chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JUL-2014, the patient was treated at a medical center for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a adult patient 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 numbness of upper extremities, tingling of extremity, injection site erythema and injection site pain. On an unknown date, the outcome of the numbness of upper extremities, tingling of extremity, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the numbness of upper extremities, tingling of extremity, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown arm and experienced injection site pain and redness but it was accompanied by the numbness or tingling. The pharmacist was looking in the package insert and he was not able to find if there was a percentage of patients who experienced numbness or tingling in the injection arm.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Chills, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, shivering, muscle pain and sweating. On an unknown date, the outcome of the influenza-like symptoms, fever, shivering, muscle pain and sweating were recovered/resolved. The reporter considered the influenza-like symptoms, fever, shivering, muscle pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 62 or 63 years. This case was reported by GlaxoSmithKline employee on behalf of his brother-in-law (patient).  In January or February of 2018, the patient received the SHINGRIX in the arm. After receiving SHINGRIX, the next day, the patient experienced first does flu like symptoms that included muscle aches, sweating, fever and shivering. The patient experienced these symptoms for 3 days. The patient was bedridden during this time. The reporter had limited details regarding this report. This case has been linked with case.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, shivering, muscle pain and sweating. On an unknown date, the outcome of the influenza-like symptoms, fever, shivering, muscle pain and sweating were recovered/resolved. The reporter considered the influenza-like symptoms, fever, shivering, muscle pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 62 or 63 years. This case was reported by GlaxoSmithKline employee on behalf of his brother-in-law (patient).  In January or February of 2018, the patient received the SHINGRIX in the arm. After receiving SHINGRIX, the next day, the patient experienced first does flu like symptoms that included muscle aches, sweating, fever and shivering. The patient experienced these symptoms for 3 days. The patient was bedridden during this time. The reporter had limited details regarding this report. This case has been linked with case.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, shivering, muscle pain and sweating. On an unknown date, the outcome of the influenza-like symptoms, fever, shivering, muscle pain and sweating were recovered/resolved. The reporter considered the influenza-like symptoms, fever, shivering, muscle pain and sweating to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 62 or 63 years. This case was reported by GlaxoSmithKline employee on behalf of his brother-in-law (patient).  In January or February of 2018, the patient received the SHINGRIX in the arm. After receiving SHINGRIX, the next day, the patient experienced first does flu like symptoms that included muscle aches, sweating, fever and shivering. The patient experienced these symptoms for 3 days. The patient was bedridden during this time. The reporter had limited details regarding this report. This case has been linked with case.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Bedridden, Chills, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old male patient who received SHNGRIX for prophylaxis. In May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, shivering, muscle pain, sweating and rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, shivering, muscle pain, sweating and rash were recovered/resolved. The reporter considered the fever, shivering, muscle pain, sweating and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 62 or 63 years. This case was reported by GlaxoSmithKline employee on behalf of his brother-in-law (patient). The patient received the SHINGRIX in the arm. After receiving SHINGRIX, following day the patient experienced muscle aches, sweating, fever and shivering. Less than a year after receiving SHINGRIX, the patient also experienced a rash across his abdomen. The symptoms lasted approximately 3 to 4 days. The reporter had limited details regarding this report. This case has been linked with case US2018114214, reported by same reporter for same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old male patient who received SHNGRIX for prophylaxis. In May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, shivering, muscle pain, sweating and rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, shivering, muscle pain, sweating and rash were recovered/resolved. The reporter considered the fever, shivering, muscle pain, sweating and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 62 or 63 years. This case was reported by GlaxoSmithKline employee on behalf of his brother-in-law (patient). The patient received the SHINGRIX in the arm. After receiving SHINGRIX, following day the patient experienced muscle aches, sweating, fever and shivering. Less than a year after receiving SHINGRIX, the patient also experienced a rash across his abdomen. The symptoms lasted approximately 3 to 4 days. The reporter had limited details regarding this report. This case has been linked with case US2018114214, reported by same reporter for same patient.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old male patient who received SHNGRIX for prophylaxis. In May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, shivering, muscle pain, sweating and rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, shivering, muscle pain, sweating and rash were recovered/resolved. The reporter considered the fever, shivering, muscle pain, sweating and rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination could be 62 or 63 years. This case was reported by GlaxoSmithKline employee on behalf of his brother-in-law (patient). The patient received the SHINGRIX in the arm. After receiving SHINGRIX, following day the patient experienced muscle aches, sweating, fever and shivering. Less than a year after receiving SHINGRIX, the patient also experienced a rash across his abdomen. The symptoms lasted approximately 3 to 4 days. The reporter had limited details regarding this report. This case has been linked with case US2018114214, reported by same reporter for same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site reaction, Injection site swelling, Muscle swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve damage in a 70-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020) for prophylaxis. Concomitant products included Escitalopram. On 5th April 2018, the patient received the 1st dose of SHINGRIX.5 ml. On 10th April 2018, 5 days after receiving SHINGRIX, the patient experienced pain in arm, injection site swelling, muscle swelling and injected limb mobility decreased. On 12th April 2018, the patient experienced shoulder pain. In April 2018, the patient experienced nerve damage and numbness of upper extremities. The patient was treated with ibuprofen. On an unknown date, the outcome of the nerve damage, injected limb mobility decreased and shoulder pain were unknown and the outcome of the pain in arm, numbness of upper extremities, injection site swelling and muscle swelling were recovering/resolving. It was unknown if the reporter considered the nerve damage, injected limb mobility decreased and shoulder pain to be related to SHINGRIX. The reporter considered the pain in arm, numbness of upper extremities, injection site swelling and muscle swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 69 or 70 years old. The patient received SHINGRIX vaccine in the left deltoid. The patient experienced pain in the left arm and swelling of the deltoid muscle in the left arm which occurred 5 days after the dose and the patient could not lift her arm due to this.The pain radiated to the shoulder and down the arm 7 to 8 days after the dose. The patient also experienced numbness which ran down the left arm to the thumb and up through the neck. After 7 days of this pain and numbness, the patient was seen by the physician and diagnosed with nerve damage. The patient was given Ibuprofen but, did not resolve the pain. The patient was prescribed physical therapy to help with the pain and numbness. The pain and numbness had gotten some better but had not yet resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nerve injury, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nerve damage in a 70-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020) for prophylaxis. Concomitant products included Escitalopram. On 5th April 2018, the patient received the 1st dose of SHINGRIX.5 ml. On 10th April 2018, 5 days after receiving SHINGRIX, the patient experienced pain in arm, injection site swelling, muscle swelling and injected limb mobility decreased. On 12th April 2018, the patient experienced shoulder pain. In April 2018, the patient experienced nerve damage and numbness of upper extremities. The patient was treated with ibuprofen. On an unknown date, the outcome of the nerve damage, injected limb mobility decreased and shoulder pain were unknown and the outcome of the pain in arm, numbness of upper extremities, injection site swelling and muscle swelling were recovering/resolving. It was unknown if the reporter considered the nerve damage, injected limb mobility decreased and shoulder pain to be related to SHINGRIX. The reporter considered the pain in arm, numbness of upper extremities, injection site swelling and muscle swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 69 or 70 years old. The patient received SHINGRIX vaccine in the left deltoid. The patient experienced pain in the left arm and swelling of the deltoid muscle in the left arm which occurred 5 days after the dose and the patient could not lift her arm due to this.The pain radiated to the shoulder and down the arm 7 to 8 days after the dose. The patient also experienced numbness which ran down the left arm to the thumb and up through the neck. After 7 days of this pain and numbness, the patient was seen by the physician and diagnosed with nerve damage. The patient was given Ibuprofen but, did not resolve the pain. The patient was prescribed physical therapy to help with the pain and numbness. The pain and numbness had gotten some better but had not yet resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in October 2017). Concomitant products included Aspirin, NORVASC, ZYRTEC, vitamin D, NEXIUM and losartan. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site warmth, injection site swelling, influenza-like symptoms, fever, generalized aching, chills, fatigue and skin discoloration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site swelling, influenza-like symptoms, fever, generalized aching, chills and fatigue were recovered/resolved and the outcome of the skin discoloration was not recovered/not resolved. The reporter considered the injection site pain, injection site erythema, injection site warmth, injection site swelling, influenza-like symptoms, fever, generalized aching, chills, fatigue and skin discoloration to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included stool softener. The patient stated that her pharmacist recommended that she take the SHINGRIX vaccine and she was concerned since she had just received the ZOSTAVAX vaccine in October 2017. When the injection was being administered, she stated that it felt like fire was being shot into her. Within 24 hours of receiving the injection, she started to experience flu-like symptoms, which included low-grade fever, aches and pain (generalized), chills, and fatigue. She stated that the injection site was extremely red, hot, painful, and swollen. She stated that it reminded her of cellulitis. All of the symptoms had resolved other than her arm was still what she described as discolored (pink and splotchy). She had reported the symptoms to her doctor who could not give her any recommendations. She stated that this was the worst reaction that she ever had from a vaccine and more likely would not get the 2nd dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia, Rash macular, Skin discolouration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in October 2017). Concomitant products included Aspirin, NORVASC, ZYRTEC, vitamin D, NEXIUM and losartan. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site warmth, injection site swelling, influenza-like symptoms, fever, generalized aching, chills, fatigue and skin discoloration. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site swelling, influenza-like symptoms, fever, generalized aching, chills and fatigue were recovered/resolved and the outcome of the skin discoloration was not recovered/not resolved. The reporter considered the injection site pain, injection site erythema, injection site warmth, injection site swelling, influenza-like symptoms, fever, generalized aching, chills, fatigue and skin discoloration to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient's concomitant medication included stool softener. The patient stated that her pharmacist recommended that she take the SHINGRIX vaccine and she was concerned since she had just received the ZOSTAVAX vaccine in October 2017. When the injection was being administered, she stated that it felt like fire was being shot into her. Within 24 hours of receiving the injection, she started to experience flu-like symptoms, which included low-grade fever, aches and pain (generalized), chills, and fatigue. She stated that the injection site was extremely red, hot, painful, and swollen. She stated that it reminded her of cellulitis. All of the symptoms had resolved other than her arm was still what she described as discolored (pink and splotchy). She had reported the symptoms to her doctor who could not give her any recommendations. She stated that this was the worst reaction that she ever had from a vaccine and more likely would not get the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure high. Concomitant products included Lisinopril/Hydrochlorothiazide. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm and approximately 20 hours after receiving SHINGRIX, the patient experienced shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain. On an unknown date, the outcome of the pain in arm, shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain were recovered/resolved. The reporter considered the pain in arm, shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm. The patient stated that 24 hours later after receiving the vaccine she had a sore arm. Approximately 20 hours later she experienced shivering, cold, fever, flu-like symptoms, upset stomach, tired, and muscle aches throughout entire body from neck to shoulder to lower muscles of the body. The patient slept for 9-10 hours as she was tired, and next day when she woke up she was normal and all her symptoms were resolved. The patient had denied permission to contact their physician. No further details were provided by the caller.
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included blood pressure high. Concomitant products included Lisinopril/Hydrochlorothiazide. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm and approximately 20 hours after receiving SHINGRIX, the patient experienced shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain. On an unknown date, the outcome of the pain in arm, shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain were recovered/resolved. The reporter considered the pain in arm, shivering, cold, fever, influenza-like symptoms, upset stomach, tiredness and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm. The patient stated that 24 hours later after receiving the vaccine she had a sore arm. Approximately 20 hours later she experienced shivering, cold, fever, flu-like symptoms, upset stomach, tired, and muscle aches throughout entire body from neck to shoulder to lower muscles of the body. The patient slept for 9-10 hours as she was tired, and next day when she woke up she was normal and all her symptoms were resolved. The patient had denied permission to contact their physician. No further details were provided by the caller.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hypersensitivity, Malaise, Pyrexia, Tremor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 23rd June 2018, the patient received SHINGRIX. On 23rd June 2018, less than a day after receiving SHINGRIX, the patient experienced allergic reaction, tremor, malaise, fever and chills. On 24th June 2018, the outcome of the allergic reaction, tremor, malaise, fever and chills were recovered/resolved. It was unknown if the reporter considered the allergic reaction, malaise and chills to be related to SHINGRIX. The reporter considered the tremor and fever to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the physician. The age at vaccination was not reported. The patient experienced overall illness and category 3 allergic reaction. At 22:05, the patient experienced violent shakiness. At 22:00, the patient experienced fever. The patient had an acute reaction and was resolved within 24 hours. This case has been linked to the US2018115060, reported by the same reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Aphasia, Asthenia, Back pain, Chills
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of slurred speech in a female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 23rd June 2018 12:13, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced slurred speech, weakness, abdominal crampy pains, rigors, low back pain, dizziness, word finding difficulty and nausea. The patient was treated with BENADRYL, REGLAN and BENTYL. On an unknown date, the outcome of the slurred speech, weakness, rigors, low back pain, dizziness and word finding difficulty were recovered/resolved and the outcome of the abdominal crampy pains and nausea were not recovered/not resolved. The reporter considered the slurred speech, weakness, abdominal crampy pains, rigors, low back pain, dizziness, word finding difficulty and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on unknown deltoid. The health care professional reported patient developed stroke like symptoms such and slurred speech and not being able to put words together after receiving the first SHINGRIX dose. The patient also experienced severe weakness, rigors, nausea, abdominal pain/cramping, severe low back pain and severe dizziness. The health care professional stated that patient was not herself. The health care professional said slurred speech went away after the patient took 2 BENADRYL. The patient was still experiencing nausea and abdominal cramping in the mornings and was taking REGLAN and BENTYL now. The health care professional felt that these effects were caused by the SHINGRIX. The health care professional did not feel that patient was jeopardized at the time of reporting but felt that the patient would be if they received the second dose of the series. The health care professional would not give the patient the second dose of the series.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysarthria, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of slurred speech in a female patient who received SHINGRIX (batch number LT533, expiry date 11th October 2020) for prophylaxis. On 23rd June 2018 12:13, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced slurred speech, weakness, abdominal crampy pains, rigors, low back pain, dizziness, word finding difficulty and nausea. The patient was treated with BENADRYL, REGLAN and BENTYL. On an unknown date, the outcome of the slurred speech, weakness, rigors, low back pain, dizziness and word finding difficulty were recovered/resolved and the outcome of the abdominal crampy pains and nausea were not recovered/not resolved. The reporter considered the slurred speech, weakness, abdominal crampy pains, rigors, low back pain, dizziness, word finding difficulty and nausea to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on unknown deltoid. The health care professional reported patient developed stroke like symptoms such and slurred speech and not being able to put words together after receiving the first SHINGRIX dose. The patient also experienced severe weakness, rigors, nausea, abdominal pain/cramping, severe low back pain and severe dizziness. The health care professional stated that patient was not herself. The health care professional said slurred speech went away after the patient took 2 BENADRYL. The patient was still experiencing nausea and abdominal cramping in the mornings and was taking REGLAN and BENTYL now. The health care professional felt that these effects were caused by the SHINGRIX. The health care professional did not feel that patient was jeopardized at the time of reporting but felt that the patient would be if they received the second dose of the series. The health care professional would not give the patient the second dose of the series.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. Concomitant products included Hepatitis A vaccine. On 13th June 2018, the patient received BEXSERO .5 ml. In June 2018, less than a month after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details reported as follows: On 13th June 2018, the patient received Hepatitis A vaccine in a different arm. The patient's mom was called on 26th June 2018 and said the patient was having the pain in her arm till the time of reporting. There were no other side effects besides pain (no redness or swelling). She did think it was related to the BEXSERO.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Accidental underdose, Vomiting
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vomiting in a 2-month-old male patient who received ROTARIX for prophylaxis. On 17th October 2017, the patient received ROTARIX (oral). On 17th October 2017, less than an hour after receiving ROTARIX, the patient experienced vomiting and accidental underdose. On an unknown date, the outcome of the vomiting was recovered/resolved and the outcome of the accidental underdose was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were provided as follows: The physician prepared other vaccines and came back to find that, the patient had vomited, which led to accidental underdose. The patient was revaccinated.
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site itching in a child female patient who received MENVEO (batch number M16130, expiry date 31st July 2018) for prophylaxis. On 15th May 2018, the patient received MENVEO. On 15th May 2018, immediately after receiving MENVEO, the patient experienced injection site itching. The patient was treated with PEPCID, TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site itching to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not provided. As soon as the patient had MENVEO she stated it itched. The reaction was not as bad as the May of 2015 reaction, the patient was brought to hospital. Records would be there.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of herpetiform lesion in a elderly female patient who received SHINGRIX for prophylaxis. On 2nd May 2018, the patient received SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced herpetiform lesion. On an unknown date, the outcome of the herpetiform lesion was unknown. It was unknown if the reporter considered the herpetiform lesion to be related to SHINGRIX. Additional details were provided as follows: The registered nurse (BS, BA) who was nursing supervisor reported this case. The patient had no history of herpes virus previously. The age at vaccination was not reported but could be 70 years or 71 years. The patient went to practice on 6th May 2018 with herpetic lesion on her finger. The nurse and provider were unsure if it was related to vaccine. The lot number was provided. The reporter did not agree to follow up contact.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a physician via other and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension (well-controlled). Concomitant products included SHINGRIX, amlodipine and enalapril. On 25th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In June 2018, 18 hrs after receiving SHINGRIX, the patient experienced chills, fever, malaise, myalgia and headache. On 25th June 2018, the patient experienced injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema. The patient was treated with Acetaminophen and ibuprofen. In June 2018, the outcome of the chills, fever, malaise, myalgia and headache were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema to be related to SHINGRIX. The reporter considered the chills, fever, malaise, myalgia and headache to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporting physician was the patient. The patient had no drug allergies or any history of vaccine allergies. The patient received 1st dose of SHINGRIX (lot number was not known) was administered in the left deltoid on 24th April 2018 and no adverse events were reported. The 2nd dose of SHINGRIX (lot number was unknown) was administered in the left deltoid on 25th June 2018. The injection site symptoms began almost immediately, and included pain and tenderness, this progressed within 12 hours to include an injection site rash that was described as indurated, erythematous, warm to the touch, and measuring approximately 10cm by 7cm. The local symptoms resolved, without sequelae, by approximately 72 hours after injection. The systemic symptoms began almost exactly 18 hours after injection, and included chills, fever to 38.8 degrees C measured via tympanic membrane sensor, malaise, myalgias, and headache. The fever was treated with acetaminophen 500mg followed, 2 hours later, by ibuprofen 800 mg. All systemic symptoms resolved, without sequelae, within 8 hours. The reporting physician's causal imputations were definitely related to SHINGRIX for the local symptoms and almost certainly related to SHINGRIX for the systemic symptoms, and considered all to have been medically anticipated. Follow-up would not be available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via other and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension (well-controlled). Concomitant products included SHINGRIX, amlodipine and enalapril. On 25th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In June 2018, 18 hrs after receiving SHINGRIX, the patient experienced chills, fever, malaise, myalgia and headache. On 25th June 2018, the patient experienced injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema. The patient was treated with Acetaminophen and ibuprofen. In June 2018, the outcome of the chills, fever, malaise, myalgia and headache were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema to be related to SHINGRIX. The reporter considered the chills, fever, malaise, myalgia and headache to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporting physician was the patient. The patient had no drug allergies or any history of vaccine allergies. The patient received 1st dose of SHINGRIX (lot number was not known) was administered in the left deltoid on 24th April 2018 and no adverse events were reported. The 2nd dose of SHINGRIX (lot number was unknown) was administered in the left deltoid on 25th June 2018. The injection site symptoms began almost immediately, and included pain and tenderness, this progressed within 12 hours to include an injection site rash that was described as indurated, erythematous, warm to the touch, and measuring approximately 10cm by 7cm. The local symptoms resolved, without sequelae, by approximately 72 hours after injection. The systemic symptoms began almost exactly 18 hours after injection, and included chills, fever to 38.8 degrees C measured via tympanic membrane sensor, malaise, myalgias, and headache. The fever was treated with acetaminophen 500mg followed, 2 hours later, by ibuprofen 800 mg. All systemic symptoms resolved, without sequelae, within 8 hours. The reporting physician's causal imputations were definitely related to SHINGRIX for the local symptoms and almost certainly related to SHINGRIX for the systemic symptoms, and considered all to have been medically anticipated. Follow-up would not be available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: This case was reported by a physician via other and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension (well-controlled). Concomitant products included SHINGRIX, amlodipine and enalapril. On 25th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In June 2018, 18 hrs after receiving SHINGRIX, the patient experienced chills, fever, malaise, myalgia and headache. On 25th June 2018, the patient experienced injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema. The patient was treated with Acetaminophen and ibuprofen. In June 2018, the outcome of the chills, fever, malaise, myalgia and headache were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site induration, injection site rash, injection site warmth and injection site erythema to be related to SHINGRIX. The reporter considered the chills, fever, malaise, myalgia and headache to be almost certainly related to SHINGRIX. Additional details were provided as follows: The reporting physician was the patient. The patient had no drug allergies or any history of vaccine allergies. The patient received 1st dose of SHINGRIX (lot number was not known) was administered in the left deltoid on 24th April 2018 and no adverse events were reported. The 2nd dose of SHINGRIX (lot number was unknown) was administered in the left deltoid on 25th June 2018. The injection site symptoms began almost immediately, and included pain and tenderness, this progressed within 12 hours to include an injection site rash that was described as indurated, erythematous, warm to the touch, and measuring approximately 10cm by 7cm. The local symptoms resolved, without sequelae, by approximately 72 hours after injection. The systemic symptoms began almost exactly 18 hours after injection, and included chills, fever to 38.8 degrees C measured via tympanic membrane sensor, malaise, myalgias, and headache. The fever was treated with acetaminophen 500mg followed, 2 hours later, by ibuprofen 800 mg. All systemic symptoms resolved, without sequelae, within 8 hours. The reporting physician's causal imputations were definitely related to SHINGRIX for the local symptoms and almost certainly related to SHINGRIX for the systemic symptoms, and considered all to have been medically anticipated. Follow-up would not be available.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia, Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of chills in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 26th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced chills, muscle pain, fever, injection site pain and rash. On an unknown date, the outcome of the chills, muscle pain, fever, injection site pain and rash were unknown. It was unknown if the reporter considered the chills, muscle pain, fever, injection site pain and rash to be related to SHINGRIX. Additional details were provided as follows: On 27th June 2018, the patient stated that, she had a significant reaction to SHINGRIX, described as severe muscle aches, chills, temperature of 102, severe pain at the injection site and rash on face. There was no anaphylaxis. The reporter agreed to be followed up .
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Patient had SHINGRIX vaccine 5 days ago, since then has been feeling tired, body aches, and redness and soreness to the injection site on left deltoid. This morning (6/29/18), started with itchy rash all over her body, scalp is itchy too. She has been on BACTRIM for 9 days for infected cyst. She doesn't remember if she has ever taken BACTRIM before as it has been years since taking any antibiotic. Denies sun exposure. Denies difficulty breathing, swelling to lips or throat, or dysphagia. Denies any new skin products. Denies fever or chills. Vitals: BP: 124/75, HR: 89, Temp: 98.1 degrees F, RR: 12. PE: General: WDWN, NAD. HENT: Head: Normocephalic, atraumatic. Ears: Canals clear. TMs pearly gray. Cone of light and bony landmarks visible. Eyes: Conjunctiva clear, sclera white bilaterally. Nose: Nares patent. Mucosa pink, moist. Turbinates without discharge or swelling. Oropharynx: Mucosa pink, moist without lesions. Pharynx pink; tonsils without hypertrophy or exudate. Resp: Nonlabored. Lungs clear to auscultation and with normal diaphragmatic excursion. No adventitious sounds. CVS: RRR. Normal S1, S2. No murmurs or extra heart sounds. NS: Erythemic macular rash from chest to legs. No rash on face, palms or pedal surfaces of feet. Left deltoid with same rash, mild tenderness to the deltoid. No urticaria. Assessment: Drug exanthem. Stop Bactrim. Short prednisone burst, daily cetirizine, BENADRYL 25-50 mg QHS. Encouraged use of daily fragrance-free lotion. Avoid bathing in hot water, use lukewarm water only. Expect can take up to 2 weeks to resolve. F/U if any worsening of rash or spreading of rash to palms or feet. ER precautions given for any symptoms of anaphylaxis. Adverse reaction to sulfa antibiotic. Sulfa added to allergy list. Adverse reaction to vaccine. Flu-like symptoms and pain and redness to injection site common side effects of SHINGRIX vaccine. Per CDC NOT a contraindication to receive 2nd dose. Plan: Tx: New PredniSONE 10 mg Tab Take 2 tabs orally daily for 2 days then 1 tab daily for 3 days #7 tablet RFx0.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Pruritus, Rash generalised, Rash macular
Clinical narrative: Patient had SHINGRIX vaccine 5 days ago, since then has been feeling tired, body aches, and redness and soreness to the injection site on left deltoid. This morning (6/29/18), started with itchy rash all over her body, scalp is itchy too. She has been on BACTRIM for 9 days for infected cyst. She doesn't remember if she has ever taken BACTRIM before as it has been years since taking any antibiotic. Denies sun exposure. Denies difficulty breathing, swelling to lips or throat, or dysphagia. Denies any new skin products. Denies fever or chills. Vitals: BP: 124/75, HR: 89, Temp: 98.1 degrees F, RR: 12. PE: General: WDWN, NAD. HENT: Head: Normocephalic, atraumatic. Ears: Canals clear. TMs pearly gray. Cone of light and bony landmarks visible. Eyes: Conjunctiva clear, sclera white bilaterally. Nose: Nares patent. Mucosa pink, moist. Turbinates without discharge or swelling. Oropharynx: Mucosa pink, moist without lesions. Pharynx pink; tonsils without hypertrophy or exudate. Resp: Nonlabored. Lungs clear to auscultation and with normal diaphragmatic excursion. No adventitious sounds. CVS: RRR. Normal S1, S2. No murmurs or extra heart sounds. NS: Erythemic macular rash from chest to legs. No rash on face, palms or pedal surfaces of feet. Left deltoid with same rash, mild tenderness to the deltoid. No urticaria. Assessment: Drug exanthem. Stop Bactrim. Short prednisone burst, daily cetirizine, BENADRYL 25-50 mg QHS. Encouraged use of daily fragrance-free lotion. Avoid bathing in hot water, use lukewarm water only. Expect can take up to 2 weeks to resolve. F/U if any worsening of rash or spreading of rash to palms or feet. ER precautions given for any symptoms of anaphylaxis. Adverse reaction to sulfa antibiotic. Sulfa added to allergy list. Adverse reaction to vaccine. Flu-like symptoms and pain and redness to injection site common side effects of SHINGRIX vaccine. Per CDC NOT a contraindication to receive 2nd dose. Plan: Tx: New PredniSONE 10 mg Tab Take 2 tabs orally daily for 2 days then 1 tab daily for 3 days #7 tablet RFx0.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Vaccination complication
Clinical narrative: Patient had SHINGRIX vaccine 5 days ago, since then has been feeling tired, body aches, and redness and soreness to the injection site on left deltoid. This morning (6/29/18), started with itchy rash all over her body, scalp is itchy too. She has been on BACTRIM for 9 days for infected cyst. She doesn't remember if she has ever taken BACTRIM before as it has been years since taking any antibiotic. Denies sun exposure. Denies difficulty breathing, swelling to lips or throat, or dysphagia. Denies any new skin products. Denies fever or chills. Vitals: BP: 124/75, HR: 89, Temp: 98.1 degrees F, RR: 12. PE: General: WDWN, NAD. HENT: Head: Normocephalic, atraumatic. Ears: Canals clear. TMs pearly gray. Cone of light and bony landmarks visible. Eyes: Conjunctiva clear, sclera white bilaterally. Nose: Nares patent. Mucosa pink, moist. Turbinates without discharge or swelling. Oropharynx: Mucosa pink, moist without lesions. Pharynx pink; tonsils without hypertrophy or exudate. Resp: Nonlabored. Lungs clear to auscultation and with normal diaphragmatic excursion. No adventitious sounds. CVS: RRR. Normal S1, S2. No murmurs or extra heart sounds. NS: Erythemic macular rash from chest to legs. No rash on face, palms or pedal surfaces of feet. Left deltoid with same rash, mild tenderness to the deltoid. No urticaria. Assessment: Drug exanthem. Stop Bactrim. Short prednisone burst, daily cetirizine, BENADRYL 25-50 mg QHS. Encouraged use of daily fragrance-free lotion. Avoid bathing in hot water, use lukewarm water only. Expect can take up to 2 weeks to resolve. F/U if any worsening of rash or spreading of rash to palms or feet. ER precautions given for any symptoms of anaphylaxis. Adverse reaction to sulfa antibiotic. Sulfa added to allergy list. Adverse reaction to vaccine. Flu-like symptoms and pain and redness to injection site common side effects of SHINGRIX vaccine. Per CDC NOT a contraindication to receive 2nd dose. Plan: Tx: New PredniSONE 10 mg Tab Take 2 tabs orally daily for 2 days then 1 tab daily for 3 days #7 tablet RFx0.