health care professional additionally reported that the patient's blood pressure was on the lower end, 98/60. On 31st May 2018, the patient returned to the primary care practice for the symptoms, but no emergency room visit, intervention or hospitalization was required at the time of the report. Did not verify patient's usual blood pressure. The reporting health care professional was the patient's primary care physician. Upon escalation, as follow up to case US-CRC-0060888, the health care professional stated that patient also experienced pain at the injection site (still tenderness today), minimal swelling at the injection site, erythema at injection site, fatigue and feeling tired. The patient was feeling better on the day of reporting, the symptoms were resolving.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Phantom pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of shoulder pain in a female patient who received SHINGRIX. 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 shoulder pain and phantom pain. On an unknown date, the outcome of the shoulder pain and phantom pain were unknown. It was unknown if the reporter considered the shoulder pain and phantom pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient complained of pain in the both shoulders. The pharmacist stated that, the patient worked for the pharmacy and she complained often. The pharmacist felt that, the issue was not related to the vaccine but a phantom pain. The pharmacist did not want to report however the sales representative submitted the report in line with GlaxoSmithKline protocols. The pharmacist did not agree to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling, Musculoskeletal stiffness, Pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 73-year-old male patient who received SHINGRIX. On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain, pain in hip, limbs stiffness, ankle swelling and swelling of feet. On an unknown date, the outcome of the general body pain, pain in hip, limbs stiffness, ankle swelling and swelling of feet were not recovered/not resolved. It was unknown if the reporter considered the general body pain, pain in hip, limbs stiffness, ankle swelling and swelling of feet to be related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. This case was reported by the patient's wife. The reporter did not wish to provide the patient's concomitant medications. The patient experienced pain in his hip joints and achiness all over. The patient's hands were hard to open and close and his ankles and feet were swollen as well. The patient denied permission to contact their physician.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Red, painful, warm spot on arm.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. 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 injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional information was received as follows: This case was reported by a Pharmacy Intern. The age at vaccination was not reported. The patient received SHINGRIX about 2 months ago from the date of reporting. The patient experienced redness and soreness at the injection site. On an unknown date, the patient recovered from the symptoms. The patient did not want to receive the 2nd dose. The reporter did not have the patient details.
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue
Clinical narrative: This case was reported by a physician via other and described the occurrence of fatigue in a male patient who received SHINGRIX. 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 fatigue and discomfort. On an unknown date, the outcome of the fatigue and discomfort were recovered/resolved. The reporter considered the fatigue and discomfort to be probably related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. This case was reported by the patient's spouse. This case was reported by the physician assistant. The reporter did not specify when they received the dose. It was unknown if the events caused the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. This case is 1 of 4 cases reported by the same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. On 26th May 2018, the patient received SHINGRIX (subcutaneous). On 26th May 2018, 2 hrs after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site erythema and intramuscular formulation administered by other route. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient might have received a dose of SHINGRIX subcutaneously, which could lead to inappropriate route of vaccination. The patient developed an injection site reaction a couple of hours after receipt of the SHINGRIX, which included soreness, redness and warmth. The health care professional had no vaccine information at the time of call, said if safety followed up with her she would send any other information she gets. The patient was given the SHINGRIX at another facility. The patient took ibuprofen and TYLENOL to help with the soreness.
Age: 60.0
Sex: F
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 60-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date unknown). On 19th April 2018, the patient received the 1st dose of SHINGRIX. On 1st May 2018, 12 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not reported. The reporter considered the shingles to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the right arm. The healthcare professional (HCP) had no expiry date for the vaccine given. The HCP was unsure if the patient saw a physician who documented the shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Myalgia, Pain
Clinical narrative: This case was reported by a nurse via other and described the occurrence of pain in a female patient who received SHINGRIX. 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 pain, erythema, swelling, fatigue, fever, myalgia and headache. On an unknown date, the outcome of the pain, erythema, swelling, fatigue, fever, myalgia and headache were recovered/resolved. The reporter considered the pain, erythema, swelling, fatigue, fever, myalgia and headache to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not specify when they received the dose. It was unknown if the events caused the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. This case is 1 of 4 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: This case was reported by a nurse via other and described the occurrence of pain in a female patient who received SHINGRIX. 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 pain, erythema, swelling, fatigue, fever, myalgia and headache. On an unknown date, the outcome of the pain, erythema, swelling, fatigue, fever, myalgia and headache were recovered/resolved. The reporter considered the pain, erythema, swelling, fatigue, fever, myalgia and headache to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not specify when they received the dose. It was unknown if the events caused the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. This case is 1 of 4 cases reported by the same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Insomnia, Pain in extremity, Vomiting
Clinical narrative: Vomiting, diarrhea, abdominal pain, insomnia, severe arm pain.
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX. Co-suspect products included ADACEL. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml and ADACEL at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and myalgia. On an unknown date, the outcome of the fever and myalgia were recovered/resolved. It was unknown if the reporter considered the fever and myalgia to be related to SHINGRIX. Additional details were provided as follows: The patient received a shot of SHINGRIX in one arm and ADACEL in another arm. The patient had fever and myalgia for a week. It was unknown if the reporter considered the fever and myalgia to be related to ADACEL as well.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer and described the occurrence of vomiting in a male patient who received SHINGRIX. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On 21st April 2018, 1 days after receiving SHINGRIX, the patient experienced vomiting, diarrhea, fever, chills and sweating. On an unknown date, the outcome of the vomiting, diarrhea, fever, chills and sweating were unknown. It was unknown if the reporter considered the vomiting, diarrhea, fever, chills and sweating to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient reported that, the next day after vaccination, he spent with vomiting, diarrhea, fever, chills and sweats. He stated he was completely out of commission. The patient enquired, whether he should have the 2nd round of vaccination with SHINGRIX and does he has to look forward to have more of the previous side effects.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Papule, Rash, Rash erythematous, Rash pruritic
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of itchy rash in a 56-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020. On 23rd May 2018, the patient received SHINGRIX. On 25th May 2018, 2 days after receiving SHINGRIX, the patient experienced itchy rash, erythematous rash, papule, vesicles and skin lesion. The patient was treated with BENADRYL and Hydrocortisone Cream. On an unknown date, the outcome of the itchy rash, erythematous rash, pustule, vesicles and skin lesion were unknown. It was unknown if the reporter considered the itchy rash, erythematous rash, pustule, vesicles and skin lesion to be related to SHINGRIX. Additional details were provided as follows: On Friday afternoon in the same week of vaccination, the patient started to have bumps and developed into pustules all over arms and legs. The bumps were red, very itchy and fluid filled. The patient called physician on call. The patient took BENADRYL and put on some hydrocortisone cream. The patient still had lesions at the time of reporting but they seem to be getting better. The physician advised her not to get the second dose. They would be contacting medical science liaison for more information. The reported agreed to be followed up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular, Skin lesion
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of itchy rash in a 56-year-old female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020. On 23rd May 2018, the patient received SHINGRIX. On 25th May 2018, 2 days after receiving SHINGRIX, the patient experienced itchy rash, erythematous rash, papule, vesicles and skin lesion. The patient was treated with BENADRYL and Hydrocortisone Cream. On an unknown date, the outcome of the itchy rash, erythematous rash, pustule, vesicles and skin lesion were unknown. It was unknown if the reporter considered the itchy rash, erythematous rash, pustule, vesicles and skin lesion to be related to SHINGRIX. Additional details were provided as follows: On Friday afternoon in the same week of vaccination, the patient started to have bumps and developed into pustules all over arms and legs. The bumps were red, very itchy and fluid filled. The patient called physician on call. The patient took BENADRYL and put on some hydrocortisone cream. The patient still had lesions at the time of reporting but they seem to be getting better. The physician advised her not to get the second dose. They would be contacting medical science liaison for more information. The reported agreed to be followed up.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of felt faint in a 20-year-old female patient who received BEXSERO. On 30th May 2018, the patient received BEXSERO. On 30th May 2018, less than a day after receiving BEXSERO, the patient experienced felt faint. On an unknown date, the outcome of the felt faint was recovered/resolved. The reporter considered the felt faint to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by a Medical Assistant and was previously not reported to anyone. After receiving the BEXSERO vaccine, the patient went into the waiting room, where the patient felt faint and woozy while she was in the waiting room and had to lie down. The caller was not sure how long after the dose was administered that this event occurred.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs were unknown. It was unknown if the reporter considered the swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details was reported as follows: From the date of reporting, last Saturday the patient received vaccine and had a reaction to the shot on her arm where it was swollen and red and very itchy. The patient was in bed all the day Sunday after the vaccination on Saturday sick with shooting pains clear through to her feet. The patient inquired as to how long the swelling and redness of arm will last longer. The patient was referred to her health care professional (HCP) before the call ended. It was unknown if the reporter gave permission to contact. No further details were provided or able to be clarified beyond what was documented above. The reporter declined to answer any form questions.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs were unknown. It was unknown if the reporter considered the swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details was reported as follows: From the date of reporting, last Saturday the patient received vaccine and had a reaction to the shot on her arm where it was swollen and red and very itchy. The patient was in bed all the day Sunday after the vaccination on Saturday sick with shooting pains clear through to her feet. The patient inquired as to how long the swelling and redness of arm will last longer. The patient was referred to her health care professional (HCP) before the call ended. It was unknown if the reporter gave permission to contact. No further details were provided or able to be clarified beyond what was documented above. The reporter declined to answer any form questions.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of asthma in a 65-year-old female patient who received SHINGRIX (batch number B9739, expiry date 20th November 2020). Concomitant products included fluticasone propionate, ADVAIR, latanoprost, Levothyroxine, Metformin, Montelukast, nateglinide, Rosuvastatin and TRADJENTA. On 24th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced asthma. On an unknown date, the outcome of the asthma was not recovered/not resolved. The reporter considered the asthma to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist reporting that one of her patients who received 1st dose of SHINGRIX was experiencing asthma symptoms. The patient noted she has not had asthma symptoms for years.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Skin warm
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of skin discoloration in a 73-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020). Concomitant products included flecainide, gabapentin and XARELTO. On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced skin discoloration, discomfort and skin warm. On an unknown date, the outcome of the skin discoloration, discomfort and skin warm were recovered/resolved. The reporter considered the skin discoloration, discomfort and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included thyroid medication. The patient received SHINGRIX in the left deltoid. The patient experienced a dark pink reaction on her upper arm, warm to the touch, and felt uncomfortable. The healthcare professional did not know when the reaction started after vaccine administration but she believed it started within a few days. The adverse events lasted for 5 days but was resolved at the time of reporting. The healthcare professional stated there was not any itching, swelling, bruising, or fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Erythema, callous tenderness (L) upper arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Back pain, Fatigue, Insomnia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of difficulty sleeping in a 60-year-old male patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping and anxiety. On 31st May 2018, the patient experienced movement disorder, tiredness, back pain, leg pain and weakness. On an unknown date, the outcome of the difficulty sleeping, back pain and leg pain were unknown and the outcome of the movement disorder, tiredness, anxiety and weakness were not recovered/not resolved. It was unknown if the reporter considered the difficulty sleeping, movement disorder, tiredness, anxiety and weakness to be related to SHINGRIX. The reporter considered the back pain and leg pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist. Less than a day after vaccination of SHINGRIX on left deltoid, the patient was anxious, had difficulty in sleeping. One day after vaccination, in the morning of the day of reporting, the patient was weak and tired and the patient called the pharmacist to report these issues along with his concern about back pain and pain in both legs, the patient also noted difficulty lifting one leg. She was encouraged to have him notify his physician and the prescribing information for stated adverse events was reviewed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of difficulty sleeping in a 60-year-old male patient who received SHINGRIX (batch number 5NY3B, expiry date 13th July 2020). On 30th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping and anxiety. On 31st May 2018, the patient experienced movement disorder, tiredness, back pain, leg pain and weakness. On an unknown date, the outcome of the difficulty sleeping, back pain and leg pain were unknown and the outcome of the movement disorder, tiredness, anxiety and weakness were not recovered/not resolved. It was unknown if the reporter considered the difficulty sleeping, movement disorder, tiredness, anxiety and weakness to be related to SHINGRIX. The reporter considered the back pain and leg pain to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the registered pharmacist. Less than a day after vaccination of SHINGRIX on left deltoid, the patient was anxious, had difficulty in sleeping. One day after vaccination, in the morning of the day of reporting, the patient was weak and tired and the patient called the pharmacist to report these issues along with his concern about back pain and pain in both legs, the patient also noted difficulty lifting one leg. She was encouraged to have him notify his physician and the prescribing information for stated adverse events was reviewed.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concomitant products included famotidine, Furosemide, Levocetirizine, glimepiride, JANUVIA, hydrochlorothiazide with losartan, Potassium, ranitidine and TRULICITY. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site lump and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site lump and injection site erythema were not recovered/not resolved. The reporter considered the injection site swelling, injection site itching, injection site lump and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swelling and redness on her entire upper left arm (injection site) and the patient had experienced these symptoms for over 1 week following the administration of the SHINGRIX vaccine. The patient also reported that her upper arm was itchy and it felt like there was a lump inside.