chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received SHINGRIX. On 24th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving. The reporter considered the pain in arm to be probably related to SHINGRIX. Additional information was received as follows: This case was not previously reported to anyone. The patient received the vaccine on the left arm. The patient experienced consistent arm pain for 1-2 days after receiving the SHINGRIX vaccination. The arm pain was resolving and at the reporting time he experienced intermittent arm pain. The arm pain did not occur every day. The patient had denied permission to contact their physician. The reporter did not want to be contacted regarding this adverse event. The reporter did not provide his birth date.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling arm in a 55-year-old female patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 15th February 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 15th February 2018, less than a day after receiving SHINGRIX, the patient experienced swelling arm, erythema of extremities, extremities hot feeling of and pain in arm. On an unknown date, the outcome of the swelling arm, erythema of extremities, extremities hot feeling of and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm, erythema of extremities, extremities hot feeling of and pain in arm to be related to SHINGRIX. Additional details were provided as follows: At the time of reporting, the patient was 56 years old.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb 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 extensive swelling of vaccinated limb, injection site warmth and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site warmth and injection site erythema were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site warmth and injection site erythema to be probably related to SHINGRIX. Additional details were reported as follows: The reporter herself was the patient. The age at vaccination was not reported. The patient received SHINGRIX on right arm. The patient experienced redness and swelling at the injection site which ran down all the way down to her elbow. It was warm to touch at the injection site. The symptoms lasted for about a week and a half. All questions were asked. No further details were provided.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site discomfort in a 74-year-old male patient who received SHINGRIX. Concomitant products included Atorvastatin, omeprazole and metoprolol. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site discomfort, fever and injection site pain. On an unknown date, the outcome of the injection site discomfort, fever and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site discomfort, fever and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he experienced discomfort and soreness at his injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Gastrointestinal disorder, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of gastrointestinal disorder in a elderly male patient who received SHINGRIX. Concomitant products included LEVITRA, LIPITOR, Magnesium, Metformin, Aspirin, AMBIEN and PRILOSEC. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced gastrointestinal disorder, diarrhea and nausea. On an unknown date, the outcome of the gastrointestinal disorder, diarrhea and nausea were recovered/resolved. The reporter considered the gastrointestinal disorder, diarrhea and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 72 or 73 years old. The patient received the vaccination at a pharmacy. The nurse practitioner reported that the patient experienced gastrointestinal issues including nausea and diarrhea after the SHINGRIX vaccination.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Lethargy, Myalgia, Nausea
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 76-year-old male patient who received SHINGRIX (batch number ZY3X4, expiry date unknown). Concomitant products included Aspirin, LIPITOR, NORVASC, vitamin D and AVAPRO. On 26th April 2018, the patient received the 1st dose of SHINGRIX. On 26th April 2018, less than  day after receiving SHINGRIX, the patient experienced muscle pain, influenza-like symptoms, lethargy, weakness and nausea. On an unknown date, the outcome of the muscle pain, weakness and nausea were recovered/resolved and the outcome of the influenza-like symptoms and lethargy were unknown. The reporter considered the muscle pain, influenza-like symptoms, lethargy, weakness and nausea to be probably related to SHINGRIX. Additional details were reported as follows: The patient received the injection at a pharmacy in left deltoid.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Impaired work ability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back muscle spasms in a 52-year-old female patient who received SHINGRIX. Concurrent medical conditions included back disorder (current and historical). Concomitant products included SHINGRIX. On 14th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced back muscle spasms, pain in hip, upset stomach, headache, tiredness and general body pain. On an unknown date, the outcome of the back muscle spasms, pain in hip, upset stomach, headache, tiredness and general body pain were unknown. The reporter considered the back muscle spasms, pain in hip, upset stomach, headache, tiredness and general body pain to be possibly related to SHINGRIX. Additional details were provided as follows: The batch number and expiration date were not known. The patient stated when she got up today on 15th May 2018, she started to have muscle spasms in her back. She had a history of a bad back, but she was wondering if the spasms could be related to the vaccine. She also had an upset stomach and a really bad headache. She feels tired and her entire body was hurting including her hips. She went to work but had to come home due to these symptoms. She had the first vaccine about 2.5 to 3 months ago and did not mention any side effects with that shot. She worked at the pharmacy where the vaccine was administered by the pharmacy manager. She said she takes no other medications and no other vaccines were administered within the last 4 weeks.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of back muscle spasms in a 52-year-old female patient who received SHINGRIX. Concurrent medical conditions included back disorder (current and historical). Concomitant products included SHINGRIX. On 14th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced back muscle spasms, pain in hip, upset stomach, headache, tiredness and general body pain. On an unknown date, the outcome of the back muscle spasms, pain in hip, upset stomach, headache, tiredness and general body pain were unknown. The reporter considered the back muscle spasms, pain in hip, upset stomach, headache, tiredness and general body pain to be possibly related to SHINGRIX. Additional details were provided as follows: The batch number and expiration date were not known. The patient stated when she got up today on 15th May 2018, she started to have muscle spasms in her back. She had a history of a bad back, but she was wondering if the spasms could be related to the vaccine. She also had an upset stomach and a really bad headache. She feels tired and her entire body was hurting including her hips. She went to work but had to come home due to these symptoms. She had the first vaccine about 2.5 to 3 months ago and did not mention any side effects with that shot. She worked at the pharmacy where the vaccine was administered by the pharmacy manager. She said she takes no other medications and no other vaccines were administered within the last 4 weeks.
Sex: M
Vaccine: VARZOS
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 adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be possibly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX on an unknown arm. The nurse reported that one of their patients received the SHINGRIX vaccine at a pharmacy and reported to the nurse that after he received the SHINGRIX vaccine, he experienced arm soreness that resolved in a couple of days. The reporter had limited information at the time of the call and stated that she might call back in to provide additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a elderly male patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced feeling unwell. In May 2018, the outcome of the feeling unwell was recovered/resolved. The reporter considered the feeling unwell to be possibly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received the SHINGRIX vaccine (unknown deltoid) in their office and reported to her that after he received the SHINGRIX vaccine, he did not feel well overall. The event lasted approximately for 3 to 4 days. The sales representative had limited details regarding the adverse event, so the sales representative asked that someone from Center reach out to the nurse who reported the adverse event to her, to obtain more details. Outbound call was placed to the nurse to obtain additional details. The reporter had limited information at the time of the call and stated that she might call back in to provide additional details.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of adverse drug reaction in a adult 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 adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had possible side effect of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a adult 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 swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site swelling, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 49 or 50 years old. The patient experienced pain, redness and swelling at injection site for 48 hours. The redness continued for 6 days. After the redness became more pronounced for 6 days, they were wondering if it was shingles, Asked to physician and he did not believe it was shingles. After speaking to the physician, wondered if it was because of a preservative. The patient would get the 2nd dose.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of muscle pain in a female patient who received SHINGRIX. On 6th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and adverse reaction. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the muscle pain and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that most of the side effects (unspecified) went away within 3 days, but she was still experiencing muscle pain in her arm around the injection site. The patient wanted to know if this was normal. The patient hesitated getting the 2nd dose of SHINGRIX.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 51-year-old female patient who received SHINGRIX. On 14th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced pain, swelling and erythema. On an unknown date, the outcome of the pain, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the pain, swelling and erythema to be related to SHINGRIX. Additional details were reported as follows: This case was reported by GlaxoSmithKline employee. The patient received SHINGRIX on right deltoid. The patient was reporter's wife. The Liaison reported that he was on the road traveling and 1st heard about his wife's experience on 16th May 2018. The patient had denied permission to contact their physician.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Nausea, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of feeling unwell in a female patient who received SHINGRIX. On 15th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced feeling unwell, fatigue, nausea and general body pain. On an unknown date, the outcome of the feeling unwell, fatigue, nausea and general body pain were unknown. It was unknown if the reporter considered the feeling unwell, fatigue, nausea and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of two shingles vaccine and at the time of reporting still feeling sick, the patient asked how long could she expect to feel sick (tired, nausea, fatigue, body aches).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: This case was reported by a physician via sales rep 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 (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site blisters. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site blisters were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site blisters to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported but the patient was in her 60's. No concomitant vaccines were given.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Nausea, Pain, Therapeutic response unexpected
Clinical narrative: This case was reported by a consumer and described the occurrence of fatigue in a adult patient who received SHINGRIX. The patient's past medical history included inflammation localized. Concurrent medical conditions included arthritis (Poly), Hashimoto's disease, ulcerative colitis, bladder inflammation (extremely inflamed due to auto-immune disease), autoimmune disorder and Sjogren's syndrome. On 15th May 2018, the patient received the 1st dose of SHINGRIX. On 15th May 2018, 4 hrs after receiving SHINGRIX, the patient experienced fatigue, nausea, influenza-like symptoms and pain. On 16th May 2018, the patient experienced unexpected therapeutic effect. On 16th May 2018, the outcome of the fatigue, nausea, influenza-like symptoms and pain were recovered/resolved. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the fatigue, nausea, influenza-like symptoms, pain and unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had quite a bit of damage to hands and wrists. About 4 hours after vaccination the patient developed the expected side effects, flu like symptoms, fatigue, nausea, pain. On the day of reporting (in the afternoon), the patient was almost symptom free from vaccination. The patient reported that in the morning on the day of reporting, although not feeling 100 percent, the patient got an unexpected benefit from this vaccination which was described as the inflammation in fingers, wrists and bladder was just gone but of course the damage was present but the redness, stiffness and pain was absent. The patient asked that if it could be the immune response to the vaccine and also said that it was amazing, been months since the patient could bend the fingers freely. The patient did not think this was the coincidence as the patient was in 60s and had suffered these diseases for decades. The patient said that the company should see if anyone else had relief of these types of symptoms, perhaps the vaccine did more than preventing Shingles. The reporter stated that, it would not be the first time a medication meant for one thing helped another. So the patient said thank you for letting her share this with the GlaxoSmithKline.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020). On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th May 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. SHINGRIX was discontinued. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The medical assistant reported that the patient was seen at the office for follow-up on 14th May 2018. The medical assistant reported that the patient experienced extreme redness at the injection site from her deltoid to her elbow including swelling. The patient required emergency room visit. The medical assistant has denied permission to contact their office.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 57-year-old female patient who received SHINGRIX (batch number BN9L9, expiry date 26th March). Concomitant products included LEXAPRO and lisinopril. On 29th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th April 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and pain in arm. The patient was treated with BENADRYL. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the pain in arm was recovering/resolving. The reporter considered the erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were reported as follows: No medical history was reported. The patient received the vaccine on the right arm. The expiration date of the vaccine was mistakenly reported same as date of birth of the patient. However, no clarification could be obtained. The patient experienced soreness in her right arm and also redness on upper underside of her right arm. The pharmacist reported that no physician visit was required but stated that the patient was counseled to use cold compresses on site. The pharmacist reported that the redness began within a day or two and resolved by the time she spoke to the patient over the weekend. The pharmacist stated that she was 100 percent certain that the patient's experiences were caused by SHINGRIX.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Hyperhidrosis, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX. On 16th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 17th May 2018, the patient experienced pain, tiredness, fever and sweating. On an unknown date, the outcome of the pain in arm, pain, tiredness, fever and sweating were unknown. It was unknown if the reporter considered the pain in arm, pain, tiredness, fever and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient also reported that in the middle of the night he felt sweaty, tired, achy, and feverish. The patient was taking other medications but the pharmacist did not have access to them.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX. Concurrent medical conditions included hypertension. Concomitant products included Estradiol Patch. On 14th May 2018, the patient received SHINGRIX. On 16th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The healthcare professional did not have access to the batch number or expiry date or the patient's exact date of birth but did say the patient was in her late 60's to 70's. The patient was taking blood pressure medications daily. The healthcare professional reported that the patient developed a rash from her elbow to her shoulder, after receiving a SHINGRIX vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of muscle soreness in a adult 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 muscle soreness, feeling unwell and pain. On an unknown date, the outcome of the muscle soreness, feeling unwell and pain were unknown. It was unknown if the reporter considered the muscle soreness, feeling unwell and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The healthcare professional reported that the 2 or 3 patients have complained of muscle soreness, achiness, and feeling not well following vaccination with SHINGRIX. The healthcare professional stated this as a general statement and was not able to provide specific details concerning any particular patient experience with the vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Musculoskeletal stiffness
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 (batch number 7FY22, expiry date 25th April 2020). On 16th May 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, limbs stiffness, injection site pain, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, limbs stiffness, injection site pain, injection site swelling and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, limbs stiffness, injection site pain, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on left deltoid. The health care professional reported that the patient developed redness, swelling, itching, pain, and stiffness below the injection site.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 77-year-old female patient who received SHINGRIX (batch number NR4Z4, expiry date 11th October 2020). On 15th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 16th May 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, headache, fatigue and injection site swelling. On an unknown date, the outcome of the injection site erythema, headache, fatigue and injection site swelling were unchanged. The reporter considered the injection site erythema, headache and fatigue to be related to SHINGRIX. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. At 9:30 AM, the patient received SHINGRIX on the left arm. At the time reporting, the patient's side effects remain unchanged.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of general body pain in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced general body pain, malaise and fever. On an unknown date, the outcome of the general body pain, malaise and fever were recovered/resolved. The reporter considered the general body pain, malaise and fever to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown deltoid. The field representative was the original caller, however, she had limited details regarding the adverse event, so she asked that someone from global response center reach out to the nurse who reported the adverse event to her, to obtain more details. Outbound call was placed to the nurse to obtain additional details. The nurse reported that a patient received the SHINGRIX vaccine in their office and reported to the nurse that she experienced body aches and overall malaise for more than 7 days. The nurse stated that the patient also experienced a fever, but she was not sure how long the fever lasted. The reporter had limited information at the time of call and stated that she might call back in to provide additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Immediate post-injection reaction, Myalgia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced fever, shivering, fatigue, pain and myalgia. On an unknown date, the outcome of the fever, shivering, fatigue, pain and myalgia were recovered/resolved. It was unknown if the reporter considered the fever, shivering, fatigue, pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The Healthcare professional did not have any patient demographics for the patient at the time of call. The patient experienced fever, pain, myalgia, chills, shivering, fatigue and felt like they had no energy shortly after receiving SHINGRIX. The patient stated these symptoms lasted about 24 hours, but symptoms had all since resolved. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced fever, shivering, fatigue, pain and myalgia. On an unknown date, the outcome of the fever, shivering, fatigue, pain and myalgia were recovered/resolved. It was unknown if the reporter considered the fever, shivering, fatigue, pain and myalgia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The Healthcare professional did not have any patient demographics for the patient at the time of call. The patient experienced fever, pain, myalgia, chills, shivering, fatigue and felt like they had no energy shortly after receiving SHINGRIX. The patient stated these symptoms lasted about 24 hours, but symptoms had all since resolved. No further information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than year after receiving SHINGRIX, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The age at vaccination was not reported. The caller declined to provide further details or identifies without getting permission from patient involved. Limited report was filed. This case was 1 of the 3 linked cases, reported by the same reporter.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of shivering in a 57-year-old male patient who received SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced shivering and malaise. The patient was treated with NSAID. On an unknown date, the outcome of the shivering and malaise were recovered/resolved. The reporter considered the shivering and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: The specific date of vaccination for 2nd dose of SHINGRIX was not given. The patient took an unspecified NSAID which helped to resolve symptoms. The symptoms lasted for a day and a half.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 50-year-female patient who received SHINGRIX. The patient's past medical history included fibromyalgia. Concurrent medical conditions included herpes simplex and multiple myeloma. Concomitant products included ZYRTEC, Aspirin, biotin, Levothyroxine, omeprazole, Valacyclovir, Venlafaxine, ATIVAN, LYRICA, ZOCOR, ZOFRAN, buspirone, meloxicam and topiramate. On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On 24th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site tenderness and injection site erythema were recovered/resolved. The reporter considered the injection site tenderness and injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient experienced tenderness and erythema adjacent to the injection site after receiving SHINGRIX vaccine on the left arm. The erythema resolved after 7 days, and the tenderness resolved after 10 days. The physician stated that, the patient received the vaccine at a pharmacy, and did not have lot number, expiry date, or certainty of route of administration. No medical intervention was taken, according to the physician.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Injection site swelling, Joint swelling, Peripheral swelling, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swollen joints in a 64-year-old male patient who received SHINGRIX. On 4th May 2018, the patient received SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced swollen joints, swollen thumb, neck swelling, injection site swelling and back pain. On an unknown date, the outcome of the swollen joints, swollen thumb, neck swelling and back pain were not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. The reporter considered the swollen joints, swollen thumb, neck swelling, injection site swelling and back pain to be possibly related to SHINGRIX. Additional details were provided as follows: The patient did not get any other vaccine on the vaccination day of SHINGRIX and said that he had been on long term medications for a long time and did not want to provide that information. The patient said the only new treatment was the SHINGRIX vaccine. The patient after about 3 to 4 days of receiving SHINGRIX vaccine started experiencing symptoms. The patient had the regular swelling at the injection site that went away immediately in May 2018. But, he also experienced swelling in all joints including knee, hips, thumbs and neck. The swelling was even getting worse. The patient was also having pain in his back. The physician details were provided.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient had a worsening reaction to the flu vaccine for the last 2 to 3 years before the date of reporting. The reporter was unsure which flu vaccine the patient received since she received it at a different facility. The patient complained of redness and swelling that was localized to the injection site but it was large and did spread a little. It lasted about a week and she applied ice. The reporter did not have further information.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, 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 70-year-old male patient who received SHINGRIX. Concurrent medical conditions included artificial cardiac pacemaker user. Concomitant products included Aspirin and Propranolol. On 9th May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th May 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, fatigue, fever and headache. The patient was treated with ADVIL. On 10th May 2018, the outcome of the pain in arm, fatigue, fever and headache was recovered/resolved. The reporter considered the pain in arm, fatigue, fever and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received the shot in the morning and on that evening, he experience extreme pain in the arm, headache, felt tired and run down and was feverish. These events lasted until the following day and then resolved. The patient used ice pack on his arm and took ADVIL for the headache. The patient was unable to provide full demographics for the pharmacy, where he received SHINGRIX or for his physician.
Sex: U
Vaccine: VARZOS
Symptoms: Full blood count abnormal, Leukocytosis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of leukocytosis in a adult patient who received SHINGRIX. Previously administered products included SHINGRIX (1st dose received on an unknown date). On 27th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced leukocytosis. On an unknown date, the outcome of the leukocytosis was unknown. It was unknown if the reporter considered the leukocytosis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had an abnormal complete blood count (CBC), clarified as leukocytosis, after receiving 2 doses of SHINGRIX. The healthcare professional declined to provide any additional information and did not want to provide information related to adverse event.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphonia, Fatigue, 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 fatigue in a 61-year-old male patient who received SHINGRIX (batch number LT533, expiry date May 2019). On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 8th May 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and overdose. On 9th May 2018, the patient experienced fatigue, hoarseness and injection site erythema. In May 2018, the outcome of the fatigue, injection site pain, hoarseness, injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the overdose was unknown. The reporter considered the fatigue, injection site pain, hoarseness, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: At 13:00, the patient received SHINGRIX in the left deltoid. The reporter had the pharmacy label which states he was administered 1 ml dose of SHINGRIX. The patient called back and said that the 1ml dose was written on the paperwork that he gets from the vaccine. It was not written on the label. Thus, it led to possible overdose. The swelling and pain at the injection site started the same day hours later and lasted for about 5 days. The patient experienced fatigue and hoarseness that started 24 hours later after receiving vaccination, and lasted for about 2 days. Redness at the injection site started 24 hours later, which was 2 inches in diameter and lasted for about 6 days. In May 2018, all the events were resolved.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 61-year-old male patient who received SHINGRIX (batch number LT533, expiry date May 2019). On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 1 ml. On 8th May 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and overdose. On 9th May 2018, the patient experienced fatigue, hoarseness and injection site erythema. In May 2018, the outcome of the fatigue, injection site pain, hoarseness, injection site swelling and injection site erythema were recovered/resolved. On an unknown date, the outcome of the overdose was unknown. The reporter considered the fatigue, injection site pain, hoarseness, injection site swelling and injection site erythema to be related to SHINGRIX. Additional information was received as follows: At 13:00, the patient received SHINGRIX in the left deltoid. The reporter had the pharmacy label which states he was administered 1 ml dose of SHINGRIX. The patient called back and said that the 1ml dose was written on the paperwork that he gets from the vaccine. It was not written on the label. Thus, it led to possible overdose. The swelling and pain at the injection site started the same day hours later and lasted for about 5 days. The patient experienced fatigue and hoarseness that started 24 hours later after receiving vaccination, and lasted for about 2 days. Redness at the injection site started 24 hours later, which was 2 inches in diameter and lasted for about 6 days. In May 2018, all the events were resolved.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site eruption in a adult female patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020). On 22nd April 2018 16:30, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, several days after receiving SHINGRIX, the patient experienced injection site eruption, injection site warmth, injection site swelling and injection site hives. On an unknown date, the outcome of the injection site eruption, injection site warmth, injection site swelling and injection site hives were recovered/resolved. The reporter considered the injection site eruption, injection site warmth, injection site swelling and injection site hives to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient was given first dose of SHINGRIX series and a few days later experienced bumps, hives, warmness, and swelling at the injection site. The health care professional reported symptoms resolved after a couple of days. The patient contacted their doctor who recommended using ice on the area.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 74-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 30th April 2020). On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 12th May 2018, 5 days after receiving SHINGRIX, the patient experienced shingles. In May 2018, the patient experienced injection site erythema and localized rash. On an unknown date, the outcome of the shingles, injection site erythema and localized rash were unknown. The reporter considered the shingles to be related to SHINGRIX. The reporter considered the injection site erythema to be probably related to SHINGRIX. It was unknown if the reporter considered the localized rash to be related to SHINGRIX. Additional details were provided as follows: At 14:15, the patient received the SHINGRIX vaccine in the right deltoid. The patient came into the pharmacy two days after reporting redness at the injection site of her right arm, approximately three inches across (latency less than a week after vaccination). On the reporting date, the patient came back to the pharmacy to report that she went to urgent care on Saturday, 12th May 2018, and was diagnosed with shingles. The shingles rash was on her right cheek and neck (latency less than a week after vaccination).
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a adult 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 facial swelling. On an unknown date, the outcome of the facial swelling was unknown. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy intern. The age at vaccination was not reported. The caller declined to provide further details or identifiers without getting permission from patient involved. Limited report was filed. This case was 1 of the 3 linked cases, reported by the same reporter.