chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included arthritis and shingles. On 25th August 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced influenza-like symptoms, wrist pain, shoulder pain, chills, tiredness, weakness, nausea and joint inflammation. On an unknown date, the outcome of the influenza-like symptoms, wrist pain, chills, tiredness, weakness, nausea and joint inflammation were unknown and the outcome of the shoulder pain was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, wrist pain, shoulder pain, chills, tiredness, weakness, nausea and joint inflammation to be related to SHINGRIX. Additional details were reported as follows: The caller reported that she experienced flu like symptoms that have persisted. She had been seen by her doctor twice by the reporting date to try and determine what was causing the symptom and she had blood work done. Her WBC was at 11,000 and that neutrophils were elevated as well. The caller also reported that her left wrist joint had been painful and feeling like it was inflamed. The caller reported she had history of arthritis and thought it might be related to that or could be from the vaccine shot since it was on the left side as well. The caller preferred any communication regarding this report go through her since she was a medical professional. The healthcare professional further defined flu like symptoms as chills, felt tired and week, and experienced nausea. She also stated she had shoulder pain but that it resolved. She was not sure if the shoulder pain occurred before or after receiving SHINGRIX.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Cold sweat, Decreased appetite, Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 68-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (1st dose received in July 2018, no adverse event). On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced mobility decreased, general body pain, headache, shivering, fever, cold sweat and dizziness. In September 2018, the patient experienced stomach pain, tiredness and appetite lost. On an unknown date, the outcome of the mobility decreased, general body pain, headache, shivering, fever, cold sweat, dizziness, stomach pain, tiredness and appetite lost were recovering/resolving. It was unknown if the reporter considered the mobility decreased, general body pain, headache, shivering, fever, cold sweat, dizziness, stomach pain, tiredness and appetite lost to be related to SHINGRIX. Additional information received as follows: The patient reported that she experienced, not being able to move arm and less than a week, after receiving SHINGRIX, the patient experienced shivering, fever, tiredness and loss of appetite. At the time of reporting, the symptoms were resolving slowly. The contact details of the physician were provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Mobility decreased, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a 68-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (1st dose received in July 2018, no adverse event). On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced mobility decreased, general body pain, headache, shivering, fever, cold sweat and dizziness. In September 2018, the patient experienced stomach pain, tiredness and appetite lost. On an unknown date, the outcome of the mobility decreased, general body pain, headache, shivering, fever, cold sweat, dizziness, stomach pain, tiredness and appetite lost were recovering/resolving. It was unknown if the reporter considered the mobility decreased, general body pain, headache, shivering, fever, cold sweat, dizziness, stomach pain, tiredness and appetite lost to be related to SHINGRIX. Additional information received as follows: The patient reported that she experienced, not being able to move arm and less than a week, after receiving SHINGRIX, the patient experienced shivering, fever, tiredness and loss of appetite. At the time of reporting, the symptoms were resolving slowly. The contact details of the physician were provided.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a 79-year-old female patient who received SHINGRIX (batch number EREC/ASO1B ?, expiry date unknown) for prophylaxis. The patient's past medical history included cataract extraction (in February 2018). Previously administered products included ZOSTAVAX (received 10 years before the day of reporting). On 17th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. The reporter considered the sickness to be related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine on arm. The patient had a severe reaction that couldn't get out of bed for 3 days due to being sick. She reported this to her doctor and her pharmacist. The doctor advised her not to get the second shot of the series. She was requesting reimbursement (lot number might be wrong but that was reported she was looking at her receipt trying to find it). The contact details of the physician was reported. The reported lot number EREC/ASO1B did not exist in sales database and was updated to EREC/ASO1B ?
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 7th September 2018 10:30, the patient received the 1st dose of SHIGNRIX (intermuscular). On 9th September 2018, 2 days after receiving SHINGRIX, the patient experienced tiredness and upset stomach. In September 2018, the patient experienced fever, chills and tremor. The patient was treated with TYLENOL. On 12th September 2018, the outcome of the tiredness and upset stomach were recovered/resolved. In September 2018, the outcome of the fever, chills and tremor were recovered/resolved. It was unknown if the reporter considered the fever, tiredness, upset stomach, chills and tremor to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. Same day of vaccination, later on around midnight the patient experienced chills, tremors and fever. He waited till 2 am and took a TYLENOL. One hour after taking the TYLENOL the tremors and chills were gone. On 8th September 2018, the patient took the body temperature around 6 am and it was at 101.5 degrees F. The patient called pharmacy, and the pharmacist told him to take another Tylenol at 6 am. Around 7 am he took his body temperature at it was finally under 100 degrees F. He finally got some sleep, and he wake up around 9 am and his temperature was 98.8 degrees F. On the following day, he experienced upset stomach on and off, and felt tired. On 12th September 2018, the patient completely recovered. The patient has denied permission to contact their physician. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Influenza like illness, Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received S for prophylaxis. On 7th September 2018, the patient received SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by Medical Assistant. The age at vaccination was not reported. The sales representative reported the adverse events he heard the day before reporting, by email. The reporter had a patient and reported incidents on 9th September 2018 to the clinic. It was stated that, the patient's arm where she received the vaccine hurt very badly. The patient also mentioned that, on the night of vaccination (on 8th September 2018), she experienced flu like symptoms and was bed ridden for 3 to 4 days. She recovered from the flu like symptoms. This case was linked with US2018167182, reported by same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 71-year-old female patient who received SHINGRIX  for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced sciatic neuralgia and myalgia of lower extremities. On 17th May 2018, the patient experienced injection site muscle pain. On 18th May 2018, the patient experienced stomach pain, tiredness and shivering. On an unknown date, the outcome of the injection site muscle pain, sciatic neuralgia, stomach pain, tiredness, shivering and myalgia of lower extremities were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain, stomach pain, tiredness and shivering to be related to SHINGRIX. The reporter considered the sciatic neuralgia and myalgia of lower extremities to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on left arm. The patient experienced muscle pain at the injection site the same day and it lasted for 1 day or 2. The rest of the symptoms presented the following day. The patient was not sure how long they lasted but she could not do her normal activities during that time. The sciatic nerve pain also presented some time after the vaccination and caused muscle pain in both thighs.   Her physician said that the sciatic nerve pain was not related to the SHINGRIX. The contact details of the physician was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Sciatica
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 71-year-old female patient who received SHINGRIX  for prophylaxis. On 17th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced sciatic neuralgia and myalgia of lower extremities. On 17th May 2018, the patient experienced injection site muscle pain. On 18th May 2018, the patient experienced stomach pain, tiredness and shivering. On an unknown date, the outcome of the injection site muscle pain, sciatic neuralgia, stomach pain, tiredness, shivering and myalgia of lower extremities were recovered/resolved. It was unknown if the reporter considered the injection site muscle pain, stomach pain, tiredness and shivering to be related to SHINGRIX. The reporter considered the sciatic neuralgia and myalgia of lower extremities to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received the vaccine on left arm. The patient experienced muscle pain at the injection site the same day and it lasted for 1 day or 2. The rest of the symptoms presented the following day. The patient was not sure how long they lasted but she could not do her normal activities during that time. The sciatic nerve pain also presented some time after the vaccination and caused muscle pain in both thighs.   Her physician said that the sciatic nerve pain was not related to the SHINGRIX. The contact details of the physician was provided.
Age: 78.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Rash, Rash maculo-papular, Rash vesicular
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of maculopapular rash in a 78-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. Previously administered products included SHINGRIX (1st dose was received on unknown date). On 12th September 2018, the patient received the 2nd dose of SHINGRIX and Influenza vaccine Quadrivalent unspecified season at an unknown dose. In September 2018, less than a week after receiving SHINGRIX and Influenza vaccine Quadrivalent unspecified season, the patient experienced maculopapular rash, vesicular rash and fever. On an unknown date, the outcome of the maculopapular rash, vesicular rash and fever were unknown. It was unknown if the reporter considered the maculopapular rash, vesicular rash and fever to be related to SHINGRIX and Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The patient also received an influenza vaccine at the same time (unknown brand) along with SHINGRIX at pharmacy. The health care professional stated that, the patient presented on the reporting date, with fever and a disseminated maculopapular vesicular rash. In the health care professional's opinion, it was not Shingles since the rash was disseminated to his chest, back, trunk with no mucosal involvement. This occurred after patient's 2nd dose of SHINGRIX (when co-administered with influenza vaccine). The patient did not have these symptoms after their 1st dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and appetite lost. On an unknown date, the outcome of the fever and appetite lost were recovered/resolved. It was unknown if the reporter considered the fever and appetite lost to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a fever and loss of appetite which persisted for 36 hours after a dose SHINGRIX. The healthcare professional did not have vaccine information available and declined giving patient initials. Lab Comments: On an unknown date, patient's body temperature was measured.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, SHINGRIX made the patient terribly sick for three days. The patient had to get the second dose and wondered if the patient was likely to experience the same side effects after 2nd dose. The patient was told, they would be contacted back by product specialist.
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Mammogram normal, Rash pustular, Ultrasound scan normal
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of breast pain female in a 65-year-old female patient who received SHINGRIX for prophylaxis. The patient had a Family History of breast cancer. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced breast pain female and pustular rash. On an unknown date, the outcome of the breast pain female was unknown and the outcome of the pustular rash was recovered/resolved. It was unknown if the reporter considered the breast pain female and pustular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 64 or 65 years old. The reporter was during call with sales representative and stated that the patient developed left breast pain with topical pustular lesions and pain piercing. The patient was sent to a center for mammogram and sonogram just to make sure it was not cancer and the results came back negative. The rash cleared up. The GSK representative did not have a lot of information on the healthcare provider, just had the name of the provider and did not know where the provider was located.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm, fatigue and erythema of extremities. On an unknown date, the outcome of the swelling arm, fatigue and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm, fatigue and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced red arm swelling size of a grapefruit. The reporter agreed to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Influenza like illness, Pain, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, swelling arm, erythema of extremities, pain and tiredness. On an unknown date, the outcome of the influenza-like symptoms, swelling arm, erythema of extremities, pain and tiredness were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, swelling arm, erythema of extremities, pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had red swollen arm, was achy, tired and had flu like symptoms. All events lasted for 2 weeks. The reporter agreed to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upper back pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (left side beginning at spine in upper back). On 6th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced upper back pain. On an unknown date, the outcome of the upper back pain was not recovered/not resolved. It was unknown if the reporter considered the upper back pain to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. The patient had pain on her left side beginning at spine in upper back where she previously had shingles and that stayed continuously. The patient stated that she was hoping that she did not activate a continuing problem for herself by having the shot. The patient wanted to know if others had this problem. She had not informed her physician about the symptoms as she wanted to see if this was a typical reaction before she contact her physician. The patient was informed that the events she had described was not listed as one of the more common side effects, but this was not to say that SHINGRIX was not causing her to experience these symptoms. It just was not observed as one of the common side effects in the clinical trials. The patient would contact her physician to see what she needed.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site lump and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump and injection site warmth to be related to SHINGRIX. Additional details were provided as follow: This case was reported by a medical assistant (MA). The patient experienced injection site reaction of large red and swollen lump around injection site which was warm to the touch. It disappeared after 4 days post SHINGRIX injection. The reporter did not agree to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, 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 female patient who received SHINGRIX for prophylaxis. On 9th September 2018, the patient received SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, injection site warmth and skin red. On an unknown date, the outcome of the pain in arm, injection site warmth and skin red were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site warmth and skin red to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At the time of reporting, the patient still had very sore arm, very warm near injection and red colored patches. The patient wanted to know of this was something to be worried about.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling and feeling bad. On an unknown date, the outcome of the swelling and feeling bad were unknown. It was unknown if the reporter considered the swelling and feeling bad to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt swelling all over their body and felt bad. The reporter agreed to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of hives in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that hives appeared within 3 days of vaccination with indeterminate length of symptoms. The reporter agreed to be followed up.
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Injection site pain, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received SHINGRIX for prophylaxis. The patient's past medical history included anaphylactic shock (after a red ant bite). 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 fever, rash, injection site pain and swallowing difficult. On an unknown date, the outcome of the fever, rash, injection site pain and swallowing difficult were recovered/resolved.  It was unknown if the reporter considered the fever, rash, injection site pain and swallowing difficult to be related to SHINGRIX. Additional details were provided as follows:  The reporter was husband of the patient. The patient stated that her physician had already reported this adverse event, however no duplicate case was identified. The age at vaccination was not reported. The patient received dose of SHINGRIX vaccine 5 to 6 weeks, before the date of reporting. For the first and second day, the patient had soreness at the injection site. She had a high fever, rash and difficulty swallowing. The rash was on her chest and upper thighs. The patient saw her physician twice for this reaction and stayed in bed for a few days because of the reaction. It resolved after one week. The patient was concerned that she might have a worse reaction after the 2nd dose so she did not plan on getting the 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Headache, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 3rd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, pain in arm and extra dose administered. On an unknown date, the outcome of the headache, pain in arm and extra dose administered were unknown. It was unknown if the reporter considered the headache and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was vaccinated with the 3rd vaccine for Shingles. The patient experienced headache, arm soreness and she was very concerned after vaccination. The patient was vaccinated with the 3rd dose of SHINGRIX, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several hours after receiving SHINGRIX, the patient experienced fever, chills and pain. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the fever, chills and pain to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient informed that he experienced mild fever and chills after vaccination with SHINGRIX, which lasted for several hours. 1 day after vaccination with SHINGRIX, the patient experienced achiness. The fever broke but the patient experienced achiness all the next day after vaccination.
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of rash in a child female patient who received FLULAVAL QUADRIVALENT 2017-2018 season for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2017-2018 season at an unknown dose. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were provided as follows: The reporter thought the event rash on arm after immunization lasted two weeks if not longer.
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Rash erythematous, Varicella
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of erythematous rash in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 15th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced erythematous rash, chickenpox and nodule. On an unknown date, the outcome of the erythematous rash, chickenpox and nodule were unknown. It was unknown if the reporter considered the erythematous rash, chickenpox and nodule to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of SHINGRIX on 15th June 2018 without any issue. After receiving vaccine the patient had red rash and went to pharmacy who thought it might be chicken pox. The patient came to provider who recorded 2 to 3 centimeter nodules of unknown cause. The report sent to dermatologist for follow up. The reporter did not agree to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a elderly female 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 pain, erythema and swelling. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain, erythema and swelling were recovered/resolved. It was unknown if the reporter considered the pain, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient's age was above 65 years. The age at vaccination was not reported. The provider stated that she had patient who complained of pain, redness and swelling. The provider recommended Tylenol and warm compress and issues resolved. No additional details were available. The reporter did not agree to be contacted for follow up. This case has been linked with case US2018GSK167499, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in a elderly female 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 pain, erythema and swelling. The patient was treated with TYLENOL. On an unknown date, the outcome of the pain, erythema and swelling were recovered/resolved. It was unknown if the reporter considered the pain, erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient's age was above 65 years. The age at vaccination was not reported. The provider stated that she had patient who complained of pain, redness and swelling. The provider recommended TYLENOL and warm compress and issues resolved. No additional details were available. The reporter did not agree to be contacted for follow up. This case has been linked with case US2018GSK167498, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a 60-year-old female 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 erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovering/resolving. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on an unknown arm. The physician reported that the day after vaccination, the patient experienced an area of redness around the area where the vaccine was given. The physician also described that the area as slightly above the elbow but did not know where the injection was given because the pharmacist administered the vaccine. The redness subsided after 2 a couple of day. The reporter did not agree to be contacted on follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received in May or June 2018, refer case US2018166300). On 11th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced chills, light headedness and fever. The patient was treated with ADVIL. On an unknown date, the outcome of the chills, light headedness and fever were recovered/resolved. It was unknown if the reporter considered the chills, light headedness and fever to be related to SHINGRIX. Additional information received as follows: The case was not reported previously to anyone. The patient received SHINGRIX on the right arm. The reporter stated that he was feeling lightheaded with a fever of 100.9 degree F and chills. The reporter stated that his symptoms resolved overnight.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, 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 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included fall (collapsed due to stress and infection, the patient was on respirator). Previously administered products included SHINGRIX (on 23rd May 2018 vaccinated with the 1st dose). Concurrent medical conditions included rotator cuff tear and carpal tunnel syndrome (causes numbness in hands and fingers). On 22nd August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 22nd August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling, injection site induration and injection site erythema. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site swelling, injection site induration and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site induration and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The patient after vaccination with SHINGRIX, experienced redness, hardness, and swelling at the injection site about the size of palm of her hand. The symptoms were mostly resolved except for some soreness if the patient pushed herself firmly. It took a few weeks for the symptoms to resolve. This case was linked with case US2018165433 (1st dose), reported by the same reporter for the same patient.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthma, Condition aggravated
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of asthma aggravated in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis. Concurrent medical conditions included asthma.  On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced asthma aggravated (serious criteria life threatening). On an unknown date, the outcome of the asthma aggravated was unknown. It was unknown if the reporter considered the asthma aggravated to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that they had asthma also and she was just told by an pulmonologist that it was uncontrolled. The patient stated that last year, she took the flu and pneumonia vaccine. The patient thought that she was going to die and said that the vaccines triggered asthma. The patient reported that as a month before the time of reporting she got better.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose, refer linked case US2018165509). On 11th September 2018, the patient received the 2nd dose of SHINGRIX. On 11th September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The case was reported by the patient's wife. On the date of reporting after vaccination with SHINGRIX, the patient experienced arm soreness. The reporter stated that till the time of reporting the patient had experienced only arm soreness as an event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (dose received on an unknown date) and SHINGRIX with an associated reaction of headache (1st dose received on 26th June 2018, refer case US2018166441). On 30th August 2018 13:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than 2 weeks after receiving SHINGRIX, the patient experienced pain, loss of energy and headache. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain, loss of energy and headache were recovered/resolved.  It was unknown if the reporter considered the pain, loss of energy and headache to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the left deltoid. The patient reported that she was experiencing a headache for a couple of days, feeling achy for a week, and having no energy like she weighed a ton. The contact details of the physician were provided.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Bone pain, Discomfort, Induration, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 92-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX and SHINGRIX with an associated reaction of fatigue (1st dose received on 26th June 2018, refer case US2018166447). On 30th August 2018 13:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than 2 weeks after receiving SHINGRIX, the patient experienced vesicular rash, bone pain, pain, blister, erythematous rash, scab and induration. On an unknown date, the outcome of the vesicular rash, blister, erythematous rash, scab and induration were recovering/resolving and the outcome of the bone pain and pain were recovered/resolved. It was unknown if the reporter considered the vesicular rash, bone pain, pain, blister, erythematous rash, scab and induration to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's daughter. The reporter reported that the patient received SHINGRIX on the left deltoid. The patient experienced feeling achy and her bones hurt like arthritis. The patient also experienced a big rash on her right buttock cheek. The daughter (reporter) thought that the rash looked like a shingles rash. She stated that the buttock was uncomfortable for her mother to sit on. It was blisters at first, red, angry-looking, hard little bumps. At the time of reporting, as these events were seemed to be getting better, the blisters were crusted over and scabby and so the patient did not visit the physician regarding this. The reporter noted that the area did not itch or hurt. The contact details of the physician were provided.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular, Scab
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 92-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX and SHINGRIX with an associated reaction of fatigue (1st dose received on 26th June 2018, refer case US2018166447). On 30th August 2018 13:00, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than 2 weeks after receiving SHINGRIX, the patient experienced vesicular rash, bone pain, pain, blister, erythematous rash, scab and induration. On an unknown date, the outcome of the vesicular rash, blister, erythematous rash, scab and induration were recovering/resolving and the outcome of the bone pain and pain were recovered/resolved. It was unknown if the reporter considered the vesicular rash, bone pain, pain, blister, erythematous rash, scab and induration to be related to SHINGRIX. Additional information received as follows: The case was reported by the patient's daughter. The reporter reported that the patient received SHINGRIX on the left deltoid. The patient experienced feeling achy and her bones hurt like arthritis. The patient also experienced a big rash on her right buttock cheek. The daughter (reporter) thought that the rash looked like a shingles rash. She stated that the buttock was uncomfortable for her mother to sit on. It was blisters at first, red, angry-looking, hard little bumps. At the time of reporting, as these events were seemed to be getting better, the blisters were crusted over and scabby and so the patient did not visit the physician regarding this. The reporter noted that the area did not itch or hurt. The contact details of the physician were provided.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 20 elderly patient who received expired doses of vaccine FLUZONE HIGH DOSE (lot number not reported) via unknown route on unknown dates. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used as it was reported that new FLUZONE HIGH DOSE was mixed with last year's supply of FLUZONE HIGH DOSE. It was unknown if the patient experienced any adverse event or not following the administration of the vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 74 years old male patient who was administered 2 doses of each 0.5 ml of FLUZONE HIGH DOSE (lot UJ022AA, expiry date: 18 Apr 2019) via intramuscular route in each arm on 17-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to extra dose administered. Patient had not reported any side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 44.0
Sex: M
Vaccine: MMR
Symptoms: Facial neuralgia, Nuclear magnetic resonance imaging, Trigeminal neuralgia
Clinical narrative: Nerve pain in face. Trigeminal neuralgia.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Cough, Ear infection, Rash, Rhinorrhoea
Clinical narrative: Runny nose, coughing, 9-8-18, rash starting on her chest and back 9-9-18 (at least that's when I noticed the rash), ear infection 9-11,18, over the course of the next 2 weeks her rash spread to her face, legs and arms, including her bottom.
Age: 1.0
Sex: F
Vaccine: FLU4, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt developed varicella.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: I ran fever on Sunday and slept almost the entire day, very lethargic. Lots of pain in my arm. The shot itself was very painful this round. The first injection, I hardly felt it but this time it was extremely painful. I never left my home on Sunday I felt so bad.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: I ran fever on Sunday and slept almost the entire day, very lethargic. Lots of pain in my arm. The shot itself was very painful this round. The first injection, I hardly felt it but this time it was extremely painful. I never left my home on Sunday I felt so bad.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Gastritis
Clinical narrative: Gastritis.