chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old female patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX. On 1st July 2018, less than a day after receiving SHINGRIX, the patient experienced fever and injection site reaction. On an unknown date, the outcome of the fever and injection site reaction were unknown. It was unknown if the reporter considered the fever and injection site reaction to be related to SHINGRIX. Additional details were reported as follows: The patient experienced fever, as high as 102, and a large local reaction on the skin (unknown), 8-10 cm, within 24 hours of the injection. The patient was not receiving the 2nd injection. The only partial information was provided.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 49-year-old female patient who received TWINRIX (batch number 53AT5, expiry date 28th November 2020) for prophylaxis. On 28th November 2018, the patient received TWINRIX (intramuscular). On 30th November 2018, 2 days after receiving TWINRIX, the patient experienced injection site swelling and injection site itching. On an unknown date, the outcome of the injection site swelling and injection site itching were unknown. It was unknown if the reporter considered the injection site swelling and injection site itching to be related to TWINRIX. Additional details were provided as follows: The patient received TWINRIX on the right deltoid. On the day of reporting, the patient experienced swelling and itching at injection site. The reporting nurse was GlaxoSmithKline employee within health clinic.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX (batch number D294J, expiry date 31st March 2019) for prophylaxis. On 25th November 2018, the patient received SHINGRIX (intramuscular). On 26th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The next day after receiving SHINGRIX, the patient experienced some redness and soreness in the left arm where the injection was given. The redness spread at the injection site to a diameter of 4 inches and was spread to the back of the left arm. The pharmacist consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the patient experienced injection site itching, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were recovered/resolved and the outcome of the injection site itching, pain in arm and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, injection site itching, pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of his patients received the SHINGRIX and complained that it was red at the injection site, swollen at the injection site, hard at the injection site. A week later patient experienced severe itchiness at the site of the injection. The patient reported that the same arm where she received the injection, she experienced pain from the shoulder down to her elbow. The patient also experienced difficulty using the arm where she received the injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received SHINGRIX (batch number 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 23rd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd August 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site induration. On an unknown date, the patient experienced injection site itching, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were recovered/resolved and the outcome of the injection site itching, pain in arm and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site induration, injection site itching, pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that one of his patients received the SHINGRIX and complained that it was red at the injection site, swollen at the injection site, hard at the injection site. A week later patient experienced severe itchiness at the site of the injection. The patient reported that the same arm where she received the injection, she experienced pain from the shoulder down to her elbow. The patient also experienced difficulty using the arm where she received the injection.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received FLUARIX QUADRIVALENT (2018-2019 season) (batch number 59H3J, expiry date 30th June 2019) for prophylaxis. On 1st November 2008, the patient received FLUARIX QUADRIVALENT 2018-2019 season (intramuscular) .5 ml. On 2nd November 2008, 1 days after receiving FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The pharmacy intern stated that the patient received the FLUARIX QUADRIVALENT vaccine in left arm. Next day the patient experienced severe soreness at the injection site. On 28th November 2018, the patient came by the pharmacy and she was still experiencing soreness. No further details were provided.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 86-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dementia with Lewy bodies. On 28th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced localized erythema, pain and skin warm. On an unknown date, the outcome of the localized erythema, pain and skin warm were not recovered/not resolved. It was unknown if the reporter considered the localized erythema, pain and skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. About 2 to 3 inches below the injection site was red covering 3 inches in circumference. It was warm and painful to touch. The patient was currently in a assisted living. The reporter had contacted her doctor for advice and was waiting to hear back. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Lethargy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 76-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received in August 2018, refer case US2018GSK225498). On 10th October 2018, the patient received the 2nd dose of SHINGRIX. On 10th October 2018, less than a day after receiving SHINGRIX, the patient experienced lethargy and sweating. On an unknown date, the outcome of the lethargy and sweating were recovered/resolved. It was unknown if the reporter considered the lethargy and sweating to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. Later that day, after vaccination, the patient felt lethargic that lasted 3 days and had sweating that lasted for 7 days. This case has been linked with case US2018201060 (wife's case), reported by the same.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, 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 66-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hip bursitis. On 25th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had 1st dose in left arm and he stated sometime after that he noticed pain from his shoulder down to his elbow. He added within the 1st week it was more severe and worse when he attempted to lift objects. He stated his physician referred him to physical therapy for the pain. He noted he had a wellness check visit and mentioned the pain to his physician. He notes the pain was better but he was not back to 100 percent. The reporter gave consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number EH9Z7, expiry date 8th March 2019) for prophylaxis. In September 2018, the patient received SHINGRIX (intramuscular). 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 not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient was complaining of soreness in the arm which was vaccinated. The reporter however could not state which arm or when the soreness began. The vaccination site of injected arm was unknown. The registered pharmacist was transferred to medical information for additional assistance.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 5th October 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information received as follows: The pharmacist stated that till the reporting time, the patient was complaining of injection site soreness or injection site pain that was persisting. The reporter consented to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 82-year-old male patient who received SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on right arm around 4:00 PM and he experienced pain at the injection site. The patient also reported a reddish circle around the injection site and the area was aching all day with touch and he described it as painful to the touch.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th December 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was not recovered/not resolved. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were provided as follows: The husband reported that his wife received SHINGRIX on left arm at 4:00 PM and her arm was swollen on the date of reporting. The reporter gave consent to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a patient who received FLULAVAL QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, unknown after receiving FLULAVAL QUADRIVALENT, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a reaction to the FLULAVAL vaccine from the multi dose vial. The pharmacist did not have any details about the adverse event but would like to follow up with the doctor who had the details. The pharmacist consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever and incomplete course of vaccination. On an unknown date, the outcome of the fever and incomplete course of vaccination were unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The caller stated she was sick with fever after the first shot. The caller also did not get the vaccine in the 6 months, from the 1st dose, which led to incomplete course of vaccination.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site warmth, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On 4th December 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain. On 5th December 2018, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the erythema of extremities and skin warm were unknown. It was unknown if the reporter considered the injection site pain, erythema of extremities and skin warm to be related to SHINGRIX. Additional details were provided as follows: A few hours after the injection, the patient experienced pain at the injection site. On 5th December 2018 at night, the patient noted that a red circle appeared about 3 inches below the injection site. It was dime sized, painful, red and hot to the touch. The reporter did not consent to follow-up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included knee operation and vertigo. In December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, 1 day after receiving SHINGRIX the patient experienced tiredness. In December 2018, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: On the month of reporting, the patient received 1st dose of SHINGRX on the left arm. The next day after receiving SHINGRIX, the patient was tired, to the point that he almost fell asleep behind the wheel which went on for about 3 days but has resolved. The patient noted he had this effect before and after surgery and has a history of vertigo that also appeared after knee operation in the past. The patient would receive the second dose, but would take it where he had time on weekend, recuperate from the reaction. The patient was encouraged to speak with his physician or pharmacist. The patient declined healthcare professional information but agree to follow up from Safety.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on unknown arm. The patient reported that she experienced arm soreness at her injection site after injection. The adverse event was recognized after the phone call. The reporter did not give consent to follow up. Limited information was provided.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Confusional state, Dizziness, Memory impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of memory impairment in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox (at 45 years old). Concurrent medical conditions included blood cholesterol increased. Concomitant products included SHINGRIX, simvastatin, citalopram and fexofenadine hydrochloride (Allegra). On 2nd November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, 7 days after receiving SHINGRIX, the patient experienced memory impairment, confusion and light-headed feeling. On an unknown date, the outcome of the memory impairment, confusion and light-headed feeling were not recovered/not resolved. It was unknown if the reporter considered the memory impairment, confusion and light-headed feeling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 17th October 2018, the patient reported getting dose 1st of SHINGRIX at the doctor's office. There were no events associated with this injection. The concomitant products included unspecified vitamins. The reporter gave consent to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received SHINGRIX. In November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were unknown. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness at the injection site, which began the 1st day the vaccine was administered. The soreness began to spread, the patient could not lift her arm over her head, and was reportedly worsening at the time of the report. The reporter was unsure of the date of administration and reported that it was 6 days to a week ago before the date of reporting. Possibly on 29th November 2018. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for an unknown indication. On 21st November 2018, the patient received the 1st dose of SHINGRIX(intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain. The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX the day before holiday. The patient claims that the injection felt like tetanus shot and it hurt. The pain resolved after 1 to 2 days. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 60-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (experienced after receiving 1st dose on 22nd June 2018, refer case US2018GSK225370). On 2nd December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, general body pain and pain in arm. Rechallenge with SHINGGRIX was positive. In December 2018, the outcome of the influenza-like symptoms, chills, general body pain and pain in arm were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, chills, general body pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 59 or 60 years. The patient experienced arm soreness, flu like symptoms such as chills and body aches which lasted about 3 days. The patient did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of taste abnormality in a elderly male patient who received SHINGRIX (batch number 9KT7T, expiry date 13th March 2021) for prophylaxis. On 6th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th December 2018, less than an hour after receiving SHINGRIX, the patient experienced taste abnormality. On an unknown date, the outcome of the taste abnormality was unknown. It was unknown if the reporter considered the taste abnormality to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but it could be 65 or 66 years. On the date of reporting, at 10:52, the patient received SHINGRIX in the left deltoid. The patient called the reporter back within 1 hour after receiving the vaccine to report that he had a medicine taste in his mouth. The reporter would not provide the date of birth for the patient except the birth year. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On 4th December 2018, the patient received the 1st dose of SHINGRIX. On 4th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills, fever and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were not recovered/not resolved and the outcome of the chills and fever were recovered/resolved. It was unknown if the reporter considered the injection site pain, chills, fever and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm at 11:00 am and he experienced chills fatigue and fever the first night. The chills and fever lasted 24 hours or the first couple of nights. He also reported pain at the injection site. The injection site pain was still unresolved and was sore to the touch. The reporter did not consent to follow-up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dehydration, Diarrhoea, Eructation, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 77-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In March 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced vomiting, diarrhea, belching, weakness and dehydration. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with vitamins nos (Vitamins) and intravenous fluid (normal saline). On an unknown date, the outcome of the vomiting, diarrhea, belching, weakness and dehydration were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the vomiting, diarrhea, belching, weakness and dehydration to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine at the end of March 2018 on the left arm. The evening of vaccination he experienced vomiting, diarrhea and continuous belching. The patient felt weak and dehydrated. The patient visited his doctor on the end of third day because he was weak, dehydrated and belching. The patient was in his doctor's office for about an hour, he was given intravenous (IV) saline and vitamins. The patient recovered by the next morning. The patient wanted to know if he should get the second dose since it passed the 6 month window, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 77-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. In March 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced vomiting, diarrhea, belching, weakness and dehydration. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with vitamins nos (Vitamins) and intravenous fluid (normal saline). On an unknown date, the outcome of the vomiting, diarrhea, belching, weakness and dehydration were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the vomiting, diarrhea, belching, weakness and dehydration to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine at the end of March 2018 on the left arm. The evening of vaccination he experienced vomiting, diarrhea and continuous belching. The patient felt weak and dehydrated. The patient visited his doctor on the end of third day because he was weak, dehydrated and belching. The patient was in his doctor's office for about an hour, he was given intravenous (IV) saline and vitamins. The patient recovered by the next morning. The patient wanted to know if he should get the second dose since it passed the 6 month window, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 1st dose of SHINGRIX. On 21st June 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue. On 22nd June 2018, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left deltoid. The patient experienced extreme fatigue the day after receiving the SHINGRIX. The event lasted about 24 hours. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd October 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness and stomach pain. On an unknown date, the patient experienced fever blister and weird feeling. The patient was treated with Valacyclovir. On an unknown date, the outcome of the pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness, stomach pain and weird feeling were recovered/resolved and the outcome of the fever blister was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness, stomach pain, fever blister and weird feeling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in the afternoon and she experienced a sore arm. Several hours later in the middle, the patient had body aches, chills and a fever. The patient had the worse headache that felt like an axe went through her head that lasted for two days. The patient started to feel weird with flu like symptoms. The patient was really tired and all of these symptoms resolved within two days. The patient also had stomach pain which also resolved during this timeframe. The patient later developed three fever blisters in the inside of her lip and she tried creams and supplements and then had to be put on Valacyclovir because they would not resolve. The patient cannot recall the onset date for the blisters. The patient stated that she visited her periodontist and the doctor told her that he had three patients with full blown shingles as well. The reporter did not consent to follow up. The patient preferred to remain anonymous and no additional details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Oral herpes, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX for prophylaxis. Concomitant products included TYLENOL. On 23rd October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd October 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness and stomach pain. On an unknown date, the patient experienced fever blister and weird feeling. The patient was treated with Valacyclovir. On an unknown date, the outcome of the pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness, stomach pain and weird feeling were recovered/resolved and the outcome of the fever blister was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, general body pain, chills, fever, headache, influenza-like symptoms, tiredness, stomach pain, fever blister and weird feeling to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine in the afternoon and she experienced a sore arm. Several hours later in the middle, the patient had body aches, chills and a fever. The patient had the worse headache that felt like an axe went through her head that lasted for two days. The patient started to feel weird with flu like symptoms. The patient was really tired and all of these symptoms resolved within two days. The patient also had stomach pain which also resolved during this timeframe. The patient later developed three fever blisters in the inside of her lip and she tried creams and supplements and then had to be put on Valacyclovir because they would not resolve. The patient cannot recall the onset date for the blisters. The patient stated that she visited her periodontist and the doctor told her that he had three patients with full blown shingles as well. The reporter did not consent to follow up. The patient preferred to remain anonymous and no additional details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a male patient who received SHINGRIX for prophylaxis. On 1st September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site swelling and injection site pain. In September 2018, the patient experienced fever, bedridden and chills. On an unknown date, the outcome of the injection site swelling, injection site pain, fever, bedridden and chills were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site pain, fever, bedridden and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX on left deltoid. His brother was a pharmacist and administered the vaccine to him. Within a day of receiving the vaccine, the patient experienced significant swelling at the injection site on his left arm. He could not roll over on his left side at night because the injection site was painful.  Also, the patient experienced a fever of 101 degrees Fahrenheit, and chills, making it so he had to stay in bed for two days. All symptoms resolved within 2 to 3 days. The reporter gave consent to follow up. Field representative thought she had 48 hours to report adverse events. Counseled that she needed to report these events within 24 hours. The reporter gave permission to be contacted. The reporter was unable to provide any additional information.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not applicable for this report. No patient or vaccine information was reported for this adverse event. The age group was not reported, but was captured as adult as per the vaccine indication. The health care professional stated the patient was hurt after receiving SHINGRIX vaccine. The reporter did not consent to follow-up.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria, Myalgia, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site urticaria in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 6th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site urticaria, generalized urticaria and muscle soreness. The patient was treated with CLARITIN and Cortisone Topical Cream. On an unknown date, the outcome of the injection site urticaria, generalized urticaria and muscle soreness were recovered/resolved. It was unknown if the reporter considered the injection site urticaria, generalized urticaria and muscle soreness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. Within 2 hours of getting the vaccine, the patient experienced urticaria on his left at injection site. Within 3 to 5 hours after the urticaria was on his right upper arm. Then within 24 hours the urticaria was on both the arms, feet, back and his torso. The patient also experienced muscle soreness the day of getting the vaccine. The patient went to a clinic due to urticaria and muscle soreness. The patient was examined by a physician and nurse. The patient took over the counter CLARITIN and topical cortisone cream. The urticaria lasted for about 10 to 14 days and then he recovered. The muscle soreness lasted for about 12 to 18 hours and then he recovered. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cold 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, unknown after receiving SHINGRIX, the patient experienced cold. On an unknown date, the outcome of the cold was unknown. It was unknown if the reporter considered the cold to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient getting second dose of SHINGRIX. The reporter asking, if the patient had a cold that was not a hindrance to getting the vaccine. The reported as possible adverse event, due to the patient in question developing a cold after 1st dose of SHINGRIX. No other information was collected. The reporter not gave consent to follow-up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injected limb mobility decreased in a 19-year-old female patient who received BEXSERO for prophylaxis. On 6th December 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 6th December 2018, unknown after receiving BEXSERO, the patient experienced vaccine administered at inappropriate site. On 7th December 2018, the patient experienced injected limb mobility decreased, injection site pain, muscle pain and fever. On 7th December 2018, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the injection site pain, muscle pain, fever and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, muscle pain and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient experienced arm pain, muscle pain and fever. The patient woke up at 4 am and could not move her arm due to the pain but that she was able to move her arm at the time of reporting. The reporter was concerned that, the injection site appears to be too high on the arm and might had gone into the joint, which led to vaccine administered at inappropriate site.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injected limb mobility decreased in a 19-year-old female patient who received BEXSERO for prophylaxis. On 6th December 2018, the patient received the 2nd dose of BEXSERO (intramuscular). On 6th December 2018, unknown after receiving BEXSERO, the patient experienced vaccine administered at inappropriate site. On 7th December 2018, the patient experienced injected limb mobility decreased, injection site pain, muscle pain and fever. On 7th December 2018, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the injection site pain, muscle pain, fever and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, muscle pain and fever to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient experienced arm pain, muscle pain and fever. The patient woke up at 4 am and could not move her arm due to the pain but that she was able to move her arm at the time of reporting. The reporter was concerned that, the injection site appears to be too high on the arm and might had gone into the joint, which led to vaccine administered at inappropriate site.
Sex: M
Vaccine: FLU4, TDAP, TYP
Symptoms: Back pain, Diarrhoea, Headache, Muscle twitching, Nausea
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of back pain in a male patient who received DTPa vaccine for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis and TYPHOID VACCINE for prophylaxis. On 20th November 2018, the patient received DTPa vaccine, Influenza vaccine Quadrivalent 2018-2019 season and TYPHOID VACCINE. In November 2018, 7 days after receiving DTPa vaccine and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced back pain, headache, diarrhea, vomiting, dry heaves, nausea and muscle twitching. On an unknown date, the outcome of the back pain, headache, nausea and muscle twitching were not recovered/not resolved and the outcome of the diarrhea, vomiting and dry heaves were unknown. It was unknown if the reporter considered the back pain, headache, diarrhea, vomiting, dry heaves, nausea and muscle twitching to be related to DTPa vaccine and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at the vaccination was not reported. A patient received an injectable typhoid vaccine, an unknown quadrivalent non-live influenza vaccine and an unknown brand Tdap vaccine on the same day. A week later, the patient developed adverse events including back pain, headache, diarrhea, severe nausea, vomiting, dry heaving and muscle twitching all over body. Symptoms were persisting for over 10 days. The health care professional and recipient (health care professional son) were unaware of the brand name of the vaccines received. The main concern of the call was the muscle twitching. The call was to see if that has been reported with Tdap vaccines.
Sex: M
Vaccine: FLU4, TDAP, TYP
Symptoms: Retching, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of back pain in a male patient who received DTPa vaccine for prophylaxis. Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis and TYPHOID VACCINE for prophylaxis. On 20th November 2018, the patient received DTPa vaccine, Influenza vaccine Quadrivalent 2018-2019 season and TYPHOID VACCINE. In November 2018, 7 days after receiving DTPa vaccine and Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced back pain, headache, diarrhea, vomiting, dry heaves, nausea and muscle twitching. On an unknown date, the outcome of the back pain, headache, nausea and muscle twitching were not recovered/not resolved and the outcome of the diarrhea, vomiting and dry heaves were unknown. It was unknown if the reporter considered the back pain, headache, diarrhea, vomiting, dry heaves, nausea and muscle twitching to be related to DTPa vaccine and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at the vaccination was not reported. A patient received an injectable typhoid vaccine, an unknown quadrivalent non-live influenza vaccine and an unknown brand Tdap vaccine on the same day. A week later, the patient developed adverse events including back pain, headache, diarrhea, severe nausea, vomiting, dry heaving and muscle twitching all over body. Symptoms were persisting for over 10 days. The health care professional and recipient (health care professional son) were unaware of the brand name of the vaccines received. The main concern of the call was the muscle twitching. The call was to see if that has been reported with Tdap vaccines.